diff --git a/.gitattributes b/.gitattributes
index 2c695418b..2f2247c5c 100644
--- a/.gitattributes
+++ b/.gitattributes
@@ -1,2 +1,8 @@
# Explicitly force LF for files
*.csv text eol=lf
+
+# Force LF line endings for text files, regardless of local core.autocrlf
+* text=auto eol=lf
+
+*.yml text eol=lf
+*.yaml text eol=lf
\ No newline at end of file
diff --git a/.github/ISSUE_TEMPLATE/1-rule-issue.yml b/.github/ISSUE_TEMPLATE/1-rule-issue.yml
index a5307fc8f..4e6f6b704 100644
--- a/.github/ISSUE_TEMPLATE/1-rule-issue.yml
+++ b/.github/ISSUE_TEMPLATE/1-rule-issue.yml
@@ -45,4 +45,4 @@ body:
attributes:
label: Test Data
description: "If reporting a bug, attach your test data files here (CSV, Excel, etc.). You can drag and drop multiple files directly into this field."
- placeholder: Drag and drop files here, or describe the test data inline.
\ No newline at end of file
+ placeholder: Drag and drop files here, or describe the test data inline.
diff --git a/.github/ISSUE_TEMPLATE/config.yml b/.github/ISSUE_TEMPLATE/config.yml
index ec4bb386b..3ba13e0ce 100644
--- a/.github/ISSUE_TEMPLATE/config.yml
+++ b/.github/ISSUE_TEMPLATE/config.yml
@@ -1 +1 @@
-blank_issues_enabled: false
\ No newline at end of file
+blank_issues_enabled: false
diff --git a/.github/workflows/auto-format-yaml.yml b/.github/workflows/auto-format-yaml.yml
new file mode 100644
index 000000000..a52dd0e7b
--- /dev/null
+++ b/.github/workflows/auto-format-yaml.yml
@@ -0,0 +1,35 @@
+name: Auto-format Rule YAML
+on:
+ workflow_dispatch: {}
+jobs:
+ format-yaml:
+ runs-on: ubuntu-latest
+ permissions:
+ contents: write
+ steps:
+ - uses: actions/checkout@v4
+ with:
+ ref: ${{ github.head_ref || github.ref_name }}
+ fetch-depth: 0
+
+ - uses: actions/setup-python@v5
+ with:
+ python-version: "3.12"
+ - run: pip install ruamel.yaml
+
+ - name: Sort rule.yml files
+ run: python scripts/sort_yaml.py
+
+ - uses: actions/setup-node@v4
+ - name: Run Prettier to format rule.yml files
+ run: |
+ npm i prettier
+ npx prettier "Published/**/rule.yml" "Unpublished/**/rule.yml" --write
+
+ - name: Commit and push formatting fixes
+ run: |
+ git config user.name github-actions
+ git config user.email github-actions@cdisc.org
+ git add Published Unpublished
+ git diff-index --quiet HEAD || git commit -m "chore: sort and format rule.yml files"
+ git push
diff --git a/.github/workflows/publish.yml b/.github/workflows/publish.yml
index 7cd64b078..4edb33086 100644
--- a/.github/workflows/publish.yml
+++ b/.github/workflows/publish.yml
@@ -97,4 +97,4 @@ jobs:
- name: Push
if: steps.newdirs.outputs.HAS_NEW_DIRS == 'true'
run: |
- git push
\ No newline at end of file
+ git push
diff --git a/.github/workflows/submodule_update.yml b/.github/workflows/submodule_update.yml
index f551a59c2..f07d3ee06 100644
--- a/.github/workflows/submodule_update.yml
+++ b/.github/workflows/submodule_update.yml
@@ -33,4 +33,4 @@ jobs:
body: |
Automated update of the `engine` submodule to the latest commit on `cdisc-rules-engine/main`.
branch: auto/update-engine-submodule
- base: main
\ No newline at end of file
+ base: main
diff --git a/.github/workflows/validate-rule-contributions.yml b/.github/workflows/validate-rule-contributions.yml
index a9cd1fc22..1316aef8e 100644
--- a/.github/workflows/validate-rule-contributions.yml
+++ b/.github/workflows/validate-rule-contributions.yml
@@ -3,7 +3,7 @@ name: Validate Rule Contributions
on:
pull_request:
paths:
- - 'Unpublished/**'
+ - "Unpublished/**"
types: [opened, synchronize, reopened]
workflow_dispatch: {}
@@ -27,7 +27,7 @@ jobs:
- name: Set up Python 3.12
uses: actions/setup-python@v5
with:
- python-version: '3.12'
+ python-version: "3.12"
- name: Install engine dependencies
run: |
diff --git a/.github/workflows/validate-yaml-format.yml b/.github/workflows/validate-yaml-format.yml
index 8afa3825b..74e5012e6 100644
--- a/.github/workflows/validate-yaml-format.yml
+++ b/.github/workflows/validate-yaml-format.yml
@@ -11,17 +11,27 @@ jobs:
runs-on: ubuntu-latest
permissions:
contents: read
+ issues: write
pull-requests: write
steps:
- name: Checkout
uses: actions/checkout@v4
with:
fetch-depth: 0
+
- name: Set up Python 3.12
uses: actions/setup-python@v5
with:
python-version: "3.12"
- run: pip install ruamel.yaml
+
+ - name: Set up Node.js
+ uses: actions/setup-node@v4
+ with:
+ node-version: "20"
+ - name: Install Prettier
+ run: npm install -g prettier
+
- name: Detect changed rule.yml files
id: changed-files
run: |
@@ -39,47 +49,116 @@ jobs:
echo "has_files=true" >> $GITHUB_OUTPUT
echo "$FILES" > /tmp/changed_rule_files.txt
fi
- - name: Check YAML sorting and formatting
- id: format-check
+
+ - name: Check YAML sorting
+ id: sort-check
if: steps.changed-files.outputs.has_files == 'true'
run: |
- FILES=$(cat /tmp/changed_rule_files.txt | tr '\n' ' ')
- python scripts/sort_yaml.py --check $FILES
+ mapfile -t FILES < /tmp/changed_rule_files.txt
+ python scripts/sort_yaml.py --check "${FILES[@]}" 2> /tmp/sort_stderr.txt
continue-on-error: true
- - name: Post format check result to PR
+
+ - name: Check Prettier formatting
+ id: prettier-check
+ if: steps.changed-files.outputs.has_files == 'true'
+ run: |
+ : > /tmp/prettier_unformatted.txt
+ while read -r f; do
+ [ -z "$f" ] && continue
+ if ! prettier --check "$f" > /dev/null 2>&1; then
+ echo " $f" >> /tmp/prettier_unformatted.txt
+ fi
+ done < /tmp/changed_rule_files.txt
+ if [ -s /tmp/prettier_unformatted.txt ]; then
+ echo "passed=false" >> $GITHUB_OUTPUT
+ else
+ echo "passed=true" >> $GITHUB_OUTPUT
+ fi
+
+ - name: Post result to PR
if: always() && github.event_name == 'pull_request' && steps.changed-files.outputs.has_files == 'true'
uses: actions/github-script@v7
with:
github-token: ${{ secrets.GITHUB_TOKEN }}
script: |
- const outcome = '${{ steps.format-check.outcome }}';
+ const fs = require('fs');
+
+ function truncatedList(path, maxChars = 3000) {
+ let raw = '';
+ try { raw = fs.readFileSync(path, 'utf8'); } catch (e) { return ''; }
+ const lines = raw.split('\n').filter(l => l.trim().length > 0);
+ let out = [];
+ let total = 0;
+ for (const line of lines) {
+ if (total + line.length > maxChars) {
+ out.push(`...and ${lines.length - out.length} more`);
+ break;
+ }
+ out.push(line);
+ total += line.length + 1;
+ }
+ return out.join('\n');
+ }
+
+ const sortOk = '${{ steps.sort-check.outcome }}' === 'success';
+ const prettierOk = '${{ steps.prettier-check.outputs.passed }}' === 'true';
const marker = '';
let body = marker + '\n';
- if (outcome === 'success') {
+
+ if (sortOk && prettierOk) {
body += '## \u2705 YAML Format Check Passed\n\nAll changed `rule.yml` files are correctly sorted and formatted.';
} else {
body += '## \u274c YAML Format Check Failed\n\n';
- body += 'One or more `rule.yml` files are not correctly sorted/formatted alphabetically by key.\n\n';
- body += 'Run the following command locally to fix them:\n\n```bash\npython scripts/sort_yaml.py\n```\n\nThen commit and push.';
+ if (!sortOk) {
+ const sortList = truncatedList('/tmp/sort_stderr.txt');
+ body += '**Sorting issue** — one or more `rule.yml` files are not sorted alphabetically by key.\n\n';
+ body += 'Run the following command locally to fix them:\n\n```bash\npython scripts/sort_yaml.py\n```\n\n';
+ if (sortList) body += 'Details
\n\n```\n' + sortList + '\n```\n \n\n';
+ }
+ if (!prettierOk) {
+ const prettierList = truncatedList('/tmp/prettier_unformatted.txt');
+ body += '**Formatting issue** — the following files are not formatted with Prettier:\n\n';
+ body += '```\n' + prettierList + '\n```\n\n';
+ body += 'Install the [Prettier VS Code extension](https://marketplace.visualstudio.com/items?itemName=esbenp.prettier-vscode) and enable "Format On Save", then re-save these files and push.\n\n';
+ body += 'Alternatively, trigger the **Auto-format Rule YAML** workflow to fix them automatically.';
+ }
}
- const { data: comments } = await github.rest.issues.listComments({
- owner: context.repo.owner, repo: context.repo.repo,
- issue_number: context.issue.number,
- });
- const existing = comments.find(c => c.user.type === 'Bot' && c.body.includes(marker));
- if (existing) {
- await github.rest.issues.updateComment({
- owner: context.repo.owner, repo: context.repo.repo,
- comment_id: existing.id, body,
- });
- } else {
- await github.rest.issues.createComment({
+
+ if (body.length > 60000) {
+ body = body.slice(0, 60000) + '\n\n...(comment truncated — see workflow run logs for full details)';
+ }
+
+ core.info(`Comment body length: ${body.length}`);
+ core.info(`Issue number: ${context.issue.number}`);
+
+ try {
+ const { data: comments } = await github.rest.issues.listComments({
owner: context.repo.owner, repo: context.repo.repo,
- issue_number: context.issue.number, body,
+ issue_number: context.issue.number,
});
+ core.info(`Found ${comments.length} existing comments on this PR.`);
+ const existing = comments.find(c => c.user.type === 'Bot' && c.body.includes(marker));
+ if (existing) {
+ core.info(`Updating existing comment id ${existing.id}`);
+ const res = await github.rest.issues.updateComment({
+ owner: context.repo.owner, repo: context.repo.repo,
+ comment_id: existing.id, body,
+ });
+ core.info(`Updated comment: ${res.data.html_url}`);
+ } else {
+ core.info('No existing marker comment found — creating a new one.');
+ const res = await github.rest.issues.createComment({
+ owner: context.repo.owner, repo: context.repo.repo,
+ issue_number: context.issue.number, body,
+ });
+ core.info(`Created comment: ${res.data.html_url}`);
+ }
+ } catch (err) {
+ core.setFailed(`Failed to post PR comment: ${err.message}`);
}
- - name: Fail if format check failed
- if: steps.format-check.outcome == 'failure'
+
+ - name: Fail if any check failed
+ if: steps.sort-check.outcome == 'failure' || steps.prettier-check.outputs.passed == 'false'
run: |
- echo "YAML format check failed. Run 'python scripts/sort_yaml.py' to fix."
+ echo "YAML sort and/or Prettier format check failed. See PR comment for details."
exit 1
diff --git a/.github/workflows/validate-yaml-schema.yml b/.github/workflows/validate-yaml-schema.yml
index 253766b26..56c92be4b 100644
--- a/.github/workflows/validate-yaml-schema.yml
+++ b/.github/workflows/validate-yaml-schema.yml
@@ -3,8 +3,8 @@ name: Validate YAML against Schema
on:
pull_request:
paths:
- - 'Published/**/rule.yml'
- - 'Unpublished/**/rule.yml'
+ - "Published/**/rule.yml"
+ - "Unpublished/**/rule.yml"
types: [opened, synchronize, reopened]
workflow_dispatch:
inputs:
@@ -14,7 +14,7 @@ on:
(e.g. "Published/CORE-000001/rule.yml"). Leave blank to validate
all changed rule files detected from the last commit.
required: false
- default: ''
+ default: ""
# Only one run per PR branch at a time; cancel superseded runs.
concurrency:
@@ -32,7 +32,7 @@ jobs:
env:
# draft/2020-12 schema — switch to rule-merged if you need $defs inlined
SCHEMA_URL: >-
- https://raw.githubusercontent.com/cdisc-org/cdisc-rules-engine/refs/heads/main/resources/schema/rule-merged/CORE-base.json
+ https://raw.githubusercontent.com/cdisc-org/cdisc-rules-engine/refs/heads/main/resources/schema/rule-merged/CORE-base.json
steps:
# -----------------------------------------------------------------------
@@ -49,7 +49,7 @@ jobs:
- name: Set up Python 3.12
uses: actions/setup-python@v6
with:
- python-version: '3.12'
+ python-version: "3.12"
# -----------------------------------------------------------------------
# 3. Install validation dependencies
diff --git a/.pre-commit-config.yaml b/.pre-commit-config.yaml
index 070e5ec2e..b4379bdfa 100644
--- a/.pre-commit-config.yaml
+++ b/.pre-commit-config.yaml
@@ -2,9 +2,9 @@ repos:
- repo: local
hooks:
- id: sort-yaml-rules
- name: Sort and format rule YAML files
+ name: Sort rule YAML files
language: python
- entry: python scripts/sort_yaml.py --check
+ entry: python scripts/sort_yaml.py --no-format
types: [yaml]
files: ".*/rule\\.yml$"
additional_dependencies: [ruamel.yaml]
diff --git a/.prettierrc b/.prettierrc
new file mode 100644
index 000000000..70be3f0bc
--- /dev/null
+++ b/.prettierrc
@@ -0,0 +1,16 @@
+{
+ "printWidth": 100,
+ "tabWidth": 2,
+ "useTabs": false,
+ "singleQuote": false,
+ "endOfLine": "lf",
+ "overrides": [
+ {
+ "files": ["*.yml", "*.yaml"],
+ "options": {
+ "printWidth": 100,
+ "tabWidth": 2
+ }
+ }
+ ]
+}
\ No newline at end of file
diff --git a/.vscode/extensions.json b/.vscode/extensions.json
index fe086e4f5..ac8464a43 100644
--- a/.vscode/extensions.json
+++ b/.vscode/extensions.json
@@ -1,8 +1,9 @@
{
"recommendations": [
"redhat.vscode-yaml",
+ "esbenp.prettier-vscode",
"GrapeCity.gc-excelviewer",
"mechatroner.rainbow-csv",
"emeraldwalk.runonsave"
]
-}
\ No newline at end of file
+}
diff --git a/.vscode/settings.json b/.vscode/settings.json
index cc469d2b4..42dc1cbf1 100644
--- a/.vscode/settings.json
+++ b/.vscode/settings.json
@@ -1,4 +1,5 @@
{
+ "extensions.autoUpdate": true,
"yaml.schemas": {
"https://raw.githubusercontent.com/cdisc-org/cdisc-rules-engine/refs/heads/main/resources/schema/rule-merged/CORE-base.json": "rule.yml"
},
@@ -10,5 +11,10 @@
"cmd": "${workspaceFolder}/venv/bin/python ${workspaceFolder}/scripts/sort_yaml.py ${file}"
}
]
- }
+ },
+ "[yaml]": {
+ "editor.defaultFormatter": "esbenp.prettier-vscode",
+ "editor.formatOnSave": true
+ },
+ "yaml.format.enable": false
}
\ No newline at end of file
diff --git a/Deprecated/CORE-000002/rule.yml b/Deprecated/CORE-000002/rule.yml
index 230f54c43..595d575c2 100644
--- a/Deprecated/CORE-000002/rule.yml
+++ b/Deprecated/CORE-000002/rule.yml
@@ -1,19 +1,20 @@
# Variable: SESTDTC
-# Condition:
+# Condition:
# Rule: SESTDTC ^= null
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0208
- Version: '3'
- Version: '2.0'
+ Version: "3"
+ Version: "2.0"
Citations:
- - Cited Guidance: Note that SESTDTC is required, although --STDTC is
+ - Cited Guidance:
+ Note that SESTDTC is required, although --STDTC is
not required in any other subject-level dataset. The purpose of
the dataset is to record the Elements a subject actually passed
through. We assume that if it is known that a subject passed through
@@ -22,17 +23,18 @@ Authorities:
may not be null, although some records may not have all the components
(e.g., year, month, day, hour, minute) of the date/time value collected.
Document: SDTM v1.4
- Section: '5.3'
+ Section: "5.3"
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0208
- Version: '3'
- Version: '2.0'
+ Version: "3"
+ Version: "2.0"
Citations:
- - Cited Guidance: Note that SESTDTC is required, although --STDTC is
+ - Cited Guidance:
+ Note that SESTDTC is required, although --STDTC is
not required in any other subject-level dataset. The purpose of
the dataset is to record the Elements a subject actually passed
through. We assume that if it is known that a subject passed through
@@ -44,15 +46,16 @@ Authorities:
Item: Assumption 11
Section: 5 SE
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0208
- Version: '3'
- Version: '2.0'
+ Version: "3"
+ Version: "2.0"
Citations:
- - Cited Guidance: Note that SESTDTC is required, although --STDTC is
+ - Cited Guidance:
+ Note that SESTDTC is required, although --STDTC is
not required in any other subject-level dataset. The purpose of
the dataset is to record the Elements a subject actually passed
through. We assume that if it is known that a subject passed through
@@ -62,7 +65,7 @@ Authorities:
(e.g., year, month, day, hour, minute) of the date/time value collected.
Document: IG v3.3
Item: Assumption 9
- Section: '5.3'
+ Section: "5.3"
Check:
all:
- name: SESTDTC
@@ -70,7 +73,7 @@ Check:
Core:
Id: CORE-000002
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when SESTDTC is null.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000003/rule.yml b/Deprecated/CORE-000003/rule.yml
index 12edd7a47..6ec06ed75 100644
--- a/Deprecated/CORE-000003/rule.yml
+++ b/Deprecated/CORE-000003/rule.yml
@@ -1,19 +1,20 @@
# Variable: TRLOC
-# Condition:
+# Condition:
# Rule: TRLOC not present in dataset
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0299
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The TR domain does not include anatomical location
+ - Cited Guidance:
+ The TR domain does not include anatomical location
information on each measurement/assessment record, because this
would be a duplication of information already represented in TU.
The multi-domain approach to representing oncology assessment data
@@ -21,32 +22,34 @@ Authorities:
Document: SDTM v3.4
Section: 6.3.12.2
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0299
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The TR domain does not include anatomical location
+ - Cited Guidance:
+ The TR domain does not include anatomical location
information on each measurement record because this would be a duplication
of information already represented in TU. This duplication of data
was a deciding factor in multi-domain approach to representing this
data.
Document: IG v3.2
Item: Specification
- Section: '6.3'
+ Section: "6.3"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0299
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The TR domain does not include anatomical location
+ - Cited Guidance:
+ The TR domain does not include anatomical location
information on each measurement record because this would be a duplication
of information already represented in TU. This duplication of data
was a deciding factor in multi-domain approach to representing this
@@ -61,7 +64,7 @@ Check:
Core:
Id: CORE-000003
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TRLOC is present.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000005/rule.yml b/Deprecated/CORE-000005/rule.yml
index 09d6090f6..76b693a20 100644
--- a/Deprecated/CORE-000005/rule.yml
+++ b/Deprecated/CORE-000005/rule.yml
@@ -5,45 +5,48 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0102
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Doses of placebo should be represented by EXTRT =
+ - Cited Guidance:
+ Doses of placebo should be represented by EXTRT =
"PLACEBO" and EXDOSE = "0" (indicating 0 mg of active ingredient
was taken or administered).
Document: SDTMIG v3.4
Item: Assumption 2b
Section: 6.1.3.1
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0102
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Doses of placebo should be represented by EXTRT =
+ - Cited Guidance:
+ Doses of placebo should be represented by EXTRT =
'PLACEBO' and EXDOSE = 0 (indicating 0 mg of active ingredient was
taken or administered).
Document: IG v3.2
Item: Assumption 2b
- Section: '6.1'
+ Section: "6.1"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0102
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Doses of placebo should be represented by EXTRT =
+ - Cited Guidance:
+ Doses of placebo should be represented by EXTRT =
'PLACEBO' and EXDOSE = 0 (indicating 0 mg of active ingredient was
taken or administered).
Document: IG v3.3
@@ -60,7 +63,7 @@ Check:
Core:
Id: CORE-000005
Status: Published
- Version: '1'
+ Version: "1"
Description: When EXTRT is PLACEBO, EXDOSE must equal 0
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000008/rule.yml b/Deprecated/CORE-000008/rule.yml
index 9799cfdf1..f2c16e27b 100644
--- a/Deprecated/CORE-000008/rule.yml
+++ b/Deprecated/CORE-000008/rule.yml
@@ -7,22 +7,24 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For example, if a subject's Survival Status is "DEAD", the date
+ - Cited Guidance:
+ For example, if a subject's Survival Status is "DEAD", the date
of death must be stored in DM and within a final disposition
record in DS.
Document: IG v3.2
Item: Assumption 2
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0132
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For example, if a subject's Survival Status is "DEAD", the date
+ - Cited Guidance:
+ For example, if a subject's Survival Status is "DEAD", the date
of death must be stored in DM and within a final disposition
record in DS.
Document: IG v3.3
@@ -31,13 +33,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0132
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 4.5.8[4. If the subject's survival status is "dead", the
+ - Cited Guidance:
+ 4.5.8[4. If the subject's survival status is "dead", the
Demographics (DM) variables DTHDTC and DTHFL must be
appropriately populated.]|6.3.11[For example, if a subject's
survival status is "DEAD", the date of death must be stored in
@@ -48,51 +51,54 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0132
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
#CG0132 is identical to rule FB0601. Added metadata for FB0601.
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0601
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0601
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0601
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: SSSTRESC
@@ -106,7 +112,7 @@ Check:
Core:
Id: CORE-000008
Status: Published
- Version: '1'
+ Version: "1"
Description: When survival status is completed as 'DEAD' in the SS dataset then
death flag (DTHFL) should be populated as 'Y' in the DM dataset for the
corresponding subject.
diff --git a/Deprecated/CORE-000031/rule.yml b/Deprecated/CORE-000031/rule.yml
index 4d2004e9e..4adcb6745 100644
--- a/Deprecated/CORE-000031/rule.yml
+++ b/Deprecated/CORE-000031/rule.yml
@@ -5,25 +5,28 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0659
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: --EVAL and --EVALID must not be used to model QRS
+ - Cited Guidance:
+ --EVAL and --EVALID must not be used to model QRS
data in SDTM.
Document: SDTMIG v3.4
Item: Assumption 8
Section: 6.3.9.1
- - Cited Guidance: --EVAL and --EVALID must not be used to model QRS
+ - Cited Guidance:
+ --EVAL and --EVALID must not be used to model QRS
data in SDTM.
Document: SDTMIG v3.4
Item: Assumption 8
Section: 6.3.9.2
- - Cited Guidance: --EVAL and --EVALID must not be used to model QRS
+ - Cited Guidance:
+ --EVAL and --EVALID must not be used to model QRS
data in SDTM.
Document: SDTMIG v3.4
Item: Assumption 8
@@ -43,8 +46,9 @@ Check:
Core:
Id: CORE-000031
Status: Published
- Version: '1'
-Description: --EVAL must not be used to model QRS data. This includes the 'QS' and
+ Version: "1"
+Description:
+ --EVAL must not be used to model QRS data. This includes the 'QS' and
'FT' domains as well as the 'RS' domain when the record pertains to a Clinical Classification
Use Case). This rule has been fully executed for the QS and FT domains only.
Executability: Fully Executable
diff --git a/Deprecated/CORE-000032/rule.yml b/Deprecated/CORE-000032/rule.yml
index 55bc68922..4fd81e67c 100644
--- a/Deprecated/CORE-000032/rule.yml
+++ b/Deprecated/CORE-000032/rule.yml
@@ -5,25 +5,28 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0660
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: --EVAL and --EVALID must not be used to model QRS
+ - Cited Guidance:
+ --EVAL and --EVALID must not be used to model QRS
data in SDTM.
Document: SDTMIG v3.4
Item: Assumption 8
Section: 6.3.9.1
- - Cited Guidance: --EVAL and --EVALID must not be used to model QRS
+ - Cited Guidance:
+ --EVAL and --EVALID must not be used to model QRS
data in SDTM.
Document: SDTMIG v3.4
Item: Assumption 8
Section: 6.3.9.2
- - Cited Guidance: --EVAL and --EVALID must not be used to model QRS
+ - Cited Guidance:
+ --EVAL and --EVALID must not be used to model QRS
data in SDTM.
Document: SDTMIG v3.4
Item: Assumption 8
@@ -43,8 +46,9 @@ Check:
Core:
Id: CORE-000032
Status: Published
- Version: '1'
-Description: --EVALID must not be used to model QRS data. This includes the 'QS'
+ Version: "1"
+Description:
+ --EVALID must not be used to model QRS data. This includes the 'QS'
and 'FT' domains as well as the 'RS' domain when the record pertains to a Clinical
Classification Use Case). This rule has been fully executed for the QS and FT domains
only.
diff --git a/Deprecated/CORE-000072/rule.yml b/Deprecated/CORE-000072/rule.yml
index c8a027b31..b75d9a413 100644
--- a/Deprecated/CORE-000072/rule.yml
+++ b/Deprecated/CORE-000072/rule.yml
@@ -1,31 +1,32 @@
# Variable: --BEATNO
-# Condition:
+# Condition:
# Rule: --BEATNO not present in dataset
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0542
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- Cited Guidance: --BEATNO is to be used in the EG domain only.
Document: SDTM v2.0
Section: Findings
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0542
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The concept of domain-specific variables was first
+ - Cited Guidance:
+ The concept of domain-specific variables was first
introduced in SDTM v1.5. These variables are for use only in a specific
domain and will be identified in the appropriate implementation
guide.
@@ -39,7 +40,7 @@ Check:
Core:
Id: CORE-000072
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --BEATNO is present.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000073/rule.yml b/Deprecated/CORE-000073/rule.yml
index e6d017683..6d7987c11 100644
--- a/Deprecated/CORE-000073/rule.yml
+++ b/Deprecated/CORE-000073/rule.yml
@@ -1,29 +1,29 @@
# Variable: RPATHCD
-# Condition:
+# Condition:
# Rule: RPATHCD not present in dataset
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0533
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- Cited Guidance: Not in clinical trials.
Document: Model v2.0
Section: Demographics
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0533
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- Cited Guidance: Not to be used with human clinical trials.
Document: Model v1.7
@@ -35,7 +35,7 @@ Check:
Core:
Id: CORE-000073
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when RPATHCD is present.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000076/rule.yml b/Deprecated/CORE-000076/rule.yml
index fab261634..6d08783b6 100644
--- a/Deprecated/CORE-000076/rule.yml
+++ b/Deprecated/CORE-000076/rule.yml
@@ -1,19 +1,20 @@
# Variable: TRPORTOT
-# Condition:
+# Condition:
# Rule: TRPORTOT not present in dataset
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0302
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The TR domain does not include anatomical location
+ - Cited Guidance:
+ The TR domain does not include anatomical location
information on each measurement/assessment record, because this
would be a duplication of information already represented in TU.
The multi-domain approach to representing oncology assessment data
@@ -22,32 +23,34 @@ Authorities:
Section: 6.3.12.2
Item: TR Description/Overview
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0302
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The TR domain does not include anatomical location
+ - Cited Guidance:
+ The TR domain does not include anatomical location
information on each measurement record because this would be a duplication
of information already represented in TU. This duplication of data
was a deciding factor in multi-domain approach to representing this
data.
Document: IG v3.2
Item: Specification
- Section: '6.3'
+ Section: "6.3"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0302
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The TR domain does not include anatomical location
+ - Cited Guidance:
+ The TR domain does not include anatomical location
information on each measurement record because this would be a duplication
of information already represented in TU. This duplication of data
was a deciding factor in multi-domain approach to representing this
@@ -62,7 +65,7 @@ Check:
Core:
Id: CORE-000076
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TRPORTOT is present.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000077/rule.yml b/Deprecated/CORE-000077/rule.yml
index 2a92c29d6..426f4f80a 100644
--- a/Deprecated/CORE-000077/rule.yml
+++ b/Deprecated/CORE-000077/rule.yml
@@ -1,19 +1,20 @@
# Variable: TRDIR
-# Condition:
+# Condition:
# Rule: TRDIR not present in dataset
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0301
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The TR domain does not include anatomical location
+ - Cited Guidance:
+ The TR domain does not include anatomical location
information on each measurement/assessment record, because this
would be a duplication of information already represented in TU.
The multi-domain approach to representing oncology assessment data
@@ -21,32 +22,34 @@ Authorities:
Document: SDTMIG v3.4
Section: 6.3.12.2
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0301
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The TR domain does not include anatomical location
+ - Cited Guidance:
+ The TR domain does not include anatomical location
information on each measurement record because this would be a duplication
of information already represented in TU. This duplication of data
was a deciding factor in multi-domain approach to representing this
data.
Document: IG v3.2
Item: Specification
- Section: '6.3'
+ Section: "6.3"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0301
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The TR domain does not include anatomical location
+ - Cited Guidance:
+ The TR domain does not include anatomical location
information on each measurement record because this would be a duplication
of information already represented in TU. This duplication of data
was a deciding factor in multi-domain approach to representing this
@@ -61,7 +64,7 @@ Check:
Core:
Id: CORE-000077
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TRDIR is present.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000078/rule.yml b/Deprecated/CORE-000078/rule.yml
index bb9bbf1f1..ff1882646 100644
--- a/Deprecated/CORE-000078/rule.yml
+++ b/Deprecated/CORE-000078/rule.yml
@@ -1,19 +1,20 @@
# Variable: TRLAT
-# Condition:
+# Condition:
# Rule: TRLAT not present in dataset
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0300
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The TR domain does not include anatomical location
+ - Cited Guidance:
+ The TR domain does not include anatomical location
information on each measurement/assessment record, because this
would be a duplication of information already represented in TU.
The multi-domain approach to representing oncology assessment data
@@ -22,32 +23,34 @@ Authorities:
Section: 6.3.12.2
Item: TR Description/Overview
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0300
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The TR domain does not include anatomical location
+ - Cited Guidance:
+ The TR domain does not include anatomical location
information on each measurement record because this would be a duplication
of information already represented in TU. This duplication of data
was a deciding factor in multi-domain approach to representing this
data.
Document: IG v3.2
Item: Specification
- Section: '6.3'
+ Section: "6.3"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0300
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The TR domain does not include anatomical location
+ - Cited Guidance:
+ The TR domain does not include anatomical location
information on each measurement record because this would be a duplication
of information already represented in TU. This duplication of data
was a deciding factor in multi-domain approach to representing this
@@ -62,7 +65,7 @@ Check:
Core:
Id: CORE-000078
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TRLAT is present.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000079/rule.yml b/Deprecated/CORE-000079/rule.yml
index ab59c8b81..5d88ae02d 100644
--- a/Deprecated/CORE-000079/rule.yml
+++ b/Deprecated/CORE-000079/rule.yml
@@ -5,45 +5,48 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0095
- Version: '2'
- Version: '2.0'
+ Version: "2"
+ Version: "2.0"
Citations:
- - Cited Guidance: Events[Variable Qualifier of --LOC]|Interventions[Variable
+ - Cited Guidance:
+ Events[Variable Qualifier of --LOC]|Interventions[Variable
Qualifier of --LOC]|Findings[Variable Qualifier of --LOC]
Document: Model v2.0
Section: Events|Interventions|Findings
Item: --LAT
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0095
- Version: '2'
- Version: '2.0'
+ Version: "2"
+ Version: "2.0"
Citations:
- - Cited Guidance: Qualifier for anatomical location further detailing
+ - Cited Guidance:
+ Qualifier for anatomical location further detailing
laterality.
Document: Model v1.4
Section: 2.2.2
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0095
- Version: '2'
- Version: '2.0'
+ Version: "2"
+ Version: "2.0"
Citations:
- - Cited Guidance: Qualifier for anatomical location further detailing
+ - Cited Guidance:
+ Qualifier for anatomical location further detailing
laterality.
Document: Model v1.7
- Item: 'Table 3.2.2: --LAT'
+ Item: "Table 3.2.2: --LAT"
Section: 2.2.2
Check:
all:
@@ -54,7 +57,7 @@ Check:
Core:
Id: CORE-000079
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --LOC is not present and --LAT is present.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000082/rule.yml b/Deprecated/CORE-000082/rule.yml
index 51bcdc6b5..c4b8d98f3 100644
--- a/Deprecated/CORE-000082/rule.yml
+++ b/Deprecated/CORE-000082/rule.yml
@@ -5,26 +5,26 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0561
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- Cited Guidance: If PEORRES is null, PESTRESC must be null.
Document: IG v3.4
Item: Specification
Section: 6.3.8
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0561
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- Cited Guidance: If PEORRES is null, PESTRESC must be null.
Document: IG v3.3
@@ -39,7 +39,7 @@ Check:
Core:
Id: CORE-000082
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify that PESTRESC is null when PEORRES is null
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000089/rule.yml b/Deprecated/CORE-000089/rule.yml
index 85371e6da..c55bc2f32 100644
--- a/Deprecated/CORE-000089/rule.yml
+++ b/Deprecated/CORE-000089/rule.yml
@@ -5,52 +5,55 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0106
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: '"--TRTV[A carrier or inert medium in which a medicinally
+ - Cited Guidance:
+ '"--TRTV[A carrier or inert medium in which a medicinally
active agent is administered.]| --VAMT[Amount of the prepared product
(treatment plus vehicle) administered.]"'
Document: Model v2.0
Item: --TRTV|--VAMT
Section: Interventions
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0106
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: '[--TRTV:Vehicle for administration of treatment,
+ - Cited Guidance:
+ "[--TRTV:Vehicle for administration of treatment,
such as a liquid in which the treatment drug is dissolved. Example:
SALINE.][--VAMT: Amount of the prepared product (treatment + vehicle)
administered or given. Note: should not be diluent amount alone.][--VAMTU:
Units for the prepared product (treatment + vehicle). Examples:
- mL, mg.]'
+ mL, mg.]"
Document: Model v1.4
Section: 2.2.1
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0106
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: '[--TRTV:Vehicle for administration of treatment,
+ - Cited Guidance:
+ "[--TRTV:Vehicle for administration of treatment,
such as a liquid in which the treatment drug is dissolved. Example:
SALINE.][--VAMT: Amount of the prepared product (treatment + vehicle)
administered or given. Note: should not be diluent amount alone.][--VAMTU:
Units for the prepared product (treatment + vehicle). Examples:
- mL, mg.]'
+ mL, mg.]"
Document: Model v1.7
Section: 2.2.1
Check:
@@ -62,7 +65,7 @@ Check:
Core:
Id: CORE-000089
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TRTV is empty, --VAMT is not empty
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000091/rule.yml b/Deprecated/CORE-000091/rule.yml
index ab8b1b073..580c2ca40 100644
--- a/Deprecated/CORE-000091/rule.yml
+++ b/Deprecated/CORE-000091/rule.yml
@@ -5,48 +5,50 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0108
- Version: '2'
- Version: '2.0'
+ Version: "2"
+ Version: "2.0"
Citations:
- Cited Guidance: Variable Qualifier of --VAMT.
Document: Model v2.0
Item: --VAMTU
Section: Interventions
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0108
- Version: '2'
- Version: '2.0'
+ Version: "2"
+ Version: "2.0"
Citations:
- - Cited Guidance: '--TRTV:Vehicle for administration of treatment, such
+ - Cited Guidance:
+ "--TRTV:Vehicle for administration of treatment, such
as a liquid in which the treatment drug is dissolved. Example: SALINE.
--VAMT: Amount of the prepared product (treatment + vehicle) administered
or given. Note: should not be diluent amount alone. --VAMTU: Units
- for the prepared product (treatment + vehicle). Examples: mL, mg.'
+ for the prepared product (treatment + vehicle). Examples: mL, mg."
Document: Model v1.4
Section: 2.2.1
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0108
- Version: '2'
- Version: '2.0'
+ Version: "2"
+ Version: "2.0"
Citations:
- - Cited Guidance: '--TRTV:Vehicle for administration of treatment, such
+ - Cited Guidance:
+ "--TRTV:Vehicle for administration of treatment, such
as a liquid in which the treatment drug is dissolved. Example: SALINE.
--VAMT: Amount of the prepared product (treatment + vehicle) administered
or given. Note: should not be diluent amount alone. --VAMTU: Units
- for the prepared product (treatment + vehicle). Examples: mL, mg.'
+ for the prepared product (treatment + vehicle). Examples: mL, mg."
Document: Model v1.7
Section: 2.2.1
Check:
@@ -58,7 +60,7 @@ Check:
Core:
Id: CORE-000091
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TRTV is null, --VAMTU is not null
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000109/rule.yml b/Deprecated/CORE-000109/rule.yml
index 428bf9683..485375586 100644
--- a/Deprecated/CORE-000109/rule.yml
+++ b/Deprecated/CORE-000109/rule.yml
@@ -1,40 +1,42 @@
# Variable: SMSTDTC
-# Condition:
+# Condition:
# Rule: SMSTDTC ^= null
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0547
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The start date/time of the Disease Milestone is the
+ - Cited Guidance:
+ The start date/time of the Disease Milestone is the
critical date/time, and must be populated. If the Disease Milestone
is an event, then the meaning of “start date” for the event may
need to be defined.
Document: SDTMIG v3.4
- Section: '5.4'
+ Section: "5.4"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0547
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The start date/time of the Disease Milestone is the
+ - Cited Guidance:
+ The start date/time of the Disease Milestone is the
critical date/time, and must be populated. If the Disease Milestone
is an event, then the meaning of 'start date' for the event may
need to be defined
Document: IG v3.3
Item: Assumption 3.a
- Section: '5.5'
+ Section: "5.5"
Check:
all:
- name: SMSTDTC
@@ -42,7 +44,7 @@ Check:
Core:
Id: CORE-000109
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when SMSTDTC is null.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000115/rule.yml b/Deprecated/CORE-000115/rule.yml
index 3b128fc58..942023723 100644
--- a/Deprecated/CORE-000115/rule.yml
+++ b/Deprecated/CORE-000115/rule.yml
@@ -1,40 +1,44 @@
# Variable: ARM
-# Condition:
+# Condition:
# Rule: ARM not in ('Screen Failure', 'Not Assigned', 'Unplanned Treatment', 'Not Treated')
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0570
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The trial arms table describes each planned arm in
+ - Cited Guidance:
+ The trial arms table describes each planned arm in
the trial.
Document: SDTMIG v3.4
- Section: '7.2'
- - Cited Guidance: The trial arms table describes each planned arm in
+ Section: "7.2"
+ - Cited Guidance:
+ The trial arms table describes each planned arm in
the trial.
Document: SDTMIG v3.4
Section: 7.3.1
- - Cited Guidance: The trial arms table describes each planned arm in
+ - Cited Guidance:
+ The trial arms table describes each planned arm in
the trial.
Document: SDTMIG v3.4
- Section: '5.2'
+ Section: "5.2"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0570
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The trial arms table describes each planned arm in
+ - Cited Guidance:
+ The trial arms table describes each planned arm in
the trial.
Document: IG v3.3
Item: Specification
@@ -51,12 +55,14 @@ Check:
Core:
Id: CORE-000115
Status: Published
- Version: '1'
-Description: Raise an error when ARM is 'Screen Failure', 'Not Assigned', 'Unplanned
+ Version: "1"
+Description:
+ Raise an error when ARM is 'Screen Failure', 'Not Assigned', 'Unplanned
Treatment', 'Not Treated'
Executability: Fully Executable
Outcome:
- Message: ARM cannot be equal to 'Screen Failure', 'Not Assigned', 'Unplanned Treatment'
+ Message:
+ ARM cannot be equal to 'Screen Failure', 'Not Assigned', 'Unplanned Treatment'
or 'Not Treated'.
Rule Type: Record Data
Scope:
diff --git a/Deprecated/CORE-000145/rule.yml b/Deprecated/CORE-000145/rule.yml
index f1ac80482..1d436b6d5 100644
--- a/Deprecated/CORE-000145/rule.yml
+++ b/Deprecated/CORE-000145/rule.yml
@@ -5,50 +5,53 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0255
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: If inclusion/exclusion criteria were amended during
+ - Cited Guidance:
+ If inclusion/exclusion criteria were amended during
the trial, then each complete set of criteria must be included in
the TI domain. TIVERS is used to distinguish between the versions.
Document: IG v3.4
Item: Assumption 1
Section: 7.4.1
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0255
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: If inclusion/exclusion criteria were amended during
+ - Cited Guidance:
+ If inclusion/exclusion criteria were amended during
the trial, then each complete set of criteria must be included in
the TI domain. TIVERS is used to distinguish between the versions.
Document: IG v3.3
Item: Assumption 1
Section: 7.4.1
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0255
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: If inclusion/exclusion criteria were amended during
+ - Cited Guidance:
+ If inclusion/exclusion criteria were amended during
the trial, then each complete set of criteria must be included in
the TI domain. TIVERS is used to distinguish between the versions.
Document: IG v3.2
Item: Assumption 1
- Section: '7.4'
+ Section: "7.4"
Check:
all:
- name: TIVERS
@@ -59,8 +62,9 @@ Check:
Core:
Id: CORE-000145
Status: Published
- Version: '1'
-Description: Trigger error when TIVERS is present and IETESTCD is not unique within
+ Version: "1"
+Description:
+ Trigger error when TIVERS is present and IETESTCD is not unique within
TIVERS
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000146/rule.yml b/Deprecated/CORE-000146/rule.yml
index 0651b70f9..b2a26b834 100644
--- a/Deprecated/CORE-000146/rule.yml
+++ b/Deprecated/CORE-000146/rule.yml
@@ -5,65 +5,71 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0256
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The number of this version of the Inclusion/Exclusion
+ - Cited Guidance:
+ The number of this version of the Inclusion/Exclusion
criteria. May be omitted if there is only one version.
Document: IG v3.4
Item: Specification
Section: 7.4.1
- - Cited Guidance: Individual criteria do not have versions. If a criterion
+ - Cited Guidance:
+ Individual criteria do not have versions. If a criterion
changes, it should be treated as a new criterion, with a new value
for IETESTCD.
Document: IG v3.4
Item: Assumption 3
Section: 7.4.1
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0256
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The number of this version of the Inclusion/Exclusion
+ - Cited Guidance:
+ The number of this version of the Inclusion/Exclusion
criteria. May be omitted if there is only one version.
Document: IG v3.3
Item: Specification
Section: 7.4.1
- - Cited Guidance: Individual criteria do not have versions. If a criterion
+ - Cited Guidance:
+ Individual criteria do not have versions. If a criterion
changes, it should be treated as a new criterion, with a new value
for IETESTCD.
Document: IG v3.3
Item: Assumption 3
Section: 7.4.1
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0256
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The number of this version of the Inclusion/Exclusion
+ - Cited Guidance:
+ The number of this version of the Inclusion/Exclusion
criteria. May be omitted if there is only one version.
Document: IG v3.2
Item: Specification
- Section: '7.4'
- - Cited Guidance: Individual criteria do not have versions. If a criterion
+ Section: "7.4"
+ - Cited Guidance:
+ Individual criteria do not have versions. If a criterion
changes, it should be treated as a new criterion, with a new value
for IETESTCD.
Document: IG v3.2
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Check:
all:
- name: TIVERS
@@ -74,7 +80,7 @@ Check:
Core:
Id: CORE-000146
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when IETESTCD is not unique within dataset
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000149/rule.yml b/Deprecated/CORE-000149/rule.yml
index 69ad5931c..24d55e75b 100644
--- a/Deprecated/CORE-000149/rule.yml
+++ b/Deprecated/CORE-000149/rule.yml
@@ -5,39 +5,39 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0259
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- Cited Guidance: TSVAL can only be null when TSVALNF is populated.
Document: IG v3.4
Item: Specification
Section: 7.4.2
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0259
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- Cited Guidance: TSVAL can only be null when TSVALNF is populated.
Document: IG v3.2
Item: Specification
- Section: '7.4'
+ Section: "7.4"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0259
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- Cited Guidance: TSVAL can only be null when TSVALNF is populated.
Document: IG v3.3
@@ -52,7 +52,7 @@ Check:
Core:
Id: CORE-000149
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when TSVAL is null and TSVALNF is null
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000150/rule.yml b/Deprecated/CORE-000150/rule.yml
index afcce4410..53e246fd2 100644
--- a/Deprecated/CORE-000150/rule.yml
+++ b/Deprecated/CORE-000150/rule.yml
@@ -5,43 +5,46 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0260
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Null flavor for the value of TSPARM, to be populated
+ - Cited Guidance:
+ Null flavor for the value of TSPARM, to be populated
if and only if TSVAL is null.
Document: IG v3.4
Item: Specification
Section: 7.4.2
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0260
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Null flavor for the value of TSPARM, to be populated
+ - Cited Guidance:
+ Null flavor for the value of TSPARM, to be populated
if and only if TSVAL = null.
Document: IG v3.2
Item: Specification
- Section: '7.4'
+ Section: "7.4"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0260
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Null flavor for the value of TSPARM, to be populated
+ - Cited Guidance:
+ Null flavor for the value of TSPARM, to be populated
if and only if TSVAL = null.
Document: IG v3.3
Item: Specification
@@ -55,7 +58,7 @@ Check:
Core:
Id: CORE-000150
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when TSVAL is populated and TSVALNF is also populated.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000153/rule.yml b/Deprecated/CORE-000153/rule.yml
index 5fbc223dc..7ab61ab77 100644
--- a/Deprecated/CORE-000153/rule.yml
+++ b/Deprecated/CORE-000153/rule.yml
@@ -5,43 +5,46 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0266
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The version number of the Reference Terminology, if
+ - Cited Guidance:
+ The version number of the Reference Terminology, if
applicable.
Document: IG v3.4
Item: Specification
Section: 7.4.2
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0266
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The version number of the Reference Terminology, if
+ - Cited Guidance:
+ The version number of the Reference Terminology, if
applicable.
Document: IG v3.2
Item: Specification
- Section: '7.4'
+ Section: "7.4"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0266
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The version number of the Reference Terminology, if
+ - Cited Guidance:
+ The version number of the Reference Terminology, if
applicable.
Document: IG v3.3
Item: Specification
@@ -55,7 +58,7 @@ Check:
Core:
Id: CORE-000153
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when TSVCDVER is populated and TSVCDREF is null
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000174/rule.yml b/Deprecated/CORE-000174/rule.yml
index 14510d205..93f2b79b0 100644
--- a/Deprecated/CORE-000174/rule.yml
+++ b/Deprecated/CORE-000174/rule.yml
@@ -1,19 +1,20 @@
# Variable: SPECIES
-# Condition:
+# Condition:
# Rule: SPECIES not present in dataset
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0356
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: "The following variables can be used for non-clinical\
+ - Cited Guidance:
+ "The following variables can be used for non-clinical\
\ studies (SEND) but must NEVER be used in the Demographics domain\
\ for human clinical trials. However, the use of these variables\
\ is currently being evaluated in Findings general observation\
@@ -21,41 +22,43 @@ Authorities:
\ data:\n SPECIES (Demographics)\n STRAIN (Demographics)\n SBSTRAIN\
\ (Demographics)"
Document: IG 3.4
- Section: '2.7'
+ Section: "2.7"
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0356
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: 'The following variables can be used for non-clinical
+ - Cited Guidance:
+ "The following variables can be used for non-clinical
studies (SEND) but must NEVER be used in the Demographics domain
for human clinical trials. However; the use of these variables is
currently being evaluated in Findings general observation class
domains being developed for use in the tabulations of virology data:
- SPECIES (Demographics) STRAIN (Demographics) SBSTRAIN (Demographics)'
+ SPECIES (Demographics) STRAIN (Demographics) SBSTRAIN (Demographics)"
Document: IG v3.2
- Section: '2.7'
+ Section: "2.7"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0356
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The following variables can be used for non-clinical
+ - Cited Guidance:
+ The following variables can be used for non-clinical
studies (SEND) but must NEVER be used in the Demographics domain
for human clinical trials; where all subjects are human. See Section
9.2; Non-host Organism Identifiers (OI); for information about representing
taxonomic information for non-host organisms such as bacteria and
viruses. SPECIES (Demographics) STRAIN (Demographics) SBSTRAIN (Demographics)
Document: IG v3.3
- Section: '2.7'
+ Section: "2.7"
Check:
all:
- name: SPECIES
@@ -63,7 +66,7 @@ Check:
Core:
Id: CORE-000174
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify variable SPECIES does not exist in DM dataset
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000175/rule.yml b/Deprecated/CORE-000175/rule.yml
index 4f8ef8e80..fbe6c3379 100644
--- a/Deprecated/CORE-000175/rule.yml
+++ b/Deprecated/CORE-000175/rule.yml
@@ -1,19 +1,20 @@
# Variable: STRAIN
-# Condition:
+# Condition:
# Rule: STRAIN not present in dataset
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0357
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: "The following variables can be used for non-clinical\
+ - Cited Guidance:
+ "The following variables can be used for non-clinical\
\ studies (SEND) but must NEVER be used in the Demographics domain\
\ for human clinical trials. However, the use of these variables\
\ is currently being evaluated in Findings general observation\
@@ -21,41 +22,43 @@ Authorities:
\ data:\n SPECIES (Demographics)\n STRAIN (Demographics)\n SBSTRAIN\
\ (Demographics)"
Document: IG 3.4
- Section: '2.7'
+ Section: "2.7"
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0357
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: 'The following variables can be used for non-clinical
+ - Cited Guidance:
+ "The following variables can be used for non-clinical
studies (SEND) but must NEVER be used in the Demographics domain
for human clinical trials. However; the use of these variables is
currently being evaluated in Findings general observation class
domains being developed for use in the tabulations of virology data:
- - SPECIES (Demographics) - STRAIN (Demographics) - SBSTRAIN (Demographics)'
+ - SPECIES (Demographics) - STRAIN (Demographics) - SBSTRAIN (Demographics)"
Document: IG v3.2
- Section: '2.7'
+ Section: "2.7"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0357
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The following variables can be used for non-clinical
+ - Cited Guidance:
+ The following variables can be used for non-clinical
studies (SEND) but must NEVER be used in the Demographics domain
for human clinical trials; where all subjects are human. See Section
9.2; Non-host Organism Identifiers (OI); for information about representing
taxonomic information for non-host organisms such as bacteria and
viruses. SPECIES (Demographics) STRAIN (Demographics) SBSTRAIN (Demographics)
Document: IG v3.3
- Section: '2.7'
+ Section: "2.7"
Check:
all:
- name: STRAIN
@@ -63,7 +66,7 @@ Check:
Core:
Id: CORE-000175
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify variable STRAIN does not exist in DM dataset
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000176/rule.yml b/Deprecated/CORE-000176/rule.yml
index 60c2de6a5..c6b0fe31e 100644
--- a/Deprecated/CORE-000176/rule.yml
+++ b/Deprecated/CORE-000176/rule.yml
@@ -1,19 +1,20 @@
# Variable: SBSTRAIN
-# Condition:
+# Condition:
# Rule: SBSTRAIN not present in dataset
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0358
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: "The following variables can be used for non-clinical\
+ - Cited Guidance:
+ "The following variables can be used for non-clinical\
\ studies (SEND) but must NEVER be used in the Demographics domain\
\ for human clinical trials. However, the use of these variables\
\ is currently being evaluated in Findings general observation\
@@ -21,41 +22,43 @@ Authorities:
\ data:\n SPECIES (Demographics)\n STRAIN (Demographics)\n SBSTRAIN\
\ (Demographics)"
Document: IG 3.4
- Section: '2.7'
+ Section: "2.7"
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0358
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: 'The following variables can be used for non-clinical
+ - Cited Guidance:
+ "The following variables can be used for non-clinical
studies (SEND) but must NEVER be used in the Demographics domain
for human clinical trials. However; the use of these variables is
currently being evaluated in Findings general observation class
domains being developed for use in the tabulations of virology data:
- SPECIES (Demographics) STRAIN (Demographics) SBSTRAIN (Demographics)'
+ SPECIES (Demographics) STRAIN (Demographics) SBSTRAIN (Demographics)"
Document: IG v3.2
- Section: '2.7'
+ Section: "2.7"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0358
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The following variables can be used for non-clinical
+ - Cited Guidance:
+ The following variables can be used for non-clinical
studies (SEND) but must NEVER be used in the Demographics domain
for human clinical trials; where all subjects are human. See Section
9.2; Non-host Organism Identifiers (OI); for information about representing
taxonomic information for non-host organisms such as bacteria and
viruses. SPECIES (Demographics) STRAIN (Demographics) SBSTRAIN (Demographics)
Document: IG v3.3
- Section: '2.7'
+ Section: "2.7"
Check:
all:
- name: SBSTRAIN
@@ -63,7 +66,7 @@ Check:
Core:
Id: CORE-000176
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify variable SBSTRAIN does not exist in DM dataset
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000178/rule.yml b/Deprecated/CORE-000178/rule.yml
index 942cdb176..62b694505 100644
--- a/Deprecated/CORE-000178/rule.yml
+++ b/Deprecated/CORE-000178/rule.yml
@@ -5,15 +5,16 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0172
- Version: '2'
- Version: '2.0'
+ Version: "2"
+ Version: "2.0"
Citations:
- - Cited Guidance: Subject Status does not contain details about the circumstances
+ - Cited Guidance:
+ Subject Status does not contain details about the circumstances
of a subject's status. The response to the status assessment
may trigger collection of additional details, but those
details are to be stored in appropriate separate domains. For
@@ -25,15 +26,16 @@ Authorities:
Item: Assumption 1
Section: 6.3.11
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0172
- Version: '2'
- Version: '2.0'
+ Version: "2"
+ Version: "2.0"
Citations:
- - Cited Guidance: Subject Status does not contain details about the circumstances
+ - Cited Guidance:
+ Subject Status does not contain details about the circumstances
of a subject's status. The response to the status assessment
may trigger collection of additional details but those details
are to be stored in appropriate separate domains. For example,
@@ -45,15 +47,16 @@ Authorities:
Item: Assumption 1
Section: 6.3.15
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0172
- Version: '2'
- Version: '2.0'
+ Version: "2"
+ Version: "2.0"
Citations:
- - Cited Guidance: Subject Status does not contain details about the circumstances
+ - Cited Guidance:
+ Subject Status does not contain details about the circumstances
of a subject's status. The response to the status assessment
may trigger collection of additional details but those details
are to be stored in appropriate separate domains. For example,
@@ -76,7 +79,7 @@ Check:
Core:
Id: CORE-000178
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when SSSTRESC = 'DEAD' and SSDTC < max DS.DSSTDTC.
Executability: Fully Executable
Operations:
diff --git a/Deprecated/CORE-000181/rule.yml b/Deprecated/CORE-000181/rule.yml
index 1ea68f131..b7d0e7508 100644
--- a/Deprecated/CORE-000181/rule.yml
+++ b/Deprecated/CORE-000181/rule.yml
@@ -1,5 +1,5 @@
# Variable: DOMAIN
-# Condition:
+# Condition:
# Rule: DOMAIN value length = 4
Authorities:
- Organization: CDISC
@@ -7,42 +7,45 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Each domain dataset is distinguished by a unique, two-character
+ - Cited Guidance:
+ Each domain dataset is distinguished by a unique, two-character
code
Document: IG v3.4
- Section: '2.2'
+ Section: "2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0309
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Each domain dataset is distinguished by a unique, two-character
+ - Cited Guidance:
+ Each domain dataset is distinguished by a unique, two-character
code
Document: IG v3.2
- Section: '2.2'
+ Section: "2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0309
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Each domain dataset is distinguished by a unique, two-character
+ - Cited Guidance:
+ Each domain dataset is distinguished by a unique, two-character
code
Document: IG v3.3
- Section: '2.2'
+ Section: "2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0309
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: DOMAIN
@@ -51,7 +54,7 @@ Check:
Core:
Id: CORE-000181
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AP-- domain value length is not equal to 4.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000188/rule.yml b/Deprecated/CORE-000188/rule.yml
index 0935a689e..f91351d4a 100644
--- a/Deprecated/CORE-000188/rule.yml
+++ b/Deprecated/CORE-000188/rule.yml
@@ -5,52 +5,56 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0191
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The domain pair uses DOMAIN as an Identifier to group
+ - Cited Guidance:
+ The domain pair uses DOMAIN as an Identifier to group
parent records (e.g., MB) from child records (e.g., MS) and enables
a dataset-level relationship to be described in RELREC.
Document: IG v3.4
Item: Item 1, bullet 5
- Section: '2.6'
- - Cited Guidance: MS is used for representing data from drug susceptibility
+ Section: "2.6"
+ - Cited Guidance:
+ MS is used for representing data from drug susceptibility
testing on the organisms identified in MB.
Document: IG v3.4
Section: 6.3.5.4
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0191
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: '2.6[Item 1, Bullet 5][The domain pair uses DOMAIN
+ - Cited Guidance:
+ "2.6[Item 1, Bullet 5][The domain pair uses DOMAIN
as an Identifier to group parent records (e.g., MB) from child records
(e.g., MS) and enables a dataset-level relationship to be described
in RELREC.]|6.3[MS Assumption 1][Definition: The MS domain is designed
to store any findings related to the organisms found and submitted
- in MB.]'
+ in MB.]"
Document: IG v3.2
Item: 2.6[Item 1, Bullet 5]|6.3[MS Assumption 1]
Section: 2.6|6.3
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0191
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: 2.6[Item 1][The domain pair uses DOMAIN as an Identifier
+ - Cited Guidance:
+ 2.6[Item 1][The domain pair uses DOMAIN as an Identifier
to group parent records (e.g., MB) from child records (e.g., MS)
and enables a dataset-level relationship to be described in RELREC.]|6.3.7[MS
is used for representing data from drug susceptibility testing on
@@ -67,7 +71,7 @@ Check:
Core:
Id: CORE-000188
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error if MS dataset is present and MB dataset is not present.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000193/rule.yml b/Deprecated/CORE-000193/rule.yml
index f442688e0..f58f9ea3d 100644
--- a/Deprecated/CORE-000193/rule.yml
+++ b/Deprecated/CORE-000193/rule.yml
@@ -5,29 +5,31 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0503
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The start date/time of the Disease Milestone Instance
+ - Cited Guidance:
+ The start date/time of the Disease Milestone Instance
Name in MIDS.
Document: Model v2.0
Item: MIDSDTC
Section: Timing
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0503
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: The start date/time of the Disease Milestone Instance
+ - Cited Guidance:
+ The start date/time of the Disease Milestone Instance
Name in MIDS.
Document: Model v1.7
Item: MIDSDTC
@@ -41,8 +43,9 @@ Check:
Core:
Id: CORE-000193
Status: Published
- Version: '1'
-Description: Raise an error when variable MIDSDTC is present and MIDS variable is
+ Version: "1"
+Description:
+ Raise an error when variable MIDSDTC is present and MIDS variable is
missing.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000211/rule.yml b/Deprecated/CORE-000211/rule.yml
index c9d5bd064..ec677c744 100644
--- a/Deprecated/CORE-000211/rule.yml
+++ b/Deprecated/CORE-000211/rule.yml
@@ -1,5 +1,5 @@
# Variable: QNAM
-# Condition:
+# Condition:
# Rule: ADSL Population flags not in SUPPDM
Authorities:
- Organization: CDISC
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The standard Supplemental Qualifiers included in previous
+ - Cited Guidance:
+ The standard Supplemental Qualifiers included in previous
versions of the SDTMIG (COMPLT, FULLSET, ITT, PPROT, and
SAFETY) should not be used. Note that the ADaM subject-level
analysis dataset (ADSL) specifies standard variable names for
@@ -17,17 +18,18 @@ Authorities:
variables.
Document: IG v3.4
Item: Assumption 5
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0528
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The standard Supplemental Qualifiers included in previous
+ - Cited Guidance:
+ The standard Supplemental Qualifiers included in previous
versions of the SDTMIG (COMPLT; FULLSET; ITT; PPROT; and
SAFETY) should not be used. Note that the ADaM subject-level
analysis dataset (ADSL) specifies standard variable names for
@@ -37,13 +39,13 @@ Authorities:
variables.
Document: IG v3.3
Item: Assumption 5
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0528
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: RDOMAIN
@@ -55,7 +57,7 @@ Check:
Core:
Id: CORE-000211
Status: Published
- Version: '1'
+ Version: "1"
Description: SUPPDM must not include population flags.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000215/rule.yml b/Deprecated/CORE-000215/rule.yml
index ef860be06..d448fdd04 100644
--- a/Deprecated/CORE-000215/rule.yml
+++ b/Deprecated/CORE-000215/rule.yml
@@ -7,12 +7,14 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: DSSCAT = 'STUDY TREATMENT' can be used as a generic identifier
+ - Cited Guidance:
+ DSSCAT = 'STUDY TREATMENT' can be used as a generic identifier
when a study has only a single treatment.
Document: IG v3.4
Item: Assumption 2.b.2
Section: 6.2.3
- - Cited Guidance: If a study has multiple treatments, then DSSCAT should name the
+ - Cited Guidance:
+ If a study has multiple treatments, then DSSCAT should name the
individual treatment.
Document: IG v3.4
Item: Assumption 2.b.3
@@ -20,13 +22,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0539
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Assumption 2.b.2[DSSCAT = 'STUDY TREATMENT' can be used as a
+ - Cited Guidance:
+ Assumption 2.b.2[DSSCAT = 'STUDY TREATMENT' can be used as a
generic identifier when a study has only a single
treatment.]|Assumption 2.b.3[If a study has multiple
treatments, then DSSCAT should name the individual treatment.]
@@ -36,9 +39,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0539
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: $disposition_event_count
@@ -56,7 +59,7 @@ Check:
Core:
Id: CORE-000215
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when subject has more than one record per Epoch with
DSCAT = 'DISPOSITION EVENT' and more than one record where DSSCAT = 'STUDY
TREATMENT'
diff --git a/Deprecated/CORE-000216/rule.yml b/Deprecated/CORE-000216/rule.yml
index 57947caa0..862cf7dc7 100644
--- a/Deprecated/CORE-000216/rule.yml
+++ b/Deprecated/CORE-000216/rule.yml
@@ -5,35 +5,37 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0545
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: For Disease Milestones that can occur only once (TMRPT = "N")
+ - Cited Guidance:
+ For Disease Milestones that can occur only once (TMRPT = "N")
the value of MIDS may be the value in MIDSTYPE or may an
abbreviated version.
Document: IG v3.4
Item: Assumption 2.a
- Section: '5.4'
+ Section: "5.4"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0545
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: For Disease Milestones that can occur only once (TMRPT = "N")
+ - Cited Guidance:
+ For Disease Milestones that can occur only once (TMRPT = "N")
the value of MIDS may be the value in MIDSTYPE or may an
abbreviated version.
Document: IG v3.4
Item: Assumption 2.a
- Section: '5.5'
+ Section: "5.5"
Check:
all:
- name: MIDSTYPE
@@ -48,7 +50,7 @@ Check:
Core:
Id: CORE-000216
Status: Published
- Version: '1'
+ Version: "1"
Description: MIDSTYPE must be unique within subject when MIDSTYPE = TM.MIDSTYPE
and TM.TMRPT = 'N'
Executability: Fully Executable
diff --git a/Deprecated/CORE-000226/rule.yml b/Deprecated/CORE-000226/rule.yml
index f7349d2ba..25fb2ba9f 100644
--- a/Deprecated/CORE-000226/rule.yml
+++ b/Deprecated/CORE-000226/rule.yml
@@ -1,5 +1,5 @@
# Variable: --DTHREL
-# Condition:
+# Condition:
# Rule: --DTHREL not present in dataset
Authorities:
- Organization: CDISC
@@ -7,52 +7,55 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables, defined for use in non-clinical
+ - Cited Guidance:
+ "The following SDTM variables, defined for use in non-clinical
studies (SEND), must NEVER be used in the submission of
SDTM-based data for human clinical trials: --DTHREL (Findings)
- --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)'
+ --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)"
Document: Model v1.4
- Item: ' '
- Section: '2.7'
+ Item: " "
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0352
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical
+ - Cited Guidance:
+ "The following SDTM variables; defined for use in non-clinical
studies (SEND); must NEVER be used in the submission of
SDTM-based data for human clinical trials: --DTHREL (Findings)
- --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)'
+ --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)"
Document: IG v3.2
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0352
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical
+ - Cited Guidance:
+ "The following SDTM variables; defined for use in non-clinical
studies (SEND); must NEVER be used in the submission of
SDTM-based data for human clinical trials: --USCHFL
(Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL
(Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID
(Identifiers) --DETECT (Timing Variables) --NOMDY (Timing
- Variables) --NOMLBL (Timing Variables)'
+ Variables) --NOMLBL (Timing Variables)"
Document: IG v3.3
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0352
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: --DTHREL
@@ -60,7 +63,7 @@ Check:
Core:
Id: CORE-000226
Status: Published
- Version: '1'
+ Version: "1"
Description: Verifying presence of SEND variable --DTHREL
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000229/rule.yml b/Deprecated/CORE-000229/rule.yml
index a67292bab..ea9c6f5be 100644
--- a/Deprecated/CORE-000229/rule.yml
+++ b/Deprecated/CORE-000229/rule.yml
@@ -15,9 +15,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0361
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -27,9 +27,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0361
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -39,9 +39,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0361
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: USUBJID
@@ -51,7 +51,7 @@ Check:
Core:
Id: CORE-000229
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify that When USUBJID is populated, POOLID is not populated
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000230/rule.yml b/Deprecated/CORE-000230/rule.yml
index d4dce7312..a5bb11866 100644
--- a/Deprecated/CORE-000230/rule.yml
+++ b/Deprecated/CORE-000230/rule.yml
@@ -18,21 +18,21 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0362
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Either USUBJID or POOLID must be populated.
Document: Model v1.4
- Section: ''
+ Section: ""
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0362
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -42,9 +42,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0362
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: POOLID
@@ -54,7 +54,7 @@ Check:
Core:
Id: CORE-000230
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify that when POOLID is populated, USUBJID is not populated
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000231/rule.yml b/Deprecated/CORE-000231/rule.yml
index 3485c4c32..379a2e42d 100644
--- a/Deprecated/CORE-000231/rule.yml
+++ b/Deprecated/CORE-000231/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifier used to identify a related subject or pool of
+ - Cited Guidance:
+ Identifier used to identify a related subject or pool of
subjects. RSUBJID will be populated with either the USUBJID of
the related subject or the POOLID of the related pool.
Document: Model v2.0
@@ -16,13 +17,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0363
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifier used to identify a related subject or pool of
+ - Cited Guidance:
+ Identifier used to identify a related subject or pool of
subjects. RSUBJID will be populated with either the USUBJID of
the related subject or the POOLID of the related pool.
Document: Model v1.4
@@ -30,13 +32,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0363
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifier used to identify a related subject or pool of
+ - Cited Guidance:
+ Identifier used to identify a related subject or pool of
subjects. RSUBJID will be populated with either the USUBJID of
the related subject or the POOLID of the related pool.
Document: Model v1.7
@@ -44,9 +47,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0363
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: RSUBJID
@@ -57,7 +60,7 @@ Check:
Core:
Id: CORE-000231
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify that when RSUBJID populated, RSUBJID does not equal USUBJID
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000232/rule.yml b/Deprecated/CORE-000232/rule.yml
index 398c668db..249dbeb82 100644
--- a/Deprecated/CORE-000232/rule.yml
+++ b/Deprecated/CORE-000232/rule.yml
@@ -5,44 +5,47 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0364
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Identifier used to identify a related subject or pool
+ - Cited Guidance:
+ Identifier used to identify a related subject or pool
of subjects. RSUBJID will be populated with either the USUBJID
of the related subject or the POOLID of the related pool.
Document: Model v2.0
Item: RSUBJID
Section: RELSUB
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0364
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Identifier used to identify a related subject or pool
+ - Cited Guidance:
+ Identifier used to identify a related subject or pool
of subjects. RSUBJID will be populated with either the USUBJID of
the related subject or the POOLID of the related pool.
Document: Model v1.4
Section: 4.1.4
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0364
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Identifier used to identify a related subject or pool
+ - Cited Guidance:
+ Identifier used to identify a related subject or pool
of subjects. RSUBJID will be populated with either the USUBJID of
the related subject or the POOLID of the related pool.
Document: Model v1.7
@@ -57,7 +60,7 @@ Check:
Core:
Id: CORE-000232
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify when RSUBJID is populated it does not equal POOLID
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000233/rule.yml b/Deprecated/CORE-000233/rule.yml
index 7adc43728..89731148d 100644
--- a/Deprecated/CORE-000233/rule.yml
+++ b/Deprecated/CORE-000233/rule.yml
@@ -5,48 +5,51 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0365
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Associated Persons (AP) are persons other than study
+ - Cited Guidance:
+ Associated Persons (AP) are persons other than study
subjects who can be associated with a study, a particular study
subject, or a device used in the study.
Document: Model v2.0
- Item: ' '
+ Item: " "
Section: Associated Persons
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0365
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Associated Persons (AP) are persons who can be associated
+ - Cited Guidance:
+ Associated Persons (AP) are persons who can be associated
with a study; a particular study subject or a device used in the
study.
Document: Model v1.4
Section: 5.1.1
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0365
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Associated Persons (AP) are persons who can be associated
+ - Cited Guidance:
+ Associated Persons (AP) are persons who can be associated
with a study; a particular study subject or a device used in the
study.
Document: Model v1.7
- Section: '6.1'
+ Section: "6.1"
Check:
all:
- name: RSUBJID
@@ -56,12 +59,14 @@ Check:
Core:
Id: CORE-000233
Status: Published
- Version: '1'
-Description: Related Device Identifier (RDEVID) and Related Subject or Pool Identifier
+ Version: "1"
+Description:
+ Related Device Identifier (RDEVID) and Related Subject or Pool Identifier
(RSUBJID) should not both be populated for the same record.
Executability: Fully Executable
Outcome:
- Message: RDEVID must be empty when RSUBJID is populated and RSUBJID must be empty
+ Message:
+ RDEVID must be empty when RSUBJID is populated and RSUBJID must be empty
when RDEVID is populated
Output Variables:
- RSUBJID
diff --git a/Deprecated/CORE-000234/rule.yml b/Deprecated/CORE-000234/rule.yml
index a66f247c6..1d6675467 100644
--- a/Deprecated/CORE-000234/rule.yml
+++ b/Deprecated/CORE-000234/rule.yml
@@ -5,48 +5,51 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0366
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Associated Persons (AP) are persons other than study
+ - Cited Guidance:
+ Associated Persons (AP) are persons other than study
subjects who can be associated with a study, a particular study
subject, or a device used in the study.
Document: Model v2.0
- Item: ' '
+ Item: " "
Section: Associated Persons
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0366
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Associated Persons (AP) are persons who can be associated
+ - Cited Guidance:
+ Associated Persons (AP) are persons who can be associated
with a study; a particular study subject or a device used in the
study.
Document: Model v1.4
Section: 5.1.1
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0366
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Associated Persons (AP) are persons who can be associated
+ - Cited Guidance:
+ Associated Persons (AP) are persons who can be associated
with a study; a particular study subject or a device used in the
study.
Document: Model v1.7
- Section: '6.1'
+ Section: "6.1"
Check:
all:
- name: RDEVID
@@ -56,7 +59,7 @@ Check:
Core:
Id: CORE-000234
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify that RSUBJID is empty when RDEVID is populated
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000235/rule.yml b/Deprecated/CORE-000235/rule.yml
index 5eaaa0a15..2ae07b9e8 100644
--- a/Deprecated/CORE-000235/rule.yml
+++ b/Deprecated/CORE-000235/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifier for a related study subject or pool of study
+ - Cited Guidance:
+ Identifier for a related study subject or pool of study
subjects. The subject(s) may be human or animal. RSUBJID will
be populated with the USUBJID of the related subject or the
POOLID of the related pool. RSUBJID will be null for data
@@ -19,13 +20,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0367
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifier for a related study subject or pool of study
+ - Cited Guidance:
+ Identifier for a related study subject or pool of study
subjects. The subject(s) may be human or animal. RSUBJID will
be populated with the USUBJID of the related subject or the
POOLID of the related pool. RSUBJID will be null for data
@@ -36,13 +38,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0367
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifier for a related subject or pool of subjects. RSUBJID
+ - Cited Guidance:
+ Identifier for a related subject or pool of subjects. RSUBJID
may be populated with the USUBJID of the related subject or
the POOLID of the related pool. RSUBJID will be null for data
about associated persons who are related to the study but not
@@ -52,9 +55,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0367
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: RSUBJID
@@ -68,7 +71,7 @@ Check:
Core:
Id: CORE-000235
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify that RSUBJID=DM.USUBJID when RSUBJID is populated and
RSUBJID is not equal to POOLID
Executability: Fully Executable
diff --git a/Deprecated/CORE-000251/rule.yml b/Deprecated/CORE-000251/rule.yml
index 97ffb764b..a6f9cfbf0 100644
--- a/Deprecated/CORE-000251/rule.yml
+++ b/Deprecated/CORE-000251/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For example, if a subject's survival status is "DEAD", the date
+ - Cited Guidance:
+ For example, if a subject's survival status is "DEAD", the date
of death must be stored in DM and within a final disposition
record in DS.
Document: SDTMIG v3.4
@@ -16,13 +17,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0067
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For example, if a subject's Survival Status is "DEAD", the date
+ - Cited Guidance:
+ For example, if a subject's Survival Status is "DEAD", the date
of death must be stored in DM and within a final disposition
record in DS.
Document: SDTMIG v3.3
@@ -31,66 +33,70 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0067
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For example, if a subject's Survival Status is "DEAD", the date
+ - Cited Guidance:
+ For example, if a subject's Survival Status is "DEAD", the date
of death must be stored in DM and within a final disposition
record in DS.
Document: SDTMIG v3.2
Item: Assumption 2
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0067
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
#CG0067 is identical to rule FB0614. Added metadata for FB0614 by Malini Narreddy on 2025-03-07
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0614
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0614
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0614
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: SSSTRESC
@@ -104,7 +110,7 @@ Check:
Core:
Id: CORE-000251
Status: Published
- Version: '1'
+ Version: "1"
Description: When survival status is completed as 'DEAD' in the SS dataset then
a record should be present in the DS dataset where DSDECOD = 'DEATH' for the
corresponding subject.
@@ -117,7 +123,8 @@ Operations:
name: DSDECOD
operator: distinct
Outcome:
- Message: SSTRESC in SS dataset is "DEAD", but a record is missing in DS dataset
+ Message:
+ SSTRESC in SS dataset is "DEAD", but a record is missing in DS dataset
where DSDECOD = "DEATH".
Output Variables:
- SSSTRESC
diff --git a/Deprecated/CORE-000259/rule.yml b/Deprecated/CORE-000259/rule.yml
index e56701308..e8b05074f 100644
--- a/Deprecated/CORE-000259/rule.yml
+++ b/Deprecated/CORE-000259/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Subject Status does not contain details about the circumstances
+ - Cited Guidance:
+ Subject Status does not contain details about the circumstances
of a subject's status. The response to the status assessment
may trigger collection of additional details, but those
details are to be stored in appropriate separate domains. For
@@ -21,13 +22,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0171
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Subject Status does not contain details about the circumstances
+ - Cited Guidance:
+ Subject Status does not contain details about the circumstances
of a subject's status. The response to the status assessment
may trigger collection of additional details but those details
are to be stored in appropriate separate domains. For example,
@@ -41,13 +43,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0171
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Subject Status does not contain details about the circumstances
+ - Cited Guidance:
+ Subject Status does not contain details about the circumstances
of a subject's status. The response to the status assessment
may trigger collection of additional details but those details
are to be stored in appropriate separate domains. For example,
@@ -61,51 +64,54 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0171
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
#CG0171 is identical to rule FB0613. Added metadata for FB0613 on 2025-01-20
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0613
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0613
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0613
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: SSSTRESC
@@ -118,7 +124,7 @@ Check:
Core:
Id: CORE-000259
Status: Published
- Version: '1'
+ Version: "1"
Description: Date/time of collection of subject status in SS dataset where
survival status (SSSTRESC) = 'DEAD' should be equal to or after the Date/Time
of Death (DTHDTC) in the DM dataset for the corresponding subject. #Message has been updated as per the FDA Business Rules Spreadsheet.
@@ -128,7 +134,8 @@ Match Datasets:
- USUBJID
Name: DM
Outcome:
- Message: SSDTC in SS dataset where SSTRESC = 'DEAD' is not equal to or after the
+ Message:
+ SSDTC in SS dataset where SSTRESC = 'DEAD' is not equal to or after the
DTHDTC in the DM dataset. #Error message has been updated as per the FDA Business Rules Spreadsheet.
Output Variables:
- SSSTRESC
diff --git a/Deprecated/CORE-000264/rule.yml b/Deprecated/CORE-000264/rule.yml
index efd52702f..42434c7da 100644
--- a/Deprecated/CORE-000264/rule.yml
+++ b/Deprecated/CORE-000264/rule.yml
@@ -5,15 +5,16 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0039
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Dictionary derived. Body system or organ class used
+ - Cited Guidance:
+ Dictionary derived. Body system or organ class used
by the sponsor from the coding dictionary (e.g., MedDRA). When using
a multi-axial dictionary such as MedDRA, this should contain the
SOC used for the sponsor's analyses and summary tables which may
@@ -21,21 +22,23 @@ Authorities:
Document: SDTMIG v3.4
Item: Specification
Section: 6.2.1
- - Cited Guidance: Body system or system organ class assigned for analysis
+ - Cited Guidance:
+ Body system or system organ class assigned for analysis
from a standard hierarchy (e.g. MedDRA) associated with an event.
Document: Model v2.0
Item: --BODSYS
Section: Events
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0039
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Dictionary derived. Body system or organ class used
+ - Cited Guidance:
+ Dictionary derived. Body system or organ class used
by the sponsor from the coding dictionary (e.g., MedDRA). When using
a multi-axial dictionary such as MedDRA, this should contain the
SOC used for the sponsor's analyses and summary tables which may
@@ -43,21 +46,23 @@ Authorities:
Document: SDTMIG v3.3
Item: Specification
Section: 6.2.1
- - Cited Guidance: Body system or system organ class assigned for analysis
+ - Cited Guidance:
+ Body system or system organ class assigned for analysis
from a standard hierarchy (e.g. MedDRA) associated with an event.
Document: Model v1.7
Item: Table 2.2.2.1 --BODSYS
Section: 2.2.2
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0039
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Dictionary derived. Body system or organ class used
+ - Cited Guidance:
+ Dictionary derived. Body system or organ class used
by the sponsor from the coding dictionary (e.g., MedDRA). When using
a multi-axial dictionary such as MedDRA, this should contain the
SOC used for the sponsor's analyses and summary tables which may
@@ -65,7 +70,8 @@ Authorities:
Document: SDTMIG v3.3
Item: Specification
Section: 6.2 AE
- - Cited Guidance: Body system or system organ class assigned for analysis
+ - Cited Guidance:
+ Body system or system organ class assigned for analysis
from a standard hierarchy (e. g. MedDRA) associated with an event.
Document: Model v1.4
Item: Table 2.2.2.1 --BODSYS
@@ -78,8 +84,9 @@ Check:
Core:
Id: CORE-000264
Status: Published
- Version: '1'
-Description: Raise an error if primary SOC is used for analysis and -BODSYS is not
+ Version: "1"
+Description:
+ Raise an error if primary SOC is used for analysis and -BODSYS is not
equal to -SOC
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000292/rule.yml b/Deprecated/CORE-000292/rule.yml
index 346ef0ed3..2d99a2e1e 100644
--- a/Deprecated/CORE-000292/rule.yml
+++ b/Deprecated/CORE-000292/rule.yml
@@ -5,46 +5,49 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0107
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: "\"When the EC domain is implemented in conjunction\
+ - Cited Guidance:
+ "\"When the EC domain is implemented in conjunction\
\ with the EX domain, EXVAMT and EXVAMTU should not be used in EX;\n\
\ collected values instead would be represented in ECDOSE and ECDOSU.\""
Document: IG v3.4
Item: Assumption 6c
Section: 6.1.3.1
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0107
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: When the EC domain (See Section 6.1.2.3) is implemented
+ - Cited Guidance:
+ When the EC domain (See Section 6.1.2.3) is implemented
in conjunction with the EX domain, EXVAMT and EXVAMTU should not
be used in EX; collected values instead would be represented in
ECDOSE and ECDOSU
Document: IG v3.2
Item: Assumption 6c
- Section: '6.1'
+ Section: "6.1"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0107
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: When the EC domain (See Section 6.1.2.3) is implemented
+ - Cited Guidance:
+ When the EC domain (See Section 6.1.2.3) is implemented
in conjunction with the EX domain, EXVAMT and EXVAMTU should not
be used in EX; collected values instead would be represented in
ECDOSE and ECDOSU
@@ -61,7 +64,7 @@ Check:
Core:
Id: CORE-000292
Status: Published
- Version: '1'
+ Version: "1"
Description: When EC exists, EXVAMTU should not be used.
Executability: Fully Executable
Operations:
diff --git a/Deprecated/CORE-000297/rule.yml b/Deprecated/CORE-000297/rule.yml
index cb5406cb2..6a2d9a22e 100644
--- a/Deprecated/CORE-000297/rule.yml
+++ b/Deprecated/CORE-000297/rule.yml
@@ -5,15 +5,16 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0501
- Version: '2'
- Version: '2.0'
+ Version: "2"
+ Version: "2.0"
Citations:
- - Cited Guidance: The name of a specific instance of a Disease Milestone
+ - Cited Guidance:
+ The name of a specific instance of a Disease Milestone
Type (MIDSTYPE) described in the Trial Disease Milestones dataset
(see Section 5.1.4.3, Trial Disease Milestones). This should be
unique within a subject. Used only in conjunction with RELMIDS and
@@ -22,15 +23,16 @@ Authorities:
Item: MIDS
Section: Timing
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0501
- Version: '2'
- Version: '2.0'
+ Version: "2"
+ Version: "2.0"
Citations:
- - Cited Guidance: The name of a specific instance of a Disease Milestone
+ - Cited Guidance:
+ The name of a specific instance of a Disease Milestone
Type (MIDSTYPE) described in the Trial Disease Milestones dataset
(see Section 3.5, Trial Disease Milestones). This should be unique
within a subject. Used only in conjunction with RELMIDS and MIDSDTC.
@@ -47,8 +49,9 @@ Check:
Core:
Id: CORE-000297
Status: Published
- Version: '1'
-Description: Raise an error when variable MIDS is present in any of the dataset and
+ Version: "1"
+Description:
+ Raise an error when variable MIDS is present in any of the dataset and
TM dataset is missing.
Executability: Fully Executable
Operations:
diff --git a/Deprecated/CORE-000322/rule.yml b/Deprecated/CORE-000322/rule.yml
index 43621b190..3985cea7d 100644
--- a/Deprecated/CORE-000322/rule.yml
+++ b/Deprecated/CORE-000322/rule.yml
@@ -5,20 +5,21 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0066
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: d. When DSCAT='PROTOCOL MILESTONE', DSTERM and DSDECOD
+ - Cited Guidance:
+ d. When DSCAT='PROTOCOL MILESTONE', DSTERM and DSDECOD
will contain the same value drawn from the sponsor's controlled
terminology.
Document: IG v3.2
Item: Assumption 3d
- Section: '6.2'
+ Section: "6.2"
Check:
all:
- name: DSCAT
@@ -31,8 +32,9 @@ Check:
Core:
Id: CORE-000322
Status: Published
- Version: '1'
-Description: When DSCAT equals PROTOCOL MILESTONE, then DSTERM should be equal to
+ Version: "1"
+Description:
+ When DSCAT equals PROTOCOL MILESTONE, then DSTERM should be equal to
DSDECOD
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000326/rule.yml b/Deprecated/CORE-000326/rule.yml
index 41c7cb2bb..5b01f4d2f 100644
--- a/Deprecated/CORE-000326/rule.yml
+++ b/Deprecated/CORE-000326/rule.yml
@@ -1,5 +1,5 @@
# Variable: EXMETHOD
-# Condition:
+# Condition:
# Rule: EXMETHOD not present in dataset
Authorities:
- Organization: CDISC
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Method of administration of the treatment. Not to be used with
+ - Cited Guidance:
+ Method of administration of the treatment. Not to be used with
human clinical trials.
Document: Model v1.7
Item: EXMETHOD
@@ -15,9 +16,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0568
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: EXMETHOD
@@ -25,7 +26,7 @@ Check:
Core:
Id: CORE-000326
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when EXMETHOD exists in the EX dataset for human clinical trials
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000329/rule.yml b/Deprecated/CORE-000329/rule.yml
index b1d9ebe3f..90894ec81 100644
--- a/Deprecated/CORE-000329/rule.yml
+++ b/Deprecated/CORE-000329/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'A sponsor may collect one disposition event for the trial as a
+ - Cited Guidance:
+ "A sponsor may collect one disposition event for the trial as a
whole, or they may collect disposition for each Epoch of the
trial. When disposition is collected for each Epoch, the
variable EPOCH should be included in the DS dataset. When
@@ -18,16 +19,16 @@ Authorities:
general-observation-class domains, where EPOCH, as a Timing
variable, is the name of the Epoch during which --STDTC or
--DTC falls. The values of EPOCH are drawn from the Trial Arms
- domain, Section 7.2 - Experimental Design: Trial Arms (TA)'
+ domain, Section 7.2 - Experimental Design: Trial Arms (TA)"
Document: IG v3.2
- Item: 'DS Assumption 3.C:'
- Section: '6.2'
+ Item: "DS Assumption 3.C:"
+ Section: "6.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0063
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: DSCAT
@@ -42,7 +43,7 @@ Check:
Core:
Id: CORE-000329
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when multiple records within same USUBJID exist with
DSCAT = DISPOSITION EVENT but EPOCH is empty
Executability: Fully Executable
diff --git a/Deprecated/CORE-000330/rule.yml b/Deprecated/CORE-000330/rule.yml
index 26aa4c971..fffd0939d 100644
--- a/Deprecated/CORE-000330/rule.yml
+++ b/Deprecated/CORE-000330/rule.yml
@@ -7,20 +7,21 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Data for screen failure subjects, if submitted, should be
+ - Cited Guidance:
+ Data for screen failure subjects, if submitted, should be
included in the Demographics dataset, with ARMCD = "SCRNFAIL'
and ARM = "Screen Failure". Subjects withdrawn from a trial
before assignment to an Arm, if they are not screen failures,
should have ARMCD ='NOTASSGN' and ARM = 'Not Assigned'.
Document: IG v3.2
Item: Assumption 4
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0122
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ARM
@@ -36,7 +37,7 @@ Check:
Core:
Id: CORE-000330
Status: Published
- Version: '1'
+ Version: "1"
Description: 'ACTARM value must match ARM value in Demographics when ARM equals
"Screen Failure" or "Not Assigned"'
Executability: Fully Executable
diff --git a/Deprecated/CORE-000331/rule.yml b/Deprecated/CORE-000331/rule.yml
index 1d1f3bf9d..4c2c9fd20 100644
--- a/Deprecated/CORE-000331/rule.yml
+++ b/Deprecated/CORE-000331/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Code of actual Arm. When an Arm is not planned (not in Trial
+ - Cited Guidance:
+ Code of actual Arm. When an Arm is not planned (not in Trial
Arms), ACTARMCD will be UNPLAN. Randomized subjects who were
not treated will be given a value of NOTTRT. Values should be
"SCRNFAIL" for screen failures and "NOTASSGN" for subjects not
@@ -15,14 +16,15 @@ Authorities:
all other cases
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0124
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
- Citations:
- - Cited Guidance: Code of actual Arm. When an Arm is not planned (not in Trial
+ - Cited Guidance:
+ Code of actual Arm. When an Arm is not planned (not in Trial
Arms), ACTARMCD will be UNPLAN. Randomized subjects who were
not treated will be given a value of NOTTRT. Values should be
"SCRNFAIL" for screen failures and "NOTASSGN" for subjects not
@@ -30,13 +32,13 @@ Authorities:
all other cases
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0125
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ACTARMCD
@@ -52,7 +54,7 @@ Check:
Core:
Id: CORE-000331
Status: Published
- Version: '1'
+ Version: "1"
Description: 'ACTARMCD values in Demographics are restricted to ARMCD values in
Trial Arms when ACTARMCD is not equal to "SCRNFAIL", "NOTASSGN", "NOTTRT", or
"UNPLAN"'
@@ -63,8 +65,8 @@ Operations:
name: ARMCD
operator: distinct
Outcome:
- Message: 'DM.ACTARMCD must equal SCRNFAIL, NOTASSGN, NOTTRT, or UNPLAN if the
- value is not present in TA.ARMCD'
+ Message: "DM.ACTARMCD must equal SCRNFAIL, NOTASSGN, NOTTRT, or UNPLAN if the
+ value is not present in TA.ARMCD"
Output Variables:
- ACTARMCD
#- $armcd_list
diff --git a/Deprecated/CORE-000332/rule.yml b/Deprecated/CORE-000332/rule.yml
index b40fa93e3..53c88f351 100644
--- a/Deprecated/CORE-000332/rule.yml
+++ b/Deprecated/CORE-000332/rule.yml
@@ -8,40 +8,41 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: MBRESCAT is expected in all records where a microorganism has
+ - Cited Guidance:
+ MBRESCAT is expected in all records where a microorganism has
been identified to differentiate between colonizing organisms
and the one(s) that are causing the infection. It is not
expected when there is 'No growth' or when the results are
from a gram stain
Document: IG v3.2
Item: Assumption 6
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0193
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
# IMPLEMENTATION: WHEN: MBTESTCD = 'ORGANISM' and MBSTRESC != 'NO GROWTH' and MBMETHOD != 'GRAM STAIN'
# THEN:
Check:
all:
- name: MBTESTCD
operator: equal_to
- value: 'ORGANISM'
+ value: "ORGANISM"
- name: MBSTRESC
operator: not_equal_to_case_insensitive
- value: 'NO GROWTH'
+ value: "NO GROWTH"
- name: MBMETHOD
operator: not_equal_to_case_insensitive
- value: 'GRAM STAIN'
+ value: "GRAM STAIN"
- name: MBRESCAT
operator: empty
Core:
Id: CORE-000332
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when MBTESTCD=ORGANISM, MSSTRESC!='NO GROWTH',
MBMETHOD!='GRAM STAIN' and MBRESCAT is empty
Executability: Fully Executable
diff --git a/Deprecated/CORE-000333/rule.yml b/Deprecated/CORE-000333/rule.yml
index 497981058..ec8efb95c 100644
--- a/Deprecated/CORE-000333/rule.yml
+++ b/Deprecated/CORE-000333/rule.yml
@@ -14,22 +14,22 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0215
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Protocol-defined description of clinical encounter.
Document: IG v3.3
Item: Specification
- Section: '5.5'
+ Section: "5.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0215
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
@@ -44,8 +44,8 @@ Check:
Core:
Id: CORE-000333
Status: Published
- Version: '1'
-Description: 'Raise an error when SVUPDES is null and SV.VISIT is not in TV.VISIT'
+ Version: "1"
+Description: "Raise an error when SVUPDES is null and SV.VISIT is not in TV.VISIT"
Executability: Partially Executable - Possible Overreporting
Operations:
- domain: TV
diff --git a/Deprecated/CORE-000335/rule.yml b/Deprecated/CORE-000335/rule.yml
index e56b38bff..e7f167089 100644
--- a/Deprecated/CORE-000335/rule.yml
+++ b/Deprecated/CORE-000335/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.2[7.4][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.2[7.4][Assumption 3][Further information about the
parameters is included below in Table 1. TSVAL may have
controlled terminology depending on the value of TSPARMCD]|IG
v3.2[Appendix C1][Required only when there is only one
@@ -21,13 +22,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0280
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.3[7.4.2][Assumption 3][Further information about the
parameters is included Appendix C1, Trial Summary Codes. TSVAL
may have controlled terminology depending on the value of
TSPARMCD. Conditions for including parameters are included in
@@ -43,9 +45,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0280
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -62,7 +64,7 @@ Check:
Core:
Id: CORE-000335
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TSPARMCD = "RANDQT" and the value provided in
TSVAL is not a number between 0 and 1.
Executability: Fully Executable
diff --git a/Deprecated/CORE-000338/rule.yml b/Deprecated/CORE-000338/rule.yml
index 7cb178b39..6571aa323 100644
--- a/Deprecated/CORE-000338/rule.yml
+++ b/Deprecated/CORE-000338/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
@@ -16,24 +17,25 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0457
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0457
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -45,7 +47,7 @@ Check:
Core:
Id: CORE-000338
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TSPARMCD = "ACTSUB" and the value provided in
TSVAL is not an integer greater than 0.
Executability: Fully Executable
diff --git a/Deprecated/CORE-000339/rule.yml b/Deprecated/CORE-000339/rule.yml
index fc1c5766a..925f4a92e 100644
--- a/Deprecated/CORE-000339/rule.yml
+++ b/Deprecated/CORE-000339/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
@@ -16,24 +17,25 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0456
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0456
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -45,7 +47,7 @@ Check:
Core:
Id: CORE-000339
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TSPARMCD = FCNTRY and TSVCDREF is not equal to
'ISO 3166-1 alpha-3'
Executability: Fully Executable
diff --git a/Deprecated/CORE-000340/rule.yml b/Deprecated/CORE-000340/rule.yml
index 068ae44cb..269fbf347 100644
--- a/Deprecated/CORE-000340/rule.yml
+++ b/Deprecated/CORE-000340/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
@@ -16,24 +17,25 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0440
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0440
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -45,7 +47,7 @@ Check:
Core:
Id: CORE-000340
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TSPARMCD = "PLANSUB" and the value provided in
TSVAL is not an integer greater than 0.
Executability: Fully Executable
diff --git a/Deprecated/CORE-000362/rule.yml b/Deprecated/CORE-000362/rule.yml
index fdd15cbf8..fdf754a85 100644
--- a/Deprecated/CORE-000362/rule.yml
+++ b/Deprecated/CORE-000362/rule.yml
@@ -5,15 +5,16 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0037
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Dictionary derived. Code for the body system or organ class used
+ - Cited Guidance:
+ Dictionary derived. Code for the body system or organ class used
by the sponsor. When using a multi-axial dictionary such as
MedDRA, this should contain the SOC used for the sponsor's
analyses and summary tables, which may not necessarily be the
@@ -21,21 +22,23 @@ Authorities:
Document: SDTMIG v3.4
Item: Specification
Section: Events
- - Cited Guidance: MedDRA System Organ Class code corresponding to --BODSYS
+ - Cited Guidance:
+ MedDRA System Organ Class code corresponding to --BODSYS
assigned for analysis.
Document: Model v2.0
Item: --BDSYCD
Section: Events
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0037
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Dictionary derived. Code for body system or organ class used by
+ - Cited Guidance:
+ Dictionary derived. Code for body system or organ class used by
the sponsor from the coding dictionary (e.g., MedDRA). When
using a multi-axial dictionary such as MedDRA, this should
contain the SOC used for the sponsor's analyses and summary
@@ -43,21 +46,23 @@ Authorities:
Document: SDTMIG v3.3
Item: Specification
Section: 6.2.1
- - Cited Guidance: MedDRA System Organ Class code corresponding to --BODSYS
+ - Cited Guidance:
+ MedDRA System Organ Class code corresponding to --BODSYS
assigned for analysis
Document: Model v1.7
Item: Table 2.2.2.1 -BDSYCD
Section: 2.2.2
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0037
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Dictionary derived. Code for body system or organ class used by
+ - Cited Guidance:
+ Dictionary derived. Code for body system or organ class used by
the sponsor from the coding dictionary (e.g., MedDRA). When
using a multi-axial dictionary such as MedDRA, this should
contain the SOC used for the sponsor's analyses and summary
@@ -65,7 +70,8 @@ Authorities:
Document: SDTMIG v3.3
Item: Specification
Section: 6.2. AE
- - Cited Guidance: MedDRA System Organ Class code corresponding to --BODSYS
+ - Cited Guidance:
+ MedDRA System Organ Class code corresponding to --BODSYS
assigned for analysis
Document: Model v1.4
Item: Table 2.2.2.1 -BDSYCD
@@ -78,7 +84,7 @@ Check:
Core:
Id: CORE-000362
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when primary SOC is used for analysis and SOC Code
is not equal to Body System Code
Executability: Fully Executable
diff --git a/Deprecated/CORE-000364/rule.yml b/Deprecated/CORE-000364/rule.yml
index ae762fac9..b45577059 100644
--- a/Deprecated/CORE-000364/rule.yml
+++ b/Deprecated/CORE-000364/rule.yml
@@ -7,20 +7,21 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When DSCAT='PROTOCOL MILESTONE', DSTERM and DSDECOD will contain
+ - Cited Guidance:
+ When DSCAT='PROTOCOL MILESTONE', DSTERM and DSDECOD will contain
the same value drawn from the sponsor's controlled
terminology. Examples of controlled terms include 'INFORMED
CONSENT OBTAINED' and 'RANDOMIZED.' EPOCH should not be
populated when DSCAT = "PROTOCOL MILESTONE".
Document: IG v3.2
Item: Assumption 3d
- Section: '6.2'
+ Section: "6.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0073
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: DSCAT
@@ -31,7 +32,7 @@ Check:
Core:
Id: CORE-000364
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when DSCAT = "PROTOCOL MILESTONE" but EPOCH is not
equal to null.
Executability: Fully Executable
diff --git a/Deprecated/CORE-000365/rule.yml b/Deprecated/CORE-000365/rule.yml
index 6b8482d3a..a1eeb3028 100644
--- a/Deprecated/CORE-000365/rule.yml
+++ b/Deprecated/CORE-000365/rule.yml
@@ -5,15 +5,16 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0077
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: This categorization should not group all records (within the MH
+ - Cited Guidance:
+ This categorization should not group all records (within the MH
Domain) into one generic group such as "Medical History" or
"General Medical History" because this is redundant
information with the domain code. If no smaller categorization
@@ -23,15 +24,16 @@ Authorities:
Item: Assumptions 3.a.1
Section: 6.2.6
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0077
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: This categorization should not group all records (within the MH
+ - Cited Guidance:
+ This categorization should not group all records (within the MH
Domain) into one generic group such as "Medical History" or
"General Medical History" because this is redundant
information with the domain code. If no smaller categorization
@@ -39,17 +41,18 @@ Authorities:
this variable.
Document: IG v3.2
Item: Assumptions 3.a.i
- Section: '6.2'
+ Section: "6.2"
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0077
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: This categorization should not group all records (within the MH
+ - Cited Guidance:
+ This categorization should not group all records (within the MH
Domain) into one generic group such as "Medical History" or
"General Medical History" because this is redundant
information with the domain code. If no smaller categorization
@@ -67,7 +70,7 @@ Check:
Core:
Id: CORE-000365
Status: Published
- Version: '1'
+ Version: "1"
Description: MHCAT should not group all records. If no smaller categorization
can be applied, then it is not necessary to include or populate this variable.
Executability: Fully Executable
diff --git a/Deprecated/CORE-000366/rule.yml b/Deprecated/CORE-000366/rule.yml
index b53e0221d..a2e6cd3f4 100644
--- a/Deprecated/CORE-000366/rule.yml
+++ b/Deprecated/CORE-000366/rule.yml
@@ -7,26 +7,27 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "Specification[ACTARMCD: Randomized subjects who were not
+ - Cited Guidance:
+ 'Specification[ACTARMCD: Randomized subjects who were not
treated will be given a value of NOTTRT. Values should be
- \"SCRNFAIL\" for screen failures and \"NOTASSGN\" for subjects
+ "SCRNFAIL" for screen failures and "NOTASSGN" for subjects
not assigned to treatment]|Assumption 4[Subjects withdrawn
from a trial before assignment to an Arm, if they are not
- screen failures, should have ARMCD = 'NOTASSGN' and ARM = 'Not
- Assigned'.]|Assumption 10[subjects who are ineligible for
+ screen failures, should have ARMCD = ''NOTASSGN'' and ARM = ''Not
+ Assigned''.]|Assumption 10[subjects who are ineligible for
treatment (e.g., screen failures with ARMCD=SCRNFAIL),
subjects who were enrolled but not assigned to an arm
(ARMCD=NOTASSGN), or subjects who were randomized but not
- treated (ACTARMCD=NOTTRT), RFSTDTC will be null.]"
+ treated (ACTARMCD=NOTTRT), RFSTDTC will be null.]'
Document: IG v3.2
Item: Specification|Assumption 4|Assumption 10
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0109
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ACTARMCD
@@ -41,7 +42,7 @@ Check:
Core:
Id: CORE-000366
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when subject has no records in EX but ACTARMCD is
not equal to SCRNFAIL, NOTASSGN or NOTTRT.
Executability: Fully Executable
diff --git a/Deprecated/CORE-000367/rule.yml b/Deprecated/CORE-000367/rule.yml
index 0f3959763..be2ebf908 100644
--- a/Deprecated/CORE-000367/rule.yml
+++ b/Deprecated/CORE-000367/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Description of actual Arm. When an Arm is not planned (not in
+ - Cited Guidance:
+ Description of actual Arm. When an Arm is not planned (not in
Trial Arms), ACTARM will be “Unplanned Treatment”. Randomized
subjects who were not treated will be given a value of “Not
Treated”. Values should be “Screen Failure” for screen
@@ -16,17 +17,18 @@ Authorities:
cases.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0117
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Description of actual Arm. When an Arm is not planned (not in
+ - Cited Guidance:
+ Description of actual Arm. When an Arm is not planned (not in
Trial Arms), ACTARM will be “Unplanned Treatment”. Randomized
subjects who were not treated will be given a value of “Not
Treated”. Values should be “Screen Failure” for screen
@@ -35,13 +37,13 @@ Authorities:
cases.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0118
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ACTARM
@@ -61,7 +63,7 @@ Check:
Core:
Id: CORE-000367
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when no TA.ARM exists for ACTARM in DM and ACTARM
does not equal Screen Failure, Not Assigned, Not Treated, or Unplanned
Treatment in DM
diff --git a/Deprecated/CORE-000368/rule.yml b/Deprecated/CORE-000368/rule.yml
index 9b168f70e..950421e10 100644
--- a/Deprecated/CORE-000368/rule.yml
+++ b/Deprecated/CORE-000368/rule.yml
@@ -10,23 +10,23 @@ Authorities:
- Cited Guidance: Name of the Arm to which the subject was assigned.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0120
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
- Citations:
- Cited Guidance: Name of the Arm to which the subject was assigned.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0121
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ARM
@@ -42,7 +42,7 @@ Check:
Core:
Id: CORE-000368
Status: Published
- Version: '1'
+ Version: "1"
Description: 'ARM values in Demographics are restricted to ARM values in Trial
Arms when not equal to "Screen Failure" or "Not Assigned"'
Executability: Fully Executable
diff --git a/Deprecated/CORE-000369/rule.yml b/Deprecated/CORE-000369/rule.yml
index 0a06e5c15..12ed9537d 100644
--- a/Deprecated/CORE-000369/rule.yml
+++ b/Deprecated/CORE-000369/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'IG v3.2[5][Specification: RFENDTC][Required for all randomized
+ - Cited Guidance:
+ "IG v3.2[5][Specification: RFENDTC][Required for all randomized
subjects; null for screen failures or unassigned subjects.]|IG
v3.2[5][Specification: ACTARM][Randomized subjects who were
not treated will be given a value of “Not Treated”. Values
@@ -21,17 +22,18 @@ Authorities:
treatment (e.g., screen failures with ARMCD=SCRNFAIL),
subjects who were enrolled but not assigned to an arm
(ARMCD=NOTASSGN), or subjects who were randomized but not
- treated (ACTARMCD=NOTTRT), RFSTDTC will be null.]'
+ treated (ACTARMCD=NOTTRT), RFSTDTC will be null.]"
Document: IG v3.2
- Item: 'IG v3.2[5][Specification: RFENDTC]|IG v3.2[5][Specification: ACTARM]|IG
- v3.2[5][Assumption 10]'
+ Item:
+ "IG v3.2[5][Specification: RFENDTC]|IG v3.2[5][Specification: ACTARM]|IG
+ v3.2[5][Assumption 10]"
Section: IG v3.2[5]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0141
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ACTARM
@@ -48,12 +50,13 @@ Check:
Core:
Id: CORE-000369
Status: Published
- Version: '1'
-Description: 'Raise an error when RFENDTC is not null, but ACTARM is Screen
- Failure, Not Assigned, or Not Treated'
+ Version: "1"
+Description: "Raise an error when RFENDTC is not null, but ACTARM is Screen
+ Failure, Not Assigned, or Not Treated"
Executability: Fully Executable
Outcome:
- Message: RFENDTC must be null when ACTARM in (Screen Failure, Not Assigned, Not
+ Message:
+ RFENDTC must be null when ACTARM in (Screen Failure, Not Assigned, Not
Treated).
Rule Type: Record Data
Scope:
diff --git a/Deprecated/CORE-000371/rule.yml b/Deprecated/CORE-000371/rule.yml
index bbe72148c..85b2d0d7a 100644
--- a/Deprecated/CORE-000371/rule.yml
+++ b/Deprecated/CORE-000371/rule.yml
@@ -1,5 +1,5 @@
# Variable: ARM
-# Condition:
+# Condition:
# Rule: ARM not in ('Screen Failure', 'Not Assigned', 'Unplanned Treatment', 'Not Treated')
Authorities:
- Organization: CDISC
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0244
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ARM
@@ -29,12 +29,13 @@ Check:
Core:
Id: CORE-000371
Status: Published
- Version: '1'
+ Version: "1"
Description: 'Raise an error when ARM is "Screen Failure", "Not Assigned",
"Unplanned Treatment" or "Not Treated"'
Executability: Fully Executable
Outcome:
- Message: 'ARM is "Screen Failure", "Not Assigned", "Unplanned Treatment" or "Not
+ Message:
+ 'ARM is "Screen Failure", "Not Assigned", "Unplanned Treatment" or "Not
Treated"'
Rule Type: Record Data
Scope:
diff --git a/Deprecated/CORE-000372/rule.yml b/Deprecated/CORE-000372/rule.yml
index ce437f269..161e1fc17 100644
--- a/Deprecated/CORE-000372/rule.yml
+++ b/Deprecated/CORE-000372/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
@@ -16,25 +17,26 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0269
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included Appendix
+ - Cited Guidance:
+ Further information about the parameters is included Appendix
C1, Trial Summary Codes. TSVAL may have controlled terminology
depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0269
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -51,7 +53,7 @@ Check:
Core:
Id: CORE-000372
Status: Published
- Version: '1'
+ Version: "1"
Description: 'For TS.TSPARMCD = "ADDON" records, TS.TSVAL value must equal "N"
or "Y" when not missing'
Executability: Fully Executable
diff --git a/Deprecated/CORE-000373/rule.yml b/Deprecated/CORE-000373/rule.yml
index b6471352c..349c183c3 100644
--- a/Deprecated/CORE-000373/rule.yml
+++ b/Deprecated/CORE-000373/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
@@ -16,25 +17,26 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0271
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included Appendix
+ - Cited Guidance:
+ Further information about the parameters is included Appendix
C1, Trial Summary Codes. TSVAL may have controlled terminology
depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0271
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -51,7 +53,7 @@ Check:
Core:
Id: CORE-000373
Status: Published
- Version: '1'
+ Version: "1"
Description: 'For TS.TSPARMCD = "RANDOM" records, TS.TSVAL value must equal "N"
or "Y" when not missing'
Executability: Fully Executable
diff --git a/Deprecated/CORE-000375/rule.yml b/Deprecated/CORE-000375/rule.yml
index 426ee07a4..674f770f8 100644
--- a/Deprecated/CORE-000375/rule.yml
+++ b/Deprecated/CORE-000375/rule.yml
@@ -7,33 +7,35 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For objective data, the value in QEVAL will be null. For
+ - Cited Guidance:
+ For objective data, the value in QEVAL will be null. For
subjective data (when QORIG=”ASSIGNED”), the value in QEVAL
should reflect the role of the person or institution assigning
the value (e.g., SPONSOR or ADJUDICATION COMMITTEE).
Document: IG v3.2
- Section: '8.4'
+ Section: "8.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0202
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For objective data, the value in QEVAL will be null. For
+ - Cited Guidance:
+ For objective data, the value in QEVAL will be null. For
subjective data (when QORIG=”ASSIGNED”), the value in QEVAL
should reflect the role of the person or institution assigning
the value (e.g., SPONSOR or ADJUDICATION COMMITTEE).
Document: IG v3.3
- Section: '8.4'
+ Section: "8.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0202
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: QORIG
@@ -45,11 +47,11 @@ Check:
Core:
Id: CORE-000375
Status: Published
- Version: '1'
-Description: 'Raise an error when QORIG = ASSIGNED and QEVAL is not populated.'
+ Version: "1"
+Description: "Raise an error when QORIG = ASSIGNED and QEVAL is not populated."
Executability: Fully Executable
Outcome:
- Message: 'QORIG = ASSIGNED but QEVAL is not populated'
+ Message: "QORIG = ASSIGNED but QEVAL is not populated"
Output Variables:
- QORIG
- QEVAL
diff --git a/Deprecated/CORE-000377/rule.yml b/Deprecated/CORE-000377/rule.yml
index 132e34dee..10383ad85 100644
--- a/Deprecated/CORE-000377/rule.yml
+++ b/Deprecated/CORE-000377/rule.yml
@@ -7,17 +7,18 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values should be "SCRNFAIL" for screen failures and "NOTASSGN"
+ - Cited Guidance:
+ Values should be "SCRNFAIL" for screen failures and "NOTASSGN"
for subjects not assigned to treatment.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0129
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ARMCD
@@ -31,13 +32,13 @@ Check:
Core:
Id: CORE-000377
Status: Published
- Version: '1'
+ Version: "1"
Description: 'ARMCD value must match ACTARMCD value in Demographics when ARMCD
equals "SCRFNFAIL" or "NOTASSGN"'
Executability: Fully Executable
Outcome:
- Message: 'DM.ARMCD must equal DM.ACTARMCD when subject is either a screen
- failure or not assigned to treatment'
+ Message: "DM.ARMCD must equal DM.ACTARMCD when subject is either a screen
+ failure or not assigned to treatment"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Deprecated/CORE-000378/rule.yml b/Deprecated/CORE-000378/rule.yml
index fa788ece3..62f460077 100644
--- a/Deprecated/CORE-000378/rule.yml
+++ b/Deprecated/CORE-000378/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'IG v3.2[5][Specification: RFENDTC][Required for all randomized
+ - Cited Guidance:
+ "IG v3.2[5][Specification: RFENDTC][Required for all randomized
subjects; null for screen failures or unassigned subjects.]|IG
v3.2[5][Specification: ACTARM][Randomized subjects who were
not treated will be given a value of “Not Treated”. Values
@@ -21,17 +22,18 @@ Authorities:
treatment (e.g., screen failures with ARMCD=SCRNFAIL),
subjects who were enrolled but not assigned to an arm
(ARMCD=NOTASSGN), or subjects who were randomized but not
- treated (ACTARMCD=NOTTRT), RFSTDTC will be null.]'
+ treated (ACTARMCD=NOTTRT), RFSTDTC will be null.]"
Document: IG v3.2
- Item: 'IG v3.2[5][Specification: RFENDTC]|IG v3.2[5][Specification: ACTARM]|IG
- v3.2[5][Assumption 10]'
+ Item:
+ "IG v3.2[5][Specification: RFENDTC]|IG v3.2[5][Specification: ACTARM]|IG
+ v3.2[5][Assumption 10]"
Section: IG v3.2[5]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0142
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ACTARM
@@ -48,9 +50,9 @@ Check:
Core:
Id: CORE-000378
Status: Published
- Version: '1'
-Description: 'Raise an error when RFENDTC is null, but ACTARM is not Screen
- Failure, Not Assigned, or Not Treated'
+ Version: "1"
+Description: "Raise an error when RFENDTC is null, but ACTARM is not Screen
+ Failure, Not Assigned, or Not Treated"
Executability: Fully Executable
Outcome:
Message: RFENDTC must not be null when ACTARM is a value other than Screen
diff --git a/Deprecated/CORE-000379/rule.yml b/Deprecated/CORE-000379/rule.yml
index 13f5cfa94..916459fc7 100644
--- a/Deprecated/CORE-000379/rule.yml
+++ b/Deprecated/CORE-000379/rule.yml
@@ -10,13 +10,13 @@ Authorities:
- Cited Guidance: Null for screen failures or unassigned subjects.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0145
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ACTARM
@@ -33,12 +33,13 @@ Check:
Core:
Id: CORE-000379
Status: Published
- Version: '1'
-Description: 'Raise an error when RFSTDTC is not null, but ACTARM is either
- Screen Failure, Not Assigned, or Not Treated'
+ Version: "1"
+Description: "Raise an error when RFSTDTC is not null, but ACTARM is either
+ Screen Failure, Not Assigned, or Not Treated"
Executability: Partially Executable
Outcome:
- Message: RFSTDTC must be null when ACTARM in (Screen failure, Not Assigned, Not
+ Message:
+ RFSTDTC must be null when ACTARM in (Screen failure, Not Assigned, Not
Treated).
Rule Type: Record Data
Scope:
diff --git a/Deprecated/CORE-000380/rule.yml b/Deprecated/CORE-000380/rule.yml
index 024e50a27..32af0154e 100644
--- a/Deprecated/CORE-000380/rule.yml
+++ b/Deprecated/CORE-000380/rule.yml
@@ -10,13 +10,13 @@ Authorities:
- Cited Guidance: Required for all randomized subjects.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0146
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ACTARM
@@ -33,9 +33,9 @@ Check:
Core:
Id: CORE-000380
Status: Published
- Version: '1'
-Description: 'Raise an error when RFSTDTC is null, but ACTARM is neither Screen
- Failure, Not Assigned, nor Not Treated'
+ Version: "1"
+Description: "Raise an error when RFSTDTC is null, but ACTARM is neither Screen
+ Failure, Not Assigned, nor Not Treated"
Executability: Fully Executable
Outcome:
Message: RFSTDTC must not be null when ACTARM is not in (Screen Failure, Not
diff --git a/Deprecated/CORE-000452/rule.yml b/Deprecated/CORE-000452/rule.yml
index 5bdc87541..a55c2e378 100644
--- a/Deprecated/CORE-000452/rule.yml
+++ b/Deprecated/CORE-000452/rule.yml
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0432
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -25,9 +25,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0432
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- any:
@@ -43,7 +43,7 @@ Check:
Core:
Id: CORE-000452
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AGEU is empty, but AGE or AGETXT is not empty.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000453/rule.yml b/Deprecated/CORE-000453/rule.yml
index 1ddb46ca6..91a2d1844 100644
--- a/Deprecated/CORE-000453/rule.yml
+++ b/Deprecated/CORE-000453/rule.yml
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0433
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -25,9 +25,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0433
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: AGEU
@@ -45,7 +45,7 @@ Check:
Core:
Id: CORE-000453
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AGE is empty, but AGEU is not empty.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000467/rule.yml b/Deprecated/CORE-000467/rule.yml
index f59a10ef9..36f6f9a10 100644
--- a/Deprecated/CORE-000467/rule.yml
+++ b/Deprecated/CORE-000467/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
@@ -16,24 +17,25 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0441
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0441
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -44,7 +46,7 @@ Check:
Core:
Id: CORE-000467
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TSPARMCD = STOPRULE and TSVAL is not completed.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000468/rule.yml b/Deprecated/CORE-000468/rule.yml
index 88337a749..5a8eb23c7 100644
--- a/Deprecated/CORE-000468/rule.yml
+++ b/Deprecated/CORE-000468/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.3[7.4.2][Assumption 3][Further information about the
parameters is included below in Table 1. TSVAL may have
controlled terminology depending on the value of TSPARMCD]|IG
v3.3[Appendix C1][If study type is INTERVENTIONAL" this
@@ -18,13 +19,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0276
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.3[7.4.2][Assumption 3][Further information about the
parameters is included Appendix C1, Trial Summary Codes. TSVAL
may have controlled terminology depending on the value of
TSPARMCD. Conditions for including parameters are included in
@@ -36,9 +38,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0276
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -52,9 +54,9 @@ Check:
Core:
Id: CORE-000468
Status: Published
- Version: '1'
-Description: 'Raise an error when a record exists in TS where TSPARMCD = STYPE
- and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = TRT is empty.'
+ Version: "1"
+Description: "Raise an error when a record exists in TS where TSPARMCD = STYPE
+ and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = TRT is empty."
Executability: Fully Executable
Operations:
- filter:
@@ -65,8 +67,8 @@ Operations:
id: $STYPE_INTERVENTIONAL
operator: record_count
Outcome:
- Message: 'A record exists in TS where TSPARMCD = STYPE and TSVAL =
- INTERVENTIONAL but TSVAL for TSPARMCD = TRT is empty.'
+ Message: "A record exists in TS where TSPARMCD = STYPE and TSVAL =
+ INTERVENTIONAL but TSVAL for TSPARMCD = TRT is empty."
Output Variables:
- TSGRPID
- TSPARMCD
diff --git a/Deprecated/CORE-000469/rule.yml b/Deprecated/CORE-000469/rule.yml
index 761b599e2..3587b540a 100644
--- a/Deprecated/CORE-000469/rule.yml
+++ b/Deprecated/CORE-000469/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.3[7.4.2][Assumption 3][Further information about the
parameters is included below in Table 1. TSVAL may have
controlled terminology depending on the value of TSPARMCD]|IG
v3.3[Appendix C1][If study type is INTERVENTIONAL" this
@@ -18,13 +19,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0277
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.3[7.4.2][Assumption 3][Further information about the
parameters is included Appendix C1, Trial Summary Codes. TSVAL
may have controlled terminology depending on the value of
TSPARMCD. Conditions for including parameters are included in
@@ -36,9 +38,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0277
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -52,9 +54,9 @@ Check:
Core:
Id: CORE-000469
Status: Published
- Version: '1'
-Description: 'Raise an error when a record exists in TS where TSPARMCD = STYPE
- and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = INTMODEL is empty.'
+ Version: "1"
+Description: "Raise an error when a record exists in TS where TSPARMCD = STYPE
+ and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = INTMODEL is empty."
Executability: Fully Executable
Operations:
- filter:
@@ -65,8 +67,8 @@ Operations:
id: $STYPE_INTERVENTIONAL
operator: record_count
Outcome:
- Message: 'A record exists in TS where TSPARMCD = STYPE and TSVAL =
- INTERVENTIONAL but TSVAL for TSPARMCD = INTMODEL is empty.'
+ Message: "A record exists in TS where TSPARMCD = STYPE and TSVAL =
+ INTERVENTIONAL but TSVAL for TSPARMCD = INTMODEL is empty."
Output Variables:
- TSGRPID
- TSPARMCD
diff --git a/Deprecated/CORE-000470/rule.yml b/Deprecated/CORE-000470/rule.yml
index 6b5130fd8..ccd9d1d62 100644
--- a/Deprecated/CORE-000470/rule.yml
+++ b/Deprecated/CORE-000470/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.3[7.4.2][Assumption 3][Further information about the
parameters is included below in Table 1. TSVAL may have
controlled terminology depending on the value of TSPARMCD]|IG
v3.3[Appendix C1][If study type is "INTERVENTIONAL" this
@@ -18,13 +19,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0278
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.3[7.4.2][Assumption 3][Further information about the
parameters is included Appendix C1, Trial Summary Codes. TSVAL
may have controlled terminology depending on the value of
TSPARMCD. Conditions for including parameters are included in
@@ -36,9 +38,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0278
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -52,9 +54,9 @@ Check:
Core:
Id: CORE-000470
Status: Published
- Version: '1'
-Description: 'Raise an error when a record exists in TS where TSPARMCD = STYPE
- and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = INTTYPE is empty.'
+ Version: "1"
+Description: "Raise an error when a record exists in TS where TSPARMCD = STYPE
+ and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = INTTYPE is empty."
Executability: Fully Executable
Operations:
- filter:
@@ -65,8 +67,8 @@ Operations:
id: $STYPE_INTERVENTIONAL
operator: record_count
Outcome:
- Message: 'A record exists in TS where TSPARMCD = STYPE and TSVAL =
- INTERVENTIONAL but TSVAL for TSPARMCD = INTTYPE is empty.'
+ Message: "A record exists in TS where TSPARMCD = STYPE and TSVAL =
+ INTERVENTIONAL but TSVAL for TSPARMCD = INTTYPE is empty."
Output Variables:
- TSGRPID
- TSPARMCD
diff --git a/Deprecated/CORE-000473/rule.yml b/Deprecated/CORE-000473/rule.yml
index d945393d3..75bd5698c 100644
--- a/Deprecated/CORE-000473/rule.yml
+++ b/Deprecated/CORE-000473/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.2[7.4][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.2[7.4][Assumption 3][Further information about the
parameters is included below in Table 1. TSVAL may have
controlled terminology depending on the value of TSPARMCD]|IG
v3.2[Appendix C1][If the study population is healthy subjects
@@ -22,13 +23,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0272
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.3[7.4.2][Assumption 3][Further information about the
parameters is included Appendix C1, Trial Summary Codes. TSVAL
may have controlled terminology depending on the value of
TSPARMCD. Conditions for including parameters are included in
@@ -45,9 +47,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0272
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -59,17 +61,17 @@ Check:
- all:
- name: TSVAL
operator: not_equal_to
- value: 'HEALTHY SUBJECTS'
+ value: "HEALTHY SUBJECTS"
value_is_literal: true
- name: TSVAL
operator: non_empty
Core:
Id: CORE-000473
Status: Published
- Version: '1'
-Description: 'Raise an error when a record exists in TS where TSPARMCD =
+ Version: "1"
+Description: "Raise an error when a record exists in TS where TSPARMCD =
HLTSUBJI and TSVAL = Y but TSVAL for TSPARMCD = TDIGRP is not empty or does
- not equal HEALTHY SUBJECTS.'
+ not equal HEALTHY SUBJECTS."
Executability: Fully Executable
Operations:
- filter:
@@ -80,9 +82,9 @@ Operations:
id: $HLTSUBJI_Y
operator: record_count
Outcome:
- Message: 'A record exists in TS where TSPARMCD = HLTSUBJI and TSVAL = Y but
+ Message: "A record exists in TS where TSPARMCD = HLTSUBJI and TSVAL = Y but
TSVAL for TSPARMCD = TDIGRP is not empty or does not equal HEALTHY
- SUBJECTS.'
+ SUBJECTS."
Output Variables:
- TSGRPID
- TSPARMCD
diff --git a/Deprecated/CORE-000483/rule.yml b/Deprecated/CORE-000483/rule.yml
index 5b8645b19..f96b7359b 100644
--- a/Deprecated/CORE-000483/rule.yml
+++ b/Deprecated/CORE-000483/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
@@ -16,24 +17,25 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0455
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0455
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -45,7 +47,7 @@ Check:
Core:
Id: CORE-000483
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TSPARMCD = PCLAS but TSVCDREF is not equal to 'MED-RT'.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000497/rule.yml b/Deprecated/CORE-000497/rule.yml
index 956d62bcc..3ba5fe26b 100644
--- a/Deprecated/CORE-000497/rule.yml
+++ b/Deprecated/CORE-000497/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.3[7.4.2][Assumption 3][Further information about the
parameters is included below in Table 1. TSVAL may have
controlled terminology depending on the value of TSPARMCD]|IG
v3.3[Appendix C1][If study type is "INTERVENTIONAL" and if
@@ -19,13 +20,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0279
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.3[7.4.2][Assumption 3][Further information about the
parameters is included Appendix C1, Trial Summary Codes. TSVAL
may have controlled terminology depending on the value of
TSPARMCD. Conditions for including parameters are included in
@@ -39,9 +41,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0279
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -55,10 +57,10 @@ Check:
Core:
Id: CORE-000497
Status: Published
- Version: '1'
-Description: 'Raise an error when a record exists in TS where TSPARMCD = STYPE
+ Version: "1"
+Description: "Raise an error when a record exists in TS where TSPARMCD = STYPE
and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = TPCLAS is empty but
- applicable.'
+ applicable."
Executability: Partially Executable - Possible Overreporting
Operations:
- filter:
@@ -69,9 +71,9 @@ Operations:
id: $STYPE_INTERVENTIONAL
operator: record_count
Outcome:
- Message: 'A record exists in TS where TSPARMCD = STYPE and TSVAL =
+ Message: "A record exists in TS where TSPARMCD = STYPE and TSVAL =
INTERVENTIONAL but TSVAL for TSPARMCD = PCLAS is empty when PCLAS is
- applicable.'
+ applicable."
Output Variables:
- TSGRPID
- TSPARMCD
diff --git a/Deprecated/CORE-000501/rule.yml b/Deprecated/CORE-000501/rule.yml
index 5c62fbe7e..4010b8fe5 100644
--- a/Deprecated/CORE-000501/rule.yml
+++ b/Deprecated/CORE-000501/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Planned study day of the start of the visit based upon RFSTDTC
+ - Cited Guidance:
+ Planned study day of the start of the visit based upon RFSTDTC
in Demographics. Should not be populated for Unplanned Visits
Document: IG v3.2
Item: Specification
@@ -15,23 +16,24 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0216
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: VISITDY is the Planned Study Day of a visit. It should not be
+ - Cited Guidance:
+ VISITDY is the Planned Study Day of a visit. It should not be
populated for unplanned visits.
Document: IG v3.3
Item: Assumption 4
- Section: '5.5'
+ Section: "5.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0216
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
@@ -42,11 +44,11 @@ Check:
Core:
Id: CORE-000501
Status: Published
- Version: '1'
-Description: 'Raise an error if SVUPDES is not null when VISITDY is populated.'
+ Version: "1"
+Description: "Raise an error if SVUPDES is not null when VISITDY is populated."
Executability: Fully Executable
Outcome:
- Message: 'VISITDY is populated when SVUPDES is also populated.'
+ Message: "VISITDY is populated when SVUPDES is also populated."
Output Variables:
- USUBJID
- SVUPDES
diff --git a/Deprecated/CORE-000504/rule.yml b/Deprecated/CORE-000504/rule.yml
index 458f81ada..12957f56c 100644
--- a/Deprecated/CORE-000504/rule.yml
+++ b/Deprecated/CORE-000504/rule.yml
@@ -7,34 +7,36 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0283
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included Appendix
+ - Cited Guidance:
+ Further information about the parameters is included Appendix
C1, Trial Summary Codes. TSVAL may have controlled terminology
depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0283
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -45,11 +47,11 @@ Check:
Core:
Id: CORE-000504
Status: Published
- Version: '1'
-Description: 'Raise an error when TSVAL for TSPARMCD=DCUTDTC is not a valid date/time'
+ Version: "1"
+Description: "Raise an error when TSVAL for TSPARMCD=DCUTDTC is not a valid date/time"
Executability: Fully Executable
Outcome:
- Message: 'Invalid date for TSVAL for TSPARMCD = DCUTDTC (Data Cutoff Date)'
+ Message: "Invalid date for TSVAL for TSPARMCD = DCUTDTC (Data Cutoff Date)"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Deprecated/CORE-000506/rule.yml b/Deprecated/CORE-000506/rule.yml
index c45beea4e..dce620d1d 100644
--- a/Deprecated/CORE-000506/rule.yml
+++ b/Deprecated/CORE-000506/rule.yml
@@ -7,34 +7,36 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0286
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included Appendix
+ - Cited Guidance:
+ Further information about the parameters is included Appendix
C1, Trial Summary Codes. TSVAL may have controlled terminology
depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0286
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -45,11 +47,11 @@ Check:
Core:
Id: CORE-000506
Status: Published
- Version: '1'
-Description: 'Raise an error when TSVAL for TSPARMCD=SENDTC is not a valid date/time'
+ Version: "1"
+Description: "Raise an error when TSVAL for TSPARMCD=SENDTC is not a valid date/time"
Executability: Fully Executable
Outcome:
- Message: 'Invalid date for TSVAL for TSPARMCD = SENDTC (Study End Date)'
+ Message: "Invalid date for TSVAL for TSPARMCD = SENDTC (Study End Date)"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Deprecated/CORE-000510/rule.yml b/Deprecated/CORE-000510/rule.yml
index 5a688429b..70d4b45d5 100644
--- a/Deprecated/CORE-000510/rule.yml
+++ b/Deprecated/CORE-000510/rule.yml
@@ -7,27 +7,29 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For domains with two-letter domain codes (i.e., other than
+ - Cited Guidance:
+ For domains with two-letter domain codes (i.e., other than
SUPPxx and RELREC), split dataset names can be up to four
characters in length... The four-character dataset-name
limitation allows the use of a Supplemental Qualifier dataset
associated with the split dataset
Document: IG v3.4
- Item: '6'
+ Item: "6"
Section: 4.1.7
- Cited Guidance: AP domain codes are therefore four characters long.
Document: AP Guide v1.0
- Section: '2'
+ Section: "2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0017
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 4.1.1.7[Split dataset names can be up to four characters in
+ - Cited Guidance:
+ 4.1.1.7[Split dataset names can be up to four characters in
length. For example, if splitting by --CAT, then dataset names
would be the domain name plus up to two additional characters
(e.g., QS36 for SF-36). If splitting Findings About by parent
@@ -41,13 +43,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0017
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 4.1.7[Split dataset names can be up to four characters in
+ - Cited Guidance:
+ 4.1.7[Split dataset names can be up to four characters in
length. For example, if splitting by --CAT, then dataset names
would be the domain name plus up to two additional characters
(e.g., QS36 for SF-36). If splitting Findings About by parent
@@ -61,9 +64,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0017
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
Check:
any:
- name: dataset_name
@@ -75,7 +78,7 @@ Check:
Core:
Id: CORE-000510
Status: Published
- Version: '1'
+ Version: "1"
Description: Split datasets (excluding supplemental qualifiers) is expected to
have a have a length of 3 or 4 characters
Executability: Fully Executable
diff --git a/Deprecated/CORE-000515/rule.yml b/Deprecated/CORE-000515/rule.yml
index 68748c8e8..6d72d6cc2 100644
--- a/Deprecated/CORE-000515/rule.yml
+++ b/Deprecated/CORE-000515/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The Disposition dataset provides an accounting for all subjects
+ - Cited Guidance:
+ The Disposition dataset provides an accounting for all subjects
who entered the study and may include protocol milestones;
such as randomization; as well as the subject's completion
status or reason for discontinuation for the entire study or
@@ -19,9 +20,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0412
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ACTARMCD
@@ -36,7 +37,7 @@ Check:
Core:
Id: CORE-000515
Status: Published
- Version: '1'
+ Version: "1"
Description: 'Raise an error when DM.ACTARMCD does not equal "SCRNFAIL",
"NOTASSGN" or "NOTTRT", and there are no DS records for the same subject'
Executability: Fully Executable
diff --git a/Deprecated/CORE-000522/rule.yml b/Deprecated/CORE-000522/rule.yml
index 5b5501348..44f934a9b 100644
--- a/Deprecated/CORE-000522/rule.yml
+++ b/Deprecated/CORE-000522/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB1401
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB1401
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -34,9 +34,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB1401
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: DSCAT
@@ -44,7 +44,7 @@ Check:
Core:
Id: CORE-000522
Status: Published
- Version: '1'
+ Version: "1"
Description: Category for Disposition Event (DSCAT) should be populated.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000530/rule.yml b/Deprecated/CORE-000530/rule.yml
index 7bea945fa..7a78739ff 100644
--- a/Deprecated/CORE-000530/rule.yml
+++ b/Deprecated/CORE-000530/rule.yml
@@ -7,17 +7,18 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values should be "Screen Failure" for screen failures and "Not
+ - Cited Guidance:
+ Values should be "Screen Failure" for screen failures and "Not
Assigned" for subjects not assigned to treatment.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0119
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ACTARM
@@ -33,9 +34,9 @@ Check:
Core:
Id: CORE-000530
Status: Published
- Version: '1'
-Description: 'Raise an error when ACTARM is Screen Failure or Not Assigned, and
- ACTARM does not equal ARM'
+ Version: "1"
+Description: "Raise an error when ACTARM is Screen Failure or Not Assigned, and
+ ACTARM does not equal ARM"
Executability: Fully Executable
Outcome:
Message: ACTARM should be equal to ARM when ACTARM is Screen Failure or Not Assigned.
diff --git a/Deprecated/CORE-000531/rule.yml b/Deprecated/CORE-000531/rule.yml
index 8899eb85b..4770659bc 100644
--- a/Deprecated/CORE-000531/rule.yml
+++ b/Deprecated/CORE-000531/rule.yml
@@ -7,34 +7,36 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Data for screen failure subjects, if submitted, should be
+ - Cited Guidance:
+ Data for screen failure subjects, if submitted, should be
included in the Demographics dataset, with ARMCD = "SCRNFAIL'
and ARM = "Screen Failure". Subjects withdrawn from a trial
before assignment to an Arm, if they are not screen failures,
should have ARMCD ='NOTASSGN' and ARM = 'Not Assigned'.
Document: IG v3.2
Item: Assumption 4
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0126
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
- Citations:
- - Cited Guidance: Data for screen failure subjects, if submitted, should be
+ - Cited Guidance:
+ Data for screen failure subjects, if submitted, should be
included in the Demographics dataset, with ARMCD = "SCRNFAIL'
and ARM = "Screen Failure". Subjects withdrawn from a trial
before assignment to an Arm, if they are not screen failures,
should have ARMCD ='NOTASSGN' and ARM = 'Not Assigned'.
Document: IG v3.2
Item: Assumption 4
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0128
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ARMCD
@@ -48,7 +50,7 @@ Check:
Core:
Id: CORE-000531
Status: Published
- Version: '1'
+ Version: "1"
Description: 'ARMCD values in Demographics are restricted to ARMCD values
in Trial Arms when DM.ARMCD is not equal to "SCRNFAIL" or "NOTASSGN"'
Executability: Fully Executable
@@ -58,8 +60,8 @@ Operations:
name: ARMCD
operator: distinct
Outcome:
- Message: 'DM.ARMCD must equal SCRNFAIL or NOTASSGN if the value is not present
- in TA.ARMCD'
+ Message: "DM.ARMCD must equal SCRNFAIL or NOTASSGN if the value is not present
+ in TA.ARMCD"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Deprecated/CORE-000532/rule.yml b/Deprecated/CORE-000532/rule.yml
index 934ce24e4..f9d2adb2d 100644
--- a/Deprecated/CORE-000532/rule.yml
+++ b/Deprecated/CORE-000532/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.2[7.4][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.2[7.4][Assumption 3][Further information about the
parameters is included below in Table 1. TSVAL may have
controlled terminology depending on the value of TSPARMCD.]|IG
v3.2[Appendix C1][Required when ADDON equals "Y"]
@@ -17,13 +18,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0275
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.3[7.4.2][Assumption 3][Further information about the
parameters is included Appendix C1, Trial Summary Codes. TSVAL
may have controlled terminology depending on the value of
TSPARMCD. Conditions for including parameters are included in
@@ -35,9 +37,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0275
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -51,9 +53,9 @@ Check:
Core:
Id: CORE-000532
Status: Published
- Version: '1'
-Description: 'Raise an error when a record exists in TS where TSPARMCD = ADDON
- and TSVAL = Y but TSVAL for TSPARMCD = CURTRT is empty.'
+ Version: "1"
+Description: "Raise an error when a record exists in TS where TSPARMCD = ADDON
+ and TSVAL = Y but TSVAL for TSPARMCD = CURTRT is empty."
Executability: Fully Executable
Operations:
- filter:
@@ -64,8 +66,8 @@ Operations:
id: $ADDON_Y
operator: record_count
Outcome:
- Message: 'A record exists in TS where TSPARMCD = ADDON and TSVAL = Y but TSVAL
- for TSPARMCD = CURTRT is empty.'
+ Message: "A record exists in TS where TSPARMCD = ADDON and TSVAL = Y but TSVAL
+ for TSPARMCD = CURTRT is empty."
Output Variables:
- TSGRPID
- TSPARMCD
diff --git a/Deprecated/CORE-000533/rule.yml b/Deprecated/CORE-000533/rule.yml
index c133f526f..995c191f3 100644
--- a/Deprecated/CORE-000533/rule.yml
+++ b/Deprecated/CORE-000533/rule.yml
@@ -7,22 +7,23 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'When study population flags are included in SDTM, they are
+ - Cited Guidance:
+ "When study population flags are included in SDTM, they are
treated as Supplemental Qualifiers (see Section 8: 8.4,
Relating Non-Standard Variables Values To A Parent Domain) to
DM and placed in the SUPPDM dataset. Controlled terms for
these subject-level population flags, (e.g., COMPLT, SAFETY,
ITT and PPROT) are listed in Appendix C2 - Supplemental
- Qualifier Name Codes.'
+ Qualifier Name Codes."
Document: IG v3.2
Item: Assumption 5
Section: 5|Appendix C2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0138
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: QNAM
@@ -36,12 +37,12 @@ Check:
Core:
Id: CORE-000533
Status: Published
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'A SUPP domain other than SUPPDM contains population flags (name
- fragments reserved)'
+ Message: "A SUPP domain other than SUPPDM contains population flags (name
+ fragments reserved)"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Deprecated/CORE-000543/rule.yml b/Deprecated/CORE-000543/rule.yml
index 8504ef994..35c4355a4 100644
--- a/Deprecated/CORE-000543/rule.yml
+++ b/Deprecated/CORE-000543/rule.yml
@@ -7,17 +7,18 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values should be "SCRNFAIL" for screen failures and "NOTASSGN"
+ - Cited Guidance:
+ Values should be "SCRNFAIL" for screen failures and "NOTASSGN"
for subjects not assigned to treatment.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0127
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: ACTARMCD
@@ -31,7 +32,7 @@ Check:
Core:
Id: CORE-000543
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when ACTARMCD equals "SCRFNFAIL" or "NOTASSGN" but
ARMCD doesn't equal ACTARMCD.
Executability: Fully Executable
diff --git a/Deprecated/CORE-000544/rule.yml b/Deprecated/CORE-000544/rule.yml
index d30d064da..312cff569 100644
--- a/Deprecated/CORE-000544/rule.yml
+++ b/Deprecated/CORE-000544/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A number used to uniquely identify records for a subject within
+ - Cited Guidance:
+ A number used to uniquely identify records for a subject within
a domain. The Trial Summary domain does not contain subject
data, and TSSEQ is a sequence number to ensure uniqueness
within the dataset.
@@ -17,29 +18,31 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0028
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Sequence number to ensure uniqueness of records within a dataset
+ - Cited Guidance:
+ Sequence number to ensure uniqueness of records within a dataset
for a subject (or within a parameter, in the case of the Trial
Summary domain). May be any valid number (including decimals)
and does not have to start at 1.
Document: Model v1.4
- Item: 'Table 2.2.4: --SEQ'
+ Item: "Table 2.2.4: --SEQ"
Section: 2.2.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0028
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Sequence number to ensure uniqueness of records within a dataset
+ - Cited Guidance:
+ Sequence number to ensure uniqueness of records within a dataset
for a subject (or within a parameter, in the case of the Trial
Summary domain). May be any valid number (including decimals)
and does not have to start at 1.
@@ -49,9 +52,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0028
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
any:
- all:
@@ -77,7 +80,7 @@ Check:
Core:
Id: CORE-000544
Status: Published
- Version: '1'
+ Version: "1"
Description: Excluding TS.TSSEQ, raise an error when --SEQ is not a unique
number per USUBJID per domain, or not a unique number per POOLID per domain,
including when the domain is split into multiple files.
diff --git a/Deprecated/CORE-000562/rule.yml b/Deprecated/CORE-000562/rule.yml
index d76939ddb..35702c7c1 100644
--- a/Deprecated/CORE-000562/rule.yml
+++ b/Deprecated/CORE-000562/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.2[7.4][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.2[7.4][Assumption 3][Further information about the
parameters is included below in Table 1. TSVAL may have
controlled terminology depending on the value of TSPARMCD]|IG
v3.2[Appendix C1][If the study population is healthy subjects
@@ -22,13 +23,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0273
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.3[7.4.2][Assumption 3][Further information about the
parameters is included Appendix C1, Trial Summary Codes. TSVAL
may have controlled terminology depending on the value of
TSPARMCD. Conditions for including parameters are included in
@@ -45,9 +47,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0273
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -61,9 +63,9 @@ Check:
Core:
Id: CORE-000562
Status: Published
- Version: '1'
-Description: 'Raise an error when a record exists in TS where TSPARMCD =
- HLTSUBJI and TSVAL = N but TSVAL for TSPARMCD = TDIGRP is empty.'
+ Version: "1"
+Description: "Raise an error when a record exists in TS where TSPARMCD =
+ HLTSUBJI and TSVAL = N but TSVAL for TSPARMCD = TDIGRP is empty."
Executability: Fully Executable
Operations:
- filter:
@@ -74,8 +76,8 @@ Operations:
id: $HLTSUBJI_N
operator: record_count
Outcome:
- Message: 'A record exists in TS where TSPARMCD = HLTSUBJI and TSVAL = N but
- TSVAL for TSPARMCD = TDIGRP is empty.'
+ Message: "A record exists in TS where TSPARMCD = HLTSUBJI and TSVAL = N but
+ TSVAL for TSPARMCD = TDIGRP is empty."
Output Variables:
- TSGRPID
- TSPARMCD
diff --git a/Deprecated/CORE-000563/rule.yml b/Deprecated/CORE-000563/rule.yml
index cf36de2a0..4409da59b 100644
--- a/Deprecated/CORE-000563/rule.yml
+++ b/Deprecated/CORE-000563/rule.yml
@@ -7,34 +7,36 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0282
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included Appendix
+ - Cited Guidance:
+ Further information about the parameters is included Appendix
C1, Trial Summary Codes. TSVAL may have controlled terminology
depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0282
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -49,11 +51,11 @@ Check:
Core:
Id: CORE-000563
Status: Published
- Version: '1'
-Description: 'TSVAL must be either Y or N when TSPARMCD is ADAPT'
+ Version: "1"
+Description: "TSVAL must be either Y or N when TSPARMCD is ADAPT"
Executability: Fully Executable
Outcome:
- Message: 'TSVAL must be either Y or N when TSPARMCD is ADAPT'
+ Message: "TSVAL must be either Y or N when TSPARMCD is ADAPT"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Deprecated/CORE-000564/rule.yml b/Deprecated/CORE-000564/rule.yml
index 8ced75488..3efec797d 100644
--- a/Deprecated/CORE-000564/rule.yml
+++ b/Deprecated/CORE-000564/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
@@ -16,24 +17,25 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0458
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0458
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -47,7 +49,7 @@ Check:
Core:
Id: CORE-000564
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TSPARMCD = INDIC or TSPARMCD = TDIGRP but
TSVCDREF is not equal to 'SNOMED'.
Executability: Fully Executable
diff --git a/Deprecated/CORE-000579/rule.yml b/Deprecated/CORE-000579/rule.yml
index 1f5596636..7e1c35c63 100644
--- a/Deprecated/CORE-000579/rule.yml
+++ b/Deprecated/CORE-000579/rule.yml
@@ -7,48 +7,51 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: In the event that no records are present in a dataset (e.g., a
+ - Cited Guidance:
+ In the event that no records are present in a dataset (e.g., a
small PK study where no subjects took concomitant
medications), the empty dataset should not be submitted and
should not be described in the Define-XML document.
Document: IG v3.4
- Section: '3.2'
+ Section: "3.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0408
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: In the event that no records are present in a dataset (e.g., a
+ - Cited Guidance:
+ In the event that no records are present in a dataset (e.g., a
small PK study where no subjects took concomitant
medications); the empty dataset should not be submitted and
should not be described in the define.xml document.
Document: IG v3.2
- Section: '3.2'
+ Section: "3.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0408
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: In the event that no records are present in a dataset (e.g., a
+ - Cited Guidance:
+ In the event that no records are present in a dataset (e.g., a
small PK study where no subjects took concomitant
medications); the empty dataset should not be submitted and
should not be described in the Define-XML document.
Document: IG v3.3
- Section: '3.2'
+ Section: "3.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0408
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: $records_in_dataset
@@ -57,7 +60,7 @@ Check:
Core:
Id: CORE-000579
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when a dataset has no records.
Executability: Fully Executable
Operations:
diff --git a/Deprecated/CORE-000582/rule.yml b/Deprecated/CORE-000582/rule.yml
index fb2baca86..50c8b57db 100644
--- a/Deprecated/CORE-000582/rule.yml
+++ b/Deprecated/CORE-000582/rule.yml
@@ -4,7 +4,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Text over 200 characters can be added to additional columns
+ - Cited Guidance:
+ Text over 200 characters can be added to additional columns
TSVAL1-TSVALn.
Document: IG v3.4
Item: Specification
@@ -12,27 +13,29 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0262
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Text over 200 characters can be added to additional columns
+ - Cited Guidance:
+ Text over 200 characters can be added to additional columns
TSVAL1-TSVALn.
Document: IG v3.2
Item: Specification
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0262
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Text over 200 characters can be added to additional columns
+ - Cited Guidance:
+ Text over 200 characters can be added to additional columns
TSVAL1-TSVALn.
Document: IG v3.3
Item: Specification
@@ -40,9 +43,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0262
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
# Variable: TSVALn
# Condition: TSVAL(n+1) ^= null
# Rule: TSVALn ^= null
@@ -53,7 +56,7 @@ Check:
Core:
Id: CORE-000582
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TSVAL(n+1) ^= null and TSVALn = null
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000585/rule.yml b/Deprecated/CORE-000585/rule.yml
index 400466733..e782cb96b 100644
--- a/Deprecated/CORE-000585/rule.yml
+++ b/Deprecated/CORE-000585/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: STUDYID, USUBJID or POOLID, DOMAIN, and --SEQ exist
Authorities:
- Organization: CDISC
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: STUDYID, DOMAIN, USUBJID (or POOLID), and --SEQ are required in
+ - Cited Guidance:
+ STUDYID, DOMAIN, USUBJID (or POOLID), and --SEQ are required in
all domains based on one of the three general observation
classes.
Document: Model v1.4
@@ -15,9 +16,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0313
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
any:
- any:
@@ -35,7 +36,7 @@ Check:
Core:
Id: CORE-000585
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when one of the following variables; STUDYID,
DOMAIN, USUBJID (or POOLID) or --SEQ is not present in the dataset.
Executability: Fully Executable
@@ -52,7 +53,7 @@ Rule Type: Record Data
Scope:
Classes:
Include:
- # Correction 2025-04-15: limit to 3 observational classes
+ # Correction 2025-04-15: limit to 3 observational classes
# This prevents requiring e.g. DMSEQ, RELREC and SUPPxx datasets
- INTERVENTIONS
- EVENTS
diff --git a/Deprecated/CORE-000586/rule.yml b/Deprecated/CORE-000586/rule.yml
index aa5064912..6adba0ad0 100644
--- a/Deprecated/CORE-000586/rule.yml
+++ b/Deprecated/CORE-000586/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "ICH E3: Section 10.1 indicates that 'the specific reason for
+ - Cited Guidance:
+ "ICH E3: Section 10.1 indicates that 'the specific reason for
discontinuation' should be presented; and that summaries
should be 'grouped by treatment and by major reason.' The
CDISC SDS Team interprets this guidance as requiring one
@@ -21,9 +22,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0398
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: DSCAT
@@ -38,13 +39,14 @@ Check:
Core:
Id: CORE-000586
Status: Published
- Version: '1'
-Description: 'Raise an error when DSCAT = DISPOSITION EVENT and there is more
- than one record per subject for an EPOCH'
+ Version: "1"
+Description: "Raise an error when DSCAT = DISPOSITION EVENT and there is more
+ than one record per subject for an EPOCH"
Executability: Fully Executable
Outcome:
- Message: 'Multiple records exist within the same EPOCH for a subject when DSCAT
- = DISPOSITION EVENT'
+ Message:
+ "Multiple records exist within the same EPOCH for a subject when DSCAT
+ = DISPOSITION EVENT"
Output Variables:
- DSCAT
- EPOCH
diff --git a/Deprecated/CORE-000587/rule.yml b/Deprecated/CORE-000587/rule.yml
index fcd484e8f..1b6e2ceed 100644
--- a/Deprecated/CORE-000587/rule.yml
+++ b/Deprecated/CORE-000587/rule.yml
@@ -7,34 +7,36 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0284
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included Appendix
+ - Cited Guidance:
+ Further information about the parameters is included Appendix
C1, Trial Summary Codes. TSVAL may have controlled terminology
depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0284
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -50,11 +52,11 @@ Check:
Core:
Id: CORE-000587
Status: Published
- Version: '1'
-Description: 'Check that TVAL is an integer > 0 when TSPARMCD is NARMS'
+ Version: "1"
+Description: "Check that TVAL is an integer > 0 when TSPARMCD is NARMS"
Executability: Fully Executable
Outcome:
- Message: 'TSVAL must be an integer greater than zero when TSPARMCD is NARMS'
+ Message: "TSVAL must be an integer greater than zero when TSPARMCD is NARMS"
Output Variables:
- TSPARMCD
- TSVAL
diff --git a/Deprecated/CORE-000655/rule.yml b/Deprecated/CORE-000655/rule.yml
index c54b628c8..4b4f6dc45 100644
--- a/Deprecated/CORE-000655/rule.yml
+++ b/Deprecated/CORE-000655/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB2501
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB2501
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -34,9 +34,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB2501
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: ARMCD
@@ -49,7 +49,7 @@ Check:
Core:
Id: CORE-000655
Status: Published
- Version: '1'
+ Version: "1"
Description: Values in ARMCD and ACTARMCD should match
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000656/rule.yml b/Deprecated/CORE-000656/rule.yml
index 3ebc21106..f35473d02 100644
--- a/Deprecated/CORE-000656/rule.yml
+++ b/Deprecated/CORE-000656/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB2502
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB2502
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -34,9 +34,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB2502
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- all:
@@ -50,7 +50,7 @@ Check:
Core:
Id: CORE-000656
Status: Published
- Version: '1'
+ Version: "1"
Description: Values in ARM and ACTARM should match
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000657/rule.yml b/Deprecated/CORE-000657/rule.yml
index 6c9bbface..bd3d3790f 100644
--- a/Deprecated/CORE-000657/rule.yml
+++ b/Deprecated/CORE-000657/rule.yml
@@ -2,58 +2,61 @@
# Condition: AEOUT = "NOT RECOVERED/NOT RESOLVED"
# Rule: AEENDTC = Null
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Study start and end date/time should include month, day, and
+ year."
+ Document: "FDA"
+ Section: "FDAB034"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3409'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB3409"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Study start and end date/time should include month, day, and
+ year."
+ Document: "FDA"
+ Section: "FDAB034"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3409'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB3409"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Study start and end date/time should include month, day, and
+ year."
+ Document: "FDA"
+ Section: "FDAB034"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3409'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB3409"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: AEOUT
operator: equal_to
- value: 'NOT RECOVERED/NOT RESOLVED'
+ value: "NOT RECOVERED/NOT RESOLVED"
- name: AEENDTC
operator: non_empty
Core:
Id: CORE-000657
Status: Published
- Version: '1'
+ Version: "1"
Description: When Adverse Event Outcome (AEOUT) is populated with 'NOT
RECOVERED/NOT RESOLVED', then the End Date/Time of Adverse Event (AEENDTC)
should not be populated
diff --git a/Deprecated/CORE-000658/rule.yml b/Deprecated/CORE-000658/rule.yml
index d490b1aa8..72a10cc9c 100644
--- a/Deprecated/CORE-000658/rule.yml
+++ b/Deprecated/CORE-000658/rule.yml
@@ -7,42 +7,45 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
+ - Cited Guidance:
+ Study start and end date/time should include month, day, and
year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3412
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
+ - Cited Guidance:
+ Study start and end date/time should include month, day, and
year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3412
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
+ - Cited Guidance:
+ Study start and end date/time should include month, day, and
year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3412
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: RFICDTC
@@ -55,7 +58,7 @@ Check:
Core:
Id: CORE-000658
Status: Published
- Version: '1'
+ Version: "1"
Description: Date/Time of Informed Consent (RFICDTC) should be prior or equal to
the Date/Time of First Study Treatment (RFXSTDTC).
Executability: Fully Executable
diff --git a/Deprecated/CORE-000659/rule.yml b/Deprecated/CORE-000659/rule.yml
index c15f46318..5a596a5bd 100644
--- a/Deprecated/CORE-000659/rule.yml
+++ b/Deprecated/CORE-000659/rule.yml
@@ -2,58 +2,61 @@
# Condition: AEOUT = "RECOVERED/RESOLVED"
# Rule: AEENDTC <> Null
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Study start and end date/time should include month, day, and
+ year."
+ Document: "FDA"
+ Section: "FDAB034"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3410'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB3410"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Study start and end date/time should include month, day, and
+ year."
+ Document: "FDA"
+ Section: "FDAB034"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3410'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB3410"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Study start and end date/time should include month, day, and
+ year."
+ Document: "FDA"
+ Section: "FDAB034"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3410'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB3410"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: AEOUT
- operator: 'equal_to'
- value: 'RECOVERED/RESOLVED'
+ operator: "equal_to"
+ value: "RECOVERED/RESOLVED"
- name: AEENDTC
operator: empty
Core:
Id: CORE-000659
Status: Published
- Version: '1'
+ Version: "1"
Description: When Adverse Event Outcome (AEOUT) is populated with
RECOVERED/RESOLVED, then the End Date/Time of Adverse Event (AEENDTC) should
be populated.
diff --git a/Deprecated/CORE-000679/rule.yml b/Deprecated/CORE-000679/rule.yml
index aa5c5c67a..cb4aeaedf 100644
--- a/Deprecated/CORE-000679/rule.yml
+++ b/Deprecated/CORE-000679/rule.yml
@@ -7,42 +7,45 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0608
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0608
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0608
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: DTHFL
@@ -56,7 +59,7 @@ Check:
Core:
Id: CORE-000679
Status: Published
- Version: '1'
+ Version: "1"
Description: When Death flag (DTHFL) in the DM dataset is populated as 'Y' then
a record should be present in the DS dataset where DSDECOD = 'DEATH' for the
corresponding subject.
@@ -73,7 +76,8 @@ Operations:
name: DSDECOD
operator: distinct
Outcome:
- Message: DTHFL in DM dataset is "Y" but a record is missing in DS dataset where
+ Message:
+ DTHFL in DM dataset is "Y" but a record is missing in DS dataset where
DSDECOD = "DEATH".
Output Variables:
- USUBJID
diff --git a/Deprecated/CORE-000685/rule.yml b/Deprecated/CORE-000685/rule.yml
index 0790b8813..e98541be6 100644
--- a/Deprecated/CORE-000685/rule.yml
+++ b/Deprecated/CORE-000685/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Within the context that defines uniqueness for a time point,
+ - Cited Guidance:
+ Within the context that defines uniqueness for a time point,
which may include domain, visit, and reference time point,
there must be a one-to-relationship between values of --TPT
and --TPTNUM. in other words, if domain, visit, and reference
@@ -20,13 +21,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0571
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Within the context that defines uniqueness for a time point,
+ - Cited Guidance:
+ Within the context that defines uniqueness for a time point,
which may include domain, visit, and reference time point,
there must be a one-to-relationship between values of --TPT
and --TPTNUM. in other words, if domain, visit, and reference
@@ -39,15 +41,16 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0571
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -56,13 +59,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0923
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -71,13 +75,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0923
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -86,9 +91,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0923
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: VISITNUM
@@ -109,7 +114,7 @@ Check:
Core:
Id: CORE-000685
Status: Published
- Version: '1'
+ Version: "1"
Description: VISITNUM is present in the dataset and --TPTREF is not present in
the dataset then --TPT and --TPTNUM should have a one-to-one relationship per
unique value of VISITNUM.
diff --git a/Deprecated/CORE-000686/rule.yml b/Deprecated/CORE-000686/rule.yml
index 49061e9c8..2cc4ad70a 100644
--- a/Deprecated/CORE-000686/rule.yml
+++ b/Deprecated/CORE-000686/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Within the context that defines uniqueness for a time point,
+ - Cited Guidance:
+ Within the context that defines uniqueness for a time point,
which may include domain, visit, and reference time point,
there must be a one-to-relationship between values of --TPT
and --TPTNUM. in other words, if domain, visit, and reference
@@ -20,13 +21,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0572
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Within the context that defines uniqueness for a time point,
+ - Cited Guidance:
+ Within the context that defines uniqueness for a time point,
which may include domain, visit, and reference time point,
there must be a one-to-relationship between values of --TPT
and --TPTNUM. in other words, if domain, visit, and reference
@@ -39,15 +41,16 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0572
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -56,13 +59,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0924
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -71,13 +75,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0924
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -86,9 +91,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0924
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: VISITNUM
@@ -109,7 +114,7 @@ Check:
Core:
Id: CORE-000686
Status: Published
- Version: '1'
+ Version: "1"
Description: VISITNUM not present in dataset and --TPTREF present in dataset
then --TPT and --TPTNUM should have a one-to-one relationship per unique
values of --TPTREF.
diff --git a/Deprecated/CORE-000689/rule.yml b/Deprecated/CORE-000689/rule.yml
index 02751e873..277416fa8 100644
--- a/Deprecated/CORE-000689/rule.yml
+++ b/Deprecated/CORE-000689/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Within the context that defines uniqueness for a time point,
+ - Cited Guidance:
+ Within the context that defines uniqueness for a time point,
which may include domain, visit, and reference time point,
there must be a one-to-relationship between values of --TPT
and --TPTNUM. in other words, if domain, visit, and reference
@@ -20,13 +21,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0573
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Within the context that defines uniqueness for a time point,
+ - Cited Guidance:
+ Within the context that defines uniqueness for a time point,
which may include domain, visit, and reference time point,
there must be a one-to-relationship between values of --TPT
and --TPTNUM. in other words, if domain, visit, and reference
@@ -39,15 +41,16 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0573
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -56,13 +59,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0925
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -71,13 +75,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0925
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -86,9 +91,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0925
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: VISITNUM
@@ -111,7 +116,7 @@ Check:
Core:
Id: CORE-000689
Status: Published
- Version: '1'
+ Version: "1"
Description: VISITNUM and --TPTREF are present then --TPT and --TPTNUM should
have a one-to-one relationship per unique combination of VISITNUM and --TPTREF
values.
diff --git a/Deprecated/CORE-000701/rule.yml b/Deprecated/CORE-000701/rule.yml
index e01bec5f3..5b1000734 100644
--- a/Deprecated/CORE-000701/rule.yml
+++ b/Deprecated/CORE-000701/rule.yml
@@ -8,7 +8,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: EPOCH should be included for clinical subject-level observations
+ - Cited Guidance:
+ EPOCH should be included for clinical subject-level observations
(e.g., adverse events, laboratory, concomitant medications,
exposure, and vital signs).
Document: FDA
@@ -16,13 +17,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB2201
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: EPOCH should be included for clinical subject-level observations
+ - Cited Guidance:
+ EPOCH should be included for clinical subject-level observations
(e.g., adverse events, laboratory, concomitant medications,
exposure, and vital signs).
Document: FDA
@@ -30,13 +32,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB2201
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: EPOCH should be included for clinical subject-level observations
+ - Cited Guidance:
+ EPOCH should be included for clinical subject-level observations
(e.g., adverse events, laboratory, concomitant medications,
exposure, and vital signs).
Document: FDA
@@ -44,9 +47,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB2201
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
any:
- name: EPOCH
@@ -56,7 +59,7 @@ Check:
Core:
Id: CORE-000701
Status: Published
- Version: '1'
+ Version: "1"
Description: EPOCH should be populated for clinical subject-level observations.
Executability: Partially Executable - Possible Overreporting
Outcome:
diff --git a/Deprecated/CORE-000705/rule.yml b/Deprecated/CORE-000705/rule.yml
index 83724a6e0..9ad43b62f 100644
--- a/Deprecated/CORE-000705/rule.yml
+++ b/Deprecated/CORE-000705/rule.yml
@@ -7,42 +7,45 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0610
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0610
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0610
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: DTHFL
@@ -53,7 +56,7 @@ Check:
Core:
Id: CORE-000705
Status: Published
- Version: '1'
+ Version: "1"
Description: When Death flag (DTHFL) in the DM dataset is populated as 'Y' then
Date/Time of Death (DTHDTC)should be populated in the DM dataset for the
corresponding subject.
diff --git a/Deprecated/CORE-000706/rule.yml b/Deprecated/CORE-000706/rule.yml
index 9d12daa75..adfd8e95f 100644
--- a/Deprecated/CORE-000706/rule.yml
+++ b/Deprecated/CORE-000706/rule.yml
@@ -1,13 +1,14 @@
# Variable: --LLT, --LLTCD
# Condition:
-# Rule: --LLTCD and --LLT have a one-to-one relationship
+# Rule: --LLTCD and --LLT have a one-to-one relationship
Authorities:
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -16,13 +17,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0906
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -31,13 +33,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0906
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -46,9 +49,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0906
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: --LLT
@@ -61,7 +64,7 @@ Check:
Core:
Id: CORE-000706
Status: Published
- Version: '1'
+ Version: "1"
Description: --LLTCD and --LLT should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000709/rule.yml b/Deprecated/CORE-000709/rule.yml
index 6a3cd17bc..d45883896 100644
--- a/Deprecated/CORE-000709/rule.yml
+++ b/Deprecated/CORE-000709/rule.yml
@@ -7,42 +7,45 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0607
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0607
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0607
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- any:
@@ -62,7 +65,7 @@ Check:
Core:
Id: CORE-000709
Status: Published
- Version: '1'
+ Version: "1"
Description: When a record is present in the CE dataset where CETERM or
CEDECOD = 'DEATH' then death flag (DTHFL) should be populated as 'Y' in the
DM dataset for the corresponding subject.
@@ -72,7 +75,8 @@ Match Datasets:
- USUBJID
Name: CE
Outcome:
- Message: CETERM or CEDECOD is 'DEATH' in CE dataset, but DTHFL in DM dataset is
+ Message:
+ CETERM or CEDECOD is 'DEATH' in CE dataset, but DTHFL in DM dataset is
not "Y".
Output Variables:
- CETERM
diff --git a/Deprecated/CORE-000713/rule.yml b/Deprecated/CORE-000713/rule.yml
index 119ed7db3..5183af6ae 100644
--- a/Deprecated/CORE-000713/rule.yml
+++ b/Deprecated/CORE-000713/rule.yml
@@ -7,29 +7,31 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
+ - Cited Guidance:
+ Study start and end date/time should include month, day, and
year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3411
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
+ - Cited Guidance:
+ Study start and end date/time should include month, day, and
year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3411
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: RFICDTC
@@ -42,7 +44,7 @@ Check:
Core:
Id: CORE-000713
Status: Published
- Version: '1'
+ Version: "1"
Description: Date/Time of Informed Consent (RFICDTC) should be prior or equal to
the Subject Reference Start Date/Time (RFSTDTC).
Executability: Fully Executable
diff --git a/Deprecated/CORE-000716/rule.yml b/Deprecated/CORE-000716/rule.yml
index 154e2fb8d..f1c3e030f 100644
--- a/Deprecated/CORE-000716/rule.yml
+++ b/Deprecated/CORE-000716/rule.yml
@@ -1,13 +1,14 @@
# Variable: --SOC, -SOCCD
# Condition:
-# Rule: --SOCCD and --SOC have a one-to-one relationship
+# Rule: --SOCCD and --SOC have a one-to-one relationship
Authorities:
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -16,13 +17,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0911
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -31,13 +33,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0911
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -46,9 +49,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0911
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: --SOC
@@ -61,7 +64,7 @@ Check:
Core:
Id: CORE-000716
Status: Published
- Version: '1'
+ Version: "1"
Description: --SOCCD and --SOC should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000717/rule.yml b/Deprecated/CORE-000717/rule.yml
index b9cbbf334..a6e769f28 100644
--- a/Deprecated/CORE-000717/rule.yml
+++ b/Deprecated/CORE-000717/rule.yml
@@ -7,42 +7,45 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
+ - Cited Guidance:
+ Study start and end date/time should include month, day, and
year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3401
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
+ - Cited Guidance:
+ Study start and end date/time should include month, day, and
year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3401
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
+ - Cited Guidance:
+ Study start and end date/time should include month, day, and
year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3401
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: AESTDTC
@@ -53,7 +56,7 @@ Check:
Core:
Id: CORE-000717
Status: Published
- Version: '1'
+ Version: "1"
Description: Start Date/Time of Adverse Event (AESTDTC) should be prior or equal
to the Start Date/Time of the latest Disposition Event (DSSTDTC).
Executability: Fully Executable
diff --git a/Deprecated/CORE-000719/rule.yml b/Deprecated/CORE-000719/rule.yml
index c6899a713..bd3a549f4 100644
--- a/Deprecated/CORE-000719/rule.yml
+++ b/Deprecated/CORE-000719/rule.yml
@@ -1,13 +1,14 @@
# Variable: --HLGT, --HLGTCD
# Condition:
-# Rule: --HLGTCD and --HLGT have a one-to-one relationship
+# Rule: --HLGTCD and --HLGT have a one-to-one relationship
Authorities:
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -16,13 +17,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0908
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -31,13 +33,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0908
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -46,9 +49,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0908
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: --HLGT
@@ -61,7 +64,7 @@ Check:
Core:
Id: CORE-000719
Status: Published
- Version: '1'
+ Version: "1"
Description: --HLGTCD and --HLGT should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000720/rule.yml b/Deprecated/CORE-000720/rule.yml
index 9d36a6b67..abe258a57 100644
--- a/Deprecated/CORE-000720/rule.yml
+++ b/Deprecated/CORE-000720/rule.yml
@@ -7,42 +7,45 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
+ - Cited Guidance:
+ Study start and end date/time should include month, day, and
year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3406
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
+ - Cited Guidance:
+ Study start and end date/time should include month, day, and
year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3406
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
+ - Cited Guidance:
+ Study start and end date/time should include month, day, and
year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3406
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: --DTC
@@ -55,7 +58,7 @@ Check:
Core:
Id: CORE-000720
Status: Published
- Version: '1'
+ Version: "1"
Description: Date/Time of Collection (--DTC) variable value should be prior or
equal to Date/Time of End of Participation (RFPENDTC).
Executability: Fully Executable
diff --git a/Deprecated/CORE-000723/rule.yml b/Deprecated/CORE-000723/rule.yml
index 66fba2547..8f5567f00 100644
--- a/Deprecated/CORE-000723/rule.yml
+++ b/Deprecated/CORE-000723/rule.yml
@@ -1,13 +1,14 @@
# Variable: --HLT, --HLTCD
# Condition:
-# Rule: --HLTCD and --HLT have a one-to-one relationship
+# Rule: --HLTCD and --HLT have a one-to-one relationship
Authorities:
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -16,13 +17,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0907
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -31,13 +33,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0907
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -46,9 +49,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0907
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: --HLT
@@ -61,7 +64,7 @@ Check:
Core:
Id: CORE-000723
Status: Published
- Version: '1'
+ Version: "1"
Description: --HLTCD and --HLT should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000726/rule.yml b/Deprecated/CORE-000726/rule.yml
index 8b07cde86..ae5a8fd0f 100644
--- a/Deprecated/CORE-000726/rule.yml
+++ b/Deprecated/CORE-000726/rule.yml
@@ -8,7 +8,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'When collecting ethnicity demographic data from clinical trial
+ - Cited Guidance:
+ 'When collecting ethnicity demographic data from clinical trial
participants, the following two minimum choices should be
offered: "HISPANIC OR LATINO" or "NOT HISPANIC OR LATINO"'
Document: FDA
@@ -16,13 +17,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB5701
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'When collecting ethnicity demographic data from clinical trial
+ - Cited Guidance:
+ 'When collecting ethnicity demographic data from clinical trial
participants, the following two minimum choices should be
offered: "HISPANIC OR LATINO" or "NOT HISPANIC OR LATINO"'
Document: FDA
@@ -30,13 +32,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB5701
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'When collecting ethnicity demographic data from clinical trial
+ - Cited Guidance:
+ 'When collecting ethnicity demographic data from clinical trial
participants, the following two minimum choices should be
offered: "HISPANIC OR LATINO" or "NOT HISPANIC OR LATINO"'
Document: FDA
@@ -44,9 +47,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB5701
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
any:
- all:
@@ -74,7 +77,7 @@ Check:
Core:
Id: CORE-000726
Status: Published
- Version: '1'
+ Version: "1"
Description: When Ethnicity was collected and it was not mapped as "HISPANIC OR
LATINO" or "NOT HISPANIC OR LATINO".
Executability: Partially Executable
@@ -83,7 +86,8 @@ Match Datasets:
- USUBJID
Name: SUPPDM
Outcome:
- Message: Ethnicity has been collected but the values is not mapped to "HISPANIC
+ Message:
+ Ethnicity has been collected but the values is not mapped to "HISPANIC
OR LATINO" or "NOT HISPANIC OR LATINO"
Output Variables:
- ETHNIC
diff --git a/Deprecated/CORE-000728/rule.yml b/Deprecated/CORE-000728/rule.yml
index f00157656..aba989ab8 100644
--- a/Deprecated/CORE-000728/rule.yml
+++ b/Deprecated/CORE-000728/rule.yml
@@ -1,13 +1,14 @@
# Variable: TSVAL, TSVALCD
# Condition: TSVCDREF ^= null
-# Rule: TSVALCD and TSVAL have a one-to-one relationship
+# Rule: TSVALCD and TSVAL have a one-to-one relationship
Authorities:
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -16,13 +17,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0904
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -31,13 +33,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0904
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -46,9 +49,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0904
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: TSVCDREF
@@ -65,7 +68,7 @@ Check:
Core:
Id: CORE-000728
Status: Published
- Version: '1'
+ Version: "1"
Description: TSVALCD and TSVAL should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000729/rule.yml b/Deprecated/CORE-000729/rule.yml
index 9390ac87b..7bed00037 100644
--- a/Deprecated/CORE-000729/rule.yml
+++ b/Deprecated/CORE-000729/rule.yml
@@ -1,13 +1,14 @@
# Variable: INVID, INVNAM
# Condition:
-# Rule: INVNAM and INVID have a one-to-one relationship
+# Rule: INVNAM and INVID have a one-to-one relationship
Authorities:
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -16,13 +17,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0912
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -31,13 +33,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0912
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -46,9 +49,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0912
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: INVID
@@ -61,7 +64,7 @@ Check:
Core:
Id: CORE-000729
Status: Published
- Version: '1'
+ Version: "1"
Description: INVID and INVNAM shoumd have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000730/rule.yml b/Deprecated/CORE-000730/rule.yml
index 29663eb2d..bc92122af 100644
--- a/Deprecated/CORE-000730/rule.yml
+++ b/Deprecated/CORE-000730/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
@@ -16,24 +17,25 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0438
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0438
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -47,12 +49,12 @@ Check:
Core:
Id: CORE-000730
Status: Published
- Version: '1'
-Description: 'When TSPARMCD is equal to AGEMIN and TSVAL is not null, TSVAL
- should conform to ISO 8601'
+ Version: "1"
+Description: "When TSPARMCD is equal to AGEMIN and TSVAL is not null, TSVAL
+ should conform to ISO 8601"
Executability: Fully Executable
Outcome:
- Message: 'TSVAL does not conform to ISO 8601'
+ Message: "TSVAL does not conform to ISO 8601"
Output Variables:
- TSVAL
- TSPARMCD
diff --git a/Deprecated/CORE-000731/rule.yml b/Deprecated/CORE-000731/rule.yml
index 17540f7c3..8c116f164 100644
--- a/Deprecated/CORE-000731/rule.yml
+++ b/Deprecated/CORE-000731/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
@@ -16,24 +17,25 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0439
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0439
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
@@ -47,12 +49,12 @@ Check:
Core:
Id: CORE-000731
Status: Published
- Version: '1'
-Description: 'When TSPARMCD = LENGTH and TSVAL ^= NULL, TSVAL needs to conform
- to ISO 8601 time period'
+ Version: "1"
+Description: "When TSPARMCD = LENGTH and TSVAL ^= NULL, TSVAL needs to conform
+ to ISO 8601 time period"
Executability: Fully Executable
Outcome:
- Message: 'TSVAL is not NULL and does not conform to ISO 8601 time period'
+ Message: "TSVAL is not NULL and does not conform to ISO 8601 time period"
Output Variables:
- TSVAL
- TSPARMCD
diff --git a/Deprecated/CORE-000733/rule.yml b/Deprecated/CORE-000733/rule.yml
index b019dc3d5..851a7dc63 100644
--- a/Deprecated/CORE-000733/rule.yml
+++ b/Deprecated/CORE-000733/rule.yml
@@ -7,27 +7,29 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '|IG v3.2[Appendix C1][Further information about the parameters
+ - Cited Guidance:
+ "|IG v3.2[Appendix C1][Further information about the parameters
is included below in Table 1. TSVAL may have controlled
terminology depending on the value of TSPARMCD]|IG
v3.2[Appendix C1][Required only when there is only one
investigational treatment. The value is always a number
between 0 and 1. There are cases where the ratio is 1 (e.g.,
crossover study or open label study where all subjects are
- exposed to investigational therapy).]'
+ exposed to investigational therapy).]"
Document: IG v3.2
Item: IG v3.2[7.4][Assumption 3]|IG v3.2[Appendix C1]
Section: IG v3.2[7.4]|IG v3.2[Appendix C1]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0281
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the
+ - Cited Guidance:
+ IG v3.3[7.4.2][Assumption 3][Further information about the
parameters is included Appendix C1, Trial Summary Codes. TSVAL
may have controlled terminology depending on the value of
TSPARMCD. Conditions for including parameters are included in
@@ -43,9 +45,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0281
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
any:
- name: $trt_count
@@ -61,9 +63,9 @@ Check:
Core:
Id: CORE-000733
Status: Published
- Version: '1'
-Description: 'At least one observation where TSPARMCD = TRT is present and there
- is only one investigational treatment'
+ Version: "1"
+Description: "At least one observation where TSPARMCD = TRT is present and there
+ is only one investigational treatment"
Executability: Fully Executable
Operations:
- domain: TS
@@ -79,7 +81,7 @@ Operations:
name: TSPARMCD
operator: record_count
Outcome:
- Message: 'TSPARMCD = RANDQT record is not present'
+ Message: "TSPARMCD = RANDQT record is not present"
Output Variables:
- TSPARMCD
- $trt_count
diff --git a/Deprecated/CORE-000735/rule.yml b/Deprecated/CORE-000735/rule.yml
index 92dd35963..2886f11d6 100644
--- a/Deprecated/CORE-000735/rule.yml
+++ b/Deprecated/CORE-000735/rule.yml
@@ -7,33 +7,35 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Further information about the parameters is included below in
+ - Cited Guidance:
+ "Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD'
+ on the value of TSPARMCD"
Document: SDTM and SDTMIG Conformance Rules v2.0
Item: Assumption 3
- Section: '7.4'
- Origin: 'SDTM and SDTMIG Conformance Rules'
+ Section: "7.4"
+ Origin: "SDTM and SDTMIG Conformance Rules"
Rule Identifier:
- Id: 'CG0444'
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Id: "CG0444"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Further information about the parameters is included below in
+ - Cited Guidance:
+ "Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD'
+ on the value of TSPARMCD"
Document: SDTM and SDTMIG Conformance Rules v2.0
Item: Assumption 3
- Section: '7.4'
- Origin: 'SDTM and SDTMIG Conformance Rules'
+ Section: "7.4"
+ Origin: "SDTM and SDTMIG Conformance Rules"
Rule Identifier:
- Id: 'CG0444'
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Id: "CG0444"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- any:
@@ -48,17 +50,17 @@ Check:
value: TRT
- name: TSVCDREF
operator: not_equal_to
- value: 'UNII'
+ value: "UNII"
Core:
Id: CORE-000735
Status: Published
- Version: '1'
-Description: 'When TSPARMCD is equal to COMPTRT, CURTRT or TRT, TSVCDREF should equal UNII'
+ Version: "1"
+Description: "When TSPARMCD is equal to COMPTRT, CURTRT or TRT, TSVCDREF should equal UNII"
Executability: Fully Executable
Outcome:
- Message: 'Throw error when TSPARMCD is equal to COMPTRT, CURTRT, or TRT and
- TSVCDREF ^= UNII'
+ Message: "Throw error when TSPARMCD is equal to COMPTRT, CURTRT, or TRT and
+ TSVCDREF ^= UNII"
Output Variables:
- TSPARMCD
- TSVCDREF
diff --git a/Deprecated/CORE-000739/rule.yml b/Deprecated/CORE-000739/rule.yml
index bb5730bb6..0fcc670aa 100644
--- a/Deprecated/CORE-000739/rule.yml
+++ b/Deprecated/CORE-000739/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The EX domain is required for all studies that include
+ - Cited Guidance:
+ The EX domain is required for all studies that include
protocol-specified study treatment.
Document: IG v3.4
Item: Assumption 1c
@@ -15,26 +16,28 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0407
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The EX domain is required for all studies that include
+ - Cited Guidance:
+ The EX domain is required for all studies that include
protocol-specified study treatment.
Document: IG v3.2
- Section: '6.1'
+ Section: "6.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0407
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The EX domain is required for all studies that include
+ - Cited Guidance:
+ The EX domain is required for all studies that include
protocol-specified study treatment.
Document: IG v3.3
Item: Assumption 1.c
@@ -42,9 +45,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0407
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: EX
@@ -52,12 +55,13 @@ Check:
Core:
Id: CORE-000739
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when study includes protocol-specified study
treatment and EX is not present
Executability: Fully Executable
Outcome:
- Message: EX is not present in study when study includes protocol-specified study
+ Message:
+ EX is not present in study when study includes protocol-specified study
treatment
Rule Type: Domain Presence Check
Scope:
diff --git a/Deprecated/CORE-000740/rule.yml b/Deprecated/CORE-000740/rule.yml
index 59a895f24..b6ad6c15f 100644
--- a/Deprecated/CORE-000740/rule.yml
+++ b/Deprecated/CORE-000740/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: A set of records exist with at least one record with TSPARMCD equal to each of the required values in the list of Trial Summary Codes in Appendix C1
Authorities:
- Organization: CDISC
@@ -7,74 +7,76 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
+ - Cited Guidance:
+ Further information about the parameters is included below in
Table 1. TSVAL may have controlled terminology depending on
the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0287
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included Appendix
+ - Cited Guidance:
+ Further information about the parameters is included Appendix
C1, Trial Summary Codes. TSVAL may have controlled terminology
depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0287
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSPARMCD
operator: not_contains_all
value:
- - 'ADDON'
- - 'AGEMAX'
- - 'AGEMIN'
- - 'LENGTH'
- - 'PLANSUB'
- - 'RANDOM'
- - 'SEXPOP'
- - 'STOPRULE'
- - 'TBLIND'
- - 'TCNTRL'
- - 'TITLE'
- - 'TPHASE'
- - 'TTYPE'
- - 'OBJPRIM'
- - 'SPONSOR'
- - 'REGID'
- - 'OUTMSPRI'
- - 'FCNTRY'
- - 'ADAPT'
- - 'DCUTDTC'
- - 'DCUTDESC'
- - 'NARMS'
- - 'STYPE'
- - 'SSTDTC'
- - 'SENDTC'
- - 'ACTSUB'
- - 'HLTSUBJI'
+ - "ADDON"
+ - "AGEMAX"
+ - "AGEMIN"
+ - "LENGTH"
+ - "PLANSUB"
+ - "RANDOM"
+ - "SEXPOP"
+ - "STOPRULE"
+ - "TBLIND"
+ - "TCNTRL"
+ - "TITLE"
+ - "TPHASE"
+ - "TTYPE"
+ - "OBJPRIM"
+ - "SPONSOR"
+ - "REGID"
+ - "OUTMSPRI"
+ - "FCNTRY"
+ - "ADAPT"
+ - "DCUTDTC"
+ - "DCUTDESC"
+ - "NARMS"
+ - "STYPE"
+ - "SSTDTC"
+ - "SENDTC"
+ - "ACTSUB"
+ - "HLTSUBJI"
Core:
Id: CORE-000740
Status: Published
- Version: '1'
-Description: 'A required value of TSPARMCD is not found'
+ Version: "1"
+Description: "A required value of TSPARMCD is not found"
Executability: Fully Executable
Outcome:
- Message: 'A required value of TSPARMCD is not found'
+ Message: "A required value of TSPARMCD is not found"
Output Variables:
- TSPARMCD
Rule Type: Record Data
diff --git a/Deprecated/CORE-000741/rule.yml b/Deprecated/CORE-000741/rule.yml
index 2b20601a1..99fc5fbec 100644
--- a/Deprecated/CORE-000741/rule.yml
+++ b/Deprecated/CORE-000741/rule.yml
@@ -1,42 +1,42 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1111'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB1111"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1111'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB1111"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1111'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB1111"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
any:
- name: TSPARMCD
@@ -69,7 +69,7 @@ Check:
value: 1
Core:
Status: Published
- Version: '1'
+ Version: "1"
Id: CORE-000741
Description: The set ('INTMODEL’, 'INTTYPE','PCLASS') is not in the list of
TSPARAMCD with TSVAL populated.
diff --git a/Deprecated/CORE-000742/rule.yml b/Deprecated/CORE-000742/rule.yml
index 9d87adc75..824719393 100644
--- a/Deprecated/CORE-000742/rule.yml
+++ b/Deprecated/CORE-000742/rule.yml
@@ -1,45 +1,45 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1110'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB1110"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1110'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB1110"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1110'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB1110"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- - name: '$HLTSUBJI'
+ - name: "$HLTSUBJI"
operator: equal_to
value: 1
- name: $INDIC
@@ -47,9 +47,9 @@ Check:
value: 1
Core:
Status: Published
- Version: '1'
+ Version: "1"
Id: CORE-000742
-Description: 'TSVALNF is not equal to NA when TSPARAMCD=INDIC'
+Description: "TSVALNF is not equal to NA when TSPARAMCD=INDIC"
Executability: Fully Executable
Operations:
- filter:
@@ -63,7 +63,7 @@ Operations:
id: $HLTSUBJI
operator: record_count
Outcome:
- Message: 'TSVALNF is not equal to NA when TSPARAMCD=INDIC'
+ Message: "TSVALNF is not equal to NA when TSPARAMCD=INDIC"
Output Variables:
- TSPARMCD
- TSVAL
diff --git a/Deprecated/CORE-000743/rule.yml b/Deprecated/CORE-000743/rule.yml
index af0594e24..f1cbbf19b 100644
--- a/Deprecated/CORE-000743/rule.yml
+++ b/Deprecated/CORE-000743/rule.yml
@@ -1,13 +1,14 @@
# Variable: IETEST, IETESTCD
# Condition:
-# Rule: IETESTCD and IETEST have a one-to-one relationship
+# Rule: IETESTCD and IETEST have a one-to-one relationship
Authorities:
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -16,13 +17,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0918
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -31,13 +33,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0918
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -46,9 +49,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0918
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: IETEST
@@ -61,7 +64,7 @@ Check:
Core:
Id: CORE-000743
Status: Published
- Version: '1'
+ Version: "1"
Description: IETESTCD and IETEST should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000745/rule.yml b/Deprecated/CORE-000745/rule.yml
index f60bb2b28..0026cc3f4 100644
--- a/Deprecated/CORE-000745/rule.yml
+++ b/Deprecated/CORE-000745/rule.yml
@@ -1,13 +1,14 @@
# Variable: OIPARM, OIPARMCD
# Condition:
-# Rule: OIPARMCD and OIPARM have a one-to-one relationship
+# Rule: OIPARMCD and OIPARM have a one-to-one relationship
Authorities:
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -16,13 +17,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0915
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -31,13 +33,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0915
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -46,9 +49,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0915
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: OIPARM
@@ -61,7 +64,7 @@ Check:
Core:
Id: CORE-000745
Status: Published
- Version: '1'
+ Version: "1"
Description: OIPARMCD and OIPARM should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000746/rule.yml b/Deprecated/CORE-000746/rule.yml
index 3025da563..c2715afc3 100644
--- a/Deprecated/CORE-000746/rule.yml
+++ b/Deprecated/CORE-000746/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The term "Spanish origin" can be used to collect ethnicity data.
+ - Cited Guidance:
+ The term "Spanish origin" can be used to collect ethnicity data.
If the term "Spanish origin" is collected, it should be mapped
to the controlled terminology "HISPANIC OR LATINO" for
submission.
@@ -16,13 +17,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB5801
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The term "Spanish origin" can be used to collect ethnicity data.
+ - Cited Guidance:
+ The term "Spanish origin" can be used to collect ethnicity data.
If the term "Spanish origin" is collected, it should be mapped
to the controlled terminology "HISPANIC OR LATINO" for
submission.
@@ -31,13 +33,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB5801
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The term "Spanish origin" can be used to collect ethnicity data.
+ - Cited Guidance:
+ The term "Spanish origin" can be used to collect ethnicity data.
If the term "Spanish origin" is collected, it should be mapped
to the controlled terminology "HISPANIC OR LATINO" for
submission.
@@ -46,26 +49,26 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB5801
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: ETHNIC
operator: non_empty
- name: ETHNIC
operator: not_equal_to
- value: 'HISPANIC OR LATINO'
+ value: "HISPANIC OR LATINO"
- name: QNAM
operator: equal_to
value: CETHNIC
- name: QVAL
operator: equal_to
- value: 'SPANISH ORIGIN'
+ value: "SPANISH ORIGIN"
Core:
Id: CORE-000746
Status: Published
- Version: '1'
+ Version: "1"
Description: When ethnicity term 'Spanish origin' is collected (SUPPDM.CETHNIC),
it should be mapped to Ethnicity (ETHNIC) 'HISPANIC OR LATINO' in the DM
dataset
diff --git a/Deprecated/CORE-000747/rule.yml b/Deprecated/CORE-000747/rule.yml
index fb3775697..0a647242e 100644
--- a/Deprecated/CORE-000747/rule.yml
+++ b/Deprecated/CORE-000747/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The term "Hatian or Negro" can be used collect race data. If the
+ - Cited Guidance:
+ The term "Hatian or Negro" can be used collect race data. If the
term "Hatian or Negro" is collected, it should be mapped to
the controlled terminology "BLACK OR AFRICAN AMERICAN" for
submission.
@@ -16,13 +17,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB6001
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The term "Hatian or Negro" can be used collect race data. If the
+ - Cited Guidance:
+ The term "Hatian or Negro" can be used collect race data. If the
term "Hatian or Negro" is collected, it should be mapped to
the controlled terminology "BLACK OR AFRICAN AMERICAN" for
submission.
@@ -31,13 +33,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB6001
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The term "Hatian or Negro" can be used collect race data. If the
+ - Cited Guidance:
+ The term "Hatian or Negro" can be used collect race data. If the
term "Hatian or Negro" is collected, it should be mapped to
the controlled terminology "BLACK OR AFRICAN AMERICAN" for
submission.
@@ -46,26 +49,26 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB6001
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: RACE
operator: non_empty
- name: RACE
operator: not_equal_to
- value: 'BLACK OR AFRICAN AMERICAN'
+ value: "BLACK OR AFRICAN AMERICAN"
- name: QNAM
operator: equal_to
value: CRACE
- name: QVAL
operator: equal_to
- value: 'HATIAN or NEGRO'
+ value: "HATIAN or NEGRO"
Core:
Id: CORE-000747
Status: Published
- Version: '1'
+ Version: "1"
Description: When Race Term 'Haitian' or 'Negro' (SUPPDM.CRACE) is collected, it
should be mapped to Race (RACE) 'BLACK OR AFRICAN AMERICAN' in the DM dataset.
Executability: Fully Executable
diff --git a/Deprecated/CORE-000761/rule.yml b/Deprecated/CORE-000761/rule.yml
index 96a011745..7b4172bb1 100644
--- a/Deprecated/CORE-000761/rule.yml
+++ b/Deprecated/CORE-000761/rule.yml
@@ -13,22 +13,22 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0289
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: The version number of the Reference Terminology, if applicable.
Document: IG v3.2
Item: Specification
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0289
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -39,9 +39,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0289
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSVCDREF
@@ -53,7 +53,7 @@ Check:
Core:
Id: CORE-000761
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when TSVCDREF = 'CDISC' and TSVCDVER is not a valid
published version (date)
Executability: Fully Executable
diff --git a/Deprecated/CORE-000766/rule.yml b/Deprecated/CORE-000766/rule.yml
index 1278d67f8..45a5c63c1 100644
--- a/Deprecated/CORE-000766/rule.yml
+++ b/Deprecated/CORE-000766/rule.yml
@@ -7,19 +7,20 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When findings are collected about an event or intervention, and
+ - Cited Guidance:
+ When findings are collected about an event or intervention, and
the name of the event or intervention is collected in an
"Other, specify" CRF field, the value in --OBJ variable
depends on whether the FA record has a parent record and
whether the "Other, specify" value was coded.
Document: IG v3.4
- Section: '4.2.7.4'
+ Section: "4.2.7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0601
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all:
- name: --DECOD
@@ -30,9 +31,9 @@ Check:
Core:
Id: CORE-000766
Status: Published
- Version: '1'
-Description: 'When findings are collected, and the Events parent record exists
- and --DECOD is null, FAOBJ should not be equal to --TERM'
+ Version: "1"
+Description: "When findings are collected, and the Events parent record exists
+ and --DECOD is null, FAOBJ should not be equal to --TERM"
Executability: Fully Executable
Match Datasets:
- Name: RELREC
diff --git a/Deprecated/CORE-000767/rule.yml b/Deprecated/CORE-000767/rule.yml
index 26b1535be..c9b5ed488 100644
--- a/Deprecated/CORE-000767/rule.yml
+++ b/Deprecated/CORE-000767/rule.yml
@@ -7,19 +7,20 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When findings are collected about an event or intervention, and
+ - Cited Guidance:
+ When findings are collected about an event or intervention, and
the name of the event or intervention is collected in an
"Other, specify" CRF field, the value in --OBJ variable
depends on whether the FA record has a parent record and
whether the "Other, specify" value was coded.
Document: IG v3.4
- Section: '4.2.7.4'
+ Section: "4.2.7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0603
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all:
- name: --DECOD
@@ -30,15 +31,16 @@ Check:
Core:
Id: CORE-000767
Status: Published
- Version: '1'
-Description: 'When findings are collected, and the parent record exists and
- --DECOD is not null, FAOBJ should not be equal to --DECOD'
+ Version: "1"
+Description: "When findings are collected, and the parent record exists and
+ --DECOD is not null, FAOBJ should not be equal to --DECOD"
Executability: Fully Executable
Match Datasets:
- Name: RELREC
Wildcard: FA
Outcome:
- Message: Parent record exists and --DECOD is not null, but FAOBJ is not equal to
+ Message:
+ Parent record exists and --DECOD is not null, but FAOBJ is not equal to
--DECOD.
Output Variables:
- RELREC.FAOBJ
diff --git a/Deprecated/CORE-000777/rule.yml b/Deprecated/CORE-000777/rule.yml
index 128c5afe1..bc8d5ba27 100644
--- a/Deprecated/CORE-000777/rule.yml
+++ b/Deprecated/CORE-000777/rule.yml
@@ -5,29 +5,31 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0502
- Version: '2'
- Version: '2.0'
+ Version: "2"
+ Version: "2.0"
Citations:
- - Cited Guidance: The temporal relationship of the observation to the Disease
+ - Cited Guidance:
+ The temporal relationship of the observation to the Disease
Milestone Instance Name in MIDS.
Document: Model v2.0
Item: RELMIDS
Section: Timing
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0502
- Version: '2'
- Version: '2.0'
+ Version: "2"
+ Version: "2.0"
Citations:
- - Cited Guidance: 'The temporal relationship of the observation to the Disease
+ - Cited Guidance:
+ 'The temporal relationship of the observation to the Disease
Milestone Instance Name in MIDS. Examples: "IMMEDIATELY
BEFORE", "AT TIME OF", "AFTER".'
Document: Model v1.7
@@ -43,7 +45,7 @@ Check:
Core:
Id: CORE-000777
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when variable RELMIDS is present in any of the
dataset and TM dataset is missing in a study.
Executability: Fully Executable
diff --git a/Deprecated/CORE-000778/rule.yml b/Deprecated/CORE-000778/rule.yml
index d116715d0..f7e4f88eb 100644
--- a/Deprecated/CORE-000778/rule.yml
+++ b/Deprecated/CORE-000778/rule.yml
@@ -5,30 +5,32 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
+ Version: "3.4"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0650
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: Supplemental Qualifier datasets for split domains would also be
+ - Cited Guidance:
+ Supplemental Qualifier datasets for split domains would also be
split. The nomenclature would include the additional
one-to-two characters used to identify the split dataset.
Document: IG v3.4
- Item: '7'
+ Item: "7"
Section: 4.1.7
- Name: SDTMIG
- Version: '3.2'
+ Version: "3.2"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0650
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: AP Guide v1.0[2][Associated Persons datasets are given a prefix
+ - Cited Guidance:
+ AP Guide v1.0[2][Associated Persons datasets are given a prefix
of AP-- to identify the data as AP data to and distinguish
them from study subject data.]|IG v3.2[4.1.1.7][Item 6][For
example, if splitting by --CAT, then dataset names would be
@@ -38,15 +40,16 @@ Authorities:
Item: AP Guide v1.0[Section 2][Bullet 1]|IG v3.2[4.1.1.7][Item 6]
Section: 2|4.1.1.7
- Name: SDTMIG
- Version: '3.3'
+ Version: "3.3"
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0650
- Version: '1'
- Version: '2.0'
+ Version: "1"
+ Version: "2.0"
Citations:
- - Cited Guidance: AP Guide v1.0[2][Associated Persons datasets are given a prefix
+ - Cited Guidance:
+ AP Guide v1.0[2][Associated Persons datasets are given a prefix
of AP-- to identify the data as AP data to and distinguish
them from study subject data.]|IG v3.3[4.1.7][Item 6][For
example, if splitting by --CAT, then dataset names would be
@@ -66,13 +69,14 @@ Check:
Core:
Id: CORE-000778
Status: Published
- Version: '1'
+ Version: "1"
Description: When an Associated Persons non-supplemental qualifier dataset is
associated with a split dataset, the dataset name length must be greater than
4 and less than, or equal to, 6.
Executability: Fully Executable
Outcome:
- Message: Associated Persons non-supplemental qualifier dataset associated with a
+ Message:
+ Associated Persons non-supplemental qualifier dataset associated with a
split dataset does not have a dataset name with a length greater than 4 and
less than, or equal to, 6.
Rule Type: Dataset Metadata Check
diff --git a/Deprecated/CORE-000779/rule.yml b/Deprecated/CORE-000779/rule.yml
index 277e8c58f..47e7d2a17 100644
--- a/Deprecated/CORE-000779/rule.yml
+++ b/Deprecated/CORE-000779/rule.yml
@@ -1,5 +1,5 @@
# Variable: TDSTOFF
-# Condition:
+# Condition:
# Rule: TDSTOFF = 0 or positive value in ISO 8601 Duration format
Authorities:
- Organization: CDISC
@@ -7,25 +7,27 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'A fixed offset from the date provided by the variable
+ - Cited Guidance:
+ "A fixed offset from the date provided by the variable
referenced in TDANCVAR. This is used when the timing of
planned cycles does not start on the exact day referenced in
the variable indicated in TDANCVAR. The value of this variable
will be either zero or a positive value and will be
- represented in ISO 8601 character format. '
+ represented in ISO 8601 character format. "
Document: IG v3.4
Item: Specification
Section: 7.3.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0376
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.2[7.3][A fixed offset from the date provided by the
+ - Cited Guidance:
+ IG v3.2[7.3][A fixed offset from the date provided by the
variable referenced in TDANCVAR. This is used when the timing
of planned cycles does not start on the exact day referenced
in the variable indicated in TDANCVAR. The value of this
@@ -42,13 +44,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0376
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[7.3][A fixed offset from the date provided by the
+ - Cited Guidance:
+ IG v3.3[7.3][A fixed offset from the date provided by the
variable referenced in TDANCVAR. This is used when the timing
of planned cycles does not start on the exact day referenced
in the variable indicated in TDANCVAR. The value of this
@@ -65,9 +68,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0376
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TDSTOFF
@@ -79,7 +82,7 @@ Check:
Core:
Id: CORE-000779
Status: Published
- Version: '1'
+ Version: "1"
Description: TDSTOFF must be equal to 0 or a positive value in ISO 8601 Duration format
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000787/rule.yml b/Deprecated/CORE-000787/rule.yml
index 56102f013..e3bb2601e 100644
--- a/Deprecated/CORE-000787/rule.yml
+++ b/Deprecated/CORE-000787/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: While it would be possible to allow a value such as NONE or
+ - Cited Guidance:
+ While it would be possible to allow a value such as NONE or
UNBOUNDED to be entered in TSVAL, validation programs would
then have to recognize this special term as an exception to
the expected data format. Therefore, it was decided that a
@@ -18,13 +19,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0291
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: While it would be possible to allow a value such as NONE or
+ - Cited Guidance:
+ While it would be possible to allow a value such as NONE or
UNBOUNDED to be entered in TSVAL, validation programs would
then have to recognize this special term as an exception to
the expected data format. Therefore, it was decided that a
@@ -35,13 +37,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0291
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: While it would be possible to allow a value such as NONE or
+ - Cited Guidance:
+ While it would be possible to allow a value such as NONE or
UNBOUNDED to be entered in TSVAL, validation programs would
then have to recognize this special term as an exception to
the expected data format. Therefore, it was decided that a
@@ -52,9 +55,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0291
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: TSVALNF
@@ -69,7 +72,7 @@ Check:
Core:
Id: CORE-000787
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TSVALNF is empty and TSVAL is populated with
values or synonyms of values in the ISO 21090 null flavor codelist (or other
terms that can be represented as null flavors)
diff --git a/Deprecated/CORE-000790/rule.yml b/Deprecated/CORE-000790/rule.yml
index 76c470612..e83d7daec 100644
--- a/Deprecated/CORE-000790/rule.yml
+++ b/Deprecated/CORE-000790/rule.yml
@@ -13,9 +13,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB2505
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
Check:
all:
- name: ARM
@@ -33,7 +33,7 @@ Check:
Core:
Id: "CORE-000790"
Status: Published
- Version: '1'
+ Version: "1"
Description: If a subject is assigned to an arm, the subject should have a record in EX.
Executability: Partially Executable
Operations:
diff --git a/Deprecated/CORE-000792/rule.yml b/Deprecated/CORE-000792/rule.yml
index 0bb3f3766..7b8199ca8 100644
--- a/Deprecated/CORE-000792/rule.yml
+++ b/Deprecated/CORE-000792/rule.yml
@@ -1,13 +1,14 @@
# Variable: --CLAS, --CLASCD
# Condition:
-# Rule: --CLASCD and --CLAS have a one-to-one relationship
+# Rule: --CLASCD and --CLAS have a one-to-one relationship
Authorities:
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -16,13 +17,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0905
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -31,13 +33,14 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0905
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship.
Examples include short name and name of test; parameter name
and parameter code or number; variable name and variable
label, etc.
@@ -46,9 +49,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0905
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: --CLAS
@@ -61,7 +64,7 @@ Check:
Core:
Id: CORE-000792
Status: Published
- Version: '1'
+ Version: "1"
Description: --CLASCD and --CLAS should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000841/rule.yml b/Deprecated/CORE-000841/rule.yml
index d9a32350c..02f5757c0 100644
--- a/Deprecated/CORE-000841/rule.yml
+++ b/Deprecated/CORE-000841/rule.yml
@@ -7,54 +7,57 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0612
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0612
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0612
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: AEOUT
operator: equal_to
- value: 'FATAL'
+ value: "FATAL"
- name: AEENDTC
operator: not_equal_to
value: DTHDTC
Core:
Id: CORE-000841
Status: Published
- Version: '1'
+ Version: "1"
Description: End Date/Time of Adverse Event (AEENDTC) in AE dataset of Adverse
Event where AEOUT = 'FATAL' should be equal to the Date/Time of Death (DTHDTC)
in the DM dataset for the corresponding subject.
diff --git a/Deprecated/CORE-000842/rule.yml b/Deprecated/CORE-000842/rule.yml
index a38fad3ca..e90e8888e 100644
--- a/Deprecated/CORE-000842/rule.yml
+++ b/Deprecated/CORE-000842/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "The method for deriving these values should be consistent with
+ - Cited Guidance:
+ "The method for deriving these values should be consistent with
the visit definitions in the Trial Visits dataset [see Section
'7.3 - Schedule for Assessments: Trial Visits (TV)']."
Document: IG v3.2
@@ -16,24 +17,25 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0213
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The method for deriving these values should be consistent with
+ - Cited Guidance:
+ The method for deriving these values should be consistent with
the visit definitions in the Trial Visits (TV) dataset
(Section 7.3.1, Trial Visits).
Document: IG v3.3
Item: Description
- Section: '5.5'
+ Section: "5.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0213
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- any:
@@ -47,7 +49,7 @@ Check:
Core:
Id: CORE-000842
Status: Published
- Version: '1'
+ Version: "1"
Description: When SVUPDES is not populated, then the VISITNUM should be equal to
a VISITNUM in TV
Executability: Partially Executable - Possible Overreporting
diff --git a/Deprecated/CORE-000843/rule.yml b/Deprecated/CORE-000843/rule.yml
index dc78b64d9..844396712 100644
--- a/Deprecated/CORE-000843/rule.yml
+++ b/Deprecated/CORE-000843/rule.yml
@@ -7,7 +7,8 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "Records for unplanned visits should be included in the SV
+ - Cited Guidance:
+ "Records for unplanned visits should be included in the SV
dataset. For unplanned visits, SVUPDES should be populated
with a description of the reason for the unplanned visit. Some
judgment may be required to determine what constitutes an
@@ -28,13 +29,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0214
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Records for unplanned visits should be included in the SV
+ - Cited Guidance:
+ Records for unplanned visits should be included in the SV
dataset. For unplanned visits, SVUPDES should be populated
with a description of the reason for the unplanned visit. Some
judgment may be required to determine what constitutes an
@@ -51,13 +53,13 @@ Authorities:
visit variables for unplanned visits.
Document: IG v3.3
Item: Assumption 3
- Section: '5.5'
+ Section: "5.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0214
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: SVUPDES
@@ -68,7 +70,7 @@ Check:
Core:
Id: CORE-000843
Status: Published
- Version: '1'
+ Version: "1"
Description: When SVUPDES is populated, then the VISITNUM should not be equal to
a VISITNUM in TV
Executability: Fully Executable
diff --git a/Deprecated/CORE-000844/rule.yml b/Deprecated/CORE-000844/rule.yml
index da5a7b446..045611a82 100644
--- a/Deprecated/CORE-000844/rule.yml
+++ b/Deprecated/CORE-000844/rule.yml
@@ -1,4 +1,4 @@
-# Variable:
+# Variable:
# Condition: RACE = MULTIPLE
# Rule: Multiple SUPPDM.QNAM records exist for the subject
Authorities:
@@ -7,33 +7,35 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple races are collected then the value of RACE should be
+ - Cited Guidance:
+ If multiple races are collected then the value of RACE should be
'MULTIPLE' and the additional information will be included in
the Supplemental Qualifiers dataset.
Document: IG v3.3
Item: Assumption 6
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0531
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple races are collected, then the value of RACE should
+ - Cited Guidance:
+ If multiple races are collected, then the value of RACE should
be “MULTIPLE” and the additional information will be included
in the Supplemental Qualifiers dataset.
Document: IG v3.4
Item: Assumption 6
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0531
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all:
- name: $multiple_race
@@ -44,7 +46,7 @@ Check:
Core:
Id: CORE-000844
Status: Published
- Version: '1'
+ Version: "1"
Description: Part A - Raise an error when RACE in DM equals 'MULTIPLE' and
SUPPDM dataset is not present.
Executability: Fully Executable
diff --git a/Deprecated/CORE-000846/rule.yml b/Deprecated/CORE-000846/rule.yml
index 078397da1..7b5fdc81c 100644
--- a/Deprecated/CORE-000846/rule.yml
+++ b/Deprecated/CORE-000846/rule.yml
@@ -1,4 +1,4 @@
-# Variable:
+# Variable:
# Condition: RACE = MULTIPLE
# Rule: Multiple SUPPDM.QNAM records exist for the subject
Authorities:
@@ -7,33 +7,35 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple races are collected then the value of RACE should be
+ - Cited Guidance:
+ If multiple races are collected then the value of RACE should be
'MULTIPLE' and the additional information will be included in
the Supplemental Qualifiers dataset.
Document: IG v3.3
Item: Assumption 6
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0531
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple races are collected, then the value of RACE should
+ - Cited Guidance:
+ If multiple races are collected, then the value of RACE should
be “MULTIPLE” and the additional information will be included
in the Supplemental Qualifiers dataset.
Document: IG v3.4
Item: Assumption 6
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0531
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all:
- name: RACE
@@ -46,7 +48,7 @@ Check:
Core:
Id: CORE-000846
Status: Published
- Version: '1'
+ Version: "1"
Description: Part C - Raise an error when RACE in DM equals 'MULTIPLE' but no
multiple RACE records are present in SUPPDM.
Executability: Fully Executable
diff --git a/Deprecated/CORE-000880/rule.yml b/Deprecated/CORE-000880/rule.yml
index c7ffceb35..06c91167b 100644
--- a/Deprecated/CORE-000880/rule.yml
+++ b/Deprecated/CORE-000880/rule.yml
@@ -1,5 +1,5 @@
-#Rule: --PDUR is greater than or equal to zero
-#Logic: --PDUR >= 0
+#Rule: --PDUR is greater than or equal to zero
+#Logic: --PDUR >= 0
#Condition: --PDUR ^= null
Authorities:
- Organization: FDA
@@ -15,9 +15,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4006
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: --PDUR
@@ -28,7 +28,7 @@ Check:
Core:
Id: CORE-000880
Status: Published
- Version: '1'
+ Version: "1"
Description: Planned Duration (--PDUR) value should not be negative.
Executability: Fully Executable
Outcome:
diff --git a/Deprecated/CORE-000885/rule.yml b/Deprecated/CORE-000885/rule.yml
index 74b604eda..79bf2dbe0 100644
--- a/Deprecated/CORE-000885/rule.yml
+++ b/Deprecated/CORE-000885/rule.yml
@@ -7,29 +7,31 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For interventional studies all treated subjects should have
+ - Cited Guidance:
+ For interventional studies all treated subjects should have
exposure data.
Document: FDA
Section: FDAB023
Origin: FDA Business Rules
Rule Identifier:
Id: FB2302
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For interventional studies all treated subjects should have
+ - Cited Guidance:
+ For interventional studies all treated subjects should have
exposure data.
Document: FDA
Section: FDAB023
Origin: FDA Business Rules
Rule Identifier:
Id: FB2302
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
any:
- all:
@@ -65,7 +67,7 @@ Check:
Core:
Id: CORE-000885
Status: Published
- Version: '1'
+ Version: "1"
Description: All subjects in the Demographics domain who are participating in a
study that includes an interventional product must have at least one
corresponding record in the Exposure domain, except for subjects who failed
diff --git a/Deprecated/CORE-000886/rule.yml b/Deprecated/CORE-000886/rule.yml
index 7d8b9c007..b1bece09c 100644
--- a/Deprecated/CORE-000886/rule.yml
+++ b/Deprecated/CORE-000886/rule.yml
@@ -1,35 +1,37 @@
# Variable: ARMNRS
# Condition: DM.USUBJID not in EX.USUBJID AND TSVAL = "INTERVENTIONAL" when TSPARMCD = "STYPE"
-# Rule: ARMNRS^=null
+# Rule: ARMNRS^=null
Authorities:
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For interventional studies all treated subjects should have
+ - Cited Guidance:
+ For interventional studies all treated subjects should have
exposure data.
Document: FDA
Section: FDAB023
Origin: FDA Business Rules
Rule Identifier:
Id: FB2306
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For interventional studies all treated subjects should have
+ - Cited Guidance:
+ For interventional studies all treated subjects should have
exposure data.
Document: FDA
Section: FDAB023
Origin: FDA Business Rules
Rule Identifier:
Id: FB2306
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: ARMNRS
@@ -47,7 +49,7 @@ Check:
value: $usubjids_in_ex
Core:
Status: Published
- Version: '1'
+ Version: "1"
Id: CORE-000886
Description: All subjects that have no record in the Exposure domain who are
participating in a study that includes an interventional product should have
diff --git a/Deprecated/CORE-000887/rule.yml b/Deprecated/CORE-000887/rule.yml
index ae035c47e..efbb36110 100644
--- a/Deprecated/CORE-000887/rule.yml
+++ b/Deprecated/CORE-000887/rule.yml
@@ -7,16 +7,17 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For interventional studies all treated subjects should have
+ - Cited Guidance:
+ For interventional studies all treated subjects should have
exposure data.
Document: FDA
Section: FDAB023
Origin: FDA Business Rules
Rule Identifier:
Id: FB2301
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
Check:
all:
- name: TSPARMCD
@@ -38,7 +39,7 @@ Check:
value: $usubjiids_in_ex
Core:
Status: Published
- Version: '1'
+ Version: "1"
Id: CORE-000887
Description: All subjects in the Demographics domain who are participating in a
study that includes an interventional product must have at least one
diff --git a/Deprecated/CORE-000913/rule.yml b/Deprecated/CORE-000913/rule.yml
index 5348ce826..06db200d2 100644
--- a/Deprecated/CORE-000913/rule.yml
+++ b/Deprecated/CORE-000913/rule.yml
@@ -7,47 +7,50 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0611
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0611
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0611
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: DSDECOD
operator: equal_to
- value: 'DEATH'
+ value: "DEATH"
value_is_literal: true
- name: DSSTDTC
operator: not_equal_to
@@ -55,7 +58,7 @@ Check:
Core:
Id: CORE-000913
Status: Published
- Version: '1'
+ Version: "1"
Description: Disposition date time (DSSTDTC) for DEATH record in the DS dataset
should be equal to the Date of Death (DTHDTC) in the DM dataset for the
corresponding subject.
@@ -65,7 +68,8 @@ Match Datasets:
- USUBJID
Name: DM
Outcome:
- Message: DSSTDTC for DEATH record in DS dataset is not equal to DTHDTC in the DM
+ Message:
+ DSSTDTC for DEATH record in DS dataset is not equal to DTHDTC in the DM
dataset.
Output Variables:
- DSDECOD
diff --git a/Deprecated/CORE-000915/rule.yml b/Deprecated/CORE-000915/rule.yml
index 457118c13..0667cacfd 100644
--- a/Deprecated/CORE-000915/rule.yml
+++ b/Deprecated/CORE-000915/rule.yml
@@ -2,41 +2,43 @@
# Condition: --LOBXFL="Y" and --STRESC ^= Null
# Rule: Only one --LOBXFL per record having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Records with a baseline flag should have a corresponding
+ - Cited Guidance:
+ Records with a baseline flag should have a corresponding
standard result with a standardized unit where available.
- Document: 'FDA'
- Section: 'FDAB026'
- Origin: 'FDA Business Rules'
+ Document: "FDA"
+ Section: "FDAB026"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB2604'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB2604"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Records with a baseline flag should have a corresponding
+ - Cited Guidance:
+ Records with a baseline flag should have a corresponding
standard result with a standardized unit where available.
- Document: 'FDA'
- Section: 'FDAB026'
- Origin: 'FDA Business Rules'
+ Document: "FDA"
+ Section: "FDAB026"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB2604'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB2604"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: --STRESC
operator: non_empty
- name: --LOBXFL
operator: equal_to
- value: 'Y'
+ value: "Y"
value_is_literal: true
- name: --LOBXFL
operator: is_not_unique_set
@@ -49,7 +51,7 @@ Check:
- USUBJID
Core:
Status: Published
- Version: '1'
+ Version: "1"
Id: CORE-000915
Description: There should be only one record with a last observation before
exposure flag and non missing character standard result value having the same
diff --git a/Deprecated/CORE-000927/rule.yml b/Deprecated/CORE-000927/rule.yml
index fbec22b97..f2086df1a 100644
--- a/Deprecated/CORE-000927/rule.yml
+++ b/Deprecated/CORE-000927/rule.yml
@@ -7,29 +7,31 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For interventional studies all treated subjects should have
+ - Cited Guidance:
+ For interventional studies all treated subjects should have
exposure data.
Document: FDA
Section: FDAB023
Origin: FDA Business Rules
Rule Identifier:
Id: FB2304
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For interventional studies all treated subjects should have
+ - Cited Guidance:
+ For interventional studies all treated subjects should have
exposure data.
Document: FDA
Section: FDAB023
Origin: FDA Business Rules
Rule Identifier:
Id: FB2304
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: ARMNRS
@@ -51,7 +53,7 @@ Check:
value: $usubjids_in_ex
Core:
Status: Published
- Version: '1'
+ Version: "1"
Id: CORE-000927
Description: All subjects in the Exposure domain who are participating in a
study that includes an interventional product must be assigned to an ARM.
diff --git a/Deprecated/CORE-000952/rule.yml b/Deprecated/CORE-000952/rule.yml
index 98e2a41d7..c24ffd54a 100644
--- a/Deprecated/CORE-000952/rule.yml
+++ b/Deprecated/CORE-000952/rule.yml
@@ -7,42 +7,45 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
+ - Cited Guidance:
+ Study start and end date/time should include month, day, and
year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3407
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
+ - Cited Guidance:
+ Study start and end date/time should include month, day, and
year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3407
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
+ - Cited Guidance:
+ Study start and end date/time should include month, day, and
year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3407
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: --ENDTC
@@ -55,7 +58,7 @@ Check:
Core:
Id: CORE-000952
Status: Published
- Version: '1'
+ Version: "1"
Description: End Date/Time (--ENDTC) variable value should be prior or equal to
the Date/Time of End of Participation (RFPENDTC).
Executability: Fully Executable
diff --git a/Deprecated/CORE-001043/rule.yml b/Deprecated/CORE-001043/rule.yml
index bdf0cce12..1f29d77b0 100644
--- a/Deprecated/CORE-001043/rule.yml
+++ b/Deprecated/CORE-001043/rule.yml
@@ -7,42 +7,45 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Age should be provided for all subjects, except where not
+ - Cited Guidance:
+ Age should be provided for all subjects, except where not
collected for screen failures.
Document: FDA
Section: FDAB005
Origin: FDA Business Rules
Rule Identifier:
Id: FB0501
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Age should be provided for all subjects, except where not
+ - Cited Guidance:
+ Age should be provided for all subjects, except where not
collected for screen failures.
Document: FDA
Section: FDAB005
Origin: FDA Business Rules
Rule Identifier:
Id: FB0501
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Age should be provided for all subjects, except where not
+ - Cited Guidance:
+ Age should be provided for all subjects, except where not
collected for screen failures.
Document: FDA
Section: FDAB005
Origin: FDA Business Rules
Rule Identifier:
Id: FB0501
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: AGE
@@ -66,7 +69,7 @@ Check:
Core:
Id: CORE-001043
Status: Published
- Version: '1'
+ Version: "1"
Description: Age should be provided for all subjects, except where not collected
for screen failures.
Executability: Fully Executable
diff --git a/Deprecated/CORE-001064/rule.yml b/Deprecated/CORE-001064/rule.yml
index e2122258e..f47752833 100644
--- a/Deprecated/CORE-001064/rule.yml
+++ b/Deprecated/CORE-001064/rule.yml
@@ -7,16 +7,17 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For interventional studies all treated subjects should have
+ - Cited Guidance:
+ For interventional studies all treated subjects should have
exposure data.
Document: FDA
Section: FDAB023
Origin: FDA Business Rules
Rule Identifier:
Id: FB2305
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
Check:
all:
- name: ACTARMCD
@@ -39,7 +40,7 @@ Check:
Core:
Id: CORE-001064
Status: Published
- Version: '1'
+ Version: "1"
Description: All subjects that have no record in the Exposure domain who are
participating in a study that includes an interventional product should not be
assigned to a treatment. #needs an update based on update in FDA business rules spreadsheet#
diff --git a/Deprecated/CORE-001078/rule.yml b/Deprecated/CORE-001078/rule.yml
index aa179d5d8..6a3629d8b 100644
--- a/Deprecated/CORE-001078/rule.yml
+++ b/Deprecated/CORE-001078/rule.yml
@@ -7,59 +7,62 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0609
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0609
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
+ - Cited Guidance:
+ All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0609
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: DTHFL
operator: equal_to
- value: 'Y'
+ value: "Y"
value_is_literal: true
- name: $ae_aeout
operator: does_not_contain
- value: 'FATAL'
+ value: "FATAL"
value_is_literal: true
- name: $ae_aesdth
operator: does_not_contain
- value: 'Y'
+ value: "Y"
value_is_literal: true
Core:
Status: Published
- Version: '1'
+ Version: "1"
Id: CORE-001078
Description: When Death flag (DTHFL) in the DM dataset is populated as 'Y' then
a record should be present in the AE dataset where AEOUT = 'FATAL' and AESDTH
@@ -89,7 +92,8 @@ Operations:
name: AESDTH
operator: distinct
Outcome:
- Message: DTHFL in DM dataset is "Y" but a record is missing in AE dataset where
+ Message:
+ DTHFL in DM dataset is "Y" but a record is missing in AE dataset where
AESDTH = "Y" and AEOUT = "FATAL".
Output Variables:
- $ae_aeout
diff --git a/Deprecated/CORE-001079/rule.yml b/Deprecated/CORE-001079/rule.yml
index e5147426d..fffa2512d 100644
--- a/Deprecated/CORE-001079/rule.yml
+++ b/Deprecated/CORE-001079/rule.yml
@@ -1,19 +1,19 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: Variable = Model List of Allowed Variables for Observation Class
Authorities:
- Organization: CDISC
Standards:
-
# 2025-11-18: SDTMIG-3-3 is implemented as a separate rule
- # as SDTMIG has "domain-specific" variables:
+ # as SDTMIG has "domain-specific" variables:
# which are NOT in the "SDTM Model"
# For SDTMIG-3-2 there are none such "domain-specific" variables
# and for SDTMIG-3-4 they are also present in the "SDTM Model".
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[2.5][Sponsors may not add any other variables. . . .
+ - Cited Guidance:
+ IG v3.3[2.5][Sponsors may not add any other variables. . . .
Standard variables must not be renamed or modified for novel
usage]|IG v3.3[2.5][[Using SDTM-specified standard variable
names]|Model v1.7[3.2.2 2.1][Each observation can be described
@@ -26,9 +26,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0013
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
#- Name: SDTMIG
# References:
# - Citations:
@@ -52,9 +52,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0351
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
# 2025-11-17: exclude EXMETHOD, EGBEATNO, ICIMPLBL, MSAGENT, MSCONC, MSCONCU
@@ -82,7 +82,7 @@ Check:
Core:
Id: CORE-001079
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when a variable is not an allowed variable for an
Observation Class
Executability: Partially Executable - Possible Underreporting
diff --git a/Deprecated/CORE-001080/rule.yml b/Deprecated/CORE-001080/rule.yml
index 21e61869e..c7d57a313 100644
--- a/Deprecated/CORE-001080/rule.yml
+++ b/Deprecated/CORE-001080/rule.yml
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0288
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -27,22 +27,22 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0288
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: The version number of the Reference Terminology, if applicable.
Document: IG v3.2
Item: Specification
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0288
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: TSVCDREF
@@ -57,7 +57,7 @@ Check:
Core:
Id: CORE-001080
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TSVCDREF ='CDISC' and TSVALCD is not a valid
code in the version identified in TSVCDVER.
Executability: Fully Executable
diff --git a/Deprecated/CORE-001081/rule.yml b/Deprecated/CORE-001081/rule.yml
index 74e9eb4bf..7922e95f5 100644
--- a/Deprecated/CORE-001081/rule.yml
+++ b/Deprecated/CORE-001081/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: Metadata attribute of Variable Role = IG Role for domains in IG, Metadata attribute of Variable Role = Model Role for custom domains
Authorities:
@@ -8,22 +8,24 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Each variable can be classified according to its Role. A Role
+ - Cited Guidance:
+ Each variable can be classified according to its Role. A Role
determines the type of information conveyed by the variable
about each distinct observation and how it can be used.
Variables can be classified into five major roles.
Document: IG v3.4
- Section: '2.1'
+ Section: "2.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0010
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.2[3.1][Since these roles are predefined for all standard
+ - Cited Guidance:
+ IG v3.2[3.1][Since these roles are predefined for all standard
domains that follow the general observation classes]|Model
v1.4[2][Each variable . . . can be classified according to its
Role]
@@ -32,24 +34,25 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0010
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Each variable can be classified according to its Role. A Role
+ - Cited Guidance:
+ Each variable can be classified according to its Role. A Role
determines the type of information conveyed by the variable
about each distinct observation and how it can be used.
Variables can be classified into five major roles.
Document: IG v3.3
- Section: '2.1'
+ Section: "2.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0010
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: define_variable_role
@@ -58,7 +61,7 @@ Check:
Core:
Id: CORE-001081
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when the metadata attribute of variable role does
not match the IG role for domain in IG, or model role (for custom domains)
Executability: Fully Executable
diff --git a/Deprecated/CORE-001082/rule.yml b/Deprecated/CORE-001082/rule.yml
index aefa3e9d2..ebd3bd0af 100644
--- a/Deprecated/CORE-001082/rule.yml
+++ b/Deprecated/CORE-001082/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: Variable Type = IG Type for domains in IG, Type = Model Type for custom domains
Authorities:
- Organization: CDISC
@@ -10,21 +10,23 @@ Authorities:
- Cited Guidance: Using SDTM-specified data types for all variables
Document: IG v3.4
Section: 3.2.2
- - Cited Guidance: Note that the SDTM type specified in this document is either
+ - Cited Guidance:
+ Note that the SDTM type specified in this document is either
character or numeric, as these are the only types supported by
SAS v.5 transport files.]
Document: Model v2.0
- Section: '2.1'
+ Section: "2.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0012
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.2[3.2.2][Using SDTM-specified data types for all
+ - Cited Guidance:
+ IG v3.2[3.2.2][Using SDTM-specified data types for all
variables]|Model v1.4[2][The data Type (e.g., whether the
variable value is a character or numeric)]
Document: IG v3.2|Model v1.4
@@ -32,13 +34,14 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0012
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[3.2.2][Using SDTM-specified data types for all
+ - Cited Guidance:
+ IG v3.3[3.2.2][Using SDTM-specified data types for all
variables]|Model v1.7[2.1][The SDTM describes the name, label,
role, and type for the standard variables. Note that the SDTM
type specified in this document is either character or
@@ -49,9 +52,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0012
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: variable_data_type
@@ -60,12 +63,13 @@ Check:
Core:
Id: CORE-001082
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when the variable type does not match IG Type (for
domains in IG) or Model Type (custom domains)
Executability: Fully Executable
Outcome:
- Message: Variable data type specified in the dataset does not match the variable
+ Message:
+ Variable data type specified in the dataset does not match the variable
data type in the IG or the Model.
Output Variables:
- variable_name
diff --git a/Published/CORE-000001/rule.yml b/Published/CORE-000001/rule.yml
index 2a5755509..ac5ae3363 100644
--- a/Published/CORE-000001/rule.yml
+++ b/Published/CORE-000001/rule.yml
@@ -7,63 +7,61 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The intent of the domain model is to collect responses to only
- those criteria that the subject did not meet, and not the
- responses to all criteria.
+ - Cited Guidance: The intent of the domain model is to collect responses to only those
+ criteria that the subject did not meet, and not the responses to all criteria.
Document: SDTM v3.4
Section: 6.3.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0176
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The intent of the domain model is to collect response to only
- those criteria that the subject did not meet, and not the
- responses to all criteria.
+ - Cited Guidance:
+ The intent of the domain model is to collect response to only those criteria
+ that the subject did not meet, and not the responses to all criteria.
Document: IG v3.2
Item: Assumption 2
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0176
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The intent of the domain model is to collect response to only
- those criteria that the subject did not meet, and not the
- responses to all criteria.
+ - Cited Guidance:
+ The intent of the domain model is to collect response to only those criteria
+ that the subject did not meet, and not the responses to all criteria.
Document: IG v3.3
Item: Assumption 1
Section: 6.3.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0176
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The intent of the domain model is to collect responses to only
- those criteria that the subject did not meet, and not the
- responses to all criteria.
+ - Cited Guidance: The intent of the domain model is to collect responses to only those
+ criteria that the subject did not meet, and not the responses to all criteria.
Document: TIG 1.0
Item: Assumption 1
- Section: '2.8.10.13'
+ Section: "2.8.10.13"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0405
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IECAT
@@ -77,9 +75,8 @@ Check:
Core:
Id: CORE-000001
Status: Published
- Version: '1'
-Description: Raise an error when IECAT is equal to 'INCLUSION' and IEORRES is
- not equal to 'N'.
+ Version: "1"
+Description: Raise an error when IECAT is equal to 'INCLUSION' and IEORRES is not equal to 'N'.
Executability: Fully Executable
Outcome:
Message: IEORRES is not equal to 'N' when IECAT equals 'INCLUSION'.
diff --git a/Published/CORE-000004/rule.yml b/Published/CORE-000004/rule.yml
index 8176f8cde..773ce818f 100644
--- a/Published/CORE-000004/rule.yml
+++ b/Published/CORE-000004/rule.yml
@@ -7,65 +7,59 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL
- is infused at a visit, then ECOCCUR = 'N' is the standard
- representation of the collected doses not taken, not
- given, or missed. Dose amount variables (e.g., ECDOSE,
- ECDOSTXT) must not be set to zero (0) as an alternative
- method for indicating doses not taken, not given, or missed.
+ - Cited Guidance:
+ For example, if 0 tablets are taken within a timeframe or 0 mL is infused at
+ a visit, then ECOCCUR = 'N' is the standard representation of the collected doses not
+ taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be
+ set to zero (0) as an alternative method for indicating doses not taken, not given, or
+ missed.
Document: IG v3.4
Item: Assumption 4a
Section: 6.1.3.2
- - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT)
- may be populated with positive (non-zero) values in cases
- where the sponsor feels it is necessary and/or appropriate to
- represent specific dose amounts not taken, not given, or
- missed.
+ - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be
+ populated with positive (non-zero) values in cases where the sponsor feels it is necessary
+ and/or appropriate to represent specific dose amounts not taken, not given, or missed.
Document: IG v3.4
Item: Assumption 4b
Section: 6.1.3.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0101
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.2[6.1][Assumption 4a][For example, if 0 tablets are taken
- within a timeframe or 0 mL infused at a visit, then ECOCCUR =
- 'N' is the standard representation of the collected doses not
- taken, not given, or missed. Dose amount variables (e.g.,
- ECDOSE, ECDOSTXT) must not be set to zero (0) as an
- alternative method for indicating doses not taken, not given,
- or missed.]|IG v3.2[6.1][Assumption 4b][Qualifiers that
- indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be populated
- with positive (non-zero) values in cases where the sponsor
- feels it is necessary and/or appropriate to represent specific
- dose amounts not taken, not given, or missed.]
+ - Cited Guidance:
+ IG v3.2[6.1][Assumption 4a][For example, if 0 tablets are taken within a
+ timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is the standard representation of
+ the collected doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE,
+ ECDOSTXT) must not be set to zero (0) as an alternative method for indicating doses not
+ taken, not given, or missed.]|IG v3.2[6.1][Assumption 4b][Qualifiers that indicate dose
+ amount (e.g., ECDOSE, ECDOSTXT) may be populated with positive (non-zero) values in cases
+ where the sponsor feels it is necessary and/or appropriate to represent specific dose
+ amounts not taken, not given, or missed.]
Document: IG v3.2
Item: IG v3.2[6.1][Assumption 4a]|IG v3.2[6.1][Assumption 4b]
Section: IG v3.2[6.1]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0101
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[6.1.3.2][Assumption 4a][For example, if 0 tablets are
- taken within a timeframe or 0 mL infused at a visit, then
- ECOCCUR = 'N' is the standard representation of the collected
- doses not taken, not given, or missed. Dose amount variables
- (e.g., ECDOSE, ECDOSTXT) must not be set to zero (0) as an
- alternative method for indicating doses not taken, not given,
- or missed.]|IIG v3.3[6.1.3.2][Assumption 4b][Qualifiers that
- indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be populated
- with positive (non-zero) values in cases where the sponsor
- feels it is necessary and/or appropriate to represent specific
+ - Cited Guidance:
+ IG v3.3[6.1.3.2][Assumption 4a][For example, if 0 tablets are taken within a
+ timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is the standard representation of
+ the collected doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE,
+ ECDOSTXT) must not be set to zero (0) as an alternative method for indicating doses not
+ taken, not given, or missed.]|IIG v3.3[6.1.3.2][Assumption 4b][Qualifiers that indicate
+ dose amount (e.g., ECDOSE, ECDOSTXT) may be populated with positive (non-zero) values in
+ cases where the sponsor feels it is necessary and/or appropriate to represent specific
dose amounts not taken, not given, or missed.]
Document: IG v3.3
Item: IG v3.3[6.1.3.2][Assumption 4a]|IG v3.3[6.1.3.2][Assumption 4b]
@@ -73,43 +67,41 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0101
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: '[Assumption 4a][For example, if 0 tablets are taken within a
- timeframe or 0 mL is infused at a visit, then ECOCCUR = ''N''
- is the standard representation of the collected doses not
- taken, not given, or missed. Dose amount variables (e.g.,
- ECDOSE, ECDOSTXT) must not be set to zero (0) as an
- alternative method for indicating doses not taken, not given,
- or missed.'
+ - Cited Guidance:
+ "[Assumption 4a][For example, if 0 tablets are taken within a timeframe or 0 mL
+ is infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected doses
+ not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be
+ set to zero (0) as an alternative method for indicating doses not taken, not given, or missed."
Document: TIG 1.0
Item: Assumption 4a
Section: 2.8.10.11
- - Cited Guidance: '[Assumption 4b][Qualifiers that indicate dose amount (e.g.,
- ECDOSE, ECDOSTXT) may be populated with positive (non-zero)
- values in cases where the sponsor feels it is necessary and/or
- appropriate to represent specific dose amounts not taken, not
- given, or missed.]'
+ - Cited Guidance:
+ "[Assumption 4b][Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT)
+ may be populated with positive (non-zero) values in cases where the sponsor feels it is necessary
+ and/or appropriate to represent specific dose amounts not taken, not given, or missed.]"
Document: TIG 1.0
Item: Assumption 4b
Section: 2.8.10.11
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0366
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ECOCCUR # The condition is ECOCCUR = "N"
operator: equal_to
value: N
- - name: ECDOSE
+ - name:
+ ECDOSE
# The rule is ECDOSE is null or > 0
# so the failure criteria is not empty and LE 0
# which is the same as just LE 0
@@ -118,13 +110,13 @@ Check:
Core:
Id: CORE-000004
Status: Published
- Version: '1'
-Description: When ECOCCUR indicates no dose, then ECDOSE needs to be null or >
- 0; it cannot be used to indicate a dose wasn't taken.
+ Version: "1"
+Description: When ECOCCUR indicates no dose, then ECDOSE needs to be null or > 0; it cannot be used
+ to indicate a dose wasn't taken.
Executability: Fully Executable
Outcome:
- Message: ECOCCUR indicates dose was not given, but ECDOSE is not blank or has a
- value less than or equal to 0
+ Message: ECOCCUR indicates dose was not given, but ECDOSE is not blank or has a value less than or
+ equal to 0
Output Variables:
- ECDOSE
- ECOCCUR
diff --git a/Published/CORE-000006/rule.yml b/Published/CORE-000006/rule.yml
index 12620bfbb..42b9240a3 100644
--- a/Published/CORE-000006/rule.yml
+++ b/Published/CORE-000006/rule.yml
@@ -1,5 +1,5 @@
# Variable: DTHFL
-# Condition:
+# Condition:
# Rule: DTHFL in ('Y',null)
Authorities:
- Organization: CDISC
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0131
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -26,9 +26,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0131
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -39,9 +39,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0131
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -52,10 +52,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0381
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: DTHFL
@@ -66,7 +66,7 @@ Check:
Core:
Id: CORE-000006
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when DTHFL ^= "Y" and not null
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000007/rule.yml b/Published/CORE-000007/rule.yml
index 46bca41b6..2bbd10660 100644
--- a/Published/CORE-000007/rule.yml
+++ b/Published/CORE-000007/rule.yml
@@ -7,102 +7,108 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: DTHDTC[The date or date and time of death, represented in a
- standardized character format.] DTHFL[An indication that the
- subject died.]
+ - Cited Guidance:
+ DTHDTC[The date or date and time of death, represented in a standardized
+ character format.] DTHFL[An indication that the subject died.]
Document: Model v2.0
Item: DTHDTC|DTHFL
Section: Demographics
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0435
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A value of 'Y' indicates the subject died. Should be Y or null.
- Should be populated even when the death date is unknown.
+ - Cited Guidance:
+ A value of 'Y' indicates the subject died. Should be Y or null. Should be
+ populated even when the death date is unknown.
Document: Model v1.4
Section: 2.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0435
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A value of "Y" indicates the subject died. Should be "Y" or
- null. Should be populated even when the death date is unknown.
+ - Cited Guidance:
+ A value of "Y" indicates the subject died. Should be "Y" or null. Should be
+ populated even when the death date is unknown.
Document: Model v1.7
Section: Table 2.2.6.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0435
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: DTHDTC[The date or date and time of death, represented in a
- standardized character format.]|DTHFL[An indication that the
- subject died.]
+ - Cited Guidance:
+ DTHDTC[The date or date and time of death, represented in a standardized
+ character format.]|DTHFL[An indication that the subject died.]
Document: SDTM v2.1
Item: DTHDTC|DTHFL
Section: 3.2.1 Demographics
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0587
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
- #CG0435 is identical to rule FB0606. Added metadata for FB0606.
+ Version:
+ "1.0"
+ #CG0435 is identical to rule FB0606. Added metadata for FB0606.
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0606
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0606
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0606
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: DTHDTC
@@ -113,10 +119,9 @@ Check:
Core:
Id: CORE-000007
Status: Published
- Version: '1'
-Description: When Date/Time of Death (DTHDTC) in the DM dataset is populated
- then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the
- corresponding subject.
+ Version: "1"
+Description: When Date/Time of Death (DTHDTC) in the DM dataset is populated then death flag (DTHFL)
+ should be populated as 'Y' in the DM dataset for the corresponding subject.
Executability: Fully Executable
Outcome:
Message: DTHDTC is populated but DTHFL in DM dataset is not "Y".
diff --git a/Published/CORE-000009/rule.yml b/Published/CORE-000009/rule.yml
index dd4916805..0c7ba1855 100644
--- a/Published/CORE-000009/rule.yml
+++ b/Published/CORE-000009/rule.yml
@@ -7,45 +7,48 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The name of the Element. If ETCD has a value of 'UNPLAN' then
- ELEMENT should be null.
+ - Cited Guidance:
+ The name of the Element. If ETCD has a value of 'UNPLAN' then ELEMENT should
+ be null.
Document: SDTMIG v3.4
Item: Specification
Section: 5.3 Specification
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0152
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The name of the Element. If ETCD has a value of "UNPLAN" then
- ELEMENT should be null.
+ - Cited Guidance:
+ The name of the Element. If ETCD has a value of "UNPLAN" then ELEMENT should
+ be null.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0152
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The name of the Element. If ETCD has a value of "UNPLAN" then
- ELEMENT should be null.
+ - Cited Guidance:
+ The name of the Element. If ETCD has a value of "UNPLAN" then ELEMENT should
+ be null.
Document: IG v3.3
Item: Specification
- Section: '5.3'
+ Section: "5.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0152
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SENDIG
References:
- Citations:
@@ -56,104 +59,99 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND124.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If the sponsor decides that the subject's experience for a
- particular period of time cannot be represented with one of
- the planned Elements, then that period of time should be
- represented as an unplanned Element.For unplanned Elements,
- ETCD should be populated with 'UNPLAN', ELEMENT should be left
- blank, and SEUPDES should be populated with a description of
- the unplanned Element.
+ - Cited Guidance:
+ If the sponsor decides that the subject's experience for a particular period
+ of time cannot be represented with one of the planned Elements, then that period of time
+ should be represented as an unplanned Element.For unplanned Elements, ETCD should be
+ populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated
+ with a description of the unplanned Element.
Document: SENDIG v3.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND124.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If the sponsor decides that the subject's experience for a
- particular period of time cannot be represented with one of
- the planned Elements, then that period of time should be
- represented as an unplanned Element.For unplanned Elements,
- ETCD should be populated with 'UNPLAN', ELEMENT should be left
- blank, and SEUPDES should be populated with a description of
- the unplanned Element.
+ - Cited Guidance:
+ If the sponsor decides that the subject's experience for a particular period
+ of time cannot be represented with one of the planned Elements, then that period of time
+ should be represented as an unplanned Element.For unplanned Elements, ETCD should be
+ populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated
+ with a description of the unplanned Element.
Document: SENDIG v3.1.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND124.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If the sponsor decides that the subject's experience for a
- particular period of time cannot be represented with one of
- the planned Elements, then that period of time should be
- represented as an unplanned Element.For unplanned Elements,
- ETCD should be populated with 'UNPLAN', ELEMENT should be left
- blank, and SEUPDES should be populated with a description of
- the unplanned Element.
+ - Cited Guidance:
+ If the sponsor decides that the subject's experience for a particular period
+ of time cannot be represented with one of the planned Elements, then that period of time
+ should be represented as an unplanned Element.For unplanned Elements, ETCD should be
+ populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated
+ with a description of the unplanned Element.
Document: SENDIG v3.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND124.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If the sponsor decides that the subject's experience for a
- particular period of time cannot be represented with one of
- the planned Elements, then that period of time should be
- represented as an unplanned Element.For unplanned Elements,
- ETCD should be populated with 'UNPLAN', ELEMENT should be left
- blank, and SEUPDES should be populated with a description of
- the unplanned Element.
+ - Cited Guidance:
+ If the sponsor decides that the subject's experience for a particular period
+ of time cannot be represented with one of the planned Elements, then that period of time
+ should be represented as an unplanned Element.For unplanned Elements, ETCD should be
+ populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated
+ with a description of the unplanned Element.
Document: SENDIG v3.1.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND124.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: If the sponsor decides that the subject's experience for a
- particular period of time cannot be represented with one of
- the planned Elements, then that period of time should be
- represented as an unplanned Element.For unplanned Elements,
- ETCD should be populated with 'UNPLAN', ELEMENT should be left
- blank, and SEUPDES should be populated with a description of
- the unplanned Element.
+ - Cited Guidance:
+ If the sponsor decides that the subject's experience for a particular period
+ of time cannot be represented with one of the planned Elements, then that period of time
+ should be represented as an unplanned Element.For unplanned Elements, ETCD should be
+ populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated
+ with a description of the unplanned Element.
Document: SENDIG v3.1.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND124.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
@@ -164,26 +162,27 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0393
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: For unplanned Elements, ETCD should be populated with “UNPLAN”,
- ELEMENT should be left blank, and SEUPDES should be populated
- with a description of the unplanned Element.
+ - Cited Guidance:
+ For unplanned Elements, ETCD should be populated with “UNPLAN”, ELEMENT
+ should be left blank, and SEUPDES should be populated with a description of the unplanned
+ Element.
Document: TIG v1.0
Item: Assumption 5
Section: 2.8.9.26
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0061
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ETCD
@@ -194,7 +193,7 @@ Check:
Core:
Id: CORE-000009
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify that ELEMENT value is blank when ETCD is equal to UNPLAN
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000010/rule.yml b/Published/CORE-000010/rule.yml
index 33aa09d2d..652d007c7 100644
--- a/Published/CORE-000010/rule.yml
+++ b/Published/CORE-000010/rule.yml
@@ -1,5 +1,5 @@
# Variable: ARMCD
-# Condition:
+# Condition:
# Rule: ARMCD value length <= 20
Authorities:
- Organization: CDISC
@@ -7,59 +7,61 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: ARMCD is limited to 20 characters and does not have the
- character restrictions that apply to --TESTCD
+ - Cited Guidance: ARMCD is limited to 20 characters and does not have the character
+ restrictions that apply to --TESTCD
Document: SDTMIG v3.4
Section: 4.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0153
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: ARMCD is limited to 20 characters and does not have special
- character restrictions.
+ - Cited Guidance:
+ ARMCD is limited to 20 characters and does not have special character
+ restrictions.
Document: IG v3.2
Section: 4.1.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0153
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: ARMCD is limited to 20 characters and does not have special
- character restrictions.
+ - Cited Guidance:
+ ARMCD is limited to 20 characters and does not have special character
+ restrictions.
Document: IG v3.3
Section: 4.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0153
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: ARMCD is limited to 20 characters and does not have special
- character restrictions. The maximum length of ARMCD is longer
- than that for other short variables to accommodate the kind of
- values that are likely to be needed for crossover trials.
+ - Cited Guidance:
+ ARMCD is limited to 20 characters and does not have special character
+ restrictions. The maximum length of ARMCD is longer than that for other short variables to
+ accommodate the kind of values that are likely to be needed for crossover trials.
Document: TIG 1.0
Item: Specification ARMCD
Section: 2.8.10.27
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0394
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ARMCD
@@ -68,7 +70,7 @@ Check:
Core:
Id: CORE-000010
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify ARMCD value length is <= 20
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000011/rule.yml b/Published/CORE-000011/rule.yml
index 1f620c3ce..8b7c2a34f 100644
--- a/Published/CORE-000011/rule.yml
+++ b/Published/CORE-000011/rule.yml
@@ -7,64 +7,62 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The intent of the domain model is to collect responses to only
- those criteria that the subject did not meet, and not the
- responses to all criteria.
+ - Cited Guidance: The intent of the domain model is to collect responses to only those
+ criteria that the subject did not meet, and not the responses to all criteria.
Document: SDTMIG v3.4
Item: Assumption 1
Section: 6.3.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0175
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The intent of the domain model is to collect response to only
- those criteria that the subject did not meet, and not the
- responses to all criteria.
+ - Cited Guidance:
+ The intent of the domain model is to collect response to only those criteria
+ that the subject did not meet, and not the responses to all criteria.
Document: IG v3.2
Item: Assumption 2
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0175
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The intent of the domain model is to collect response to only
- those criteria that the subject did not meet, and not the
- responses to all criteria.
+ - Cited Guidance:
+ The intent of the domain model is to collect response to only those criteria
+ that the subject did not meet, and not the responses to all criteria.
Document: IG v3.3
Item: Assumption 1
Section: 6.3.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0175
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The intent of the domain model is to collect responses to only
- those criteria that the subject did not meet, and not the
- responses to all criteria.
+ - Cited Guidance: The intent of the domain model is to collect responses to only those
+ criteria that the subject did not meet, and not the responses to all criteria.
Document: TIG 1.0
Item: Assumption 1
- Section: '2.8.10.13'
+ Section: "2.8.10.13"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0404
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IECAT
@@ -78,9 +76,8 @@ Check:
Core:
Id: CORE-000011
Status: Published
- Version: '1'
-Description: Raise an error when IECAT is equal to 'EXCLUSION' and IEORRES is
- not equal to 'Y'.
+ Version: "1"
+Description: Raise an error when IECAT is equal to 'EXCLUSION' and IEORRES is not equal to 'Y'.
Executability: Fully Executable
Outcome:
Message: IEORRES is not equal to 'Y' when IECAT equals 'EXCLUSION'.
diff --git a/Published/CORE-000012/rule.yml b/Published/CORE-000012/rule.yml
index 959b6b98b..3728bdba0 100644
--- a/Published/CORE-000012/rule.yml
+++ b/Published/CORE-000012/rule.yml
@@ -1,5 +1,5 @@
# Variable: AEOCCUR
-# Condition:
+# Condition:
# Rule: AEOCCUR not present in dataset
Authorities:
- Organization: CDISC
@@ -7,72 +7,69 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR,
- --STAT, and --REASND. They are the only Qualifiers from the
- SDTM Events Class not in the AE domain. They are not permitted
- because the AE domain contains only records for adverse events
- that actually occurred.
+ - Cited Guidance:
+ The following Qualifiers would not be used in AE; --OCCUR, --STAT, and
+ --REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain.
+ They are not permitted because the AE domain contains only records for adverse events that
+ actually occurred.
Document: SDTMIG v3.4
Item: Assumption 9
Section: 6.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0040
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR,
- --STAT, and--REASND. They are the only Qualifiers from the
- SDTM Events Class not in the AE domain. They are not permitted
- because the AE domain contains only records for adverse events
- that actually occurred.
+ - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR, --STAT,
+ and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain.
+ They are not permitted because the AE domain contains only records for adverse events that
+ actually occurred.
Document: SDTMIG v3.3
Item: Assumption 9
Section: 6.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0040
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR,
- --STAT, and--REASND. They are the only Qualifiers from the
- SDTM Events Class not in the AE domain. They are not permitted
- because the AE domain contains only records for adverse events
- that actually occurred.
+ - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR, --STAT,
+ and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain.
+ They are not permitted because the AE domain contains only records for adverse events that
+ actually occurred.
Document: SDTMIG v3.2
Item: Assumption 8
Section: 6.2.
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0040
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 'The following qualifiers would not be used in AE: --OCCUR,
- --STAT, and--REASND. They are the only qualifiers from the
- SDTM Events class not in the AE domain. They are not permitted
- because the AE domain contains only records for adverse events
- that actually occurred.'''
+ - Cited Guidance:
+ "The following qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND.
+ They are the only qualifiers from the SDTM Events class not in the AE domain. They are not permitted
+ because the AE domain contains only records for adverse events that actually occurred.'"
Document: TIG 1.0
Item: Assumption 10
Section: 2.8.10.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0319
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AEOCCUR
@@ -80,7 +77,7 @@ Check:
Core:
Id: CORE-000012
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AEOCCUR exists in AE dataset.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000013/rule.yml b/Published/CORE-000013/rule.yml
index ca67f1cef..a9fa6b143 100644
--- a/Published/CORE-000013/rule.yml
+++ b/Published/CORE-000013/rule.yml
@@ -1,5 +1,5 @@
# Variable: AESTAT
-# Condition:
+# Condition:
# Rule: AESTAT not present in dataset
Authorities:
- Organization: CDISC
@@ -7,74 +7,73 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: --> The following Qualifiers would not be used in AE; "--OCCUR",
- "--STAT", and "--REASND". They are the only Qualifiers from
- the SDTM Events Class not in the AE domain. They are not
- permitted because the AE domain contains only records for
- adverse events that actually occurred.
+ - Cited Guidance:
+ --> The following Qualifiers would not be used in AE; "--OCCUR", "--STAT",
+ and "--REASND". They are the only Qualifiers from the SDTM Events Class not in the AE
+ domain. They are not permitted because the AE domain contains only records for adverse
+ events that actually occurred.
Document: SDTMIG v3.4
Item: Assumption 9
Section: 6.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0044
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: --> The following Qualifiers would not be used in AE; "--OCCUR",
- "--STAT", and "--REASND". They are the only Qualifiers from
- the SDTM Events Class not in the AE domain. They are not
- permitted because the AE domain contains only records for
- adverse events that actually occurred.
+ - Cited Guidance:
+ --> The following Qualifiers would not be used in AE; "--OCCUR", "--STAT",
+ and "--REASND". They are the only Qualifiers from the SDTM Events Class not in the AE
+ domain. They are not permitted because the AE domain contains only records for adverse
+ events that actually occurred.
Document: SDTMIG v3.3
Item: Assumption 9
Section: 6.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0044
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: --> The following Qualifiers would not be used in AE; "--OCCUR",
- "--STAT", and "--REASND". They are the only Qualifiers from
- the SDTM Events Class not in the AE domain. They are not
- permitted because the AE domain contains only records for
- adverse events that actually occurred.
+ - Cited Guidance:
+ --> The following Qualifiers would not be used in AE; "--OCCUR", "--STAT",
+ and "--REASND". They are the only Qualifiers from the SDTM Events Class not in the AE
+ domain. They are not permitted because the AE domain contains only records for adverse
+ events that actually occurred.
Document: SDTMIG v3.2
Item: Assumption 8
Section: 6.2.
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0044
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 'The following qualifiers would not be used in AE: --OCCUR,
- --STAT, and--REASND. They are the only qualifiers from the
- SDTM Events class not in the AE domain. They are not permitted
- because the AE domain contains only records for adverse events
- that actually occurred. See Assumption 4b for information on
- how to deal with negative responses or missing responses to
- probing questions for prespecified adverse events.'
+ - Cited Guidance:
+ "The following qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND.
+ They are the only qualifiers from the SDTM Events class not in the AE domain. They are not permitted
+ because the AE domain contains only records for adverse events that actually occurred. See Assumption
+ 4b for information on how to deal with negative responses or missing responses to probing questions
+ for prespecified adverse events."
Document: TIG 1.0
Item: Assumption 10
Section: 2.8.10.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0323
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AESTAT
@@ -82,7 +81,7 @@ Check:
Core:
Id: CORE-000013
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AESTAT is present in AE dataset.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000014/rule.yml b/Published/CORE-000014/rule.yml
index fa64c9888..8c03eb9ae 100644
--- a/Published/CORE-000014/rule.yml
+++ b/Published/CORE-000014/rule.yml
@@ -7,20 +7,16 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Events[--PRESP][An indication that the event was prospectively
- stated or detailed on the CRF. Values should be "Y" or
- null.]|Events|[--OCCUR][An indication as to whether a
- prespecified event has occurred.]|Events[--STAT][Used to
- indicate when a question about the occurrence of a
- prespecified event was not answered. Should be null or have a
- value of "NOT DONE".]|Interventions[--PRESP][An indication
- that the intervention was prospectively stated or detailed on
- the CRF. Values should be "Y" or
- null.]|Interventions[--OCCUR][An indication as to whether a
- prespecified intervention has
- occurred.]|Interventions[--STAT][Used to indicate when a
- question about the occurrence of a prespecified intervention
- was not answered. Should be null or have a value of "NOT
+ - Cited Guidance:
+ Events[--PRESP][An indication that the event was prospectively stated or
+ detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to
+ whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a
+ question about the occurrence of a prespecified event was not answered. Should be null or
+ have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention
+ was prospectively stated or detailed on the CRF. Values should be "Y" or
+ null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has
+ occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of
+ a prespecified intervention was not answered. Should be null or have a value of "NOT
DONE".]
Document: Model v2.0
Item: --PRESP|--OCCUR|--STAT
@@ -28,92 +24,78 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0087
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.][--OCCUR: Used to record whether a
- pre-specified event occurred when information about the
- occurrence of a specific event is solicited.][--STAT: Used to
- indicate when a question about the occurrence of a
- pre-specified event was not answered. Should be null or hav a
- value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to
- indicate whether the event describe by --TERM was
- pre-specified on a CRF. Value is Y for pre-specified events,
- null for spontaneously reported events.][--OCCUR: Used to
- record whether a pre-specified event occurred when information
- about the occurrence of a specific event is
- solicited.][--STAT: Used to indicate when a question about the
- occurrence of a pre-specified event was not answered . Should
- be null or have a value of NOT DONE]'
+ - Cited Guidance:
+ 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
+ is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a
+ pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT:
+ Used to indicate when a question about the occurrence of a pre-specified event was not answered.
+ Should be null or hav a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate
+ whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified
+ events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified
+ event occurred when information about the occurrence of a specific event is solicited.][--STAT:
+ Used to indicate when a question about the occurrence of a pre-specified event was not answered
+ . Should be null or have a value of NOT DONE]'
Document: Model v1.4
Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0087
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.][--OCCUR: Used to record whether a
- pre-specified event occurred when information about the
- occurrence of a specific event is solicited.][--STAT: Used to
- indicate when a question about the occurrence of a
- pre-specified event was not answered. Should be null or hav a
- value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to
- indicate whether the event describe by --TERM was
- pre-specified on a CRF. Value is Y for pre-specified events,
- null for spontaneously reported events.][--OCCUR: Used to
- record whether a pre-specified event occurred when information
- about the occurrence of a specific event is
- solicited.][--STAT: Used to indicate when a question about the
- occurrence of a pre-specified event was not answered . Should
- be null or have a value of NOT DONE]'
+ - Cited Guidance:
+ 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
+ is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a
+ pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT:
+ Used to indicate when a question about the occurrence of a pre-specified event was not answered.
+ Should be null or hav a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate
+ whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified
+ events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified
+ event occurred when information about the occurrence of a specific event is solicited.][--STAT:
+ Used to indicate when a question about the occurrence of a pre-specified event was not answered
+ . Should be null or have a value of NOT DONE]'
Document: Model v1.7
Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0087
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Events[--PRESP][An indication that the event was prospectively
- stated or detailed on the CRF. Values should be "Y" or
- null.]|Events|[--OCCUR][An indication as to whether a
- prespecified event has occurred.]|Events[--STAT][Used to
- indicate when a question about the occurrence of a
- prespecified event was not answered. Should be null or have a
- value of "NOT DONE".]|Interventions[--PRESP][An indication
- that the intervention was prospectively stated or detailed on
- the CRF. Values should be "Y" or
- null.]|Interventions[--OCCUR][An indication as to whether a
- prespecified intervention has
- occurred.]|Interventions[--STAT][Used to indicate when a
- question about the occurrence of a prespecified intervention
- was not answered. Should be null or have a value of "NOT
+ - Cited Guidance:
+ Events[--PRESP][An indication that the event was prospectively stated or
+ detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to
+ whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a
+ question about the occurrence of a prespecified event was not answered. Should be null or
+ have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention
+ was prospectively stated or detailed on the CRF. Values should be "Y" or
+ null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has
+ occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of
+ a prespecified intervention was not answered. Should be null or have a value of "NOT
DONE".]
Document: SDTM v2.1
Item: --PRESP|--OCCUR|--STAT
- Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The
- Interventions Observation Class
+ Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions
+ Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0352
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- any:
@@ -139,9 +121,9 @@ Check:
Core:
Id: CORE-000014
Status: Published
- Version: '1'
-Description: Raise an error when --PRESP is not equals to "Y" and --OCCUR is
- present in dataset or --STAT is equal to "NOT DONE" and --OCCUR is not blank
+ Version: "1"
+Description: Raise an error when --PRESP is not equals to "Y" and --OCCUR is present in dataset or
+ --STAT is equal to "NOT DONE" and --OCCUR is not blank
Executability: Fully Executable
Outcome:
Message: --OCCUR should only be provided when --PRESP is equal to "Y".
diff --git a/Published/CORE-000015/rule.yml b/Published/CORE-000015/rule.yml
index d4956b7a8..ebfe132ad 100644
--- a/Published/CORE-000015/rule.yml
+++ b/Published/CORE-000015/rule.yml
@@ -7,102 +7,88 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Events[--PRESP][An indication that the event was prospectively
- stated or detailed on the CRF. Values should be "Y" or
- null.]|Events|[--OCCUR][An indication as to whether a
- prespecified event has occurred.]|Events[--STAT][Used to
- indicate when a question about the occurrence of a
- prespecified event was not answered. Should be null or have a
- value of "NOT DONE".]|Interventions[--PRESP][An indication
- that the intervention was prospectively stated or detailed on
- the CRF. Values should be "Y" or
- null.]|Interventions[--OCCUR][An indication as to whether a
- prespecified intervention has
- occurred.]|Interventions[--STAT][Used to indicate when a
- question about the occurrence of a prespecified intervention
- was not answered. Should be null or have a value of "NOT
+ - Cited Guidance:
+ Events[--PRESP][An indication that the event was prospectively stated or
+ detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to
+ whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a
+ question about the occurrence of a prespecified event was not answered. Should be null or
+ have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention
+ was prospectively stated or detailed on the CRF. Values should be "Y" or
+ null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has
+ occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of
+ a prespecified intervention was not answered. Should be null or have a value of "NOT
DONE".]
Document: Model v2.0
Section: Events|Interventions
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0088
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.][--OCCUR: Used to record whether a
- pre-specified event occurred when information about the
- occurrence of a specific event is solicited.]|Model v1.4[2.2.2
- (Events)][--PRESP: Used to indicate whether the event describe
- by --TERM was pre-specified on a CRF. Value is Y for
- pre-specified events, null for spontaneously reported
- events.][--OCCUR: Used to record whether a pre-specified event
- occurred when information about the occurrence of a specific
- event is solicited.]'
+ - Cited Guidance:
+ 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
+ is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a
+ pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model
+ v1.4[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified
+ on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR:
+ Used to record whether a pre-specified event occurred when information about the occurrence
+ of a specific event is solicited.]'
Document: Model v1.4
Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0088
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.][--OCCUR: Used to record whether a
- pre-specified event occurred when information about the
- occurrence of a specific event is solicited.]|Model v1.7[2.2.2
- (Events)][--PRESP: Used to indicate whether the event describe
- by --TERM was pre-specified on a CRF. Value is Y for
- pre-specified events, null for spontaneously reported
- events.][--OCCUR: Used to record whether a pre-specified event
- occurred when information about the occurrence of a specific
- event is solicited.]'
+ - Cited Guidance:
+ 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
+ is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a
+ pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model
+ v1.7[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified
+ on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR:
+ Used to record whether a pre-specified event occurred when information about the occurrence
+ of a specific event is solicited.]'
Document: Model v1.7
Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0088
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Events[--PRESP][An indication that the event was prospectively
- stated or detailed on the CRF. Values should be "Y" or
- null.]|Events|[--OCCUR][An indication as to whether a
- prespecified event has occurred.]|Events[--STAT][Used to
- indicate when a question about the occurrence of a
- prespecified event was not answered. Should be null or have a
- value of "NOT DONE".]|Interventions[--PRESP][An indication
- that the intervention was prospectively stated or detailed on
- the CRF. Values should be "Y" or
- null.]|Interventions[--OCCUR][An indication as to whether a
- prespecified intervention has
- occurred.]|Interventions[--STAT][Used to indicate when a
- question about the occurrence of a prespecified intervention
- was not answered. Should be null or have a value of "NOT
+ - Cited Guidance:
+ Events[--PRESP][An indication that the event was prospectively stated or
+ detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to
+ whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a
+ question about the occurrence of a prespecified event was not answered. Should be null or
+ have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention
+ was prospectively stated or detailed on the CRF. Values should be "Y" or
+ null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has
+ occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of
+ a prespecified intervention was not answered. Should be null or have a value of "NOT
DONE".]
Document: SDTM v2.1
Item: --PRESP|--OCCUR|--STAT
- Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The
- Interventions Observation Class
+ Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions
+ Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0353
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --PRESP
@@ -112,7 +98,7 @@ Check:
Core:
Id: CORE-000015
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --PRESP does not exists in a dataset and --OCCUR exist.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000016/rule.yml b/Published/CORE-000016/rule.yml
index 48183190c..100d78b3b 100644
--- a/Published/CORE-000016/rule.yml
+++ b/Published/CORE-000016/rule.yml
@@ -7,92 +7,86 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Events[--PRESP][An indication that the event was prospectively
- stated or detailed on the CRF. Values should be "Y" or
- null.]|Events|[--OCCUR][An indication as to whether a
- prespecified event has occurred.]
+ - Cited Guidance:
+ Events[--PRESP][An indication that the event was prospectively stated or
+ detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to
+ whether a prespecified event has occurred.]
Document: Model v2.0
Section: Events
- - Cited Guidance: Interventions[--PRESP][An indication that the intervention was
- prospectively stated or detailed on the CRF. Values should be
- "Y" or null.]|Interventions[--OCCUR][An indication as to
- whether a prespecified intervention has occurred.]
+ - Cited Guidance:
+ Interventions[--PRESP][An indication that the intervention was prospectively
+ stated or detailed on the CRF. Values should be "Y" or null.]|Interventions[--OCCUR][An
+ indication as to whether a prespecified intervention has occurred.]
Document: Model v2.0
Section: Interventions
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0089
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.][--OCCUR: Used to record whether a
- pre-specified event occurred when information about the
- occurrence of a specific event is solicited.]|Model v1.4[2.2.2
- (Events)][--PRESP: Used to indicate whether the event describe
- by --TERM was pre-specified on a CRF. Value is Y for
- pre-specified events, null for spontaneously reported
- events.][--OCCUR: Used to record whether a pre-specified event
- occurred when information about the occurrence of a specific
- event is solicited.]'
+ - Cited Guidance:
+ 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
+ is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a
+ pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model
+ v1.4[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified
+ on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR:
+ Used to record whether a pre-specified event occurred when information about the occurrence
+ of a specific event is solicited.]'
Document: Model v1.4
Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0089
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.][--OCCUR: Used to record whether a
- pre-specified event occurred when information about the
- occurrence of a specific event is solicited.]|Model v1.7[2.2.2
- (Events)][--PRESP: Used to indicate whether the event describe
- by --TERM was pre-specified on a CRF. Value is Y for
- pre-specified events, null for spontaneously reported
- events.][--OCCUR: Used to record whether a pre-specified event
- occurred when information about the occurrence of a specific
- event is solicited.]'
+ - Cited Guidance:
+ 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
+ is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a
+ pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model
+ v1.7[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified
+ on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR:
+ Used to record whether a pre-specified event occurred when information about the occurrence
+ of a specific event is solicited.]'
Document: Model v1.7
Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0089
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: (--PRESP) An indication that the event was prospectively stated
- or detailed on the CRF. Values should be "Y" or null.
- (--OCCUR) An indication as to whether a prespecified event has
- occurred.
+ - Cited Guidance:
+ (--PRESP) An indication that the event was prospectively stated or detailed
+ on the CRF. Values should be "Y" or null. (--OCCUR) An indication as to whether a
+ prespecified event has occurred.
Document: SDTM v2.1
Item: --PRESP|--OCCUR
Section: Section 3.1.2 The Events Observation Class
- - Cited Guidance: (--PRESP) An indication that the intervention was prospectively
- stated or detailed on the CRF. Values should be "Y" or
- null.(--OCCUR) An indication as to whether a prespecified
- intervention has occurred.
+ - Cited Guidance:
+ (--PRESP) An indication that the intervention was prospectively stated or
+ detailed on the CRF. Values should be "Y" or null.(--OCCUR) An indication as to whether a
+ prespecified intervention has occurred.
Document: SDTM v2.1
Item: --PRESP|--OCCUR
Section: 3.1.1 The Interventions Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0354
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --OCCUR
@@ -107,7 +101,7 @@ Check:
Core:
Id: CORE-000016
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --OCCUR is not empty and --PRESP is not equal to "Y".
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000017/rule.yml b/Published/CORE-000017/rule.yml
index 6c639bb0e..f42eed095 100644
--- a/Published/CORE-000017/rule.yml
+++ b/Published/CORE-000017/rule.yml
@@ -7,64 +7,66 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Two-character abbreviation for the domain of the parent
- record(s). Null for comments collected on a general comments
- or additional information CRF page.
+ - Cited Guidance:
+ Two-character abbreviation for the domain of the parent record(s). Null for
+ comments collected on a general comments or additional information CRF page.
Document: SDTMIG v3.4
Item: Specification
- Section: '5.1'
+ Section: "5.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0166
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Value of identifying variable of the parent record(s). Used only
- when individual comments are related to domain records. null
- for comments collected on separate CRFs.
+ - Cited Guidance:
+ Value of identifying variable of the parent record(s). Used only when
+ individual comments are related to domain records. null for comments collected on separate
+ CRFs.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0166
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Value of identifying variable of the parent record(s). Used only
- when individual comments are related to domain records. null
- for comments collected on separate CRFs.
+ - Cited Guidance:
+ Value of identifying variable of the parent record(s). Used only when
+ individual comments are related to domain records. null for comments collected on separate
+ CRFs.
Document: IG v3.3
Item: Specification
- Section: '5.1'
+ Section: "5.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0166
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Two-character abbreviation for the domain of the parent
- record(s). Null for comments collected on a general comments
- or additional information CRF page.
+ - Cited Guidance:
+ Two-character abbreviation for the domain of the parent record(s). Null for
+ comments collected on a general comments or additional information CRF page.
Document: TIG 1.0
Item: Specification
Section: 2.8.10.2
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0398
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
@@ -78,7 +80,7 @@ Check:
Core:
Id: CORE-000017
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when RDOMAIN is null when IDVARVAL is not null.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000018/rule.yml b/Published/CORE-000018/rule.yml
index 4651c6d63..6195b831a 100644
--- a/Published/CORE-000018/rule.yml
+++ b/Published/CORE-000018/rule.yml
@@ -7,20 +7,16 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Events[--PRESP][An indication that the event was prospectively
- stated or detailed on the CRF. Values should be "Y" or
- null.]|Events|[--OCCUR][An indication as to whether a
- prespecified event has occurred.]|Events[--STAT][Used to
- indicate when a question about the occurrence of a
- prespecified event was not answered. Should be null or have a
- value of "NOT DONE".]|Interventions[--PRESP][An indication
- that the intervention was prospectively stated or detailed on
- the CRF. Values should be "Y" or
- null.]|Interventions[--OCCUR][An indication as to whether a
- prespecified intervention has
- occurred.]|Interventions[--STAT][Used to indicate when a
- question about the occurrence of a prespecified intervention
- was not answered. Should be null or have a value of "NOT
+ - Cited Guidance:
+ Events[--PRESP][An indication that the event was prospectively stated or
+ detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to
+ whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a
+ question about the occurrence of a prespecified event was not answered. Should be null or
+ have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention
+ was prospectively stated or detailed on the CRF. Values should be "Y" or
+ null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has
+ occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of
+ a prespecified intervention was not answered. Should be null or have a value of "NOT
DONE".]
Document: Model v2.0
Item: --PRESP|--OCCUR|--STAT
@@ -28,92 +24,78 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0086
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.][--OCCUR: Used to record whether a
- pre-specified event occurred when information about the
- occurrence of a specific event is solicited.][--STAT: Used to
- indicate when a question about the occurrence of a
- pre-specified event was not answered. Should be null or hav a
- value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to
- indicate whether the event describe by --TERM was
- pre-specified on a CRF. Value is Y for pre-specified events,
- null for spontaneously reported events.][--OCCUR: Used to
- record whether a pre-specified event occurred when information
- about the occurrence of a specific event is
- solicited.][--STAT: Used to indicate when a question about the
- occurrence of a pre-specified event was not answered . Should
- be null or have a value of NOT DONE]'
+ - Cited Guidance:
+ 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
+ is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a
+ pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT:
+ Used to indicate when a question about the occurrence of a pre-specified event was not answered.
+ Should be null or hav a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate
+ whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified
+ events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified
+ event occurred when information about the occurrence of a specific event is solicited.][--STAT:
+ Used to indicate when a question about the occurrence of a pre-specified event was not answered
+ . Should be null or have a value of NOT DONE]'
Document: Model v1.4
Section: Model v1.4[2.2.1 (Interventions)]|Model v1.4[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0086
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.][--OCCUR: Used to record whether a
- pre-specified event occurred when information about the
- occurrence of a specific event is solicited.][--STAT: Used to
- indicate when a question about the occurrence of a
- pre-specified event was not answered. Should be null or hav a
- value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to
- indicate whether the event describe by --TERM was
- pre-specified on a CRF. Value is Y for pre-specified events,
- null for spontaneously reported events.][--OCCUR: Used to
- record whether a pre-specified event occurred when information
- about the occurrence of a specific event is
- solicited.][--STAT: Used to indicate when a question about the
- occurrence of a pre-specified event was not answered . Should
- be null or have a value of NOT DONE]'
+ - Cited Guidance:
+ 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
+ is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a
+ pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT:
+ Used to indicate when a question about the occurrence of a pre-specified event was not answered.
+ Should be null or hav a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate
+ whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified
+ events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified
+ event occurred when information about the occurrence of a specific event is solicited.][--STAT:
+ Used to indicate when a question about the occurrence of a pre-specified event was not answered
+ . Should be null or have a value of NOT DONE]'
Document: Model v1.7
Section: Model v1.7[2.2.1 (Interventions)]|Model v1.7[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0086
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Events[--PRESP][An indication that the event was prospectively
- stated or detailed on the CRF. Values should be "Y" or
- null.]|Events|[--OCCUR][An indication as to whether a
- prespecified event has occurred.]|Events[--STAT][Used to
- indicate when a question about the occurrence of a
- prespecified event was not answered. Should be null or have a
- value of "NOT DONE".]|Interventions[--PRESP][An indication
- that the intervention was prospectively stated or detailed on
- the CRF. Values should be "Y" or
- null.]|Interventions[--OCCUR][An indication as to whether a
- prespecified intervention has
- occurred.]|Interventions[--STAT][Used to indicate when a
- question about the occurrence of a prespecified intervention
- was not answered. Should be null or have a value of "NOT
+ - Cited Guidance:
+ Events[--PRESP][An indication that the event was prospectively stated or
+ detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to
+ whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a
+ question about the occurrence of a prespecified event was not answered. Should be null or
+ have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention
+ was prospectively stated or detailed on the CRF. Values should be "Y" or
+ null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has
+ occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of
+ a prespecified intervention was not answered. Should be null or have a value of "NOT
DONE".]
Document: SDTM v2.1
Item: --PRESP|--OCCUR|--STAT
- Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The
- Interventions Observation Class
+ Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions
+ Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0351
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --PRESP
@@ -128,9 +110,9 @@ Check:
Core:
Id: CORE-000018
Status: Published
- Version: '1'
-Description: Raise an error when --PRESP is equal to "Y", --STAT is blank,
- --OCCUR is present in dataset and --OCCUR is blank
+ Version: "1"
+Description: Raise an error when --PRESP is equal to "Y", --STAT is blank, --OCCUR is present in
+ dataset and --OCCUR is blank
Executability: Fully Executable
Outcome:
Message: --OCCUR is blank when --PRESP is equal to "Y" and --STAT is not provided.
diff --git a/Published/CORE-000019/rule.yml b/Published/CORE-000019/rule.yml
index aa190bd88..ad141ed60 100644
--- a/Published/CORE-000019/rule.yml
+++ b/Published/CORE-000019/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: Variable label length <= 40
Authorities:
- Organization: CDISC
@@ -7,154 +7,161 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Variable descriptive names (labels), up to 40 characters, should
- be provided as data variable labels for all variables,
- including Supplemental Qualifier variables.
+ - Cited Guidance:
+ Variable descriptive names (labels), up to 40 characters, should be provided
+ as data variable labels for all variables, including Supplemental Qualifier variables.
Document: IG v3.4
Section: 4.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0311
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which
- should be unique for each variable in the dataset
+ - Cited Guidance:
+ A descriptive Variable Label, using up to 40 characters, which should be
+ unique for each variable in the dataset
Document: IG v3.2
- Section: '2.2'
+ Section: "2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0311
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Variable descriptive names (labels), up to 40 characters, should
- be provided as data variable labels for all variables,
- including Supplemental Qualifier variables.
+ - Cited Guidance:
+ Variable descriptive names (labels), up to 40 characters, should be provided
+ as data variable labels for all variables, including Supplemental Qualifier variables.
Document: IG v3.3
Section: 4.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0311
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which
- should be unique for each variable in the dataset.
+ - Cited Guidance:
+ A descriptive Variable Label, using up to 40 characters, which should be
+ unique for each variable in the dataset.
Document: IG v3.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND3
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which
- should be unique for each variable in the dataset.
+ - Cited Guidance:
+ A descriptive Variable Label, using up to 40 characters, which should be
+ unique for each variable in the dataset.
Document: IG v3.1.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND3
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which
- should be unique for each variable in the dataset.
+ - Cited Guidance:
+ A descriptive Variable Label, using up to 40 characters, which should be
+ unique for each variable in the dataset.
Document: IG v3.0
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND3
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which
- should be unique for each variable in the dataset.
+ - Cited Guidance:
+ A descriptive Variable Label, using up to 40 characters, which should be
+ unique for each variable in the dataset.
Document: IG v3.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND3
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which
- should be unique for each variable in the dataset.
+ - Cited Guidance:
+ A descriptive Variable Label, using up to 40 characters, which should be
+ unique for each variable in the dataset.
Document: IG v3.1.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND3
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which
- should be unique for each variable in the dataset.
+ - Cited Guidance:
+ A descriptive Variable Label, using up to 40 characters, which should be
+ unique for each variable in the dataset.
Document: IG v3.1.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND3
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be
- provided as data variable labels for all variables, including
- Supplemental Qualifier variables.
+ - Cited Guidance:
+ Descriptive labels per this guide, up to 40 characters, will be provided as
+ data variable labels for all variables, including Supplemental Qualifier variables.
Document: TIG 1.0
- Item: 'Num 5'
- Section: '2.6'
+ Item: "Num 5"
+ Section: "2.6"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0486
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be
- provided as data variable labels for all variables, including
- Supplemental Qualifier variables.
+ - Cited Guidance:
+ Descriptive labels per this guide, up to 40 characters, will be provided as
+ data variable labels for all variables, including Supplemental Qualifier variables.
Document: TIG v1.0
Item: Tabulation Datasets Table, Num 5
Section: 2.6 Guidance for Datasets
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0211
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: variable_label
@@ -163,7 +170,7 @@ Check:
Core:
Id: CORE-000019
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise and error if Variable label length > 40 characters
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000020/rule.yml b/Published/CORE-000020/rule.yml
index 8fd41d560..270151f91 100644
--- a/Published/CORE-000020/rule.yml
+++ b/Published/CORE-000020/rule.yml
@@ -7,90 +7,84 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: TAETORD will not be populated for subject Elements that are not
- planned for the Arm to which the subject was assigned. Thus,
- TAETORD will not be populated for any Element with an ETCD
- value of UNPLAN.
+ - Cited Guidance:
+ TAETORD will not be populated for subject Elements that are not planned for
+ the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any
+ Element with an ETCD value of UNPLAN.
Document: IG v3.4
Item: Assumption 6
- Section: '5.3'
+ Section: "5.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0206
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: TAETORD will not be populated for subject Elements that are not
- planned for the Arm to which the subject was assigned. Thus,
- TAETORD will not be populated for any Element with an ETCD
- value of "UNPLAN". TAETORD will also not be populated if a
- subject passed through an Element that, although defined in
- the TE dataset, was out of place for the Arm to which the
- subject was assigned. For example, if a subject in a parallel
- study of Drug A vs. Drug B was assigned to receive Drug A, but
- received Drug B instead, then TAETORD would be left blank for
- the SE record for their Drug B Element. If a subject was
- assigned to receive the sequence of Elements A, B, C, D, and
- instead received A, D, B, C, then the sponsor would have to
- decide for which of these subject Element records TAETORD
- should be populated. The rationale for this decision should be
- documented in the Comments column of the define.xml.
+ - Cited Guidance:
+ TAETORD will not be populated for subject Elements that are not planned for
+ the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any
+ Element with an ETCD value of "UNPLAN". TAETORD will also not be populated if a subject
+ passed through an Element that, although defined in the TE dataset, was out of place for
+ the Arm to which the subject was assigned. For example, if a subject in a parallel study
+ of Drug A vs. Drug B was assigned to receive Drug A, but received Drug B instead, then
+ TAETORD would be left blank for the SE record for their Drug B Element. If a subject was
+ assigned to receive the sequence of Elements A, B, C, D, and instead received A, D, B, C,
+ then the sponsor would have to decide for which of these subject Element records TAETORD
+ should be populated. The rationale for this decision should be documented in the Comments
+ column of the define.xml.
Document: IG v3.2
Item: Assumption 8
Section: 5 SE
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0206
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: TAETORD will not be populated for subject Elements that are not
- planned for the Arm to which the subject was assigned. Thus,
- TAETORD will not be populated for any Element with an ETCD
- value of "UNPLAN". TAETORD will also not be populated if a
- subject passed through an Element that, although defined in
- the TE dataset, was out of place for the Arm to which the
- subject was assigned. For example, if a subject in a parallel
- study of Drug A vs. Drug B was assigned to receive Drug A, but
- received Drug B instead, then TAETORD would be left blank for
- the SE record for their Drug B Element. If a subject was
- assigned to receive the sequence of Elements A, B, C, D, and
- instead received A, D, B, C, then the sponsor would have to
- decide for which of these subject Element records TAETORD
- should be populated. The rationale for this decision should be
- documented in the Comments column of the define.xml.
+ - Cited Guidance:
+ TAETORD will not be populated for subject Elements that are not planned for
+ the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any
+ Element with an ETCD value of "UNPLAN". TAETORD will also not be populated if a subject
+ passed through an Element that, although defined in the TE dataset, was out of place for
+ the Arm to which the subject was assigned. For example, if a subject in a parallel study
+ of Drug A vs. Drug B was assigned to receive Drug A, but received Drug B instead, then
+ TAETORD would be left blank for the SE record for their Drug B Element. If a subject was
+ assigned to receive the sequence of Elements A, B, C, D, and instead received A, D, B, C,
+ then the sponsor would have to decide for which of these subject Element records TAETORD
+ should be populated. The rationale for this decision should be documented in the Comments
+ column of the define.xml.
Document: IG v3.3
Item: Assumption 6
- Section: '5.3'
+ Section: "5.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0206
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: TAETORD will not be populated for subject Elements that are not
- planned for the Arm to which the subject was assigned. Thus,
- TAETORD will not be populated for any Element with an ETCD
- value of “UNPLAN”.
+ - Cited Guidance:
+ TAETORD will not be populated for subject Elements that are not planned for
+ the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any
+ Element with an ETCD value of “UNPLAN”.
Document: TIG 1.0
Item: Assumption 5
Section: 2.8.10.24
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0426
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ETCD
@@ -101,7 +95,7 @@ Check:
Core:
Id: CORE-000020
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when ETCD="UNPLAN" and TAETORD is not null.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000021/rule.yml b/Published/CORE-000021/rule.yml
index 9130757ee..b42afb7da 100644
--- a/Published/CORE-000021/rule.yml
+++ b/Published/CORE-000021/rule.yml
@@ -7,97 +7,87 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Model v2.0[Findings][The standardized result of the measurement,
- test, or examination in character format. --STRESC should
- store all results or findings in character format; if results
- are numeric, they should also be stored in numeric format in
- --STRESN. If various tests have results "NONE", "NEG", and
- "NEGATIVE" in --ORRES and these results effectively have the
- same meaning, they could be represented in standard format in
- --STRESC as "NEGATIVE".]|IG v3.4[6.3.5.3][Contains the result
- value for all findings, copied or derived from LBORRES in a
- standard format or standard units.]
+ - Cited Guidance:
+ Model v2.0[Findings][The standardized result of the measurement, test, or
+ examination in character format. --STRESC should store all results or findings in
+ character format; if results are numeric, they should also be stored in numeric format in
+ --STRESN. If various tests have results "NONE", "NEG", and "NEGATIVE" in --ORRES and these
+ results effectively have the same meaning, they could be represented in standard format in
+ --STRESC as "NEGATIVE".]|IG v3.4[6.3.5.3][Contains the result value for all findings,
+ copied or derived from LBORRES in a standard format or standard units.]
Document: Model v2.0|IG v3.4
Item: Specification
Section: Findings|6.3.5.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0397
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.2[6.3 LB][Contains the result value for all findings;
- copied or derived from LBORRES in a standard format or
- standard units. LBSTRESC should store all results or findings
- in character format; if results are numeric; they should also
- be stored in numeric format in LBSTRESN. For example; if a
- test has results 'NONE'; 'NEG'; and 'NEGATIVE' in LBORRES and
- these results effectively have the same meaning; they could be
- represented in standard format in LBSTRESC as 'NEGATIVE'. For
- other examples; see general assumptions.]|Model
- v1.4[2.2.3][Contains the result value for all findings; copied
- or derived from --ORRES in a standard format or in standard
- units.]
+ - Cited Guidance:
+ IG v3.2[6.3 LB][Contains the result value for all findings; copied or
+ derived from LBORRES in a standard format or standard units. LBSTRESC should store all
+ results or findings in character format; if results are numeric; they should also be
+ stored in numeric format in LBSTRESN. For example; if a test has results 'NONE'; 'NEG';
+ and 'NEGATIVE' in LBORRES and these results effectively have the same meaning; they could
+ be represented in standard format in LBSTRESC as 'NEGATIVE'. For other examples; see
+ general assumptions.]|Model v1.4[2.2.3][Contains the result value for all findings; copied
+ or derived from --ORRES in a standard format or in standard units.]
Document: IG v3.2|Model v1.4
Section: IG v3.2[6.3 LB]|Model v1.4[2.2.3]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0397
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[6.3.6][Contains the result value for all findings;
- copied or derived from --ORRES in a standard format or in
- standard units.]|Model v1.7[2.2.3] Contains the result value
- for all findings; copied or derived from LBORRES in a standard
- format or standard units. LBSTRESC should store all results or
- findings in character format; if results are numeric; they
- should also be stored in numeric format in LBSTRESN. For
- example; if a test has results 'NONE'; 'NEG'; and 'NEGATIVE'
- in LBORRES and these results effectively have the same
- meaning; they could be represented in standard format in
- LBSTRESC as 'NEGATIVE'. For other examples; see general
- assumptions.]
+ - Cited Guidance:
+ IG v3.3[6.3.6][Contains the result value for all findings; copied or derived
+ from --ORRES in a standard format or in standard units.]|Model v1.7[2.2.3] Contains the
+ result value for all findings; copied or derived from LBORRES in a standard format or
+ standard units. LBSTRESC should store all results or findings in character format; if
+ results are numeric; they should also be stored in numeric format in LBSTRESN. For
+ example; if a test has results 'NONE'; 'NEG'; and 'NEGATIVE' in LBORRES and these results
+ effectively have the same meaning; they could be represented in standard format in
+ LBSTRESC as 'NEGATIVE'. For other examples; see general assumptions.]
Document: IG v3.3|Model v1.7
Section: IG v3.3[6.3.6]|Model v1.7[2.2.3]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0397
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The standardized result of the measurement, test, or examination
- in character format. --STRESC should store all results or
- findings in character format; if results are numeric, they
- should also be stored in numeric format in --STRESN. If
- various tests have results "NONE", "NEG", and "NEGATIVE" in
- --ORRES and these results effectively have the same meaning,
- they could be represented in standard format in --STRESC as
+ - Cited Guidance: The standardized result of the measurement, test, or examination in
+ character format. --STRESC should store all results or findings in character format; if
+ results are numeric, they should also be stored in numeric format in --STRESN. If various
+ tests have results "NONE", "NEG", and "NEGATIVE" in --ORRES and these results effectively
+ have the same meaning, they could be represented in standard format in --STRESC as
"NEGATIVE"
Document: SDTM v2.1
Section: 3.3.3 The Findings Observation Class
- - Cited Guidance: Values will be populated in --STRESC when --ORRES is populated.
- Numeric values represented in --STRESC will be assigned to
- --STRESN.
+ - Cited Guidance:
+ Values will be populated in --STRESC when --ORRES is populated. Numeric
+ values represented in --STRESC will be assigned to --STRESN.
Document: TIG v1.0
Item: Table 3 Num 3
Section: 2.8.7.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0559
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- any:
@@ -112,12 +102,11 @@ Check:
Core:
Id: CORE-000021
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when the value for --STRESC is null.
Executability: Fully Executable
Outcome:
- Message: --STRESC should not be blank when either --ORRES is provided or --DRVFL
- = 'Y' .
+ Message: --STRESC should not be blank when either --ORRES is provided or --DRVFL = 'Y' .
Output Variables:
- --ORRES
- --DRVFL
diff --git a/Published/CORE-000022/rule.yml b/Published/CORE-000022/rule.yml
index e2a75c58b..d3a9f3188 100644
--- a/Published/CORE-000022/rule.yml
+++ b/Published/CORE-000022/rule.yml
@@ -7,80 +7,76 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If categories of serious events are collected secondarily to a
- leading question, as in the example below, the values of the
- variables that capture reasons an event is considered serious
- (i.e., AESCAN, AESCONG, etc.) may be null. For example, if
- Serious is answered "No", the values for these variables maybe
- null. However, if Serious is answered "Yes", at least one of
- them will have a "Y" response.
+ - Cited Guidance:
+ If categories of serious events are collected secondarily to a leading
+ question, as in the example below, the values of the variables that capture reasons an
+ event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if
+ Serious is answered "No", the values for these variables maybe null. However, if Serious
+ is answered "Yes", at least one of them will have a "Y" response.
Document: SDTMIG v3.4
Item: Assumption 6a
Section: 6.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0041
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If categories of serious events are collected secondarily to a
- leading question, as in the example below, the values of the
- variables that capture reasons an event is considered serious
- (i.e., AESCAN, AESCONG, etc.) may be null. For example, if
- Serious is answered "No", the values for these variables maybe
- null. However, if Serious is answered "Yes", at least one of
- them will have a "Y" response.
+ - Cited Guidance:
+ If categories of serious events are collected secondarily to a leading
+ question, as in the example below, the values of the variables that capture reasons an
+ event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if
+ Serious is answered "No", the values for these variables maybe null. However, if Serious
+ is answered "Yes", at least one of them will have a "Y" response.
Document: SDTMIG v3.3
Item: Assumption 6a
Section: 6.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0041
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If categories of serious events are collected secondarily to a
- leading question, as in the example below, the values of the
- variables that capture reasons an event is considered serious
- (i.e., AESCAN, AESCONG, etc.) may be null. For example, if
- Serious is answered "No", the values for these variables may
- be null. However, if Serious is answered "Yes", at least one
- of them will have a "Y" response.
+ - Cited Guidance:
+ If categories of serious events are collected secondarily to a leading
+ question, as in the example below, the values of the variables that capture reasons an
+ event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if
+ Serious is answered "No", the values for these variables may be null. However, if Serious
+ is answered "Yes", at least one of them will have a "Y" response.
Document: SDTMIG v3.2
Item: Assumption 6a
Section: 6.2.
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0041
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If categories of serious events are collected secondarily to a
- leading question the values of the variables that capture
- reasons an event is considered serious (e.g., AESCAN, AESCONG)
- may be null. On the other hand, if the CRF is structured so
- that a response is collected for each seriousness category,
- all category variables (e.g., AESDTH, AESHOSP) would be
- populated and AESER would be derived.
+ - Cited Guidance:
+ If categories of serious events are collected secondarily to a leading
+ question the values of the variables that capture reasons an event is considered serious
+ (e.g., AESCAN, AESCONG) may be null. On the other hand, if the CRF is structured so that a
+ response is collected for each seriousness category, all category variables (e.g., AESDTH,
+ AESHOSP) would be populated and AESER would be derived.
Document: TIG 1.0
Item: Assumption 7a
Section: 2.8.10.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0320
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- any:
@@ -123,13 +119,13 @@ Check:
Core:
Id: CORE-000022
Status: Published
- Version: '1'
-Description: Raise an error when AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP,
- AESLIFE, AESOD or AESMIE = 'Y' and AESER = 'N' or is empty.
+ Version: "1"
+Description: Raise an error when AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, AESLIFE, AESOD or
+ AESMIE = 'Y' and AESER = 'N' or is empty.
Executability: Fully Executable
Outcome:
- Message: At least one of the Seriousness criteria (AESCAN, AESCONG, AESDISAB,
- AESDTH, AESHOSP, AESLIFE, AESOD or AESMIE) = 'Y', but AESER = 'N' or empty.
+ Message: At least one of the Seriousness criteria (AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP,
+ AESLIFE, AESOD or AESMIE) = 'Y', but AESER = 'N' or empty.
Output Variables:
- AETERM
- AESTDTC
diff --git a/Published/CORE-000023/rule.yml b/Published/CORE-000023/rule.yml
index 022a3ba10..7b8d4ae0f 100644
--- a/Published/CORE-000023/rule.yml
+++ b/Published/CORE-000023/rule.yml
@@ -24,9 +24,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0084
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -47,9 +47,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0084
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -70,25 +70,27 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0084
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Events[--TOX][Variable Qualifier of
- --TOXGR]|Findings[--TOX][Variable Qualifier of --TOXGR]
+ - Cited Guidance:
+ Events[--TOX][Variable Qualifier of --TOXGR]|Findings[--TOX][Variable
+ Qualifier of --TOXGR]
Document: SDTM v2.1
Item: --TOX
- Section: Section 3.1.2 The Events Observation Class|Section 3.1.3 The Findings
- Observation Class
+ Section:
+ Section 3.1.2 The Events Observation Class|Section 3.1.3 The Findings Observation
+ Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0349
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --TOXGR
@@ -98,7 +100,7 @@ Check:
Core:
Id: CORE-000023
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TOXGR is not present in dataset, but --TOX is present
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000024/rule.yml b/Published/CORE-000024/rule.yml
index 4b01d859d..2c68c4972 100644
--- a/Published/CORE-000024/rule.yml
+++ b/Published/CORE-000024/rule.yml
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0082
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -26,9 +26,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0082
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -38,9 +38,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0082
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
@@ -51,10 +51,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0347
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --BODSYS
@@ -64,7 +64,7 @@ Check:
Core:
Id: CORE-000024
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error if --BODSYS is not empty, --BDSYCD is empty
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000025/rule.yml b/Published/CORE-000025/rule.yml
index dea598aee..519df490b 100644
--- a/Published/CORE-000025/rule.yml
+++ b/Published/CORE-000025/rule.yml
@@ -1,5 +1,5 @@
# Variable: IESTRESC
-# Condition:
+# Condition:
# Rule: IESTRESC = IEORRES
Authorities:
- Organization: CDISC
@@ -7,60 +7,56 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard
- format
+ - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format
Document: SDTMIG v3.4
- Item: ''
+ Item: ""
Section: 6.3.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0177
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard
- format.
+ - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format.
Document: IG v3.2
Item: Specification
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0177
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard
- format.
+ - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format.
Document: IG v3.3
Item: Specification
Section: 6.3.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0177
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard
- format.
+ - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format.
Document: TIG 1.0
Item: Specification-IESTRESC
Section: 2.8.10.13
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0406
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IESTRESC
@@ -69,7 +65,7 @@ Check:
Core:
Id: CORE-000025
Status: Published
- Version: '1'
+ Version: "1"
Description: IESTRESC is not equal to IEORRES
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000026/rule.yml b/Published/CORE-000026/rule.yml
index 7ef69d819..40f47e4b7 100644
--- a/Published/CORE-000026/rule.yml
+++ b/Published/CORE-000026/rule.yml
@@ -7,72 +7,69 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When time points are represented in SDTMIG domains, both --TPT
- and --TPTNUM must be used.
+ - Cited Guidance:
+ When time points are represented in SDTMIG domains, both --TPT and --TPTNUM
+ must be used.
Document: IG v3.3
Section: 4.4.10 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0468
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When time points are used, --TPTNUM is expected. Within the
- context that defines uniqueness for a time point, which may
- include domain, visit, and reference time point, there must be
- a one-to-relationship between values of --TPT and --TPTNUM. in
- other words, if domain, visit, and reference time point
- uniquely identify subject data, then if two subjects have
- records with the same values of DOMAIN, VISITNUM, --TPTREF,
- and --TPTNUM, then these records may not have different time
- point descriptions in --TPT.
+ - Cited Guidance:
+ When time points are used, --TPTNUM is expected. Within the context that
+ defines uniqueness for a time point, which may include domain, visit, and reference time
+ point, there must be a one-to-relationship between values of --TPT and --TPTNUM. in other
+ words, if domain, visit, and reference time point uniquely identify subject data, then if
+ two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and
+ --TPTNUM, then these records may not have different time point descriptions in --TPT.
Document: IG v3.2
Section: 4.1.4.10
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0468
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When time points are used, --TPTNUM is expected. Within the
- context that defines uniqueness for a time point, which may
- include domain, visit, and reference time point, there must be
- a one-to-relationship between values of --TPT and --TPTNUM. in
- other words, if domain, visit, and reference time point
- uniquely identify subject data, then if two subjects have
- records with the same values of DOMAIN, VISITNUM, --TPTREF,
- and --TPTNUM, then these records may not have different time
- point descriptions in --TPT.
+ - Cited Guidance:
+ When time points are used, --TPTNUM is expected. Within the context that
+ defines uniqueness for a time point, which may include domain, visit, and reference time
+ point, there must be a one-to-relationship between values of --TPT and --TPTNUM. in other
+ words, if domain, visit, and reference time point uniquely identify subject data, then if
+ two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and
+ --TPTNUM, then these records may not have different time point descriptions in --TPT.
Document: IG v3.3
Section: 4.4.10
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0468
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Time points will be represented using both --TPT and --TPTNUM.
- There will be a one-to-one relationship between values of
- --TPT and --TPTNUM.
+ - Cited Guidance:
+ Time points will be represented using both --TPT and --TPTNUM. There will be
+ a one-to-one relationship between values of --TPT and --TPTNUM.
Document: TIG 1.0
Item: Num 5
Section: 2.8.7.5
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0598
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --TPT
@@ -82,7 +79,7 @@ Check:
Core:
Id: CORE-000026
Status: Published
- Version: '1'
+ Version: "1"
Description: When --TPT is present in a dataset, --TPTNUM must also be present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000027/rule.yml b/Published/CORE-000027/rule.yml
index 664ead6be..b4342adb0 100644
--- a/Published/CORE-000027/rule.yml
+++ b/Published/CORE-000027/rule.yml
@@ -11,47 +11,46 @@ Authorities:
Document: SDTMIG v3.4
Item: Specification
Section: 7.2.2
- - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be
- populated.
+ - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be populated.
Document: SDTMIG v3.4
Item: Assumption 12
Section: 7.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0328
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each
- Element.]|Assumption 12[At least one of TEENRL or TEDUR must
- be populated. Both may be populated.]
+ Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be
+ populated.]
Document: IG v3.2
Item: Specification|Assumption 12
- Section: '7.2'
+ Section: "7.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0328
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each
- Element.]|Assumption 12[At least one of TEENRL or TEDUR must
- be populated. Both may be populated.]
+ Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be
+ populated.]
Document: IG v3.3
Item: Specification|Assumption 12
Section: 7.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0328
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -59,18 +58,17 @@ Authorities:
Document: TIG 1.0
Item: Specification TEENRL
Section: 2.8.10.28
- - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be
- populated.
+ - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be populated.
Document: TIG 1.0
Item: Assumption 12
Section: 2.8.10.28
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0496
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SDTMIG
References:
- Citations:
@@ -78,166 +76,167 @@ Authorities:
Document: IG v3.4
Item: Specification
Section: 7.2.2
- - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be
- populated.
+ - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be populated.
Document: IG v3.4
Item: Assumption 12
Section: 7.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0329
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each
- Element.]|Assumption 12[At least one of TEENRL or TEDUR must
- be populated. Both may be populated.]
+ Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be
+ populated.]
Document: IG v3.2
Item: Specification|Assumption 12
- Section: '7.2'
+ Section: "7.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0329
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each
- Element.]|Assumption 12[At least one of TEENRL or TEDUR must
- be populated. Both may be populated.]
+ Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be
+ populated.]
Document: IG v3.3
Item: Specification|Assumption 12
Section: 7.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0329
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Specification TEENRL [Either TEENRL or TEDUR must be present for
- each Element.
+ - Cited Guidance:
+ Specification TEENRL [Either TEENRL or TEDUR must be present for each
+ Element.
Document: TIG 1.0
Item: Specification TEENRL
Section: 2.8.10.28
- - Cited Guidance: Assumption 12[At least one of TEENRL and TEDUR must be
- populated. Both may be populated.]
+ - Cited Guidance:
+ Assumption 12[At least one of TEENRL and TEDUR must be populated. Both may
+ be populated.]
Document: TIG 1.0
Item: Assumption 12
Section: 2.8.10.28
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0497
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both
- may be present.
+ - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be
+ present.
Document: IG v3.0
Item: Specification
Section: 7.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND214
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both
- may be present.
+ - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be
+ present.
Document: IG v3.1
Item: Specification
Section: 7.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND214
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both
- may be present.
+ - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be
+ present.
Document: IG v3.1.1
Item: Specification
Section: 7.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND214
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both
- may be present.
+ - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be
+ present.
Document: IG v3.1
Item: Specification
Section: 7.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND214
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both
- may be present.
+ - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be
+ present.
Document: IG v3.1.1
Item: Specification
Section: 7.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND214
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both
- may be present.
+ - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be
+ present.
Document: IG v3.1.1
Item: Specification
Section: 7.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND214
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both
- may be present.
+ - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be
+ present.
Document: TIG v1.0
Item: TEENRL CDISC Notes
Section: 2.8.9.29
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0141
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- any:
@@ -253,7 +252,7 @@ Check:
Core:
Id: CORE-000027
Status: Published
- Version: '1'
+ Version: "1"
Description: Either TEENRL or TEDUR must be present for each Element.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000028/rule.yml b/Published/CORE-000028/rule.yml
index 803e743dc..d04a33512 100644
--- a/Published/CORE-000028/rule.yml
+++ b/Published/CORE-000028/rule.yml
@@ -7,70 +7,69 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The interval of time between a planned time point and a fixed
- reference point, represented in a standardized character
- format. The fixed reference point is in --TPTREF.
+ - Cited Guidance:
+ The interval of time between a planned time point and a fixed reference
+ point, represented in a standardized character format. The fixed reference point is in
+ --TPTREF.
Document: SDTM Model v2.0
Item: --ELTM
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0008
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Planned Elapsed time relative to a planned fixed reference
- (--TPTREF) such as "Previous Dose" or "Previous Meal". This
- variable is useful where there are repetitive measures. Not a
- clock time or a date/time variable, but an
- interval. Format=ISO8601
+ - Cited Guidance:
+ Planned Elapsed time relative to a planned fixed reference (--TPTREF) such
+ as "Previous Dose" or "Previous Meal". This variable is useful where there are repetitive
+ measures. Not a clock time or a date/time variable, but an interval. Format=ISO8601
Document: SDTM Model v1.7
Item: Table 2.2.5, --ELTM
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0008
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Planned Elapsed time in ISO 8601 character format relative to a
- planned fixed reference (--TPTREF) such as "Previous Dose" or
- "Previous Meal".
+ - Cited Guidance:
+ Planned Elapsed time in ISO 8601 character format relative to a planned
+ fixed reference (--TPTREF) such as "Previous Dose" or "Previous Meal".
Document: SDTM Model v1.4
Item: Table 2.2.5, --ELTM
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0008
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: "When instances of an activity are scheduled at planned time
- intervals relative to a fixed reference point (e.g., an
- exposure), the following timing variables will be used:
- --TPTREF- Represents a description of the fixed reference
- point from which the planned observation will be made.-ELTM
- represents the planned elapsed time from the fixed timepoint
- reference to the planned observation."
+ - Cited Guidance:
+ "When instances of an activity are scheduled at planned time intervals relative
+ to a fixed reference point (e.g., an exposure), the following timing variables will be used:
+ --TPTREF- Represents a description of the fixed reference point from which the planned observation
+ will be made.-ELTM represents the planned elapsed time from the fixed timepoint reference to
+ the planned observation."
Document: TIG 1.0
Item: Table 2 Num 3
Section: 2.8.7.6
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0293
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --TPTREF
@@ -80,7 +79,7 @@ Check:
Core:
Id: CORE-000028
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TPTREF is empty, but --ELTM is not empty
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000029/rule.yml b/Published/CORE-000029/rule.yml
index 289d509db..c4293b799 100644
--- a/Published/CORE-000029/rule.yml
+++ b/Published/CORE-000029/rule.yml
@@ -7,32 +7,33 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When time points are represented in SDTMIG domains, both --TPT
- and --TPTNUM must be used.
+ - Cited Guidance:
+ When time points are represented in SDTMIG domains, both --TPT and --TPTNUM
+ must be used.
Document: IG v3.4
Section: 4.4.10
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0661
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- Cited Guidance: TIG 1.0
- Document: Time points will be represented using both --TPT and --TPTNUM. There
- will be a one-to-one relationship between values of --TPT and
- --TPTNUM.
+ Document:
+ Time points will be represented using both --TPT and --TPTNUM. There will be a
+ one-to-one relationship between values of --TPT and --TPTNUM.
Item: Planned Timing table NUM 5
Section: 2.8.7.5
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0697
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --TPTNUM
@@ -42,13 +43,12 @@ Check:
Core:
Id: CORE-000029
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TPTNUM exists in a dataset and --TPT does not exist.
Executability: Fully Executable
Outcome:
- Message: --TPTNUM exists in a dataset, but --TPT does not exist. When time
- points are represented in SDTMIG domains, both --TPT and --TPTNUM must be
- used.
+ Message: --TPTNUM exists in a dataset, but --TPT does not exist. When time points are represented
+ in SDTMIG domains, both --TPT and --TPTNUM must be used.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000030/rule.yml b/Published/CORE-000030/rule.yml
index e037b3aea..c7d0577ef 100644
--- a/Published/CORE-000030/rule.yml
+++ b/Published/CORE-000030/rule.yml
@@ -7,72 +7,69 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: --PRESP[An indication that the event or intervention was
- prospectively stated or detailed on the CRF.]|--OCCUR[An
- indication as to whether a prespecified event or intervention
- has occurred.]
+ - Cited Guidance:
+ --PRESP[An indication that the event or intervention was prospectively
+ stated or detailed on the CRF.]|--OCCUR[An indication as to whether a prespecified event
+ or intervention has occurred.]
Document: SDTM v2.0
Section: Events|Interventions
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0053
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: (--PRESP/Events) Used to indicate whether the event describe by
- --TERM was pre-specified on a CRF. Value is Y for
- pre-specified events, null for spontaneously reported events.
- (--PRESP/Interventions) Used when a specific intervention is
- pre-specified on a CRF. Values should be "Y" or null.
- (--REASND) Used in conjunction with --STAT when value is NOT
- DONE
+ - Cited Guidance:
+ (--PRESP/Events) Used to indicate whether the event describe by --TERM was
+ pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously
+ reported events. (--PRESP/Interventions) Used when a specific intervention is
+ pre-specified on a CRF. Values should be "Y" or null. (--REASND) Used in conjunction with
+ --STAT when value is NOT DONE
Document: SDTM v1.7
Section: 2.2.1 (Interventions )|2.2.2 (Events)
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0053
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: (--PRESP/Events) Used to indicate whether the event describe by
- --TERM was pre-specified on a CRF. Value is Y for
- pre-specified events, null for spontaneously reported events.
- (--PRESP/Interventions) Used when a specific intervention is
- pre-specified on a CRF. Values should be "Y" or null.
- (--REASND) Used in conjunction with --STAT when value is NOT
- DONE
+ - Cited Guidance:
+ (--PRESP/Events) Used to indicate whether the event describe by --TERM was
+ pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously
+ reported events. (--PRESP/Interventions) Used when a specific intervention is
+ pre-specified on a CRF. Values should be "Y" or null. (--REASND) Used in conjunction with
+ --STAT when value is NOT DONE
Document: SDTM v1.4
Section: 2.2.1 (Interventions )|2.2.2 (Events)
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0053
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: --PRESP[An indication that the event or intervention was
- prospectively stated or detailed on the CRF.]|--OCCUR[An
- indication as to whether a prespecified event or intervention
- has occurred.]
+ - Cited Guidance:
+ --PRESP[An indication that the event or intervention was prospectively
+ stated or detailed on the CRF.]|--OCCUR[An indication as to whether a prespecified event
+ or intervention has occurred.]
Document: SDTM v2.1
- Item: '--PRESP|--STAT'
- Section: 3.1.2 The Events Observation Class|3.1.2 The Interventions Observation
- Class
+ Item: "--PRESP|--STAT"
+ Section: 3.1.2 The Events Observation Class|3.1.2 The Interventions Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0329
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --PRESP
@@ -82,13 +79,12 @@ Check:
Core:
Id: CORE-000030
Status: Published
- Version: '1'
-Description: Raise and error when --REASND is present in dataset and --PRESP is
- not present in dataset
+ Version: "1"
+Description: Raise and error when --REASND is present in dataset and --PRESP is not present in
+ dataset
Executability: Fully Executable
Outcome:
- Message: --REASND should not be present in dataset when --PRESP is not present
- in dataset
+ Message: --REASND should not be present in dataset when --PRESP is not present in dataset
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000033/rule.yml b/Published/CORE-000033/rule.yml
index b56e22526..8b13f1473 100644
--- a/Published/CORE-000033/rule.yml
+++ b/Published/CORE-000033/rule.yml
@@ -7,17 +7,17 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from
- the controlled terminology codelist NCOMPLT.
+ - Cited Guidance: When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from the
+ controlled terminology codelist NCOMPLT.
Document: SDTMIG v3.4
Item: Assumption 3.b.i.
Section: 6.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0065
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -28,37 +28,37 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0065
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: b. When DSTERM = 'COMPLETED', DSDECOD = 'COMPLETED'.
Document: SDTMIG v3.2
Item: Assumption 3b
- Section: '6.2'
+ Section: "6.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0065
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from
- the Controlled Terminology codelist NCOMPLT.
+ - Cited Guidance: When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from the
+ Controlled Terminology codelist NCOMPLT.
Document: TIG 1.0
Item: Assumption 3.b.i.
Section: 2.8.10.8
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0337
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: DSTERM
@@ -70,7 +70,7 @@ Check:
Core:
Id: CORE-000033
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when DSTERM = "COMPLETED" and DSDECOD not equal to "COMPLETED".
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000034/rule.yml b/Published/CORE-000034/rule.yml
index 2552c4643..efe69c20a 100644
--- a/Published/CORE-000034/rule.yml
+++ b/Published/CORE-000034/rule.yml
@@ -7,64 +7,64 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format.
- Should represent the date/time that is captured in the
- clinical-trial database.
+ - Cited Guidance:
+ Date/time of death for any subject who died, in ISO 8601 format. Should
+ represent the date/time that is captured in the clinical-trial database.
Document: SDTMIG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0069
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format.
- Should represent the date/time that is captured in the
- clinical-trial database.
+ - Cited Guidance:
+ Date/time of death for any subject who died, in ISO 8601 format. Should
+ represent the date/time that is captured in the clinical-trial database.
Document: SDTMIG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0069
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format.
- Should represent the date/time that is captured in the
- clinical-trial database.
+ - Cited Guidance:
+ Date/time of death for any subject who died, in ISO 8601 format. Should
+ represent the date/time that is captured in the clinical-trial database.
Document: SDTMIG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0069
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format.
- Should represent the date/time that is captured in the
- clinical-trial database.
+ - Cited Guidance:
+ Date/time of death for any subject who died, in ISO 8601 format. Should
+ represent the date/time that is captured in the clinical-trial database.
Document: TIG 1.0
Item: Specification
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0339
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: DSDECOD
@@ -76,9 +76,8 @@ Check:
Core:
Id: CORE-000034
Status: Published
- Version: '1'
-Description: Raise an error when DSSTDTC is not equal to DM.DTHDTC and DSDECOD
- is equal to "DEATH"
+ Version: "1"
+Description: Raise an error when DSSTDTC is not equal to DM.DTHDTC and DSDECOD is equal to "DEATH"
Executability: Fully Executable
Match Datasets:
- Keys:
diff --git a/Published/CORE-000035/rule.yml b/Published/CORE-000035/rule.yml
index f241920c2..afd6c141d 100644
--- a/Published/CORE-000035/rule.yml
+++ b/Published/CORE-000035/rule.yml
@@ -7,31 +7,33 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: VISITDY is the Planned Study Day of a visit. It should not be
- populated for unplanned visits.
+ - Cited Guidance:
+ VISITDY is the Planned Study Day of a visit. It should not be populated for
+ unplanned visits.
Document: SDTMIG v3.4
- Section: '5.5'
+ Section: "5.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0658
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The planned study day of visit variable (VISITDY) should not be
- populated for unplanned visits.
+ - Cited Guidance:
+ The planned study day of visit variable (VISITDY) should not be populated
+ for unplanned visits.
Document: TIG 1.0
Item: Assumption 8
Section: 2.8.10.25
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0696
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SVPRESP
@@ -41,12 +43,12 @@ Check:
Core:
Id: CORE-000035
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when SVPRESP is null and VISITDY is not null.
Executability: Fully Executable
Outcome:
- Message: VISITDY is populated when SVPRESP is null. VISITDY is the Planned
- Study Day of a visit. It should not be populated for unplanned visits.
+ Message: VISITDY is populated when SVPRESP is null. VISITDY is the Planned Study Day of a visit.
+ It should not be populated for unplanned visits.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000036/rule.yml b/Published/CORE-000036/rule.yml
index 1bbe1d3b6..80a4efac3 100644
--- a/Published/CORE-000036/rule.yml
+++ b/Published/CORE-000036/rule.yml
@@ -10,47 +10,44 @@ Authorities:
- Cited Guidance: Value is "Y" for planned visits, null for unplanned visits.
Document: SDTMIG v3.4
Item: SVPRESP
- Section: '5.5'
- - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of
- VISITNUM for planned Visits. Any values of VISITNUM that
- appear in subject-level datasets that are not in the TV
- dataset are assumed to correspond to unplanned Visits.... If
- a subject-level dataset includes both VISITNUM and VISIT, then
- records that include values of VISITNUM that appear in the TV
- dataset should also include the corresponding values of VISIT
- from the TV dataset.
+ Section: "5.5"
+ - Cited Guidance:
+ The values of VISITNUM in the TV dataset are the valid values of VISITNUM
+ for planned Visits. Any values of VISITNUM that appear in subject-level datasets that are
+ not in the TV dataset are assumed to correspond to unplanned Visits.... If a
+ subject-level dataset includes both VISITNUM and VISIT, then records that include values
+ of VISITNUM that appear in the TV dataset should also include the corresponding values of
+ VISIT from the TV dataset.
Document: SDTMIG v3.4
Item: Assumption 6
Section: 7.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0657
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 2.8.10.25 [Specification][SVPRESP] [Value is "Y" for planned
- visits, null for unplanned visits.]|Section 10.8.33[Assumption
- 6] [The values of VISITNUM in the TV dataset are the valid
- values of VISITNUM for planned Visits. Any values of VISITNUM
- that appear in subject-level datasets that are not in the TV
- dataset are assumed to correspond to unplanned Visits. If a
- subject-level dataset includes both VISITNUM and VISIT, then
- records that include values of VISITNUM that appear in the TV
- dataset should also include the corresponding values of VISIT
- from the TV dataset.]
+ - Cited Guidance:
+ 2.8.10.25 [Specification][SVPRESP] [Value is "Y" for planned visits, null
+ for unplanned visits.]|Section 10.8.33[Assumption 6] [The values of VISITNUM in the TV
+ dataset are the valid values of VISITNUM for planned Visits. Any values of VISITNUM that
+ appear in subject-level datasets that are not in the TV dataset are assumed to correspond
+ to unplanned Visits. If a subject-level dataset includes both VISITNUM and VISIT, then
+ records that include values of VISITNUM that appear in the TV dataset should also include
+ the corresponding values of VISIT from the TV dataset.]
Document: TIG 1.0
Item: Specification
Section: 2.8.10.25|2.8.10.33
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0695
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SVPRESP
@@ -62,7 +59,7 @@ Check:
Core:
Id: CORE-000036
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when SVPRESP is "Y" and VISIT is not present in TV.VISIT.
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000037/rule.yml b/Published/CORE-000037/rule.yml
index b05b08de3..e6d4ca40d 100644
--- a/Published/CORE-000037/rule.yml
+++ b/Published/CORE-000037/rule.yml
@@ -1,5 +1,5 @@
# Variable: SVPRESP
-# Condition:
+# Condition:
# Rule: SVPRESP in ("Y", null)
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0653
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0691
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SVPRESP
@@ -40,7 +40,7 @@ Check:
Core:
Id: CORE-000037
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when SVPRESP not "Y" or null.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000038/rule.yml b/Published/CORE-000038/rule.yml
index 127f9e25b..7eac71920 100644
--- a/Published/CORE-000038/rule.yml
+++ b/Published/CORE-000038/rule.yml
@@ -7,42 +7,42 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: An indication that the visit is planned. Values should be "Y" or
- null.
+ - Cited Guidance: An indication that the visit is planned. Values should be "Y" or null.
Document: SDTM v2.0
Item: SVPRESP
Section: Subject Visits
- - Cited Guidance: An indication as to whether a prespecified (planned) visit has
- occurred.
+ - Cited Guidance: An indication as to whether a prespecified (planned) visit has occurred.
Document: SDTM v2.0
Item: SVOCCUR
Section: Subject Visits
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0654
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Subject Visits[SVPRESP][An indication that the visit is planned.
- Values should be "Y" or null.]
+ - Cited Guidance:
+ Subject Visits[SVPRESP][An indication that the visit is planned. Values
+ should be "Y" or null.]
Document: SDTM v1.0
Item: SVPRESP
Section: 3.2.3.3 Subject Visits
- - Cited Guidance: Subject Visits[SVOCCUR][An indication as to whether a
- prespecified (planned) visit has occurred.]
+ - Cited Guidance:
+ Subject Visits[SVOCCUR][An indication as to whether a prespecified (planned)
+ visit has occurred.]
Document: SDTM v1.0
Item: SVOCCUR
Section: 3.2.3.3 Subject Visits
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0692
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SVOCCUR
@@ -53,7 +53,7 @@ Check:
Core:
Id: CORE-000038
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when SVOCCUR is not null and SVPRESP is not "Y".
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000039/rule.yml b/Published/CORE-000039/rule.yml
index 474819f80..e0e632906 100644
--- a/Published/CORE-000039/rule.yml
+++ b/Published/CORE-000039/rule.yml
@@ -10,42 +10,41 @@ Authorities:
- Cited Guidance: Value is "Y" for planned visits, null for unplanned visits.
Document: SDTMIG v3.4
Item: SVPRESP
- Section: '5.5'
- - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of
- VISITNUM for planned Visits. Any values of VISITNUM that
- appear in subject-level datasets that are not in the TV
- dataset are assumed to correspond to unplanned Visits. This
- applies, in particular, to the subject-level Subject Visits
- (SV) dataset; see SV under Section 5, Models for
- Special-Purpose Domains, for additional information about
- handling unplanned Visits.
+ Section: "5.5"
+ - Cited Guidance:
+ The values of VISITNUM in the TV dataset are the valid values of VISITNUM
+ for planned Visits. Any values of VISITNUM that appear in subject-level datasets that are
+ not in the TV dataset are assumed to correspond to unplanned Visits. This applies, in
+ particular, to the subject-level Subject Visits (SV) dataset; see SV under Section 5,
+ Models for Special-Purpose Domains, for additional information about handling unplanned
+ Visits.
Document: SDTMIG v3.4
Item: Assumption 6
Section: 7.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0655
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Specification-SVPRESP Used to indicate whether the visit was
- planned (i.e., visits specified in the TV domain). Value is
- "Y" for planned visits, null for unplanned visits. Planned and
- unplanned visits with a subject, whether or not they are
- physical visits to the site, are represented in this domain.
+ - Cited Guidance:
+ Specification-SVPRESP Used to indicate whether the visit was planned (i.e.,
+ visits specified in the TV domain). Value is "Y" for planned visits, null for unplanned
+ visits. Planned and unplanned visits with a subject, whether or not they are physical
+ visits to the site, are represented in this domain.
Document: TIG 1.0
Item: Specifications
Section: 2.8.10.25
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0693
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SVPRESP
@@ -57,7 +56,7 @@ Check:
Core:
Id: CORE-000039
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when SVPRESP="Y" and VISITNUM is not in TV.VISITNUM
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000040/rule.yml b/Published/CORE-000040/rule.yml
index 6186ddc04..428367c29 100644
--- a/Published/CORE-000040/rule.yml
+++ b/Published/CORE-000040/rule.yml
@@ -10,42 +10,41 @@ Authorities:
- Cited Guidance: Value is "Y" for planned visits, null for unplanned visits.
Document: SDTMIG v3.4
Item: SVPRESP
- Section: '5.5'
- - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of
- VISITNUM for planned Visits. Any values of VISITNUM that
- appear in subject-level datasets that are not in the TV
- dataset are assumed to correspond to unplanned Visits. This
- applies, in particular, to the subject-level Subject Visits
- (SV) dataset; see SV under Section 5, Models for
- Special-Purpose Domains, for additional information about
- handling unplanned Visits.
+ Section: "5.5"
+ - Cited Guidance:
+ The values of VISITNUM in the TV dataset are the valid values of VISITNUM
+ for planned Visits. Any values of VISITNUM that appear in subject-level datasets that are
+ not in the TV dataset are assumed to correspond to unplanned Visits. This applies, in
+ particular, to the subject-level Subject Visits (SV) dataset; see SV under Section 5,
+ Models for Special-Purpose Domains, for additional information about handling unplanned
+ Visits.
Document: SDTMIG v3.4
Item: Assumption 6
Section: 7.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0656
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Specification-SVPRESP Used to indicate whether the visit was
- planned (i.e., visits specified in the TV domain). Value is
- "Y" for planned visits, null for unplanned visits. Planned and
- unplanned visits with a subject, whether or not they are
- physical visits to the site, are represented in this domain.
+ - Cited Guidance:
+ Specification-SVPRESP Used to indicate whether the visit was planned (i.e.,
+ visits specified in the TV domain). Value is "Y" for planned visits, null for unplanned
+ visits. Planned and unplanned visits with a subject, whether or not they are physical
+ visits to the site, are represented in this domain.
Document: TIG 1.0
Item: Specifications
Section: 2.8.10.25
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0694
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SVPRESP
@@ -56,7 +55,7 @@ Check:
Core:
Id: CORE-000040
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when SVPRESP is null and VISITNUM is present in TV.VISITNUM
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000041/rule.yml b/Published/CORE-000041/rule.yml
index 847540a68..029cde961 100644
--- a/Published/CORE-000041/rule.yml
+++ b/Published/CORE-000041/rule.yml
@@ -7,106 +7,103 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Some codelists used for TSVAL include terms which are also null
- flavors. For example, the Pharmaceutical Dosage Form codelist
- includes the values 'UNKNOWN' and 'NOT APPLICABLE. In such
- cases, TSVAL should have the term from the codelist and
- TSVALNF should be null.
+ - Cited Guidance:
+ Some codelists used for TSVAL include terms which are also null flavors. For
+ example, the Pharmaceutical Dosage Form codelist includes the values 'UNKNOWN' and 'NOT
+ APPLICABLE. In such cases, TSVAL should have the term from the codelist and TSVALNF should
+ be null.
Document: SDTMIG v3.4
Item: Assumption 11
Section: 7.4.2
- - Cited Guidance: While it would be possible to allow a value such as NONE or
- UNBOUNDED to be entered in TSVAL, validation programs would
- then have to recognize this special term as an exception to
- the expected data format. Therefore, it was decided that a
- separate null flavor variable that uses the ISO 21090 null
- flavor terminology would be a better solution.
+ - Cited Guidance:
+ While it would be possible to allow a value such as NONE or UNBOUNDED to be
+ entered in TSVAL, validation programs would then have to recognize this special term as
+ an exception to the expected data format. Therefore, it was decided that a separate null
+ flavor variable that uses the ISO 21090 null flavor terminology would be a better
+ solution.
Document: SDTMIG v3.4
Section: 7.4.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0649
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Some codelists used for TSVAL include terms which are also null
- flavors. For example, the Pharmaceutical Dosage Form codelist
- includes the values "UNKNOWN" and "NOT APPLICABLE". In such
- cases, TSVAL should have the term from the codelist and
- TSVALNF should be null.
+ - Cited Guidance:
+ Some codelists used for TSVAL include terms which are also null flavors. For
+ example, the Pharmaceutical Dosage Form codelist includes the values "UNKNOWN" and "NOT
+ APPLICABLE". In such cases, TSVAL should have the term from the codelist and TSVALNF
+ should be null.
Document: TIG v1.0
Item: Assumption 11
Section: 2.8.10.32
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0689
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: While it would be possible to allow a value such as NONE or
- UNBOUNDED to be entered in TSVAL, validation programs would
- then have to recognize this special term as an exception to
- the expected data format. Therefore, it was decided that a
- separate null flavor variable that uses the ISO 21090 null
- flavor terminology would be a better solution.
+ - Cited Guidance:
+ While it would be possible to allow a value such as NONE or UNBOUNDED to be
+ entered in TSVAL, validation programs would then have to recognize this special term as an
+ exception to the expected data format. Therefore, it was decided that a separate null
+ flavor variable that uses the ISO 21090 null flavor terminology would be a better
+ solution.
Document: IG v3.2
- Section: 'Section 7.4-TS: Use of Null Flavor Enumeration'
+ Section: "Section 7.4-TS: Use of Null Flavor Enumeration"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0459
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The variable TSVALNF is based on the idea of a "null flavor" as
- embodied in the ISO 21090 standard; "Health Informatics'
- Harmonized data types for information exchange." A null flavor
- is an ancillary piece of data that provides additional
- information when its primary piece of data is null (has a
- missing value). There is controlled terminology for the null
- flavor data item which includes such familiar values as
- Unknown; Other; and Not Applicable among its fourteen terms
+ - Cited Guidance:
+ The variable TSVALNF is based on the idea of a "null flavor" as embodied in
+ the ISO 21090 standard; "Health Informatics' Harmonized data types for information
+ exchange." A null flavor is an ancillary piece of data that provides additional
+ information when its primary piece of data is null (has a missing value). There is
+ controlled terminology for the null flavor data item which includes such familiar values
+ as Unknown; Other; and Not Applicable among its fourteen terms
Document: IG v3.3
Section: 7.4.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0459
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TSVAL
operator: non_empty
- name: TSVAL
operator: not_matches_regex
- value: (?i:^(NI|No information|INV|Invalid|OTH|Other|PINF|Positive
- infinity|NINF|Negative
- infinity|UNC|Unencoded|DER|Derived|UNK|Unknown|ASKU|Asked but
- unknown|NAV|Temporarily unavailable|NASK|Not
- asked|TRC|Trace|MSK|Masked|QS|Sufficient Quantity)$)
+ value: (?i:^(NI|No information|INV|Invalid|OTH|Other|PINF|Positive infinity|NINF|Negative
+ infinity|UNC|Unencoded|DER|Derived|UNK|Unknown|ASKU|Asked but unknown|NAV|Temporarily
+ unavailable|NASK|Not asked|TRC|Trace|MSK|Masked|QS|Sufficient Quantity)$)
- name: TSVALNF
operator: non_empty
Core:
Id: CORE-000041
Status: Published
- Version: '1'
-Description: Raise and error when TSVAL is not populated TSVAL is populated with
- values or synonyms of values in the ISO 21090 null flavor codelist (or other
- terms that can be represented as null flavors) but TSVALNF is completed.
+ Version: "1"
+Description: Raise and error when TSVAL is not populated TSVAL is populated with values or synonyms
+ of values in the ISO 21090 null flavor codelist (or other terms that can be represented as null
+ flavors) but TSVALNF is completed.
Executability: Fully Executable
Outcome:
- Message: TSVAL is not populated with an ISO 21090 null flavor or null flavor
- description but TSVALNF is populated.
+ Message: TSVAL is not populated with an ISO 21090 null flavor or null flavor description but
+ TSVALNF is populated.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000042/rule.yml b/Published/CORE-000042/rule.yml
index b48acd3de..3c19cc7d2 100644
--- a/Published/CORE-000042/rule.yml
+++ b/Published/CORE-000042/rule.yml
@@ -1,5 +1,5 @@
-# Variable:
-# Condition:
+# Variable:
+# Condition:
# Rule: TJ dataset not present
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0647
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -25,10 +25,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0687
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- name: TT
@@ -36,7 +36,7 @@ Check:
Core:
Id: CORE-000042
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TT dataset is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000043/rule.yml b/Published/CORE-000043/rule.yml
index 9512b9598..482efd4b6 100644
--- a/Published/CORE-000043/rule.yml
+++ b/Published/CORE-000043/rule.yml
@@ -1,5 +1,5 @@
-# Variable:
-# Condition:
+# Variable:
+# Condition:
# Rule: TP dataset not present
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0648
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -25,10 +25,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0688
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: TP
@@ -36,7 +36,7 @@ Check:
Core:
Id: CORE-000043
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when TP dataset is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000044/rule.yml b/Published/CORE-000044/rule.yml
index caf6d33e0..5f500408e 100644
--- a/Published/CORE-000044/rule.yml
+++ b/Published/CORE-000044/rule.yml
@@ -1,5 +1,5 @@
-# Variable:
-# Condition:
+# Variable:
+# Condition:
# Rule: SJ dataset not present
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0646
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -25,10 +25,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0686
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- name: SJ
@@ -36,7 +36,7 @@ Check:
Core:
Id: CORE-000044
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when SJ dataset is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000045/rule.yml b/Published/CORE-000045/rule.yml
index 71319be25..3cb012780 100644
--- a/Published/CORE-000045/rule.yml
+++ b/Published/CORE-000045/rule.yml
@@ -7,53 +7,53 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage Arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an Arm, ARMCD is
- null and ARMNRS is populated
+ - Cited Guidance:
+ With the exception of studies which use multi-stage Arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm,
+ ARMCD is null and ARMNRS is populated
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0517
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an arm or followed
- a course not described by any planned arm, ACTARMCD is null
- and ARMNRS is populated.
+ - Cited Guidance:
+ With the exception of studies which use multi-stage arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or
+ followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is
+ populated.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0517
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage Arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an Arm, ARMCD is
- null and ARMNRS is populated
+ - Cited Guidance:
+ With the exception of studies which use multi-stage Arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm,
+ ARMCD is null and ARMNRS is populated
Document: TIG 1.0
Item: Specification:ARMNRS
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0612
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ARMCD
@@ -63,7 +63,7 @@ Check:
Core:
Id: CORE-000045
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify ARMNRS is not null when ARMCD is null
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000046/rule.yml b/Published/CORE-000046/rule.yml
index 66c03538f..380a3ccc1 100644
--- a/Published/CORE-000046/rule.yml
+++ b/Published/CORE-000046/rule.yml
@@ -7,54 +7,53 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage Arm
- assignments, must be a value of ARM in the Trial Arms Dataset.
- If the subject was not assigned to an Arm, ARM is null and
- ARMNRS is populated.
+ - Cited Guidance:
+ With the exception of studies which use multi-stage Arm assignments, must be
+ a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm, ARM
+ is null and ARMNRS is populated.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0519
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an arm or followed
- a course not described by any planned arm, ACTARMCD is null
- and ARMNRS is populated.
+ - Cited Guidance:
+ With the exception of studies which use multi-stage arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or
+ followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is
+ populated.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0519
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multistage Arm
- assignments, must be a value of ARM in the Trial Arms Dataset.
- If the subject was not assigned to an Arm or followed a course
- not described by any planned arm, ARM is null and ARMNRS is
- populated.
+ - Cited Guidance:
+ With the exception of studies which use multistage Arm assignments, must be
+ a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or
+ followed a course not described by any planned arm, ARM is null and ARMNRS is populated.
Document: TIG 1.0
Item: Specification:ARMNRS
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0614
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ARM
@@ -64,7 +63,7 @@ Check:
Core:
Id: CORE-000046
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify ARMNRS is not null when ARM is null
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000047/rule.yml b/Published/CORE-000047/rule.yml
index 91e911edb..67a407882 100644
--- a/Published/CORE-000047/rule.yml
+++ b/Published/CORE-000047/rule.yml
@@ -2,89 +2,92 @@
# Condition: Study does not use multi-stage arm assignments and ACTARM ^= null
# Rule: ARM in TA.ARM
Authorities:
-- Organization: CDISC
- Standards:
- - Name: SDTMIG
- References:
- - Citations:
- - Cited Guidance: With the exception of studies which use multistage Arm assignments, must be
- a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or
- followed a course not described by any planned arm, ARM is null and ARMNRS is populated."
- Document: SDTMIG v3.4
- Item: Specification and ACTARM CDISC Notes
- Section: '5.2'
- Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0518
- Version: '1'
- Version: '2.0'
- Version: '3.4'
- - Name: SDTMIG
- References:
- - Citations:
- - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be
- a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or
- followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is
- populated.
- Document: IG v3.3
- Item: Specification
- Section: '5.2'
- Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0518
- Version: '1'
- Version: '2.0'
- Version: '3.3'
- - Name: TIG
- References:
- - Citations:
- - Cited Guidance: With the exception of studies which use multistage Arm assignments, must be
- a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or
- followed a course not described by any planned arm, ARM is null and ARMNRS is populated.
- Document: TIG 1.0
- Item: Specification:ARM
- Section: 2.8.10.4
- Origin: TIG Conformance Rules
- Rule Identifier:
- Id: TIG0613
- Version: '1'
- Version: '1.0'
- Substandard: SDTM
- Version: '1.0'
+ - Organization: CDISC
+ Standards:
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ With the exception of studies which use multistage Arm assignments, must be
+ a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or
+ followed a course not described by any planned arm, ARM is null and ARMNRS is populated."
+ Document: SDTMIG v3.4
+ Item: Specification and ACTARM CDISC Notes
+ Section: "5.2"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0518
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ With the exception of studies which use multi-stage arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or
+ followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is
+ populated.
+ Document: IG v3.3
+ Item: Specification
+ Section: "5.2"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0518
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
+ - Name: TIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ With the exception of studies which use multistage Arm assignments, must be
+ a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or
+ followed a course not described by any planned arm, ARM is null and ARMNRS is populated.
+ Document: TIG 1.0
+ Item: Specification:ARM
+ Section: 2.8.10.4
+ Origin: TIG Conformance Rules
+ Rule Identifier:
+ Id: TIG0613
+ Version: "1"
+ Version: "1.0"
+ Substandard: SDTM
+ Version: "1.0"
Check:
all:
- - name: ACTARM
- operator: non_empty
- - name: ARM
- operator: non_empty
- - name: ARM
- operator: is_not_contained_by
- value: $ta_arm
+ - name: ACTARM
+ operator: non_empty
+ - name: ARM
+ operator: non_empty
+ - name: ARM
+ operator: is_not_contained_by
+ value: $ta_arm
Core:
Id: CORE-000047
Status: Published
- Version: '1'
-Description: When study does not use multi-stage arm assignments and ARM is populated, ARM must be
- present in TA.ARM. This rule has been executed to identify all cases when ARM is not present in
- TA.ARM and therefore acknowledges that false positives may be recorded when multi-stage arm
+ Version: "1"
+Description: When study does not use multi-stage arm assignments and ARM is populated, ARM must be
+ present in TA.ARM. This rule has been executed to identify all cases when ARM is not present in
+ TA.ARM and therefore acknowledges that false positives may be recorded when multi-stage arm
assignments are in use.
Executability: Partially Executable - Possible Overreporting
Operations:
-- domain: TA
- id: $ta_arm
- name: ARM
- operator: distinct
+ - domain: TA
+ id: $ta_arm
+ name: ARM
+ operator: distinct
Outcome:
- Message: ARM value in DM dataset is not among the values of ARM variable in TA dataset. This is
- allowed only in a multistage study with incomplete ARM assignment. Please confirm if your study
+ Message: ARM value in DM dataset is not among the values of ARM variable in TA dataset. This is
+ allowed only in a multistage study with incomplete ARM assignment. Please confirm if your study
is a multistage assignment study
Rule Type: Record Data
Scope:
Classes:
Include:
- - SPECIAL PURPOSE
+ - SPECIAL PURPOSE
Domains:
Include:
- - DM
+ - DM
Use Case: INDH
Sensitivity: Record
diff --git a/Published/CORE-000048/rule.yml b/Published/CORE-000048/rule.yml
index 520c0da96..284078c98 100644
--- a/Published/CORE-000048/rule.yml
+++ b/Published/CORE-000048/rule.yml
@@ -1,5 +1,5 @@
# Variable: --METHOD
-# Condition:
+# Condition:
# Rule: --METHOD not present in dataset
Authorities:
- Organization: CDISC
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0621
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -27,10 +27,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0662
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --METHOD
@@ -38,7 +38,7 @@ Check:
Core:
Id: CORE-000048
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --METHOD is present in an Interventions dataset.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000049/rule.yml b/Published/CORE-000049/rule.yml
index fd7cee701..587792c0b 100644
--- a/Published/CORE-000049/rule.yml
+++ b/Published/CORE-000049/rule.yml
@@ -1,5 +1,5 @@
# Variable: --USCHFL
-# Condition:
+# Condition:
# Rule: --USCHFL not present in dataset
Authorities:
- Organization: CDISC
@@ -7,22 +7,21 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The following SDTM variables, defined for use in non-clinical
- studies (SEND), must NEVER be used in the submission of
- SDTM-based data for human clinical trials, --USCHFL
- (Interventions, Events, Findings), --DTHREL (Findings),
- --EXCLFL (Findings), --REASEX (Findings), --IMPLBL (Findings),
- FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY
- (Timing Variables), --NOMLBL (Timing Variables)
+ - Cited Guidance:
+ The following SDTM variables, defined for use in non-clinical studies
+ (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials,
+ --USCHFL (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings),
+ --REASEX (Findings), --IMPLBL (Findings), FETUSID (Identifiers), --DETECT (Timing
+ Variables), --NOMDY (Timing Variables), --NOMLBL (Timing Variables)
Document: IG v3.4
Item: SDTM Variables Not Allowed in SDTMIG
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0507
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -33,46 +32,45 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0622
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical
- studies (SEND); must NEVER be used in the submission of
- SDTM-based data for human clinical trials: --USCHFL
- (Interventions, Events, Findings), --DTHREL (Findings),
- --EXCLFL (Findings), --REASEX (Findings), --IMPLBL (Findings),
- --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY
- (Timing Variables), --NOMLBL (Timing Variables)'
+ - Cited Guidance:
+ "The following SDTM variables; defined for use in non-clinical studies (SEND);
+ must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL
+ (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings),
+ --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables),
+ --NOMLBL (Timing Variables)"
Document: IG v3.3
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0507
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Not in human clinical trials. Select variables for the domain
- from the SDTM. Selection of variables must align with SDTM
- Usage Restrictions.
+ - Cited Guidance:
+ Not in human clinical trials. Select variables for the domain from the SDTM.
+ Selection of variables must align with SDTM Usage Restrictions.
Document: SDTM v2.1|TIG v1.0
Item: Specification|--USCHFL
- Section: Section 3.1.1 - The Interventions Observations Class | Section 3.1.2 -
- The Events Observations Class | Section 3.1.1 - The Findings
- Observations Class | 2.8.2 How Extend Domains | 2.8.3 How to
- Create New Specifications
+ Section:
+ Section 3.1.1 - The Interventions Observations Class | Section 3.1.2 - The Events
+ Observations Class | Section 3.1.1 - The Findings Observations Class | 2.8.2 How Extend
+ Domains | 2.8.3 How to Create New Specifications
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0602
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
@@ -83,10 +81,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0663
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --USCHFL
@@ -94,7 +92,7 @@ Check:
Core:
Id: CORE-000049
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --USCHFL is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000050/rule.yml b/Published/CORE-000050/rule.yml
index 5cf9a138b..addc5f422 100644
--- a/Published/CORE-000050/rule.yml
+++ b/Published/CORE-000050/rule.yml
@@ -1,5 +1,5 @@
# Variable: --RSTIND
-# Condition:
+# Condition:
# Rule: --RSTIND not present in dataset
Authorities:
- Organization: CDISC
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0623
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -27,10 +27,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0664
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --RSTIND
@@ -38,7 +38,7 @@ Check:
Core:
Id: CORE-000050
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --RSTIND is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000051/rule.yml b/Published/CORE-000051/rule.yml
index ababf00d4..8b7bd1030 100644
--- a/Published/CORE-000051/rule.yml
+++ b/Published/CORE-000051/rule.yml
@@ -1,5 +1,5 @@
# Variable: --RSTMOD
-# Condition:
+# Condition:
# Rule: --RSTMOD not present in dataset
Authorities:
- Organization: CDISC
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0624
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -27,10 +27,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0665
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --RSTMOD
@@ -38,7 +38,7 @@ Check:
Core:
Id: CORE-000051
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --RSTMOD is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000052/rule.yml b/Published/CORE-000052/rule.yml
index 0f317dae5..53f98b0b2 100644
--- a/Published/CORE-000052/rule.yml
+++ b/Published/CORE-000052/rule.yml
@@ -1,5 +1,5 @@
# Variable: --IMPBL
-# Condition:
+# Condition:
# Rule: --IMPBL not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0625
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0666
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --IMPLBL
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000052
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --IMPLBL is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000054/rule.yml b/Published/CORE-000054/rule.yml
index 7e38177ac..7cc5a5dd7 100644
--- a/Published/CORE-000054/rule.yml
+++ b/Published/CORE-000054/rule.yml
@@ -1,5 +1,5 @@
# Variable: --DTHREL
-# Condition:
+# Condition:
# Rule: --DTHREL not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0627
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0668
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --DTHREL
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000054
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --DTHREL is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000055/rule.yml b/Published/CORE-000055/rule.yml
index d7b2c2174..00a77384d 100644
--- a/Published/CORE-000055/rule.yml
+++ b/Published/CORE-000055/rule.yml
@@ -1,5 +1,5 @@
# Variable: --EXCLFL
-# Condition:
+# Condition:
# Rule: --EXCLFL not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0628
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0669
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --EXCLFL
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000055
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --EXCLFL is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000056/rule.yml b/Published/CORE-000056/rule.yml
index 8ecd10e2c..9494c0a70 100644
--- a/Published/CORE-000056/rule.yml
+++ b/Published/CORE-000056/rule.yml
@@ -1,5 +1,5 @@
# Variable: --REASEX
-# Condition:
+# Condition:
# Rule: --REASEX not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0629
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0670
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --REASEX
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000056
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --REASEX is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000057/rule.yml b/Published/CORE-000057/rule.yml
index 505b839f8..c9e73e13d 100644
--- a/Published/CORE-000057/rule.yml
+++ b/Published/CORE-000057/rule.yml
@@ -1,5 +1,5 @@
# Variable: FETUSID
-# Condition:
+# Condition:
# Rule: FETUSID not present in dataset
Authorities:
- Organization: CDISC
@@ -13,63 +13,62 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0509
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The following SDTM variables, defined for use in non-clinical
- studies (SEND), must NEVER be used in the submission of
- SDTM-based data for human clinical trials --USCHFL
- (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL
- (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID
- (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing
- Variables) --NOMLBL (Timing Variables)
+ - Cited Guidance:
+ The following SDTM variables, defined for use in non-clinical studies
+ (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials
+ --USCHFL (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL (Findings)
+ --REASEX (Findings) --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables)
+ --NOMDY (Timing Variables) --NOMLBL (Timing Variables)
Document: IG v3.4
Item: SDTM Variables Not Allowed in SDTMIG
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0630
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical
- studies (SEND); must NEVER be used in the submission of
- SDTM-based data for human clinical trials: --USCHFL
- (Interventions, Events, Findings), --DTHREL (Findings),
- --EXCLFL (Findings), --REASEX (Findings), --IMPLBL (Findings),
- --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY
- (Timing Variables), --NOMLBL (Timing Variables)'
+ - Cited Guidance:
+ "The following SDTM variables; defined for use in non-clinical studies (SEND);
+ must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL
+ (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings),
+ --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables),
+ --NOMLBL (Timing Variables)"
Document: IG v3.3
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0509
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Not in human clinical trials. Select variables for the domain
- from the SDTM. Selection of variables must align with SDTM
- Usage Restrictions.
+ - Cited Guidance:
+ Not in human clinical trials. Select variables for the domain from the SDTM.
+ Selection of variables must align with SDTM Usage Restrictions.
Document: SDTM v2.1|TIG v1.0
Item: Specification|--FETUSID
- Section: Section 3.1.4 - Identifiers for All Classes | 2.8.2 How Extend Domains
- |2.8.3 How to Create New Specifications
+ Section:
+ Section 3.1.4 - Identifiers for All Classes | 2.8.2 How Extend Domains |2.8.3 How
+ to Create New Specifications
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0604
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
@@ -80,10 +79,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0671
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: FETUSID
@@ -91,7 +90,7 @@ Check:
Core:
Id: CORE-000057
Status: Published
- Version: '1'
+ Version: "1"
Description: FETUSID must not be present in SDTM domains.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000058/rule.yml b/Published/CORE-000058/rule.yml
index b91cebb0c..cac905751 100644
--- a/Published/CORE-000058/rule.yml
+++ b/Published/CORE-000058/rule.yml
@@ -1,5 +1,5 @@
# Variable: RPHASE
-# Condition:
+# Condition:
# Rule: RPHASE not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0631
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0672
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: RPHASE
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000058
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when RPHASE is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000059/rule.yml b/Published/CORE-000059/rule.yml
index 00a0ee9a1..1e8b5f8a5 100644
--- a/Published/CORE-000059/rule.yml
+++ b/Published/CORE-000059/rule.yml
@@ -1,5 +1,5 @@
# Variable: RPPLDY
-# Condition:
+# Condition:
# Rule: RPPLDY not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0632
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0673
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: RPPLDY
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000059
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when RPPLDY is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000060/rule.yml b/Published/CORE-000060/rule.yml
index 5af07411f..2c0a461c1 100644
--- a/Published/CORE-000060/rule.yml
+++ b/Published/CORE-000060/rule.yml
@@ -1,5 +1,5 @@
# Variable: RPPLSTDY
-# Condition:
+# Condition:
# Rule: RPPLSTDY not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0633
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0674
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: RPPLSTDY
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000060
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when RPPLSTDY is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000061/rule.yml b/Published/CORE-000061/rule.yml
index d92a95f2f..b2a822d69 100644
--- a/Published/CORE-000061/rule.yml
+++ b/Published/CORE-000061/rule.yml
@@ -1,5 +1,5 @@
# Variable: RPLENDY
-# Condition:
+# Condition:
# Rule: RPLENDY not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0634
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0675
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: RPPLENDY
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000061
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when RPPLENDY is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000064/rule.yml b/Published/CORE-000064/rule.yml
index 42e077510..c09e5fb55 100644
--- a/Published/CORE-000064/rule.yml
+++ b/Published/CORE-000064/rule.yml
@@ -1,5 +1,5 @@
# Variable: --RPDY
-# Condition:
+# Condition:
# Rule: --NOMLBL not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0637
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0678
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --RPDY
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000064
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --RPDY is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000065/rule.yml b/Published/CORE-000065/rule.yml
index 50876da13..fa7975cd5 100644
--- a/Published/CORE-000065/rule.yml
+++ b/Published/CORE-000065/rule.yml
@@ -1,5 +1,5 @@
# Variable: --RPSTDY
-# Condition:
+# Condition:
# Rule: --RPSTDY not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0638
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0679
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --RPSTDY
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000065
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --RPSTDY is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000066/rule.yml b/Published/CORE-000066/rule.yml
index c0d80dd28..80023fddc 100644
--- a/Published/CORE-000066/rule.yml
+++ b/Published/CORE-000066/rule.yml
@@ -1,5 +1,5 @@
# Variable: --RPENDY
-# Condition:
+# Condition:
# Rule: --RPENDY not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0639
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0680
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --RPENDY
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000066
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --RPENDY is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000067/rule.yml b/Published/CORE-000067/rule.yml
index 08a84c001..c99dd83f7 100644
--- a/Published/CORE-000067/rule.yml
+++ b/Published/CORE-000067/rule.yml
@@ -1,5 +1,5 @@
# Variable: --DETECT
-# Condition:
+# Condition:
# Rule: --DETECT not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0640
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0681
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --DETECT
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000067
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --DETECT is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000068/rule.yml b/Published/CORE-000068/rule.yml
index 5e952d962..0273ee1a7 100644
--- a/Published/CORE-000068/rule.yml
+++ b/Published/CORE-000068/rule.yml
@@ -1,5 +1,5 @@
# Variable: AGETXT
-# Condition:
+# Condition:
# Rule: AGETXT not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0641
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0682
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AGETXT
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000068
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AGETXT is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000069/rule.yml b/Published/CORE-000069/rule.yml
index f73a3818e..ce9176462 100644
--- a/Published/CORE-000069/rule.yml
+++ b/Published/CORE-000069/rule.yml
@@ -1,5 +1,5 @@
# Variable: SPECIES
-# Condition:
+# Condition:
# Rule: SPECIES not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0642
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0683
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SPECIES
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000069
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when SPECIES is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000070/rule.yml b/Published/CORE-000070/rule.yml
index 0a9dace03..785f53b69 100644
--- a/Published/CORE-000070/rule.yml
+++ b/Published/CORE-000070/rule.yml
@@ -1,5 +1,5 @@
# Variable: STRAIN
-# Condition:
+# Condition:
# Rule: STRAIN not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0643
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0684
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: STRAIN
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000070
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when STRAIN is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000071/rule.yml b/Published/CORE-000071/rule.yml
index baca3ce86..dae7c62be 100644
--- a/Published/CORE-000071/rule.yml
+++ b/Published/CORE-000071/rule.yml
@@ -1,5 +1,5 @@
# Variable: SBSTRAIN
-# Condition:
+# Condition:
# Rule: SBSTRAIN not present in dataset
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0644
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -26,10 +26,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0685
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SBSTRAIN
@@ -37,7 +37,7 @@ Check:
Core:
Id: CORE-000071
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when SBSTRAIN is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000074/rule.yml b/Published/CORE-000074/rule.yml
index eb901189c..87c5dc167 100644
--- a/Published/CORE-000074/rule.yml
+++ b/Published/CORE-000074/rule.yml
@@ -1,5 +1,5 @@
# Variable: --IMPLBL
-# Condition:
+# Condition:
# Rule: --IMPLBL not present in dataset
Authorities:
- Organization: CDISC
@@ -7,57 +7,56 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The following SDTM variables, defined for use in non-clinical
- studies (SEND), must NEVER be used in the submission of
- SDTM-based data for human clinical trials, --USCHFL
- (Interventions, Events, Findings), --DTHREL (Findings),
- --EXCLFL (Findings), --REASEX (Findings), --IMPLBL (Findings),
- FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY
- (Timing Variables), --NOMLBL (Timing Variables)
+ - Cited Guidance:
+ The following SDTM variables, defined for use in non-clinical studies
+ (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials,
+ --USCHFL (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings),
+ --REASEX (Findings), --IMPLBL (Findings), FETUSID (Identifiers), --DETECT (Timing
+ Variables), --NOMDY (Timing Variables), --NOMLBL (Timing Variables)
Document: IG v3.4
Item: SDTM Variables Not Allowed in SDTMIG
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0508
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical
- studies (SEND); must NEVER be used in the submission of
- SDTM-based data for human clinical trials: --USCHFL
- (Interventions, Events, Findings), --DTHREL (Findings),
- --EXCLFL (Findings), --REASEX (Findings), --IMPLBL (Findings),
- --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY
- (Timing Variables), --NOMLBL (Timing Variables)'
+ - Cited Guidance:
+ "The following SDTM variables; defined for use in non-clinical studies (SEND);
+ must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL
+ (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings),
+ --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables),
+ --NOMLBL (Timing Variables)"
Document: IG v3.3
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0508
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Not in human clinical trials. Select variables for the domain
- from the SDTM. Selection of variables must align with SDTM
- Usage Restrictions.
+ - Cited Guidance:
+ Not in human clinical trials. Select variables for the domain from the SDTM.
+ Selection of variables must align with SDTM Usage Restrictions.
Document: SDTM v2.1|TIG v1.0
Item: Specification|--IMPLBL
- Section: Section 3.1.1 - The Findings Observations Class | 2.8.2 How Extend
- Domains |2.8.3 How to Create New Specifications
+ Section:
+ Section 3.1.1 - The Findings Observations Class | 2.8.2 How Extend Domains |2.8.3
+ How to Create New Specifications
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0603
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --IMPLBL
@@ -65,7 +64,7 @@ Check:
Core:
Id: CORE-000074
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --IMPLBL is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000075/rule.yml b/Published/CORE-000075/rule.yml
index ecfd4663c..d43f0e48a 100644
--- a/Published/CORE-000075/rule.yml
+++ b/Published/CORE-000075/rule.yml
@@ -1,5 +1,5 @@
# Variable: AEREASND
-# Condition:
+# Condition:
# Rule: AEREASND not present in dataset
Authorities:
- Organization: CDISC
@@ -7,71 +7,67 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The following Qualifiers would not be used in AE, --OCCUR,
- --STAT, and--REASND. They are the only Qualifiers from the
- SDTM Events Class not in the AE domain. They are not permitted
- because the AE domain contains only records for adverse events
- that actually occurred.
+ - Cited Guidance: The following Qualifiers would not be used in AE, --OCCUR, --STAT,
+ and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain.
+ They are not permitted because the AE domain contains only records for adverse events that
+ actually occurred.
Document: IG v3.4
Section: 6.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0304
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following Qualifiers would not be used in AE: --OCCUR,
- --STAT, and--REASND. They are the only Qualifiers from the
- SDTM Events Class not in the AE domain. They are not permitted
- because the AE domain contains only records for adverse events
- that actually occurred.'
+ - Cited Guidance:
+ "The following Qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND.
+ They are the only Qualifiers from the SDTM Events Class not in the AE domain. They are not permitted
+ because the AE domain contains only records for adverse events that actually occurred."
Document: IG v3.2
Item: Assumption 8
- Section: '6.2'
+ Section: "6.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0304
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following Qualifiers would not be used in AE: --OCCUR,
- --STAT, and--REASND. They are the only Qualifiers from the
- SDTM Events Class not in the AE domain. They are not permitted
- because the AE domain contains only records for adverse events
- that actually occurred.'
+ - Cited Guidance:
+ "The following Qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND.
+ They are the only Qualifiers from the SDTM Events Class not in the AE domain. They are not permitted
+ because the AE domain contains only records for adverse events that actually occurred."
Document: IG v3.3
Item: Assumption 9
Section: 6.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0304
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The following qualifiers would not be used in AE; --OCCUR,
- --STAT, and--REASND. They are the only qualifiers from the
- SDTM Events class not in the AE domain. They are not permitted
- because the AE domain contains only records for adverse events
- that actually occurred
+ - Cited Guidance: The following qualifiers would not be used in AE; --OCCUR, --STAT,
+ and--REASND. They are the only qualifiers from the SDTM Events class not in the AE domain.
+ They are not permitted because the AE domain contains only records for adverse events that
+ actually occurred
Document: TIG 1.0
Item: Assumption 10
Section: 2.8.10.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0481
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AEREASND
@@ -79,7 +75,7 @@ Check:
Core:
Id: CORE-000075
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AEREASND is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000080/rule.yml b/Published/CORE-000080/rule.yml
index 15343f6ad..83a692e1d 100644
--- a/Published/CORE-000080/rule.yml
+++ b/Published/CORE-000080/rule.yml
@@ -7,66 +7,66 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The description of a time point that acts as a fixed reference
- for a series of planned time points, used for study data
- tabulation. Description of the fixed reference point referred
- to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT.
+ - Cited Guidance:
+ The description of a time point that acts as a fixed reference for a series
+ of planned time points, used for study data tabulation. Description of the fixed reference
+ point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT.
Document: Model v2.0
Item: --TPTREF
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0093
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '(--TPTREF) Description of the fixed reference point referred to
- by --ELTM, --TPTNUM, and --TPT. Examples: PREVIOUS DOSE,
- PREVIOUS MEAL.'
+ - Cited Guidance:
+ "(--TPTREF) Description of the fixed reference point referred to by --ELTM, --TPTNUM,
+ and --TPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL."
Document: Model v1.4
Item: Specification
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0093
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Description of the fixed reference point referred to by --ELTM,
- --TPTNUM, --TPT, --STINT, and --ENINT. Examples: "PREVIOUS
- DOSE", "PREVIOUS MEAL".'
+ - Cited Guidance:
+ 'Description of the fixed reference point referred to by --ELTM, --TPTNUM, --TPT,
+ --STINT, and --ENINT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".'
Document: Model v1.7
- Item: 'Table 2.2.5.1: --TPTREF'
+ Item: "Table 2.2.5.1: --TPTREF"
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0093
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The description of a time point that acts as a fixed reference
- for a series of planned time points, used for study data
- tabulation. Description of the fixed reference point referred
- to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT.
+ - Cited Guidance:
+ The description of a time point that acts as a fixed reference for a series
+ of planned time points, used for study data tabulation. Description of the fixed reference
+ point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT.
Document: SDTM v2.1
Item: --TPTREF
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0358
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --ELTM
@@ -80,9 +80,9 @@ Check:
Core:
Id: CORE-000080
Status: Published
- Version: '1'
-Description: Raise an error when --ELTM, --TPTNUM, and --TPT are not present in
- dataset, but --TPTREF is present.
+ Version: "1"
+Description: Raise an error when --ELTM, --TPTNUM, and --TPT are not present in dataset, but
+ --TPTREF is present.
Executability: Fully Executable
Outcome:
Message: --TPTREF is present when --ELTM, --TPTNUM, and --TPT are not present.
diff --git a/Published/CORE-000081/rule.yml b/Published/CORE-000081/rule.yml
index 2226fa03e..0904b5d4d 100644
--- a/Published/CORE-000081/rule.yml
+++ b/Published/CORE-000081/rule.yml
@@ -7,167 +7,157 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: --PRESP, an indication that the event was prospectively stated
- or detailed on the CRF. --STAT, used to indicate when a
- question about the occurrence of a prespecified event was not
- answered.
+ - Cited Guidance:
+ --PRESP, an indication that the event was prospectively stated or detailed
+ on the CRF. --STAT, used to indicate when a question about the occurrence of a
+ prespecified event was not answered.
Document: SDTM v2.0
Section: Events
- - Cited Guidance: --PRESP, an indication that the intervention was prospectively
- stated or detailed on the CRF. --STAT, used to indicate when
- a question about the occurrence of a prespecified intervention
- was not answered.
+ - Cited Guidance:
+ --PRESP, an indication that the intervention was prospectively stated or
+ detailed on the CRF. --STAT, used to indicate when a question about the occurrence of a
+ prespecified intervention was not answered.
Document: SDTM v2.0
Section: Interventions
- - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.]|
+ - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific
+ intervention is pre-specified on a CRF. Values should be "Y" or null.]|
Document: SDTM v1.7
Section: Model v1.7[2.2.1 (Interventions )]
- - Cited Guidance: Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the
- event describe by --TERM was pre-specified on a CRF. Value is
- Y for pre-specified events, null for spontaneously reported
- events. --STAT Used to indicate when a question about the
- occurrence of a pre-specified event was not answered. Should
- be null or hav a value of NOT DONE]
+ - Cited Guidance:
+ Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the event
+ describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null
+ for spontaneously reported events. --STAT Used to indicate when a question about the
+ occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT
+ DONE]
Document: SDTM v1.7
Section: Model v1.7[2.2.2 (Events)]
- - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.]
+ - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific
+ intervention is pre-specified on a CRF. Values should be "Y" or null.]
Document: SDTM v1.4
Section: Model v1.4[2.2.1 (Interventions)
- - Cited Guidance: Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the
- event describe by --TERM was pre-specified on a CRF. Value is
- Y for pre-specified events, null for spontaneously reported
- events. --STAT Used to indicate when a question about the
- occurrence of a pre-specified event was not answered. Should
- be null or hav a value of NOT DONE]
+ - Cited Guidance:
+ Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the event
+ describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null
+ for spontaneously reported events. --STAT Used to indicate when a question about the
+ occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT
+ DONE]
Document: SDTM v1.4
Section: Model v1.4[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0056
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: --PRESP, an indication that the event was prospectively stated
- or detailed on the CRF. --STAT, used to indicate when a
- question about the occurrence of a prespecified event was not
- answered.
+ - Cited Guidance:
+ --PRESP, an indication that the event was prospectively stated or detailed
+ on the CRF. --STAT, used to indicate when a question about the occurrence of a
+ prespecified event was not answered.
Document: SDTM v2.0
Section: Events
- - Cited Guidance: --PRESP, an indication that the intervention was prospectively
- stated or detailed on the CRF. --STAT, used to indicate when
- a question about the occurrence of a prespecified intervention
- was not answered.
+ - Cited Guidance:
+ --PRESP, an indication that the intervention was prospectively stated or
+ detailed on the CRF. --STAT, used to indicate when a question about the occurrence of a
+ prespecified intervention was not answered.
Document: SDTM v2.0
Section: Interventions
- - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.]|
+ - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific
+ intervention is pre-specified on a CRF. Values should be "Y" or null.]|
Document: SDTM v1.7
Section: Model v1.7[2.2.1 (Interventions )]
- - Cited Guidance: Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the
- event describe by --TERM was pre-specified on a CRF. Value is
- Y for pre-specified events, null for spontaneously reported
- events. --STAT Used to indicate when a question about the
- occurrence of a pre-specified event was not answered. Should
- be null or hav a value of NOT DONE]
+ - Cited Guidance:
+ Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the event
+ describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null
+ for spontaneously reported events. --STAT Used to indicate when a question about the
+ occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT
+ DONE]
Document: SDTM v1.7
Section: Model v1.7[2.2.2 (Events)]
- - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.]
+ - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific
+ intervention is pre-specified on a CRF. Values should be "Y" or null.]
Document: SDTM v1.4
Section: Model v1.4[2.2.1 (Interventions)
- - Cited Guidance: Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the
- event describe by --TERM was pre-specified on a CRF. Value is
- Y for pre-specified events, null for spontaneously reported
- events. --STAT Used to indicate when a question about the
- occurrence of a pre-specified event was not answered. Should
- be null or hav a value of NOT DONE]
+ - Cited Guidance:
+ Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the event
+ describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null
+ for spontaneously reported events. --STAT Used to indicate when a question about the
+ occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT
+ DONE]
Document: SDTM v1.4
Section: Model v1.4[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0056
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: --PRESP, an indication that the event was prospectively stated
- or detailed on the CRF. --STAT, used to indicate when a
- question about the occurrence of a prespecified event was not
- answered.
+ - Cited Guidance:
+ --PRESP, an indication that the event was prospectively stated or detailed
+ on the CRF. --STAT, used to indicate when a question about the occurrence of a
+ prespecified event was not answered.
Document: SDTM v2.0
Section: Events
- - Cited Guidance: --PRESP, an indication that the intervention was prospectively
- stated or detailed on the CRF. --STAT, used to indicate when
- a question about the occurrence of a prespecified intervention
- was not answered.
+ - Cited Guidance:
+ --PRESP, an indication that the intervention was prospectively stated or
+ detailed on the CRF. --STAT, used to indicate when a question about the occurrence of a
+ prespecified intervention was not answered.
Document: SDTM v2.0
Section: Interventions
- - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.]|
+ - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific
+ intervention is pre-specified on a CRF. Values should be "Y" or null.]|
Document: SDTM v1.7
Section: Model v1.7[2.2.1 (Interventions )]
- - Cited Guidance: Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the
- event describe by --TERM was pre-specified on a CRF. Value is
- Y for pre-specified events, null for spontaneously reported
- events. --STAT Used to indicate when a question about the
- occurrence of a pre-specified event was not answered. Should
- be null or hav a value of NOT DONE]
+ - Cited Guidance:
+ Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the event
+ describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null
+ for spontaneously reported events. --STAT Used to indicate when a question about the
+ occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT
+ DONE]
Document: SDTM v1.7
Section: Model v1.7[2.2.2 (Events)]
- - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.]
+ - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific
+ intervention is pre-specified on a CRF. Values should be "Y" or null.]
Document: SDTM v1.4
Section: Model v1.4[2.2.1 (Interventions)
- - Cited Guidance: Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the
- event describe by --TERM was pre-specified on a CRF. Value is
- Y for pre-specified events, null for spontaneously reported
- events. --STAT Used to indicate when a question about the
- occurrence of a pre-specified event was not answered. Should
- be null or hav a value of NOT DONE]
+ - Cited Guidance:
+ Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the event
+ describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null
+ for spontaneously reported events. --STAT Used to indicate when a question about the
+ occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT
+ DONE]
Document: SDTM v1.4
Section: Model v1.4[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0056
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 'Events[--PRESP][An indication that the event was prospectively
- stated or detailed on the CRF.]|Events[--STAT][Used to
- indicate when a question about the occurrence of a
- prespecified event was not
- answered.]|Interventions[--PRESP][An indication that the
- intervention was prospectively stated or detailed on the
- CRF.]|Interventions[--STAT][Used to indicate when a question
- about the occurrence of a prespecified intervention was not
- answered.]'
+ - Cited Guidance:
+ "Events[--PRESP][An indication that the event was prospectively stated or detailed
+ on the CRF.]|Events[--STAT][Used to indicate when a question about the occurrence of a prespecified
+ event was not answered.]|Interventions[--PRESP][An indication that the intervention was prospectively
+ stated or detailed on the CRF.]|Interventions[--STAT][Used to indicate when a question about
+ the occurrence of a prespecified intervention was not answered.]"
Document: SDTM v2.1
Item: --PRESP|--STAT
- Section: 3.1.1The Interventions Observation Class|3.1.2 The Events Observation
- Class
+ Section: 3.1.1The Interventions Observation Class|3.1.2 The Events Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0330
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --PRESP
@@ -177,7 +167,7 @@ Check:
Core:
Id: CORE-000081
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --PRESP is not present but --STAT is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000083/rule.yml b/Published/CORE-000083/rule.yml
index d208c1b32..793649c66 100644
--- a/Published/CORE-000083/rule.yml
+++ b/Published/CORE-000083/rule.yml
@@ -7,48 +7,49 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Operationally derived indicator used to identify the last
- non-missing value prior to RFXSTDTC. Result value is in
- --STRESC. Should be "Y" or null.
+ - Cited Guidance:
+ Operationally derived indicator used to identify the last non-missing value
+ prior to RFXSTDTC. Result value is in --STRESC. Should be "Y" or null.
Document: Model v2.0
Item: --LOBXFL
Section: The Findings Observation Class
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0553
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Operationally-derived indicator used to identify the last
- non-missing value prior to RFXSTDTC. Should be "Y" or null.
+ - Cited Guidance:
+ Operationally-derived indicator used to identify the last non-missing value
+ prior to RFXSTDTC. Should be "Y" or null.
Document: Model v1.7
Item: --LOBXFL
Section: Table 2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0553
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Operationally derived indicator used to identify the last
- non-missing value prior to RFXSTDTC. Result value is in
- --STRESC. Should be "Y" or null.
+ - Cited Guidance:
+ Operationally derived indicator used to identify the last non-missing value
+ prior to RFXSTDTC. Result value is in --STRESC. Should be "Y" or null.
Document: SDTM v2.1
Item: --LOBXFL
Section: 3.1.3 The Findings Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0641
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --ORRES
@@ -65,13 +66,13 @@ Check:
Core:
Id: CORE-000083
Status: Published
- Version: '1'
-Description: Verify that --ORRES is not null when --LOBXFL = Y and --DRVFL= null
- or --DRVFL is not present in the dataset
+ Version: "1"
+Description: Verify that --ORRES is not null when --LOBXFL = Y and --DRVFL= null or --DRVFL is not
+ present in the dataset
Executability: Fully Executable
Outcome:
- Message: --ORRES is missing even though --LOBXFL= "Y" and either --DRVFL is not
- present in dataset or is not equal to "Y"
+ Message: --ORRES is missing even though --LOBXFL= "Y" and either --DRVFL is not present in dataset
+ or is not equal to "Y"
Output Variables:
- --ORRES
- --LOBXFL
diff --git a/Published/CORE-000084/rule.yml b/Published/CORE-000084/rule.yml
index 9424602f6..fcfe64f68 100644
--- a/Published/CORE-000084/rule.yml
+++ b/Published/CORE-000084/rule.yml
@@ -7,64 +7,63 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The characterization of the end of an observation relative to a
- reference time point. The sponsor-defined reference time point
- is in --ENTPT.
+ - Cited Guidance:
+ The characterization of the end of an observation relative to a reference
+ time point. The sponsor-defined reference time point is in --ENTPT.
Document: Model v2.0
Item: --ENRTPT
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0057
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the end of the observation as being before or after
- the sponsor-defined reference time point defined by variable
- --ENTPT.
+ - Cited Guidance: Identifies the end of the observation as being before or after the
+ sponsor-defined reference time point defined by variable --ENTPT.
Document: Model v1.7
Item: Table 2.2.5.1 --ENRTPT
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0057
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: (--ENRTPT) Identifies the end of the observation as being before
- or after the sponsor-defined reference time point defined by
- variable --ENTPT.
+ - Cited Guidance:
+ (--ENRTPT) Identifies the end of the observation as being before or after
+ the sponsor-defined reference time point defined by variable --ENTPT.
Document: Model v1.4
Item: Specification
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0057
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The characterization of the end of an observation relative to a
- reference time point. The sponsor-defined reference time point
- is in --ENTPT.
+ - Cited Guidance:
+ The characterization of the end of an observation relative to a reference
+ time point. The sponsor-defined reference time point is in --ENTPT.
Document: SDTM v2.1
Item: --ENRTPT
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0331
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --ENTPT
@@ -74,7 +73,7 @@ Check:
Core:
Id: CORE-000084
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --ENTPT exists in a dataset and --ENRTPT does not exist.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000085/rule.yml b/Published/CORE-000085/rule.yml
index 44c102060..141cdadf1 100644
--- a/Published/CORE-000085/rule.yml
+++ b/Published/CORE-000085/rule.yml
@@ -7,64 +7,63 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The characterization of the start of an observation relative to
- a reference time point. The sponsor-defined reference time
- point is in --STTPT.
+ - Cited Guidance:
+ The characterization of the start of an observation relative to a reference
+ time point. The sponsor-defined reference time point is in --STTPT.
Document: Model v2.0
Item: --STRTPT
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0059
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the start of the observation as being before or after
- the sponsor-defined reference time point defined by variable
- --STTPT.
+ - Cited Guidance: Identifies the start of the observation as being before or after the
+ sponsor-defined reference time point defined by variable --STTPT.
Document: Model v1.7
Item: Table 2.2.5.1, --STRTPT
Section: 2.2.5. Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0059
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: (--STRTPT) Identifies the start of the observation as being
- before or after the sponsor-defined reference time point
- defined by variable --STTPT.
+ - Cited Guidance:
+ (--STRTPT) Identifies the start of the observation as being before or after
+ the sponsor-defined reference time point defined by variable --STTPT.
Document: Model v1.4
Item: Specification
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0059
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The characterization of the start of an observation relative to
- a reference time point. The sponsor-defined reference time
- point is in --STTPT.
+ - Cited Guidance:
+ The characterization of the start of an observation relative to a reference
+ time point. The sponsor-defined reference time point is in --STTPT.
Document: SDTM v2.1
Item: --STRTPT
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0333
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --STTPT
@@ -74,7 +73,7 @@ Check:
Core:
Id: CORE-000085
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --STTPT is completed and --STRTPT is empty
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000086/rule.yml b/Published/CORE-000086/rule.yml
index d47e14294..ee7a6d900 100644
--- a/Published/CORE-000086/rule.yml
+++ b/Published/CORE-000086/rule.yml
@@ -1,5 +1,5 @@
# Variable: DVSTDTC
-# Condition:
+# Condition:
# Rule: DVSTDTC >= DM.RFICDTC
Authorities:
- Organization: CDISC
@@ -7,76 +7,75 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The intent of the domain model is to capture protocol deviations
- that occurred during the course of the study (see ICH E3
- Section 10.2 at
+ - Cited Guidance:
+ The intent of the domain model is to capture protocol deviations that
+ occurred during the course of the study (see ICH E3 Section 10.2 at
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf).
- Usually these are deviations that occur after the subject has
- been randomized or received the first treatment.
+ Usually these are deviations that occur after the subject has been randomized or received
+ the first treatment.
Document: IG v3.4
Item: Assumption 1
Section: 6.2.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0075
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The intent of the domain model is to capture protocol deviations
- that occurred during the course of the study (see ICH E3
- Section 10.2 at
+ - Cited Guidance:
+ The intent of the domain model is to capture protocol deviations that
+ occurred during the course of the study (see ICH E3 Section 10.2 at
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf).
- Usually these are deviations that occur after the subject has
- been randomized or received the first treatment.
+ Usually these are deviations that occur after the subject has been randomized or received
+ the first treatment.
Document: IG v3.3
Item: Assumption 1
Section: 6.2.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0075
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The intent of the domain is to capture protocol violations and
- deviations during the course of the study and will store only
- those criteria violation by or deviated from by the subject
- and not a response to each violation or deviation.
+ - Cited Guidance:
+ The intent of the domain is to capture protocol violations and deviations
+ during the course of the study and will store only those criteria violation by or deviated
+ from by the subject and not a response to each violation or deviation.
Document: IG v3.2
- Item: ''
- Section: '6.2'
+ Item: ""
+ Section: "6.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0075
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 1. The DV domain is an Events model for collected protocol
- deviations and not for derived protocol deviations that are
- more likely to be part of analysis. Events typically include
- what the event was, captured in --TERM (the topic variable),
- and when it happened (captured in its start and/or end dates).
- The intent of the domain model is to capture protocol
- deviations that occurred during the course of the study (see
- ICH E3, Section 10.2[1]).
+ - Cited Guidance:
+ 1. The DV domain is an Events model for collected protocol deviations and
+ not for derived protocol deviations that are more likely to be part of analysis. Events
+ typically include what the event was, captured in --TERM (the topic variable), and when it
+ happened (captured in its start and/or end dates). The intent of the domain model is to
+ capture protocol deviations that occurred during the course of the study (see ICH E3,
+ Section 10.2[1]).
Document: TIG 1.0
Item: Assumption 1
Section: 2.8.10.19
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0341
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: DVSTDTC
@@ -85,7 +84,7 @@ Check:
Core:
Id: CORE-000086
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when DVSTDTC is earlier than RFICDTC in DM.
Executability: Fully Executable
Match Datasets:
diff --git a/Published/CORE-000087/rule.yml b/Published/CORE-000087/rule.yml
index a91bd482e..67934bddc 100644
--- a/Published/CORE-000087/rule.yml
+++ b/Published/CORE-000087/rule.yml
@@ -14,35 +14,35 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0387
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Is this is a serious event? Valid values are 'Y' and 'N'.
Document: Model v1.7
- Item: ''
+ Item: ""
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0387
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Is this is a serious event? Valid values are 'Y' and 'N'.
Document: Model v1.4
- Item: ''
+ Item: ""
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0387
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
@@ -53,10 +53,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0549
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AESER
@@ -69,7 +69,7 @@ Check:
Core:
Id: CORE-000087
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AESER is completed and value is not 'Y' or 'N'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000088/rule.yml b/Published/CORE-000088/rule.yml
index d5f18d1f9..408188add 100644
--- a/Published/CORE-000088/rule.yml
+++ b/Published/CORE-000088/rule.yml
@@ -1,5 +1,5 @@
# Variable: SETCD
-# Condition:
+# Condition:
# Rule: SETCD value length <= 8
Authorities:
- Organization: CDISC
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0149
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -26,9 +26,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0149
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -38,120 +38,121 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0149
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters, but do not have special character
- restrictions
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have
+ special character restrictions
Document: IG v3.0
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND25
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters, but do not have special character
- restrictions
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have
+ special character restrictions
Document: IG v3.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND25
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters, but do not have special character
- restrictions
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have
+ special character restrictions
Document: IG v3.1.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND25
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters, but do not have special character
- restrictions
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have
+ special character restrictions
Document: IG v3.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND25
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters, but do not have special character
- restrictions
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have
+ special character restrictions
Document: IG v3.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND25
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters, but do not have special character
- restrictions
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have
+ special character restrictions
Document: IG v3.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND25
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Short name of the Trial Set. The same element may occur more
- than once within an Arm. Maximum 8 characters.
+ - Cited Guidance:
+ Short name of the Trial Set. The same element may occur more than once
+ within an Arm. Maximum 8 characters.
Document: TIG v1.0
Item: SETCD CDISC Notes
Section: 2.8.9.31
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0169
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
@@ -162,10 +163,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0390
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SETCD
@@ -174,7 +175,7 @@ Check:
Core:
Id: CORE-000088
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify that the length of value in SETCD variable is <= 8
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000090/rule.yml b/Published/CORE-000090/rule.yml
index 67c031838..aa1cc8c60 100644
--- a/Published/CORE-000090/rule.yml
+++ b/Published/CORE-000090/rule.yml
@@ -7,68 +7,68 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies. Examples AESEQ or
- CMGRPID. Used only when individual comments are related to
- domain records.Null for comments collected on separate CRFs.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies. Examples AESEQ or CMGRPID. Used only when individual
+ comments are related to domain records.Null for comments collected on separate CRFs.
Document: SDTMIG v3.4
Item: Specification
- Section: '5.1'
+ Section: "5.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0164
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies. Examples AESEQ or
- CMGRPID. Used only when individual comments are related to
- domain records. null for comments collected on separate CRFs.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments
+ are related to domain records. null for comments collected on separate CRFs.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0164
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies. Examples AESEQ or
- CMGRPID. Used only when individual comments are related to
- domain records. null for comments collected on separate CRFs.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments
+ are related to domain records. null for comments collected on separate CRFs.
Document: IG v3.3
Item: Specification
- Section: '5.1'
+ Section: "5.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0164
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies. Examples AESEQ or
- CMGRPID. Used only when individual comments are related to
- domain records. Null for comments collected on separate CRFs.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments
+ are related to domain records. Null for comments collected on separate CRFs.
Document: TIG 1.0
Item: Specification
Section: 2.8.10.2
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0397
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
@@ -79,7 +79,7 @@ Check:
Core:
Id: CORE-000090
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify IDVAR is null when RDOMAIN is null
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000092/rule.yml b/Published/CORE-000092/rule.yml
index f9414e6a7..0d6133209 100644
--- a/Published/CORE-000092/rule.yml
+++ b/Published/CORE-000092/rule.yml
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0110
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -27,23 +27,22 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0111
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Amount of --TRT when numeric. Not populated when --DOSTXT is
- populated.
+ - Cited Guidance: Amount of --TRT when numeric. Not populated when --DOSTXT is populated.
Document: Model v1.4
Item: --DOSE Specification
Section: 2.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0110
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -54,23 +53,22 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0111
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Amount of --TRT when numeric. Not populated when --DOSTXT is
- populated.
+ - Cited Guidance: Amount of --TRT when numeric. Not populated when --DOSTXT is populated.
Document: Model v1.7
Item: --DOSE Specification
Section: 2.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0110
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -81,9 +79,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0111
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -94,10 +92,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0374
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
@@ -108,10 +106,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0375
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --DOSTXT
@@ -121,7 +119,7 @@ Check:
Core:
Id: CORE-000092
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --DOSE ^= null and --DOSTXT ^= null.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000093/rule.yml b/Published/CORE-000093/rule.yml
index 408b2bcc1..5cb51bd6a 100644
--- a/Published/CORE-000093/rule.yml
+++ b/Published/CORE-000093/rule.yml
@@ -14,37 +14,35 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0114
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Units for --DOSE, --DOSTOT, or --DOSTXT (Examples: ng, mg,
- mg/kg).'
+ - Cited Guidance: "Units for --DOSE, --DOSTOT, or --DOSTXT (Examples: ng, mg, mg/kg)."
Document: Model v1.4
Item: --DOSU Specification
Section: 2.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0114
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Units for --DOSE, --DOSTOT, or --DOSTXT. Examples: "ng", "mg",
- "mg/kg".'
+ - Cited Guidance: 'Units for --DOSE, --DOSTOT, or --DOSTXT. Examples: "ng", "mg", "mg/kg".'
Document: Model v1.7
Item: Specification
Section: 2.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0114
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -55,10 +53,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0377
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --DOSU
@@ -73,9 +71,9 @@ Check:
Core:
Id: CORE-000093
Status: Published
- Version: '1'
-Description: Raise an error when --DOSU = null and (--DOSE ^= null or --DOSTOT
- ^= null or --DOSTXT ^= null)
+ Version: "1"
+Description: Raise an error when --DOSU = null and (--DOSE ^= null or --DOSTOT ^= null or --DOSTXT
+ ^= null)
Executability: Fully Executable
Outcome:
Message: Missing value for --DOSU, when --DOSE, --DOSTXT or --DOSTOT is provided
diff --git a/Published/CORE-000094/rule.yml b/Published/CORE-000094/rule.yml
index 509d34d5d..3a988a39d 100644
--- a/Published/CORE-000094/rule.yml
+++ b/Published/CORE-000094/rule.yml
@@ -1,5 +1,5 @@
# Variable: --DOSTXT
-# Condition:
+# Condition:
# Rule: --DOSTXT value is non-numeric
Authorities:
- Organization: CDISC
@@ -7,61 +7,63 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A textual description of the quantity of an agent (e.g., drug,
- substance, radiation) taken or absorbed at a single
- administration.
+ - Cited Guidance:
+ A textual description of the quantity of an agent (e.g., drug, substance,
+ radiation) taken or absorbed at a single administration.
Document: Model v2.0
Section: Interventions
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0112
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Dosing information collected in text form. Examples: <1 per
- day, 200-400. Not populated when --DOSE is populated.'
+ - Cited Guidance:
+ "Dosing information collected in text form. Examples: <1 per day, 200-400. Not
+ populated when --DOSE is populated."
Document: Model v1.4
- Item: 'Specification: --DOSTXT'
+ Item: "Specification: --DOSTXT"
Section: 2.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0112
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Dosing information collected in text form. Examples: <1 per
- day, 200-400. Not populated when --DOSE is populated.'
+ - Cited Guidance:
+ "Dosing information collected in text form. Examples: <1 per day, 200-400. Not
+ populated when --DOSE is populated."
Document: Model v1.7
Item: Specification
Section: 2.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0112
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: A textual description of the quantity of an agent (e.g., drug,
- substance, radiation) taken or absorbed at a single
- administration.
+ - Cited Guidance:
+ A textual description of the quantity of an agent (e.g., drug, substance,
+ radiation) taken or absorbed at a single administration.
Document: SDTM v2.1
Item: --DOSTXT
Section: 3.1.1 The Interventions Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0376
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --DOSTXT
@@ -72,7 +74,7 @@ Check:
Core:
Id: CORE-000094
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error if --DOSTXT value is numeric.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000095/rule.yml b/Published/CORE-000095/rule.yml
index f5a7cc9ad..1cbad677e 100644
--- a/Published/CORE-000095/rule.yml
+++ b/Published/CORE-000095/rule.yml
@@ -7,78 +7,75 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If the sponsor decides that the subject's experience for a
- particular period of time cannot be represented with one of
- the planned Elements, then that period of time should be
- represented as an unplanned Element. The value of ETCD for an
- unplanned Element is "UNPLAN" and SEUPDES should be populated
- with a description of the unplanned Element.
+ - Cited Guidance:
+ If the sponsor decides that the subject's experience for a particular period
+ of time cannot be represented with one of the planned Elements, then that period of time
+ should be represented as an unplanned Element. The value of ETCD for an unplanned Element
+ is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element.
Document: IG v3.4
Item: Assumption 4
- Section: '5.3'
+ Section: "5.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0211
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If the sponsor decides that the subject's experience for a
- particular period of time cannot be represented with one of
- the planned Elements, then that period of time should be
- represented as an unplanned Element. The value of ETCD for an
- unplanned Element is "UNPLAN" and SEUPDES should be populated
- with a description of the unplanned Element only if ETCD has
- the value of "UNPLAN".
+ - Cited Guidance:
+ If the sponsor decides that the subject's experience for a particular period
+ of time cannot be represented with one of the planned Elements, then that period of time
+ should be represented as an unplanned Element. The value of ETCD for an unplanned Element
+ is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element
+ only if ETCD has the value of "UNPLAN".
Document: IG v3.2
Item: Assumption 6
Section: 5 SE
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0211
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If the sponsor decides that the subject's experience for a
- particular period of time cannot be represented with one of
- the planned Elements, then that period of time should be
- represented as an unplanned Element. The value of ETCD for an
- unplanned Element is "UNPLAN" and SEUPDES should be populated
- with a description of the unplanned Element only if ETCD has
- the value of "UNPLAN".
+ - Cited Guidance:
+ If the sponsor decides that the subject's experience for a particular period
+ of time cannot be represented with one of the planned Elements, then that period of time
+ should be represented as an unplanned Element. The value of ETCD for an unplanned Element
+ is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element
+ only if ETCD has the value of "UNPLAN".
Document: IG v3.3
Item: Assumption 4
- Section: '5.3'
+ Section: "5.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0211
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If the applicant decides that the subject's experience for a
- particular period of time cannot be represented with one of
- the planned elements, then that period of time should be
- represented as an unplanned element. The value of ETCD for an
- unplanned element is “UNPLAN” and SEUPDES should be populated
- with a description of the unplanned element.
+ - Cited Guidance:
+ If the applicant decides that the subject's experience for a particular
+ period of time cannot be represented with one of the planned elements, then that period of
+ time should be represented as an unplanned element. The value of ETCD for an unplanned
+ element is “UNPLAN” and SEUPDES should be populated with a description of the unplanned
+ element.
Document: TIG 1.0
Item: Assumption 3
Section: 2.8.10.24
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0430
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SEUPDES
@@ -89,7 +86,7 @@ Check:
Core:
Id: CORE-000095
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when SEUPDES ^= null, ETCD ^= 'UNPLAN'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000096/rule.yml b/Published/CORE-000096/rule.yml
index 922a2067a..46a012b63 100644
--- a/Published/CORE-000096/rule.yml
+++ b/Published/CORE-000096/rule.yml
@@ -7,47 +7,48 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Events[Variable Qualifer of --LOC.] Interventions[Variable
- Qualifer of --LOC.] Findings[Variable Qualifer of --LOC.]
+ - Cited Guidance:
+ Events[Variable Qualifer of --LOC.] Interventions[Variable Qualifer of
+ --LOC.] Findings[Variable Qualifer of --LOC.]
Document: Model v2.0
Item: --PORTOT
Section: Events Interventions Findings
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0115
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Qualifier for anatomical location further detailing the
- distribution, which means arrangement of, apportioning of the
- intervention administration.
+ - Cited Guidance:
+ Qualifier for anatomical location further detailing the distribution, which
+ means arrangement of, apportioning of the intervention administration.
Document: Model v1.4
Item: --PORTOT Specification
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0115
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Qualifier for anatomical location further detailing the
- distribution, which means arrangement of, apportioning of the
- intervention administration.
+ - Cited Guidance:
+ Qualifier for anatomical location further detailing the distribution, which
+ means arrangement of, apportioning of the intervention administration.
Document: Model v1.7
Item: --PORTOT Specification
Section: 2.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0115
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -66,10 +67,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0378
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --LOC
@@ -79,12 +80,11 @@ Check:
Core:
Id: CORE-000096
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --LOC does not exists in a dataset, --PORTOT exists.
Executability: Fully Executable
Outcome:
- Message: --PORTOT variable is present, when --LOC variable does not exist in a
- dataset.
+ Message: --PORTOT variable is present, when --LOC variable does not exist in a dataset.
Output Variables:
- --LOC
- --PORTOT
diff --git a/Published/CORE-000097/rule.yml b/Published/CORE-000097/rule.yml
index 76bdd88b1..a6193ac69 100644
--- a/Published/CORE-000097/rule.yml
+++ b/Published/CORE-000097/rule.yml
@@ -2,108 +2,112 @@
# Condition: EPOCH present in dataset and SESTDTC <= SVSTDTC and SVSTDTC <= SEENDTC
# Rule: EPOCH = SE.EPOCH
Authorities:
-- Organization: CDISC
- Standards:
- - Name: SDTMIG
- References:
- - Citations:
- - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the
- start of the visit.
- Document: IG v3.4
- Item: Assumption 11
- Section: "5.5"
- Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0218
- Version: "1"
- Version: "2.0"
- Version: "3.4"
- - Name: SDTMIG
- References:
- - Citations:
- - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the
- start of the visit.It would be inappropriate to add the variables that support time points
- (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is
- visits.
- Document: IG v3.2
- Item: Assumption 11
- Section: 5 SV
- Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0218
- Version: "1"
- Version: "2.0"
- Version: "3.2"
- - Name: SDTMIG
- References:
- - Citations:
- - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the
- start of the visit.It would be inappropriate to add the variables that support time points
- (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is
- visits.
- Document: IG v3.3
- Item: Assumption 11
- Section: "5.5"
- Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0218
- Version: "1"
- Version: "2.0"
- Version: "3.3"
- - Name: TIG
- References:
- - Citations:
- - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the
- start of the visit.
- Document: TIG 1.0
- Item: Assumption 11
- Section: 2.8.10.25
- Origin: TIG Conformance Rules
- Rule Identifier:
- Id: TIG0432
- Version: "1"
- Version: "1.0"
- Substandard: SDTM
- Version: "1.0"
+ - Organization: CDISC
+ Standards:
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If TAETORD and/or EPOCH are added, then the values must be those at the
+ start of the visit.
+ Document: IG v3.4
+ Item: Assumption 11
+ Section: "5.5"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0218
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If TAETORD and/or EPOCH are added, then the values must be those at the
+ start of the visit.It would be inappropriate to add the variables that support time points
+ (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is
+ visits.
+ Document: IG v3.2
+ Item: Assumption 11
+ Section: 5 SV
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0218
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If TAETORD and/or EPOCH are added, then the values must be those at the
+ start of the visit.It would be inappropriate to add the variables that support time points
+ (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is
+ visits.
+ Document: IG v3.3
+ Item: Assumption 11
+ Section: "5.5"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0218
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
+ - Name: TIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If TAETORD and/or EPOCH are added, then the values must be those at the
+ start of the visit.
+ Document: TIG 1.0
+ Item: Assumption 11
+ Section: 2.8.10.25
+ Origin: TIG Conformance Rules
+ Rule Identifier:
+ Id: TIG0432
+ Version: "1"
+ Version: "1.0"
+ Substandard: SDTM
+ Version: "1.0"
Check:
all:
- - name: EPOCH
- operator: exists
- - name: SESTDTC
- operator: date_less_than_or_equal_to
- value: SVSTDTC
- - name: SVSTDTC
- operator: date_less_than_or_equal_to
- value: SEENDTC
- - name: EPOCH
- operator: not_equal_to
- value: SE.EPOCH
+ - name: EPOCH
+ operator: exists
+ - name: SESTDTC
+ operator: date_less_than_or_equal_to
+ value: SVSTDTC
+ - name: SVSTDTC
+ operator: date_less_than_or_equal_to
+ value: SEENDTC
+ - name: EPOCH
+ operator: not_equal_to
+ value: SE.EPOCH
Core:
Id: CORE-000097
Status: Published
Version: "1"
-Description: Raise an error when variable EPOCH values don't match between Subject Visits (SV) and
+Description: Raise an error when variable EPOCH values don't match between Subject Visits (SV) and
Subject Elements (SE) datasets.
Executability: Partially Executable - Possible Overreporting
Match Datasets:
-- Keys:
- - USUBJID
- Name: SE
+ - Keys:
+ - USUBJID
+ Name: SE
Outcome:
Message: EPOCH values don't match between Subject Visits (SV) and Subject Elements (SE) datasets.
Output Variables:
- - SESTDTC
- - SVSTDTC
- - SEENDTC
- - EPOCH
- - SE.EPOCH
+ - SESTDTC
+ - SVSTDTC
+ - SEENDTC
+ - EPOCH
+ - SE.EPOCH
Rule Type: Record Data
Scope:
Classes:
Include:
- - SPECIAL PURPOSE
+ - SPECIAL PURPOSE
Domains:
Include:
- - SV
+ - SV
Use Case: INDH
Sensitivity: Record
diff --git a/Published/CORE-000098/rule.yml b/Published/CORE-000098/rule.yml
index 2fddb9db2..9d1292f76 100644
--- a/Published/CORE-000098/rule.yml
+++ b/Published/CORE-000098/rule.yml
@@ -22,37 +22,35 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0116
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Qualifier for anatomical location further detailing
- directionality ...
+ - Cited Guidance: Qualifier for anatomical location further detailing directionality ...
Document: Model v1.4
Item: --DIR Specification
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0116
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Qualifier for anatomical location further detailing
- directionality ...
+ - Cited Guidance: Qualifier for anatomical location further detailing directionality ...
Document: Model v1.7
Item: --DIR Specification
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0116
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -71,10 +69,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0379
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --LOC
@@ -84,7 +82,7 @@ Check:
Core:
Id: CORE-000098
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --LOC does not exists in a dataset, --DIR exists.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000099/rule.yml b/Published/CORE-000099/rule.yml
index 18f01d0b5..e8385f6ac 100644
--- a/Published/CORE-000099/rule.yml
+++ b/Published/CORE-000099/rule.yml
@@ -7,11 +7,11 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The --ORRES variable contains the result of the measurement or
- finding as originally received or collected. --ORRES is an
- expected variable and should always be populated, except (1)
- when --STAT = "NOT DONE" (because there is no result for such
- a record) or (2) for derived records.
+ - Cited Guidance:
+ The --ORRES variable contains the result of the measurement or finding as
+ originally received or collected. --ORRES is an expected variable and should always be
+ populated, except (1) when --STAT = "NOT DONE" (because there is no result for such a
+ record) or (2) for derived records.
Document: IG v3.4
Item: --STAT
Section: 4.5.1.1
@@ -22,53 +22,53 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0422
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Used to indicate exam not done. Should be null if a result
- exists in LBORRES.
+ - Cited Guidance: Used to indicate exam not done. Should be null if a result exists in
+ LBORRES.
Document: IG v3.2
Section: 6.3 LB
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0422
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Used to indicate exam not done. Should be null if a result
- exists in LBORRES.
+ - Cited Guidance: Used to indicate exam not done. Should be null if a result exists in
+ LBORRES.
Document: IG v3.3
Section: 6.3.6 LB
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0422
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 2.8.7.3 This section describes how to populate --ORRES. Tests
- Not Done have --ORRES null and --STAT "NOT DONE". {All
- Findings Domain Specifications- --STAT} Used to indicate that
- a test was not done or a measurement was not taken. Should be
- null if a result exists in REORRES.
+ - Cited Guidance:
+ 2.8.7.3 This section describes how to populate --ORRES. Tests Not Done have
+ --ORRES null and --STAT "NOT DONE". {All Findings Domain Specifications- --STAT} Used
+ to indicate that a test was not done or a measurement was not taken. Should be null if a
+ result exists in REORRES.
Document: TIG 1.0
Item: Findings Class Domains- Num 3 and Num 5
Section: 2.8.7.3
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0577
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --ORRES
@@ -78,7 +78,7 @@ Check:
Core:
Id: CORE-000099
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when both --ORRES and --STAT values are populated
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000100/rule.yml b/Published/CORE-000100/rule.yml
index 9766ed427..0e47c1c10 100644
--- a/Published/CORE-000100/rule.yml
+++ b/Published/CORE-000100/rule.yml
@@ -12,67 +12,65 @@ Authorities:
Document: Model v2.0
Item: --TRTV
Section: Interventions
- - Cited Guidance: Amount of the prepared product (treatment plus vehicle)
- administered.
+ - Cited Guidance: Amount of the prepared product (treatment plus vehicle) administered.
Document: Model v2.0
Item: --VAMT
Section: Interventions
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0423
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '--TRTV:Vehicle for administration of treatment; such as a
- liquid in which the treatment drug is dissolved. Example:
- SALINE. --VAMT: Amount of the prepared product (treatment +
- vehicle) administered or given. Note: should not be diluent
- amount alone. --VAMTU: Units for the prepared product
- (treatment + vehicle). Examples: mL; mg.'
+ - Cited Guidance:
+ "--TRTV:Vehicle for administration of treatment; such as a liquid in which the
+ treatment drug is dissolved. Example: SALINE. --VAMT: Amount of the prepared product (treatment
+ + vehicle) administered or given. Note: should not be diluent amount alone. --VAMTU: Units for
+ the prepared product (treatment + vehicle). Examples: mL; mg."
Document: Model v1.4
Section: 2.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0423
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '--TRTV:Vehicle for administration of treatment; such as a
- liquid in which the treatment drug is dissolved. Example:
- SALINE. --VAMT: Amount of the prepared product (treatment +
- vehicle) administered or given. Note: should not be diluent
- amount alone. --VAMTU: Units for the prepared product
- (treatment + vehicle). Examples: mL; mg.'
+ - Cited Guidance:
+ "--TRTV:Vehicle for administration of treatment; such as a liquid in which the
+ treatment drug is dissolved. Example: SALINE. --VAMT: Amount of the prepared product (treatment
+ + vehicle) administered or given. Note: should not be diluent amount alone. --VAMTU: Units for
+ the prepared product (treatment + vehicle). Examples: mL; mg."
Document: Model v1.7
Section: 2.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0423
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: --TRTV[A carrier or inert medium in which a medicinally active
- agent is administered.]|--VAMT[Amount of the prepared product
- (treatment plus vehicle) administered.]
+ - Cited Guidance:
+ --TRTV[A carrier or inert medium in which a medicinally active agent is
+ administered.]|--VAMT[Amount of the prepared product (treatment plus vehicle)
+ administered.]
Document: SDTM v2.1
Item: Specifications '--TRTV|'--VAMT
Section: Section 3.1.1 The Interventions Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0578
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --VAMT
@@ -82,7 +80,7 @@ Check:
Core:
Id: CORE-000100
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --VAMT is not empty, but --TRTV is empty.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000101/rule.yml b/Published/CORE-000101/rule.yml
index a29672d77..754c53f29 100644
--- a/Published/CORE-000101/rule.yml
+++ b/Published/CORE-000101/rule.yml
@@ -7,60 +7,64 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A grouping or classification of the results of an assessment.
- The result is in --STRESC.
+ - Cited Guidance:
+ A grouping or classification of the results of an assessment. The result is
+ in --STRESC.
Document: Model v2.0
Item: --RESCAT
Section: Findings
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0427
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '--STRESC: Contains the result value for all findings, copied or
- derived from --ORRES in a standard format or in standard
- units. --RESCAT: used to categorize the result of a finding.'
+ - Cited Guidance:
+ "--STRESC: Contains the result value for all findings, copied or derived from
+ --ORRES in a standard format or in standard units. --RESCAT: used to categorize the result of
+ a finding."
Document: Model v1.4
Section: 2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0427
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '--STRESC: Contains the result value for all findings, copied or
- derived from --ORRES in a standard format or in standard
- units. --RESCAT: used to categorize the result of a finding.'
+ - Cited Guidance:
+ "--STRESC: Contains the result value for all findings, copied or derived from
+ --ORRES in a standard format or in standard units. --RESCAT: used to categorize the result of
+ a finding."
Document: Model v1.7
Section: 2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0427
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: --RESCAT A grouping or classification of the results of an
- assessment. The result is in --STRESC.
+ - Cited Guidance:
+ --RESCAT A grouping or classification of the results of an assessment. The
+ result is in --STRESC.
Document: SDTM v2.1
Item: Specification --RESCAT
Section: 3.1.3 The Findings Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0581
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --RESCAT
@@ -70,7 +74,7 @@ Check:
Core:
Id: CORE-000101
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --RESCAT is not empty, but --STRESC is empty
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000102/rule.yml b/Published/CORE-000102/rule.yml
index 9dd5ba0fc..a465dbe8d 100644
--- a/Published/CORE-000102/rule.yml
+++ b/Published/CORE-000102/rule.yml
@@ -14,56 +14,57 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0428
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Description of toxicity quantified by --TOXGR such as NCI CTCAE
- Short Name. Examples: HYPERCALCEMIA; HYPOCALCEMIA. Sponsor
- should specify which scale and version is used in the Sponsor
- Comments column of the Define-XML document.'
+ - Cited Guidance:
+ "Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples:
+ HYPERCALCEMIA; HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor
+ Comments column of the Define-XML document."
Document: Model v1.4
Item: --TOX
Section: 2.2.2|2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0428
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Description of toxicity quantified by --TOXGR such as NCI CTCAE
- Short Name. Examples: HYPERCALCEMIA; HYPOCALCEMIA. Sponsor
- should specify which scale and version is used in the Sponsor
- Comments column of the Define-XML document.'
+ - Cited Guidance:
+ "Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples:
+ HYPERCALCEMIA; HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor
+ Comments column of the Define-XML document."
Document: Model v1.7
Item: --TOX
Section: 2.2.2|2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0428
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- Cited Guidance: Variable Qualifier of --TOXGR
Document: SDTM v2.1
Item: --TOX
- Section: Section 3.1.2 The Events Observation Class Section|3.1.3 The Findings
- Observation Class
+ Section:
+ Section 3.1.2 The Events Observation Class Section|3.1.3 The Findings Observation
+ Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0582
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
@@ -74,7 +75,7 @@ Check:
Core:
Id: CORE-000102
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TOX is not empty, but --TOXGR is empty.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000103/rule.yml b/Published/CORE-000103/rule.yml
index ae964d68a..14528c81a 100644
--- a/Published/CORE-000103/rule.yml
+++ b/Published/CORE-000103/rule.yml
@@ -7,30 +7,30 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: Model v2.0
Item: --SCAT
Section: Interventions
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: Model v2.0
Item: --SCAT
Section: Events
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: Model v2.0
Item: --SCAT
Section: Findings
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0429
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -40,50 +40,46 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0429
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '2.2.1[Table 3.2.1 --SCAT][Used to define a further
- categorization of --CAT values.]|2.2.2[Table 3.2.2
- --SCAT][Used to define a further categorization of --CAT
- values.]|2.2.3[Table 3.2.3 --SCAT][Used to define a further
- categorization of --CAT values.]'
+ - Cited Guidance:
+ "2.2.1[Table 3.2.1 --SCAT][Used to define a further categorization of --CAT values.]|2.2.2[Table
+ 3.2.2 --SCAT][Used to define a further categorization of --CAT values.]|2.2.3[Table 3.2.3 --SCAT][Used
+ to define a further categorization of --CAT values.]"
Document: Model v1.7
- Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3:
- --SCAT]'
+ Item: "2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]"
Section: 2.2.1|2.2.2|2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0429
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Interventions[A further grouping or classification of the
- category for the topic of the finding, event, or intervention.
- The category is in --CAT.]|Events[A further grouping or
- classification of the category for the topic of the finding,
- event, or intervention. The category is in --CAT.]|Findings[A
- further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.]
+ - Cited Guidance:
+ Interventions[A further grouping or classification of the category for the
+ topic of the finding, event, or intervention. The category is in --CAT.]|Events[A further
+ grouping or classification of the category for the topic of the finding, event, or
+ intervention. The category is in --CAT.]|Findings[A further grouping or classification of
+ the category for the topic of the finding, event, or intervention. The category is in
+ --CAT.]
Document: SDTM v2.1
Item: Specifications --SCAT
- Section: Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The
- Events Observation Class Section|3.1.3 The Findings
- Observation Class
+ Section: Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The Events
+ Observation Class Section|3.1.3 The Findings Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0583
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --SCAT
@@ -93,7 +89,7 @@ Check:
Core:
Id: CORE-000103
Status: Published
- Version: '1'
+ Version: "1"
Description: Part A - Raise an error when --SCAT is not empty, but --CAT is empty.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000104/rule.yml b/Published/CORE-000104/rule.yml
index 71aca76f4..c7fb51083 100644
--- a/Published/CORE-000104/rule.yml
+++ b/Published/CORE-000104/rule.yml
@@ -7,30 +7,30 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: Model v2.0
Item: --SCAT
Section: Interventions
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: Model v2.0
Item: --SCAT
Section: Events
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: Model v2.0
Item: --SCAT
Section: Findings
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0430
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -40,51 +40,50 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0430
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Used to define a further categorization of --CAT values.]'
Document: Model v1.7
- Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3:
- --SCAT]'
+ Item: "2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]"
Section: 2.2.1|2.2.2|2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0430
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: SDTM v2.1
Item: Specifications --SCAT
Section: Section 3.1.1 The Interventions Observation Class
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: SDTM v2.1
Item: Specifications --SCAT
Section: Section 3.1.2 The Events Observation Class Section
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: SDTM v2.1
Item: Specifications --SCAT
Section: 3.1.3 The Findings Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0584
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --SCAT
@@ -94,9 +93,8 @@ Check:
Core:
Id: CORE-000104
Status: Published
- Version: '1'
-Description: Part A - Raise an error when --SCAT exists in a dataset, but --CAT
- does not exist.
+ Version: "1"
+Description: Part A - Raise an error when --SCAT exists in a dataset, but --CAT does not exist.
Executability: Fully Executable
Outcome:
Message: --SCAT exists in a dataset, but --CAT does not exist.
diff --git a/Published/CORE-000105/rule.yml b/Published/CORE-000105/rule.yml
index 4472327f0..35e6d4535 100644
--- a/Published/CORE-000105/rule.yml
+++ b/Published/CORE-000105/rule.yml
@@ -7,76 +7,79 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Operationally-derived indicator used to identify the last
- non-missing value prior to RFXSTDTC. Result value is in
- --STRESC.
+ - Cited Guidance:
+ Operationally-derived indicator used to identify the last non-missing value
+ prior to RFXSTDTC. Result value is in --STRESC.
Document: Model v2.0
Item: --STRESC
Section: Findings
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0569
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Operationally-derived indicator used to identify the last
- non-missing value prior to RFXSTDTC. Should be "Y" or null.
+ - Cited Guidance:
+ Operationally-derived indicator used to identify the last non-missing value
+ prior to RFXSTDTC. Should be "Y" or null.
Document: Model v1.7
Item: --LOXBFL
Section: Table 2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0569
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Operationally-derived indicator used to identify the last
- non-missing value prior to RFXSTDTC. Result value is in
- --STRESC.
+ - Cited Guidance:
+ Operationally-derived indicator used to identify the last non-missing value
+ prior to RFXSTDTC. Result value is in --STRESC.
Document: SDTM v2.1
Item: --STRESC
Section: 3.1.3 The Findings Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0653
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.'
+ - Cited Guidance:
+ "Records with a baseline flag should have a corresponding standard result with
+ a standardized unit where available."
Document: FDA
Section: FDAB026
Origin: FDA Business Rules
Rule Identifier:
Id: FB2602
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.'
+ - Cited Guidance:
+ "Records with a baseline flag should have a corresponding standard result with
+ a standardized unit where available."
Document: FDA
Section: FDAB026
Origin: FDA Business Rules
Rule Identifier:
Id: FB2602
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: --LOBXFL
@@ -88,7 +91,7 @@ Check:
Core:
Id: CORE-000105
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --LOBXFL = 'Y' and --STRESC is empty.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000106/rule.yml b/Published/CORE-000106/rule.yml
index a81a28f25..34a191c41 100644
--- a/Published/CORE-000106/rule.yml
+++ b/Published/CORE-000106/rule.yml
@@ -7,66 +7,65 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The description or date and/or time of a time point that acts as
- a fixed reference for characterizing the end of an
- observation. This is the sponsor-defined reference point
- referred to by --ENRTPT.
+ - Cited Guidance:
+ The description or date and/or time of a time point that acts as a fixed
+ reference for characterizing the end of an observation. This is the sponsor-defined
+ reference point referred to by --ENRTPT.
Document: Model v2.0
Item: --ENTPT
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0045
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the end of the observation as being before or after
- the sponsor-defined reference time point defined by variable
- --ENTPT.
+ - Cited Guidance: Identifies the end of the observation as being before or after the
+ sponsor-defined reference time point defined by variable --ENTPT.
Document: Model v1.7
Item: Table 2.2.5.1 --ENTPT
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0045
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: (--ENRTPT) Identifies the end of the observation as being before
- or after the sponsor-defined reference time point defined by
- variable --ENTPT.
+ - Cited Guidance:
+ (--ENRTPT) Identifies the end of the observation as being before or after
+ the sponsor-defined reference time point defined by variable --ENTPT.
Document: Model v1.4
Item: Specification
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0045
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The description or date and/or time of a time point that acts as
- a fixed reference for characterizing the end of an
- observation. This is the sponsor-defined reference point
- referred to by --ENRTPT
+ - Cited Guidance:
+ The description or date and/or time of a time point that acts as a fixed
+ reference for characterizing the end of an observation. This is the sponsor-defined
+ reference point referred to by --ENRTPT
Document: SDTM v2.1
Item: --ENTPT
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0324
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --ENTPT
@@ -76,7 +75,7 @@ Check:
Core:
Id: CORE-000106
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --ENTPT is completed and --ENRTPT is not completed.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000107/rule.yml b/Published/CORE-000107/rule.yml
index 677c730e7..1a72e1a17 100644
--- a/Published/CORE-000107/rule.yml
+++ b/Published/CORE-000107/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: STUDYID, DOMAIN, and --SEQ exist and at least one of USUBJID, APID, SPDEVID, or POOLID
Authorities:
- Organization: CDISC
@@ -7,57 +7,57 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: STUDYID, DOMAIN, and --SEQ are required in all domains based on
- one of the 3 general observation classes. Each general class
- domain must also include at least one of the following subject
- identifiers USUBJID, SPDEVID, or POOLID.
+ - Cited Guidance:
+ STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3
+ general observation classes. Each general class domain must also include at least one of
+ the following subject identifiers USUBJID, SPDEVID, or POOLID.
Document: Model v2.0
Section: Identifiers
- - Cited Guidance: The Associated Persons Identifier (APID) will be required in all
- AP datasets, and will identify records as AP data.'
+ - Cited Guidance: The Associated Persons Identifier (APID) will be required in all AP
+ datasets, and will identify records as AP data.'
Document: Model v2.0
Section: Associated Persons Data
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0554
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'STUDYID, DOMAIN, and --SEQ are required in all domains based on
- one of the 3 general observation classes. Each general class
- domain must also include at least one of the following subject
- identifiers: USUBJID, APID, SPDEVID, or POOLID.'
+ - Cited Guidance:
+ "STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3
+ general observation classes. Each general class domain must also include at least one of the
+ following subject identifiers: USUBJID, APID, SPDEVID, or POOLID."
Document: Model v1.7
Section: 2.2.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0554
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: STUDYID, DOMAIN, and --SEQ are required in all domains based on
- one of the 3 general observation classes. Each general class
- domain must also include at least one of the following subject
- identifiers - SUBJID, SPDEVID, or POOLID.
+ - Cited Guidance:
+ STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3
+ general observation classes. Each general class domain must also include at least one of
+ the following subject identifiers - SUBJID, SPDEVID, or POOLID.
Document: SDTM v2.1
Section: Section 3.1.4 Identifiers For All Classes
- - Cited Guidance: The Associated Persons Identifier (APID) will be required in all
- AP datasets, and will identify records as AP data.
+ - Cited Guidance: The Associated Persons Identifier (APID) will be required in all AP
+ datasets, and will identify records as AP data.
Document: SDTM v2.1
Section: Section 4.0 Associated Persons Data
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0642
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -81,8 +81,9 @@ Check:
- name: SPDEVID
operator: not_exists
- name: POOLID
- operator: not_exists
- #added for TIG
+ operator:
+ not_exists
+ #added for TIG
- name: SPTOBID
operator: not_exists
- name: STOCONID
@@ -90,15 +91,14 @@ Check:
Core:
Id: CORE-000107
Status: Published
- Version: '1'
-Description: APID is required in all Associated Persons Data. In addition to
- STUDYID, DOMAIN, and --SEQ being required for all domains based on one of the
- 3 general observation classes, one of USUBJID, APID, SPDEVID, or POOLID must
- also be present.
+ Version: "1"
+Description: APID is required in all Associated Persons Data. In addition to STUDYID, DOMAIN, and
+ --SEQ being required for all domains based on one of the 3 general observation classes, one of
+ USUBJID, APID, SPDEVID, or POOLID must also be present.
Executability: Fully Executable
Outcome:
- Message: An appropriate identifier is not present; USUBJID, APID, SPDEVID,
- SPTOBID, POOLID, SPTOBID, STOCONID should be present.
+ Message: An appropriate identifier is not present; USUBJID, APID, SPDEVID, SPTOBID, POOLID,
+ SPTOBID, STOCONID should be present.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000108/rule.yml b/Published/CORE-000108/rule.yml
index d67ff5b20..4b7a56256 100644
--- a/Published/CORE-000108/rule.yml
+++ b/Published/CORE-000108/rule.yml
@@ -7,124 +7,131 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be
- populated even when the death date is unknown.
+ - Cited Guidance:
+ Indicates the subject died. Should be "Y" or null. Should be populated even
+ when the death date is unknown.
Document: IG v3.4
Item: Specification
- Section: '5.2'
- - Cited Guidance: A findings domain that contains the diagnosis of the cause of
- death for a subject.
+ Section: "5.2"
+ - Cited Guidance:
+ A findings domain that contains the diagnosis of the cause of death for a
+ subject.
Document: IG v3.4
Item: DD Description
Section: 6.3.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0133
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Specification[Indicates the subject died. Should be Y or null.
- Should be populated even when the death date is unknown.]|DD
- Assumption 1[This domain captures information pertaining to
- the death of a subject, including the causes of death.]
+ - Cited Guidance:
+ Specification[Indicates the subject died. Should be Y or null. Should be
+ populated even when the death date is unknown.]|DD Assumption 1[This domain captures
+ information pertaining to the death of a subject, including the causes of death.]
Document: IG v3.2
Item: Specification|DD Assumption 1
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0133
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[5.2][Indicates the subject died. Should be Y or null.
- Should be populated even when the death date is unknown.]||IG
- v3.3[6.3.2][A findings domain that contains the diagnosis of
- the cause of death for a subject]
+ - Cited Guidance:
+ IG v3.3[5.2][Indicates the subject died. Should be Y or null. Should be
+ populated even when the death date is unknown.]||IG v3.3[6.3.2][A findings domain that
+ contains the diagnosis of the cause of death for a subject]
Document: IG v3.3
Section: IG v3.3[5.2]|IG v3.3[6.3.2]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0133
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be
- populated even when the death date is unknown.
+ - Cited Guidance:
+ Indicates the subject died. Should be "Y" or null. Should be populated even
+ when the death date is unknown.
Document: TIG 1.0
Item: Specification
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0382
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
- #CG0133 is identical to rule FB0602. Added metadata for FB0602.
+ Version:
+ "1.0"
+ #CG0133 is identical to rule FB0602. Added metadata for FB0602.
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0602
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0602
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0602
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: DTHFL
operator: not_equal_to
- value: 'Y'
+ value: "Y"
- name: USUBJID
operator: is_contained_by
value: $usubjids_in_dd
Core:
Id: CORE-000108
Status: Published
- Version: '1'
-Description: When a record is present in the DD dataset then death flag (DTHFL)
- should be populated as 'Y' in the DM dataset for the corresponding subject.
+ Version: "1"
+Description: When a record is present in the DD dataset then death flag (DTHFL) should be populated
+ as 'Y' in the DM dataset for the corresponding subject.
Executability: Fully Executable
Match Datasets:
- Keys:
diff --git a/Published/CORE-000110/rule.yml b/Published/CORE-000110/rule.yml
index 607a56406..5b0d67ad4 100644
--- a/Published/CORE-000110/rule.yml
+++ b/Published/CORE-000110/rule.yml
@@ -7,46 +7,49 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Reference value for the result or finding copied or derived from
- --ORREF in a standard format.
+ - Cited Guidance:
+ Reference value for the result or finding copied or derived from --ORREF in
+ a standard format.
Document: SDTM v2.0
Item: --STREFC
Section: Findings
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0549
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Reference value for the result or finding copied or derived from
- --ORREF in a standard format.
+ - Cited Guidance:
+ Reference value for the result or finding copied or derived from --ORREF in
+ a standard format.
Document: Model v1.7
Item: --STREFC
Section: Table 2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0549
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Reference value for the result or finding copied or derived from
- --ORREF in a standard format.
+ - Cited Guidance:
+ Reference value for the result or finding copied or derived from --ORREF in
+ a standard format.
Document: SDTM v2.1
Item: --STREFC
Section: 3.1.3 The Findings Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0637
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- any:
@@ -60,7 +63,7 @@ Check:
Core:
Id: CORE-000110
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when (--ORREF ^= null or --DRVFL='Y') and --STREFC is null.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000111/rule.yml b/Published/CORE-000111/rule.yml
index 655d09582..ce6bef3b3 100644
--- a/Published/CORE-000111/rule.yml
+++ b/Published/CORE-000111/rule.yml
@@ -1,5 +1,5 @@
# Variable: --AGENT
-# Condition:
+# Condition:
# Rule: --AGENT not present in dataset
Authorities:
- Organization: CDISC
@@ -14,25 +14,25 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0564
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The concept of domain-specific variables was first introduced in
- SDTM v1.5. These variables are for use only in a specific
- domain and will be identified in the appropriate
- implementation guide.
+ - Cited Guidance:
+ The concept of domain-specific variables was first introduced in SDTM v1.5.
+ These variables are for use only in a specific domain and will be identified in the
+ appropriate implementation guide.
Document: Model v1.7
Item: MSAGENT
Section: Table 2.2.12.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0564
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -43,10 +43,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0649
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --AGENT
@@ -54,7 +54,7 @@ Check:
Core:
Id: CORE-000111
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --AGENT is present in a dataset other than MS.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000112/rule.yml b/Published/CORE-000112/rule.yml
index 8ce690ecc..a162e78fe 100644
--- a/Published/CORE-000112/rule.yml
+++ b/Published/CORE-000112/rule.yml
@@ -1,5 +1,5 @@
# Variable: --CONC
-# Condition:
+# Condition:
# Rule: --CONC not present in dataset
Authorities:
- Organization: CDISC
@@ -14,25 +14,25 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0565
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The concept of domain-specific variables was first introduced in
- SDTM v1.5. These variables are for use only in a specific
- domain and will be identified in the appropriate
- implementation guide.
+ - Cited Guidance:
+ The concept of domain-specific variables was first introduced in SDTM v1.5.
+ These variables are for use only in a specific domain and will be identified in the
+ appropriate implementation guide.
Document: Model v1.7
Item: MSCONC
Section: Table 2.2.12.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0565
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -43,10 +43,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0650
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --CONC
@@ -54,7 +54,7 @@ Check:
Core:
Id: CORE-000112
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --CONC is present in a dataset other than MS.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000113/rule.yml b/Published/CORE-000113/rule.yml
index cc06b6af4..ec2b7ca7f 100644
--- a/Published/CORE-000113/rule.yml
+++ b/Published/CORE-000113/rule.yml
@@ -1,5 +1,5 @@
# Variable: --CONCU
-# Condition:
+# Condition:
# Rule: --CONCU not present in dataset
Authorities:
- Organization: CDISC
@@ -14,25 +14,25 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0566
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The concept of domain-specific variables was first introduced in
- SDTM v1.5. These variables are for use only in a specific
- domain and will be identified in the appropriate
- implementation guide.
+ - Cited Guidance:
+ The concept of domain-specific variables was first introduced in SDTM v1.5.
+ These variables are for use only in a specific domain and will be identified in the
+ appropriate implementation guide.
Document: Model v1.7
Item: MSCONCU
Section: Table 2.2.12.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0566
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -43,10 +43,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0651
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --CONCU
@@ -54,7 +54,7 @@ Check:
Core:
Id: CORE-000113
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --CONCU is present in a dataset other than MS.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000114/rule.yml b/Published/CORE-000114/rule.yml
index c93e7dc62..7962e429d 100644
--- a/Published/CORE-000114/rule.yml
+++ b/Published/CORE-000114/rule.yml
@@ -1,5 +1,5 @@
# Variable: --EVDTYP
-# Condition:
+# Condition:
# Rule: --EVDTYP not present in dataset
Authorities:
- Organization: CDISC
@@ -14,25 +14,25 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0567
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The concept of domain-specific variables was first introduced in
- SDTM v1.5. These variables are for use only in a specific
- domain and will be identified in the appropriate
- implementation guide.
+ - Cited Guidance:
+ The concept of domain-specific variables was first introduced in SDTM v1.5.
+ These variables are for use only in a specific domain and will be identified in the
+ appropriate implementation guide.
Document: Model v1.7
Item: MHEVDTYP
Section: Table 2.2.12.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0567
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -43,10 +43,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0652
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --EVDTYP
@@ -54,7 +54,7 @@ Check:
Core:
Id: CORE-000114
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --EVDTYP is present in a dataset other than MH.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000116/rule.yml b/Published/CORE-000116/rule.yml
index b8217d95e..975b6e12d 100644
--- a/Published/CORE-000116/rule.yml
+++ b/Published/CORE-000116/rule.yml
@@ -1,5 +1,5 @@
# Variable: --SPCUFL
-# Condition:
+# Condition:
# Rule: --SPCUFL = 'N' or null
Authorities:
- Organization: CDISC
@@ -7,31 +7,31 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The value will be "N" if the specimen is not usable, and null if
- the specimen is usable.
+ - Cited Guidance: The value will be "N" if the specimen is not usable, and null if the
+ specimen is usable.
Document: SDTM v2.0
Section: Findings
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0619
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The value will be "N" if the specimen is not usable, and null if
- the specimen is usable.
+ - Cited Guidance: The value will be "N" if the specimen is not usable, and null if the
+ specimen is usable.
Document: SDTM v2.1
Item: Specification
Section: 3.1.3 The Findings Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0660
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --SPCUFL
@@ -44,7 +44,7 @@ Check:
Core:
Id: CORE-000116
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --SPCUFL is not null or equal to "N"
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000117/rule.yml b/Published/CORE-000117/rule.yml
index a8e00eca0..fca18d2e5 100644
--- a/Published/CORE-000117/rule.yml
+++ b/Published/CORE-000117/rule.yml
@@ -7,8 +7,9 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: An indication that the event was prospectively stated or
- detailed on the CRF.
+ - Cited Guidance:
+ An indication that the event was prospectively stated or detailed on the
+ CRF.
Document: Model v2.0
Item: --PRESP
Section: Events
@@ -16,118 +17,103 @@ Authorities:
Document: Model v2.0
Item: --OCCUR
Section: Events
- - Cited Guidance: Used to indicate when a question about the occurrence of a
- prespecified event was not answered.
+ - Cited Guidance:
+ Used to indicate when a question about the occurrence of a prespecified
+ event was not answered.
Document: Model v2.0
Item: STAT
Section: Events
- - Cited Guidance: An indication that the intervention was prospectively stated or
- detailed on the CRF.
+ - Cited Guidance:
+ An indication that the intervention was prospectively stated or detailed on
+ the CRF.
Document: Model v2.0
Item: --PRESP
Section: Interventions
- - Cited Guidance: An indication as to whether a prespecified intervention has
- occurred.
+ - Cited Guidance: An indication as to whether a prespecified intervention has occurred.
Document: Model v2.0
Item: --OCCUR
Section: Interventions
- - Cited Guidance: Used to indicate when a question about the occurrence of a
- prespecified intervention was not answered. Should be null or
- have a value of "NOT DONE".
+ - Cited Guidance:
+ Used to indicate when a question about the occurrence of a prespecified
+ intervention was not answered. Should be null or have a value of "NOT DONE".
Document: Model v2.0
Item: STAT
Section: Interventions
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0081
- Version: '1.0'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.][--OCCUR: Used to record whether a
- pre-specified event occurred when information about the
- occurrence of a specific event is solicited.][--STAT: Used to
- indicate when a question about the occurrence of a
- pre-specified event was not answered. Should be null or hav a
- value of NOT DONE][--REASND: Used in conjunction with --STAT
- when value is NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP:
- Used to indicate whether the event describe by --TERM was
- pre-specified on a CRF. Value is Y for pre-specified events,
- null for spontaneously reported events.][--OCCUR: Used to
- record whether a pre-specified event occurred when information
- about the occurrence of a specific event is
- solicited.][--STAT: Used to indicate when a question about the
- occurrence of a pre-specified event was not answered . Should
- be null or hav a value of NOT DONE][--REASND: Used in
- conjunction with --STAT when value is NOT DONE]'
+ - Cited Guidance:
+ 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
+ is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a
+ pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT:
+ Used to indicate when a question about the occurrence of a pre-specified event was not answered.
+ Should be null or hav a value of NOT DONE][--REASND: Used in conjunction with --STAT when value
+ is NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe
+ by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously
+ reported events.][--OCCUR: Used to record whether a pre-specified event occurred when information
+ about the occurrence of a specific event is solicited.][--STAT: Used to indicate when a question
+ about the occurrence of a pre-specified event was not answered . Should be null or hav a value
+ of NOT DONE][--REASND: Used in conjunction with --STAT when value is NOT DONE]'
Document: Model v1.4
Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0081
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a
- specific intervention is pre-specified on a CRF. Values should
- be "Y" or null.][--OCCUR: Used to record whether a
- pre-specified event occurred when information about the
- occurrence of a specific event is solicited.][--STAT: Used to
- indicate when a question about the occurrence of a
- pre-specified event was not answered. Should be null or hav a
- value of NOT DONE][--REASND: Used in conjunction with --STAT
- when value is NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP:
- Used to indicate whether the event describe by --TERM was
- pre-specified on a CRF. Value is Y for pre-specified events,
- null for spontaneously reported events.][--OCCUR: Used to
- record whether a pre-specified event occurred when information
- about the occurrence of a specific event is
- solicited.][--STAT: Used to indicate when a question about the
- occurrence of a pre-specified event was not answered . Should
- be null or hav a value of NOT DONE][--REASND: Used in
- conjunction with --STAT when value is NOT DONE]'
+ - Cited Guidance:
+ 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
+ is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a
+ pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT:
+ Used to indicate when a question about the occurrence of a pre-specified event was not answered.
+ Should be null or hav a value of NOT DONE][--REASND: Used in conjunction with --STAT when value
+ is NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe
+ by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously
+ reported events.][--OCCUR: Used to record whether a pre-specified event occurred when information
+ about the occurrence of a specific event is solicited.][--STAT: Used to indicate when a question
+ about the occurrence of a pre-specified event was not answered . Should be null or hav a value
+ of NOT DONE][--REASND: Used in conjunction with --STAT when value is NOT DONE]'
Document: Model v1.7
Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0081
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Events[--PRESP][An indication that the event was prospectively
- stated or detailed on the CRF.]|Events|[--OCCUR][An indication
- as to whether a prespecified event has
- occurred.]|Events[--STAT][Used to indicate when a question
- about the occurrence of a prespecified event was not
- answered.]|Interventions[--PRESP][An indication that the
- intervention was prospectively stated or detailed on the
- CRF.]|Interventions[--OCCUR][An indication as to whether a
- prespecified intervention has
- occurred.]|Interventions[--STAT][Used to indicate when a
- question about the occurrence of a prespecified intervention
- was not answered. Should be null or have a value of "NOT
+ - Cited Guidance:
+ Events[--PRESP][An indication that the event was prospectively stated or
+ detailed on the CRF.]|Events|[--OCCUR][An indication as to whether a prespecified event
+ has occurred.]|Events[--STAT][Used to indicate when a question about the occurrence of a
+ prespecified event was not answered.]|Interventions[--PRESP][An indication that the
+ intervention was prospectively stated or detailed on the CRF.]|Interventions[--OCCUR][An
+ indication as to whether a prespecified intervention has
+ occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of
+ a prespecified intervention was not answered. Should be null or have a value of "NOT
DONE".]
Document: SDTM v2.1
Item: --PRESP|--OCCUR|STAT
- Section: 3.1.1The Interventions Observation Class|3.1.2 The Events Observation
- Class
+ Section: 3.1.1The Interventions Observation Class|3.1.2 The Events Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0346
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --PRESP
@@ -141,9 +127,9 @@ Check:
Core:
Id: CORE-000117
Status: Published
- Version: '1'
-Description: Raise an error when --STAT not equal to 'NOT DONE' when --PRESP =
- 'Y' and --OCCUR is null
+ Version: "1"
+Description: Raise an error when --STAT not equal to 'NOT DONE' when --PRESP = 'Y' and --OCCUR is
+ null
Executability: Fully Executable
Outcome:
Message: --STAT should equal 'NOT DONE' when --PRESP = 'Y' and --OCCUR = null
diff --git a/Published/CORE-000118/rule.yml b/Published/CORE-000118/rule.yml
index 77e23ded7..3135e4af8 100644
--- a/Published/CORE-000118/rule.yml
+++ b/Published/CORE-000118/rule.yml
@@ -2,145 +2,158 @@
# Condition: --PRESP = 'Y' and --OCCUR = null
# Rule: --STAT present in dataset
Authorities:
-- Organization: CDISC
- Standards:
- - Name: SDTMIG
- References:
- - Citations:
- - Cited Guidance: An indication that the event was prospectively stated or detailed on the CRF
- Document: SDTM v2.0
- Item: --PRESP
- Section: Events
- - Cited Guidance: An indication as to whether a prespecified event has occurred
- Document: SDTM v2.0
- Item: --OCCUR
- Section: Events
- - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified
- event was not answered. Should be null or have a value of 'NOT DONE'
- Document: Model v2.0
- Item: --STAT
- Section: Events
- - Cited Guidance: An indication that the intervention was prospectively stated or detailed on
- the CRF
- Document: Model v2.0
- Item: --PRESP
- Section: Interventions
- - Cited Guidance: An indication as to whether a prespecified intervention has occurred.
- Document: Model v2.0
- Item: --OCCUR
- Section: Interventions
- - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified
- intervention was not answered. Should be null or have a value of 'NOT DONE'
- Document: Model v2.0
- Item: --STAT
- Section: Interventions
- Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0404
- Version: "2"
- Version: "2.0"
- Version: "3.4"
- - Name: SDTMIG
- References:
- - Citations:
- - Cited Guidance: "Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
- is pre-specified on a CRF. Values should be 'Y' or null.][--OCCUR: Used to record whether a
- pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT:
- Used to indicate when a question about the occurrence of a pre-specified event was not answered.
- Should be null or have a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate
- whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified
- events; null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified
- event occurred when information about the occurrence of a specific event is solicited.][--STAT:
- Used to indicate when a question about the occurrence of a pre-specified event was not answered.
- Should be null or have a value of NOT DONE]"
- Document: Model v1.4
- Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)]
- Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0404
- Version: "2"
- Version: "2.0"
- Version: "3.2"
- - Name: SDTMIG
- References:
- - Citations:
- - Cited Guidance: "Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
- is pre-specified on a CRF. Values should be 'Y' or null.][--OCCUR: Used to record whether a
- pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT:
- Used to indicate when a question about the occurrence of a pre-specified event was not answered.
- Should be null or have a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate
- whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified
- events; null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified
- event occurred when information about the occurrence of a specific event is solicited.][--STAT:
- Used to indicate when a question about the occurrence of a pre-specified event was not answered.
- Should be null or have a value of NOT DONE]"
- Document: Model v1.7
- Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)]
- Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0404
- Version: "2"
- Version: "2.0"
- Version: "3.3"
- - Name: TIG
- References:
- - Citations:
- - Cited Guidance: An indication that the event was prospectively stated or detailed on the CRF
- | An indication that the intervention was prospectively stated or detailed on the CRF.
- Document: SDTM v2.1
- Item: --PRESP
- Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings
- Observation Class
- - Cited Guidance: An indication as to whether a prespecified event has occurred. | An
- indication as to whether a prespecified intervention has occurred
- Document: SDTM v2.1
- Item: --OCCUR
- Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings
- Observation Class
- - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified
- event was not answered. Should be null or have a value of "NOT DONE" | Used to indicate
- when a question about the occurrence of a prespecified intervention was not answered.
- Should be null or have a value of "NOT DONE".
- Document: SDTM v2.1
- Item: --STAT
- Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings
- Observation Class
- Origin: TIG Conformance Rules
- Rule Identifier:
- Id: TIG0562
- Version: "1"
- Version: "1.0"
- Substandard: SDTM
- Version: "1.0"
+ - Organization: CDISC
+ Standards:
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance: An indication that the event was prospectively stated or detailed on the CRF
+ Document: SDTM v2.0
+ Item: --PRESP
+ Section: Events
+ - Cited Guidance: An indication as to whether a prespecified event has occurred
+ Document: SDTM v2.0
+ Item: --OCCUR
+ Section: Events
+ - Cited Guidance:
+ Used to indicate when a question about the occurrence of a prespecified
+ event was not answered. Should be null or have a value of 'NOT DONE'
+ Document: Model v2.0
+ Item: --STAT
+ Section: Events
+ - Cited Guidance:
+ An indication that the intervention was prospectively stated or detailed on
+ the CRF
+ Document: Model v2.0
+ Item: --PRESP
+ Section: Interventions
+ - Cited Guidance: An indication as to whether a prespecified intervention has occurred.
+ Document: Model v2.0
+ Item: --OCCUR
+ Section: Interventions
+ - Cited Guidance:
+ Used to indicate when a question about the occurrence of a prespecified
+ intervention was not answered. Should be null or have a value of 'NOT DONE'
+ Document: Model v2.0
+ Item: --STAT
+ Section: Interventions
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0404
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ "Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
+ is pre-specified on a CRF. Values should be 'Y' or null.][--OCCUR: Used to record whether a
+ pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT:
+ Used to indicate when a question about the occurrence of a pre-specified event was not answered.
+ Should be null or have a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate
+ whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified
+ events; null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified
+ event occurred when information about the occurrence of a specific event is solicited.][--STAT:
+ Used to indicate when a question about the occurrence of a pre-specified event was not answered.
+ Should be null or have a value of NOT DONE]"
+ Document: Model v1.4
+ Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)]
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0404
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ "Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
+ is pre-specified on a CRF. Values should be 'Y' or null.][--OCCUR: Used to record whether a
+ pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT:
+ Used to indicate when a question about the occurrence of a pre-specified event was not answered.
+ Should be null or have a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate
+ whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified
+ events; null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified
+ event occurred when information about the occurrence of a specific event is solicited.][--STAT:
+ Used to indicate when a question about the occurrence of a pre-specified event was not answered.
+ Should be null or have a value of NOT DONE]"
+ Document: Model v1.7
+ Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)]
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0404
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
+ - Name: TIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ An indication that the event was prospectively stated or detailed on the CRF
+ | An indication that the intervention was prospectively stated or detailed on the CRF.
+ Document: SDTM v2.1
+ Item: --PRESP
+ Section:
+ Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings
+ Observation Class
+ - Cited Guidance: An indication as to whether a prespecified event has occurred. | An
+ indication as to whether a prespecified intervention has occurred
+ Document: SDTM v2.1
+ Item: --OCCUR
+ Section:
+ Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings
+ Observation Class
+ - Cited Guidance:
+ Used to indicate when a question about the occurrence of a prespecified
+ event was not answered. Should be null or have a value of "NOT DONE" | Used to indicate
+ when a question about the occurrence of a prespecified intervention was not answered.
+ Should be null or have a value of "NOT DONE".
+ Document: SDTM v2.1
+ Item: --STAT
+ Section:
+ Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings
+ Observation Class
+ Origin: TIG Conformance Rules
+ Rule Identifier:
+ Id: TIG0562
+ Version: "1"
+ Version: "1.0"
+ Substandard: SDTM
+ Version: "1.0"
Check:
all:
- - name: --PRESP
- operator: equal_to
- value: Y
- - name: --OCCUR
- operator: empty
- - name: --STAT
- operator: not_exists
+ - name: --PRESP
+ operator: equal_to
+ value: Y
+ - name: --OCCUR
+ operator: empty
+ - name: --STAT
+ operator: not_exists
Core:
Id: CORE-000118
Status: Published
Version: "1"
-Description: Raise an error when --PRESP is equal to 'Y' and --OCCUR is empty and --STAT is not
+Description: Raise an error when --PRESP is equal to 'Y' and --OCCUR is empty and --STAT is not
present in dataset.
Executability: Fully Executable
Outcome:
Message: --STAT is not present in dataset when --PRESP is equal to "Y" and --OCCUR is blank
+ Output Variables:
+ - --PRESP
+ - --OCCUR
Rule Type: Record Data
Scope:
Classes:
Include:
- - EVENTS
- - INTERVENTIONS
+ - EVENTS
+ - INTERVENTIONS
Domains:
Exclude:
- - DS
- - DV
- - EX
+ - DS
+ - DV
+ - EX
Use Case: INDH, PROD
Sensitivity: Record
diff --git a/Published/CORE-000119/rule.yml b/Published/CORE-000119/rule.yml
index 754046a57..060ea5b3e 100644
--- a/Published/CORE-000119/rule.yml
+++ b/Published/CORE-000119/rule.yml
@@ -7,46 +7,49 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If ARMCD is null, then ARM must be null and ARMNRS must be
- populated with the reason ARMCD is null.
+ - Cited Guidance:
+ If ARMCD is null, then ARM must be null and ARMNRS must be populated with
+ the reason ARMCD is null.
Document: IG v3.4
Item: Assumption 4
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0521
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If ARMCD is null, then ARM must be null and ARMNRS must be
- populated with the reason ARMCD is null.
+ - Cited Guidance:
+ If ARMCD is null, then ARM must be null and ARMNRS must be populated with
+ the reason ARMCD is null.
Document: IG v3.3
Item: Assumption 4
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0521
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If ARMCD is null, then ARM must be null and ARMNRS must be
- populated with the reason ARMCD is null.
+ - Cited Guidance:
+ If ARMCD is null, then ARM must be null and ARMNRS must be populated with
+ the reason ARMCD is null.
Document: TIG 1.0
Item: Assumption 4.a.ii
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0616
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ARMCD
@@ -56,7 +59,7 @@ Check:
Core:
Id: CORE-000119
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when ARM is not empty, but ARMCD is empty
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000120/rule.yml b/Published/CORE-000120/rule.yml
index a6b36a9bc..1fd712287 100644
--- a/Published/CORE-000120/rule.yml
+++ b/Published/CORE-000120/rule.yml
@@ -7,55 +7,51 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "\"If ACTARMCD is null, then ACTARM must be null and ARMNRS
- must be populated with the reason ACTARMCD is null.
-
- \ Both ARMCD and ACTARMCD will be null for
- subjects who were not assigned to treatment.\
-
- \ The same reason will provide the reason
- that both are null.\""
+ - Cited Guidance:
+ "\"If ACTARMCD is null, then ACTARM must be null and ARMNRS must be populated
+ with the reason ACTARMCD is null.\n Both ARMCD and ACTARMCD will be null for subjects who were
+ not assigned to treatment. \n The same reason will provide the reason that both are null.\""
Document: IG v3.4
Item: Assumption 4
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0522
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If ACTARMCD is null, then ACTARM must be null and ARMNRS must be
- populated with the reason ACTARMCD is null.
+ - Cited Guidance:
+ If ACTARMCD is null, then ACTARM must be null and ARMNRS must be populated
+ with the reason ACTARMCD is null.
Document: IG v3.3
Item: Assumption 4
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0522
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If ACTARMCD is null, then ACTARM must be null and ARMNRS must be
- populated with the reason ACTARMCD is null. Both ARMCD and
- ACTARMCD will be null for subjects who were not assigned to an
- arm. The same reason will provide the reason that both are
- null.
+ - Cited Guidance:
+ If ACTARMCD is null, then ACTARM must be null and ARMNRS must be populated
+ with the reason ACTARMCD is null. Both ARMCD and ACTARMCD will be null for subjects who
+ were not assigned to an arm. The same reason will provide the reason that both are null.
Document: TIG 1.0
Item: Assumption 4.a.ii
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0617
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ACTARMCD
@@ -65,7 +61,7 @@ Check:
Core:
Id: CORE-000120
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when ACTARM is not empty, but ACTARMCD is empty
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000121/rule.yml b/Published/CORE-000121/rule.yml
index a1c00324b..94336c088 100644
--- a/Published/CORE-000121/rule.yml
+++ b/Published/CORE-000121/rule.yml
@@ -7,54 +7,52 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "\"Specification [A coded reason that arm variables (ARM and
- ARMCD) and/or actual arm variables (ACTARM and ACTARMCD) are
- null.]
-
- \ Assumption 4[ARMNRS may not be populated if both ARMCD and
- ACTARMCD are populated]\""
+ - Cited Guidance:
+ "\"Specification [A coded reason that arm variables (ARM and ARMCD) and/or actual
+ arm variables (ACTARM and ACTARMCD) are null.]\n Assumption 4[ARMNRS may not be populated if
+ both ARMCD and ACTARMCD are populated]\""
Document: IG v3.4
Item: Specification|Assumption 4
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0520
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Specification[A coded reason that arm variables (ARM and ARMCD)
- and/or actual arm variables (ACTARM and ACTARMCD) are
- null.]|Assumption 4[ARMNRS may not be populated if both ARMCD
- and ACTARMCD are populated]
+ - Cited Guidance:
+ Specification[A coded reason that arm variables (ARM and ARMCD) and/or
+ actual arm variables (ACTARM and ACTARMCD) are null.]|Assumption 4[ARMNRS may not be
+ populated if both ARMCD and ACTARMCD are populated]
Document: IG v3.3
Item: Specification|Assumption 4
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0520
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Specification ARMNRS [A coded reason that arm variables (ARM
- and ARMCD) and/or actual arm variables (ACTARM and ACTARMCD)
- are null.]|Assumption 4[ARMNRS may not be populated if both
- ARMCD and ACTARMCD are populated]
+ - Cited Guidance:
+ Specification ARMNRS [A coded reason that arm variables (ARM and ARMCD)
+ and/or actual arm variables (ACTARM and ACTARMCD) are null.]|Assumption 4[ARMNRS may not
+ be populated if both ARMCD and ACTARMCD are populated]
Document: TIG 1.0
Item: Specification|Assumption 4.a.iii
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0615
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ARMCD
@@ -66,12 +64,11 @@ Check:
Core:
Id: CORE-000121
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify the value for ARMNRS, when both ARMCD and ACTARMCD values are populated
Executability: Fully Executable
Outcome:
- Message: Value for ARMNRS is populated, when both ARMCD and ACTARMCD values are
- populated
+ Message: Value for ARMNRS is populated, when both ARMCD and ACTARMCD values are populated
Output Variables:
- ARMCD
- ACTARMCD
diff --git a/Published/CORE-000122/rule.yml b/Published/CORE-000122/rule.yml
index f3ed80647..94ecd3b5d 100644
--- a/Published/CORE-000122/rule.yml
+++ b/Published/CORE-000122/rule.yml
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0434
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -26,9 +26,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0434
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -38,9 +38,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0434
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -51,10 +51,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0586
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -74,9 +74,8 @@ Check:
Core:
Id: CORE-000122
Status: Published
- Version: '1'
-Description: Raise an error when AGEU is completed but both AGETXT and AGE are
- not completed.
+ Version: "1"
+Description: Raise an error when AGEU is completed but both AGETXT and AGE are not completed.
Executability: Fully Executable
Outcome:
Message: AGEU is completed, but both AGE and AGETXT are not completed.
diff --git a/Published/CORE-000123/rule.yml b/Published/CORE-000123/rule.yml
index b13ad7be8..f6e5ad35b 100644
--- a/Published/CORE-000123/rule.yml
+++ b/Published/CORE-000123/rule.yml
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0388
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -27,23 +27,24 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0388
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Was the event associated with the development of cancer? Valid
- values are 'Y' and 'N'.
+ - Cited Guidance:
+ Was the event associated with the development of cancer? Valid values are
+ 'Y' and 'N'.
Document: Model v1.4
- Item: ''
+ Item: ""
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0388
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
@@ -54,10 +55,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0550
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AESCAN
@@ -70,7 +71,7 @@ Check:
Core:
Id: CORE-000123
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AESCAN is completed and value is not 'Y' or 'N'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000124/rule.yml b/Published/CORE-000124/rule.yml
index 36703a36a..4ad8100b6 100644
--- a/Published/CORE-000124/rule.yml
+++ b/Published/CORE-000124/rule.yml
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0389
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -27,23 +27,24 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0389
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Was the event associated with congenital anomaly or birth
- defect? Valid values are 'Y' and 'N'.
+ - Cited Guidance:
+ Was the event associated with congenital anomaly or birth defect? Valid
+ values are 'Y' and 'N'.
Document: Model v1.4
- Item: ''
+ Item: ""
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0389
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
@@ -54,10 +55,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0551
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AESCONG
@@ -70,7 +71,7 @@ Check:
Core:
Id: CORE-000124
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AESCONG is completed and value is not 'Y' or 'N'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000125/rule.yml b/Published/CORE-000125/rule.yml
index bab5f2102..7ea3e2e7c 100644
--- a/Published/CORE-000125/rule.yml
+++ b/Published/CORE-000125/rule.yml
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0390
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -27,23 +27,24 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0390
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Did the event result in persistent or significant
- disability/incapacity? Valid values are 'Y' and 'N'.
+ - Cited Guidance:
+ Did the event result in persistent or significant disability/incapacity?
+ Valid values are 'Y' and 'N'.
Document: Model v1.4
- Item: ''
+ Item: ""
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0390
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
@@ -54,10 +55,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0552
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AESDISAB
@@ -70,7 +71,7 @@ Check:
Core:
Id: CORE-000125
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AESDISAB is completed and value is not 'Y' or 'N'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000126/rule.yml b/Published/CORE-000126/rule.yml
index 8a60e362f..5a94dc078 100644
--- a/Published/CORE-000126/rule.yml
+++ b/Published/CORE-000126/rule.yml
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0391
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -27,22 +27,22 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0391
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Did the event result in death? Valid values are 'Y' and 'N'.
Document: Model v1.4
- Item: ''
+ Item: ""
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0391
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
@@ -53,10 +53,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0553
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AESDTH
@@ -69,7 +69,7 @@ Check:
Core:
Id: CORE-000126
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AESDTH is completed and value is not 'Y' or 'N'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000127/rule.yml b/Published/CORE-000127/rule.yml
index 3492297f6..ba2b7375e 100644
--- a/Published/CORE-000127/rule.yml
+++ b/Published/CORE-000127/rule.yml
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0392
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -27,23 +27,24 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0392
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Did the event require or prolong hospitalization? Valid values
- are 'Y' and 'N'.
+ - Cited Guidance:
+ Did the event require or prolong hospitalization? Valid values are 'Y' and
+ 'N'.
Document: Model v1.4
- Item: ''
+ Item: ""
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0392
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
@@ -54,10 +55,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0554
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AESHOSP
@@ -70,7 +71,7 @@ Check:
Core:
Id: CORE-000127
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AESHOSP is completed and value is not 'Y' or 'N'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000128/rule.yml b/Published/CORE-000128/rule.yml
index dbd56508a..6285435b4 100644
--- a/Published/CORE-000128/rule.yml
+++ b/Published/CORE-000128/rule.yml
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0393
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -27,23 +27,24 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0393
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Did the event require or prolong hospitalization? Valid values
- are 'Y' and 'N'.
+ - Cited Guidance:
+ Did the event require or prolong hospitalization? Valid values are 'Y' and
+ 'N'.
Document: Model v1.4
- Item: ''
+ Item: ""
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0393
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
@@ -54,10 +55,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0555
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AESLIFE
@@ -70,7 +71,7 @@ Check:
Core:
Id: CORE-000128
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AESLIFE is completed and value is not 'Y' or 'N'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000129/rule.yml b/Published/CORE-000129/rule.yml
index 0363bf1e3..b67a688b5 100644
--- a/Published/CORE-000129/rule.yml
+++ b/Published/CORE-000129/rule.yml
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0394
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -27,23 +27,22 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0394
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Did the event occur with an overdose? Valid values are 'Y' and
- 'N'.
+ - Cited Guidance: Did the event occur with an overdose? Valid values are 'Y' and 'N'.
Document: Model v1.4
- Item: ''
+ Item: ""
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0394
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
@@ -54,10 +53,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0556
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AESOD
@@ -70,7 +69,7 @@ Check:
Core:
Id: CORE-000129
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AESOD is completed and value is not 'Y' or 'N'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000130/rule.yml b/Published/CORE-000130/rule.yml
index 91cdc2c42..54b214a51 100644
--- a/Published/CORE-000130/rule.yml
+++ b/Published/CORE-000130/rule.yml
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0395
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -27,23 +27,24 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0395
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Do additional categories for seriousness apply? Valid values are
- 'Y' and 'N'.
+ - Cited Guidance:
+ Do additional categories for seriousness apply? Valid values are 'Y' and
+ 'N'.
Document: Model v1.4
- Item: ''
+ Item: ""
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0395
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
@@ -54,10 +55,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0557
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AESMIE
@@ -70,7 +71,7 @@ Check:
Core:
Id: CORE-000130
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AESMIE is completed and value is not 'Y' or 'N'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000131/rule.yml b/Published/CORE-000131/rule.yml
index 5cfcf9875..c370ff42b 100644
--- a/Published/CORE-000131/rule.yml
+++ b/Published/CORE-000131/rule.yml
@@ -14,37 +14,39 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0396
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Was another treatment given because of the occurrence of the
- event? Valid values are "Y", "N", and null.
+ - Cited Guidance:
+ Was another treatment given because of the occurrence of the event? Valid
+ values are "Y", "N", and null.
Document: Model v1.7
Item: --CONTRT
Section: 2.2.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0396
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Was another treatment given because of the occurrence of the
- event? Valid values are 'Y' and 'N'.
+ - Cited Guidance:
+ Was another treatment given because of the occurrence of the event? Valid
+ values are 'Y' and 'N'.
Document: Model v1.4
- Item: ''
+ Item: ""
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0396
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
@@ -55,10 +57,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0558
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AECONTRT
@@ -71,7 +73,7 @@ Check:
Core:
Id: CORE-000131
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AECONTRT is completed and value is not 'Y' or 'N'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000132/rule.yml b/Published/CORE-000132/rule.yml
index 4ab241785..3a07b4eac 100644
--- a/Published/CORE-000132/rule.yml
+++ b/Published/CORE-000132/rule.yml
@@ -7,287 +7,290 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and
- does not have special character restrictions.
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT) is limited to 8 characters and does not have
+ special character restrictions.
Document: IG v3.4
Item: Specification
Section: 5.3|7.2.1|7.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0154
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and
- does not have special character restrictions.
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT) is limited to 8 characters and does not have
+ special character restrictions.
Document: IG v3.2
Item: Specification
Section: 5|7.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0154
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and
- does not have special character restrictions.
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT) is limited to 8 characters and does not have
+ special character restrictions.
Document: IG v3.3
Item: Specification
Section: 5.2|7.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0154
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Elements with different start and end rules are different
- Elements and must be represented as unique values in ELEMENT
- and ETCD.
+ - Cited Guidance:
+ Elements with different start and end rules are different Elements and must
+ be represented as unique values in ELEMENT and ETCD.
Document: IG v3.0
Item: Specification
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND213
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Elements with different start and end rules are different
- Elements and must be represented as unique values in ELEMENT
- and ETCD.
+ - Cited Guidance:
+ Elements with different start and end rules are different Elements and must
+ be represented as unique values in ELEMENT and ETCD.
Document: IG v3.1
Item: Specification
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND213
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Elements with different start and end rules are different
- Elements and must be represented as unique values in ELEMENT
- and ETCD.
+ - Cited Guidance:
+ Elements with different start and end rules are different Elements and must
+ be represented as unique values in ELEMENT and ETCD.
Document: IG v3.1.1
Item: Specification
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND213
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Elements with different start and end rules are different
- Elements and must be represented as unique values in ELEMENT
- and ETCD.
+ - Cited Guidance:
+ Elements with different start and end rules are different Elements and must
+ be represented as unique values in ELEMENT and ETCD.
Document: IG v3.1
Item: Specification
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND213
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Elements with different start and end rules are different
- Elements and must be represented as unique values in ELEMENT
- and ETCD.
+ - Cited Guidance:
+ Elements with different start and end rules are different Elements and must
+ be represented as unique values in ELEMENT and ETCD.
Document: IG v3.1.1
Item: Specification
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND213
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Elements with different start and end rules are different
- Elements and must be represented as unique values in ELEMENT
- and ETCD.
+ - Cited Guidance:
+ Elements with different start and end rules are different Elements and must
+ be represented as unique values in ELEMENT and ETCD.
Document: IG v3.1.1
Item: Specification
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND213
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0914
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0914
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0914
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0914
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0914
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0914
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0914
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0914
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0914
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0914
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: ETCD
@@ -304,7 +307,7 @@ Check:
Core:
Id: CORE-000132
Status: Published
- Version: '1'
+ Version: "1"
Description: ETCD and ELEMENT should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000133/rule.yml b/Published/CORE-000133/rule.yml
index be8224842..188b1ffd7 100644
--- a/Published/CORE-000133/rule.yml
+++ b/Published/CORE-000133/rule.yml
@@ -4,60 +4,61 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The unit of measure for the standardized result of the
- measurement, test, or examination. Variable(s) Qualified,
- --STRESC and --STRESN and --STNRLO and --STNRHI and --STREFC
- and --STREFN and --LLOQ and --ULOQ.
+ - Cited Guidance:
+ The unit of measure for the standardized result of the measurement, test, or
+ examination. Variable(s) Qualified, --STRESC and --STRESN and --STNRLO and --STNRHI and
+ --STREFC and --STREFN and --LLOQ and --ULOQ.
Document: Model v2.0
Section: Findings
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0426
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '--STRESU: Standardized units used for --STRESC and --STRESN.'
+ - Cited Guidance: "--STRESU: Standardized units used for --STRESC and --STRESN."
Document: Model v1.4
Section: 2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0426
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '--STRESU: Standardized units used for --STRESC, --STRESN,
- --STREFC, and --STREFN. Example: "mol/L".'
+ - Cited Guidance:
+ '--STRESU: Standardized units used for --STRESC, --STRESN, --STREFC, and --STREFN.
+ Example: "mol/L".'
Document: Model v1.7
Section: 2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0426
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 'The unit of measure for the standardized result of the
- measurement, test, or examination. Variable(s) Qualified:
- --STRESC and --STRESN and --STNRLO and --STNRHI and --STREFC
- and --STREFN and --LLOQ and --ULOQ.'
+ - Cited Guidance:
+ "The unit of measure for the standardized result of the measurement, test, or
+ examination. Variable(s) Qualified: --STRESC and --STRESN and --STNRLO and --STNRHI and --STREFC
+ and --STREFN and --LLOQ and --ULOQ."
Document: SDTM v2.1
Item: --STRESU
Section: 3.1.3 The Findings Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0580
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
# Variable: --STRESC
# Condition: --STRESU ^= null
# Rule: --STRESC (in standard units) ^= null
@@ -70,10 +71,9 @@ Check:
Core:
Id: CORE-000133
Status: Published
- Version: '1'
-Description: When --STRESU is populated, --STRESC must also be populated. Please
- note that this rule, as executed, cannot check if --STRESC is populated with
- the standardized unit.
+ Version: "1"
+Description: When --STRESU is populated, --STRESC must also be populated. Please note that this
+ rule, as executed, cannot check if --STRESC is populated with the standardized unit.
Executability: Fully Executable
Outcome:
Message: Missing value for --STRESC, when --STRESU is provided
diff --git a/Published/CORE-000134/rule.yml b/Published/CORE-000134/rule.yml
index 84993b4e0..fdcc6a1b5 100644
--- a/Published/CORE-000134/rule.yml
+++ b/Published/CORE-000134/rule.yml
@@ -7,77 +7,71 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A record in a SUPP-- dataset relates back to its parent
- record(s) via the key identified by the STUDYID, RDOMAIN,
- USUBJID, and IDVAR/IDVARVAL variables. An exception is SUPP--
- dataset records that are related to Demographics (DM)
- records, where both IDVAR and IDVARVAL will be null because
- the key variables STUDYID, RDOMAIN, and USUBJID are sufficient
- to identify the unique parent record in DM (DM has one record
- per USUBJID)
+ - Cited Guidance:
+ A record in a SUPP-- dataset relates back to its parent record(s) via the
+ key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. An
+ exception is SUPP-- dataset records that are related to Demographics (DM) records, where
+ both IDVAR and IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and
+ USUBJID are sufficient to identify the unique parent record in DM (DM has one record per
+ USUBJID)
Document: SDTMIG v3.4
Section: 8.4.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0203
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A record in a SUPP-- dataset relates back to its parent
- record(s) via the key identified by the STUDYID, RDOMAIN,and
- IDVAR/IDVARVAL variables. An exception is SUPP-- dataset
- records that are related to Demographics (DM) records, such as
- the Intent To Treat (ITT) and Safety (SAFETY) subject-level
- population flags, where both IDVAR and IDVARVAL will be null
- because the key variables STUDYID, RDOMAIN, and USUBJID are
- sufficient to identify the unique parent record in DM (DM has
- one record per USUBJID).
+ - Cited Guidance:
+ A record in a SUPP-- dataset relates back to its parent record(s) via the
+ key identified by the STUDYID, RDOMAIN,and IDVAR/IDVARVAL variables. An exception is
+ SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent
+ To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and
+ IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are
+ sufficient to identify the unique parent record in DM (DM has one record per USUBJID).
Document: SDTMIG v3.3
Section: 8.4.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0203
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A record in a SUPP-- dataset relates back to its parent
- record(s) via the key identified by the STUDYID, RDOMAIN,and
- IDVAR/IDVARVAL variables. An exception is SUPP-- dataset
- records that are related to Demographics (DM) records, such as
- the Intent To Treat (ITT) and Safety (SAFETY) subject-level
- population flags, where both IDVAR and IDVARVAL will be null
- because the key variables STUDYID, RDOMAIN, and USUBJID are
- sufficient to identify the unique parent record in DM (DM has
- one record per USUBJID).
+ - Cited Guidance:
+ A record in a SUPP-- dataset relates back to its parent record(s) via the
+ key identified by the STUDYID, RDOMAIN,and IDVAR/IDVARVAL variables. An exception is
+ SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent
+ To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and
+ IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are
+ sufficient to identify the unique parent record in DM (DM has one record per USUBJID).
Document: SDTMIG v3.2
Section: 8.4.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0203
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: IDVAR and IDVARVAL will be populated in all SUPP-- datasets with
- the exception of SUPPDM. IDVAR and IDVARVAL will not be
- populated in SUPPDM.
+ - Cited Guidance: IDVAR and IDVARVAL will be populated in all SUPP-- datasets with the
+ exception of SUPPDM. IDVAR and IDVARVAL will not be populated in SUPPDM.
Document: TIG 1.0
Section: 2.8.5.3
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0423
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: RDOMAIN
@@ -89,7 +83,7 @@ Check:
Core:
Id: CORE-000134
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when RDOMAIN ^= 'DM' and IDVAR is empty.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000135/rule.yml b/Published/CORE-000135/rule.yml
index 0415cfb5b..1caa191fb 100644
--- a/Published/CORE-000135/rule.yml
+++ b/Published/CORE-000135/rule.yml
@@ -7,76 +7,71 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A record in a SUPP-- dataset relates back to its parent
- record(s) via the key identified by the STUDYID, RDOMAIN,
- USUBJID, and IDVAR/IDVARVAL variables. An exception is SUPP--
- dataset records that are related to Demographics (DM)
- records, where both IDVAR and IDVARVAL will be null because
- the key variables STUDYID, RDOMAIN, and USUBJID are sufficient
- to identify the unique parent record in DM (DM has one record
- per USUBJID)
+ - Cited Guidance:
+ A record in a SUPP-- dataset relates back to its parent record(s) via the
+ key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. An
+ exception is SUPP-- dataset records that are related to Demographics (DM) records, where
+ both IDVAR and IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and
+ USUBJID are sufficient to identify the unique parent record in DM (DM has one record per
+ USUBJID)
Document: SDTMIG v3.4
Section: 8.4.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0204
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A record in a SUPP-- dataset relates back to its parent
- record(s) via the key identified by the STUDYID, RDOMAIN, and
- IDVAR/IDVARVAL variables. An exception is SUPP-- dataset
- records that are related to Demographics (DM) records, such as
- the Intent To Treat (ITT) and Safety (SAFETY) subject-level
- population flags, where both IDVAR and IDVARVAL will be null
- because the key variables STUDYID, RDOMAIN, and USUBJID are
- sufficient to identify the unique parent record in DM (DM has
- one record per USUBJID).
+ - Cited Guidance:
+ A record in a SUPP-- dataset relates back to its parent record(s) via the
+ key identified by the STUDYID, RDOMAIN, and IDVAR/IDVARVAL variables. An exception is
+ SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent
+ To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and
+ IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are
+ sufficient to identify the unique parent record in DM (DM has one record per USUBJID).
Document: SDTMIG v3.3
Section: 8.4.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0204
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A record in a SUPP-- dataset relates back to its parent
- record(s) via the key identified by the STUDYID, RDOMAIN, and
- IDVAR/IDVARVAL variables. An exception is SUPP-- dataset
- records that are related to Demographics (DM) records, such as
- the Intent To Treat (ITT) and Safety (SAFETY) subject-level
- population flags, where both IDVAR and IDVARVAL will be null
- because the key variables STUDYID, RDOMAIN, and USUBJID are
- sufficient to identify the unique parent record in DM (DM has
- one record per USUBJID).
+ - Cited Guidance:
+ A record in a SUPP-- dataset relates back to its parent record(s) via the
+ key identified by the STUDYID, RDOMAIN, and IDVAR/IDVARVAL variables. An exception is
+ SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent
+ To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and
+ IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are
+ sufficient to identify the unique parent record in DM (DM has one record per USUBJID).
Document: SDTMIG v3.2
Section: 8.4.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0204
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: IDVAR and IDVARVAL will be populated in all SUPP-- datasets with
- the exception of SUPPDM.
+ - Cited Guidance: IDVAR and IDVARVAL will be populated in all SUPP-- datasets with the
+ exception of SUPPDM.
Document: TIG 1.0
Section: 2.8.5.3
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0424
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IDVAR
@@ -86,7 +81,7 @@ Check:
Core:
Id: CORE-000135
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when IDVAR is not empty and IDVARVAL is empty.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000136/rule.yml b/Published/CORE-000136/rule.yml
index 9769ec3b7..5f0eb2c5a 100644
--- a/Published/CORE-000136/rule.yml
+++ b/Published/CORE-000136/rule.yml
@@ -7,71 +7,68 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: This example shows how to use the RELREC dataset to represent
- related information that is submitted as two datasets that
- have a one-to-many relationship. in the example below all the
- records in one domain are being related to all of the records
- in the other, so both USUBJID and IDVARVAL are null.... Since
- IDVAR identifies the keys that can be used to
- merge/join records between the datasets, --SEQ cannot be used
- because --SEQ only has meaning within a subject within a
- dataset, not across datasets.
+ - Cited Guidance:
+ This example shows how to use the RELREC dataset to represent related
+ information that is submitted as two datasets that have a one-to-many relationship. in the
+ example below all the records in one domain are being related to all of the records in
+ the other, so both USUBJID and IDVARVAL are null.... Since IDVAR identifies the keys that
+ can be used to merge/join records between the datasets, --SEQ cannot be used because
+ --SEQ only has meaning within a subject within a dataset, not across datasets.
Document: IG v3.4
Section: 8.3.1 RELREC Dataset Relationship Example
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0201
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: This example shows how to use the RELREC dataset to represent
- related information that is submitted as two datasets that
- have a one-to-many relationship. in the example below all the
- records in one domain are being related to all of the records
- in the other, so both USUBJID and IDVARVAL are null.
+ - Cited Guidance:
+ This example shows how to use the RELREC dataset to represent related
+ information that is submitted as two datasets that have a one-to-many relationship. in the
+ example below all the records in one domain are being related to all of the records in the
+ other, so both USUBJID and IDVARVAL are null.
Document: IG v3.3
Section: 8.3.1 RELREC Dataset Relationship Example
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0201
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: This example shows how to use the RELREC dataset to represent
- related information that is submitted as two datasets that
- have a one-to-many relationship. in the example below all the
- records in one domain are being related to all of the records
- in the other, so both USUBJID and IDVARVAL are null.
+ - Cited Guidance:
+ This example shows how to use the RELREC dataset to represent related
+ information that is submitted as two datasets that have a one-to-many relationship. in the
+ example below all the records in one domain are being related to all of the records in the
+ other, so both USUBJID and IDVARVAL are null.
Document: IG v3.2
Section: 8.3.1 RELREC Dataset Relationship Example
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0201
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Relationships between datasets are specified using the key
- variables STUDYID, RDOMAIN, and IDVAR only. The values of
- variables USUBJID and IDVARVAL will be null as relationships
- between specific subject records will not be identified.
+ - Cited Guidance: Relationships between datasets are specified using the key variables
+ STUDYID, RDOMAIN, and IDVAR only. The values of variables USUBJID and IDVARVAL will be
+ null as relationships between specific subject records will not be identified.
Document: TIG 1.0
Section: 2.8.5.2
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0422
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IDVARVAL
@@ -84,7 +81,7 @@ Check:
Core:
Id: CORE-000136
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when IDVARVAL and USUBJID are empty and IDVAR = Sequence Number.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000137/rule.yml b/Published/CORE-000137/rule.yml
index 2e1f60916..37d9626a8 100644
--- a/Published/CORE-000137/rule.yml
+++ b/Published/CORE-000137/rule.yml
@@ -7,108 +7,99 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL
- infused at a visit, then ECOCCUR = 'N' is the standard
- representation of the collected doses not taken, not given, or
- missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must
- not be set to zero (0) as an alternative method for indicating
- doses not taken, not given, or missed.
+ - Cited Guidance:
+ For example, if 0 tablets are taken within a timeframe or 0 mL infused at a
+ visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken,
+ not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to
+ zero (0) as an alternative method for indicating doses not taken, not given, or missed.
Document: IG v3.4
Item: Assumption 4a
Section: 6.1.3.2
- - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT)
- may be populated with positive (non-zero) values in cases
- where the sponsor feels it is necessary and/or appropriate to
- represent specific dose amounts not taken, not given, or
- missed.
+ - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be
+ populated with positive (non-zero) values in cases where the sponsor feels it is necessary
+ and/or appropriate to represent specific dose amounts not taken, not given, or missed.
Document: IG v3.4
Item: Assumption 4b
Section: 6.1.3.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0100
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL
- infused at a visit, then ECOCCUR = 'N' is the standard
- representation of the collected doses not taken, not given, or
- missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must
- not be set to zero (0) as an alternative method for indicating
- doses not taken, not given, or missed.
+ - Cited Guidance:
+ For example, if 0 tablets are taken within a timeframe or 0 mL infused at a
+ visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken,
+ not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to
+ zero (0) as an alternative method for indicating doses not taken, not given, or missed.
Document: IG v3.3
Item: Assumption 4a
Section: 6.1.3.2
- - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT)
- may be populated with positive (non-zero) values in cases
- where the sponsor feels it is necessary and/or appropriate to
- represent specific dose amounts not taken, not given, or
- missed.
+ - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be
+ populated with positive (non-zero) values in cases where the sponsor feels it is necessary
+ and/or appropriate to represent specific dose amounts not taken, not given, or missed.
Document: IG v3.3
Item: Assumption 4b
Section: 6.1.3.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0100
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL
- infused at a visit, then ECOCCUR = 'N' is the standard
- representation of the collected doses not taken, not given, or
- missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must
- not be set to zero (0) as an alternative method for indicating
- doses not taken, not given, or missed.
+ - Cited Guidance:
+ For example, if 0 tablets are taken within a timeframe or 0 mL infused at a
+ visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken,
+ not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to
+ zero (0) as an alternative method for indicating doses not taken, not given, or missed.
Document: IG v3.2
Item: Assumption 4a
Section: 6.1.
- - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT)
- may be populated with positive (non-zero) values in cases
- where the sponsor feels it is necessary and/or appropriate to
- represent specific dose amounts not taken, not given, or
- missed.
+ - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be
+ populated with positive (non-zero) values in cases where the sponsor feels it is necessary
+ and/or appropriate to represent specific dose amounts not taken, not given, or missed.
Document: IG v3.2
Item: Assumption 4b
Section: 6.1.
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0100
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a
- timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is
- the standard representation of the collected doses not taken,
- not given, or missed. Dose amount variables (e.g., ECDOSE,
- ECDOSTXT) must not be set to zero (0) as an alternative method
- for indicating doses not taken, not given, or missed.]
+ - Cited Guidance:
+ Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL
+ infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected
+ doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must
+ not be set to zero (0) as an alternative method for indicating doses not taken, not given,
+ or missed.]
Document: TIG 1.0
Item: Assumption 4a
Section: 2.8.10.11
- - Cited Guidance: Assumption 4b[Qualifiers that indicate dose amount (e.g.,
- ECDOSE, ECDOSTXT) may be populated with positive (non-zero)
- values in cases where the sponsor feels it is necessary and/or
- appropriate to represent specific dose amounts not taken, not
- given, or missed.]
+ - Cited Guidance:
+ Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT)
+ may be populated with positive (non-zero) values in cases where the sponsor feels it is
+ necessary and/or appropriate to represent specific dose amounts not taken, not given, or
+ missed.]
Document: TIG 1.0
Item: Assumption 4b
Section: 2.8.10.11
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0365
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -162,13 +153,13 @@ Check:
Core:
Id: CORE-000137
Status: Published
- Version: '1'
-Description: Raise an error when ECOCCUR is not equal to 'N', ECSTAT and
- ECDOSTXT are both empty but ECDOSE less than or equal to 0.
+ Version: "1"
+Description: Raise an error when ECOCCUR is not equal to 'N', ECSTAT and ECDOSTXT are both empty but
+ ECDOSE less than or equal to 0.
Executability: Fully Executable
Outcome:
- Message: ECOCCUR is not 'N', ECSTAT and ECDOSTXT are both empty but ECDOSE is
- less than or equal to 0.
+ Message: ECOCCUR is not 'N', ECSTAT and ECDOSTXT are both empty but ECDOSE is less than or equal
+ to 0.
Output Variables:
- ECOCCUR
- ECSTAT
diff --git a/Published/CORE-000138/rule.yml b/Published/CORE-000138/rule.yml
index 1dfce1da1..19c12b443 100644
--- a/Published/CORE-000138/rule.yml
+++ b/Published/CORE-000138/rule.yml
@@ -7,98 +7,89 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1. They are determined by comparing the
- date portion of the respective date/time variables (--DTC,
- --STDTC, and --ENDTC) to the date portion of the Subject
- Reference Start Date (RFSTDTC from the Demographics domain).
+ - Cited Guidance:
+ The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1. They are
+ determined by comparing the date portion of the respective date/time variables (--DTC,
+ --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC
+ from the Demographics domain).
Document: IG v3.4
Section: 4.4.4
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day.
- --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1
- if --DTC is on or after RFSTDTC, --DY = (date portion of
- --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.
- This algorithm should be used across all domains.
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day. --DY =
+ (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC,
+ --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This
+ algorithm should be used across all domains.
Document: IG v3.4
Section: 4.4.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0221
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1. They are determined by comparing the
- date portion of the respective date/time variables (--DTC,
- --STDTC, and --ENDTC) to the date portion of the Subject
- Reference Start Date (RFSTDTC from the Demographics
- domain).][All Study Day values are integers. Thus, to
- calculate Study Day: --DY = (date portion of --DTC) - (date
- portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
- = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.]'
+ - Cited Guidance:
+ "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1. They are determined
+ by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC)
+ to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All
+ Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across
+ all domains.]"
Document: IG v3.2
Section: 4.1.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0221
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1. They are determined by comparing the
- date portion of the respective date/time variables (--DTC,
- --STDTC, and --ENDTC) to the date portion of the Subject
- Reference Start Date (RFSTDTC from the Demographics
- domain).][All Study Day values are integers. Thus, to
- calculate Study Day: --DY = (date portion of --DTC) - (date
- portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
- = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.]'
+ - Cited Guidance:
+ "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1. They are determined
+ by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC)
+ to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All
+ Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across
+ all domains.]"
Document: IG v3.3
Section: 4.4.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0221
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1. They are determined by comparing the
- date portion of the respective date/time variables (--DTC,
- --STDTC, and --ENDTC) to the date portion of the Subject
- Reference Start Date (RFSTDTC from the Demographics
- domain).][All Study Day values are integers. Thus, to
- calculate Study Day: --DY = (date portion of --DTC) - (date
- portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
- = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.'
+ - Cited Guidance:
+ "The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative
+ day of the observation starting with the reference date as Day 1. They are determined by comparing
+ the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the
+ date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All
+ Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across
+ all domains."
Document: TIG 1.0
Item: Num 1
Section: 2.8.7.6
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0435
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -114,17 +105,16 @@ Check:
Core:
Id: CORE-000138
Status: Published
- Version: '1'
-Description: If --STDTC or DM.RFSTDTC does not contain a complete values, --STDY
- must be null.
+ Version: "1"
+Description: If --STDTC or DM.RFSTDTC does not contain a complete values, --STDY must be null.
Executability: Fully Executable
Match Datasets:
- Keys:
- USUBJID
Name: DM
Outcome:
- Message: --STDY is not null when either --STDTC or DM.RFSTDTC do not contain
- complete values in their date portion
+ Message: --STDY is not null when either --STDTC or DM.RFSTDTC do not contain complete values in
+ their date portion
Output Variables:
- --STDY
- --STDTC
diff --git a/Published/CORE-000139/rule.yml b/Published/CORE-000139/rule.yml
index 08b65df78..f58b07576 100644
--- a/Published/CORE-000139/rule.yml
+++ b/Published/CORE-000139/rule.yml
@@ -7,97 +7,85 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1. They are determined by comparing the
- date portion of the respective date/time variables (--DTC,
- --STDTC, and --ENDTC) to the date portion of the Subject
- Reference Start Date (RFSTDTC from the Demographics domain).
- All Study Day values are integers. Thus, to calculate Study
- Day, --DY = (date portion of --DTC) - (date portion of
- RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date
- portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.
+ - Cited Guidance:
+ The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1. They are
+ determined by comparing the date portion of the respective date/time variables (--DTC,
+ --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC
+ from the Demographics domain). All Study Day values are integers. Thus, to calculate Study
+ Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or
+ after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
+ precedes RFSTDTC. This algorithm should be used across all domains.
Document: IG v3.4
Section: 4.4.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0223
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1. They are determined by comparing the
- date portion of the respective date/time variables (--DTC,
- --STDTC, and --ENDTC) to the date portion of the Subject
- Reference Start Date (RFSTDTC from the Demographics
- domain).][All Study Day values are integers. Thus, to
- calculate Study Day, --DY = (date portion of --DTC) - (date
- portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
- = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.]'
+ - Cited Guidance:
+ "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1. They are determined
+ by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC)
+ to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All
+ Study Day values are integers. Thus, to calculate Study Day, --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across
+ all domains.]"
Document: IG v3.3
Section: 4.4.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0223
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1. They are determined by comparing the
- date portion of the respective date/time variables (--DTC,
- --STDTC, and --ENDTC) to the date portion of the Subject
- Reference Start Date (RFSTDTC from the Demographics
- domain).][All Study Day values are integers. Thus, to
- calculate Study Day, --DY = (date portion of --DTC) - (date
- portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
- = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.]'
+ - Cited Guidance:
+ "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1. They are determined
+ by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC)
+ to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All
+ Study Day values are integers. Thus, to calculate Study Day, --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across
+ all domains.]"
Document: IG v3.2
Section: 4.1.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0223
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1. They are determined by comparing the
- date portion of the respective date/time variables (--DTC,
- --STDTC, and --ENDTC) to the date portion of the Subject
- Reference Start Date (RFSTDTC from the Demographics
- domain).][All Study Day values are integers. Thus, to
- calculate Study Day: --DY = (date portion of --DTC) - (date
- portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
- = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.'
+ - Cited Guidance:
+ "The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative
+ day of the observation starting with the reference date as Day 1. They are determined by comparing
+ the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the
+ date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All
+ Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across
+ all domains."
Document: TIG 1.0
Item: Num 1
Section: 2.8.7.6
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0437
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -113,17 +101,17 @@ Check:
Core:
Id: CORE-000139
Status: Published
- Version: '1'
-Description: Trigger error if --ENDTC or DM.RFSTDTC does not contain complete
- values in their date portion, and --ENDY is not null.
+ Version: "1"
+Description: Trigger error if --ENDTC or DM.RFSTDTC does not contain complete values in their date
+ portion, and --ENDY is not null.
Executability: Fully Executable
Match Datasets:
- Keys:
- USUBJID
Name: DM
Outcome:
- Message: --ENDY is not null when either --ENDTC or DM.RFSTDTC do not contain
- complete values in their date portion
+ Message: --ENDY is not null when either --ENDTC or DM.RFSTDTC do not contain complete values in
+ their date portion
Output Variables:
- --ENDTC
- RFSTDTC
diff --git a/Published/CORE-000140/rule.yml b/Published/CORE-000140/rule.yml
index 662dda643..a6736c0b7 100644
--- a/Published/CORE-000140/rule.yml
+++ b/Published/CORE-000140/rule.yml
@@ -7,65 +7,65 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: VISITDY must not be populated for unplanned visits, since
- VISITDY is, by definition, the planned study day of visit, and
- since the actual study day of an unplanned visit belongs in a
- --DY variable.
+ - Cited Guidance:
+ VISITDY must not be populated for unplanned visits, since VISITDY is, by
+ definition, the planned study day of visit, and since the actual study day of an unplanned
+ visit belongs in a --DY variable.
Document: IG v3.4
Section: 4.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0225
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: VISITDY must not be populated for unplanned visits, since
- VISITDY is, by definition, the planned study day of visit, and
- since the actual study day of an unplanned visit belongs in a
- --DY variable.
+ - Cited Guidance:
+ VISITDY must not be populated for unplanned visits, since VISITDY is, by
+ definition, the planned study day of visit, and since the actual study day of an unplanned
+ visit belongs in a --DY variable.
Document: IG v3.3
Section: 4.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0225
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: VISITDY must not be populated for unplanned visits, since
- VISITDY is, by definition, the planned study day of visit, and
- since the actual study day of an unplanned visit belongs in a
- --DY variable.
+ - Cited Guidance:
+ VISITDY must not be populated for unplanned visits, since VISITDY is, by
+ definition, the planned study day of visit, and since the actual study day of an unplanned
+ visit belongs in a --DY variable.
Document: IG v3.2
Section: 4.1.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0225
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: VISITDY must not be populated for unplanned visits, since
- VISITDY is, by definition, the planned study day of visit, and
- since the actual study day of an unplanned visit belongs in a
- --DY variable.
+ - Cited Guidance:
+ VISITDY must not be populated for unplanned visits, since VISITDY is, by
+ definition, the planned study day of visit, and since the actual study day of an unplanned
+ visit belongs in a --DY variable.
Document: TIG 1.0
Item: Num 1
Section: 2.8.7.5
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0438
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: VISITNUM
@@ -76,7 +76,7 @@ Check:
Core:
Id: CORE-000140
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error if VISITDY is populated when VISITNUM is not in TV.
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000141/rule.yml b/Published/CORE-000141/rule.yml
index c6c96a6e3..32343ed33 100644
--- a/Published/CORE-000141/rule.yml
+++ b/Published/CORE-000141/rule.yml
@@ -2,148 +2,155 @@
# Condition: VISITNUM and --TPTREF are not present in dataset
# Rule: --TPT and --TPTNUM have a one-to-one relationship
Authorities:
-- Organization: CDISC
- Standards:
- - Name: SDTMIG
- References:
- - Citations:
- - Cited Guidance: Within the context that defines uniqueness for a time point, which may
- include domain, visit, and reference time point, there must be a one-to-relationship
- between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time
- point uniquely identify subject data, then if two subjects have records with the same
- values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have
- different time point descriptions in --TPT.
- Document: IG v3.4
- Section: 4.4.10
- Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0240
- Version: '2'
- Version: '2.0'
- Version: '3.4'
- - Name: SDTMIG
- References:
- - Citations:
- - Cited Guidance: Within the context that defines uniqueness for a time point, which may
- include domain, visit, and reference time point, there must be a one-to-relationship
- between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time
- point uniquely identify subject data, then if two subjects have records with the same
- values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have
- different time point descriptions in --TPT.
- Document: IG v3.3
- Section: 4.4.10
- Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0240
- Version: '2'
- Version: '2.0'
- Version: '3.3'
- - Name: SDTMIG
- References:
- - Citations:
- - Cited Guidance: Within the context that defines uniqueness for a time point, which may
- include domain, visit, and reference time point, there must be a one-to-relationship
- between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time
- point uniquely identify subject data, then if two subjects have records with the same
- values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have
- different time point descriptions in --TPT.
- Document: IG v3.2
- Section: 4.1.4.10
- Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0240
- Version: '2'
- Version: '2.0'
- Version: '3.2'
- - Name: TIG
- References:
- - Citations:
- - Cited Guidance: Timepoints will be represented using both --TPT and --TPTNUM. There will be
- a one-to-one relationship between the values of --TPT and --TPTNUM.
- Document: TIG 1.0
- Item: Sub Section Planned Timing Num 5
- Section: '2.8.7.5'
- Origin: TIG Conformance Rules
- Rule Identifier:
- Id: TIG0448
- Version: '1'
- Version: '1.0'
- Substandard: SDTM
- Version: '1.0'
-- Organization: FDA
- Standards:
- - Name: SDTMIG
- References:
- - Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include
- short name and name of test; parameter name and parameter code or number; variable name
- and variable label, etc.
- Document: FDA
- Section: FDAB009
- Origin: FDA Business Rules
- Rule Identifier:
- Id: FB0922
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: SDTMIG
- References:
- - Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include
- short name and name of test; parameter name and parameter code or number; variable name
- and variable label, etc.
- Document: FDA
- Section: FDAB009
- Origin: FDA Business Rules
- Rule Identifier:
- Id: FB0922
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: SDTMIG
- References:
- - Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include
- short name and name of test; parameter name and parameter code or number; variable name
- and variable label, etc.
- Document: FDA
- Section: FDAB009
- Origin: FDA Business Rules
- Rule Identifier:
- Id: FB0922
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ - Organization: CDISC
+ Standards:
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Within the context that defines uniqueness for a time point, which may
+ include domain, visit, and reference time point, there must be a one-to-relationship
+ between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time
+ point uniquely identify subject data, then if two subjects have records with the same
+ values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have
+ different time point descriptions in --TPT.
+ Document: IG v3.4
+ Section: 4.4.10
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0240
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Within the context that defines uniqueness for a time point, which may
+ include domain, visit, and reference time point, there must be a one-to-relationship
+ between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time
+ point uniquely identify subject data, then if two subjects have records with the same
+ values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have
+ different time point descriptions in --TPT.
+ Document: IG v3.3
+ Section: 4.4.10
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0240
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Within the context that defines uniqueness for a time point, which may
+ include domain, visit, and reference time point, there must be a one-to-relationship
+ between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time
+ point uniquely identify subject data, then if two subjects have records with the same
+ values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have
+ different time point descriptions in --TPT.
+ Document: IG v3.2
+ Section: 4.1.4.10
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0240
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: TIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Timepoints will be represented using both --TPT and --TPTNUM. There will be
+ a one-to-one relationship between the values of --TPT and --TPTNUM.
+ Document: TIG 1.0
+ Item: Sub Section Planned Timing Num 5
+ Section: "2.8.7.5"
+ Origin: TIG Conformance Rules
+ Rule Identifier:
+ Id: TIG0448
+ Version: "1"
+ Version: "1.0"
+ Substandard: SDTM
+ Version: "1.0"
+ - Organization: FDA
+ Standards:
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
+ Document: FDA
+ Section: FDAB009
+ Origin: FDA Business Rules
+ Rule Identifier:
+ Id: FB0922
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
+ Document: FDA
+ Section: FDAB009
+ Origin: FDA Business Rules
+ Rule Identifier:
+ Id: FB0922
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
+ Document: FDA
+ Section: FDAB009
+ Origin: FDA Business Rules
+ Rule Identifier:
+ Id: FB0922
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- - name: VISITNUM
- operator: not_exists
- - name: --TPTREF
- operator: not_exists
- - name: --TPT
- operator: is_not_unique_relationship
- value: --TPTNUM
+ - name: VISITNUM
+ operator: not_exists
+ - name: --TPTREF
+ operator: not_exists
+ - name: --TPT
+ operator: is_not_unique_relationship
+ value: --TPTNUM
Core:
Id: CORE-000141
Status: Published
- Version: '1'
-Description: VISITNUM and --TPTREF are not present then --TPT and --TPTNUM should have a one-to-one
+ Version: "1"
+Description: VISITNUM and --TPTREF are not present then --TPT and --TPTNUM should have a one-to-one
relationship.
Executability: Fully Executable
Outcome:
Message: --TPT and --TPTNUM do not have a one-to-one relationship.
Output Variables:
- - VISITNUM
- - --TPTREF
- - --TPT
- - --TPTNUM
+ - VISITNUM
+ - --TPTREF
+ - --TPT
+ - --TPTNUM
Rule Type: Record Data
Scope:
Classes:
Include:
- - ALL
+ - ALL
Domains:
Include:
- - ALL
+ - ALL
Use Case: INDH
Sensitivity: Record
diff --git a/Published/CORE-000142/rule.yml b/Published/CORE-000142/rule.yml
index fde217498..be9c69f6d 100644
--- a/Published/CORE-000142/rule.yml
+++ b/Published/CORE-000142/rule.yml
@@ -7,88 +7,80 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Within the context that defines uniqueness for a time point,
- there is likely to be a one-to-one relationship between most
- values of --TPT and --ELTM. However, since --ELTM can only be
- populated with ISO 8601 periods of time (as described in
- Section 4.4.3, Intervals of Time and Use of Duration for --DUR
- Variables), --ELTM may not be populated for all time points.
- For example, --ELTM is likely to be null for time points
- described by text such as 'pre-dose' or 'before breakfast.'
- When --ELTM is populated, if two subjects have records with
- the same values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM,
- then these records may not have different values in --ELTM.
+ - Cited Guidance:
+ Within the context that defines uniqueness for a time point, there is likely
+ to be a one-to-one relationship between most values of --TPT and --ELTM. However, since
+ --ELTM can only be populated with ISO 8601 periods of time (as described in Section 4.4.3,
+ Intervals of Time and Use of Duration for --DUR Variables), --ELTM may not be populated
+ for all time points. For example, --ELTM is likely to be null for time points described by
+ text such as 'pre-dose' or 'before breakfast.' When --ELTM is populated, if two subjects
+ have records with the same values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these
+ records may not have different values in --ELTM.
Document: IG v3.4
Section: 4.4.10
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0241
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Within the context that defines uniqueness for a time point,
- there is likely to be a one-to-one relationship between most
- values of --TPT and --ELTM. However, since --ELTM can only be
- populated with ISO 8601 periods of time (as described in
- Section 4.1.4.3, Intervals of Time and Use of Duration for
- --DUR Variables), --ELTM may not be populated for all time
- points. For example, --ELTM is likely to be null for time
- points described by text such as 'pre-dose' or 'before
- breakfast.' When --ELTM is populated, if two subjects have
- records with the same values of DOMAIN, VISITNUM, --TPTREF,
- and --TPTNUM, then these records may not have different values
- in --ELTM.
+ - Cited Guidance:
+ Within the context that defines uniqueness for a time point, there is likely
+ to be a one-to-one relationship between most values of --TPT and --ELTM. However, since
+ --ELTM can only be populated with ISO 8601 periods of time (as described in Section
+ 4.1.4.3, Intervals of Time and Use of Duration for --DUR Variables), --ELTM may not be
+ populated for all time points. For example, --ELTM is likely to be null for time points
+ described by text such as 'pre-dose' or 'before breakfast.' When --ELTM is populated, if
+ two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and
+ --TPTNUM, then these records may not have different values in --ELTM.
Document: IG v3.3
Section: 4.4.10
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0241
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Within the context that defines uniqueness for a time point,
- there is likely to be a one-to-one relationship between most
- values of --TPT and --ELTM. However, since --ELTM can only be
- populated with ISO 8601 periods of time (as described in
- Section 4.1.4.3, Intervals of Time and Use of Duration for
- --DUR Variables), --ELTM may not be populated for all time
- points. For example, --ELTM is likely to be null for time
- points described by text such as 'pre-dose' or 'before
- breakfast.' When --ELTM is populated, if two subjects have
- records with the same values of DOMAIN, VISITNUM, --TPTREF,
- and --TPTNUM, then these records may not have different values
- in --ELTM.
+ - Cited Guidance:
+ Within the context that defines uniqueness for a time point, there is likely
+ to be a one-to-one relationship between most values of --TPT and --ELTM. However, since
+ --ELTM can only be populated with ISO 8601 periods of time (as described in Section
+ 4.1.4.3, Intervals of Time and Use of Duration for --DUR Variables), --ELTM may not be
+ populated for all time points. For example, --ELTM is likely to be null for time points
+ described by text such as 'pre-dose' or 'before breakfast.' When --ELTM is populated, if
+ two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and
+ --TPTNUM, then these records may not have different values in --ELTM.
Document: IG v3.2
Section: 4.1.4.10
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0241
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Represents the planned elapsed time from the fixed timepoint
- reference to the planned observation. The value of this
- variable is usually also reflected in the value of variable
- --TPT.
+ - Cited Guidance:
+ Represents the planned elapsed time from the fixed timepoint reference to
+ the planned observation. The value of this variable is usually also reflected in the value
+ of variable --TPT.
Document: TIG 1.0
Item: Sub Section Timing Relative to Reference Points Num 3
- Section: '2.8.7.5'
+ Section: "2.8.7.5"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0449
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --TPT
@@ -107,14 +99,14 @@ Check:
Core:
Id: CORE-000142
Status: Published
- Version: '1'
-Description: Raise an error when --TPT ^= null and --TPTNUM ^= null and --ELTM
- ^= null and --ELTM does not have the same value across records with the same
- values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM.
+ Version: "1"
+Description: Raise an error when --TPT ^= null and --TPTNUM ^= null and --ELTM ^= null and --ELTM
+ does not have the same value across records with the same values of DOMAIN, VISITNUM, --TPTREF,
+ and --TPTNUM.
Executability: Fully Executable
Outcome:
- Message: --ELTM is not the same value across records with the same values of
- DOMAIN, VISITNUM, --TPTREF, and --TPTNUM.
+ Message: --ELTM is not the same value across records with the same values of DOMAIN, VISITNUM,
+ --TPTREF, and --TPTNUM.
Output Variables:
- --TPT
- --TPTNUM
diff --git a/Published/CORE-000143/rule.yml b/Published/CORE-000143/rule.yml
index e94daaa12..a398a587b 100644
--- a/Published/CORE-000143/rule.yml
+++ b/Published/CORE-000143/rule.yml
@@ -1,5 +1,5 @@
# Variable: ETCD
-# Condition:
+# Condition:
# Rule: ETCD value length <= 8
Authorities:
- Organization: CDISC
@@ -10,7 +10,7 @@ Authorities:
- Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters
Document: IG v3.4
Item: Specification
- Section: '5.3'
+ Section: "5.3"
- Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters
Document: IG v3.4
Item: Specification
@@ -22,165 +22,166 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0246
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
- Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters
Document: IG v3.3
Item: Specification
- Section: '7.2'
+ Section: "7.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0246
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
- Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters
Document: IG v3.2
Item: Specification
- Section: '7.2'
+ Section: "7.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0246
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters
Document: IG v3.0
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND24
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters
Document: IG v3.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND24
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters
Document: IG v3.1.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND24
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters
Document: IG v3.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND24
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters
Document: IG v3.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND24
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters
Document: IG v3.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND24
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and
- does not have special character restrictions. These values
- should be short for ease of use in programming, but it is not
- expected that ETCD will need to serve as a variable name.
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT) is limited to 8 characters and does not have
+ special character restrictions. These values should be short for ease of use in
+ programming, but it is not expected that ETCD will need to serve as a variable name.
Document: TIG 1.0
Item: Specification:ECTD
Section: 2.8.10.24|2.8.10.29|2.8.10.30
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0450
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters, but
- do not have special character restrictions.
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT) is limited to 8 characters, but do not have
+ special character restrictions.
Document: TIG v1.0
Item: SE CDISC Notes
Section: 2.8.9.26
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0165
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ETCD
@@ -189,7 +190,7 @@ Check:
Core:
Id: CORE-000143
Status: Published
- Version: '1'
+ Version: "1"
Description: The length of ETCD should be no greater than 8
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000144/rule.yml b/Published/CORE-000144/rule.yml
index 5e9cb3b2f..1c4f82f03 100644
--- a/Published/CORE-000144/rule.yml
+++ b/Published/CORE-000144/rule.yml
@@ -1,5 +1,5 @@
# Variable: TAETORD
-# Condition:
+# Condition:
# Rule: TAETORD is unique within an ARM
Authorities:
- Organization: CDISC
@@ -14,35 +14,35 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0247
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Number that gives the order of the Element within the Arm.
Document: IG v3.3
Item: Specification
- Section: '7.2'
+ Section: "7.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0247
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Number that gives the order of the Element within the Arm.
Document: IG v3.2
Item: Specification
- Section: '7.2'
+ Section: "7.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0247
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
@@ -53,10 +53,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0451
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: TAETORD
@@ -66,7 +66,7 @@ Check:
Core:
Id: CORE-000144
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when TAETORD is not unique within an ARM
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000147/rule.yml b/Published/CORE-000147/rule.yml
index 997f532f1..e1012e2d9 100644
--- a/Published/CORE-000147/rule.yml
+++ b/Published/CORE-000147/rule.yml
@@ -4,141 +4,144 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters
- and does not have special character restrictions.
+ - Cited Guidance:
+ TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not
+ have special character restrictions.
Document: IG v3.4
Item: Specification
Section: 7.4.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0257
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters
- and does not have special character restrictions.
+ - Cited Guidance:
+ TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not
+ have special character restrictions.
Document: IG v3.2
Item: Specification
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0257
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters
- and does not have special character restrictions.
+ - Cited Guidance:
+ TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not
+ have special character restrictions.
Document: IG v3.3
Item: Specification
Section: 7.4.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0257
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters, but do not have special character
- restrictions
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have
+ special character restrictions
Document: IG v3.0
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND26
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters, but do not have special character
- restrictions
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have
+ special character restrictions
Document: IG v3.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND26
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters, but do not have special character
- restrictions
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have
+ special character restrictions
Document: IG v3.1.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND26
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters, but do not have special character
- restrictions
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have
+ special character restrictions
Document: IG v3.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND26
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters, but do not have special character
- restrictions
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have
+ special character restrictions
Document: IG v3.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND26
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a
- specific Trial Set), and TSPARMCD (the companion to TSPARM)
- are limited to 8 characters, but do not have special character
- restrictions
+ - Cited Guidance:
+ ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial
+ Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have
+ special character restrictions
Document: IG v3.1
Item: Specification
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND26
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
@@ -149,27 +152,28 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0178
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters
- and does not have special character restrictions.
+ - Cited Guidance:
+ TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not
+ have special character restrictions.
Document: TIG 1.0
Item: Specification:TSPARMCD
Section: 2.8.10.30
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0461
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
# Variable: TSPARMCD
-# Condition:
+# Condition:
# Rule: TSPARMCD value length <= 8
Check:
all:
@@ -179,7 +183,7 @@ Check:
Core:
Id: CORE-000147
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when length of TSPARMCD is greater than 8
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000148/rule.yml b/Published/CORE-000148/rule.yml
index 33de930f3..eca4f3208 100644
--- a/Published/CORE-000148/rule.yml
+++ b/Published/CORE-000148/rule.yml
@@ -11,22 +11,22 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0258
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: The value in TSPARM cannot be longer than 40 characters.
Document: IG v3.2
Item: Specification
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0258
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -37,9 +37,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0258
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -50,12 +50,12 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0462
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
# Variable: TSPARM
-# Condition:
+# Condition:
# Rule: TSPARM value length <= 40
Check:
all:
@@ -65,7 +65,7 @@ Check:
Core:
Id: CORE-000148
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when length of TSPARM value is greater than 40
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000151/rule.yml b/Published/CORE-000151/rule.yml
index 5a3c2f4fa..27c76f79a 100644
--- a/Published/CORE-000151/rule.yml
+++ b/Published/CORE-000151/rule.yml
@@ -7,136 +7,128 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Text over 200 characters can be added to additional columns
- TSVAL1-TSVALn.
+ - Cited Guidance: Text over 200 characters can be added to additional columns TSVAL1-TSVALn.
Document: IG v3.4
Item: Specification
Section: 7.4.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0261
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Text over 200 characters can be added to additional columns
- TSVAL1-TSVALn.
+ - Cited Guidance: Text over 200 characters can be added to additional columns TSVAL1-TSVALn.
Document: IG v3.2
Item: Specification
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0261
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Text over 200 characters can be added to additional columns
- TSVAL1-TSVALn.
+ - Cited Guidance: Text over 200 characters can be added to additional columns TSVAL1-TSVALn.
Document: IG v3.3
Item: Specification
Section: 7.4.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0261
- Version: '1'
- Version: '2.0'
- Version: '3.3'
- # Extended for SEND rule SEND281 by Jozef
+ Version: "1"
+ Version: "2.0"
+ Version:
+ "3.3"
+ # Extended for SEND rule SEND281 by Jozef
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple
- variables (TSVAL-TSVALn), in order to accommodate values
- longer than 200 characters.
+ - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables
+ (TSVAL-TSVALn), in order to accommodate values longer than 200 characters.
Document: IG v3.0
Item: Specification
Section: 7.6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND281
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple
- variables (TSVAL-TSVALn), in order to accommodate values
- longer than 200 characters.
+ - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables
+ (TSVAL-TSVALn), in order to accommodate values longer than 200 characters.
Document: IG v3.1
Item: Specification
Section: 7.6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND281
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple
- variables (TSVAL-TSVALn), in order to accommodate values
- longer than 200 characters.
+ - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables
+ (TSVAL-TSVALn), in order to accommodate values longer than 200 characters.
Document: IG v3.1.1
Item: Specification
Section: 7.6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND281
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple
- variables (TSVAL-TSVALn), in order to accommodate values
- longer than 200 characters.
+ - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables
+ (TSVAL-TSVALn), in order to accommodate values longer than 200 characters.
Document: IG v3.1
Item: Specification
Section: 7.6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND281
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple
- variables (TSVAL-TSVALn), in order to accommodate values
- longer than 200 characters.
+ - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables
+ (TSVAL-TSVALn), in order to accommodate values longer than 200 characters.
Document: IG v3.1.1
Item: Specification
Section: 7.6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND281
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple
- variables (TSVAL-TSVALn), in order to accommodate values
- longer than 200 characters.
+ - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables
+ (TSVAL-TSVALn), in order to accommodate values longer than 200 characters.
Document: IG v3.1.1
Item: Specification
Section: 7.6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND281
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: TSVAL1
@@ -146,7 +138,7 @@ Check:
Core:
Id: CORE-000151
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when TSVAL1 is populated and TSVAL is null
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000152/rule.yml b/Published/CORE-000152/rule.yml
index 0ac963d43..cf8655a33 100644
--- a/Published/CORE-000152/rule.yml
+++ b/Published/CORE-000152/rule.yml
@@ -14,22 +14,22 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0265
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: This is the code of the term in TSVAL.
Document: IG v3.2
Item: Specification
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0265
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -40,9 +40,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0265
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -53,10 +53,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0467
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: TSVAL
@@ -69,9 +69,9 @@ Check:
Core:
Id: CORE-000152
Status: Published
- Version: '1'
-Description: When TSVAL and TSVALCD are populated, there must be a one-to-one
- relationship between TSVALCD and TSVAL
+ Version: "1"
+Description: When TSVAL and TSVALCD are populated, there must be a one-to-one relationship between
+ TSVALCD and TSVAL
Executability: Fully Executable
Outcome:
Message: There is not a one-to-one relationship between TSVAL and TSVALCD
diff --git a/Published/CORE-000154/rule.yml b/Published/CORE-000154/rule.yml
index 45b125b9f..786c16ff4 100644
--- a/Published/CORE-000154/rule.yml
+++ b/Published/CORE-000154/rule.yml
@@ -7,179 +7,171 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Sequence number given to ensure uniqueness within a dataset.
- Allows inclusion of multiple records for the same TSPARMCD.
+ - Cited Guidance: Sequence number given to ensure uniqueness within a dataset. Allows
+ inclusion of multiple records for the same TSPARMCD.
Document: IG v3.4
Item: Specification
Section: 7.4.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0268
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: TSSEQ has a different value for each record for the same
- parameter.
+ - Cited Guidance: TSSEQ has a different value for each record for the same parameter.
Document: IG v3.2
Item: Assumption 5
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0268
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: TSSEQ has a different value for each record for the same
- parameter.
+ - Cited Guidance: TSSEQ has a different value for each record for the same parameter.
Document: IG v3.3
Item: Assumption 5
Section: 7.4.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0268
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and
- is Required to identify each record as unique in cases where
- the same TSPARMCD is used within the dataset. The TSSEQ
- variable must be populated for all records within the TS
- dataset.'
+ - Cited Guidance:
+ "The TSSEQ variable is a unique identifier for each record and is Required to
+ identify each record as unique in cases where the same TSPARMCD is used within the dataset.
+ The TSSEQ variable must be populated for all records within the TS dataset."
Document: IG v3.0
Item: Assumption 7
- Section: '7.6.1.1'
+ Section: "7.6.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND246
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and
- is Required to identify each record as unique in cases where
- the same TSPARMCD is used within the dataset. The TSSEQ
- variable must be populated for all records within the TS
- dataset.'
+ - Cited Guidance:
+ "The TSSEQ variable is a unique identifier for each record and is Required to
+ identify each record as unique in cases where the same TSPARMCD is used within the dataset.
+ The TSSEQ variable must be populated for all records within the TS dataset."
Document: IG v3.1
Item: Assumption 7
- Section: '7.6.1.1'
+ Section: "7.6.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND246
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and
- is Required to identify each record as unique in cases where
- the same TSPARMCD is used within the dataset. The TSSEQ
- variable must be populated for all records within the TS
- dataset.'
+ - Cited Guidance:
+ "The TSSEQ variable is a unique identifier for each record and is Required to
+ identify each record as unique in cases where the same TSPARMCD is used within the dataset.
+ The TSSEQ variable must be populated for all records within the TS dataset."
Document: IG v3.1.1
Item: Assumption 7
- Section: '7.6.1.1'
+ Section: "7.6.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND246
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and
- is Required to identify each record as unique in cases where
- the same TSPARMCD is used within the dataset. The TSSEQ
- variable must be populated for all records within the TS
- dataset.'
+ - Cited Guidance:
+ "The TSSEQ variable is a unique identifier for each record and is Required to
+ identify each record as unique in cases where the same TSPARMCD is used within the dataset.
+ The TSSEQ variable must be populated for all records within the TS dataset."
Document: IG v3.1
Item: Assumption 7
- Section: '7.6.1.1'
+ Section: "7.6.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND246
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and
- is Required to identify each record as unique in cases where
- the same TSPARMCD is used within the dataset. The TSSEQ
- variable must be populated for all records within the TS
- dataset.'
+ - Cited Guidance:
+ "The TSSEQ variable is a unique identifier for each record and is Required to
+ identify each record as unique in cases where the same TSPARMCD is used within the dataset.
+ The TSSEQ variable must be populated for all records within the TS dataset."
Document: IG v3.1.1
Item: Assumption 7
- Section: '7.6.1.1'
+ Section: "7.6.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND246
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and
- is Required to identify each record as unique in cases where
- the same TSPARMCD is used within the dataset. The TSSEQ
- variable must be populated for all records within the TS
- dataset.'
+ - Cited Guidance:
+ "The TSSEQ variable is a unique identifier for each record and is Required to
+ identify each record as unique in cases where the same TSPARMCD is used within the dataset.
+ The TSSEQ variable must be populated for all records within the TS dataset."
Document: IG v3.1.1
Item: Assumption 7
- Section: '7.6.1.1'
+ Section: "7.6.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND246
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 'The TSSEQ variable is required to identify each record as
- unique, in cases where the same TSPARMCD is used within the
- dataset. The TSSEQ variable must be populated for all records
- within the TS dataset.'
+ - Cited Guidance:
+ "The TSSEQ variable is required to identify each record as unique, in cases where
+ the same TSPARMCD is used within the dataset. The TSSEQ variable must be populated for all records
+ within the TS dataset."
Document: TIG v1.0
Item: Assumption 7
Section: 2.8.9.32
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0167
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Sequence number given to ensure uniqueness within a dataset.
- Allows inclusion of multiple records for the same TSPARMCD.
+ - Cited Guidance: Sequence number given to ensure uniqueness within a dataset. Allows
+ inclusion of multiple records for the same TSPARMCD.
Document: TIG 1.0
Item: Specification
Section: 2.8.10.30
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0470
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: TSPARMCD
@@ -192,7 +184,7 @@ Check:
Core:
Id: CORE-000154
Status: Published
- Version: '1'
+ Version: "1"
Description: TSSEQ must be unique within TSPARMCD
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000155/rule.yml b/Published/CORE-000155/rule.yml
index 549d56e0a..214d1ce48 100644
--- a/Published/CORE-000155/rule.yml
+++ b/Published/CORE-000155/rule.yml
@@ -7,60 +7,64 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which
- ARM a subject is in, then ARMCD should be null.
+ - Cited Guidance:
+ 2. If the timing of Visits for a trial does not depend on which ARM a
+ subject is in, then ARMCD should be null.
Document: IG v3.4
Item: Specification
Section: 7.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0293
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which
- ARM a subject is in, then ARMCD should be null.
+ - Cited Guidance:
+ 2. If the timing of Visits for a trial does not depend on which ARM a
+ subject is in, then ARMCD should be null.
Document: IG v3.2
Item: Specification
- Section: '7'
+ Section: "7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0293
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which
- ARM a subject is in, then ARMCD should be null.
+ - Cited Guidance:
+ 2. If the timing of Visits for a trial does not depend on which ARM a
+ subject is in, then ARMCD should be null.
Document: IG v3.3
Item: Specification
Section: 7.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0293
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which
- ARM a subject is in, then ARMCD should be null.
+ - Cited Guidance:
+ 2. If the timing of Visits for a trial does not depend on which ARM a
+ subject is in, then ARMCD should be null.
Document: TIG 1.0
Item: Specification ARMCD
Section: 2.8.10.31
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0475
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ARMCD
@@ -71,7 +75,7 @@ Check:
Core:
Id: CORE-000155
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when ARMCD is populated and ARMCD is not in TA.ARMCD
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000156/rule.yml b/Published/CORE-000156/rule.yml
index 39e1965e1..5cf2beee3 100644
--- a/Published/CORE-000156/rule.yml
+++ b/Published/CORE-000156/rule.yml
@@ -7,64 +7,65 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 1. Name given to an Arm or Treatment Group. 2. If the timing of
- visits for a trial does not depend on which Arm a subject is
- in, then Arm should be left blank.
+ - Cited Guidance:
+ 1. Name given to an Arm or Treatment Group. 2. If the timing of visits for a
+ trial does not depend on which Arm a subject is in, then Arm should be left blank.
Document: IG v3.4
Item: Specification
Section: 7.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0294
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 1. Name given to an Arm or Treatment Group. 2. If the timing of
- Visits for a trial does not depend on which Arm a subject is
- in, then Arm should be left blank.
+ - Cited Guidance:
+ 1. Name given to an Arm or Treatment Group. 2. If the timing of Visits for a
+ trial does not depend on which Arm a subject is in, then Arm should be left blank.
Document: IG v3.2
Item: Specification
- Section: '7'
+ Section: "7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0294
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 1. Name given to an Arm or Treatment Group. 2. If the timing of
- Visits for a trial does not depend on which Arm a subject is
- in, then Arm should be left blank.
+ - Cited Guidance:
+ 1. Name given to an Arm or Treatment Group. 2. If the timing of Visits for a
+ trial does not depend on which Arm a subject is in, then Arm should be left blank.
Document: IG v3.3
Item: Specification
Section: 7.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0294
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 1. Name given to an Arm or Product Exposure Group. 2. If the
- timing of Visits for a trial does not depend on which Arm a
- subject is in, then Arm should be left blank.
+ - Cited Guidance:
+ 1. Name given to an Arm or Product Exposure Group. 2. If the timing of
+ Visits for a trial does not depend on which Arm a subject is in, then Arm should be left
+ blank.
Document: TIG 1.0
Item: Specification:ARM
Section: 2.8.10.31
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0476
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ARM
@@ -75,7 +76,7 @@ Check:
Core:
Id: CORE-000156
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when ARM is populated and ARM is not in TA.ARM
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000157/rule.yml b/Published/CORE-000157/rule.yml
index 1aa7b075e..feaf6a3f0 100644
--- a/Published/CORE-000157/rule.yml
+++ b/Published/CORE-000157/rule.yml
@@ -1,5 +1,5 @@
# Variable: ARMCD
-# Condition:
+# Condition:
# Rule: ARMCD value length <= 20
Authorities:
- Organization: CDISC
@@ -7,60 +7,64 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: ARMCD is limited to 20 characters and does not have special
- character restrictions.
+ - Cited Guidance:
+ ARMCD is limited to 20 characters and does not have special character
+ restrictions.
Document: IG v3.4
Item: Specification
Section: 7.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0297
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: ARMCD is limited to 20 characters and does not have special
- character restrictions.
+ - Cited Guidance:
+ ARMCD is limited to 20 characters and does not have special character
+ restrictions.
Document: IG v3.2
Item: Specification
- Section: '7'
+ Section: "7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0297
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: ARMCD is limited to 20 characters and does not have special
- character restrictions.
+ - Cited Guidance:
+ ARMCD is limited to 20 characters and does not have special character
+ restrictions.
Document: IG v3.3
Item: Specification
Section: 7.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0297
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: ARMCD is limited to 20 characters and does not have special
- character restrictions.
+ - Cited Guidance:
+ ARMCD is limited to 20 characters and does not have special character
+ restrictions.
Document: TIG 1.0
Item: Specification:ARMCD
Section: 2.8.10.31
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0479
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ARMCD
@@ -69,7 +73,7 @@ Check:
Core:
Id: CORE-000157
Status: Published
- Version: '1'
+ Version: "1"
Description: The length of ARMCD is limited to 20 characters.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000158/rule.yml b/Published/CORE-000158/rule.yml
index 1e1369ac2..397e5f8f2 100644
--- a/Published/CORE-000158/rule.yml
+++ b/Published/CORE-000158/rule.yml
@@ -7,68 +7,68 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies. Examples AESEQ or
- CMGRPID. Used only when individual comments are related to
- domain records. Null for comments collected on separate CRFs.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments
+ are related to domain records. Null for comments collected on separate CRFs.
Document: IG v3.4
Item: Specification
- Section: '5.1'
+ Section: "5.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0163
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies. Examples AESEQ or
- CMGRPID. Used only when individual comments are related to
- domain records. null for comments collected on separate CRFs.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments
+ are related to domain records. null for comments collected on separate CRFs.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0163
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies. Examples AESEQ or
- CMGRPID. Used only when individual comments are related to
- domain records. null for comments collected on separate CRFs.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments
+ are related to domain records. null for comments collected on separate CRFs.
Document: IG v3.3
Item: Specification
- Section: '5.1'
+ Section: "5.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0163
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies. Examples AESEQ or
- CMGRPID. Used only when individual comments are related to
- domain records. Null for comments collected on separate CRFs.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments
+ are related to domain records. Null for comments collected on separate CRFs.
Document: TIG 1.0
Item: Specification
Section: 2.8.10.2
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0396
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
@@ -84,7 +84,7 @@ Check:
Core:
Id: CORE-000158
Status: Published
- Version: '1'
+ Version: "1"
Description: IDVAR must be specified.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000159/rule.yml b/Published/CORE-000159/rule.yml
index 08e3f1702..0ffed3f31 100644
--- a/Published/CORE-000159/rule.yml
+++ b/Published/CORE-000159/rule.yml
@@ -1,5 +1,5 @@
# Variable: --TESTCD
-# Condition:
+# Condition:
# Rule: --TESTCD ^= 'OTHER'
Authorities:
- Organization: CDISC
@@ -7,76 +7,70 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Findings: "Other, Specify" for tests may be handled similarly
- to Interventions. --TESTCD and --TEST should be populated with
- the code and description of the test found in the specified
- text. If specific tests are not prespecified on the CRF and
- the investigator has the option of writing in tests, then the
- name of the test would have to be coded to ensure that all
- --TESTCD and --TEST values are consistent with the test
- controlled terminology.'
+ - Cited Guidance:
+ 'Findings: "Other, Specify" for tests may be handled similarly to Interventions.
+ --TESTCD and --TEST should be populated with the code and description of the test found in the
+ specified text. If specific tests are not prespecified on the CRF and the investigator has the
+ option of writing in tests, then the name of the test would have to be coded to ensure that
+ all --TESTCD and --TEST values are consistent with the test controlled terminology.'
Document: IG v3.4
Section: 4.2.7.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0341
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Findings: "Other; Specify" for tests may be handled similarly
- to Interventions. --TESTCD and --TEST should be populated with
- the code and description of the test found in the specified
- text. If specific tests are not prespecified on the CRF and
- the investigator has the option of writing in tests, then the
- name of the test would have to be coded to ensure that all
- --TESTCD and --TEST values are consistent with the test
- controlled terminology.'
+ - Cited Guidance:
+ 'Findings: "Other; Specify" for tests may be handled similarly to Interventions.
+ --TESTCD and --TEST should be populated with the code and description of the test found in the
+ specified text. If specific tests are not prespecified on the CRF and the investigator has the
+ option of writing in tests, then the name of the test would have to be coded to ensure that
+ all --TESTCD and --TEST values are consistent with the test controlled terminology.'
Document: IG v3.3
Section: 4.2.7.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0341
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Findings: "Other; Specify" for tests may be handled similarly
- to Interventions. --TESTCD and --TEST should be populated with
- the code and description of the test found in the specified
- text. If specific tests are not prespecified on the CRF and
- the investigator has the option of writing free text for
- tests; then the name of the test would have to be coded to
- ensure that all --TESTCD and --TEST values are controlled
- terminology and are not free text.'
+ - Cited Guidance:
+ 'Findings: "Other; Specify" for tests may be handled similarly to Interventions.
+ --TESTCD and --TEST should be populated with the code and description of the test found in the
+ specified text. If specific tests are not prespecified on the CRF and the investigator has the
+ option of writing free text for tests; then the name of the test would have to be coded to ensure
+ that all --TESTCD and --TEST values are controlled terminology and are not free text.'
Document: IG v3.2
Section: 4.1.2.7.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0341
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: For Findings general observations class domains, each collected
- value will be represented in --TESTCD and --TEST in its own
- record per controlled terminology.
+ - Cited Guidance:
+ For Findings general observations class domains, each collected value will
+ be represented in --TESTCD and --TEST in its own record per controlled terminology.
Document: TIG 1.0
Item: Num 3
- Section: '2.8.7.4'
+ Section: "2.8.7.4"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0506
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --TESTCD
@@ -85,7 +79,7 @@ Check:
Core:
Id: CORE-000159
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TESTCD = 'OTHER'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000160/rule.yml b/Published/CORE-000160/rule.yml
index f97c5c14d..df764d2ac 100644
--- a/Published/CORE-000160/rule.yml
+++ b/Published/CORE-000160/rule.yml
@@ -1,5 +1,5 @@
# Variable: --TRT
-# Condition:
+# Condition:
# Rule: --TRT ^= 'OTHER'
Authorities:
- Organization: CDISC
@@ -7,61 +7,61 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Interventions: If a list of specific treatments is provided
- along with "Other, Specify", --TRT should be populated with
- the name of the treatment found in the specified text.'
+ - Cited Guidance:
+ 'Interventions: If a list of specific treatments is provided along with "Other,
+ Specify", --TRT should be populated with the name of the treatment found in the specified text.'
Document: IG v3.4
Section: 4.2.7.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0342
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Interventions: If a list of specific treatments is provided
- along with "Other, Specify", --TRT should be populated with
- the name of the treatment found in the specified text.'
+ - Cited Guidance:
+ 'Interventions: If a list of specific treatments is provided along with "Other,
+ Specify", --TRT should be populated with the name of the treatment found in the specified text.'
Document: IG v3.3
Section: 4.2.7.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0342
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Interventions: If a list of specific treatments is provided
- along with "Other, Specify", --TRT should be populated with
- the name of the treatment found in the specified text.'
+ - Cited Guidance:
+ 'Interventions: If a list of specific treatments is provided along with "Other,
+ Specify", --TRT should be populated with the name of the treatment found in the specified text.'
Document: IG v3.2
Section: 4.1.2.7.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0342
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: For Interventions general observations class domains, each
- collected value will be represented in --TRT in its own
- record.
+ - Cited Guidance:
+ For Interventions general observations class domains, each collected value
+ will be represented in --TRT in its own record.
Document: TIG 1.0
Item: Num 3
Section: 2.8.7.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0507
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --TRT
@@ -70,7 +70,7 @@ Check:
Core:
Id: CORE-000160
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TRT = 'OTHER'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000161/rule.yml b/Published/CORE-000161/rule.yml
index 1ed900346..69d7adabe 100644
--- a/Published/CORE-000161/rule.yml
+++ b/Published/CORE-000161/rule.yml
@@ -1,5 +1,5 @@
# Variable: --TERM
-# Condition:
+# Condition:
# Rule: --TERM ^= 'OTHER'
Authorities:
- Organization: CDISC
@@ -7,66 +7,64 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Events: "Other, Specify" for Events may be handled similarly to
- Interventions. --TERM should be populated with the description
- of the event found in the specified text and --PRESP could be
- used to distinguish between prespecified and free text
- responses.'
+ - Cited Guidance:
+ 'Events: "Other, Specify" for Events may be handled similarly to Interventions.
+ --TERM should be populated with the description of the event found in the specified text and
+ --PRESP could be used to distinguish between prespecified and free text responses.'
Document: IG v3.4
Section: 4.2.7.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0343
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Events: "Other, Specify" for Events may be handled similarly to
- Interventions. --TERM should be populated with the description
- of the event found in the specified text and --PRESP could be
- used to distinguish between prespecified and free text
- responses.'
+ - Cited Guidance:
+ 'Events: "Other, Specify" for Events may be handled similarly to Interventions.
+ --TERM should be populated with the description of the event found in the specified text and
+ --PRESP could be used to distinguish between prespecified and free text responses.'
Document: IG v3.3
Section: 4.2.7.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0343
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Events: "Other, Specify" for Events may be handled similarly to
- Interventions. --TERM should be populated with the description
- of the event found in the specified text and --PRESP could be
- used to distinguish between prespecified and free text
- responses.'
+ - Cited Guidance:
+ 'Events: "Other, Specify" for Events may be handled similarly to Interventions.
+ --TERM should be populated with the description of the event found in the specified text and
+ --PRESP could be used to distinguish between prespecified and free text responses.'
Document: IG v3.2
Section: 4.1.2.7.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0343
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: For Events general observations class domains, each collected
- value will be represented in --TERM in its own record.
+ - Cited Guidance:
+ For Events general observations class domains, each collected value will be
+ represented in --TERM in its own record.
Document: TIG 1.0
Item: Num 3
Section: 2.8.7.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0508
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
@@ -76,7 +74,7 @@ Check:
Core:
Id: CORE-000161
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TERM = 'OTHER'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000162/rule.yml b/Published/CORE-000162/rule.yml
index 58e9fa565..13e67e754 100644
--- a/Published/CORE-000162/rule.yml
+++ b/Published/CORE-000162/rule.yml
@@ -1,5 +1,5 @@
# Variable: --TESTCD
-# Condition:
+# Condition:
# Rule: --TESTCD ^= 'MULTIPLE'
Authorities:
- Organization: CDISC
@@ -7,67 +7,67 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple result values (--ORRES) are reported for a test in a
- Findings class dataset, multiple records should be submitted
- for that --TESTCD.
+ - Cited Guidance:
+ If multiple result values (--ORRES) are reported for a test in a Findings
+ class dataset, multiple records should be submitted for that --TESTCD.
Document: IG v3.4
Section: 4.2.8.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0344
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple values are reported for a topic variable (i.e.;
- --TRT in an Interventions general-observation-class dataset or
- --TERM in an Events general-observation-class dataset); it is
- assumed that the sponsor will split the values into multiple
- records or otherwise resolve the multiplicity as per the
- sponsor's standard data management procedures.
+ - Cited Guidance:
+ If multiple values are reported for a topic variable (i.e.; --TRT in an
+ Interventions general-observation-class dataset or --TERM in an Events
+ general-observation-class dataset); it is assumed that the sponsor will split the values
+ into multiple records or otherwise resolve the multiplicity as per the sponsor's standard
+ data management procedures.
Document: IG v3.3
Section: 4.2.8.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0344
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple values are reported for a topic variable (i.e.;
- --TRT in an Interventions general-observation-class dataset or
- --TERM in an Events general-observation-class dataset); it is
- assumed that the sponsor will split the values into multiple
- records or otherwise resolve the multiplicity as per the
- sponsor's standard data management procedures.
+ - Cited Guidance:
+ If multiple values are reported for a topic variable (i.e.; --TRT in an
+ Interventions general-observation-class dataset or --TERM in an Events
+ general-observation-class dataset); it is assumed that the sponsor will split the values
+ into multiple records or otherwise resolve the multiplicity as per the sponsor's standard
+ data management procedures.
Document: IG v3.2
Section: 4.1.2.8.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0344
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If multiple result values (represented in --ORRES) are collected
- for a test, then multiple records will be represented for the
- test (represented in --TESTCD)
+ - Cited Guidance:
+ If multiple result values (represented in --ORRES) are collected for a test,
+ then multiple records will be represented for the test (represented in --TESTCD)
Document: TIG 1.0
Item: Num 2
Section: 2.8.7.3
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0509
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --TESTCD
@@ -76,7 +76,7 @@ Check:
Core:
Id: CORE-000162
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TESTCD = 'MULTIPLE'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000163/rule.yml b/Published/CORE-000163/rule.yml
index c576a59d9..76854627d 100644
--- a/Published/CORE-000163/rule.yml
+++ b/Published/CORE-000163/rule.yml
@@ -1,5 +1,5 @@
# Variable: --TRT
-# Condition:
+# Condition:
# Rule: --TRT ^= 'MULTIPLE'
Authorities:
- Organization: CDISC
@@ -7,73 +7,73 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple values are reported for a topic variable (i.e.,
- --TRT in an Interventions general-observation-class dataset or
- --TERM in an Events general-observation-class dataset), it is
- expected that the sponsor will split the values into multiple
- records or otherwise resolve the multiplicity per the
- sponsor's data management standard operating procedures.
+ - Cited Guidance:
+ If multiple values are reported for a topic variable (i.e., --TRT in an
+ Interventions general-observation-class dataset or --TERM in an Events
+ general-observation-class dataset), it is expected that the sponsor will split the values
+ into multiple records or otherwise resolve the multiplicity per the sponsor's data
+ management standard operating procedures.
Document: IG v3.4
Section: 4.2.8.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0345
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple values are reported for a topic variable (i.e.;
- --TRT in an Interventions general-observation-class dataset or
- --TERM in an Events general-observation-class dataset); it is
- assumed that the sponsor will split the values into multiple
- records or otherwise resolve the multiplicity as per the
- sponsor's standard data management procedures.
+ - Cited Guidance:
+ If multiple values are reported for a topic variable (i.e.; --TRT in an
+ Interventions general-observation-class dataset or --TERM in an Events
+ general-observation-class dataset); it is assumed that the sponsor will split the values
+ into multiple records or otherwise resolve the multiplicity as per the sponsor's standard
+ data management procedures.
Document: IG v3.3
Section: 4.2.8.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0345
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple values are reported for a topic variable (i.e.;
- --TRT in an Interventions general-observation-class dataset or
- --TERM in an Events general-observation-class dataset); it is
- assumed that the sponsor will split the values into multiple
- records or otherwise resolve the multiplicity as per the
- sponsor's standard data management procedures.
+ - Cited Guidance:
+ If multiple values are reported for a topic variable (i.e.; --TRT in an
+ Interventions general-observation-class dataset or --TERM in an Events
+ general-observation-class dataset); it is assumed that the sponsor will split the values
+ into multiple records or otherwise resolve the multiplicity as per the sponsor's standard
+ data management procedures.
Document: IG v3.2
Section: 4.1.2.8.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0345
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If multiple values are reported for a topic variable (i.e.,
- --TRT in an Interventions general-observation-class dataset or
- --TERM in an Events general-observation-class dataset), it is
- expected that the sponsor will split the values into multiple
- records or otherwise resolve the multiplicity per the
- sponsor's data management standard operating procedures.
+ - Cited Guidance:
+ If multiple values are reported for a topic variable (i.e., --TRT in an
+ Interventions general-observation-class dataset or --TERM in an Events
+ general-observation-class dataset), it is expected that the sponsor will split the values
+ into multiple records or otherwise resolve the multiplicity per the sponsor's data
+ management standard operating procedures.
Document: TIG 1.0
Item: Num 1, Num 2
- Section: '2.8.7.3'
+ Section: "2.8.7.3"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0510
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --TRT
@@ -82,7 +82,7 @@ Check:
Core:
Id: CORE-000163
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TRT = 'MULTIPLE'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000164/rule.yml b/Published/CORE-000164/rule.yml
index 61a883215..2fde53032 100644
--- a/Published/CORE-000164/rule.yml
+++ b/Published/CORE-000164/rule.yml
@@ -1,5 +1,5 @@
# Variable: --TERM
-# Condition:
+# Condition:
# Rule: --TERM ^= 'MULTIPLE'
Authorities:
- Organization: CDISC
@@ -7,73 +7,73 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple values are reported for a topic variable (i.e.,
- --TRT in an Interventions general-observation-class dataset or
- --TERM in an Events general-observation-class dataset), it is
- expected that the sponsor will split the values into multiple
- records or otherwise resolve the multiplicity per the
- sponsor's data management standard operating procedures.
+ - Cited Guidance:
+ If multiple values are reported for a topic variable (i.e., --TRT in an
+ Interventions general-observation-class dataset or --TERM in an Events
+ general-observation-class dataset), it is expected that the sponsor will split the values
+ into multiple records or otherwise resolve the multiplicity per the sponsor's data
+ management standard operating procedures.
Document: IG v3.4
Section: 4.2.8.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0346
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple values are reported for a topic variable (i.e.;
- --TRT in an Interventions general-observation-class dataset or
- --TERM in an Events general-observation-class dataset); it is
- assumed that the sponsor will split the values into multiple
- records or otherwise resolve the multiplicity as per the
- sponsor's standard data management procedures.
+ - Cited Guidance:
+ If multiple values are reported for a topic variable (i.e.; --TRT in an
+ Interventions general-observation-class dataset or --TERM in an Events
+ general-observation-class dataset); it is assumed that the sponsor will split the values
+ into multiple records or otherwise resolve the multiplicity as per the sponsor's standard
+ data management procedures.
Document: IG v3.3
Section: 4.2.8.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0346
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple values are reported for a topic variable (i.e.;
- --TRT in an Interventions general-observation-class
- dataset or --TERM in an Events general-observation-class
- dataset); it is assumed that the sponsor will split the values
- into multiple records or otherwise resolve the multiplicity as
- per the sponsor's standard data management procedures.
+ - Cited Guidance:
+ If multiple values are reported for a topic variable (i.e.; --TRT in an
+ Interventions general-observation-class dataset or --TERM in an Events
+ general-observation-class dataset); it is assumed that the sponsor will split the values
+ into multiple records or otherwise resolve the multiplicity as per the sponsor's standard
+ data management procedures.
Document: IG v3.2
Section: 4.1.2.8.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0346
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If multiple values are reported for a topic variable (i.e.,
- --TRT in an Interventions general-observation-class dataset or
- --TERM in an Events general-observation-class dataset), it is
- expected that the sponsor will split the values into multiple
- records or otherwise resolve the multiplicity per the
- sponsor's data management standard operating procedures.
+ - Cited Guidance:
+ If multiple values are reported for a topic variable (i.e., --TRT in an
+ Interventions general-observation-class dataset or --TERM in an Events
+ general-observation-class dataset), it is expected that the sponsor will split the values
+ into multiple records or otherwise resolve the multiplicity per the sponsor's data
+ management standard operating procedures.
Document: TIG 1.0
Item: Num 1, Num 2
- Section: '2.8.7.3'
+ Section: "2.8.7.3"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0511
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --TERM
@@ -82,7 +82,7 @@ Check:
Core:
Id: CORE-000164
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TERM = 'MULTIPLE'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000165/rule.yml b/Published/CORE-000165/rule.yml
index 60f63548b..da0c7b8eb 100644
--- a/Published/CORE-000165/rule.yml
+++ b/Published/CORE-000165/rule.yml
@@ -7,9 +7,9 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '"The actual date or date and time of a time point that acts as
- a fixed reference for a series of planned time points,
- represented in a standardized character format. The fixed
+ - Cited Guidance:
+ '"The actual date or date and time of a time point that acts as a fixed reference
+ for a series of planned time points, represented in a standardized character format. The fixed
reference point is in --TPTREF"'
Document: Model v2.0
Item: RFTDTC
@@ -17,186 +17,176 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0090
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '"Date/time for a fixed reference time point defined by
- --TPTREF."'
+ - Cited Guidance: '"Date/time for a fixed reference time point defined by --TPTREF."'
Document: Model v1.7
Item: Table 2.2.5.1 --RFTDTC
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0090
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '"(--RFTDTC) Date/time for a fixed reference time point defined
- by --TPTREF in ISO 8601 character format."'
+ - Cited Guidance:
+ '"(--RFTDTC) Date/time for a fixed reference time point defined by --TPTREF in
+ ISO 8601 character format."'
Document: Model v1.4
Item: Specification
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0090
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The actual date or date and time of a time point that acts as a
- fixed reference for a series of planned time points,
- represented in a standardized character format. The fixed
- reference point is in --TPTREF.
+ - Cited Guidance:
+ The actual date or date and time of a time point that acts as a fixed
+ reference for a series of planned time points, represented in a standardized character
+ format. The fixed reference point is in --TPTREF.
Document: SDTM v2.1
Item: --RFTDTC
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0355
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3701
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3701
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3701
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3701
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3701
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3701
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3701
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3701
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3701
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3701
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --RFTDTC
@@ -206,9 +196,9 @@ Check:
Core:
Id: CORE-000165
Status: Published
- Version: '1'
-Description: Time point reference (--TPTREF) should be present in the dataset,
- when reference time point (--RFTDTC) is also present in the dataset.
+ Version: "1"
+Description: Time point reference (--TPTREF) should be present in the dataset, when reference time
+ point (--RFTDTC) is also present in the dataset.
Executability: Fully Executable
Outcome:
Message: --TPTREF is missing when --RFTDTC is present.
diff --git a/Published/CORE-000166/rule.yml b/Published/CORE-000166/rule.yml
index 19ccb3758..0033bfb15 100644
--- a/Published/CORE-000166/rule.yml
+++ b/Published/CORE-000166/rule.yml
@@ -4,32 +4,34 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '"The description of the time when a protocol-defined activity
- is planned to occur, used for study data tabulation."'
+ - Cited Guidance:
+ '"The description of the time when a protocol-defined activity is planned to occur,
+ used for study data tabulation."'
Document: Model v2.0
Item: --TPT
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0091
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The description of the time when a protocol-defined activity is
- planned to occur, used for study data tabulation.
+ - Cited Guidance:
+ The description of the time when a protocol-defined activity is planned to
+ occur, used for study data tabulation.
Document: SDTM v2.1
Item: --TPT
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0356
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --TPTNUM
@@ -39,7 +41,7 @@ Check:
Core:
Id: CORE-000166
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TPT is not present but --TPTNUM is present in dataset.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000167/rule.yml b/Published/CORE-000167/rule.yml
index 4878dbec7..168502f3d 100644
--- a/Published/CORE-000167/rule.yml
+++ b/Published/CORE-000167/rule.yml
@@ -7,84 +7,79 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The description of a time point that acts as a fixed reference
- for a series of planned time points, used for study data
- tabulation. Description of the fixed reference point referred
- to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT.
+ - Cited Guidance:
+ The description of a time point that acts as a fixed reference for a series
+ of planned time points, used for study data tabulation. Description of the fixed reference
+ point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT.
Document: Model v2.0
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0092
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Model v1.4[2.2.5 Timing Variables for All
- Classes][Specification][(--TPTREF) Description of the fixed
- reference point referred to by --ELTM, --TPTNUM, and --TPT.
- Examples: PREVIOUS DOSE, PREVIOUS MEAL.]|IG v3.2[4.1.4.10
- Representing Time Points][If the protocol describes the
- scheduling of a dose using a reference intervention or
- assessment, then --TPTREF should be populated, even if it does
- not contribute to uniqueness. The fact that time points are
- related to a reference time point, and what that reference
- time point is, are important for interpreting the data
- collected at the time point.]'
+ - Cited Guidance:
+ "Model v1.4[2.2.5 Timing Variables for All Classes][Specification][(--TPTREF)
+ Description of the fixed reference point referred to by --ELTM, --TPTNUM, and --TPT. Examples:
+ PREVIOUS DOSE, PREVIOUS MEAL.]|IG v3.2[4.1.4.10 Representing Time Points][If the protocol describes
+ the scheduling of a dose using a reference intervention or assessment, then --TPTREF should
+ be populated, even if it does not contribute to uniqueness. The fact that time points are related
+ to a reference time point, and what that reference time point is, are important for interpreting
+ the data collected at the time point.]"
Document: Model v1.4|IG v3.2
Item: Model v1.4[2.2.5 Timing Variables for All Classes][Specification]
- Section: Model v1.4[2.2.5 Timing Variables for All Classes]|IG v3.2[4.1.4.10
- Representing Time Points]
+ Section:
+ Model v1.4[2.2.5 Timing Variables for All Classes]|IG v3.2[4.1.4.10 Representing
+ Time Points]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0092
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Model v1.7[2.2.5 Timing Variables for All Classes][Table
- 2.2.5.1: --TPTREF]Description of the fixed reference point
- referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT.
- Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".]|IG v3.3[4.4.10
- Representing Time Points][If the protocol describes the
- scheduling of a dose using a reference intervention or
- assessment, then --TPTREF should be populated, even if it does
- not contribute to uniqueness. The fact that time points are
- related to a reference time point, and what that reference
- time point is, are important for interpreting the data
- collected at the time point.]'
+ - Cited Guidance:
+ 'Model v1.7[2.2.5 Timing Variables for All Classes][Table 2.2.5.1: --TPTREF]Description
+ of the fixed reference point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. Examples:
+ "PREVIOUS DOSE", "PREVIOUS MEAL".]|IG v3.3[4.4.10 Representing Time Points][If the protocol
+ describes the scheduling of a dose using a reference intervention or assessment, then --TPTREF
+ should be populated, even if it does not contribute to uniqueness. The fact that time points
+ are related to a reference time point, and what that reference time point is, are important
+ for interpreting the data collected at the time point.]'
Document: Model v1.7|IG v3.3
- Item: 'Model v1.7[2.2.5 Timing Variables for All Classes][Table 2.2.5.1:
- --TPTREF]'
- Section: Model v1.7[2.2.5 Timing Variables for All Classes]|IG v3.3[4.4.10
- Representing Time Points]
+ Item: "Model v1.7[2.2.5 Timing Variables for All Classes][Table 2.2.5.1: --TPTREF]"
+ Section:
+ Model v1.7[2.2.5 Timing Variables for All Classes]|IG v3.3[4.4.10 Representing Time
+ Points]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0092
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The description of a time point that acts as a fixed reference
- for a series of planned time points, used for study data
- tabulation. Description of the fixed reference point referred
- to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT.
+ - Cited Guidance:
+ The description of a time point that acts as a fixed reference for a series
+ of planned time points, used for study data tabulation. Description of the fixed reference
+ point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT.
Document: SDTM v2.1
Item: --TPTREF
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0357
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --ELTM
@@ -94,7 +89,7 @@ Check:
Core:
Id: CORE-000167
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when--ELTM is present but --TPTREF is not present in dataset.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000168/rule.yml b/Published/CORE-000168/rule.yml
index 50f7e0aac..491e13f1e 100644
--- a/Published/CORE-000168/rule.yml
+++ b/Published/CORE-000168/rule.yml
@@ -7,65 +7,65 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The Subject Visits domain consolidates information about the
- timing of subject visits that is otherwise spread over domains
- that include the visit variables (VISITNUM and possibly VISIT
- and/or VISITDY).
+ - Cited Guidance:
+ The Subject Visits domain consolidates information about the timing of
+ subject visits that is otherwise spread over domains that include the visit variables
+ (VISITNUM and possibly VISIT and/or VISITDY).
Document: IG v3.4
- Section: '5.5'
+ Section: "5.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0034
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The Subject Visits domain consolidates information about the
- timing of subject visits that is otherwise spread over domains
- that include the visit variables (VISITNUM and possibly VISIT
- and/or VISITDY).
+ - Cited Guidance:
+ The Subject Visits domain consolidates information about the timing of
+ subject visits that is otherwise spread over domains that include the visit variables
+ (VISITNUM and possibly VISIT and/or VISITDY).
Document: IG v3.3
- Section: '5.5'
+ Section: "5.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0034
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The Subject Visits domain consolidates information about the
- timing of subject visits that is otherwise spread over domains
- that include the visit variables (VISITNUM and possibly VISIT
- and/or VISITDY).
+ - Cited Guidance:
+ The Subject Visits domain consolidates information about the timing of
+ subject visits that is otherwise spread over domains that include the visit variables
+ (VISITNUM and possibly VISIT and/or VISITDY).
Document: IG v3.2
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0034
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The Subject Visits domain consolidates information about the
- timing of subject visits that is otherwise spread over domains
- that include the visit variables (VISITNUM and possibly VISIT
- and/or VISITDY).
+ - Cited Guidance:
+ The Subject Visits domain consolidates information about the timing of
+ subject visits that is otherwise spread over domains that include the visit variables
+ (VISITNUM and possibly VISIT and/or VISITDY).
Document: TIG 1.0
Item: Assumption 1
Section: 2.8.10.25
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0315
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: VISITNUM
@@ -76,7 +76,7 @@ Check:
Core:
Id: CORE-000168
Status: Published
- Version: '1'
+ Version: "1"
Description: If VISITNUM is not null then VISITNUM should be among SV.VISITNUM
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000169/rule.yml b/Published/CORE-000169/rule.yml
index 04d8546e1..06d49382f 100644
--- a/Published/CORE-000169/rule.yml
+++ b/Published/CORE-000169/rule.yml
@@ -7,61 +7,65 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '"If value is from a numeric scale, represent only the
- number (e.g., "2" and not "Grade 2")."'
+ - Cited Guidance:
+ '"If value is from a numeric scale, represent only the number (e.g., "2" and
+ not "Grade 2")."'
Document: IG v3.4
Item: Specification
Section: 6.3.5.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0185
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If value is from a numeric scale, represent only the number
- (e.g., "2" and not "Grade 2").
+ - Cited Guidance:
+ If value is from a numeric scale, represent only the number (e.g., "2" and
+ not "Grade 2").
Document: IG v3.2
Item: Specification
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0185
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If value is from a numeric scale, represent only the number
- (e.g., "2" and not "Grade 2").
+ - Cited Guidance:
+ If value is from a numeric scale, represent only the number (e.g., "2" and
+ not "Grade 2").
Document: IG v3.3
Item: Specification
Section: 6.3.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0185
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Records toxicity grade value using a standard toxicity scale
- (such as the NCI CTCAE). If value is from a numeric scale,
- represent only the number (e.g., "2" and not "Grade 2").
+ - Cited Guidance:
+ Records toxicity grade value using a standard toxicity scale (such as the
+ NCI CTCAE). If value is from a numeric scale, represent only the number (e.g., "2" and not
+ "Grade 2").
Document: TIG 1.0
Item: Specification-LBTOXGR
Section: 2.8.10.14
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0414
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: LBTOXGR
@@ -69,11 +73,11 @@ Check:
value: .*[a-zA-Z].* # identifiers string contains characters
- name: LBTOXGR
operator: matches_regex
- value: .*[0-9].* #identifies that string also contains a number
+ value: .*[0-9].* #identifies that string also contains a number
Core:
Id: CORE-000169
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise a warning when LBTOXGR is not numeric
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000170/rule.yml b/Published/CORE-000170/rule.yml
index 46f2c787f..20ce88291 100644
--- a/Published/CORE-000170/rule.yml
+++ b/Published/CORE-000170/rule.yml
@@ -1,5 +1,5 @@
# Variable: --LOBXFL
-# Condition:
+# Condition:
# Rule: Value must be 'Y' or null
Authorities:
- Organization: CDISC
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0541
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -27,9 +27,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0541
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -40,10 +40,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0634
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --LOBXFL
@@ -54,7 +54,7 @@ Check:
Core:
Id: CORE-000170
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --LOBXFL is not 'Y' or null
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000171/rule.yml b/Published/CORE-000171/rule.yml
index f118e3934..bc0c99003 100644
--- a/Published/CORE-000171/rule.yml
+++ b/Published/CORE-000171/rule.yml
@@ -7,66 +7,68 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The description or date and/or time of a time point that acts as
- a fixed reference for characterizing the end of an
- observation. This is the sponsor-defined reference point
- referred to by --ENRTPT.
+ - Cited Guidance:
+ The description or date and/or time of a time point that acts as a fixed
+ reference for characterizing the end of an observation. This is the sponsor-defined
+ reference point referred to by --ENRTPT.
Document: Model v2.0
Item: --ENTPT
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0058
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Description or date/time in ISO 8601 or other character format
- of the sponsor-defined reference point referred to by
- --ENRTPT. Examples "2003-12-25" or "VISIT 2".
+ - Cited Guidance:
+ Description or date/time in ISO 8601 or other character format of the
+ sponsor-defined reference point referred to by --ENRTPT. Examples "2003-12-25" or "VISIT
+ 2".
Document: Model v1.7
Item: Table 2.2.5.1, --ENTPT
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0058
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: (--ENTPT) Description or date/time in ISO 8601 or other
- character format of the sponsor-defined reference point
- referred to by --ENRTPT. Examples "2003-12-25" or "VISIT 2".
+ - Cited Guidance:
+ (--ENTPT) Description or date/time in ISO 8601 or other character format of
+ the sponsor-defined reference point referred to by --ENRTPT. Examples "2003-12-25" or
+ "VISIT 2".
Document: Model v1.4
Item: Specification
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0058
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The description or date and/or time of a time point that acts as
- a fixed reference for characterizing the end of an
- observation. This is the sponsor-defined reference point
- referred to by --ENRTPT.
+ - Cited Guidance:
+ The description or date and/or time of a time point that acts as a fixed
+ reference for characterizing the end of an observation. This is the sponsor-defined
+ reference point referred to by --ENRTPT.
Document: SDTM v2.1
Item: --ENTPT
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0332
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --ENRTPT
@@ -76,9 +78,9 @@ Check:
Core:
Id: CORE-000171
Status: Published
- Version: '1'
-Description: Raises an error when --ENRTPT is present in dataset but --ENTPT is
- not present in dataset.
+ Version: "1"
+Description: Raises an error when --ENRTPT is present in dataset but --ENTPT is not present in
+ dataset.
Executability: Fully Executable
Outcome:
Message: --ENTPT should be present when --ENRTPT is present in a dataset
diff --git a/Published/CORE-000172/rule.yml b/Published/CORE-000172/rule.yml
index ca3de6a78..6625e9dc2 100644
--- a/Published/CORE-000172/rule.yml
+++ b/Published/CORE-000172/rule.yml
@@ -1,5 +1,5 @@
# Variable: STUDYID
-# Condition:
+# Condition:
# Rule: STUDYID = DM.STUDYID
Authorities:
- Organization: CDISC
@@ -7,112 +7,111 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All records with the same STUDYID value are a group of records
- that describe that study.
+ - Cited Guidance:
+ All records with the same STUDYID value are a group of records that describe
+ that study.
Document: IG v3.4
Item: 2.B.1
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0409
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All records with the same STUDYID value are a group of records
- that describe that study
+ - Cited Guidance:
+ All records with the same STUDYID value are a group of records that describe
+ that study
Document: IG v3.3
Item: 2.B.1
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0409
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All records with the same STUDYID value are a group of records
- that describe that study
+ - Cited Guidance:
+ All records with the same STUDYID value are a group of records that describe
+ that study
Document: IG v3.2
Item: 2.B.1
Section: 4.1.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0409
- Version: '1'
- Version: '2.0'
- Version: '3.2'
- - Name: SENDIG
- # IMPORTANT: Rule is different from SEND249, which is for SENDIG-3.0 ONLY,
- # and which explicitely requires STUDYID=TS.STUDYID
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name:
+ SENDIG
+ # IMPORTANT: Rule is different from SEND249, which is for SENDIG-3.0 ONLY,
+ # and which explicitely requires STUDYID=TS.STUDYID
References:
- Citations:
- - Cited Guidance: The STUDYID in all domains must be the same in all records
- across the study.
+ - Cited Guidance: The STUDYID in all domains must be the same in all records across the study.
Document: IG v3.1
Section: 3.7.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND249.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The STUDYID in all domains must be the same in all records
- across the study.
+ - Cited Guidance: The STUDYID in all domains must be the same in all records across the study.
Document: IG v3.1.1
Section: 3.7.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND249.1
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The STUDYID in all domains must be the same in all records
- across the study.
+ - Cited Guidance: The STUDYID in all domains must be the same in all records across the study.
Document: IG v3.1
Section: 3.7.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND249.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The STUDYID in all domains must be the same in all records
- across the study.
+ - Cited Guidance: The STUDYID in all domains must be the same in all records across the study.
Document: IG v3.1.1
Section: 3.7.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND249.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The STUDYID in all domains must be the same in all records
- across the study.
+ - Cited Guidance: The STUDYID in all domains must be the same in all records across the study.
Document: IG v3.1.1
Section: 3.7.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND249.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
@@ -123,10 +122,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0168
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
@@ -137,10 +136,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0565
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: STUDYID
@@ -149,9 +148,9 @@ Check:
Core:
Id: CORE-000172
Status: Published
- Version: '1'
-Description: Raise an error when STUDYID is not equal to DM.STUDYID. The STUDYID
- in all domains must be the same in all records across the study.
+ Version: "1"
+Description: Raise an error when STUDYID is not equal to DM.STUDYID. The STUDYID in all domains must
+ be the same in all records across the study.
Executability: Fully Executable
Operations:
- domain: DM
diff --git a/Published/CORE-000173/rule.yml b/Published/CORE-000173/rule.yml
index 49647c376..b158df342 100644
--- a/Published/CORE-000173/rule.yml
+++ b/Published/CORE-000173/rule.yml
@@ -7,81 +7,78 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The Subject Elements domain allows the submission of data on the
- timing of the trial Elements a subject actually passed through
- in their participation in the trial. Read Section 7.2.2, Trial
- Elements, on the Trial Elements (TE) dataset and Section
- 7.2.1, Trial Arms, on the Trial Arms (TA) dataset, as these
- datasets define a trial's planned Elements and describe the
- planned sequences of Elements for the Arms of the trial.
+ - Cited Guidance:
+ The Subject Elements domain allows the submission of data on the timing of
+ the trial Elements a subject actually passed through in their participation in the trial.
+ Read Section 7.2.2, Trial Elements, on the Trial Elements (TE) dataset and Section 7.2.1,
+ Trial Arms, on the Trial Arms (TA) dataset, as these datasets define a trial's planned
+ Elements and describe the planned sequences of Elements for the Arms of the trial.
Document: IG V3.4
Item: Assumptions
- Section: '5.3'
+ Section: "5.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0414
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The Subject Elements domain allows the submission of data on the
- timing of the trial Elements a subject actually passed through
- in their participation in the trial. Please read Section 7.2.2
- - Experimental Design; Trial Elements (TE); on the Trial
- Elements dataset and Section 7.2.1 - Experimental Design;
- Trial Arms (TA); on the Trial Arms dataset; as these datasets
- define a trial's planned Elements; and describe the planned
- sequences of lements for the Arms of the trial.
+ - Cited Guidance:
+ The Subject Elements domain allows the submission of data on the timing of
+ the trial Elements a subject actually passed through in their participation in the trial.
+ Please read Section 7.2.2 - Experimental Design; Trial Elements (TE); on the Trial
+ Elements dataset and Section 7.2.1 - Experimental Design; Trial Arms (TA); on the Trial
+ Arms dataset; as these datasets define a trial's planned Elements; and describe the
+ planned sequences of lements for the Arms of the trial.
Document: IG V3.3
Item: Assumptions
Section: 5 SE
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0414
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The Subject Elements domain allows the submission of data on the
- timing of the trial Elements a subject actually passed through
- in their participation in the trial. Please read Section 7.2 -
- Experimental Design; Trial Elements (TE); on the Trial
- Elements dataset and Section 7.2 - Experimental Design; Trial
- Arms (TA); on the Trial Arms dataset; as these datasets define
- a trial's planned Elements; and describe the planned sequences
- of lements for the Arms of the trial.
+ - Cited Guidance:
+ The Subject Elements domain allows the submission of data on the timing of
+ the trial Elements a subject actually passed through in their participation in the trial.
+ Please read Section 7.2 - Experimental Design; Trial Elements (TE); on the Trial Elements
+ dataset and Section 7.2 - Experimental Design; Trial Arms (TA); on the Trial Arms dataset;
+ as these datasets define a trial's planned Elements; and describe the planned sequences of
+ lements for the Arms of the trial.
Document: IG V3.2
Item: Assumptions 2
Section: 5 SE
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0414
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The Subject Elements domain allows the submission of data on the
- timing of the trial Elements a subject actually passed through
- in their participation in the trial. Section 10.8.30 Trial
- Elements and Section 10.8.29 Trial Arms, as these datasets
- define a trial's planned Elements and describe the planned
- sequences of Elements for the Arms of the trial.
+ - Cited Guidance:
+ The Subject Elements domain allows the submission of data on the timing of
+ the trial Elements a subject actually passed through in their participation in the trial.
+ Section 10.8.30 Trial Elements and Section 10.8.29 Trial Arms, as these datasets define
+ a trial's planned Elements and describe the planned sequences of Elements for the Arms of
+ the trial.
Document: TIG 1.0
Item: Assumptions
Section: 2.8.10.24|2.8.10.29
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0569
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ETCD
@@ -93,7 +90,7 @@ Check:
Core:
Id: CORE-000173
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when ETCD is not equal to 'UNPLAN' and not equal to TE.ETCD
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000177/rule.yml b/Published/CORE-000177/rule.yml
index afeb12ac9..b40ae79dc 100644
--- a/Published/CORE-000177/rule.yml
+++ b/Published/CORE-000177/rule.yml
@@ -7,73 +7,71 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The characterization of the end of an observation relative to
- the study reference period. The sponsor-defined reference
- period is a continuous period of time defined by a discrete
- starting point and a discrete ending point represented by
- RFSTDTC and RFENDTC in Demographics.
+ - Cited Guidance:
+ The characterization of the end of an observation relative to the study
+ reference period. The sponsor-defined reference period is a continuous period of time
+ defined by a discrete starting point and a discrete ending point represented by RFSTDTC
+ and RFENDTC in Demographics.
Document: Model v2.0
Item: --ENRF
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0227
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the end of the observation as being before, during or
- after the sponsor-defined reference period. The
- sponsor-defined reference period is a continuous period of
- time defined by a discrete starting point and a discrete
- ending point represented by RFSTDTC and RFENDTC in
- Demographics.
+ - Cited Guidance:
+ Identifies the end of the observation as being before, during or after the
+ sponsor-defined reference period. The sponsor-defined reference period is a continuous
+ period of time defined by a discrete starting point and a discrete ending point
+ represented by RFSTDTC and RFENDTC in Demographics.
Document: Model v1.7
Item: Table 2.2.5.1 --ENRF
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0227
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the end of the observation as being before, during or
- after the sponsor-defined reference period. The
- sponsor-defined reference period is a continuous period of
- time defined by a discrete starting point and a discrete
- ending point represented by RFSTDTC and RFENDTC in
- Demographics.
+ - Cited Guidance:
+ Identifies the end of the observation as being before, during or after the
+ sponsor-defined reference period. The sponsor-defined reference period is a continuous
+ period of time defined by a discrete starting point and a discrete ending point
+ represented by RFSTDTC and RFENDTC in Demographics.
Document: Model v1.4
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0227
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The characterization of the end of an observation relative to
- the study reference period. The sponsor-defined reference
- period is a continuous period of time defined by a discrete
- starting point and a discrete ending point represented by
- RFSTDTC and RFENDTC in Demographics.
+ - Cited Guidance:
+ The characterization of the end of an observation relative to the study
+ reference period. The sponsor-defined reference period is a continuous period of time
+ defined by a discrete starting point and a discrete ending point represented by RFSTDTC
+ and RFENDTC in Demographics.
Document: SDTM v2.1
Item: --ENRF
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0440
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: RFENDTC
@@ -83,7 +81,7 @@ Check:
Core:
Id: CORE-000177
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when DM.RFENDTC is empty and --ENRF is not empty.
Executability: Fully Executable
Match Datasets:
diff --git a/Published/CORE-000179/rule.yml b/Published/CORE-000179/rule.yml
index 961b2205e..38479b436 100644
--- a/Published/CORE-000179/rule.yml
+++ b/Published/CORE-000179/rule.yml
@@ -1,5 +1,5 @@
# Variable: TSPARMCD AND TSPARM
-# Condition:
+# Condition:
# Rule: TSPARM and TSPARMCD have a one-to-one relationship
Authorities:
- Organization: CDISC
@@ -14,22 +14,22 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0307
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: TSPARMCD (the companion to TSPARM)
Document: IG v3.2
Item: Specification
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0307
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -40,9 +40,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0307
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -53,162 +53,162 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0482
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0916
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0916
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0916
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0916
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0916
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0916
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0916
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0916
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0916
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0916
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: TSPARM
@@ -217,7 +217,7 @@ Check:
Core:
Id: CORE-000179
Status: Published
- Version: '1'
+ Version: "1"
Description: TSPARMCD and TSPARM should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000180/rule.yml b/Published/CORE-000180/rule.yml
index 8f63bc6ff..78e1480a6 100644
--- a/Published/CORE-000180/rule.yml
+++ b/Published/CORE-000180/rule.yml
@@ -1,5 +1,5 @@
# Variable: DOMAIN
-# Condition:
+# Condition:
# Rule: DOMAIN value length = 2
Authorities:
- Organization: CDISC
@@ -7,59 +7,56 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Each domain dataset is distinguished by a unique, two-character
- code
+ - Cited Guidance: Each domain dataset is distinguished by a unique, two-character code
Document: IG v3.4
- Section: '2.2'
+ Section: "2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0308
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Each domain dataset is distinguished by a unique, two-character
- code
+ - Cited Guidance: Each domain dataset is distinguished by a unique, two-character code
Document: IG v3.2
- Section: '2.2'
+ Section: "2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0308
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Each domain dataset is distinguished by a unique, two-character
- code
+ - Cited Guidance: Each domain dataset is distinguished by a unique, two-character code
Document: IG v3.3
- Section: '2.2'
+ Section: "2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0308
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Domain datasets based on the SDTM general observations classes
- will be named using the two-character code for the domain or
- using the applicable four-character code when a dataset is
- split.
+ - Cited Guidance:
+ Domain datasets based on the SDTM general observations classes will be named
+ using the two-character code for the domain or using the applicable four-character code
+ when a dataset is split.
Document: TIG 1.0
Item: Num 2
- Section: '2.6'
+ Section: "2.6"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0483
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
@@ -69,7 +66,7 @@ Check:
Core:
Id: CORE-000180
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when DOMAIN value length is not equal 2.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000182/rule.yml b/Published/CORE-000182/rule.yml
index bbfd2ec7f..2e2c11a01 100644
--- a/Published/CORE-000182/rule.yml
+++ b/Published/CORE-000182/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: Variable name length <= 8
Authorities:
- Organization: CDISC
@@ -7,149 +7,159 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: In some cases, the standard variable name will be shortened to
- meet the 8-character variable name requirement...
+ - Cited Guidance:
+ In some cases, the standard variable name will be shortened to meet the
+ 8-character variable name requirement...
Document: IG v3.4
Section: 4.2.8.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0310
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The Variable Name (limited to 8 characters for compatibility
- with the SAS Transport format)
+ - Cited Guidance:
+ The Variable Name (limited to 8 characters for compatibility with the SAS
+ Transport format)
Document: IG v3.2
- Section: '2.2'
+ Section: "2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0310
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: In some cases, the standard variable name will be shortened to
- meet the 8-character variable name requirement...
+ - Cited Guidance:
+ In some cases, the standard variable name will be shortened to meet the
+ 8-character variable name requirement...
Document: IG v3.3
Section: 4.2.8.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0310
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The Variable Name (limited to 8 characters for compatibility
- with the SAS v5 Transport format).
+ - Cited Guidance:
+ The Variable Name (limited to 8 characters for compatibility with the SAS v5
+ Transport format).
Document: IG v3.1.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND2
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The Variable Name (limited to 8 characters for compatibility
- with the SAS v5 Transport format).
+ - Cited Guidance:
+ The Variable Name (limited to 8 characters for compatibility with the SAS v5
+ Transport format).
Document: IG v3.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND2
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The Variable Name (limited to 8 characters for compatibility
- with the SAS v5 Transport format).
+ - Cited Guidance:
+ The Variable Name (limited to 8 characters for compatibility with the SAS v5
+ Transport format).
Document: IG v3.0
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND2
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The Variable Name (limited to 8 characters for compatibility
- with the SAS v5 Transport format).
+ - Cited Guidance:
+ The Variable Name (limited to 8 characters for compatibility with the SAS v5
+ Transport format).
Document: IG v1.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND2
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The Variable Name (limited to 8 characters for compatibility
- with the SAS v5 Transport format).
+ - Cited Guidance:
+ The Variable Name (limited to 8 characters for compatibility with the SAS v5
+ Transport format).
Document: IG v1.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND2
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The Variable Name (limited to 8 characters for compatibility
- with the SAS v5 Transport format).
+ - Cited Guidance:
+ The Variable Name (limited to 8 characters for compatibility with the SAS v5
+ Transport format).
Document: IG v1.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND2
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- Cited Guidance: Variable names will be 8 characters or less and upper case.
Document: TIG 1.0
- Item: 'Num 4'
- Section: '2.6'
+ Item: "Num 4"
+ Section: "2.6"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0485
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The Variable Name (limited to 8 characters for compatibility
- with the SAS v5 Transport format).
+ - Cited Guidance:
+ The Variable Name (limited to 8 characters for compatibility with the SAS v5
+ Transport format).
Document: TIG v1.0
Item: Text
Section: 2.6 Guidance for Datasets, tabulation table Num 4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0128
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: variable_name
@@ -158,7 +168,7 @@ Check:
Core:
Id: CORE-000182
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when variable name length is greater than 8.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000183/rule.yml b/Published/CORE-000183/rule.yml
index ff5fb77d3..330c756cf 100644
--- a/Published/CORE-000183/rule.yml
+++ b/Published/CORE-000183/rule.yml
@@ -7,73 +7,76 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Note, domain pairs have been modeled for microbiology data
- (MB/MS domains) and PK data (PC/PP domains) to enable
- dataset-level relationships to be described using RELREC.
+ - Cited Guidance:
+ Note, domain pairs have been modeled for microbiology data (MB/MS domains)
+ and PK data (PC/PP domains) to enable dataset-level relationships to be described using
+ RELREC.
Document: IG v3.4
- Item: '1'
- Section: '2.6'
- - Cited Guidance: A findings domain that contains pharmacokinetic parameters
- derived from pharmacokinetic concentration-time (PC) data.
+ Item: "1"
+ Section: "2.6"
+ - Cited Guidance:
+ A findings domain that contains pharmacokinetic parameters derived from
+ pharmacokinetic concentration-time (PC) data.
Document: IG v3.4
Item: PP - Description/Overview
Section: 6.3.5.6.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0318
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.2[2.6][The domain pair uses DOMAIN as an Identifier to
- group parent records (e.g., MB) from child records (e.g., MS)
- and enables a dataset-level relationship to be described in
- RELREC.]|IG v3.2[6.3][PP][Pharmacokinetic parameters derived
- from pharmacokinetic concentration-time (PC) data.]
+ - Cited Guidance:
+ IG v3.2[2.6][The domain pair uses DOMAIN as an Identifier to group parent
+ records (e.g., MB) from child records (e.g., MS) and enables a dataset-level relationship
+ to be described in RELREC.]|IG v3.2[6.3][PP][Pharmacokinetic parameters derived from
+ pharmacokinetic concentration-time (PC) data.]
Document: IG v3.2
Item: IG v3.2[2.6]|IG v3.2[6.3][PP]
Section: IG v3.2[2.6]|IG v3.2[6.3]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0318
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[2.6]|IG v3.3[6.3.11.2][The domain pair uses DOMAIN as an
- Identifier to group parent records (e.g., MB) from child
- records (e.g., MS) and enables a dataset-level relationship to
- be described in RELREC.]|IG v3.3[6.3.11.2][A findings domain
- that contains pharmacokinetic parameters derived from
- pharmacokinetic concentration-time (PC) data.]
+ - Cited Guidance:
+ IG v3.3[2.6]|IG v3.3[6.3.11.2][The domain pair uses DOMAIN as an Identifier
+ to group parent records (e.g., MB) from child records (e.g., MS) and enables a
+ dataset-level relationship to be described in RELREC.]|IG v3.3[6.3.11.2][A findings domain
+ that contains pharmacokinetic parameters derived from pharmacokinetic concentration-time
+ (PC) data.]
Document: IG v3.3
Item: IG v3.3[2.6]|IG v3.3[6.3.11.2]
Section: IG v3.3[2.6]|IG v3.3[6.3.11.2]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0318
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: A findings domain that contains pharmacokinetic parameters
- derived from pharmacokinetic concentration-time (PC) data.
+ - Cited Guidance:
+ A findings domain that contains pharmacokinetic parameters derived from
+ pharmacokinetic concentration-time (PC) data.
Document: TIG 1.0
Item: Description
Section: 2.8.10.17
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0489
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: PP
@@ -83,9 +86,9 @@ Check:
Core:
Id: CORE-000183
Status: Published
- Version: '1'
-Description: Raise an error when a PP dataset is present in study, but a PC
- dataset is not present in study.
+ Version: "1"
+Description: Raise an error when a PP dataset is present in study, but a PC dataset is not present
+ in study.
Executability: Fully Executable
Outcome:
Message: PP dataset is present in study, but PC dataset is not present in study.
diff --git a/Published/CORE-000184/rule.yml b/Published/CORE-000184/rule.yml
index 26d0803d8..a32005a6f 100644
--- a/Published/CORE-000184/rule.yml
+++ b/Published/CORE-000184/rule.yml
@@ -1,5 +1,5 @@
# Variable: --BDSYCD
-# Condition:
+# Condition:
# Rule: --BDSYCD and --BODSYS have a one-to-one relationship
Authorities:
- Organization: CDISC
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0083
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -26,9 +26,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0083
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -38,9 +38,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0083
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
@@ -51,57 +51,57 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0348
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0910
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0910
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0910
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: --BDSYCD
@@ -114,7 +114,7 @@ Check:
Core:
Id: CORE-000184
Status: Published
- Version: '1'
+ Version: "1"
Description: --BODSYS and --BDSYCD have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000185/rule.yml b/Published/CORE-000185/rule.yml
index 71fe9f9b0..61c796e15 100644
--- a/Published/CORE-000185/rule.yml
+++ b/Published/CORE-000185/rule.yml
@@ -1,5 +1,5 @@
# Variable: ACTARMCD
-# Condition:
+# Condition:
# Rule: ACTARMCD value length <= 20
Authorities:
- Organization: CDISC
@@ -7,63 +7,64 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Code of actual Arm. ACTARMCD is limited to 20 characters. It is
- not subject to the character restrictions that apply to
- TESTCD.
+ - Cited Guidance:
+ Code of actual Arm. ACTARMCD is limited to 20 characters. It is not subject
+ to the character restrictions that apply to TESTCD.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0123
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: ACTARMCD is limited to 20 characters and does not have special
- character restrictions.
+ - Cited Guidance:
+ ACTARMCD is limited to 20 characters and does not have special character
+ restrictions.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0123
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Code of actual Arm. ACTARMCD is limited to 20 characters. It is
- not subject to the character restrictions that apply to
- TESTCD.
+ - Cited Guidance:
+ Code of actual Arm. ACTARMCD is limited to 20 characters. It is not subject
+ to the character restrictions that apply to TESTCD.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0123
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Code of actual Arm. ACTARMCD is limited to 20 characters. It is
- not subject to the character restrictions that apply to
- TESTCD.
+ - Cited Guidance:
+ Code of actual Arm. ACTARMCD is limited to 20 characters. It is not subject
+ to the character restrictions that apply to TESTCD.
Document: TIG 1.0
Item: ACTARMCD
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0380
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ACTARMCD
@@ -72,7 +73,7 @@ Check:
Core:
Id: CORE-000185
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error if length of ACTARMCD is greater than 20 characters
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000186/rule.yml b/Published/CORE-000186/rule.yml
index 272240164..8121f4ff5 100644
--- a/Published/CORE-000186/rule.yml
+++ b/Published/CORE-000186/rule.yml
@@ -1,5 +1,5 @@
# Variable: SUBJID
-# Condition:
+# Condition:
# Rule: SUBJID unique within a study
Authorities:
- Organization: CDISC
@@ -10,39 +10,39 @@ Authorities:
- Cited Guidance: Subject identifier, which must be unique within the study.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0150
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Subject identifier, which must be unique within the study.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0150
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Subject identifier, which must be unique within the study.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0150
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -53,10 +53,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0391
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SUBJID
@@ -66,7 +66,7 @@ Check:
Core:
Id: CORE-000186
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error if SUBJID is not unique
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000187/rule.yml b/Published/CORE-000187/rule.yml
index 19823a7fe..a325d0298 100644
--- a/Published/CORE-000187/rule.yml
+++ b/Published/CORE-000187/rule.yml
@@ -7,103 +7,93 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Date/time of comment on dedicated comment form. Should be null
- if this is a child record of another domain or if comment date
- was not collected.
+ - Cited Guidance:
+ Date/time of comment on dedicated comment form. Should be null if this is a
+ child record of another domain or if comment date was not collected.
Document: IG v3.4
Item: Specification
- Section: '5.1'
- - Cited Guidance: Those related to a specific parent record or group of parent
- records, in which case the value of the variable RDOMAIN is
- set to the DOMAIN code of the parent record(s) and the
- variables IDVAR and IDVARVAL are populated with the key
- variable name and value of the parent record(s). Assumptions
- for populating IDVAR and IDVARVAL are further described in
- Section 8.5, Relating Comments to a Parent Domain. CODTC
- should be null because the timing of the parent record(s) is
- inherited by the comment record. See example, Rows 3-5.
+ Section: "5.1"
+ - Cited Guidance:
+ Those related to a specific parent record or group of parent records, in
+ which case the value of the variable RDOMAIN is set to the DOMAIN code of the parent
+ record(s) and the variables IDVAR and IDVARVAL are populated with the key variable name
+ and value of the parent record(s). Assumptions for populating IDVAR and IDVARVAL are
+ further described in Section 8.5, Relating Comments to a Parent Domain. CODTC should be
+ null because the timing of the parent record(s) is inherited by the comment record. See
+ example, Rows 3-5.
Document: IG v3.4
Item: Assumption 2c
- Section: '5.1'
+ Section: "5.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0168
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '[Date/time of comment on dedicated comment form. Should be null
- if this is a child record of another domain or if comment date
- was not collected.][Those related to a specific parent record
- or group of parent records, in which case the value of the
- variable RDOMAIN is set to the DOMAIN code of the parent
- record(s) and the variables IDVAR and IDVARVAL are populated
- with the key variable name and value of the parent
- record(s).][Assumptions for populating IDVAR and IDVARVAL are
- further described in Section 8: 8.5, Relating Comments To A
- Parent Domain. CODTC should be null because the timing of the
- parent record(s) is inherited by the comment record. See
- example, Rows 3-5.]'
+ - Cited Guidance:
+ "[Date/time of comment on dedicated comment form. Should be null if this is a
+ child record of another domain or if comment date was not collected.][Those related to a specific
+ parent record or group of parent records, in which case the value of the variable RDOMAIN is
+ set to the DOMAIN code of the parent record(s) and the variables IDVAR and IDVARVAL are populated
+ with the key variable name and value of the parent record(s).][Assumptions for populating IDVAR
+ and IDVARVAL are further described in Section 8: 8.5, Relating Comments To A Parent Domain.
+ CODTC should be null because the timing of the parent record(s) is inherited by the comment
+ record. See example, Rows 3-5.]"
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0168
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '[Date/time of comment on dedicated comment form. Should be null
- if this is a child record of another domain or if comment date
- was not collected.][Those related to a specific parent record
- or group of parent records, in which case the value of the
- variable RDOMAIN is set to the DOMAIN code of the parent
- record(s) and the variables IDVAR and IDVARVAL are populated
- with the key variable name and value of the parent
- record(s).][Assumptions for populating IDVAR and IDVARVAL are
- further described in Section 8: 8.5, Relating Comments To A
- Parent Domain. CODTC should be null because the timing of the
- parent record(s) is inherited by the comment record. See
- example, Rows 3-5.]'
+ - Cited Guidance:
+ "[Date/time of comment on dedicated comment form. Should be null if this is a
+ child record of another domain or if comment date was not collected.][Those related to a specific
+ parent record or group of parent records, in which case the value of the variable RDOMAIN is
+ set to the DOMAIN code of the parent record(s) and the variables IDVAR and IDVARVAL are populated
+ with the key variable name and value of the parent record(s).][Assumptions for populating IDVAR
+ and IDVARVAL are further described in Section 8: 8.5, Relating Comments To A Parent Domain.
+ CODTC should be null because the timing of the parent record(s) is inherited by the comment
+ record. See example, Rows 3-5.]"
Document: IG v3.3
Item: Specification
- Section: '5.1'
+ Section: "5.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0168
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Specification[Date/time of comment on dedicated comment form.
- Should be null if this is a child record of another domain or
- if comment date was not collected.]|Assumption 2c[Those
- related to a specific parent record or group of parent
- records, in which case the value of the variable RDOMAIN is
- set to the DOMAIN code of the parent record(s) and the
- variables IDVAR and IDVARVAL are populated with the key
- variable name and value of the parent record(s). Assumptions
- for populating IDVAR and IDVARVAL are further described in
- Section 2.8.5.4 Relating Comments to a Domain. CODTC should
- be null because the timing of the parent record(s) is
- inherited by the comment record
+ - Cited Guidance:
+ Specification[Date/time of comment on dedicated comment form. Should be null
+ if this is a child record of another domain or if comment date was not
+ collected.]|Assumption 2c[Those related to a specific parent record or group of parent
+ records, in which case the value of the variable RDOMAIN is set to the DOMAIN code of the
+ parent record(s) and the variables IDVAR and IDVARVAL are populated with the key variable
+ name and value of the parent record(s). Assumptions for populating IDVAR and IDVARVAL are
+ further described in Section 2.8.5.4 Relating Comments to a Domain. CODTC should be null
+ because the timing of the parent record(s) is inherited by the comment record
Document: TIG 1.0
Item: Specification|Assumption 3c
Section: 2.8.10.2
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0400
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
@@ -114,7 +104,7 @@ Check:
Core:
Id: CORE-000187
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when IDVAR is not null and CODTC is not null
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000189/rule.yml b/Published/CORE-000189/rule.yml
index fcaaf3049..8c7b1a2b5 100644
--- a/Published/CORE-000189/rule.yml
+++ b/Published/CORE-000189/rule.yml
@@ -7,32 +7,30 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human
- clinical trials.'
+ - Cited Guidance: "[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials."
Document: Model v2.0
Item: AGEU|AGETXT
Section: Demographics
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0665
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- - Cited Guidance: '[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human
- clinical trials.'
+ - Cited Guidance: "[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials."
Document: SDTM v2.1
Item: AGEU|AGETXT
Section: Section 3.2.1 Demographics
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0699
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AGE
@@ -42,7 +40,7 @@ Check:
Core:
Id: CORE-000189
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AGE is not blank and AGEU is blank.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000190/rule.yml b/Published/CORE-000190/rule.yml
index 8f5cd04d0..729935137 100644
--- a/Published/CORE-000190/rule.yml
+++ b/Published/CORE-000190/rule.yml
@@ -7,32 +7,30 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human
- clinical trials.'
+ - Cited Guidance: "[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials."
Document: Model v2.0
Item: AGEU|AGETXT
Section: Demographics
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0666
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 'AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human
- clinical trials.'
+ - Cited Guidance: "AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials."
Document: SDTM v2.1
Item: AGEU|AGETXT
Section: Section 3.2.1 Demographics
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0700
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AGEU
@@ -42,7 +40,7 @@ Check:
Core:
Id: CORE-000190
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when AGEU is not blank and AGE is blank.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000191/rule.yml b/Published/CORE-000191/rule.yml
index 235a6e236..717b1677c 100644
--- a/Published/CORE-000191/rule.yml
+++ b/Published/CORE-000191/rule.yml
@@ -7,46 +7,49 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Required for all randomized subjects; null for screen failures
- or unassigned subjects.
+ - Cited Guidance:
+ Required for all randomized subjects; null for screen failures or unassigned
+ subjects.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0529
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Required for all randomized subjects; null for screen failures
- or unassigned subjects.
+ - Cited Guidance:
+ Required for all randomized subjects; null for screen failures or unassigned
+ subjects.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0529
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Required for all randomized subjects; null for screen failures
- or unassigned subjects.
+ - Cited Guidance:
+ Required for all randomized subjects; null for screen failures or unassigned
+ subjects.
Document: TIG 1.0
Item: Specification:RFENDTC
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0622
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ARM
@@ -56,7 +59,7 @@ Check:
Core:
Id: CORE-000191
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when ARM is not empty and RFENDTC is empty.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000192/rule.yml b/Published/CORE-000192/rule.yml
index dd4e4e241..4dfa0c5de 100644
--- a/Published/CORE-000192/rule.yml
+++ b/Published/CORE-000192/rule.yml
@@ -7,46 +7,49 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Required for all randomized subjects; null for screen failures
- or unassigned subjects.
+ - Cited Guidance:
+ Required for all randomized subjects; null for screen failures or unassigned
+ subjects.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0530
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Required for all randomized subjects; null for screen failures
- or unassigned subjects.
+ - Cited Guidance:
+ Required for all randomized subjects; null for screen failures or unassigned
+ subjects.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0530
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Required for all randomized subjects; null for screen failures
- or unassigned subjects.
+ - Cited Guidance:
+ Required for all randomized subjects; null for screen failures or unassigned
+ subjects.
Document: TIG 1.0
Item: Specification:RFENDTC
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0623
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ARMNRS
@@ -56,7 +59,7 @@ Check:
Core:
Id: CORE-000192
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when ARMNRS is not blank and RFENDTC is provided.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000195/rule.yml b/Published/CORE-000195/rule.yml
index bdcb04b4e..11b2d94db 100644
--- a/Published/CORE-000195/rule.yml
+++ b/Published/CORE-000195/rule.yml
@@ -1,5 +1,5 @@
# Variable: --SCAT
-# Condition:
+# Condition:
# Rule: --SCAT ^= --DECOD
Authorities:
- Organization: CDISC
@@ -7,60 +7,61 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.4
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0338
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.3
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0338
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.2
Section: 4.1.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0338
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or
- dictionary classification represented in --DECOD and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT will not be the domain name or dictionary
+ classification represented in --DECOD and --BODSYS.
Document: TIG 1.0
Item: General Conventions table NUM 7
Section: 2.8.7.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0503
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --SCAT
@@ -69,7 +70,7 @@ Check:
Core:
Id: CORE-000195
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --SCAT = --DECOD.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000196/rule.yml b/Published/CORE-000196/rule.yml
index 28633f2bd..413b06578 100644
--- a/Published/CORE-000196/rule.yml
+++ b/Published/CORE-000196/rule.yml
@@ -1,5 +1,5 @@
# Variable: --CAT
-# Condition:
+# Condition:
# Rule: --CAT ^= --DECOD
Authorities:
- Organization: CDISC
@@ -7,60 +7,61 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.4
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0337
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.3
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0337
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.2
Section: 4.1.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0337
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or
- dictionary classification represented in --DECOD and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT will not be the domain name or dictionary
+ classification represented in --DECOD and --BODSYS.
Document: TIG 1.0
Item: General Conventions table NUM 7
Section: 2.8.7.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0502
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --CAT
@@ -69,7 +70,7 @@ Check:
Core:
Id: CORE-000196
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --CAT = --DECOD.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000197/rule.yml b/Published/CORE-000197/rule.yml
index 1a8a0fcc8..3812af893 100644
--- a/Published/CORE-000197/rule.yml
+++ b/Published/CORE-000197/rule.yml
@@ -1,5 +1,5 @@
# Variable: --CAT
-# Condition:
+# Condition:
# Rule: --CAT ^= --BODSYS
Authorities:
- Organization: CDISC
@@ -7,60 +7,61 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.4
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0339
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.3
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0339
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.2
Section: 4.1.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0339
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or
- dictionary classification represented in --DECOD and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT will not be the domain name or dictionary
+ classification represented in --DECOD and --BODSYS.
Document: TIG 1.0
Item: General Conventions table NUM 7
Section: 2.8.7.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0504
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --CAT
@@ -69,7 +70,7 @@ Check:
Core:
Id: CORE-000197
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --CAT = --BODSYS.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000198/rule.yml b/Published/CORE-000198/rule.yml
index b892dc8e9..b586d3178 100644
--- a/Published/CORE-000198/rule.yml
+++ b/Published/CORE-000198/rule.yml
@@ -1,5 +1,5 @@
# Variable: --SCAT
-# Condition:
+# Condition:
# Rule: --SCAT ^= --BODSYS
Authorities:
- Organization: CDISC
@@ -7,60 +7,61 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.4
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0340
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.3
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0340
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.2
Section: 4.1.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0340
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or
- dictionary classification represented in --DECOD and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT will not be the domain name or dictionary
+ classification represented in --DECOD and --BODSYS.
Document: TIG 1.0
Item: General Conventions table NUM 7
Section: 2.8.7.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0505
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --SCAT
@@ -69,7 +70,7 @@ Check:
Core:
Id: CORE-000198
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --SCAT = --BODSYS.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000199/rule.yml b/Published/CORE-000199/rule.yml
index ca8546685..2fee4724f 100644
--- a/Published/CORE-000199/rule.yml
+++ b/Published/CORE-000199/rule.yml
@@ -1,5 +1,5 @@
# Variable: --TEST
-# Condition:
+# Condition:
# Rule: --TEST length <= 40
Authorities:
- Organization: CDISC
@@ -7,64 +7,60 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Since the --TEST variable is meant to serve as a label for a
- --TESTCD when a Findings dataset is transposed to a more
- horizontal format, the length of --TEST is limited to 40
- characters (except as noted below) to conform to the
- limitations of the SAS v5 Transport format currently used for
- submission datasets.... IETEST values in IE and TI are
- exceptions to the above 40-character rule and are limited to
- 200 characters, since they are not expected to be transformed
- to column labels.
+ - Cited Guidance:
+ Since the --TEST variable is meant to serve as a label for a --TESTCD when a
+ Findings dataset is transposed to a more horizontal format, the length of --TEST is
+ limited to 40 characters (except as noted below) to conform to the limitations of the SAS
+ v5 Transport format currently used for submission datasets.... IETEST values in IE and TI
+ are exceptions to the above 40-character rule and are limited to 200 characters, since
+ they are not expected to be transformed to column labels.
Document: IG v3.4
Section: 4.5.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0406
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The length of --TEST is normally limited to 40 characters to
- conform to the limitations of the SAS V5 Transport format
- currently used for submission datasets. IETEST values in IE
- and TI are exceptions to the above 40-character rule and are
- limited to 200 characters since they are not expected to be
- transformed to a column labels.
+ - Cited Guidance:
+ The length of --TEST is normally limited to 40 characters to conform to the
+ limitations of the SAS V5 Transport format currently used for submission datasets. IETEST
+ values in IE and TI are exceptions to the above 40-character rule and are limited to 200
+ characters since they are not expected to be transformed to a column labels.
Document: IG v3.3
Section: 4.5.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0406
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The length of --TEST is normally limited to 40 characters to
- conform to the limitations of the SAS V5 Transport format
- currently used for submission datasets. IETEST values in IE
- and TI are exceptions to the above 40-character rule and are
- limited to 200 characters since they are not expected to be
- transformed to a column labels.
+ - Cited Guidance:
+ The length of --TEST is normally limited to 40 characters to conform to the
+ limitations of the SAS V5 Transport format currently used for submission datasets. IETEST
+ values in IE and TI are exceptions to the above 40-character rule and are limited to 200
+ characters since they are not expected to be transformed to a column labels.
Document: IG v3.2
Section: 4.1.5.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0406
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Because of limitations of SAS v5 Transport files, the lengths of
- data values cannot exceed 200 characters. Because --TEST
- values may become column labels upon transformation, the SDTM
- additionally restricts them to 40 characters.
+ - Cited Guidance:
+ Because of limitations of SAS v5 Transport files, the lengths of data values
+ cannot exceed 200 characters. Because --TEST values may become column labels upon
+ transformation, the SDTM additionally restricts them to 40 characters.
Document: IG v3.0
Section: 4.5.3
Origin: SEND Conformance Rules
@@ -76,9 +72,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Because --TEST values may become column labels upon
- transformation, the SDTM additionally restricts them to 40
- characters.
+ - Cited Guidance:
+ Because --TEST values may become column labels upon transformation, the SDTM
+ additionally restricts them to 40 characters.
Document: IG v3.1
Section: 4.5.2
Origin: SEND Conformance Rules
@@ -90,9 +86,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Because --TEST values may become column labels upon
- transformation, the SDTM additionally restricts them to 40
- characters.
+ - Cited Guidance:
+ Because --TEST values may become column labels upon transformation, the SDTM
+ additionally restricts them to 40 characters.
Document: IG v3.1.1
Section: 4.5.2
Origin: SEND Conformance Rules
@@ -104,9 +100,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Because --TEST values may become column labels upon
- transformation, the SDTM additionally restricts them to 40
- characters.
+ - Cited Guidance:
+ Because --TEST values may become column labels upon transformation, the SDTM
+ additionally restricts them to 40 characters.
Document: IG v3.1
Section: 4.5.2
Origin: SEND Conformance Rules
@@ -118,9 +114,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Because --TEST values may become column labels upon
- transformation, the SDTM additionally restricts them to 40
- characters.
+ - Cited Guidance:
+ Because --TEST values may become column labels upon transformation, the SDTM
+ additionally restricts them to 40 characters.
Document: IG v3.1.1
Section: 4.5.2
Origin: SEND Conformance Rules
@@ -132,9 +128,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Because --TEST values may become column labels upon
- transformation, the SDTM additionally restricts them to 40
- characters.
+ - Cited Guidance:
+ Because --TEST values may become column labels upon transformation, the SDTM
+ additionally restricts them to 40 characters.
Document: IG v3.1.1
Section: 4.5.2
Origin: SEND Conformance Rules
@@ -146,21 +142,20 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: Since the --TEST variable is meant to serve as a label for a
- --TESTCD when a Findings dataset is transposed to a more
- horizontal format, the length of --TEST is limited to 40
- characters (except as noted below) to conform to the
- limitations of the SAS v5 Transport format currently used for
- submission datasets.
+ - Cited Guidance:
+ Since the --TEST variable is meant to serve as a label for a --TESTCD when a
+ Findings dataset is transposed to a more horizontal format, the length of --TEST is
+ limited to 40 characters (except as noted below) to conform to the limitations of the SAS
+ v5 Transport format currently used for submission datasets.
Document: TIG 1.0
Section: Finding Domain Specifications
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0563
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --TEST
@@ -169,7 +164,7 @@ Check:
Core:
Id: CORE-000199
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when length of --TEST > 40.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000200/rule.yml b/Published/CORE-000200/rule.yml
index e1eab4299..575a4296f 100644
--- a/Published/CORE-000200/rule.yml
+++ b/Published/CORE-000200/rule.yml
@@ -7,70 +7,69 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "--ORRES variable contains the result of the measurement or
- finding as originally received or collected. --ORRES is an
- expected variable and should always be populated, with two
- exceptions':' When --STAT = \"NOT DONE\" since there is no
- result for such a record When --DRVFL = \"Y\" since the
- distinction between an original result and a standard result
- is not applicable for records for which --DRVFL = \"Y\" "
+ - Cited Guidance:
+ '--ORRES variable contains the result of the measurement or finding as originally
+ received or collected. --ORRES is an expected variable and should always be populated, with
+ two exceptions'':'' When --STAT = "NOT DONE" since there is no result for such a record When
+ --DRVFL = "Y" since the distinction between an original result and a standard result is not
+ applicable for records for which --DRVFL = "Y" '
Document: IG v3.4
- Item: ' '
+ Item: " "
Section: 4.5.1.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0348
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "The --ORRES variable contains the result of the measurement or
- finding as originally received or collected. --ORRES is an
- expected variable and should always be populated; with two
- exceptions: When --STAT = 'NOT DONE'. --ORRES should generally
- not be populated for derived records."
+ - Cited Guidance:
+ "The --ORRES variable contains the result of the measurement or finding as originally
+ received or collected. --ORRES is an expected variable and should always be populated; with
+ two exceptions: When --STAT = 'NOT DONE'. --ORRES should generally not be populated for derived
+ records."
Document: IG v3.2
Section: 4.1.5.1.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0348
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "The --ORRES variable contains the result of the measurement or
- finding as originally received or collected. --ORRES is an
- expected variable and should always be populated; with two
- exceptions: When --STAT = 'NOT DONE'. --ORRES should generally
- not be populated for derived records."
+ - Cited Guidance:
+ "The --ORRES variable contains the result of the measurement or finding as originally
+ received or collected. --ORRES is an expected variable and should always be populated; with
+ two exceptions: When --STAT = 'NOT DONE'. --ORRES should generally not be populated for derived
+ records."
Document: IG v3.3
Section: 4.5.1.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0348
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: In general observation class domains, --STAT will be populated
- with "NOT DONE" when data are not collected for the topic of
- the observation.
+ - Cited Guidance:
+ In general observation class domains, --STAT will be populated with "NOT
+ DONE" when data are not collected for the topic of the observation.
Document: TIG 1.0
Item: Findings table Num 5
Section: 2.8.7.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0513
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -78,7 +77,7 @@ Check:
operator: empty
- name: --DRVFL
operator: not_equal_to
- value: 'Y'
+ value: "Y"
value_is_literal: true
- name: --ORRES
operator: empty
@@ -94,16 +93,16 @@ Check:
operator: not_exists
- name: --DRVFL
operator: not_equal_to
- value: 'Y'
+ value: "Y"
value_is_literal: true
- name: --ORRES
operator: empty
Core:
Id: CORE-000200
Status: Published
- Version: '1'
-Description: Verify that --ORRES is not missing when either --STAT is null or
- --DRVFL not equal to 'Y'
+ Version: "1"
+Description: Verify that --ORRES is not missing when either --STAT is null or --DRVFL not equal to
+ 'Y'
Executability: Fully Executable
Outcome:
Message: --ORRES cannot be null when --STAT is null or --DRVFL not equal to 'Y'
diff --git a/Published/CORE-000201/rule.yml b/Published/CORE-000201/rule.yml
index b6ffd4270..596a66221 100644
--- a/Published/CORE-000201/rule.yml
+++ b/Published/CORE-000201/rule.yml
@@ -7,171 +7,175 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The unique subject identifier (USUBJID) is required in all
- datasets containing subject-level data. USUBJID values must be
- unique for each trial participant (subject) across all trials
- in the submission.
+ - Cited Guidance: The unique subject identifier (USUBJID) is required in all datasets
+ containing subject-level data. USUBJID values must be unique for each trial participant
+ (subject) across all trials in the submission.
Document: IG v3.4
Section: 4.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0029
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The unique subject identifier (USUBJID) is required in all
- datasets containing subject-level data. USUBJID values must be
- unique for each trial participant (subject) across all trials
- in the submission.
+ - Cited Guidance: The unique subject identifier (USUBJID) is required in all datasets
+ containing subject-level data. USUBJID values must be unique for each trial participant
+ (subject) across all trials in the submission.
Document: IG v3.3
Section: 4.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0029
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '... a unique identifier (USUBJID) should be assigned and
- included in all datasets. The unique subject identifier
- (USUBJID) is required in all datasets containing subject-level
- data.'
+ - Cited Guidance:
+ "... a unique identifier (USUBJID) should be assigned and included in all datasets.
+ The unique subject identifier (USUBJID) is required in all datasets containing subject-level
+ data."
Document: IG v3.2
Section: 4.1.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0029
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Identifier used to uniquely identify a subject across all
- studies for all applications or submissions involving the
- product. This must be a unique value, and could be a compound
- identifier formed by concatenating STUDYID-SITEID-SUBJID.
+ - Cited Guidance:
+ Identifier used to uniquely identify a subject across all studies for all
+ applications or submissions involving the product. This must be a unique value, and could
+ be a compound identifier formed by concatenating STUDYID-SITEID-SUBJID.
Document: TIG 1.0
Item: Specification- USUBJID
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0311
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: To identify a subject uniquely across a submission, a unique
- identifier (USUBJID) should be assigned and included in all
- subject-related datasets in the submission.
+ - Cited Guidance:
+ To identify a subject uniquely across a submission, a unique identifier
+ (USUBJID) should be assigned and included in all subject-related datasets in the
+ submission.
Document: SENDIG v3.0
Item: Assumption 1
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND109
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: To identify a subject uniquely across a submission, a unique
- identifier (USUBJID) should be assigned and included in all
- subject-related datasets in the submission.
+ - Cited Guidance:
+ To identify a subject uniquely across a submission, a unique identifier
+ (USUBJID) should be assigned and included in all subject-related datasets in the
+ submission.
Document: SENDIG v3.1
Item: Assumption 1
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND109
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: To identify a subject uniquely across a submission, a unique
- identifier (USUBJID) should be assigned and included in all
- subject-related datasets in the submission.
+ - Cited Guidance:
+ To identify a subject uniquely across a submission, a unique identifier
+ (USUBJID) should be assigned and included in all subject-related datasets in the
+ submission.
Document: SENDIG v3.1.1
Item: Assumption 1
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND109
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: To identify a subject uniquely across a submission, a unique
- identifier (USUBJID) should be assigned and included in all
- subject-related datasets in the submission.
+ - Cited Guidance:
+ To identify a subject uniquely across a submission, a unique identifier
+ (USUBJID) should be assigned and included in all subject-related datasets in the
+ submission.
Document: SENDIG v3.1
Item: Assumption 1
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND109
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: To identify a subject uniquely across a submission, a unique
- identifier (USUBJID) should be assigned and included in all
- subject-related datasets in the submission.
+ - Cited Guidance:
+ To identify a subject uniquely across a submission, a unique identifier
+ (USUBJID) should be assigned and included in all subject-related datasets in the
+ submission.
Document: SENDIG v3.1.1
Item: Assumption 1
Section: 5.5.5.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND109
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: To identify a subject uniquely across a submission, a unique
- identifier (USUBJID) should be assigned and included in all
- subject-related datasets in the submission.
+ - Cited Guidance:
+ To identify a subject uniquely across a submission, a unique identifier
+ (USUBJID) should be assigned and included in all subject-related datasets in the
+ submission.
Document: SENDIG v3.1.1
Item: Assumption 1
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND109
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Identifier used to uniquely identify a subject across all
- studies for all applications or submissions involving the
- product.
+ - Cited Guidance:
+ Identifier used to uniquely identify a subject across all studies for all
+ applications or submissions involving the product.
Document: TIG 1.0
Item: USUBJID CDISC Notes
Section: 2.8.9.6 SEND Demographics (DM)
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0046
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: USUBJID
@@ -182,9 +186,9 @@ Check:
Core:
Id: CORE-000201
Status: Published
- Version: '1'
-Description: Trigger error when domain is not an AP-- domain and USUBJID is not
- present in DM.USUBJID
+ Version: "1"
+Description: Trigger error when domain is not an AP-- domain and USUBJID is not present in
+ DM.USUBJID
Executability: Fully Executable
Operations:
- domain: DM
diff --git a/Published/CORE-000202/rule.yml b/Published/CORE-000202/rule.yml
index 43937667b..6cf7f3471 100644
--- a/Published/CORE-000202/rule.yml
+++ b/Published/CORE-000202/rule.yml
@@ -7,82 +7,82 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the hierarchical level of the records in the
- relationship. Values should be either ONE or MANY. Used only
- when identifying a relationship between datasets (as described
- in Section 8.3, Relating Datasets).
+ - Cited Guidance:
+ Identifies the hierarchical level of the records in the relationship. Values
+ should be either ONE or MANY. Used only when identifying a relationship between datasets
+ (as described in Section 8.3, Relating Datasets).
Document: IG 3.4
Section: 8.2.1
- - Cited Guidance: Since IDVAR identifies the keys that can be used to merge/join
- records between the datasets, --SEQ cannot be used because
- --SEQ only has meaning within a subject within a dataset, not
- across datasets.
+ - Cited Guidance:
+ Since IDVAR identifies the keys that can be used to merge/join records
+ between the datasets, --SEQ cannot be used because --SEQ only has meaning within a subject
+ within a dataset, not across datasets.
Document: IG 3.4
Section: 8.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0419
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the hierarchical level of the records in the
- relationship. Values should be either ONE or MANY. Used only
- when identifying a relationship between datasets (as described
- in Section 8.3, Relating Datasets).
+ - Cited Guidance:
+ Identifies the hierarchical level of the records in the relationship. Values
+ should be either ONE or MANY. Used only when identifying a relationship between datasets
+ (as described in Section 8.3, Relating Datasets).
Document: IG v3.2
Section: 8.2.1
- - Cited Guidance: Since IDVAR identifies the keys that can be used to merge/join
- records between the datasets, --SEQ cannot be used because
- --SEQ only has meaning within a subject within a dataset, not
- across datasets.
+ - Cited Guidance:
+ Since IDVAR identifies the keys that can be used to merge/join records
+ between the datasets, --SEQ cannot be used because --SEQ only has meaning within a subject
+ within a dataset, not across datasets.
Document: IG v3.2
Section: 8.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0419
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the hierarchical level of the records in the
- relationship. Values should be either ONE or MANY. Used only
- when identifying a relationship between datasets (as described
- in Section 8.3, Relating Datasets).
+ - Cited Guidance:
+ Identifies the hierarchical level of the records in the relationship. Values
+ should be either ONE or MANY. Used only when identifying a relationship between datasets
+ (as described in Section 8.3, Relating Datasets).
Document: IG 3.3
Section: 8.2.1
- - Cited Guidance: Since IDVAR identifies the keys that can be used to merge/join
- records between the datasets, --SEQ cannot be used because
- --SEQ only has meaning within a subject within a dataset, not
- across datasets.
+ - Cited Guidance:
+ Since IDVAR identifies the keys that can be used to merge/join records
+ between the datasets, --SEQ cannot be used because --SEQ only has meaning within a subject
+ within a dataset, not across datasets.
Document: IG 3.3
Section: 8.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0419
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Identifies the hierarchical level of the records in the
- relationship. Values should be either ONE or MANY. Used only
- when identifying a relationship between datasets (as described
- in Section 2.8.5.2.
+ - Cited Guidance:
+ Identifies the hierarchical level of the records in the relationship. Values
+ should be either ONE or MANY. Used only when identifying a relationship between datasets
+ (as described in Section 2.8.5.2.
Document: TIG 1.0
Section: 2.8.5.2|2.8.10.21
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0574
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IDVAR
@@ -94,7 +94,7 @@ Check:
Core:
Id: CORE-000202
Status: Published
- Version: '1'
+ Version: "1"
Description: When IDVAR is populated with a --SEQ value, RELTYPE must be null.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000203/rule.yml b/Published/CORE-000203/rule.yml
index e91a100c3..74bdcbd44 100644
--- a/Published/CORE-000203/rule.yml
+++ b/Published/CORE-000203/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: IDVAR, IDVARVAL, and QNAM a unique combination per parent subject record
Authorities:
- Organization: CDISC
@@ -7,19 +7,19 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The combined set of values for the first six columns
- (STUDYID…QNAM) should be unique for every record. That is,
- there should not be multiple records in a SUPP-- dataset for
- the same QNAM value, as it relates to IDVAR/IDVARVAL for a
- USUBJID in a domain.
+ - Cited Guidance:
+ The combined set of values for the first six columns (STUDYID…QNAM) should
+ be unique for every record. That is, there should not be multiple records in a SUPP--
+ dataset for the same QNAM value, as it relates to IDVAR/IDVARVAL for a USUBJID in a
+ domain.
Document: IG v3.4
- Section: '8.4'
+ Section: "8.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0411
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -29,41 +29,41 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0411
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The combined set of values for the first six columns
- (STUDYID-QNAM) should be unique for every record. That is;
- there should not be multiple records in a SUPP-- dataset for
- the same QNAM value; as it relates to IDVAR/IDVARVAL for a
- USUBJID in a domain.
+ - Cited Guidance:
+ The combined set of values for the first six columns (STUDYID-QNAM) should
+ be unique for every record. That is; there should not be multiple records in a SUPP--
+ dataset for the same QNAM value; as it relates to IDVAR/IDVARVAL for a USUBJID in a
+ domain.
Document: IG v3.3
- Section: '8.4'
+ Section: "8.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0411
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: A relationship dataset used to describe nonstandard variables
- and their association to parent records in general-observation
- class datasets.
+ - Cited Guidance:
+ A relationship dataset used to describe nonstandard variables and their
+ association to parent records in general-observation class datasets.
Document: TIG 1.0
Item: Specifications IDVAR,IDVARVAL,QNAM|Description
Section: 2.8.10.27
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0567
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -89,13 +89,12 @@ Check:
Core:
Id: CORE-000203
Status: Published
- Version: '1'
-Description: Trigger error when the combination of IDVAR, IDVARVAL, and QNAM is
- not unique per parent subject record
+ Version: "1"
+Description: Trigger error when the combination of IDVAR, IDVARVAL, and QNAM is not unique per
+ parent subject record
Executability: Fully Executable
Outcome:
- Message: The combination of IDVAR, IDVARVAL, and QNAM is not unique per parent
- subject record
+ Message: The combination of IDVAR, IDVARVAL, and QNAM is not unique per parent subject record
Output Variables:
- USUBJID
- IDVAR
diff --git a/Published/CORE-000204/rule.yml b/Published/CORE-000204/rule.yml
index a041d62f7..5fd7a3c96 100644
--- a/Published/CORE-000204/rule.yml
+++ b/Published/CORE-000204/rule.yml
@@ -10,30 +10,27 @@ Authorities:
- Cited Guidance: One record per subject per actual visit.
Document: IG v3.4
Item: 7.3.1.1 TV
- Section: '5.5'
- - Cited Guidance: Some data collection is contingent on the occurrence of a
- "trigger" event, or disease milestone (see the Trial Disease
- Milestones (TM) dataset under Section 7.3, Schedule for
- Assessments (TV, TD, and TM)). When such planned data
- collection involves an additional clinic visit, a "contingent"
- Visit may be included in the trial visits table, with start a
- rule that describes the circumstances under which it will take
- place. Since values of VISITNUM must be assigned to all
- records in the Trial Visits dataset, a contingent Visit
- included in the Trial Visits dataset must have a VISITNUM, but
- the VISITNUM value may not be a "chronological" value, due to
- the uncertain timing of a contingent Visit. If contingent
- visits are not included in the TV dataset, then they would be
- treated as unplanned visits in the Subject Visits (SV) domain.
+ Section: "5.5"
+ - Cited Guidance:
+ Some data collection is contingent on the occurrence of a "trigger" event,
+ or disease milestone (see the Trial Disease Milestones (TM) dataset under Section 7.3,
+ Schedule for Assessments (TV, TD, and TM)). When such planned data collection involves an
+ additional clinic visit, a "contingent" Visit may be included in the trial visits table,
+ with start a rule that describes the circumstances under which it will take place. Since
+ values of VISITNUM must be assigned to all records in the Trial Visits dataset, a
+ contingent Visit included in the Trial Visits dataset must have a VISITNUM, but the
+ VISITNUM value may not be a "chronological" value, due to the uncertain timing of a
+ contingent Visit. If contingent visits are not included in the TV dataset, then they would
+ be treated as unplanned visits in the Subject Visits (SV) domain.
Document: IG v3.4
Item: TV Issues 4
Section: 7.3.1.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0410
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -43,28 +40,27 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0410
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[5.5 SV][One record per subject per actual visit.]|IG
- v3.3[7.3.1.1 TV][TV Issues 4][Some data collection is
- contingent on the occurrence of a "trigger" event; or disease
- milestone (see Section 7.3.3 Trial Disease Milestones). When
- such planned data collection involves an additional clinic
- visit; a "contingent" Visit may be included in the trial
- visits table;]
+ - Cited Guidance:
+ IG v3.3[5.5 SV][One record per subject per actual visit.]|IG v3.3[7.3.1.1
+ TV][TV Issues 4][Some data collection is contingent on the occurrence of a "trigger"
+ event; or disease milestone (see Section 7.3.3 Trial Disease Milestones). When such
+ planned data collection involves an additional clinic visit; a "contingent" Visit may be
+ included in the trial visits table;]
Document: IG v3.3
Item: IG v3.3[5.5 SV]|IG v3.3[7.3.1.1 TV][TV Issues 4]
Section: IG v3.3[5.5 SV]|IG v3.3[7.3.1.1 TV]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0410
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -75,10 +71,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0566
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: VISITNUM
@@ -90,9 +86,8 @@ Check:
Core:
Id: CORE-000204
Status: Published
- Version: '1'
-Description: When VISITNUM is present in TV.VISITNUM, SV.VISITNUM must be unique
- within subject
+ Version: "1"
+Description: When VISITNUM is present in TV.VISITNUM, SV.VISITNUM must be unique within subject
Executability: Fully Executable
Operations:
- domain: TV
diff --git a/Published/CORE-000206/rule.yml b/Published/CORE-000206/rule.yml
index 53ffee142..34044d82d 100644
--- a/Published/CORE-000206/rule.yml
+++ b/Published/CORE-000206/rule.yml
@@ -19,9 +19,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0371
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -31,9 +31,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0371
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -43,160 +43,160 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0371
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies.
Document: SDTM v2.1
Item: IDVARVAL
Section: 3.2.2 Comments
- - Cited Guidance: Name of the identifying variable in the
- general-observation-class dataset that identifies the related
- record(s).
+ - Cited Guidance:
+ Name of the identifying variable in the general-observation-class dataset
+ that identifies the related record(s).
Document: SDTM v2.1
Item: IDVARVAL
Section: 6.2 Supplemental Qualifiers Datasets
- - Cited Guidance: Name of the identifying variable in the
- general-observation-class dataset that identifies the related
- record(s).
+ - Cited Guidance:
+ Name of the identifying variable in the general-observation-class dataset
+ that identifies the related record(s).
Document: SDTM v2.1
Item: IDVARVAL
Section: Section 6.1 Related Records Dataset
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0535
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "CDISC Notes for IDVAR and IDVARVAL: 'Identifiying variable of
- the parent record(s)to which the comment applies.' and 'Value
- of identifying variable of the parent record(s).',
- respectively."
+ - Cited Guidance:
+ "CDISC Notes for IDVAR and IDVARVAL: 'Identifiying variable of the parent record(s)to
+ which the comment applies.' and 'Value of identifying variable of the parent record(s).', respectively."
Document: SENDIG v3.0
Item: Assumption 3.a
Section: 5.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND121
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Related to a specific parent record or group of parent records,
- in which case the value of the variable RDOMAIN is set to the
- DOMAIN code of the parent record(s), and the variables IDVAR
- and IDVARVAL are populated with the key variable name and
- value of the parent record(s). Assumptions for populating
- IDVAR and IDVARVAL are further described in Section 8.2.
+ - Cited Guidance:
+ Related to a specific parent record or group of parent records, in which
+ case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s),
+ and the variables IDVAR and IDVARVAL are populated with the key variable name and value of
+ the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described
+ in Section 8.2.
Document: SENDIG v3.1
Item: Assumption 3.a
Section: 5.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND121
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Related to a specific parent record or group of parent records,
- in which case the value of the variable RDOMAIN is set to the
- DOMAIN code of the parent record(s), and the variables IDVAR
- and IDVARVAL are populated with the key variable name and
- value of the parent record(s). Assumptions for populating
- IDVAR and IDVARVAL are further described in Section 8.2.
+ - Cited Guidance:
+ Related to a specific parent record or group of parent records, in which
+ case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s),
+ and the variables IDVAR and IDVARVAL are populated with the key variable name and value of
+ the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described
+ in Section 8.2.
Document: SENDIG v3.1.1
Item: Assumption 3.a
Section: 5.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND121
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Related to a specific parent record or group of parent records,
- in which case the value of the variable RDOMAIN is set to the
- DOMAIN code of the parent record(s), and the variables IDVAR
- and IDVARVAL are populated with the key variable name and
- value of the parent record(s). Assumptions for populating
- IDVAR and IDVARVAL are further described in Section 8.2.
+ - Cited Guidance:
+ Related to a specific parent record or group of parent records, in which
+ case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s),
+ and the variables IDVAR and IDVARVAL are populated with the key variable name and value of
+ the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described
+ in Section 8.2.
Document: SENDIG v3.1
Item: Assumption 3.a
Section: 5.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND121
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Related to a specific parent record or group of parent records,
- in which case the value of the variable RDOMAIN is set to the
- DOMAIN code of the parent record(s), and the variables IDVAR
- and IDVARVAL are populated with the key variable name and
- value of the parent record(s). Assumptions for populating
- IDVAR and IDVARVAL are further described in Section 8.2.
+ - Cited Guidance:
+ Related to a specific parent record or group of parent records, in which
+ case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s),
+ and the variables IDVAR and IDVARVAL are populated with the key variable name and value of
+ the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described
+ in Section 8.2.
Document: SENDIG v3.1.1
Item: Assumption 3.a
Section: 5.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND121
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Related to a specific parent record or group of parent records,
- in which case the value of the variable RDOMAIN is set to the
- DOMAIN code of the parent record(s), and the variables IDVAR
- and IDVARVAL are populated with the key variable name and
- value of the parent record(s). Assumptions for populating
- IDVAR and IDVARVAL are further described in Section 8.2.
+ - Cited Guidance:
+ Related to a specific parent record or group of parent records, in which
+ case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s),
+ and the variables IDVAR and IDVARVAL are populated with the key variable name and value of
+ the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described
+ in Section 8.2.
Document: SENDIG v3.1.1
Item: Assumption 3.a
Section: 5.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND121
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Related to a specific parent record or group of parent records,
- in which case the value of the variable RDOMAIN is set to the
- DOMAIN code of the parent record(s), and the variables IDVAR
- and IDVARVAL are populated with the key variable name and
- value of the parent record(s).
+ - Cited Guidance:
+ Related to a specific parent record or group of parent records, in which
+ case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s),
+ and the variables IDVAR and IDVARVAL are populated with the key variable name and value of
+ the parent record(s).
Document: TIG v1.0
Item: Assumption 3.a
Section: 2.8.9.4 SEND Comments (CO)
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0058
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
# Variable: IDVARVAL
# Condition: IDVAR ^= null
# Rule: IDVARVAL = value of variable = IDVAR in domain = RDOMAIN
@@ -214,9 +214,9 @@ Check:
Core:
Id: CORE-000206
Status: Published
- Version: '1'
-Description: When IDVAR is populated, IDVARVAL must equal a value of the
- variable referenced by IDVAR within the domain referenced by RDOMAIN
+ Version: "1"
+Description: When IDVAR is populated, IDVARVAL must equal a value of the variable referenced by
+ IDVAR within the domain referenced by RDOMAIN
Executability: Fully Executable
Match Datasets:
- Child: true
@@ -238,8 +238,7 @@ Match Datasets:
- IDVARVAL
Name: RELREC
Outcome:
- Message: IDVARVAL does not equal a value of the variable referenced by IDVAR in
- domain = RDOMAIN.
+ Message: IDVARVAL does not equal a value of the variable referenced by IDVAR in domain = RDOMAIN.
Output Variables:
- RDOMAIN
- USUBJID
diff --git a/Published/CORE-000207/rule.yml b/Published/CORE-000207/rule.yml
index 03b29f687..f920fb9aa 100644
--- a/Published/CORE-000207/rule.yml
+++ b/Published/CORE-000207/rule.yml
@@ -1,5 +1,5 @@
# Variable: --STDTC
-# Condition:
+# Condition:
# Rule: --STDTC not present
Authorities:
- Organization: CDISC
@@ -7,108 +7,91 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Note that --STDTC should not be used in the Findings general
- observation class and is therefore blank in the following
- table.
+ - Cited Guidance:
+ Note that --STDTC should not be used in the Findings general observation
+ class and is therefore blank in the following table.
Document: IG v3.4
Section: 4.4.8
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0467
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.2[4.1.1.3][Additional Timing variables can be added as
- needed to a standard domain model based on the three general
- observation classes except where discouraged in Assumption
- 4.1.4.8 and specific domain assumptions. Timing variables can
- be added to special-purpose domains only where specified in
- the SDTMIG domain model assumptions. Timing variables cannot
- be added to SUPPQUAL datasets or to RELREC]|IG
- v3.2[4.1.1.8][AEENTPT = final subject contact date, e.g.,
- "2006-11-02"Date and Time Reported in a Domain Based on
- Findings. When the date/time of collection is reported in any
- domain, the date/time should go into the --DTC field (e.g.,
- EGDTC for Date/Time of ECG). For any domain based on the
- Findings general observation class, such as lab tests which
- are based on a specimen, the collection date is likely to be
- tied to when the specimen or source of the finding was
- captured, not necessarily when the data was recorded. In order
- to ensure that the critical timing information is always
- represented in the same variable, the --DTC variable is used
- to represent the time of specimen collection. For example, in
- the LB domain the LBDTC variable would be used for all
- single-point blood collections or spot urine collections. For
- timed lab collections (e.g., 24-hour urine collections) the
- LBDTC variable would be used for the start date/time of the
- collection and LBENDTC for the end date/time of the
- collection. This approach will allow the single-point and
- interval collections to use the same date/time variables
- consistently across all datasets for the Findings general
- observation class. The table below illustrates the proper use
- of these variables. Note that --STDTC is not used for
- collection dates over an interval, so is blank in the
- following table.]
+ - Cited Guidance:
+ IG v3.2[4.1.1.3][Additional Timing variables can be added as needed to a
+ standard domain model based on the three general observation classes except where
+ discouraged in Assumption 4.1.4.8 and specific domain assumptions. Timing variables can be
+ added to special-purpose domains only where specified in the SDTMIG domain model
+ assumptions. Timing variables cannot be added to SUPPQUAL datasets or to RELREC]|IG
+ v3.2[4.1.1.8][AEENTPT = final subject contact date, e.g., "2006-11-02"Date and Time
+ Reported in a Domain Based on Findings. When the date/time of collection is reported in
+ any domain, the date/time should go into the --DTC field (e.g., EGDTC for Date/Time of
+ ECG). For any domain based on the Findings general observation class, such as lab tests
+ which are based on a specimen, the collection date is likely to be tied to when the
+ specimen or source of the finding was captured, not necessarily when the data was
+ recorded. In order to ensure that the critical timing information is always represented in
+ the same variable, the --DTC variable is used to represent the time of specimen
+ collection. For example, in the LB domain the LBDTC variable would be used for all
+ single-point blood collections or spot urine collections. For timed lab collections (e.g.,
+ 24-hour urine collections) the LBDTC variable would be used for the start date/time of the
+ collection and LBENDTC for the end date/time of the collection. This approach will allow
+ the single-point and interval collections to use the same date/time variables consistently
+ across all datasets for the Findings general observation class. The table below
+ illustrates the proper use of these variables. Note that --STDTC is not used for
+ collection dates over an interval, so is blank in the following table.]
Document: IG v3.2
Section: IG v3.2[4.1.1.3]|IG v3.2[4.1.1.8]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0467
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[4.1.3][Additional Timing variables can be added as
- needed to a standard domain model based on the three general
- observation classes except where discouraged in Assumption
- 4.4.8 and specific domain assumptions. Timing variables can be
- added to special-purpose domains only where specified in the
- SDTMIG domain model assumptions. Timing variables cannot be
- added to SUPPQUAL datasets or to RELREC]|IG v3.3[4.4.8][When
- the date/time of collection is reported in any domain, the
- date/time should go into the --DTC field (e.g., EGDTC for
- Date/Time of ECG). For any domain based on the Findings
- general observation class, such as lab tests which are based
- on a specimen, the collection date is likely to be tied to
- when the specimen or source of the finding was captured, not
- necessarily when the data was recorded. In order to ensure
- that the critical timing information is always represented in
- the same variable, the --DTC variable is used to represent the
- time of specimen collection. For example, in the LB domain the
- LBDTC variable would be used for all single-point blood
- collections or spot urine collections. For timed lab
- collections (e.g., 24-hour urine collections) the LBDTC
- variable would be used for the start date/time of the
- collection and LBENDTC for the end date/time of the
- collection. This approach will allow the single-point and
- interval collections to use the same date/time variables
- consistently across all datasets for the Findings general
- observation class. The table below illustrates the proper use
- of these variables. Note that --STDTC is not used for
- collection dates over an interval, so is blank in the
+ - Cited Guidance:
+ IG v3.3[4.1.3][Additional Timing variables can be added as needed to a
+ standard domain model based on the three general observation classes except where
+ discouraged in Assumption 4.4.8 and specific domain assumptions. Timing variables can be
+ added to special-purpose domains only where specified in the SDTMIG domain model
+ assumptions. Timing variables cannot be added to SUPPQUAL datasets or to RELREC]|IG
+ v3.3[4.4.8][When the date/time of collection is reported in any domain, the date/time
+ should go into the --DTC field (e.g., EGDTC for Date/Time of ECG). For any domain based on
+ the Findings general observation class, such as lab tests which are based on a specimen,
+ the collection date is likely to be tied to when the specimen or source of the finding was
+ captured, not necessarily when the data was recorded. In order to ensure that the critical
+ timing information is always represented in the same variable, the --DTC variable is used
+ to represent the time of specimen collection. For example, in the LB domain the LBDTC
+ variable would be used for all single-point blood collections or spot urine collections.
+ For timed lab collections (e.g., 24-hour urine collections) the LBDTC variable would be
+ used for the start date/time of the collection and LBENDTC for the end date/time of the
+ collection. This approach will allow the single-point and interval collections to use the
+ same date/time variables consistently across all datasets for the Findings general
+ observation class. The table below illustrates the proper use of these variables. Note
+ that --STDTC is not used for collection dates over an interval, so is blank in the
following table.]
Document: IG v3.3
Section: IG v3.3[4.1.3]|IG v3.3[4.4.8]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0467
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When the date/time of collection is reported in any domain, the
- date/time should go into the --DTC field...In order to ensure
- that the critical timing information is always represented in
- the same variable, the --DTC variable is used to represent the
- time of specimen collection...Note that --STDTC is not used
- for collection dates over an interval...
+ - Cited Guidance:
+ When the date/time of collection is reported in any domain, the date/time
+ should go into the --DTC field...In order to ensure that the critical timing information
+ is always represented in the same variable, the --DTC variable is used to represent the
+ time of specimen collection...Note that --STDTC is not used for collection dates over an
+ interval...
Document: IG v3.0
Section: 4.4.6
Origin: SEND Conformance Rules
@@ -120,12 +103,12 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When the date/time of collection is reported in any domain, the
- date/time should go into the --DTC field...In order to ensure
- that the critical timing information is always represented in
- the same variable, the --DTC variable is used to represent the
- time of specimen collection...Note that --STDTC is not used
- for collection dates over an interval...
+ - Cited Guidance:
+ When the date/time of collection is reported in any domain, the date/time
+ should go into the --DTC field...In order to ensure that the critical timing information
+ is always represented in the same variable, the --DTC variable is used to represent the
+ time of specimen collection...Note that --STDTC is not used for collection dates over an
+ interval...
Document: IG v3.1
Section: 4.4.6
Origin: SEND Conformance Rules
@@ -137,12 +120,12 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When the date/time of collection is reported in any domain, the
- date/time should go into the --DTC field...In order to ensure
- that the critical timing information is always represented in
- the same variable, the --DTC variable is used to represent the
- time of specimen collection...Note that --STDTC is not used
- for collection dates over an interval...
+ - Cited Guidance:
+ When the date/time of collection is reported in any domain, the date/time
+ should go into the --DTC field...In order to ensure that the critical timing information
+ is always represented in the same variable, the --DTC variable is used to represent the
+ time of specimen collection...Note that --STDTC is not used for collection dates over an
+ interval...
Document: IG v3.1.1
Section: 4.4.6
Origin: SEND Conformance Rules
@@ -154,12 +137,12 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When the date/time of collection is reported in any domain, the
- date/time should go into the --DTC field...In order to ensure
- that the critical timing information is always represented in
- the same variable, the --DTC variable is used to represent the
- time of specimen collection...Note that --STDTC is not used
- for collection dates over an interval...
+ - Cited Guidance:
+ When the date/time of collection is reported in any domain, the date/time
+ should go into the --DTC field...In order to ensure that the critical timing information
+ is always represented in the same variable, the --DTC variable is used to represent the
+ time of specimen collection...Note that --STDTC is not used for collection dates over an
+ interval...
Document: IG v3.1
Section: 4.4.6
Origin: SEND Conformance Rules
@@ -171,12 +154,12 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When the date/time of collection is reported in any domain, the
- date/time should go into the --DTC field...In order to ensure
- that the critical timing information is always represented in
- the same variable, the --DTC variable is used to represent the
- time of specimen collection...Note that --STDTC is not used
- for collection dates over an interval...
+ - Cited Guidance:
+ When the date/time of collection is reported in any domain, the date/time
+ should go into the --DTC field...In order to ensure that the critical timing information
+ is always represented in the same variable, the --DTC variable is used to represent the
+ time of specimen collection...Note that --STDTC is not used for collection dates over an
+ interval...
Document: IG v3.1.1
Section: 4.4.6
Origin: SEND Conformance Rules
@@ -188,12 +171,12 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: When the date/time of collection is reported in any domain, the
- date/time should go into the --DTC field...In order to ensure
- that the critical timing information is always represented in
- the same variable, the --DTC variable is used to represent the
- time of specimen collection...Note that --STDTC is not used
- for collection dates over an interval...
+ - Cited Guidance:
+ When the date/time of collection is reported in any domain, the date/time
+ should go into the --DTC field...In order to ensure that the critical timing information
+ is always represented in the same variable, the --DTC variable is used to represent the
+ time of specimen collection...Note that --STDTC is not used for collection dates over an
+ interval...
Document: IG v3.1.1
Section: 4.4.6
Origin: SEND Conformance Rules
@@ -205,39 +188,40 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: Not in Findings class domains | Select variables for the domain
- from the SDTM. Selection of variables must align with SDTM
- Usage Restrictions.
+ - Cited Guidance:
+ Not in Findings class domains | Select variables for the domain from the
+ SDTM. Selection of variables must align with SDTM Usage Restrictions.
Document: SDTM v2.1|TIG v1.0
Item: Specification|--STDTC
- Section: Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend
- Domains | 2.8.3 How to Create New Specifications
+ Section:
+ Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend Domains | 2.8.3
+ How to Create New Specifications
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0597
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: When the date/time of collection is reported in any domain, the
- date/time should go into the --DTC field...In order to ensure
- that the critical timing information is always represented in
- the same variable, the --DTC variable is used to represent the
- time of specimen collection...Note that --STDTC is not used
- for collection dates over an interval.
+ - Cited Guidance:
+ When the date/time of collection is reported in any domain, the date/time
+ should go into the --DTC field...In order to ensure that the critical timing information
+ is always represented in the same variable, the --DTC variable is used to represent the
+ time of specimen collection...Note that --STDTC is not used for collection dates over an
+ interval.
Document: TIG v1.0
Item: text
Section: 2.8.7.5
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0276
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --STDTC
@@ -245,7 +229,7 @@ Check:
Core:
Id: CORE-000207
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when --STDTC is present in a Findings general observation class
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000208/rule.yml b/Published/CORE-000208/rule.yml
index ab31ae2ae..9bc68212b 100644
--- a/Published/CORE-000208/rule.yml
+++ b/Published/CORE-000208/rule.yml
@@ -7,55 +7,55 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage Arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an Arm or followed
- a course not described by any planned Arm, ACTARMCD is null
- and ARMNRS is populated.
+ - Cited Guidance:
+ With the exception of studies which use multi-stage Arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or
+ followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is
+ populated.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0512
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an arm or followed
- a course not described by any planned arm, ACTARMCD is null
- and ARMNRS is populated.
+ - Cited Guidance:
+ With the exception of studies which use multi-stage arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or
+ followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is
+ populated.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0512
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage Arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an Arm or followed
- a course not described by any planned Arm, ACTARMCD is null
- and ARMNRS is populated.
+ - Cited Guidance:
+ With the exception of studies which use multi-stage Arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or
+ followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is
+ populated.
Document: TIG 1.0
Item: Specification:ACTARMCD
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0607
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ACTARMCD
@@ -66,9 +66,9 @@ Check:
Core:
Id: CORE-000208
Status: Published
- Version: '1'
-Description: Trigger error when study does not use multi-stage arm assignments
- and ACTARMCD ^= null, and ACTARMCD is not in TA.ARMCD
+ Version: "1"
+Description: Trigger error when study does not use multi-stage arm assignments and ACTARMCD ^= null,
+ and ACTARMCD is not in TA.ARMCD
Executability: Partially Executable - Possible Overreporting
Operations:
- domain: TA
diff --git a/Published/CORE-000209/rule.yml b/Published/CORE-000209/rule.yml
index 8230360e0..99beb2582 100644
--- a/Published/CORE-000209/rule.yml
+++ b/Published/CORE-000209/rule.yml
@@ -7,55 +7,55 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage Arm
- assignments, must be a value of ARM in the Trial Arms Dataset.
- If the subject was not assigned to an Arm or followed a course
- not described by any planned Arm, ACTARM is null and ARMNRS is
+ - Cited Guidance:
+ With the exception of studies which use multi-stage Arm assignments, must be
+ a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or
+ followed a course not described by any planned Arm, ACTARM is null and ARMNRS is
populated.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0514
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an arm or followed
- a course not described by any planned arm, ACTARMCD is null
- and ARMNRS is populated.
+ - Cited Guidance:
+ With the exception of studies which use multi-stage arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or
+ followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is
+ populated.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0514
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage Arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an Arm or followed
- a course not described by any planned Arm, ACTARMCD is null
- and ARMNRS is populated.
+ - Cited Guidance:
+ With the exception of studies which use multi-stage Arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or
+ followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is
+ populated.
Document: TIG 1.0
Item: Specification:ACTARM
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0609
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ACTARM
@@ -66,12 +66,11 @@ Check:
Core:
Id: CORE-000209
Status: Published
- Version: '1'
-Description: When study does not use multi-stage arm assignments and ACTARM is
- populated, ACTARM must be present in TA.ARM. This rule has been executed to
- identify all cases when ACTARM is not present in TA.ARM and therefore
- acknowledges that false positives may be recorded when multi-stage arm
- assignments are in use.
+ Version: "1"
+Description: When study does not use multi-stage arm assignments and ACTARM is populated, ACTARM
+ must be present in TA.ARM. This rule has been executed to identify all cases when ACTARM is not
+ present in TA.ARM and therefore acknowledges that false positives may be recorded when multi-stage
+ arm assignments are in use.
Executability: Partially Executable - Possible Overreporting
Operations:
- domain: TA
@@ -79,10 +78,9 @@ Operations:
name: ARM
operator: distinct
Outcome:
- Message: ACTARM value in DM dataset is not among the values of ARM variable in
- the TA dataset. This is allowed only in a multistage study with incomplete
- ARM assignment. Please confirm if your study is a multistage assignment
- study.
+ Message: ACTARM value in DM dataset is not among the values of ARM variable in the TA dataset.
+ This is allowed only in a multistage study with incomplete ARM assignment. Please confirm if
+ your study is a multistage assignment study.
Output Variables:
- ACTARM
Rule Type: Record Data
diff --git a/Published/CORE-000210/rule.yml b/Published/CORE-000210/rule.yml
index ef2b2b857..626a7429f 100644
--- a/Published/CORE-000210/rule.yml
+++ b/Published/CORE-000210/rule.yml
@@ -7,53 +7,53 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage Arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an Arm, ARMCD is
- null and ARMNRS is populated
+ - Cited Guidance:
+ With the exception of studies which use multi-stage Arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm,
+ ARMCD is null and ARMNRS is populated
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0516
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an arm or followed
- a course not described by any planned arm, ACTARMCD is null
- and ARMNRS is populated.
+ - Cited Guidance:
+ With the exception of studies which use multi-stage arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or
+ followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is
+ populated.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0516
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage Arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an Arm, ARMCD is
- null and ARMNRS is populated
+ - Cited Guidance:
+ With the exception of studies which use multi-stage Arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm,
+ ARMCD is null and ARMNRS is populated
Document: TIG 1.0
Item: Specification:ARMCD
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0611
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ARMCD
@@ -64,12 +64,11 @@ Check:
Core:
Id: CORE-000210
Status: Published
- Version: '1'
-Description: When study does not use multi-stage arm assignments and ARMCD is
- populated, ARMCD must be present in TA.ARMCD. This rule has been executed to
- identify all cases when ARMCD is not present in TA.ARMCD and therefore
- acknowledges that false positives may be recorded when multi-stage arm
- assignments are in use.
+ Version: "1"
+Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must
+ be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not
+ present in TA.ARMCD and therefore acknowledges that false positives may be recorded when
+ multi-stage arm assignments are in use.
Executability: Partially Executable - Possible Overreporting
Operations:
- domain: TA
diff --git a/Published/CORE-000212/rule.yml b/Published/CORE-000212/rule.yml
index 202efdf9e..ff5426491 100644
--- a/Published/CORE-000212/rule.yml
+++ b/Published/CORE-000212/rule.yml
@@ -7,68 +7,63 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either
- disposition of study participation or of a study
- treatment. It describes whether a subject completed study
- participation or a study treatment, and if not, the reason
- they did not complete it. Dispositions may be described for
- each Epoch (e.g., screening, initial treatment, washout,
- cross-over treatment, follow-up) or for the study as a whole.
- If disposition events for both study participation and study
- treatment(s) are to be represented, then DSSCAT provides this
- distinction. The value of DSSCAT is based on the sponsor's
- controlled terminology, however for records with DSCAT =
- "DISPOSITION EVENT", DSSCAT = "STUDY PARTICIPATION" is used to
- represent disposition of study participation. DSSCAT = "STUDY
- TREATMENT" can be used as a generic identifier when a study
- has only a single treatment. If a study has multiple
- treatments, then DSSCAT should name the individual treatment.
+ - Cited Guidance:
+ An event with DSCAT = “DISPOSITION EVENT” describes either disposition of
+ study participation or of a study treatment. It describes whether a subject completed
+ study participation or a study treatment, and if not, the reason they did not complete it.
+ Dispositions may be described for each Epoch (e.g., screening, initial treatment, washout,
+ cross-over treatment, follow-up) or for the study as a whole. If disposition events for
+ both study participation and study treatment(s) are to be represented, then DSSCAT
+ provides this distinction. The value of DSSCAT is based on the sponsor's controlled
+ terminology, however for records with DSCAT = "DISPOSITION EVENT", DSSCAT = "STUDY
+ PARTICIPATION" is used to represent disposition of study participation. DSSCAT = "STUDY
+ TREATMENT" can be used as a generic identifier when a study has only a single treatment.
+ If a study has multiple treatments, then DSSCAT should name the individual treatment.
Document: IG v3.4
Item: DS – Assumption 2b
Section: 6.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0535
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If separate disposition events for both study participation and
- study treatment(s) are to be represented, then DSSCAT provides
- this distinction.
+ - Cited Guidance:
+ If separate disposition events for both study participation and study
+ treatment(s) are to be represented, then DSSCAT provides this distinction.
Document: IG v3.3
Item: Assumption 2.b
Section: 6.2.3 DS
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0535
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either
- disposition of study participation or of a product exposure.
- It describes whether a subject completed study participation
- or a product exposure and, if not, the reason they did not
- complete it. Dispositions may be described for each epoch
- (e.g., screening, initial exposure, washout, cross-over,
- follow-up) or for the study as a whole. If disposition events
- for both study participation and product exposure(s) are to be
- represented, then DSSCAT provides this distinction.
+ - Cited Guidance:
+ An event with DSCAT = “DISPOSITION EVENT” describes either disposition of
+ study participation or of a product exposure. It describes whether a subject completed
+ study participation or a product exposure and, if not, the reason they did not complete
+ it. Dispositions may be described for each epoch (e.g., screening, initial exposure,
+ washout, cross-over, follow-up) or for the study as a whole. If disposition events for
+ both study participation and product exposure(s) are to be represented, then DSSCAT
+ provides this distinction.
Document: TIG 1.0
Item: Assumption 2b
Section: 2.8.10.8
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0628
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: DSCAT
@@ -84,13 +79,13 @@ Check:
Core:
Id: CORE-000212
Status: Published
- Version: '1'
-Description: When subject has more than one record per Epoch with DSCAT =
- DISPOSITION EVENT, DSSCAT must be present.
+ Version: "1"
+Description: When subject has more than one record per Epoch with DSCAT = DISPOSITION EVENT, DSSCAT
+ must be present.
Executability: Fully Executable
Outcome:
- Message: DSSCAT is not present when subject has more than one record per Epoch
- with DSCAT = 'DISPOSITION EVENT'.
+ Message: DSSCAT is not present when subject has more than one record per Epoch with DSCAT =
+ 'DISPOSITION EVENT'.
Output Variables:
- USUBJID
Rule Type: Record Data
diff --git a/Published/CORE-000213/rule.yml b/Published/CORE-000213/rule.yml
index 6ecc79698..ad2d9b534 100644
--- a/Published/CORE-000213/rule.yml
+++ b/Published/CORE-000213/rule.yml
@@ -7,69 +7,64 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If disposition events for both study participation and study
- treatment(s) are to be represented, then DSSCAT provides this
- distinction.
+ - Cited Guidance:
+ If disposition events for both study participation and study treatment(s)
+ are to be represented, then DSSCAT provides this distinction.
Document: IG v3.4
Item: Assumption 2.b
Section: 6.2.3
- - Cited Guidance: "ICH E3: Section 10.1 indicates that 'the specific reason for
- discontinuation' should be presented, and that summaries
- should be 'grouped by treatment and by major reason.' The
- CDISC SDS Team interprets this guidance as requiring one
- standardized disposition term (DSDECOD) per disposition event.
- If multiple reasons are reported, the sponsor should identify
- a primary reason and use that to populate DSTERM and DSDECOD.
- Additional reasons should be submitted in SUPPDS."
+ - Cited Guidance:
+ "ICH E3: Section 10.1 indicates that 'the specific reason for discontinuation'
+ should be presented, and that summaries should be 'grouped by treatment and by major reason.'
+ The CDISC SDS Team interprets this guidance as requiring one standardized disposition term (DSDECOD)
+ per disposition event. If multiple reasons are reported, the sponsor should identify a primary
+ reason and use that to populate DSTERM and DSDECOD. Additional reasons should be submitted in
+ SUPPDS."
Document: IG v3.4
Item: Assumption 5
Section: 6.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0536
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "Assumption 2.b[If disposition events for both study
- participation and study treatment(s) are to be represented,
- then DSSCAT provides this distinction.]|Assumption
- 2.b|Assumption 5[ICH E3: Section 10.1 indicates that 'the
- specific reason for discontinuation' should be presented, and
- that summaries should be 'grouped by treatment and by major
- reason.' The CDISC SDS Team interprets this guidance as
- requiring one standardized disposition term (DSDECOD) per
- disposition event. If multiple reasons are reported, the
- sponsor should identify a primary reason and use that to
- populate DSTERM and DSDECOD. Additional reasons should be
- submitted in SUPPDS.]"
+ - Cited Guidance:
+ "Assumption 2.b[If disposition events for both study participation and study treatment(s)
+ are to be represented, then DSSCAT provides this distinction.]|Assumption 2.b|Assumption 5[ICH
+ E3: Section 10.1 indicates that 'the specific reason for discontinuation' should be presented,
+ and that summaries should be 'grouped by treatment and by major reason.' The CDISC SDS Team
+ interprets this guidance as requiring one standardized disposition term (DSDECOD) per disposition
+ event. If multiple reasons are reported, the sponsor should identify a primary reason and use
+ that to populate DSTERM and DSDECOD. Additional reasons should be submitted in SUPPDS.]"
Document: IG v3.3
Item: Assumption 2.b|Assumption 5
Section: 6.2.3 DS
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0536
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If disposition events for both study participation and product
- exposure(s) are to be represented, then DSSCAT provides this
- distinction
+ - Cited Guidance:
+ If disposition events for both study participation and product exposure(s)
+ are to be represented, then DSSCAT provides this distinction
Document: TIG 1.0
Item: Assumption 2.b
Section: 2.8.10.8
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0629
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: DSCAT
@@ -87,9 +82,8 @@ Check:
Core:
Id: CORE-000213
Status: Published
- Version: '1'
-Description: Trigger error when there is more than one record per subject per
- DSSCAT per EPOCH
+ Version: "1"
+Description: Trigger error when there is more than one record per subject per DSSCAT per EPOCH
Executability: Fully Executable
Outcome:
Message: More than one record per subject per DSSCAT per EPOCH
diff --git a/Published/CORE-000214/rule.yml b/Published/CORE-000214/rule.yml
index 026188586..95b36e7d7 100644
--- a/Published/CORE-000214/rule.yml
+++ b/Published/CORE-000214/rule.yml
@@ -7,46 +7,49 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: DSSCAT = "STUDY PARTICIPATION" is used to represent disposition
- of study participation
+ - Cited Guidance:
+ DSSCAT = "STUDY PARTICIPATION" is used to represent disposition of study
+ participation
Document: IG v3.4
Item: Assumption 2.b.1
Section: 6.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0538
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: DSSCAT = "STUDY PARTICIPATION" is used to represent disposition
- of study participation.
+ - Cited Guidance:
+ DSSCAT = "STUDY PARTICIPATION" is used to represent disposition of study
+ participation.
Document: IG v3.3
Item: Assumption 2.b.1
Section: 6.2.3 DS
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0538
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: DSSCAT = "STUDY PARTICIPATION" is used to represent disposition
- of study participation.
+ - Cited Guidance:
+ DSSCAT = "STUDY PARTICIPATION" is used to represent disposition of study
+ participation.
Document: TIG 1.0
Item: 2.b.i
Section: 2.8.10.8
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0631
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: $disposition_event_count
@@ -64,10 +67,9 @@ Check:
Core:
Id: CORE-000214
Status: Published
- Version: '1'
-Description: Trigger error when subject has more than one record per Epoch with
- DSCAT = 'DISPOSITION EVENT' and more than one record where DSSCAT = 'STUDY
- PARTICIPATION'
+ Version: "1"
+Description: Trigger error when subject has more than one record per Epoch with DSCAT = 'DISPOSITION
+ EVENT' and more than one record where DSSCAT = 'STUDY PARTICIPATION'
Executability: Fully Executable
Operations:
- domain: DS
@@ -80,8 +82,8 @@ Operations:
name: DSCAT
operator: record_count
Outcome:
- Message: More than 1 record exists per subject per EPOCH with DSCAT =
- 'DISPOSITION EVENT' and DSSCAT = 'STUDY PARTICIPATION'.
+ Message: More than 1 record exists per subject per EPOCH with DSCAT = 'DISPOSITION EVENT' and
+ DSSCAT = 'STUDY PARTICIPATION'.
Output Variables:
- DSSCAT
- USUBJID
diff --git a/Published/CORE-000217/rule.yml b/Published/CORE-000217/rule.yml
index 79c2a524b..1c27b96b6 100644
--- a/Published/CORE-000217/rule.yml
+++ b/Published/CORE-000217/rule.yml
@@ -7,96 +7,88 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a
- timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is
- the standard representation of the collected doses not taken,
- not given, or missed. Dose amount variables (e.g., ECDOSE,
- ECDOSTXT) must not be set to zero (0) as an alternative method
- for indicating doses not taken, not given, or
- missed.]|Assumption 4b[Qualifiers that indicate dose amount
- (e.g., ECDOSE, ECDOSTXT) may be populated with positive
- (non-zero) values in cases where the sponsor feels it is
- necessary and/or appropriate to represent specific dose
- amounts not taken, not given, or missed.]
+ - Cited Guidance:
+ Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL
+ infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected
+ doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must
+ not be set to zero (0) as an alternative method for indicating doses not taken, not given,
+ or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT)
+ may be populated with positive (non-zero) values in cases where the sponsor feels it is
+ necessary and/or appropriate to represent specific dose amounts not taken, not given, or
+ missed.]
Document: IG v3.4
Item: Assumption 4a|Assumption 4b
Section: 6.1.3.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0462
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a
- timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is
- the standard representation of the collected doses not taken,
- not given, or missed. Dose amount variables (e.g., ECDOSE,
- ECDOSTXT) must not be set to zero (0) as an alternative method
- for indicating doses not taken, not given, or
- missed.]|Assumption 4b[Qualifiers that indicate dose amount
- (e.g., ECDOSE, ECDOSTXT) may be populated with positive
- (non-zero) values in cases where the sponsor feels it is
- necessary and/or appropriate to represent specific dose
- amounts not taken, not given, or missed.]
+ - Cited Guidance:
+ Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL
+ infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected
+ doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must
+ not be set to zero (0) as an alternative method for indicating doses not taken, not given,
+ or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT)
+ may be populated with positive (non-zero) values in cases where the sponsor feels it is
+ necessary and/or appropriate to represent specific dose amounts not taken, not given, or
+ missed.]
Document: IG v3.3
Item: Assumption 4a|Assumption 4b
Section: 6.1.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0462
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a
- timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is
- the standard representation of the collected doses not taken,
- not given, or missed. Dose amount variables (e.g., ECDOSE,
- ECDOSTXT) must not be set to zero (0) as an alternative method
- for indicating doses not taken, not given, or
- missed.]|Assumption 4b[Qualifiers that indicate dose amount
- (e.g., ECDOSE, ECDOSTXT) may be populated with positive
- (non-zero) values in cases where the sponsor feels it is
- necessary and/or appropriate to represent specific dose
- amounts not taken, not given, or missed.]
+ - Cited Guidance:
+ Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL
+ infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected
+ doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must
+ not be set to zero (0) as an alternative method for indicating doses not taken, not given,
+ or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT)
+ may be populated with positive (non-zero) values in cases where the sponsor feels it is
+ necessary and/or appropriate to represent specific dose amounts not taken, not given, or
+ missed.]
Document: IG v3.2
Item: Assumption 4a|Assumption 4b
- Section: '6.1'
+ Section: "6.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0462
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a
- timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is
- the standard representation of the collected doses not taken,
- not given, or missed. Dose amount variables (e.g., ECDOSE,
- ECDOSTXT) must not be set to zero (0) as an alternative method
- for indicating doses not taken, not given, or
- missed.]|Assumption 4b[Qualifiers that indicate dose amount
- (e.g., ECDOSE, ECDOSTXT) may be populated with positive
- (non-zero) values in cases where the sponsor feels it is
- necessary and/or appropriate to represent specific dose
- amounts not taken, not given, or missed.]
+ - Cited Guidance:
+ Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL
+ infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected
+ doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must
+ not be set to zero (0) as an alternative method for indicating doses not taken, not given,
+ or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT)
+ may be populated with positive (non-zero) values in cases where the sponsor feels it is
+ necessary and/or appropriate to represent specific dose amounts not taken, not given, or
+ missed.]
Document: TIG 1.0
Item: Assumption 4a|4b
Section: 2.8.10.11
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0592
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -142,13 +134,13 @@ Check:
Core:
Id: CORE-000217
Status: Published
- Version: '1'
-Description: Raise an error when ECDOSE is empty, ECOCCUR is not equal to 'N',
- ECSTAT is empty and ECDOSTXT is empty
+ Version: "1"
+Description: Raise an error when ECDOSE is empty, ECOCCUR is not equal to 'N', ECSTAT is empty and
+ ECDOSTXT is empty
Executability: Fully Executable
Outcome:
- Message: ECDOSE is empty, ECOCCUR is not equal to 'N' and ECSTAT is empty, but
- ECDOSTXT is also empty.
+ Message: ECDOSE is empty, ECOCCUR is not equal to 'N' and ECSTAT is empty, but ECDOSTXT is also
+ empty.
Output Variables:
- ECDOSE
- ECOCCUR
diff --git a/Published/CORE-000218/rule.yml b/Published/CORE-000218/rule.yml
index 66b57641e..a9134fbdb 100644
--- a/Published/CORE-000218/rule.yml
+++ b/Published/CORE-000218/rule.yml
@@ -8,137 +8,137 @@ Authorities:
References:
- Citations:
- Cited Guidance: Comments[Value of identifying variable of the parent
- record(s).]|Supplemental Qualifiers[Value of identifying
- variable of the parent record(s).]
+ record(s).]|Supplemental Qualifiers[Value of identifying variable of the parent
+ record(s).]
Document: Model v2.0
Item: IDVARVAL
Section: Comments|Supplemental Qualifiers
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0465
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies. Examples AESEQ or
- CMGRPID. Used only when individual comments are related to
- domain records. Null for comments collected on separate CRFs.
- Value of identifying variable of the parent record(s). Null
- for comments collected on separate CRFs.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments
+ are related to domain records. Null for comments collected on separate CRFs. Value of
+ identifying variable of the parent record(s). Null for comments collected on separate
+ CRFs.
Document: Model v1.7
- Item: ''
+ Item: ""
Section: 2.2.7|5.1.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0465
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies. Examples AESEQ or
- CMGRPID. Used only when individual comments are related to
- domain records. Null for comments collected on separate CRFs.
- Value of identifying variable of the parent record(s). Null
- for comments collected on separate CRFs.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments
+ are related to domain records. Null for comments collected on separate CRFs. Value of
+ identifying variable of the parent record(s). Null for comments collected on separate
+ CRFs.
Document: Model v1.4
- Item: ''
+ Item: ""
Section: 2.2.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0465
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: IDVARVAL is used only when individual comments are related to
- domain records. Cannot be populated if IDVAR is null.
+ - Cited Guidance: IDVARVAL is used only when individual comments are related to domain
+ records. Cannot be populated if IDVAR is null.
Document: IG v3.0
Item: Specification
Section: 5.2.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND118
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: IDVARVAL is used only when individual comments are related to
- domain records. Cannot be populated if IDVAR is null.
+ - Cited Guidance: IDVARVAL is used only when individual comments are related to domain
+ records. Cannot be populated if IDVAR is null.
Document: IG v3.1
Item: Specification
Section: 5.2.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND118
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: IDVARVAL is used only when individual comments are related to
- domain records. Cannot be populated if IDVAR is null.
+ - Cited Guidance: IDVARVAL is used only when individual comments are related to domain
+ records. Cannot be populated if IDVAR is null.
Document: IG v3.1.1
Item: Specification
Section: 5.2.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND118
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: IDVARVAL is used only when individual comments are related to
- domain records. Cannot be populated if IDVAR is null.
+ - Cited Guidance: IDVARVAL is used only when individual comments are related to domain
+ records. Cannot be populated if IDVAR is null.
Document: IG v3.1
Item: Specification
Section: 5.2.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND118
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: IDVARVAL is used only when individual comments are related to
- domain records. Cannot be populated if IDVAR is null.
+ - Cited Guidance: IDVARVAL is used only when individual comments are related to domain
+ records. Cannot be populated if IDVAR is null.
Document: IG v3.1.1
Item: Specification
Section: 5.2.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND118
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: IDVARVAL is used only when individual comments are related to
- domain records. Cannot be populated if IDVAR is null.
+ - Cited Guidance: IDVARVAL is used only when individual comments are related to domain
+ records. Cannot be populated if IDVAR is null.
Document: IG v3.1
Item: Specification
Section: 5.2.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND118
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
@@ -149,25 +149,26 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0595
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Used only when individual comments are related to domain
- records. Cannot be populated if IDVAR is null.
+ - Cited Guidance:
+ Used only when individual comments are related to domain records. Cannot be
+ populated if IDVAR is null.
Document: TIG v1.0
Item: IDVARVAL CDISC Notes
Section: 2.8.9.4 SEND Comments (CO)
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0055
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IDVAR
@@ -177,7 +178,7 @@ Check:
Core:
Id: CORE-000218
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when IDVAR is empty and IDVARVAL is not empty
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000219/rule.yml b/Published/CORE-000219/rule.yml
index fccca1dfe..54f45c7f0 100644
--- a/Published/CORE-000219/rule.yml
+++ b/Published/CORE-000219/rule.yml
@@ -1,5 +1,5 @@
# Variable: --SCAT
-# Condition:
+# Condition:
# Rule: --SCAT ^= Domain Name
Authorities:
- Organization: CDISC
@@ -7,51 +7,51 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.4
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0350
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.3
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0350
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.2
Section: 4.1.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0350
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.0
Section: 4.2.6
Origin: SEND Conformance Rules
@@ -63,9 +63,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1
Section: 4.2.6
Origin: SEND Conformance Rules
@@ -77,9 +77,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1.1
Section: 4.2.6
Origin: SEND Conformance Rules
@@ -91,9 +91,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1.1
Section: 4.2.6
Origin: SEND Conformance Rules
@@ -105,9 +105,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1
Section: 4.2.6
Origin: SEND Conformance Rules
@@ -119,9 +119,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1.1
Section: 4.2.6
Origin: SEND Conformance Rules
@@ -133,18 +133,19 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or
- dictionary classification represented in --DECOD and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT will not be the domain name or dictionary
+ classification represented in --DECOD and --BODSYS.
Document: TIG 1.0
Item: General Conventions table NUM 7
- Section: '2.8.7.1'
+ Section: "2.8.7.1"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0515
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --SCAT
@@ -153,7 +154,7 @@ Check:
Core:
Id: CORE-000219
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --SCAT = domain dataset label.
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000220/rule.yml b/Published/CORE-000220/rule.yml
index 67f180b49..8e275e55e 100644
--- a/Published/CORE-000220/rule.yml
+++ b/Published/CORE-000220/rule.yml
@@ -1,5 +1,5 @@
# Variable: --TESTCD
-# Condition:
+# Condition:
# Rule: --TESTCD <= 8 chars and contains only letters, numbers, and underscores and can not start with a number
Authorities:
- Organization: CDISC
@@ -7,74 +7,74 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot
- start with a number; nor can they contain characters other
- than letters; numbers; or underscores
+ - Cited Guidance:
+ Values of --TESTCD must be limited to 8 characters; and cannot start with a
+ number; nor can they contain characters other than letters; numbers; or underscores
Document: IG v3.4
Section: 4.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0372
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot
- start with a number; nor can they contain characters other
- than letters; numbers; or underscores
+ - Cited Guidance:
+ Values of --TESTCD must be limited to 8 characters; and cannot start with a
+ number; nor can they contain characters other than letters; numbers; or underscores
Document: IG v3.3
Section: 7.4.1
- - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor
- can it start with a number (e.g., '1TEST'). IETESTCD cannot
- contain characters other than letters; numbers; or
- underscores.
+ - Cited Guidance:
+ The value in IETESTCD cannot be longer than 8 characters; nor can it start
+ with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters;
+ numbers; or underscores.
Document: Model v1.7
Section: 3.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0372
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot
- start with a number; nor can they contain characters other
- than letters; numbers; or underscores
+ - Cited Guidance:
+ Values of --TESTCD must be limited to 8 characters; and cannot start with a
+ number; nor can they contain characters other than letters; numbers; or underscores
Document: IG v3.2
Section: 4.1.2.1
- - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor
- can it start with a number (e.g., '1TEST'). IETESTCD cannot
- contain characters other than letters; numbers; or
- underscores.
+ - Cited Guidance:
+ The value in IETESTCD cannot be longer than 8 characters; nor can it start
+ with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters;
+ numbers; or underscores.
Document: Model v1.4
Section: 3.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0372
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The value in --TESTCD cannot be longer than 8 characters, nor
- can it start with a number (e.g., "1TEST" is not valid).
- --TESTCD cannot contain characters other than letters,
- numbers, or underscores.
+ - Cited Guidance:
+ The value in --TESTCD cannot be longer than 8 characters, nor can it start
+ with a number (e.g., "1TEST" is not valid). --TESTCD cannot contain characters other than
+ letters, numbers, or underscores.
Document: TIG 1.0
Item: Specifications --TESTCD
Section: Finding Domain Specifications
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0536
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- name: --TESTCD
@@ -83,13 +83,13 @@ Check:
Core:
Id: CORE-000220
Status: Published
- Version: '1'
-Description: Part A - Raise an error when --TESTCD > 8 chars or contains more
- than only letters, numbers and underscores, or starts with a number.
+ Version: "1"
+Description: Part A - Raise an error when --TESTCD > 8 chars or contains more than only letters,
+ numbers and underscores, or starts with a number.
Executability: Fully Executable
Outcome:
- Message: --TESTCD > 8 chars or contains more than only letters, numbers,
- underscores, or starts with a number.
+ Message: --TESTCD > 8 chars or contains more than only letters, numbers, underscores, or starts
+ with a number.
Output Variables:
- --TESTCD
Rule Type: Record Data
diff --git a/Published/CORE-000221/rule.yml b/Published/CORE-000221/rule.yml
index 1bb910bcf..7d1d43931 100644
--- a/Published/CORE-000221/rule.yml
+++ b/Published/CORE-000221/rule.yml
@@ -1,5 +1,5 @@
# Variable: QNAM
-# Condition:
+# Condition:
# Rule: QNAM value length <=8 and cannot start with a number and cannot contain characters other than letters in upper case, numbers, or underscores
Authorities:
- Organization: CDISC
@@ -7,78 +7,83 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it
- start with a number (e.g., '1TEST'). QNAM cannot contain
- characters other than letters; numbers; or underscores.
+ - Cited Guidance:
+ The value in QNAM cannot be longer than 8 characters; nor can it start with
+ a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or
+ underscores.
Document: Model v2.0
Item: QNAM
Section: Supplemental Qualifiers
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0417
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it
- start with a number (e.g., '1TEST'). QNAM cannot contain
- characters other than letters; numbers; or underscores.
+ - Cited Guidance:
+ The value in QNAM cannot be longer than 8 characters; nor can it start with
+ a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or
+ underscores.
Document: Model v1.7
Item: QNAM
Section: 4.1.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0417
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it
- start with a number (e.g., '1TEST'). QNAM cannot contain
- characters other than letters; numbers; or underscores.
+ - Cited Guidance:
+ The value in QNAM cannot be longer than 8 characters; nor can it start with
+ a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or
+ underscores.
Document: Model v1.4
Item: QNAM
Section: 4.1.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0417
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it
- start with a number (e.g., '1TEST'). QNAM cannot contain
- characters other than letters; numbers; or underscores.
+ - Cited Guidance:
+ The value in QNAM cannot be longer than 8 characters; nor can it start with
+ a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or
+ underscores.
Document: Model v1.4
Section: 4.1.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0417
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it
- start with a number (e.g., '1TEST'). QNAM cannot contain
- characters other than letters; numbers; or underscores.
+ - Cited Guidance:
+ The value in QNAM cannot be longer than 8 characters; nor can it start with
+ a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or
+ underscores.
Document: SDTM v2.1
Item: QNAM
Section: Section 6.2 Supplemental Qualifiers Data set
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0572
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: QNAM
@@ -87,13 +92,13 @@ Check:
Core:
Id: CORE-000221
Status: Published
- Version: '1'
-Description: Raise an error when QNAM > 8 chars or contains more than only
- letters in uppercase, numbers and underscores, or starts with a number.
+ Version: "1"
+Description: Raise an error when QNAM > 8 chars or contains more than only letters in uppercase,
+ numbers and underscores, or starts with a number.
Executability: Fully Executable
Outcome:
- Message: QNAM > 8 chars or contains letters that are in not in uppercase, more
- than only letters, numbers, underscores, or starts with a number.
+ Message: QNAM > 8 chars or contains letters that are in not in uppercase, more than only letters,
+ numbers, underscores, or starts with a number.
Output Variables:
- IDVAR
- IDVARVAL
diff --git a/Published/CORE-000222/rule.yml b/Published/CORE-000222/rule.yml
index 5fa55f596..c8dd70f35 100644
--- a/Published/CORE-000222/rule.yml
+++ b/Published/CORE-000222/rule.yml
@@ -1,5 +1,5 @@
# Variable: QLABEL
-# Condition:
+# Condition:
# Rule: QLABEL value length <= 40
Authorities:
- Organization: CDISC
@@ -7,62 +7,66 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: This is the long name or label associated with QNAM. The value
- in QLABEL cannot be longer than 40 characters. This will often
- be the column label in the sponsor's original dataset.
+ - Cited Guidance:
+ This is the long name or label associated with QNAM. The value in QLABEL
+ cannot be longer than 40 characters. This will often be the column label in the sponsor's
+ original dataset.
Document: Model v2.0
Item: QLABEL
Section: Supplemental Qualifiers
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0416
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: This is the long name or label associated with QNAM. The value
- in QLABEL cannot be longer than 40 characters. This will often
- be the column label in the sponsor's original dataset.
+ - Cited Guidance:
+ This is the long name or label associated with QNAM. The value in QLABEL
+ cannot be longer than 40 characters. This will often be the column label in the sponsor's
+ original dataset.
Document: Model v1.7
Section: 4.1.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0416
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: This is the long name or label associated with QNAM. The value
- in QLABEL cannot be longer than 40 characters. This will often
- be the column label in the sponsor's original dataset.
+ - Cited Guidance:
+ This is the long name or label associated with QNAM. The value in QLABEL
+ cannot be longer than 40 characters. This will often be the column label in the sponsor's
+ original dataset.
Document: Model v1.4
Section: 4.1.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0416
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: This is the long name or label associated with QNAM. The value
- in QLABEL cannot be longer than 40 characters. This will often
- be the column label in the sponsor's original dataset.
+ - Cited Guidance:
+ This is the long name or label associated with QNAM. The value in QLABEL
+ cannot be longer than 40 characters. This will often be the column label in the sponsor's
+ original dataset.
Document: SDTM v2.1
Item: QLABEL
Section: Section 6.2 Supplemental Qualifiers Data set
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0571
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: QLABEL
@@ -71,7 +75,7 @@ Check:
Core:
Id: CORE-000222
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when QLABEL > 40 chars.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000223/rule.yml b/Published/CORE-000223/rule.yml
index 5c4b0ee12..0a0d8c09b 100644
--- a/Published/CORE-000223/rule.yml
+++ b/Published/CORE-000223/rule.yml
@@ -7,55 +7,55 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage Arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an Arm or followed
- a course not described by any planned Arm, ACTARMCD is null
- and ARMNRS is populated.
+ - Cited Guidance:
+ With the exception of studies which use multi-stage Arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or
+ followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is
+ populated.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0513
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an arm or followed
- a course not described by any planned arm, ACTARMCD is null
- and ARMNRS is populated.
+ - Cited Guidance:
+ With the exception of studies which use multi-stage arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or
+ followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is
+ populated.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0513
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage Arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an Arm or followed
- a course not described by any planned Arm, ACTARMCD is null
- and ARMNRS is populated.
+ - Cited Guidance:
+ With the exception of studies which use multi-stage Arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or
+ followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is
+ populated.
Document: TIG 1.0
Item: Specification:ARMNRS
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0608
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ACTARMCD
@@ -65,7 +65,7 @@ Check:
Core:
Id: CORE-000223
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when ACTARMCD is empty and ARMNRS is not completed.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000224/rule.yml b/Published/CORE-000224/rule.yml
index 68c6960bb..a0f34485a 100644
--- a/Published/CORE-000224/rule.yml
+++ b/Published/CORE-000224/rule.yml
@@ -7,55 +7,55 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage Arm
- assignments, must be a value of ARM in the Trial Arms Dataset.
- If the subject was not assigned to an Arm or followed a course
- not described by any planned Arm, ACTARM is null and ARMNRS is
+ - Cited Guidance:
+ With the exception of studies which use multi-stage Arm assignments, must be
+ a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or
+ followed a course not described by any planned Arm, ACTARM is null and ARMNRS is
populated.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0515
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an arm or followed
- a course not described by any planned arm, ACTARMCD is null
- and ARMNRS is populated.
+ - Cited Guidance:
+ With the exception of studies which use multi-stage arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or
+ followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is
+ populated.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0515
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: With the exception of studies which use multi-stage Arm
- assignments, must be a value of ARMCD in the Trial Arms
- Dataset. If the subject was not assigned to an Arm or followed
- a course not described by any planned Arm, ACTARMCD is null
- and ARMNRS is populated.
+ - Cited Guidance:
+ With the exception of studies which use multi-stage Arm assignments, must be
+ a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or
+ followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is
+ populated.
Document: TIG 1.0
Item: Specification:ARMNRS
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0610
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ACTARM
@@ -65,7 +65,7 @@ Check:
Core:
Id: CORE-000224
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when ACTARM is empty and ARMNRS is not completed.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000225/rule.yml b/Published/CORE-000225/rule.yml
index 1a38fe316..12b6914c2 100644
--- a/Published/CORE-000225/rule.yml
+++ b/Published/CORE-000225/rule.yml
@@ -4,74 +4,73 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The explanation for why requested information was not available.
- Used in conjunction with --STAT when value is "NOT DONE".
+ - Cited Guidance:
+ The explanation for why requested information was not available. Used in
+ conjunction with --STAT when value is "NOT DONE".
Document: Model v2.0
Section: Interventions
- - Cited Guidance: The explanation for why requested information was not available.
- Used in conjunction with --STAT when value is "NOT DONE".
+ - Cited Guidance:
+ The explanation for why requested information was not available. Used in
+ conjunction with --STAT when value is "NOT DONE".
Document: Model v2.0
Section: Events
- - Cited Guidance: The explanation for why requested information was not available.
- Used in conjunction with --STAT when value is "NOT DONE".
+ - Cited Guidance:
+ The explanation for why requested information was not available. Used in
+ conjunction with --STAT when value is "NOT DONE".
Document: Model v2.0
Section: Findings
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0094
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Reason not done. Used in conjunction with --STAT when value is
- NOT DONE.
+ - Cited Guidance: Reason not done. Used in conjunction with --STAT when value is NOT DONE.
Document: Model v1.4
Item: The Findings Observation Class
Section: 2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0094
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Reason not done. Used in conjunction with --STAT when value is
- "NOT DONE".
+ - Cited Guidance: Reason not done. Used in conjunction with --STAT when value is "NOT DONE".
Document: Model v1.7
- Item: 'Table 2.2.1.1, 2.2.2.1, 2.2.3.1: --REASND'
+ Item: "Table 2.2.1.1, 2.2.2.1, 2.2.3.1: --REASND"
Section: 2.2.1|2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0094
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Events[The explanation for why requested information was not
- available. Used in conjunction with --STAT when value is "NOT
- DONE".]|Interventions[The explanation for why requested
- information was not available. Used in conjunction with --STAT
- when value is "NOT DONE".]|Findings[The explanation for why
- requested information was not available. Used in conjunction
- with --STAT when value is "NOT DONE".]
+ - Cited Guidance:
+ Events[The explanation for why requested information was not available. Used
+ in conjunction with --STAT when value is "NOT DONE".]|Interventions[The explanation for
+ why requested information was not available. Used in conjunction with --STAT when value is
+ "NOT DONE".]|Findings[The explanation for why requested information was not available.
+ Used in conjunction with --STAT when value is "NOT DONE".]
Document: SDTM v2.1
Item: --REASND
- Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The
- Interventions Observation Class|Section 3.1.3 The Findings
- Observation Class
+ Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions
+ Observation Class|Section 3.1.3 The Findings Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0359
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
# Variable: --STAT
# Condition: --REASND ^= null
# Rule: --STAT = 'NOT DONE'
@@ -85,7 +84,7 @@ Check:
Core:
Id: CORE-000225
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --REASND is provided and --STAT is not equal to "NOT DONE".
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000227/rule.yml b/Published/CORE-000227/rule.yml
index dcdd46f74..b1c5c7668 100644
--- a/Published/CORE-000227/rule.yml
+++ b/Published/CORE-000227/rule.yml
@@ -1,5 +1,5 @@
# Variable: IETEST
-# Condition:
+# Condition:
# Rule: IETEST in TI.IETEST
Authorities:
- Organization: CDISC
@@ -7,66 +7,67 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found
- in the Trial Inclusion/Exclusion Criteria (TI) dataset
- described in Section 7.4.1, Trial Inclusion/Exclusion
- Criteria.
+ - Cited Guidance:
+ The complete list of Inclusion/Exclusion criteria can be found in the Trial
+ Inclusion/Exclusion Criteria (TI) dataset described in Section 7.4.1, Trial
+ Inclusion/Exclusion Criteria.
Document: IG v3.4
Item: Specification
Section: 6.3.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0178
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The complete list of Inclusion/Exclusion criteria can be found
- in the TI trial inclusion/exclusion criteria dataset described
- in Section 7.4 - Trial Summary and Eligibility: Trial
- Inclusion/Exclusion Criteria (TI).'
+ - Cited Guidance:
+ "The complete list of Inclusion/Exclusion criteria can be found in the TI trial
+ inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary and Eligibility:
+ Trial Inclusion/Exclusion Criteria (TI)."
Document: IG v3.2
Item: Assumption 2
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0178
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The complete list of Inclusion/Exclusion criteria can be found
- in the TI trial inclusion/exclusion criteria dataset described
- in Section 7.4 - Trial Summary and Eligibility: Trial
- Inclusion/Exclusion Criteria (TI).'
+ - Cited Guidance:
+ "The complete list of Inclusion/Exclusion criteria can be found in the TI trial
+ inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary and Eligibility:
+ Trial Inclusion/Exclusion Criteria (TI)."
Document: IG v3.3
Item: Assumption 1
Section: 6.3.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0178
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found
- in the Trial Inclusion/Exclusion Criteria (TI) dataset.
+ - Cited Guidance:
+ The complete list of Inclusion/Exclusion criteria can be found in the Trial
+ Inclusion/Exclusion Criteria (TI) dataset.
Document: TIG 1.0
Item: Assumption 1
Section: 2.8.10.13
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0407
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IETEST
@@ -75,7 +76,7 @@ Check:
Core:
Id: CORE-000227
Status: Published
- Version: '1'
+ Version: "1"
Description: Check if IETEST is not in TI.IETEST
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000228/rule.yml b/Published/CORE-000228/rule.yml
index fadab684e..28a86e6e3 100644
--- a/Published/CORE-000228/rule.yml
+++ b/Published/CORE-000228/rule.yml
@@ -1,5 +1,5 @@
# Variable: IETESTCD
-# Condition:
+# Condition:
# Rule: IETESTCD in TI.IETESTCD
Authorities:
- Organization: CDISC
@@ -7,66 +7,67 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found
- in the Trial Inclusion/Exclusion Criteria (TI) dataset
- described in Section 7.4.1, Trial Inclusion/Exclusion
- Criteria.
+ - Cited Guidance:
+ The complete list of Inclusion/Exclusion criteria can be found in the Trial
+ Inclusion/Exclusion Criteria (TI) dataset described in Section 7.4.1, Trial
+ Inclusion/Exclusion Criteria.
Document: IG v3.4
Item: Specification
Section: 6.3.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0179
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The complete list of Inclusion/Exclusion criteria can be found
- in the TI trial inclusion/exclusion criteria dataset described
- in Section 7.4 - Trial Summary and Eligibility: Trial
- Inclusion/Exclusion Criteria (TI).'
+ - Cited Guidance:
+ "The complete list of Inclusion/Exclusion criteria can be found in the TI trial
+ inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary and Eligibility:
+ Trial Inclusion/Exclusion Criteria (TI)."
Document: IG v3.2
Item: Assumption 2
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0179
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found
- in the Trial Inclusion/Exclusion Criteria (TI) dataset
- described in Section 7.4.1, Trial Inclusion/Exclusion
- Criteria.
+ - Cited Guidance:
+ The complete list of Inclusion/Exclusion criteria can be found in the Trial
+ Inclusion/Exclusion Criteria (TI) dataset described in Section 7.4.1, Trial
+ Inclusion/Exclusion Criteria.
Document: IG v3.3
Item: Assumption 1
Section: 6.3.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0179
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found
- in the Trial Inclusion/Exclusion Criteria (TI) dataset.
+ - Cited Guidance:
+ The complete list of Inclusion/Exclusion criteria can be found in the Trial
+ Inclusion/Exclusion Criteria (TI) dataset.
Document: TIG 1.0
Item: Assumption 1
Section: 2.8.10.13
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0408
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IETESTCD
@@ -75,7 +76,7 @@ Check:
Core:
Id: CORE-000228
Status: Published
- Version: '1'
+ Version: "1"
Description: Check if IETESTCD is present in TI.IETESTCD
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000236/rule.yml b/Published/CORE-000236/rule.yml
index 3155c389c..8354696b5 100644
--- a/Published/CORE-000236/rule.yml
+++ b/Published/CORE-000236/rule.yml
@@ -7,103 +7,94 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Do not create separate domains based on time; rather, represent
- both prior and current observations in a domain (e.g., CM for
- all non-study medications). Note that Adverse Events and
- Medical History are an exception to this best practice because
- of regulatory reporting needs.
+ - Cited Guidance:
+ Do not create separate domains based on time; rather, represent both prior
+ and current observations in a domain (e.g., CM for all non-study medications). Note that
+ Adverse Events and Medical History are an exception to this best practice because of
+ regulatory reporting needs.
Document: IG v3.4
- Item: '1'
- Section: '2.6'
- - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events
- (CE), for example, are conceptually the same data, the only
- differences being when the event started relative to the study
- start and whether the event is considered a
- regulatory-reportable adverse event in the study.
+ Item: "1"
+ Section: "2.6"
+ - Cited Guidance:
+ Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for
+ example, are conceptually the same data, the only differences being when the event started
+ relative to the study start and whether the event is considered a regulatory-reportable
+ adverse event in the study.
Document: SDTMIG v3.4
Item: 3a
Section: 4.2.6
- - Cited Guidance: An events domain that contains data that includes the subject's
- prior medical history at the start of the trial.
+ - Cited Guidance:
+ An events domain that contains data that includes the subject's prior
+ medical history at the start of the trial.
Document: SDTMIG v3.4
- Section: '6.2'
+ Section: "6.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0079
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "IG v3.2[2.6][Section 2.6: Do not create separate domains based
- on time, rather represent both prior and current observations
- in a domain (e.g., CM for all non-study medications). Note
- that AE and MH are an exception to this best practice because
- of regulatory reporting needs.]|IG v3.2[4.1.2.6][Section
- 4.1.2.6, Item 2.B.3.A (Discussion of --CAT/--SCAT): Adverse
- Events (AE), Medical History (MH) and Clinical Events (CE),
- for example, are conceptually the same data, the only
- differences being when the event started relative to the study
- start and whether the event is considered a regulatory
- reportable adverse event in the study.]|IG v3.2[6.2][Domain
- Code Table: The medical history dataset includes the subject's
- prior history at the start of the trial.][MH: The medical
- history dataset includes the subject's prior history at the
- start of the trial.][Assumption 1:The Medical History dataset
- generally includes the subject's prior and concomitant
- conditions at the start of the trial.]"
+ - Cited Guidance:
+ "IG v3.2[2.6][Section 2.6: Do not create separate domains based on time, rather
+ represent both prior and current observations in a domain (e.g., CM for all non-study medications).
+ Note that AE and MH are an exception to this best practice because of regulatory reporting needs.]|IG
+ v3.2[4.1.2.6][Section 4.1.2.6, Item 2.B.3.A (Discussion of --CAT/--SCAT): Adverse Events (AE),
+ Medical History (MH) and Clinical Events (CE), for example, are conceptually the same data,
+ the only differences being when the event started relative to the study start and whether the
+ event is considered a regulatory reportable adverse event in the study.]|IG v3.2[6.2][Domain
+ Code Table: The medical history dataset includes the subject's prior history at the start of
+ the trial.][MH: The medical history dataset includes the subject's prior history at the start
+ of the trial.][Assumption 1:The Medical History dataset generally includes the subject's prior
+ and concomitant conditions at the start of the trial.]"
Document: IG v3.2
Section: IG v3.2[2.6]|IG v3.2[4.1.2.6]|IG v3.2[6.2]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0079
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "IG v3.3[2.6][Do not create separate domains based on time;
- rather, represent both prior and current observations in a
- domain (e.g., CM for all non-study medications). Note that AE
- and MH are an exception to this best practice because of
- regulatory reporting needs]|IG v3.3[4.2.6][Item 2.B.3.A
- (Discussion of --CAT/--SCAT): Adverse Events (AE), Medical
- History (MH), and Clinical Events (CE), for example, are
- conceptually the same data, the only differences being when
- the event started relative to the study start and whether the
- event is considered a regulatory reportable adverse event in
- the study.]|IG v3.3[6.2][Domain Code Table: The medical
- history dataset includes the subject's prior history at the
- start of the trial.][MH: The medical history dataset includes
- the subject's prior history at the start of the trial.]"
+ - Cited Guidance:
+ "IG v3.3[2.6][Do not create separate domains based on time; rather, represent
+ both prior and current observations in a domain (e.g., CM for all non-study medications). Note
+ that AE and MH are an exception to this best practice because of regulatory reporting needs]|IG
+ v3.3[4.2.6][Item 2.B.3.A (Discussion of --CAT/--SCAT): Adverse Events (AE), Medical History
+ (MH), and Clinical Events (CE), for example, are conceptually the same data, the only differences
+ being when the event started relative to the study start and whether the event is considered
+ a regulatory reportable adverse event in the study.]|IG v3.3[6.2][Domain Code Table: The medical
+ history dataset includes the subject's prior history at the start of the trial.][MH: The medical
+ history dataset includes the subject's prior history at the start of the trial.]"
Document: IG v3.3
Section: IG v3.3[2.6]|IG v3.3[4.2.6]|IG v3.3[6.2]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0079
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Custom domains will be used to represent logically related
- observations based on the scientific subject matter of the
- data and will not be created based on:The timing of collected
- observations (e.g., all vital signs measurements will be
- represented in domain Vital Signs (VS) irrespective of when
- measurements occurred).
+ - Cited Guidance:
+ Custom domains will be used to represent logically related observations
+ based on the scientific subject matter of the data and will not be created based on:The
+ timing of collected observations (e.g., all vital signs measurements will be represented
+ in domain Vital Signs (VS) irrespective of when measurements occurred).
Document: TIG 1.0
Section: 2.8.3
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0345
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: MHSTDTC
@@ -114,7 +105,7 @@ Check:
Core:
Id: CORE-000236
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an issue if MHSTDTC has a non-empty date that later than DM.RFSTDTC
Executability: Fully Executable
Match Datasets:
@@ -122,9 +113,8 @@ Match Datasets:
- USUBJID
Name: DM
Outcome:
- Message: MHSTDTC ^= null and MHSTDTC is on or after the DM.RFSTDTC. The medical
- history dataset should include the subject's prior history at the start of
- the trial.
+ Message: MHSTDTC ^= null and MHSTDTC is on or after the DM.RFSTDTC. The medical history dataset
+ should include the subject's prior history at the start of the trial.
Output Variables:
- MHSTDTC
- RFSTDTC
diff --git a/Published/CORE-000237/rule.yml b/Published/CORE-000237/rule.yml
index 735f91608..04a527481 100644
--- a/Published/CORE-000237/rule.yml
+++ b/Published/CORE-000237/rule.yml
@@ -7,18 +7,18 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: Model v2.0
Item: --SCAT
Section: Interventions
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0027
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -29,9 +29,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0027
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -42,109 +42,109 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0027
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.0
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND43
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND43
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND43
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND43
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND43
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND43
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: SDTM v2.1
Item: --SCAT
Section: 3.1.4 Identifiers for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0309
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --SCAT
@@ -155,7 +155,7 @@ Check:
Core:
Id: CORE-000237
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when --SCAT is not null and --SCAT is equal to --CAT
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000238/rule.yml b/Published/CORE-000238/rule.yml
index a22b0996c..621646b76 100644
--- a/Published/CORE-000238/rule.yml
+++ b/Published/CORE-000238/rule.yml
@@ -7,61 +7,65 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Equal to the latest value of EXENDTC (or the latest value of
- EXSTDTC if EXENDTC was not collected or is missing).
+ - Cited Guidance:
+ Equal to the latest value of EXENDTC (or the latest value of EXSTDTC if
+ EXENDTC was not collected or is missing).
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0147
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Equal to the latest value of EXENDTC (or the latest value of
- EXSTDTC if EXENDTC was not collected or is missing).
+ - Cited Guidance:
+ Equal to the latest value of EXENDTC (or the latest value of EXSTDTC if
+ EXENDTC was not collected or is missing).
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0147
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Equal to the latest value of EXENDTC (or the latest value of
- EXSTDTC if EXENDTC was not collected or is missing).
+ - Cited Guidance:
+ Equal to the latest value of EXENDTC (or the latest value of EXSTDTC if
+ EXENDTC was not collected or is missing).
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0147
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Last date/time of exposure to any protocol-specified product,
- equal to the latest value of EXENDTC (or the latest value of
- EXSTDTC if EXENDTC was not collected or is missing).
+ - Cited Guidance:
+ Last date/time of exposure to any protocol-specified product, equal to the
+ latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is
+ missing).
Document: TIG 1.0
Item: Specification
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0388
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: USUBJID
@@ -76,9 +80,9 @@ Check:
Core:
Id: CORE-000238
Status: Published
- Version: '1'
-Description: Raise an error when EX records are present for subject but RFXENDTC
- does not equal the latest value of EX.EXSTDTC or EX.EXENDTC
+ Version: "1"
+Description: Raise an error when EX records are present for subject but RFXENDTC does not equal the
+ latest value of EX.EXSTDTC or EX.EXENDTC
Executability: Fully Executable
Operations:
- domain: EX
diff --git a/Published/CORE-000239/rule.yml b/Published/CORE-000239/rule.yml
index 1c86355a7..67d5f9573 100644
--- a/Published/CORE-000239/rule.yml
+++ b/Published/CORE-000239/rule.yml
@@ -7,61 +7,65 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: First date of exposure to any protocol-specified treatment or
- therapy, equal to the earliest value of EXSTDTC.
+ - Cited Guidance:
+ First date of exposure to any protocol-specified treatment or therapy, equal
+ to the earliest value of EXSTDTC.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0148
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: First date of exposure to any protocol-specified treatment or
- therapy, equal to the earliest value of EXSTDTC.
+ - Cited Guidance:
+ First date of exposure to any protocol-specified treatment or therapy, equal
+ to the earliest value of EXSTDTC.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0148
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: First date/time of exposure to any protocol-specified treatment
- or therapy, equal to the earliest value of EXSTDTC.
+ - Cited Guidance:
+ First date/time of exposure to any protocol-specified treatment or therapy,
+ equal to the earliest value of EXSTDTC.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0148
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: First date/time of exposure to any protocol-specified product,
- equal to the earliest value of EXSTDTC.
+ - Cited Guidance:
+ First date/time of exposure to any protocol-specified product, equal to the
+ earliest value of EXSTDTC.
Document: TIG 1.0
Item: Specification
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0389
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: USUBJID
@@ -73,9 +77,9 @@ Check:
Core:
Id: CORE-000239
Status: Published
- Version: '1'
-Description: Raise an error when EX records are present for subject but RFXSTDTC
- does not equal the earliest value of EX.EXSTDTC
+ Version: "1"
+Description: Raise an error when EX records are present for subject but RFXSTDTC does not equal the
+ earliest value of EX.EXSTDTC
Executability: Fully Executable
Operations:
- domain: EX
diff --git a/Published/CORE-000240/rule.yml b/Published/CORE-000240/rule.yml
index 117f59801..03decfc98 100644
--- a/Published/CORE-000240/rule.yml
+++ b/Published/CORE-000240/rule.yml
@@ -7,72 +7,70 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The characterization of the start of an observation relative to
- the study reference period. The sponsor-defined reference
- period is a continuous period of time defined by a discrete
- starting point and a discrete ending point represented by
- RFSTDTC and RFENDTC in Demographics.
+ - Cited Guidance:
+ The characterization of the start of an observation relative to the study
+ reference period. The sponsor-defined reference period is a continuous period of time
+ defined by a discrete starting point and a discrete ending point represented by RFSTDTC
+ and RFENDTC in Demographics.
Document: Model v2.0
Item: --STRF
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0420
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the start of the observation as being before; during;
- or after the sponsor-defined reference period. The
- sponsor-defined reference period is a continuous period of
- time defined by a discrete starting point and a discrete
- ending point represented by RFSTDTC and RFENDTC in
- Demographics.
+ - Cited Guidance:
+ Identifies the start of the observation as being before; during; or after
+ the sponsor-defined reference period. The sponsor-defined reference period is a continuous
+ period of time defined by a discrete starting point and a discrete ending point
+ represented by RFSTDTC and RFENDTC in Demographics.
Document: Model v1.4
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0420
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the start of the observation as being before; during;
- or after the sponsor-defined reference period. The
- sponsor-defined reference period is a continuous period of
- time defined by a discrete starting point and a discrete
- ending point represented by RFSTDTC and RFENDTC in
- Demographics.
+ - Cited Guidance:
+ Identifies the start of the observation as being before; during; or after
+ the sponsor-defined reference period. The sponsor-defined reference period is a continuous
+ period of time defined by a discrete starting point and a discrete ending point
+ represented by RFSTDTC and RFENDTC in Demographics.
Document: Model v1.7
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0420
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The characterization of the start of an observation relative to
- the study reference period. The sponsor-defined reference
- period is a continuous period of time defined by a discrete
- starting point and a discrete ending point represented by
- RFSTDTC and RFENDTC in Demographics.
+ - Cited Guidance:
+ The characterization of the start of an observation relative to the study
+ reference period. The sponsor-defined reference period is a continuous period of time
+ defined by a discrete starting point and a discrete ending point represented by RFSTDTC
+ and RFENDTC in Demographics.
Document: SDTM v2.1
Item: --STRF
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0575
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --OCCUR
@@ -83,7 +81,7 @@ Check:
Core:
Id: CORE-000240
Status: Published
- Version: '1'
+ Version: "1"
Description: When --OCCUR = 'N', --STRF must not be populated
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000241/rule.yml b/Published/CORE-000241/rule.yml
index b75f0c470..4614273eb 100644
--- a/Published/CORE-000241/rule.yml
+++ b/Published/CORE-000241/rule.yml
@@ -7,72 +7,70 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The characterization of the end of an observation relative to
- the study reference period. The sponsor-defined reference
- period is a continuous period of time defined by a discrete
- starting point and a discrete ending point represented by
- RFSTDTC and RFENDTC in Demographics.
+ - Cited Guidance:
+ The characterization of the end of an observation relative to the study
+ reference period. The sponsor-defined reference period is a continuous period of time
+ defined by a discrete starting point and a discrete ending point represented by RFSTDTC
+ and RFENDTC in Demographics.
Document: Model v2.0
Item: --ENRF
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0421
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the end of the observation as being before; during or
- after the sponsor-defined reference period. The
- sponsor-defined reference period is a continuous period of
- time defined by a discrete starting point and a discrete
- ending point represented by RFSTDTC and RFENDTC in
- Demographics.
+ - Cited Guidance:
+ Identifies the end of the observation as being before; during or after the
+ sponsor-defined reference period. The sponsor-defined reference period is a continuous
+ period of time defined by a discrete starting point and a discrete ending point
+ represented by RFSTDTC and RFENDTC in Demographics.
Document: Model v1.4
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0421
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the end of the observation as being before; during or
- after the sponsor-defined reference period. The
- sponsor-defined reference period is a continuous period of
- time defined by a discrete starting point and a discrete
- ending point represented by RFSTDTC and RFENDTC in
- Demographics.
+ - Cited Guidance:
+ Identifies the end of the observation as being before; during or after the
+ sponsor-defined reference period. The sponsor-defined reference period is a continuous
+ period of time defined by a discrete starting point and a discrete ending point
+ represented by RFSTDTC and RFENDTC in Demographics.
Document: Model v1.7
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0421
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The characterization of the end of an observation relative to
- the study reference period. The sponsor-defined reference
- period is a continuous period of time defined by a discrete
- starting point and a discrete ending point represented by
- RFSTDTC and RFENDTC in Demographics.
+ - Cited Guidance:
+ The characterization of the end of an observation relative to the study
+ reference period. The sponsor-defined reference period is a continuous period of time
+ defined by a discrete starting point and a discrete ending point represented by RFSTDTC
+ and RFENDTC in Demographics.
Document: SDTM v2.1
Item: --ENRF
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0576
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --OCCUR
@@ -83,7 +81,7 @@ Check:
Core:
Id: CORE-000241
Status: Published
- Version: '1'
+ Version: "1"
Description: When --OCCUR = 'N', --ENRF must not be populated
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000242/rule.yml b/Published/CORE-000242/rule.yml
index b8c00abe2..7ad23f78e 100644
--- a/Published/CORE-000242/rule.yml
+++ b/Published/CORE-000242/rule.yml
@@ -1,5 +1,5 @@
# Variable: --EXCLFL
-# Condition:
+# Condition:
# Rule: --EXCLFL not present in dataset
Authorities:
- Organization: CDISC
@@ -7,68 +7,68 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables, defined for use in non-clinical
- studies (SEND), must NEVER be used in the submission of
- SDTM-based data for human clinical trials: --DTHREL (Findings)
- --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)'
+ - Cited Guidance:
+ "The following SDTM variables, defined for use in non-clinical studies (SEND),
+ must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL
+ (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)"
Document: IG v3.4
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0353
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical
- studies (SEND); must NEVER be used in the submission of
- SDTM-based data for human clinical trials: --DTHREL (Findings)
- --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)'
+ - Cited Guidance:
+ "The following SDTM variables; defined for use in non-clinical studies (SEND);
+ must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL
+ (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)"
Document: IG v3.2
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0353
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical
- studies (SEND); must NEVER be used in the submission of
- SDTM-based data for human clinical trials: --USCHFL
- (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL
- (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID
- (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing
- Variables) --NOMLBL (Timing Variables)'
+ - Cited Guidance:
+ "The following SDTM variables; defined for use in non-clinical studies (SEND);
+ must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL
+ (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings)
+ --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables)
+ --NOMLBL (Timing Variables)"
Document: IG v3.3
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0353
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Not in human clinical trials Select variables for the domain
- from the SDTM. Selection of variables must align with SDTM
- Usage Restrictions.
+ - Cited Guidance:
+ Not in human clinical trials Select variables for the domain from the SDTM.
+ Selection of variables must align with SDTM Usage Restrictions.
Document: SDTM v2.1|TIG v1.0
Item: Specification|--EXCLFL
- Section: "Section 3.1.3 - The Findings Observation Class 2.8.2 How Extend
- Domains 2.8.3 How to Create New Specifications"
+ Section:
+ "Section 3.1.3 - The Findings Observation Class 2.8.2 How Extend Domains 2.8.3 How to
+ Create New Specifications"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0518
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --EXCLFL
@@ -76,7 +76,7 @@ Check:
Core:
Id: CORE-000242
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --EXCLFL is present in dataset.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000243/rule.yml b/Published/CORE-000243/rule.yml
index a4272457a..5d2dc33aa 100644
--- a/Published/CORE-000243/rule.yml
+++ b/Published/CORE-000243/rule.yml
@@ -1,5 +1,5 @@
# Variable: --REASEX
-# Condition:
+# Condition:
# Rule: --REASEX not present in dataset
Authorities:
- Organization: CDISC
@@ -7,68 +7,68 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables, defined for use in non-clinical
- studies (SEND), must NEVER be used in the submission of
- SDTM-based data for human clinical trials: --DTHREL (Findings)
- --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)'
+ - Cited Guidance:
+ "The following SDTM variables, defined for use in non-clinical studies (SEND),
+ must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL
+ (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)"
Document: IG v3.4
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0354
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical
- studies (SEND); must NEVER be used in the submission of
- SDTM-based data for human clinical trials: --DTHREL (Findings)
- --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)'
+ - Cited Guidance:
+ "The following SDTM variables; defined for use in non-clinical studies (SEND);
+ must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL
+ (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)"
Document: IG v3.2
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0354
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical
- studies (SEND); must NEVER be used in the submission of
- SDTM-based data for human clinical trials: --USCHFL
- (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL
- (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID
- (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing
- Variables) --NOMLBL (Timing Variables)'
+ - Cited Guidance:
+ "The following SDTM variables; defined for use in non-clinical studies (SEND);
+ must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL
+ (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings)
+ --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables)
+ --NOMLBL (Timing Variables)"
Document: IG v3.3
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0354
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: "Not in human clinical trials Select variables for the domain
- from the SDTM. Selection of variables must align with SDTM
- Usage Restrictions. "
+ - Cited Guidance:
+ "Not in human clinical trials Select variables for the domain from the SDTM. Selection
+ of variables must align with SDTM Usage Restrictions. "
Document: SDTM v2.1|TIG v1.0
Item: Specification|--REASEX
- Section: "Section 3.1.3 - The Findings Observation Class 2.8.2 How Extend
- Domains 2.8.3 How to Create New Specifications"
+ Section:
+ "Section 3.1.3 - The Findings Observation Class 2.8.2 How Extend Domains 2.8.3 How to
+ Create New Specifications"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0519
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --REASEX
@@ -76,7 +76,7 @@ Check:
Core:
Id: CORE-000243
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --REASEX is present in dataset.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000244/rule.yml b/Published/CORE-000244/rule.yml
index 7555240f2..2f8045f77 100644
--- a/Published/CORE-000244/rule.yml
+++ b/Published/CORE-000244/rule.yml
@@ -1,5 +1,5 @@
# Variable: --DETECT
-# Condition:
+# Condition:
# Rule: --DETECT not present in dataset
Authorities:
- Organization: CDISC
@@ -7,68 +7,68 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables, defined for use in non-clinical
- studies (SEND), must NEVER be used in the submission of
- SDTM-based data for human clinical trials: --DTHREL (Findings)
- --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)'
+ - Cited Guidance:
+ "The following SDTM variables, defined for use in non-clinical studies (SEND),
+ must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL
+ (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)"
Document: IG v3.4
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0355
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical
- studies (SEND); must NEVER be used in the submission of
- SDTM-based data for human clinical trials: --DTHREL (Findings)
- --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)'
+ - Cited Guidance:
+ "The following SDTM variables; defined for use in non-clinical studies (SEND);
+ must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL
+ (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)"
Document: IG v3.2
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0355
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical
- studies (SEND); must NEVER be used in the submission of
- SDTM-based data for human clinical trials: --USCHFL
- (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL
- (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID
- (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing
- Variables) --NOMLBL (Timing Variables)'
+ - Cited Guidance:
+ "The following SDTM variables; defined for use in non-clinical studies (SEND);
+ must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL
+ (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings)
+ --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables)
+ --NOMLBL (Timing Variables)"
Document: IG v3.3
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0355
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Not in human clinical trials. Select variables for the domain
- from the SDTM. Selection of variables must align with SDTM
- Usage Restrictions.
+ - Cited Guidance:
+ Not in human clinical trials. Select variables for the domain from the SDTM.
+ Selection of variables must align with SDTM Usage Restrictions.
Document: SDTM v2.1|TIG v1.0
Item: Specification|--DETECT
- Section: Section 3.1.3 - The Findings Observation Class| 2.8.2 How Extend
- Domains | 2.8.3 How to Create New Specifications
+ Section:
+ Section 3.1.3 - The Findings Observation Class| 2.8.2 How Extend Domains | 2.8.3
+ How to Create New Specifications
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0520
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --DETECT
@@ -76,7 +76,7 @@ Check:
Core:
Id: CORE-000244
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --DETECT is present in dataset.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000245/rule.yml b/Published/CORE-000245/rule.yml
index 655a6a8a2..bdf53e49c 100644
--- a/Published/CORE-000245/rule.yml
+++ b/Published/CORE-000245/rule.yml
@@ -1,5 +1,5 @@
# Variable: --NOMDY
-# Condition:
+# Condition:
# Rule: --NOMDY not present in dataset
Authorities:
- Organization: CDISC
@@ -7,57 +7,56 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The following SDTM variables, defined for use in non-clinical
- studies (SEND), must NEVER be used in the submission of
- SDTM-based data for human clinical trials --USCHFL
- (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL
- (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID
- (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing
- Variables) --NOMLBL (Timing Variables)
+ - Cited Guidance:
+ The following SDTM variables, defined for use in non-clinical studies
+ (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials
+ --USCHFL (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL (Findings)
+ --REASEX (Findings) --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables)
+ --NOMDY (Timing Variables) --NOMLBL (Timing Variables)
Document: IG v3.4
Item: SDTM Variables Not Allowed in SDTMIG
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0510
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical
- studies (SEND); must NEVER be used in the submission of
- SDTM-based data for human clinical trials: --USCHFL
- (Interventions, Events, Findings), --DTHREL (Findings),
- --EXCLFL (Findings), --REASEX (Findings), --IMPLBL (Findings),
- --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY
- (Timing Variables), --NOMLBL (Timing Variables)'
+ - Cited Guidance:
+ "The following SDTM variables; defined for use in non-clinical studies (SEND);
+ must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL
+ (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings),
+ --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables),
+ --NOMLBL (Timing Variables)"
Document: IG v3.3
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0510
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Not in human clinical trials. Select variables for the domain
- from the SDTM. Selection of variables must align with SDTM
- Usage Restrictions.
+ - Cited Guidance:
+ Not in human clinical trials. Select variables for the domain from the SDTM.
+ Selection of variables must align with SDTM Usage Restrictions.
Document: SDTM v2.1|TIG v1.0
Item: Specification|--NOMDY
- Section: Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend
- Domains |2.8.3 How to Create New Specifications
+ Section:
+ Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend Domains |2.8.3
+ How to Create New Specifications
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0605
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SDTMIG
References:
- Citations:
@@ -67,9 +66,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0635
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -80,10 +79,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0676
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --NOMDY
@@ -91,7 +90,7 @@ Check:
Core:
Id: CORE-000245
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --NOMDY is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000246/rule.yml b/Published/CORE-000246/rule.yml
index 24bc9c7a1..64cab3106 100644
--- a/Published/CORE-000246/rule.yml
+++ b/Published/CORE-000246/rule.yml
@@ -1,5 +1,5 @@
# Variable: --NOMLBL
-# Condition:
+# Condition:
# Rule: --NOMLBL not present in dataset
Authorities:
- Organization: CDISC
@@ -7,57 +7,56 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The following SDTM variables, defined for use in non-clinical
- studies (SEND), must NEVER be used in the submission of
- SDTM-based data for human clinical trials --USCHFL
- (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL
- (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID
- (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing
- Variables) --NOMLBL (Timing Variables)
+ - Cited Guidance:
+ The following SDTM variables, defined for use in non-clinical studies
+ (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials
+ --USCHFL (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL (Findings)
+ --REASEX (Findings) --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables)
+ --NOMDY (Timing Variables) --NOMLBL (Timing Variables)
Document: IG v3.4
Item: SDTM Variables Not Allowed in SDTMIG
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0511
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical
- studies (SEND); must NEVER be used in the submission of
- SDTM-based data for human clinical trials: --USCHFL
- (Interventions, Events, Findings), --DTHREL (Findings),
- --EXCLFL (Findings), --REASEX (Findings), --IMPLBL (Findings),
- --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY
- (Timing Variables), --NOMLBL (Timing Variables)'
+ - Cited Guidance:
+ "The following SDTM variables; defined for use in non-clinical studies (SEND);
+ must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL
+ (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings),
+ --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables),
+ --NOMLBL (Timing Variables)"
Document: IG v3.3
- Section: '2.7'
+ Section: "2.7"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0511
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Not in human clinical trials. Select variables for the domain
- from the SDTM. Selection of variables must align with SDTM
- Usage Restrictions.
+ - Cited Guidance:
+ Not in human clinical trials. Select variables for the domain from the SDTM.
+ Selection of variables must align with SDTM Usage Restrictions.
Document: SDTM v2.1|TIG v1.0
Item: Specification|--NOMLBL
- Section: Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend
- Domains |2.8.3 How to Create New Specifications
+ Section:
+ Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend Domains |2.8.3
+ How to Create New Specifications
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0606
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SDTMIG
References:
- Citations:
@@ -67,9 +66,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0636
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -80,10 +79,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0677
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --NOMLBL
@@ -91,7 +90,7 @@ Check:
Core:
Id: CORE-000246
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --NOMLBL is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000247/rule.yml b/Published/CORE-000247/rule.yml
index 8aa41d153..49878ec09 100644
--- a/Published/CORE-000247/rule.yml
+++ b/Published/CORE-000247/rule.yml
@@ -1,5 +1,5 @@
# Variable: --RESLOC
-# Condition:
+# Condition:
# Rule: --RESLOC not present in dataset
Authorities:
- Organization: CDISC
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0552
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -27,9 +27,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0552
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
@@ -40,10 +40,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0640
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SDTMIG
References:
- Citations:
@@ -54,9 +54,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0626
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
@@ -67,10 +67,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0667
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --RESLOC
@@ -78,7 +78,7 @@ Check:
Core:
Id: CORE-000247
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --RESLOC is present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000248/rule.yml b/Published/CORE-000248/rule.yml
index 5b7ca3734..1f05459c9 100644
--- a/Published/CORE-000248/rule.yml
+++ b/Published/CORE-000248/rule.yml
@@ -7,19 +7,19 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The actual date or date and time of a time point that acts as a
- fixed reference for a series of planned time points,
- represented in a standardized character format. The fixed
- reference point is in --TPTREF
+ - Cited Guidance:
+ The actual date or date and time of a time point that acts as a fixed
+ reference for a series of planned time points, represented in a standardized character
+ format. The fixed reference point is in --TPTREF
Document: Model v2.0
Item: --RFTDTC
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0026
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -30,28 +30,28 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0026
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Date/time for a fixed reference time point defined by --TPTREF
- in ISO 8601 character format.
+ - Cited Guidance:
+ Date/time for a fixed reference time point defined by --TPTREF in ISO 8601
+ character format.
Document: Model v1.4
Item: Table 2.2.5, --RFTDTC
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0026
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If an --RFTDTC entry is used, then the --TPTREF should be
- provided.
+ - Cited Guidance: If an --RFTDTC entry is used, then the --TPTREF should be provided.
Document: IG v3.0
Section: 4.4.7
Origin: SEND Conformance Rules
@@ -63,9 +63,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed
- reference point (--TPTREF), the --TPTREF should be provided
- whenever --RFTDTC is populated.
+ - Cited Guidance:
+ Since the --RFTDTC represents the actual date/time of the fixed reference
+ point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated.
Document: IG v3.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
@@ -77,9 +77,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed
- reference point (--TPTREF), the --TPTREF should be provided
- whenever --RFTDTC is populated.
+ - Cited Guidance:
+ Since the --RFTDTC represents the actual date/time of the fixed reference
+ point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated.
Document: IG v3.1.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
@@ -91,9 +91,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed
- reference point (--TPTREF), the --TPTREF should be provided
- whenever --RFTDTC is populated.
+ - Cited Guidance:
+ Since the --RFTDTC represents the actual date/time of the fixed reference
+ point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated.
Document: IG v3.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
@@ -105,9 +105,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed
- reference point (--TPTREF), the --TPTREF should be provided
- whenever --RFTDTC is populated.
+ - Cited Guidance:
+ Since the --RFTDTC represents the actual date/time of the fixed reference
+ point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated.
Document: IG v3.1.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
@@ -119,9 +119,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed
- reference point (--TPTREF), the --TPTREF should be provided
- whenever --RFTDTC is populated.
+ - Cited Guidance:
+ Since the --RFTDTC represents the actual date/time of the fixed reference
+ point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated.
Document: IG v3.1.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
@@ -133,12 +133,11 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: "When instances of an activity are scheduled at planned time
- intervals relative to a fixed reference point (e.g., an
- exposure), the following timing variables will be used
- --TPTREF Represents a description of the fixed reference point
- from which the planned observation will be made. --RFTDTC
- Represents the actual date/time of the value of --TPTREF"
+ - Cited Guidance:
+ "When instances of an activity are scheduled at planned time intervals relative
+ to a fixed reference point (e.g., an exposure), the following timing variables will be used
+ --TPTREF Represents a description of the fixed reference point from which the planned observation
+ will be made. --RFTDTC Represents the actual date/time of the value of --TPTREF"
Document: TIG v1.0
Item: Timing Relative to Reference Points, Table Num 3
Section: 2.8.7.6 Representing References and Relative Timing
@@ -152,10 +151,10 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: The actual date or date and time of a time point that acts as a
- fixed reference for a series of planned time points,
- represented in a standardized character format. The fixed
- reference point is in --TPTREF.
+ - Cited Guidance:
+ The actual date or date and time of a time point that acts as a fixed
+ reference for a series of planned time points, represented in a standardized character
+ format. The fixed reference point is in --TPTREF.
Document: SDTM v2.1
Item: --RFTDTC
Section: 3.1.5 Timing Variables for All Classes
@@ -171,133 +170,123 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3702
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3702
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3702
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3702
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3702
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3702
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3702
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3702
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3702
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Time point reference should be provided, when reference time
- point is used.
+ - Cited Guidance: Time point reference should be provided, when reference time point is used.
Document: FDA
Section: FDAB037
Origin: FDA Business Rules
Rule Identifier:
Id: FB3702
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --TPTREF
@@ -309,9 +298,9 @@ Check:
Core:
Id: CORE-000248
Status: Published
- Version: '1'
-Description: Time point reference (--TPTREF) should be populated when reference
- time point (--RFTDTC) is populated.
+ Version: "1"
+Description: Time point reference (--TPTREF) should be populated when reference time point
+ (--RFTDTC) is populated.
Executability: Fully Executable
Outcome:
Message: --TPTREF value is missing when --RFTDTC is populated.
diff --git a/Published/CORE-000249/rule.yml b/Published/CORE-000249/rule.yml
index 47bfc6530..57e7ca13e 100644
--- a/Published/CORE-000249/rule.yml
+++ b/Published/CORE-000249/rule.yml
@@ -7,58 +7,59 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must
- be those defined in the Trial Visits (TV) dataset (Section
- 7.3.1, Trial Visits).
+ - Cited Guidance:
+ For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
+ defined in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits).
Document: IG v3.4
- Item: ''
+ Item: ""
Section: 4.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0032
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must
- be those defined in the Trial Visits dataset,
+ - Cited Guidance:
+ For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
+ defined in the Trial Visits dataset,
Document: IG v3.3
- Item: ''
+ Item: ""
Section: 4.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0032
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must
- be those defined in the Trial Visits dataset,
+ - Cited Guidance:
+ For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
+ defined in the Trial Visits dataset,
Document: IG v3.2
- Item: ''
+ Item: ""
Section: 4.1.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0032
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of
- VISITNUM for planned visits. Any values of VISITNUM that
- appear in subject-level datasets that are not in the TV
- dataset are assumed to correspond to unplanned visits. There
- will be a one-to-one relationship between values of VISIT and
- VISITNUM in TV. If a subject-level dataset includes both
- VISITNUM and VISIT, then records that include values of
- VISITNUM that appear in the TV dataset should also include the
- corresponding values of VISIT from the TV dataset.
+ - Cited Guidance:
+ The values of VISITNUM in the TV dataset are the valid values of VISITNUM
+ for planned visits. Any values of VISITNUM that appear in subject-level datasets that are
+ not in the TV dataset are assumed to correspond to unplanned visits. There will be a
+ one-to-one relationship between values of VISIT and VISITNUM in TV. If a subject-level
+ dataset includes both VISITNUM and VISIT, then records that include values of VISITNUM
+ that appear in the TV dataset should also include the corresponding values of VISIT from
+ the TV dataset.
Document: TIG 1.0
Item: 2.8.10.31 Assumption 6
Section: 2.8.7.5
@@ -69,10 +70,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0313
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: VISITDY
@@ -86,7 +87,7 @@ Check:
Core:
Id: CORE-000249
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify that visitdy is planned and exists in TV
Executability: Fully Executable
Match Datasets:
diff --git a/Published/CORE-000250/rule.yml b/Published/CORE-000250/rule.yml
index 22e4eaf7a..ecb9c12c8 100644
--- a/Published/CORE-000250/rule.yml
+++ b/Published/CORE-000250/rule.yml
@@ -7,243 +7,233 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Do not create separate domains based on time; rather, represent
- both prior and current observations in a domain (e.g., CM for
- all non-study medications). Note that Adverse Events and
- Medical History are an exception to this best practice because
- of regulatory reporting needs.
+ - Cited Guidance:
+ Do not create separate domains based on time; rather, represent both prior
+ and current observations in a domain (e.g., CM for all non-study medications). Note that
+ Adverse Events and Medical History are an exception to this best practice because of
+ regulatory reporting needs.
Document: SDTMIG v3.4
- Section: '2.6'
- - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events
- (CE), for example, are conceptually the same data, the only
- differences being when the event started relative to the study
- start and whether the event is considered a
- regulatory-reportable adverse event in the study.
+ Section: "2.6"
+ - Cited Guidance:
+ Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for
+ example, are conceptually the same data, the only differences being when the event started
+ relative to the study start and whether the event is considered a regulatory-reportable
+ adverse event in the study.
Document: SDTMIG v3.4
Item: 2.B.3.a
Section: 4.2.6
- - Cited Guidance: MH Description The medical history dataset includes the
- subject's prior history at the start of the trial.
+ - Cited Guidance:
+ MH Description The medical history dataset includes the subject's prior
+ history at the start of the trial.
Document: SDTMIG v3.4
- Section: '6.2'
- - Cited Guidance: Do not create separate domains based on time; rather, represent
- both prior and current observations in a domain (e.g., CM for
- all non-study medications). Note that AE and MH are an
- exception to this best practice because of regulatory
- reporting needs
+ Section: "6.2"
+ - Cited Guidance:
+ Do not create separate domains based on time; rather, represent both prior
+ and current observations in a domain (e.g., CM for all non-study medications). Note that
+ AE and MH are an exception to this best practice because of regulatory reporting needs
Document: SDTMIG v3.3
- Section: '2.6'
- - Cited Guidance: (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical
- History (MH), and Clinical Events (CE), for example, are
- conceptually the same data, the only differences being when
- the event started relative to the study start and whether the
- event is considered a regulatory reportable adverse event in
- the study.
+ Section: "2.6"
+ - Cited Guidance:
+ (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH), and
+ Clinical Events (CE), for example, are conceptually the same data, the only differences
+ being when the event started relative to the study start and whether the event is
+ considered a regulatory reportable adverse event in the study.
Document: SDTMIG v3.3
Item: 2.B.3.A
Section: 4.2.6
- - Cited Guidance: The medical history dataset includes the subject's prior history
- at the start of the trial.][MH The medical history dataset
- includes the subject's prior history at the start of the
- trial.
+ - Cited Guidance:
+ The medical history dataset includes the subject's prior history at the
+ start of the trial.][MH The medical history dataset includes the subject's prior history
+ at the start of the trial.
Document: SDTMIG v3.3
- Section: '6.2'
- - Cited Guidance: Do not create separate domains based on time, rather represent
- both prior and current observations in a domain (e.g., CM for
- all non-study medications). Note that AE and MH are an
- exception to this best practice because of regulatory
- reporting needs.
+ Section: "6.2"
+ - Cited Guidance:
+ Do not create separate domains based on time, rather represent both prior
+ and current observations in a domain (e.g., CM for all non-study medications). Note that
+ AE and MH are an exception to this best practice because of regulatory reporting needs.
Document: SDTMIG v3.2
- Section: '2.6'
- - Cited Guidance: Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History
- (MH) and Clinical Events (CE), for example, are conceptually
- the same data, the only differences being when the event
- started relative to the study start and whether the event is
+ Section: "2.6"
+ - Cited Guidance:
+ Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH) and
+ Clinical Events (CE), for example, are conceptually the same data, the only differences
+ being when the event started relative to the study start and whether the event is
considered a regulatory reportable adverse event in the study.
Document: SDTMIG v3.2
Item: Item 2.B.3.A (Discussion of --CAT/--SCAT)
Section: 4.1.2.6
- - Cited Guidance: The medical history dataset includes the subject's prior history
- at the start of the trial.][MH The medical history dataset
- includes the subject's prior history at the start of the
- trial.][Assumption 1:The Medical History dataset generally
- includes the subject's prior and concomitant conditions at the
- start of the trial.]
+ - Cited Guidance:
+ The medical history dataset includes the subject's prior history at the
+ start of the trial.][MH The medical history dataset includes the subject's prior history
+ at the start of the trial.][Assumption 1:The Medical History dataset generally includes
+ the subject's prior and concomitant conditions at the start of the trial.]
Document: SDTMIG v3.2
Item: Domain Code Table | Assumption 1
- Section: '6.2'
+ Section: "6.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0078
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Do not create separate domains based on time; rather, represent
- both prior and current observations in a domain (e.g., CM for
- all non-study medications). Note that Adverse Events and
- Medical History are an exception to this best practice because
- of regulatory reporting needs.
+ - Cited Guidance:
+ Do not create separate domains based on time; rather, represent both prior
+ and current observations in a domain (e.g., CM for all non-study medications). Note that
+ Adverse Events and Medical History are an exception to this best practice because of
+ regulatory reporting needs.
Document: SDTMIG v3.4
- Section: '2.6'
- - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events
- (CE), for example, are conceptually the same data, the only
- differences being when the event started relative to the study
- start and whether the event is considered a
- regulatory-reportable adverse event in the study.
+ Section: "2.6"
+ - Cited Guidance:
+ Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for
+ example, are conceptually the same data, the only differences being when the event started
+ relative to the study start and whether the event is considered a regulatory-reportable
+ adverse event in the study.
Document: SDTMIG v3.4
Item: 2.B.3.a
Section: 4.2.6
- - Cited Guidance: MH Description The medical history dataset includes the
- subject's prior history at the start of the trial.
+ - Cited Guidance:
+ MH Description The medical history dataset includes the subject's prior
+ history at the start of the trial.
Document: SDTMIG v3.4
- Section: '6.2'
- - Cited Guidance: Do not create separate domains based on time; rather, represent
- both prior and current observations in a domain (e.g., CM for
- all non-study medications). Note that AE and MH are an
- exception to this best practice because of regulatory
- reporting needs
+ Section: "6.2"
+ - Cited Guidance:
+ Do not create separate domains based on time; rather, represent both prior
+ and current observations in a domain (e.g., CM for all non-study medications). Note that
+ AE and MH are an exception to this best practice because of regulatory reporting needs
Document: SDTMIG v3.3
- Section: '2.6'
- - Cited Guidance: (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical
- History (MH), and Clinical Events (CE), for example, are
- conceptually the same data, the only differences being when
- the event started relative to the study start and whether the
- event is considered a regulatory reportable adverse event in
- the study.
+ Section: "2.6"
+ - Cited Guidance:
+ (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH), and
+ Clinical Events (CE), for example, are conceptually the same data, the only differences
+ being when the event started relative to the study start and whether the event is
+ considered a regulatory reportable adverse event in the study.
Document: SDTMIG v3.3
Item: 2.B.3.A
Section: 4.2.6
- - Cited Guidance: The medical history dataset includes the subject's prior history
- at the start of the trial.][MH The medical history dataset
- includes the subject's prior history at the start of the
- trial.
+ - Cited Guidance:
+ The medical history dataset includes the subject's prior history at the
+ start of the trial.][MH The medical history dataset includes the subject's prior history
+ at the start of the trial.
Document: SDTMIG v3.3
- Section: '6.2'
- - Cited Guidance: Do not create separate domains based on time, rather represent
- both prior and current observations in a domain (e.g., CM for
- all non-study medications). Note that AE and MH are an
- exception to this best practice because of regulatory
- reporting needs.
+ Section: "6.2"
+ - Cited Guidance:
+ Do not create separate domains based on time, rather represent both prior
+ and current observations in a domain (e.g., CM for all non-study medications). Note that
+ AE and MH are an exception to this best practice because of regulatory reporting needs.
Document: SDTMIG v3.2
- Section: '2.6'
- - Cited Guidance: Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History
- (MH) and Clinical Events (CE), for example, are conceptually
- the same data, the only differences being when the event
- started relative to the study start and whether the event is
+ Section: "2.6"
+ - Cited Guidance:
+ Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH) and
+ Clinical Events (CE), for example, are conceptually the same data, the only differences
+ being when the event started relative to the study start and whether the event is
considered a regulatory reportable adverse event in the study.
Document: SDTMIG v3.2
Item: Item 2.B.3.A (Discussion of --CAT/--SCAT)
Section: 4.1.2.6
- - Cited Guidance: The medical history dataset includes the subject's prior history
- at the start of the trial.][MH The medical history dataset
- includes the subject's prior history at the start of the
- trial.][Assumption 1:The Medical History dataset generally
- includes the subject's prior and concomitant conditions at the
- start of the trial.]
+ - Cited Guidance:
+ The medical history dataset includes the subject's prior history at the
+ start of the trial.][MH The medical history dataset includes the subject's prior history
+ at the start of the trial.][Assumption 1:The Medical History dataset generally includes
+ the subject's prior and concomitant conditions at the start of the trial.]
Document: SDTMIG v3.2
Item: Domain Code Table | Assumption 1
- Section: '6.2'
+ Section: "6.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0078
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Do not create separate domains based on time; rather, represent
- both prior and current observations in a domain (e.g., CM for
- all non-study medications). Note that Adverse Events and
- Medical History are an exception to this best practice because
- of regulatory reporting needs.
+ - Cited Guidance:
+ Do not create separate domains based on time; rather, represent both prior
+ and current observations in a domain (e.g., CM for all non-study medications). Note that
+ Adverse Events and Medical History are an exception to this best practice because of
+ regulatory reporting needs.
Document: SDTMIG v3.4
- Section: '2.6'
- - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events
- (CE), for example, are conceptually the same data, the only
- differences being when the event started relative to the study
- start and whether the event is considered a
- regulatory-reportable adverse event in the study.
+ Section: "2.6"
+ - Cited Guidance:
+ Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for
+ example, are conceptually the same data, the only differences being when the event started
+ relative to the study start and whether the event is considered a regulatory-reportable
+ adverse event in the study.
Document: SDTMIG v3.4
Item: 2.B.3.a
Section: 4.2.6
- - Cited Guidance: MH Description The medical history dataset includes the
- subject's prior history at the start of the trial.
+ - Cited Guidance:
+ MH Description The medical history dataset includes the subject's prior
+ history at the start of the trial.
Document: SDTMIG v3.4
- Section: '6.2'
- - Cited Guidance: Do not create separate domains based on time; rather, represent
- both prior and current observations in a domain (e.g., CM for
- all non-study medications). Note that AE and MH are an
- exception to this best practice because of regulatory
- reporting needs
+ Section: "6.2"
+ - Cited Guidance:
+ Do not create separate domains based on time; rather, represent both prior
+ and current observations in a domain (e.g., CM for all non-study medications). Note that
+ AE and MH are an exception to this best practice because of regulatory reporting needs
Document: SDTMIG v3.3
- Section: '2.6'
- - Cited Guidance: (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical
- History (MH), and Clinical Events (CE), for example, are
- conceptually the same data, the only differences being when
- the event started relative to the study start and whether the
- event is considered a regulatory reportable adverse event in
- the study.
+ Section: "2.6"
+ - Cited Guidance:
+ (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH), and
+ Clinical Events (CE), for example, are conceptually the same data, the only differences
+ being when the event started relative to the study start and whether the event is
+ considered a regulatory reportable adverse event in the study.
Document: SDTMIG v3.3
Item: 2.B.3.A
Section: 4.2.6
- - Cited Guidance: The medical history dataset includes the subject's prior history
- at the start of the trial.][MH The medical history dataset
- includes the subject's prior history at the start of the
- trial.
+ - Cited Guidance:
+ The medical history dataset includes the subject's prior history at the
+ start of the trial.][MH The medical history dataset includes the subject's prior history
+ at the start of the trial.
Document: SDTMIG v3.3
- Section: '6.2'
- - Cited Guidance: Do not create separate domains based on time, rather represent
- both prior and current observations in a domain (e.g., CM for
- all non-study medications). Note that AE and MH are an
- exception to this best practice because of regulatory
- reporting needs.
+ Section: "6.2"
+ - Cited Guidance:
+ Do not create separate domains based on time, rather represent both prior
+ and current observations in a domain (e.g., CM for all non-study medications). Note that
+ AE and MH are an exception to this best practice because of regulatory reporting needs.
Document: SDTMIG v3.2
- Section: '2.6'
- - Cited Guidance: Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History
- (MH) and Clinical Events (CE), for example, are conceptually
- the same data, the only differences being when the event
- started relative to the study start and whether the event is
+ Section: "2.6"
+ - Cited Guidance:
+ Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH) and
+ Clinical Events (CE), for example, are conceptually the same data, the only differences
+ being when the event started relative to the study start and whether the event is
considered a regulatory reportable adverse event in the study.
Document: SDTMIG v3.2
Item: Item 2.B.3.A (Discussion of --CAT/--SCAT)
Section: 4.1.2.6
- - Cited Guidance: The medical history dataset includes the subject's prior history
- at the start of the trial.][MH The medical history dataset
- includes the subject's prior history at the start of the
- trial.][Assumption 1:The Medical History dataset generally
- includes the subject's prior and concomitant conditions at the
- start of the trial.]
+ - Cited Guidance:
+ The medical history dataset includes the subject's prior history at the
+ start of the trial.][MH The medical history dataset includes the subject's prior history
+ at the start of the trial.][Assumption 1:The Medical History dataset generally includes
+ the subject's prior and concomitant conditions at the start of the trial.]
Document: SDTMIG v3.2
Item: Domain Code Table | Assumption 1
- Section: '6.2'
+ Section: "6.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0078
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Custom domains will be used to represent logically related
- observations based on the scientific subject matter of the
- data and will not be created based on:The timing of collected
- observations (e.g., all vital signs measurements will be
- represented in domain Vital Signs (VS) irrespective of when
- measurements occurred).
+ - Cited Guidance:
+ Custom domains will be used to represent logically related observations
+ based on the scientific subject matter of the data and will not be created based on:The
+ timing of collected observations (e.g., all vital signs measurements will be represented
+ in domain Vital Signs (VS) irrespective of when measurements occurred).
Document: TIG 1.0
Section: 2.8.3
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0344
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: MHENDTC
@@ -254,7 +244,7 @@ Check:
Core:
Id: CORE-000250
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an issue if MHENDTC has a non-empty date that is on or after DM.RFSTDTC
Executability: Fully Executable
Match Datasets:
@@ -262,9 +252,8 @@ Match Datasets:
- USUBJID
Name: DM
Outcome:
- Message: MHENDTC ^= null and MHENDTC is on or after the DM.RFSTDTC. The medical
- history dataset should include the subject's prior history at the start of
- the trial.
+ Message: MHENDTC ^= null and MHENDTC is on or after the DM.RFSTDTC. The medical history dataset
+ should include the subject's prior history at the start of the trial.
Output Variables:
- MHENDTC
- RFSTDTC
diff --git a/Published/CORE-000252/rule.yml b/Published/CORE-000252/rule.yml
index 817848ba9..9e7a02f62 100644
--- a/Published/CORE-000252/rule.yml
+++ b/Published/CORE-000252/rule.yml
@@ -7,102 +7,110 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Indicates the subject died. Should be Y or null. Should be
- populated even when the death date is unknown.
+ - Cited Guidance:
+ Indicates the subject died. Should be Y or null. Should be populated even
+ when the death date is unknown.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0136
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Indicates the subject died. Should be Y or null. Should be
- populated even when the death date is unknown.
+ - Cited Guidance:
+ Indicates the subject died. Should be Y or null. Should be populated even
+ when the death date is unknown.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0136
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Indicates the subject died. Should be Y or null. Should be
- populated even when the death date is unknown.
+ - Cited Guidance:
+ Indicates the subject died. Should be Y or null. Should be populated even
+ when the death date is unknown.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0136
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be
- populated even when the death date is unknown.
+ - Cited Guidance:
+ Indicates the subject died. Should be "Y" or null. Should be populated even
+ when the death date is unknown.
Document: TIG 1.0
Item: Specification
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0385
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
- #CG0136 is identical to rule FB0605. Added metadata for FB0605 by Malini Narreddy on 2025-03-05
+ Version:
+ "1.0"
+ #CG0136 is identical to rule FB0605. Added metadata for FB0605 by Malini Narreddy on 2025-03-05
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0605
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0605
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0605
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: DSDECOD
@@ -116,10 +124,9 @@ Check:
Core:
Id: CORE-000252
Status: Published
- Version: '1'
-Description: When a record is present in the DS dataset where DSDECOD = 'DEATH'
- then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the
- corresponding subject.
+ Version: "1"
+Description: When a record is present in the DS dataset where DSDECOD = 'DEATH' then death flag
+ (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject.
Executability: Fully Executable
Match Datasets:
- Keys:
diff --git a/Published/CORE-000253/rule.yml b/Published/CORE-000253/rule.yml
index b9b095076..03d816da1 100644
--- a/Published/CORE-000253/rule.yml
+++ b/Published/CORE-000253/rule.yml
@@ -7,102 +7,110 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Indicates the subject died. Should be Y or null. Should be
- populated even when the death date is unknown.
+ - Cited Guidance:
+ Indicates the subject died. Should be Y or null. Should be populated even
+ when the death date is unknown.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0135
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Indicates the subject died. Should be Y or null. Should be
- populated even when the death date is unknown.
+ - Cited Guidance:
+ Indicates the subject died. Should be Y or null. Should be populated even
+ when the death date is unknown.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0135
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Indicates the subject died. Should be Y or null. Should be
- populated even when the death date is unknown.
+ - Cited Guidance:
+ Indicates the subject died. Should be Y or null. Should be populated even
+ when the death date is unknown.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0135
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be
- populated even when the death date is unknown.
+ - Cited Guidance:
+ Indicates the subject died. Should be "Y" or null. Should be populated even
+ when the death date is unknown.
Document: TIG 1.0
Item: Specification
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0384
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
- #CG0135 is identical to rule FB0604. Added metadata for FB0604 by Malini Narreddy on 2025-03-05
+ Version:
+ "1.0"
+ #CG0135 is identical to rule FB0604. Added metadata for FB0604 by Malini Narreddy on 2025-03-05
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0604
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0604
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0604
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: AESDTH
@@ -116,10 +124,9 @@ Check:
Core:
Id: CORE-000253
Status: Published
- Version: '1'
-Description: When a record is present in the AE dataset where AESDTH = 'Y' then
- death flag (DTHFL) should be populated as 'Y' in the DM dataset for the
- corresponding subject.
+ Version: "1"
+Description: When a record is present in the AE dataset where AESDTH = 'Y' then death flag (DTHFL)
+ should be populated as 'Y' in the DM dataset for the corresponding subject.
Executability: Fully Executable
Match Datasets:
- Keys:
diff --git a/Published/CORE-000254/rule.yml b/Published/CORE-000254/rule.yml
index 1f16c9aa1..0fe4d8adb 100644
--- a/Published/CORE-000254/rule.yml
+++ b/Published/CORE-000254/rule.yml
@@ -7,102 +7,110 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Indicates the subject died. Should be Y or null. Should be
- populated even when the death date is unknown.
+ - Cited Guidance:
+ Indicates the subject died. Should be Y or null. Should be populated even
+ when the death date is unknown.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0134
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Indicates the subject died. Should be Y or null. Should be
- populated even when the death date is unknown.
+ - Cited Guidance:
+ Indicates the subject died. Should be Y or null. Should be populated even
+ when the death date is unknown.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0134
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Indicates the subject died. Should be Y or null. Should be
- populated even when the death date is unknown.
+ - Cited Guidance:
+ Indicates the subject died. Should be Y or null. Should be populated even
+ when the death date is unknown.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0134
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be
- populated even when the death date is unknown.
+ - Cited Guidance:
+ Indicates the subject died. Should be "Y" or null. Should be populated even
+ when the death date is unknown.
Document: TIG 1.0
Item: Specification
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0383
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
- #CG0134 is identical to rule FB0603. Added metadata for FB0603 by Malini Narreddy on 2025-03-05
+ Version:
+ "1.0"
+ #CG0134 is identical to rule FB0603. Added metadata for FB0603 by Malini Narreddy on 2025-03-05
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0603
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0603
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All death information should be populated for subjects that died
- during the study including any post treatment follow-up.
+ - Cited Guidance:
+ All death information should be populated for subjects that died during the
+ study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0603
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: AEOUT
@@ -116,10 +124,9 @@ Check:
Core:
Id: CORE-000254
Status: Published
- Version: '1'
-Description: When a record is present in the AE dataset where AEOUT = 'FATAL'
- then death flag (DTHFL) should be populated as 'Y' in the DM dataset for
- the corresponding subject.
+ Version: "1"
+Description: When a record is present in the AE dataset where AEOUT = 'FATAL' then death flag
+ (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject.
Executability: Fully Executable
Match Datasets:
- Keys:
diff --git a/Published/CORE-000255/rule.yml b/Published/CORE-000255/rule.yml
index dc6150063..d7b08bd26 100644
--- a/Published/CORE-000255/rule.yml
+++ b/Published/CORE-000255/rule.yml
@@ -4,81 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: --ORRES is an Expected variable and should always be populated
- except when --STAT = 'NOT DONE'
+ - Cited Guidance:
+ --ORRES is an Expected variable and should always be populated except when
+ --STAT = 'NOT DONE'
Document: IG v3.0
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND85.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: --ORRES is an Expected variable and should always be populated
- except when --STAT = 'NOT DONE'
+ - Cited Guidance:
+ --ORRES is an Expected variable and should always be populated except when
+ --STAT = 'NOT DONE'
Document: IG v3.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND85.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: --ORRES is an Expected variable and should always be populated
- except when --STAT = 'NOT DONE'
+ - Cited Guidance:
+ --ORRES is an Expected variable and should always be populated except when
+ --STAT = 'NOT DONE'
Document: IG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND85.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: --ORRES is an Expected variable and should always be populated
- except when --STAT = 'NOT DONE'
+ - Cited Guidance:
+ --ORRES is an Expected variable and should always be populated except when
+ --STAT = 'NOT DONE'
Document: IG v3.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND85.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: --ORRES is an Expected variable and should always be populated
- except when --STAT = 'NOT DONE'
+ - Cited Guidance:
+ --ORRES is an Expected variable and should always be populated except when
+ --STAT = 'NOT DONE'
Document: IG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND85.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: --ORRES is an Expected variable and should always be populated
- except when --STAT = 'NOT DONE'
+ - Cited Guidance:
+ --ORRES is an Expected variable and should always be populated except when
+ --STAT = 'NOT DONE'
Document: IG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND85.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: --STAT
@@ -89,9 +95,9 @@ Check:
Core:
Id: CORE-000255
Status: Published
- Version: '1'
-Description: There should always be data presented in the --ORRES variable
- unless --STAT = "NOT DONE".
+ Version: "1"
+Description: There should always be data presented in the --ORRES variable unless --STAT = "NOT
+ DONE".
Executability: Fully Executable
Outcome:
Message: --ORRES must be populated as --STAT is not equal to 'NOT DONE'
diff --git a/Published/CORE-000256/rule.yml b/Published/CORE-000256/rule.yml
index 940346524..150caf9f2 100644
--- a/Published/CORE-000256/rule.yml
+++ b/Published/CORE-000256/rule.yml
@@ -7,183 +7,186 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If the sponsor decides that the subject's experience for a
- particular\ \ period of time cannot be represented with one of
- the planned Elements, then\ \ that period of time should be
- represented as an unplanned Element. The value\ \ of ETCD for
- an unplanned Element is "UNPLAN" and SEUPDES should\ \ be
- populated with a description of the unplanned Element.
+ - Cited Guidance:
+ If the sponsor decides that the subject's experience for a particular\ \
+ period of time cannot be represented with one of the planned Elements, then\ \ that period
+ of time should be represented as an unplanned Element. The value\ \ of ETCD for an
+ unplanned Element is "UNPLAN" and SEUPDES should\ \ be populated with a description of the
+ unplanned Element.
Document: IG v3.4
Item: Assumption 4
- Section: '5.3'
+ Section: "5.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0210
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If the sponsor decides that the subject's experience for a
- particular period of time cannot be represented with one of
- the planned Elements, then that period of time should be
- represented as an unplanned Element. The value of ETCD for an
- unplanned Element is "UNPLAN" and SEUPDES should be populated
- with a description of the unplanned Element only if ETCD has
- the value of "UNPLAN".
+ - Cited Guidance:
+ If the sponsor decides that the subject's experience for a particular period
+ of time cannot be represented with one of the planned Elements, then that period of time
+ should be represented as an unplanned Element. The value of ETCD for an unplanned Element
+ is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element
+ only if ETCD has the value of "UNPLAN".
Document: IG v3.2
Item: Assumption 6
Section: 5 SE
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0210
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If the sponsor decides that the subject's experience for a
- particular period of time cannot be represented with one of
- the planned Elements, then that period of time should be
- represented as an unplanned Element. The value of ETCD for an
- unplanned Element is "UNPLAN" and SEUPDES should be populated
- with a description of the unplanned Element only if ETCD has
- the value of "UNPLAN".
+ - Cited Guidance:
+ If the sponsor decides that the subject's experience for a particular period
+ of time cannot be represented with one of the planned Elements, then that period of time
+ should be represented as an unplanned Element. The value of ETCD for an unplanned Element
+ is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element
+ only if ETCD has the value of "UNPLAN".
Document: IG v3.3
Item: Assumption 4
- Section: '5.3'
+ Section: "5.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0210
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If the applicant decides that the subject's experience for a
- particular period of time cannot be represented with one of
- the planned elements, then that period of time should be
- represented as an unplanned element. The value of ETCD for an
- unplanned element is “UNPLAN” and SEUPDES should be populated
- with a description of the unplanned element.
+ - Cited Guidance:
+ If the applicant decides that the subject's experience for a particular
+ period of time cannot be represented with one of the planned elements, then that period of
+ time should be represented as an unplanned element. The value of ETCD for an unplanned
+ element is “UNPLAN” and SEUPDES should be populated with a description of the unplanned
+ element.
Document: TIG v1.0
Item: Assumption 3
Section: 2.8.10.24
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0429
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Description of what happened to the subject during this
- unplanned Element.
+ - Cited Guidance: Description of what happened to the subject during this unplanned Element.
Document: SENDIG v3.0
Item: Specification
Section: 5.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND125.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN',
- ELEMENT should be left blank, and SEUPDES should be populated
- with a description of the unplanned Element.
+ - Cited Guidance:
+ For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT
+ should be left blank, and SEUPDES should be populated with a description of the unplanned
+ Element.
Document: SENDIG v3.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND125.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN',
- ELEMENT should be left blank, and SEUPDES should be populated
- with a description of the unplanned Element.
+ - Cited Guidance:
+ For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT
+ should be left blank, and SEUPDES should be populated with a description of the unplanned
+ Element.
Document: SENDIG v3.1.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND125.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN',
- ELEMENT should be left blank, and SEUPDES should be populated
- with a description of the unplanned Element.
+ - Cited Guidance:
+ For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT
+ should be left blank, and SEUPDES should be populated with a description of the unplanned
+ Element.
Document: SENDIG v3.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND125.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN',
- ELEMENT should be left blank, and SEUPDES should be populated
- with a description of the unplanned Element.
+ - Cited Guidance:
+ For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT
+ should be left blank, and SEUPDES should be populated with a description of the unplanned
+ Element.
Document: SENDIG v3.1.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND125.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN',
- ELEMENT should be left blank, and SEUPDES should be populated
- with a description of the unplanned Element.
+ - Cited Guidance:
+ For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT
+ should be left blank, and SEUPDES should be populated with a description of the unplanned
+ Element.
Document: SENDIG v3.1.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND125.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: For unplanned Elements, ETCD should be populated with “UNPLAN”,
- ELEMENT should be left blank, and SEUPDES should be populated
- with a description of the unplanned Element.
+ - Cited Guidance:
+ For unplanned Elements, ETCD should be populated with “UNPLAN”, ELEMENT
+ should be left blank, and SEUPDES should be populated with a description of the unplanned
+ Element.
Document: TIG v1.0
Item: Assumption 5
Section: 2.8.9.26
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0062
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SEUPDES
@@ -194,7 +197,7 @@ Check:
Core:
Id: CORE-000256
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when ETCD = 'UNPLAN', SEUPDES = null
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000257/rule.yml b/Published/CORE-000257/rule.yml
index 5013d652c..aa25d73d2 100644
--- a/Published/CORE-000257/rule.yml
+++ b/Published/CORE-000257/rule.yml
@@ -7,209 +7,212 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The description or date and/or time of a time point that acts as
- a fixed reference for characterizing the start of an
- observation. This is the sponsor-defined reference point
- referred to by --STRTPT.
+ - Cited Guidance:
+ The description or date and/or time of a time point that acts as a fixed
+ reference for characterizing the start of an observation. This is the sponsor-defined
+ reference point referred to by --STRTPT.
Document: Model v2.0
Item: --STTPT
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0061
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Description or date/time in ISO 8601 or other character format
- of the sponsor-defined reference point referred to by
- --STRTPT. Examples; "2003-12-15" or "VISIT 1".
+ - Cited Guidance:
+ Description or date/time in ISO 8601 or other character format of the
+ sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or "VISIT
+ 1".
Document: Model v1.7
Item: Table 2.2.5.1 --STTPT
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0061
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: (--STTPT) Description or date/time in ISO 8601 or other
- character format of the sponsor-defined reference point
- referred to by --STRTPT. Examples; "2003-12-15" or "VISIT 1".
+ - Cited Guidance:
+ (--STTPT) Description or date/time in ISO 8601 or other character format of
+ the sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or
+ "VISIT 1".
Document: Model v1.4
Item: Specification
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0061
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The description or date and/or time of a time point that acts as
- a fixed reference for characterizing the start of an
- observation. This is the sponsor-defined reference point
- referred to by --STRTPT.
+ - Cited Guidance:
+ The description or date and/or time of a time point that acts as a fixed
+ reference for characterizing the start of an observation. This is the sponsor-defined
+ reference point referred to by --STRTPT.
Document: SDTM v2.1
Item: --STTPT
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0335
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
- # FDA rule FB4401 is identical - added Jozef 2024-12-19
- - Organization: 'FDA'
+ Version:
+ "1.0"
+ # FDA rule FB4401 is identical - added Jozef 2024-12-19
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the
- time point established by --STTPT to characterize the start of
- an observation'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established
+ by --STTPT to characterize the start of an observation"
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4401'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB4401"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the
- time point established by --STTPT to characterize the start of
- an observation'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established
+ by --STTPT to characterize the start of an observation"
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4401'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB4401"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the
- time point established by --STTPT to characterize the start of
- an observation'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established
+ by --STTPT to characterize the start of an observation"
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4401'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB4401"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the
- time point established by --STTPT to characterize the start of
- an observation'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established
+ by --STTPT to characterize the start of an observation"
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4401'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB4401"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the
- time point established by --STTPT to characterize the start of
- an observation'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established
+ by --STTPT to characterize the start of an observation"
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4401'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB4401"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the
- time point established by --STTPT to characterize the start of
- an observation'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established
+ by --STTPT to characterize the start of an observation"
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4401'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4401"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the
- time point established by --STTPT to characterize the start of
- an observation'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established
+ by --STTPT to characterize the start of an observation"
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4401'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4401"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the
- time point established by --STTPT to characterize the start of
- an observation'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established
+ by --STTPT to characterize the start of an observation"
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4401'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB4401"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the
- time point established by --STTPT to characterize the start of
- an observation'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established
+ by --STTPT to characterize the start of an observation"
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4401'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB4401"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the
- time point established by --STTPT to characterize the start of
- an observation'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established
+ by --STTPT to characterize the start of an observation"
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4401'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB4401"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --STRTPT
@@ -219,8 +222,10 @@ Check:
Core:
Id: CORE-000257
Status: Published
- Version: '1'
-Description: 'When Start Relative to Reference Time Point (--STRTPT) is populated, Start Reference Time Point (--STTPT) should also be populated.'
+ Version: "1"
+Description:
+ "When Start Relative to Reference Time Point (--STRTPT) is populated, Start Reference Time
+ Point (--STTPT) should also be populated."
Executability: Fully Executable
Outcome:
Message: --STRTPT is populated, but --STTPT is missing.
diff --git a/Published/CORE-000258/rule.yml b/Published/CORE-000258/rule.yml
index a1742a28d..974b65693 100644
--- a/Published/CORE-000258/rule.yml
+++ b/Published/CORE-000258/rule.yml
@@ -7,66 +7,68 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The description or date and/or time of a time point that acts as
- a fixed reference for characterizing the start of an
- observation. This is the sponsor-defined reference point
- referred to by --STRTPT.
+ - Cited Guidance:
+ The description or date and/or time of a time point that acts as a fixed
+ reference for characterizing the start of an observation. This is the sponsor-defined
+ reference point referred to by --STRTPT.
Document: Model v2.0
Item: --STTPT
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0062
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Description or date/time in ISO 8601 or other character format
- of the sponsor-defined reference point referred to by
- --STRTPT. Examples; "2003-12-15" or "VISIT 1".
+ - Cited Guidance:
+ Description or date/time in ISO 8601 or other character format of the
+ sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or "VISIT
+ 1".
Document: Model v1.7
Item: Table 2.2.5.1 --STTPT
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0062
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: (--STTPT) Description or date/time in ISO 8601 or other
- character format of the sponsor-defined reference point
- referred to by --STRTPT. Examples; "2003-12-15" or "VISIT 1".
+ - Cited Guidance:
+ (--STTPT) Description or date/time in ISO 8601 or other character format of
+ the sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or
+ "VISIT 1".
Document: Model v1.4
Item: Specification
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0062
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The description or date and/or time of a time point that acts as
- a fixed reference for characterizing the start of an
- observation. This is the sponsor-defined reference point
- referred to by --STRTPT.
+ - Cited Guidance:
+ The description or date and/or time of a time point that acts as a fixed
+ reference for characterizing the start of an observation. This is the sponsor-defined
+ reference point referred to by --STRTPT.
Document: SDTM v2.1
Item: --STTPT
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0336
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --STRTPT
@@ -76,9 +78,9 @@ Check:
Core:
Id: CORE-000258
Status: Published
- Version: '1'
-Description: Raise an error when --STRTPT is present in dataset and --STTPT is
- not present in dataset.
+ Version: "1"
+Description: Raise an error when --STRTPT is present in dataset and --STTPT is not present in
+ dataset.
Executability: Fully Executable
Outcome:
Message: --STRTPT is present in dataset, but --STTPT is not present in dataset.
diff --git a/Published/CORE-000260/rule.yml b/Published/CORE-000260/rule.yml
index 439f4a0a0..49e5ac3d4 100644
--- a/Published/CORE-000260/rule.yml
+++ b/Published/CORE-000260/rule.yml
@@ -1,5 +1,5 @@
# Variable: --PRESP
-# Condition:
+# Condition:
# Rule: --PRESP in ('Y', null)
Authorities:
- Organization: CDISC
@@ -7,53 +7,54 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Events[--PRESP][Value is "Y" for prespecified events, null for
- spontaneously reported events.] Interventions[--PRESP][Values
- should be "Y" or null.]
+ - Cited Guidance:
+ Events[--PRESP][Value is "Y" for prespecified events, null for spontaneously
+ reported events.] Interventions[--PRESP][Values should be "Y" or null.]
Document: Model v2.0
Item: --PRESP
Section: Events|Interventions
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0085
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Model v1.7[2.2.1 (Interventions )][--PRESP; Values should be "Y"
- or null.] | Model v1.7[2.2.2 (Events)][--PRESP; Values should
- be "Y" or null.]
+ - Cited Guidance:
+ Model v1.7[2.2.1 (Interventions )][--PRESP; Values should be "Y" or null.] |
+ Model v1.7[2.2.2 (Events)][--PRESP; Values should be "Y" or null.]
Document: Model v1.7
- Item: ''
+ Item: ""
Section: Model v1.7[2.2.1 (Interventions)]|Model v1.7[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0085
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Model v1.4[2.2.1 (Interventions )][--PRESP; Values should be "Y"
- or null.] |Model v1.4[2.2.2 (Events)][--PRESP; Values should
- be "Y" or null.]
+ - Cited Guidance:
+ Model v1.4[2.2.1 (Interventions )][--PRESP; Values should be "Y" or null.]
+ |Model v1.4[2.2.2 (Events)][--PRESP; Values should be "Y" or null.]
Document: Model v1.4
- Item: ''
+ Item: ""
Section: Model v1.4[2.2.1 (Interventions)]|Model v1.4[2.2.2 (Events)]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0085
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Events[--PRESP][Value is "Y" for prespecified events, null for
- spontaneously reported events.]
+ - Cited Guidance:
+ Events[--PRESP][Value is "Y" for prespecified events, null for spontaneously
+ reported events.]
Document: SDTM v2.1
Item: --PRESP
Section: Section 3.1.2 The Events Observation Class
@@ -64,10 +65,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0350
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --PRESP
@@ -79,7 +80,7 @@ Check:
Core:
Id: CORE-000260
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --PRESP does not equal 'Y' or is not empty.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000261/rule.yml b/Published/CORE-000261/rule.yml
index 2f3ddbf9c..800329184 100644
--- a/Published/CORE-000261/rule.yml
+++ b/Published/CORE-000261/rule.yml
@@ -7,64 +7,63 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The characterization of the start of an observation relative to
- a reference time point. The sponsor-defined reference time
- point is in --STTPT.
+ - Cited Guidance:
+ The characterization of the start of an observation relative to a reference
+ time point. The sponsor-defined reference time point is in --STTPT.
Document: Model v2.0
Item: --STRTPT
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0060
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the start of the observation as being before or after
- the sponsor-defined reference time point defined by variable
- --STTPT.
+ - Cited Guidance: Identifies the start of the observation as being before or after the
+ sponsor-defined reference time point defined by variable --STTPT.
Document: Model v1.7
Item: Table 2.2.5.1 --STRTPT
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0060
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: (--STRTPT) Identifies the start of the observation as being
- before or after the sponsor-defined reference time point
- defined by variable --STTPT.
+ - Cited Guidance:
+ (--STRTPT) Identifies the start of the observation as being before or after
+ the sponsor-defined reference time point defined by variable --STTPT.
Document: Model v1.4
Item: Specification
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0060
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The characterization of the start of an observation relative to
- a reference time point. The sponsor-defined reference time
- point is in --STTPT.
+ - Cited Guidance:
+ The characterization of the start of an observation relative to a reference
+ time point. The sponsor-defined reference time point is in --STTPT.
Document: SDTM v2.1
Item: --STRTPT
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0334
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --STTPT
@@ -74,9 +73,9 @@ Check:
Core:
Id: CORE-000261
Status: Published
- Version: '1'
-Description: Raise an error when --STTPT is present in dataset and --STRTPT is
- not present in dataset.
+ Version: "1"
+Description: Raise an error when --STTPT is present in dataset and --STRTPT is not present in
+ dataset.
Executability: Fully Executable
Outcome:
Message: --STTPT is present in dataset, but --STRTPT is not present in dataset.
diff --git a/Published/CORE-000262/rule.yml b/Published/CORE-000262/rule.yml
index 86f4d386d..e51b19711 100644
--- a/Published/CORE-000262/rule.yml
+++ b/Published/CORE-000262/rule.yml
@@ -7,73 +7,71 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The characterization of the start of an observation relative to
- the study reference period. The sponsor-defined reference
- period is a continuous period of time defined by a discrete
- starting point and a discrete ending point represented by
- RFSTDTC and RFENDTC in Demographics.
+ - Cited Guidance:
+ The characterization of the start of an observation relative to the study
+ reference period. The sponsor-defined reference period is a continuous period of time
+ defined by a discrete starting point and a discrete ending point represented by RFSTDTC
+ and RFENDTC in Demographics.
Document: Model 2.0
Item: --STRF
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0226
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the start of the observation as being before, during,
- or after the sponsor-defined reference period.The
- sponsor-defined reference period is a continuous period of
- time defined by a discrete starting point and a discrete
- ending point represented by RFSTDTC and RFENDTC in
- Demographics.
+ - Cited Guidance:
+ Identifies the start of the observation as being before, during, or after
+ the sponsor-defined reference period.The sponsor-defined reference period is a continuous
+ period of time defined by a discrete starting point and a discrete ending point
+ represented by RFSTDTC and RFENDTC in Demographics.
Document: Model 1.7
- Item: 'Table 2.2.5.1: --STRF'
+ Item: "Table 2.2.5.1: --STRF"
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0226
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the start of the observation as being before, during,
- or after the sponsor-defined reference period. The
- sponsor-defined reference period is a continuous period of
- time defined by a discrete starting point and a discrete
- ending point represented by RFSTDTC and RFENDTC in
- Demographics.
+ - Cited Guidance:
+ Identifies the start of the observation as being before, during, or after
+ the sponsor-defined reference period. The sponsor-defined reference period is a continuous
+ period of time defined by a discrete starting point and a discrete ending point
+ represented by RFSTDTC and RFENDTC in Demographics.
Document: Model 1.4
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0226
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The characterization of the start of an observation relative to
- the study reference period. The sponsor-defined reference
- period is a continuous period of time defined by a discrete
- starting point and a discrete ending point represented by
- RFSTDTC and RFENDTC in Demographics.
+ - Cited Guidance:
+ The characterization of the start of an observation relative to the study
+ reference period. The sponsor-defined reference period is a continuous period of time
+ defined by a discrete starting point and a discrete ending point represented by RFSTDTC
+ and RFENDTC in Demographics.
Document: SDTM v2.1
Item: --STRF
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0439
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: RFSTDTC
@@ -83,7 +81,7 @@ Check:
Core:
Id: CORE-000262
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when RFSTDTC in DM is empty and --STRF is not empty.
Executability: Fully Executable
Match Datasets:
diff --git a/Published/CORE-000265/rule.yml b/Published/CORE-000265/rule.yml
index 23a264d10..4e4b0332b 100644
--- a/Published/CORE-000265/rule.yml
+++ b/Published/CORE-000265/rule.yml
@@ -7,207 +7,207 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The characterization of the end of an observation relative to a
- reference time point. The sponsor-defined reference time
- point is in --ENTPT.
+ - Cited Guidance:
+ The characterization of the end of an observation relative to a reference
+ time point. The sponsor-defined reference time point is in --ENTPT.
Document: Model v2.0
Item: --ENRTPT
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0046
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifies the end of the observation as being before or after
- the sponsor-defined reference time point defined by variable
- --ENTPT.
+ - Cited Guidance: Identifies the end of the observation as being before or after the
+ sponsor-defined reference time point defined by variable --ENTPT.
Document: Model v1.7
Item: Table 2.2.5.1 --ENTPT
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0046
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: (--ENRTPT) Identifies the end of the observation as being before
- or after the sponsor-defined reference time point defined by
- variable --ENTPT.
+ - Cited Guidance:
+ (--ENRTPT) Identifies the end of the observation as being before or after
+ the sponsor-defined reference time point defined by variable --ENTPT.
Document: Model v1.4
Item: Specification
Section: 2.2.5 Timing Variables for All Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0046
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The characterization of the end of an observation relative to a
- reference time point. The sponsor-defined reference time point
- is in --ENTPT.
+ - Cited Guidance:
+ The characterization of the end of an observation relative to a reference
+ time point. The sponsor-defined reference time point is in --ENTPT.
Document: SDTM v2.1
Item: --ENRTPT
Section: Section 3.1.5 Timing Variables for All Classes
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0325
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
- # CG0046 is identical to rule FB4402. Added metadata for FB4402 Jozef Aerts 2024-12-19
- - Organization: 'FDA'
+ Version:
+ "1.0"
+ # CG0046 is identical to rule FB4402. Added metadata for FB4402 Jozef Aerts 2024-12-19
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the
- time point established by --ENTPT to characterize the start of
- an observation.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established
+ by --ENTPT to characterize the start of an observation."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4402'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB4402"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the
- time point established by --ENTPT to characterize the start of
- an observation.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established
+ by --ENTPT to characterize the start of an observation."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4402'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB4402"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the
- time point established by --ENTPT to characterize the start of
- an observation.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established
+ by --ENTPT to characterize the start of an observation."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4402'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB4402"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the
- time point established by --ENTPT to characterize the start of
- an observation.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established
+ by --ENTPT to characterize the start of an observation."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4402'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB4402"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the
- time point established by --ENTPT to characterize the start of
- an observation.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established
+ by --ENTPT to characterize the start of an observation."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4402'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB4402"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the
- time point established by --ENTPT to characterize the start of
- an observation.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established
+ by --ENTPT to characterize the start of an observation."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4402'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4402"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the
- time point established by --ENTPT to characterize the start of
- an observation.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established
+ by --ENTPT to characterize the start of an observation."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4402'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4402"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the
- time point established by --ENTPT to characterize the start of
- an observation.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established
+ by --ENTPT to characterize the start of an observation."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4402'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB4402"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the
- time point established by --ENTPT to characterize the start of
- an observation.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established
+ by --ENTPT to characterize the start of an observation."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4402'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB4402"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the
- time point established by --ENTPT to characterize the start of
- an observation.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established
+ by --ENTPT to characterize the start of an observation."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4402'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB4402"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --ENRTPT
@@ -217,8 +217,10 @@ Check:
Core:
Id: CORE-000265
Status: Published
- Version: '1'
-Description: 'When End Relative to Reference Time Point (--ENRTPT) is populated, End Reference Time Point (--ENTPT) should also be populated.'
+ Version: "1"
+Description:
+ "When End Relative to Reference Time Point (--ENRTPT) is populated, End Reference Time Point
+ (--ENTPT) should also be populated."
Executability: Fully Executable
Outcome:
Message: --ENRTPT is populated, but --ENTPT is missing.
diff --git a/Published/CORE-000266/rule.yml b/Published/CORE-000266/rule.yml
index 6d6390ff0..7a99d1857 100644
--- a/Published/CORE-000266/rule.yml
+++ b/Published/CORE-000266/rule.yml
@@ -7,84 +7,76 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "If categories of serious events are collected secondarily to a
- leading question, as in the example below, the values of the
- variables that capture reasons an event is considered serious
- (i.e., AESCAN, AESCONG, etc.) may be null. For example, if
- Serious = \"No\", the values for these variables may be null.
- However, if Serious = \"Yes\", at least one of them will have
- a \"Y\" response.
-
-
-
- \ "
+ - Cited Guidance:
+ "If categories of serious events are collected secondarily to a leading question,
+ as in the example below, the values of the variables that capture reasons an event is considered
+ serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if Serious = \"No\", the values
+ for these variables may be null. However, if Serious = \"Yes\", at least one of them will have
+ a \"Y\" response.\n\n\n "
Document: IG v3.4
Item: Assumption 6a
Section: 6.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0042
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If categories of serious events are collected secondarily to a
- leading question, as in the example below, the values of the
- variables that capture reasons an event is considered serious
- (i.e., AESCAN, AESCONG, etc.) may be null. For example, if
- Serious is answered "No, " the values for these variables may
- be null. However, if Serious is answered "Yes, " at least one
- of them will have a "Y" response.
+ - Cited Guidance:
+ If categories of serious events are collected secondarily to a leading
+ question, as in the example below, the values of the variables that capture reasons an
+ event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if
+ Serious is answered "No, " the values for these variables may be null. However, if Serious
+ is answered "Yes, " at least one of them will have a "Y" response.
Document: IG v3.2
Item: Assumption 6a
- Section: '6.2'
+ Section: "6.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0042
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If categories of serious events are collected secondarily to a
- leading question, as in the example below, the values of the
- variables that capture reasons an event is considered serious
- (i.e., AESCAN, AESCONG, etc.) may be null. For example, if
- Serious is answered "No, " the values for these variables may
- be null. However, if Serious is answered "Yes, " at least one
- of them will have a "Y" response.
+ - Cited Guidance:
+ If categories of serious events are collected secondarily to a leading
+ question, as in the example below, the values of the variables that capture reasons an
+ event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if
+ Serious is answered "No, " the values for these variables may be null. However, if Serious
+ is answered "Yes, " at least one of them will have a "Y" response.
Document: IG v3.3
Item: Assumption 6a
Section: 6.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0042
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If categories of serious events are collected secondarily to a
- leading question the values of the variables that capture
- reasons an event is considered serious (e.g., AESCAN, AESCONG)
- may be null. On the other hand, if the CRF is structured so
- that a response is collected for each seriousness category,
- all category variables (e.g., AESDTH, AESHOSP) would be
- populated and AESER would be derived.
+ - Cited Guidance:
+ If categories of serious events are collected secondarily to a leading
+ question the values of the variables that capture reasons an event is considered serious
+ (e.g., AESCAN, AESCONG) may be null. On the other hand, if the CRF is structured so that a
+ response is collected for each seriousness category, all category variables (e.g., AESDTH,
+ AESHOSP) would be populated and AESER would be derived.
Document: TIG 1.0
Item: Assumption 7a
Section: 2.8.10.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0321
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: AESER
@@ -142,13 +134,13 @@ Check:
Core:
Id: CORE-000266
Status: Published
- Version: '1'
-Description: Select record where AESCAN and AESCONG and AESDISAB and AESDTH and
- AESHOSP and AESLIFE and AESOD and AESMIE ^= "Y" However, AESER ^= "N"
+ Version: "1"
+Description: Select record where AESCAN and AESCONG and AESDISAB and AESDTH and AESHOSP and AESLIFE
+ and AESOD and AESMIE ^= "Y" However, AESER ^= "N"
Executability: Fully Executable
Outcome:
- Message: If AESER = "N" then none of the seriousness criteria (AESCAN, AESCONG,
- AESDISAB, AESDTH, AESHOSP, AESLIFE, AESOD, AESMIE) could be equal to "Y".
+ Message: If AESER = "N" then none of the seriousness criteria (AESCAN, AESCONG, AESDISAB, AESDTH,
+ AESHOSP, AESLIFE, AESOD, AESMIE) could be equal to "Y".
Output Variables:
- AESER
- AESCAN
diff --git a/Published/CORE-000267/rule.yml b/Published/CORE-000267/rule.yml
index 7444237ec..6647880d8 100644
--- a/Published/CORE-000267/rule.yml
+++ b/Published/CORE-000267/rule.yml
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0050
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -27,9 +27,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0050
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -40,26 +40,26 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0050
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: --DECOD[Standardized or dictionary-derived text for the
- description of an event or intervention. Equivalent to the
- Preferred Term (PT in MedDRA).]|--PTCD[The preferred term code
- assigned to the event from MedDRA.]
+ - Cited Guidance:
+ --DECOD[Standardized or dictionary-derived text for the description of an
+ event or intervention. Equivalent to the Preferred Term (PT in MedDRA).]|--PTCD[The
+ preferred term code assigned to the event from MedDRA.]
Document: SDTM v2.1
Item: --PTCD
Section: 3.1.2 The Events Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0328
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --PTCD
@@ -69,7 +69,7 @@ Check:
Core:
Id: CORE-000267
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --DECOD is not populated but --PTCD is populated
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000268/rule.yml b/Published/CORE-000268/rule.yml
index f037a1474..d813222ec 100644
--- a/Published/CORE-000268/rule.yml
+++ b/Published/CORE-000268/rule.yml
@@ -1,5 +1,5 @@
# Variable: --PTCD
-# Condition:
+# Condition:
# Rule: --DECOD and --PTCD have a one-to-one relationship
Authorities:
- Organization: CDISC
@@ -7,9 +7,9 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Standardized or dictionary-derived text for the description of
- an event or intervention. Equivalent to the Preferred Term (PT
- in MedDRA).
+ - Cited Guidance:
+ Standardized or dictionary-derived text for the description of an event or
+ intervention. Equivalent to the Preferred Term (PT in MedDRA).
Document: Model v2.0
Item: --DECOD
Section: Events
@@ -20,16 +20,15 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0049
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Dictionary or sponsor-defined derived text description of the
- topic variable, --TERM, or the modified topic variable
- (--MODIFY), if applicable. Equivalent to the Preferred Term
- (PT in MedDRA).
+ - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic
+ variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to
+ the Preferred Term (PT in MedDRA).
Document: Model v1.7
Item: --DECOD
Section: 2.2.2
@@ -40,16 +39,15 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0049
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Dictionary or sponsor-defined derived text description of the
- topic variable, --TERM, or the modified topic variable
- (--MODIFY), if applicable. Equivalent to the Preferred Term
- (PT in MedDRA).
+ - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic
+ variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to
+ the Preferred Term (PT in MedDRA).
Document: Model v1.4
Item: --DECOD
Section: 2.2.2
@@ -60,73 +58,73 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0049
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: --DECOD[Standardized or dictionary-derived text for the
- description of an event or intervention. Equivalent to the
- Preferred Term (PT in MedDRA).]|--PTCD[The preferred term code
- assigned to the event from MedDRA.]
+ - Cited Guidance:
+ --DECOD[Standardized or dictionary-derived text for the description of an
+ event or intervention. Equivalent to the Preferred Term (PT in MedDRA).]|--PTCD[The
+ preferred term code assigned to the event from MedDRA.]
Document: SDTM v2.1
Item: --DECOD|--PTCD
Section: 3.1.2 The Events Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0327
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0909
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0909
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0909
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: --DECOD
@@ -139,7 +137,7 @@ Check:
Core:
Id: CORE-000268
Status: Published
- Version: '1'
+ Version: "1"
Description: --DECOD and --PTCD should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000269/rule.yml b/Published/CORE-000269/rule.yml
index 0cf235d32..2fe651ede 100644
--- a/Published/CORE-000269/rule.yml
+++ b/Published/CORE-000269/rule.yml
@@ -7,58 +7,59 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must
- be those defined in the Trial Visits (TV) dataset (Section
- 7.3.1, Trial Visits).
+ - Cited Guidance:
+ For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
+ defined in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits).
Document: IG v3.4
- Item: ''
+ Item: ""
Section: 4.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0031
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must
- be those defined in the Trial Visits dataset,
+ - Cited Guidance:
+ For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
+ defined in the Trial Visits dataset,
Document: IG v3.3
- Item: ''
+ Item: ""
Section: 4.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0031
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must
- be those defined in the Trial Visits dataset,
+ - Cited Guidance:
+ For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
+ defined in the Trial Visits dataset,
Document: IG v3.2
- Item: ''
+ Item: ""
Section: 4.1.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0031
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of
- VISITNUM for planned visits. Any values of VISITNUM that
- appear in subject-level datasets that are not in the TV
- dataset are assumed to correspond to unplanned visits. There
- will be a one-to-one relationship between values of VISIT and
- VISITNUM in TV. If a subject-level dataset includes both
- VISITNUM and VISIT, then records that include values of
- VISITNUM that appear in the TV dataset should also include the
- corresponding values of VISIT from the TV dataset.
+ - Cited Guidance:
+ The values of VISITNUM in the TV dataset are the valid values of VISITNUM
+ for planned visits. Any values of VISITNUM that appear in subject-level datasets that are
+ not in the TV dataset are assumed to correspond to unplanned visits. There will be a
+ one-to-one relationship between values of VISIT and VISITNUM in TV. If a subject-level
+ dataset includes both VISITNUM and VISIT, then records that include values of VISITNUM
+ that appear in the TV dataset should also include the corresponding values of VISIT from
+ the TV dataset.
Document: TIG 1.0
Item: 2.8.10.31 Assumption 6
Section: 2.8.7.5
@@ -69,10 +70,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0312
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: VISIT
@@ -86,9 +87,9 @@ Check:
Core:
Id: CORE-000269
Status: Published
- Version: '1'
-Description: Verify when VISIT is not null in any given domain and VISIT is
- planned (SVPRESP = 'Y'), then VISIT should be among TV.VISIT.
+ Version: "1"
+Description: Verify when VISIT is not null in any given domain and VISIT is planned (SVPRESP = 'Y'),
+ then VISIT should be among TV.VISIT.
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -101,8 +102,8 @@ Operations:
name: VISIT
operator: distinct
Outcome:
- Message: For a planned visit (SVPRESP = 'Y'), non-missing VISIT value must be
- among those present in TV.VISIT.
+ Message: For a planned visit (SVPRESP = 'Y'), non-missing VISIT value must be among those present
+ in TV.VISIT.
Output Variables:
- VISIT
- VISITNUM
diff --git a/Published/CORE-000270/rule.yml b/Published/CORE-000270/rule.yml
index b5a53f52c..1a7c272b4 100644
--- a/Published/CORE-000270/rule.yml
+++ b/Published/CORE-000270/rule.yml
@@ -7,69 +7,69 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must
- be those defined in the Trial Visits (TV) dataset (Section
- 7.3.1, Trial Visits).
+ - Cited Guidance:
+ For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
+ defined in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits).
Document: SDTMIG v3.4
- Item: ''
+ Item: ""
Section: 4.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0033
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must
- be those defined in the Trial Visits dataset.
+ - Cited Guidance:
+ For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
+ defined in the Trial Visits dataset.
Document: SDTMIG v3.3
- Item: ''
+ Item: ""
Section: 4.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0033
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must
- be those defined in the Trial Visits dataset.
+ - Cited Guidance:
+ For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
+ defined in the Trial Visits dataset.
Document: SDTMIG v3.2
- Item: ''
+ Item: ""
Section: 4.1.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0033
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of
- VISITNUM for planned visits. Any values of VISITNUM that
- appear in subject-level datasets that are not in the TV
- dataset are assumed to correspond to unplanned visits. There
- will be a one-to-one relationship between values of VISIT and
- VISITNUM in TV. If a subject-level dataset includes both
- VISITNUM and VISIT, then records that include values of
- VISITNUM that appear in the TV dataset should also include the
- corresponding values of VISIT from the TV dataset.
- Specification VISITDY Planned study day of VISIT.
+ - Cited Guidance:
+ The values of VISITNUM in the TV dataset are the valid values of VISITNUM
+ for planned visits. Any values of VISITNUM that appear in subject-level datasets that are
+ not in the TV dataset are assumed to correspond to unplanned visits. There will be a
+ one-to-one relationship between values of VISIT and VISITNUM in TV. If a subject-level
+ dataset includes both VISITNUM and VISIT, then records that include values of VISITNUM
+ that appear in the TV dataset should also include the corresponding values of VISIT from
+ the TV dataset. Specification VISITDY Planned study day of VISIT.
Document: TIG 1.0
Item: Assumption 6 |Specifications VISITDY
Section: 2.8.10.31
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0314
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SVPRESP
@@ -81,9 +81,9 @@ Check:
Core:
Id: CORE-000270
Status: Published
- Version: '1'
-Description: Verify when VISITNUM is not null in any given domain and VISITNUM
- is planned (SVPRESP = 'Y'), then VISIT should be among TV.VISITNUM.
+ Version: "1"
+Description: Verify when VISITNUM is not null in any given domain and VISITNUM is planned (SVPRESP =
+ 'Y'), then VISIT should be among TV.VISITNUM.
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -96,8 +96,8 @@ Operations:
name: VISITNUM
operator: distinct
Outcome:
- Message: For a planned visit (SVPRESP = 'Y'), non-missing VISITNUM value must be
- among those present in TV.VISITNUM. in TV.VISITNUM
+ Message: For a planned visit (SVPRESP = 'Y'), non-missing VISITNUM value must be among those
+ present in TV.VISITNUM. in TV.VISITNUM
Output Variables:
- VISITNUM
- SVPRESP
diff --git a/Published/CORE-000271/rule.yml b/Published/CORE-000271/rule.yml
index 9964e38e5..4db6d977a 100644
--- a/Published/CORE-000271/rule.yml
+++ b/Published/CORE-000271/rule.yml
@@ -1,5 +1,5 @@
# Variable: EPOCH
-# Condition:
+# Condition:
# Rule: EPOCH in TA.EPOCH
Authorities:
- Organization: CDISC
@@ -8,67 +8,64 @@ Authorities:
References:
- Citations:
- Cited Guidance: EPOCH may be included as a timing variable as in other
- general-observation-class domains. In DS, EPOCH is based on
- DSSTDTC. The values of EPOCH are drawn from the Trial Arms(TA)
- dataset (Section 7.2.1, Trial Arms).
+ general-observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH
+ are drawn from the Trial Arms(TA) dataset (Section 7.2.1, Trial Arms).
Document: SDTMIG v3.4
Item: DS, Assumption 4.c
Section: 6.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0009
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: EPOCH may be included as a timing variable as in other
- general-observation-class domains. In DS, EPOCH is based on
- DSSTDTC. The values of EPOCH are drawn from the Trial Arms
- (TA) dataset (Section 7.2.1, Trial Arms).
+ general-observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH
+ are drawn from the Trial Arms (TA) dataset (Section 7.2.1, Trial Arms).
Document: SDTMIG v3.3
Item: DS, Assumption 4.c
Section: 6.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0009
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '...EPOCH, as a Timing variable, is the name of the Epoch during
- which --STDTC or --DTC falls. The values of EPOCH are drawn
- from the Trial Arms domain, Section 7.2 - Experimental Design
- Trial Arms (TA)'
+ - Cited Guidance:
+ "...EPOCH, as a Timing variable, is the name of the Epoch during which --STDTC
+ or --DTC falls. The values of EPOCH are drawn from the Trial Arms domain, Section 7.2 - Experimental
+ Design Trial Arms (TA)"
Document: SDTMIG v3.2
Item: DS, Assumption 3.c
- Section: '6.2'
+ Section: "6.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0009
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- Cited Guidance: EPOCH may be included as a timing variable as in other general
- observation-class domains. In DS, EPOCH is based on DSSTDTC.
- The values of EPOCH are drawn from the Trial Arms (TA)
- dataset.
+ observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH are drawn
+ from the Trial Arms (TA) dataset.
Document: TIG 1.0
Item: Assumption 4.c
Section: 2.8.10.8
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0294
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: EPOCH
@@ -79,7 +76,7 @@ Check:
Core:
Id: CORE-000271
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when EPOCH is not in TA.EPOCH
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000272/rule.yml b/Published/CORE-000272/rule.yml
index 44e4c3c8c..6445a3ce0 100644
--- a/Published/CORE-000272/rule.yml
+++ b/Published/CORE-000272/rule.yml
@@ -1,5 +1,5 @@
# Variable: --CAT
-# Condition:
+# Condition:
# Rule: --CAT ^= Domain Name
Authorities:
- Organization: CDISC
@@ -7,144 +7,145 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.4
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0336
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.3
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0336
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain name or dictionary classification provided by --DECOD
- and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain name or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v3.2
Section: 4.1.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0336
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.0
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND46
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND46
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND46
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND46
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND46
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND46
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or
- dictionary classification represented in --DECOD and --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT will not be the domain name or dictionary
+ classification represented in --DECOD and --BODSYS.
Document: TIG 1.0
Item: General Conventions table NUM 7
- Section: '2.8.7.1'
+ Section: "2.8.7.1"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0501
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --CAT
@@ -153,7 +154,7 @@ Check:
Core:
Id: CORE-000272
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --CAT = DOMAIN.
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000273/rule.yml b/Published/CORE-000273/rule.yml
index 8e2554038..bc59ee2ec 100644
--- a/Published/CORE-000273/rule.yml
+++ b/Published/CORE-000273/rule.yml
@@ -4,118 +4,117 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.0
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND19
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND19
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND19
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND19
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND19
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND19
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers,
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
or underscores.
Document: TIG v1.0
- Item: LBTESTCD CDISC Notes (and in all CDISC Notes for --TESTCD in all TIG
- Domains)
+ Item: LBTESTCD CDISC Notes (and in all CDISC Notes for --TESTCD in all TIG Domains)
Section: 2.8.9.14 (and all other domains with --TESTCD)
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: TIG v1.0
Item: QNAM CDISC Notes
Section: 2.8.9.27
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0118
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- name: --TESTCD
@@ -124,13 +123,11 @@ Check:
Core:
Id: CORE-000273
Status: Published
- Version: '1'
-Description: Raise an error when --TESTCD contains anything else than a letter,
- number or underscore
+ Version: "1"
+Description: Raise an error when --TESTCD contains anything else than a letter, number or underscore
Executability: Fully Executable
Outcome:
- Message: --TESTCD value cannot contain characters other than letters, numbers or
- underscores
+ Message: --TESTCD value cannot contain characters other than letters, numbers or underscores
Output Variables:
- --TESTCD
Rule Type: Record Data
diff --git a/Published/CORE-000274/rule.yml b/Published/CORE-000274/rule.yml
index b4f33da17..965d1ae11 100644
--- a/Published/CORE-000274/rule.yml
+++ b/Published/CORE-000274/rule.yml
@@ -4,118 +4,117 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.0
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND17
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND17
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND17
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND17
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND17
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND17
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: TIG v1.0
- Item: LBTESTCD CDISC Notes (and in all CDISC Notes for --TESTCD in all TIG
- Domains)
+ Item: LBTESTCD CDISC Notes (and in all CDISC Notes for --TESTCD in all TIG Domains)
Section: 2.8.9.14 (and all other domains with --TESTCD)
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: TIG v1.0
Item: QNAM CDISC Notes
Section: 2.8.9.27
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0099
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- name: --TESTCD
@@ -124,7 +123,7 @@ Check:
Core:
Id: CORE-000274
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TESTCD > 8 chars
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000289/rule.yml b/Published/CORE-000289/rule.yml
index 57657437a..772b05f74 100644
--- a/Published/CORE-000289/rule.yml
+++ b/Published/CORE-000289/rule.yml
@@ -7,64 +7,64 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Upper end of reference range for continuous measurement in
- original units. Should be populated only for continuous
- results.
+ - Cited Guidance:
+ Upper end of reference range for continuous measurement in original units.
+ Should be populated only for continuous results.
Document: SDTMIG v3.4
Item: Specification
Section: 6.3.5.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0181
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Upper end of reference range for continuous measurements in
- original units. Should be populated only for continuous
- results.
+ - Cited Guidance:
+ Upper end of reference range for continuous measurements in original units.
+ Should be populated only for continuous results.
Document: IG v3.2
Item: Specification
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0181
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Upper end of reference range for continuous measurements in
- original units. Should be populated only for continuous
- results.
+ - Cited Guidance:
+ Upper end of reference range for continuous measurements in original units.
+ Should be populated only for continuous results.
Document: IG v3.3
Item: Specification
Section: 6.3.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0181
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Upper end of reference range for continuous measurement in
- original units. Should be populated only for continuous
- results.
+ - Cited Guidance:
+ Upper end of reference range for continuous measurement in original units.
+ Should be populated only for continuous results.
Document: TIG 1.0
Item: Specification-LBORNRHI
Section: 2.8.10.14
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0410
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
# Changed by Marcelina Hungria on 2025-05-29
@@ -72,10 +72,11 @@ Check:
# Changed to Fully Executable. See Jira ticket: CORERULES-156 (CG0180)
all:
- name: LBORRES
- operator: not_matches_regex
- # value: ^-?(0|[1-9]\d*)(\.\d+)?$
- # Change by Jozef Aerts to allow values starting with a dot, e.g. ".25"
- # Also see Github ticket https://github.com/cdisc-org/cdisc-rules-engine/issues/520
+ operator:
+ not_matches_regex
+ # value: ^-?(0|[1-9]\d*)(\.\d+)?$
+ # Change by Jozef Aerts to allow values starting with a dot, e.g. ".25"
+ # Also see Github ticket https://github.com/cdisc-org/cdisc-rules-engine/issues/520
value: ^-?(\d+(\.\d+)?$)|(\.\d+$)
- name: LBORNRHI
operator: non_empty
@@ -84,10 +85,9 @@ Check:
Core:
Id: CORE-000289
Status: Published
- Version: '1'
-Description: Raise an error when LBORRES is not a continuous measurement and
- LBORNRHI is not empty. The interpretation of the guidance is that LBORRES is
- populated (not null).
+ Version: "1"
+Description: Raise an error when LBORRES is not a continuous measurement and LBORNRHI is not empty.
+ The interpretation of the guidance is that LBORRES is populated (not null).
Executability: Fully Executable
Outcome:
Message: LBORRES is not a continuous measurement but LBORNRHI is not empty.
diff --git a/Published/CORE-000290/rule.yml b/Published/CORE-000290/rule.yml
index aab3d3e30..aea94ad13 100644
--- a/Published/CORE-000290/rule.yml
+++ b/Published/CORE-000290/rule.yml
@@ -8,63 +8,62 @@ Authorities:
References:
- Citations:
- Cited Guidance: Lower end of reference range for continuous measurements for
- LBSTRESC/LBSTRESN in standardized units. Should be populated
- only for continuous results.
+ LBSTRESC/LBSTRESN in standardized units. Should be populated only for continuous results.
Document: SDTMIG v3.4
Item: Specification
Section: 6.3.5.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0180
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Lower end of reference range for continuous measurements in
- original units. Should be populated only for continuous
- results.
+ - Cited Guidance:
+ Lower end of reference range for continuous measurements in original units.
+ Should be populated only for continuous results.
Document: IG v3.2
Item: Specification
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0180
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Lower end of reference range for continuous measurements in
- original units. Should be populated only for continuous
- results.
+ - Cited Guidance:
+ Lower end of reference range for continuous measurements in original units.
+ Should be populated only for continuous results.
Document: IG v3.3
Item: Specification
Section: 6.3.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0180
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Lower end of reference range for continuous measurement in
- original units. Should be populated only for continuous
- results.
+ - Cited Guidance:
+ Lower end of reference range for continuous measurement in original units.
+ Should be populated only for continuous results.
Document: TIG 1.0
Item: Specification
Section: 2.8.10.14
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0409
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
# Changed by Marcelina Hungria on 2025-05-29
@@ -81,10 +80,9 @@ Check:
Core:
Id: CORE-000290
Status: Published
- Version: '1'
-Description: Raise an error when LBORRES ^= continuous measurement and LBORNRLO
- is not empty. The interpretation of the guidance is that LBORRES is populated
- (not null).
+ Version: "1"
+Description: Raise an error when LBORRES ^= continuous measurement and LBORNRLO is not empty. The
+ interpretation of the guidance is that LBORRES is populated (not null).
Executability: Fully Executable
Outcome:
Message: LBORRES is not a continuous measurement but LBORNRLO is not empty.
diff --git a/Published/CORE-000291/rule.yml b/Published/CORE-000291/rule.yml
index 1de3b5976..6ba2500d9 100644
--- a/Published/CORE-000291/rule.yml
+++ b/Published/CORE-000291/rule.yml
@@ -7,9 +7,9 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '"When the EC domain is implemented in conjunction with the EX
- domain, EXVAMT and EXVAMTU should not be used in
- EX; collected values instead would be represented in ECDOSE
+ - Cited Guidance:
+ '"When the EC domain is implemented in conjunction with the EX domain, EXVAMT
+ and EXVAMTU should not be used in EX; collected values instead would be represented in ECDOSE
and ECDOSU."'
Document: IG v3.4
Item: Assumption 6c
@@ -17,56 +17,58 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0105
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When the EC domain is implemented in conjunction with the EX
- domain, EXVAMT and EXVAMTU should not be used in EX; collected
- values instead would be represented in ECDOSE and ECDOSU.
+ - Cited Guidance:
+ When the EC domain is implemented in conjunction with the EX domain, EXVAMT
+ and EXVAMTU should not be used in EX; collected values instead would be represented in
+ ECDOSE and ECDOSU.
Document: IG v3.3
Item: Assumption 6c
Section: 6.1.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0105
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When the EC domain (See Section 6.1.2.3) is implemented in
- conjunction with the EX domain, EXVAMT and EXVAMTU should not
- be used in EX; collected values instead would be represented
- in ECDOSE and ECDOSU
+ - Cited Guidance:
+ When the EC domain (See Section 6.1.2.3) is implemented in conjunction with
+ the EX domain, EXVAMT and EXVAMTU should not be used in EX; collected values instead would
+ be represented in ECDOSE and ECDOSU
Document: IG v3.2
Item: Assumption 6c
- Section: '6.1'
+ Section: "6.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0105
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: When the EC domain is implemented in conjunction with the EX
- domain, EXVAMT and EXVAMTU should not be used in EX; collected
- values instead would be represented in ECDOSE and ECDOSU.
+ - Cited Guidance:
+ When the EC domain is implemented in conjunction with the EX domain, EXVAMT
+ and EXVAMTU should not be used in EX; collected values instead would be represented in
+ ECDOSE and ECDOSU.
Document: TIG 1.0
Item: Assumption 6c
Section: 2.8.10.10
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0370
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
@@ -78,7 +80,7 @@ Check:
Core:
Id: CORE-000291
Status: Published
- Version: '1'
+ Version: "1"
Description: When EC exists, EXVAMT should not be used.
Executability: Fully Executable
Match Datasets:
diff --git a/Published/CORE-000293/rule.yml b/Published/CORE-000293/rule.yml
index f8d8f6be6..b17ec7918 100644
--- a/Published/CORE-000293/rule.yml
+++ b/Published/CORE-000293/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: Suppqual dataset names <= 8 characters
Authorities:
- Organization: CDISC
@@ -7,81 +7,73 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "\"When data have been split into multiple datasets (see Section
- 4.1.7, Splitting Domains), longer names such as SUPPFAMH may
- be needed. In cases where data about Associated Persons (see
- Associated Persons Implementation Guide) have been collected,
- Supplemental Qualifiers for Findings About events or
- interventions for an associated person may need to be
- represented. A dataset name with the SUPP fragment, e.g.,
- SUPPAPFAMH, would be too long. In this case only, the 'SUPP'
- portion should be shortened to 'SQ', resulting in a dataset
- name such as SQAPFAMH.\""
+ - Cited Guidance:
+ '"When data have been split into multiple datasets (see Section 4.1.7, Splitting
+ Domains), longer names such as SUPPFAMH may be needed. In cases where data about Associated
+ Persons (see Associated Persons Implementation Guide) have been collected, Supplemental Qualifiers
+ for Findings About events or interventions for an associated person may need to be represented.
+ A dataset name with the SUPP fragment, e.g., SUPPAPFAMH, would be too long. In this case only,
+ the ''SUPP'' portion should be shortened to ''SQ'', resulting in a dataset name such as SQAPFAMH."'
Document: IG v3.4
Section: 8.4.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0205
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'When data have been split into multiple datasets (see Section
- 4: 4.1.1.7, Splitting Domains), longer names such as SUPPFAMH
- may be needed. In cases where data about Associated Persons
- (see Associated Persons Implementation Guide) have been
- collected, an associated person with Supplemental Qualifiers
- for Findings About their medical history, the resulting
- dataset name SUPPAPFAMH) would be too long so that, in this
- case only, the "SUPP" portion should be shortened to "SQ".
- resulting in a dataset name of SQAPFAMH.'
+ - Cited Guidance:
+ 'When data have been split into multiple datasets (see Section 4: 4.1.1.7, Splitting
+ Domains), longer names such as SUPPFAMH may be needed. In cases where data about Associated
+ Persons (see Associated Persons Implementation Guide) have been collected, an associated person
+ with Supplemental Qualifiers for Findings About their medical history, the resulting dataset
+ name SUPPAPFAMH) would be too long so that, in this case only, the "SUPP" portion should be
+ shortened to "SQ". resulting in a dataset name of SQAPFAMH.'
Document: IG v3.2
Section: 8.4.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0205
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'When data have been split into multiple datasets (see Section
- 4: 4.1.1.7, Splitting Domains), longer names such as SUPPFAMH
- may be needed. In cases where data about Associated Persons
- (see Associated Persons Implementation Guide) have been
- collected, an associated person with Supplemental Qualifiers
- for Findings About their medical history, the resulting
- dataset name SUPPAPFAMH) would be too long so that, in this
- case only, the "SUPP" portion should be shortened to "SQ".
- resulting in a dataset name of SQAPFAMH.'
+ - Cited Guidance:
+ 'When data have been split into multiple datasets (see Section 4: 4.1.1.7, Splitting
+ Domains), longer names such as SUPPFAMH may be needed. In cases where data about Associated
+ Persons (see Associated Persons Implementation Guide) have been collected, an associated person
+ with Supplemental Qualifiers for Findings About their medical history, the resulting dataset
+ name SUPPAPFAMH) would be too long so that, in this case only, the "SUPP" portion should be
+ shortened to "SQ". resulting in a dataset name of SQAPFAMH.'
Document: IG v3.3
Section: 8.4.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0205
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Supplemental Qualifier datasets will be named using convention
- SUPP concatenated with the two-character domain code or
- four-character code when a dataset is split (e.g., SUPPDM,
- SUPPFA, SUPPFACM).
+ - Cited Guidance: Supplemental Qualifier datasets will be named using convention SUPP
+ concatenated with the two-character domain code or four-character code when a dataset is
+ split (e.g., SUPPDM, SUPPFA, SUPPFACM).
Document: TIG 1.0
Item: Tabulation table NUM 2
- Section: '2.6'
+ Section: "2.6"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0425
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: dataset_name
@@ -90,7 +82,7 @@ Check:
Core:
Id: CORE-000293
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error if length of dataset name is greater than 8
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000294/rule.yml b/Published/CORE-000294/rule.yml
index 638fcb9b6..85c52b7bf 100644
--- a/Published/CORE-000294/rule.yml
+++ b/Published/CORE-000294/rule.yml
@@ -7,65 +7,66 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When the trial summary parameter is AGEMAX, then TSVAL should
- have a value expressed as an ISO8601 time duration (e.g., P43Y
- for 43 years old or P6M for 6 months old).
+ - Cited Guidance:
+ When the trial summary parameter is AGEMAX, then TSVAL should have a value
+ expressed as an ISO8601 time duration (e.g., P43Y for 43 years old or P6M for 6 months
+ old).
Document: IG v3.4
Section: 7.4.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0270
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
- Table 1. TSVAL may have controlled terminology depending on
- the value of TSPARMCD
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
Section: 7.4|Appendix C1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0270
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included Appendix
- C1, Trial Summary Codes. TSVAL may have controlled terminology
- depending on the value of TSPARMCD. Conditions for including
- parameters are included in Appendix C1, Trial Summary Codes.
+ - Cited Guidance:
+ Further information about the parameters is included Appendix C1, Trial
+ Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD.
+ Conditions for including parameters are included in Appendix C1, Trial Summary Codes.
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0270
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Standards for tabulation and analysis require representation of
- dates and/or times, intervals of time, and durations of time
- in ISO 8601 format as defined by the International
- Organization for Standardization (ISO) (http://www.iso.org).
+ - Cited Guidance:
+ Standards for tabulation and analysis require representation of dates and/or
+ times, intervals of time, and durations of time in ISO 8601 format as defined by the
+ International Organization for Standardization (ISO) (http://www.iso.org).
Document: TIG 1.0
- Item: ''
- Section: '2.3'
+ Item: ""
+ Section: "2.3"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0471
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: TSPARMCD
@@ -79,9 +80,9 @@ Check:
Core:
Id: CORE-000294
Status: Published
- Version: '1'
-Description: Trigger error when TSPARMCD = 'AGEMAX' and TSVAL ^= null and TSVAL
- does not conform to ISO 8601
+ Version: "1"
+Description: Trigger error when TSPARMCD = 'AGEMAX' and TSVAL ^= null and TSVAL does not conform to
+ ISO 8601
Executability: Fully Executable
Outcome:
Message: TSVAL is not in ISO 8601 format
diff --git a/Published/CORE-000295/rule.yml b/Published/CORE-000295/rule.yml
index e25211818..03c497abb 100644
--- a/Published/CORE-000295/rule.yml
+++ b/Published/CORE-000295/rule.yml
@@ -7,49 +7,49 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Reference value for continuous or numeric results or findings in
- standard format or in standard units. --STREFN uses the same
- units as --STRESN, if applicable.
+ - Cited Guidance:
+ Reference value for continuous or numeric results or findings in standard
+ format or in standard units. --STREFN uses the same units as --STRESN, if applicable.
Document: SDTM v2.0
Item: --STREFN
Section: Findings
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0550
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Reference value for continuous or numeric results or findings in
- standard format or in standard units. --STREFN uses the same
- units as --STRESN, if applicable
+ - Cited Guidance:
+ Reference value for continuous or numeric results or findings in standard
+ format or in standard units. --STREFN uses the same units as --STRESN, if applicable
Document: Model v1.7
Item: --STREFN
Section: Table 2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0550
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Reference value for continuous or numeric results or findings in
- standard format or in standard units. --STREFN uses the same
- units as --STRESN, if applicable.
+ - Cited Guidance:
+ Reference value for continuous or numeric results or findings in standard
+ format or in standard units. --STREFN uses the same units as --STRESN, if applicable.
Document: SDTM v2.1
Item: --STREFN
Section: 3.1.3 The Findings Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0638
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --STREFC
@@ -59,7 +59,7 @@ Check:
Core:
Id: CORE-000295
Status: Published
- Version: '1'
+ Version: "1"
Description: When --STREFC is populated, --STREFN should also be populated.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000296/rule.yml b/Published/CORE-000296/rule.yml
index 3f69f26be..665052976 100644
--- a/Published/CORE-000296/rule.yml
+++ b/Published/CORE-000296/rule.yml
@@ -7,60 +7,57 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The Disposition dataset provides an accounting for all subjects
- who entered the study and may include protocol milestones,
- such as randomization, as well as the subject's completion
- status or reason for discontinuation for the entire study or
- each phase or segment of the study, including screening and
- post-treatment follow-up.
+ - Cited Guidance:
+ The Disposition dataset provides an accounting for all subjects who entered
+ the study and may include protocol milestones, such as randomization, as well as the
+ subject's completion status or reason for discontinuation for the entire study or each
+ phase or segment of the study, including screening and post-treatment follow-up.
Document: IG v3.4
Item: Assumption 1
Section: 6.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0540
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The Disposition dataset provides an accounting for all subjects
- who entered the study and may include protocol milestones,
- such as randomization, as well as the subject's completion
- status or reason for discontinuation for the entire study or
- each phase or segment of the study, including screening and
- post-treatment follow-up.
+ - Cited Guidance:
+ The Disposition dataset provides an accounting for all subjects who entered
+ the study and may include protocol milestones, such as randomization, as well as the
+ subject's completion status or reason for discontinuation for the entire study or each
+ phase or segment of the study, including screening and post-treatment follow-up.
Document: IG v3.3
Item: Assumption 1
Section: 6.2.3 DS
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0540
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The Disposition (DS) dataset provides an accounting for all
- subjects who entered the study and may include protocol
- milestones, such as randomization, as well as the subject's
- completion status or reason for discontinuation for the entire
- study or each phase or segment of the study, including
- screening and follow-up. Applicants may choose which
- disposition events and milestones to submit for a study in
- alignment with regulatory requirements.
+ - Cited Guidance:
+ The Disposition (DS) dataset provides an accounting for all subjects who
+ entered the study and may include protocol milestones, such as randomization, as well as
+ the subject's completion status or reason for discontinuation for the entire study or each
+ phase or segment of the study, including screening and follow-up. Applicants may choose
+ which disposition events and milestones to submit for a study in alignment with regulatory
+ requirements.
Document: TIG 1.0
Item: Assumption 1
Section: 2.8.10.8
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0633
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ACTARMCD
@@ -71,7 +68,7 @@ Check:
Core:
Id: CORE-000296
Status: Published
- Version: '1'
+ Version: "1"
Description: When ACTARMCD is populated, disposition data for subject must be present
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000298/rule.yml b/Published/CORE-000298/rule.yml
index d85cf8750..3ecc85812 100644
--- a/Published/CORE-000298/rule.yml
+++ b/Published/CORE-000298/rule.yml
@@ -7,64 +7,63 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Lower end of reference range for continuous measurements for
- LBSTRESC/LBSTRESN in standardized units. Should be
- populated only for continuous results. '
+ - Cited Guidance:
+ "Lower end of reference range for continuous measurements for LBSTRESC/LBSTRESN
+ in standardized units. Should be populated only for continuous results. "
Document: SDTMIG v3.4
Item: Specification
Section: 6.3.5.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0182
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Lower end of reference range for continuous measurements in
- original units. Should be populated only for continuous
- results.
+ - Cited Guidance:
+ Lower end of reference range for continuous measurements in original units.
+ Should be populated only for continuous results.
Document: IG v3.2
Item: Specification
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0182
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Lower end of reference range for continuous measurements in
- original units. Should be populated only for continuous
- results.
+ - Cited Guidance:
+ Lower end of reference range for continuous measurements in original units.
+ Should be populated only for continuous results.
Document: IG v3.3
Item: Specification
Section: 6.3.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0182
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- Cited Guidance: Lower end of reference range for continuous measurements for
- LBSTRESC/LBSTRESN in standardized units. Should be populated
- only for continuous results.
+ LBSTRESC/LBSTRESN in standardized units. Should be populated only for continuous results.
Document: TIG 1.0
Item: Specification-LBSTNRLO
Section: 2.8.10.14
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0411
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
# Changed by Marcelina Hungria on 2025-05-29
@@ -81,10 +80,9 @@ Check:
Core:
Id: CORE-000298
Status: Published
- Version: '1'
-Description: Raise an error when LBORRES is not a continuous measurement and
- LBSTNRLO is not empty. The interpretation of the guidance is that LBORRES is
- populated (not null).
+ Version: "1"
+Description: Raise an error when LBORRES is not a continuous measurement and LBSTNRLO is not empty.
+ The interpretation of the guidance is that LBORRES is populated (not null).
Executability: Fully Executable
Outcome:
Message: LBORRES is not a continuous measurment but LBSTNRLO is not empty.
diff --git a/Published/CORE-000299/rule.yml b/Published/CORE-000299/rule.yml
index 45fc3f166..199af8e97 100644
--- a/Published/CORE-000299/rule.yml
+++ b/Published/CORE-000299/rule.yml
@@ -7,64 +7,64 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Upper end of reference range for continuous measurements in
- standardized units. Should be populated only for continuous
- results. '
+ - Cited Guidance:
+ "Upper end of reference range for continuous measurements in standardized units.
+ Should be populated only for continuous results. "
Document: SDTMIG v3.4
Item: Specification
Section: 6.3.5.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0183
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Upper end of reference range for continuous measurements in
- original units. Should be populated only for continuous
- results.
+ - Cited Guidance:
+ Upper end of reference range for continuous measurements in original units.
+ Should be populated only for continuous results.
Document: IG v3.2
Item: Specification
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0183
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Upper end of reference range for continuous measurements in
- original units. Should be populated only for continuous
- results.
+ - Cited Guidance:
+ Upper end of reference range for continuous measurements in original units.
+ Should be populated only for continuous results.
Document: IG v3.3
Item: Specification
Section: 6.3.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0183
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Upper end of reference range for continuous measurements in
- standardized units. Should be populated only for continuous
- results.
+ - Cited Guidance:
+ Upper end of reference range for continuous measurements in standardized
+ units. Should be populated only for continuous results.
Document: TIG 1.0
Item: Specification-LBSTNRHI
Section: 2.8.10.14
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0412
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
# Changed by Marcelina Hungria on 2025-05-29
# Fixed the regex and the LBORRES non-empty condition per revised Description.
@@ -80,10 +80,9 @@ Check:
Core:
Id: CORE-000299
Status: Published
- Version: '1'
-Description: Raise an error when LBORRES is not a continuous measurement and
- LBSTNRHI is not empty. The interpretation of the guidance is that LBORRES is
- populated (not null).
+ Version: "1"
+Description: Raise an error when LBORRES is not a continuous measurement and LBSTNRHI is not empty.
+ The interpretation of the guidance is that LBORRES is populated (not null).
Executability: Fully Executable
Outcome:
Message: LBORRES is not a continuous measurement but LBSTNRHI is not empty.
diff --git a/Published/CORE-000302/rule.yml b/Published/CORE-000302/rule.yml
index 2f31f4825..ef7dbb2f2 100644
--- a/Published/CORE-000302/rule.yml
+++ b/Published/CORE-000302/rule.yml
@@ -4,153 +4,153 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0920
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0920
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0920
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0920
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0920
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0920
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0920
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0920
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0920
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0920
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: QLABEL
@@ -159,7 +159,7 @@ Check:
Core:
Id: CORE-000302
Status: Published
- Version: '1'
+ Version: "1"
Description: QNAM and QLABEL should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000303/rule.yml b/Published/CORE-000303/rule.yml
index cb41a29c2..1e2d66d3e 100644
--- a/Published/CORE-000303/rule.yml
+++ b/Published/CORE-000303/rule.yml
@@ -4,153 +4,153 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0901
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0901
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0901
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0901
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0901
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0901
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0901
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0901
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0901
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0901
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --TEST
@@ -159,7 +159,7 @@ Check:
Core:
Id: CORE-000303
Status: Published
- Version: '1'
+ Version: "1"
Description: --TESTCD and --TEST should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000305/rule.yml b/Published/CORE-000305/rule.yml
index 153561e03..1c74a7c7e 100644
--- a/Published/CORE-000305/rule.yml
+++ b/Published/CORE-000305/rule.yml
@@ -12,9 +12,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4005
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -26,9 +26,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4005
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -40,9 +40,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4005
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
@@ -54,9 +54,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4005
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -68,9 +68,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4005
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -82,8 +82,8 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4005
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
@@ -96,9 +96,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4005
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
@@ -110,9 +110,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4005
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -124,9 +124,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4005
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
@@ -138,20 +138,20 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4005
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --DUR
operator: non_empty
- name: --DUR
operator: contains
- value: '-'
+ value: "-"
Core:
Id: CORE-000305
Status: Published
- Version: '1'
+ Version: "1"
Description: Collected Duration (--DUR) value should not be negative.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000308/rule.yml b/Published/CORE-000308/rule.yml
index 52043c0de..56da1ec85 100644
--- a/Published/CORE-000308/rule.yml
+++ b/Published/CORE-000308/rule.yml
@@ -12,9 +12,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4002
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -26,9 +26,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4002
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -40,9 +40,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4002
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
@@ -54,9 +54,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4002
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -68,9 +68,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4002
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -82,8 +82,8 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4002
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
@@ -96,9 +96,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4002
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
@@ -110,9 +110,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4002
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -124,9 +124,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4002
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
@@ -138,9 +138,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4002
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --DOSE
@@ -151,7 +151,7 @@ Check:
Core:
Id: CORE-000308
Status: Published
- Version: '1'
+ Version: "1"
Description: Dose (--DOSE) value should not be negative
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000310/rule.yml b/Published/CORE-000310/rule.yml
index bc920b9f0..d20a46f10 100644
--- a/Published/CORE-000310/rule.yml
+++ b/Published/CORE-000310/rule.yml
@@ -12,9 +12,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4001
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -26,9 +26,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4001
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -40,9 +40,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4001
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
@@ -54,9 +54,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4001
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -68,9 +68,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4001
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -82,8 +82,8 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4001
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
@@ -96,9 +96,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4001
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
@@ -110,9 +110,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4001
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -124,9 +124,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4001
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
@@ -138,9 +138,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4001
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: AGE
@@ -149,7 +149,7 @@ Check:
Core:
Id: CORE-000310
Status: Published
- Version: '1'
+ Version: "1"
Description: Age (AGE) value should not be negative
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000318/rule.yml b/Published/CORE-000318/rule.yml
index 426f6b93c..da7f6c031 100644
--- a/Published/CORE-000318/rule.yml
+++ b/Published/CORE-000318/rule.yml
@@ -4,153 +4,153 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0902
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0902
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0902
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0902
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0902
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0902
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0902
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0902
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0902
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0902
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: ARM
@@ -159,7 +159,7 @@ Check:
Core:
Id: CORE-000318
Status: Published
- Version: '1'
+ Version: "1"
Description: ARMCD and ARM should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000321/rule.yml b/Published/CORE-000321/rule.yml
index 52422bf3f..a962bb328 100644
--- a/Published/CORE-000321/rule.yml
+++ b/Published/CORE-000321/rule.yml
@@ -4,143 +4,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3201
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3201
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3201
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3201
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3201
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3201
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3201
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3201
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3201
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3201
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --DY
@@ -150,14 +150,13 @@ Check:
Core:
Id: CORE-000321
Status: Published
- Version: '1'
-Description: When Date/Time of Collection (--DTC) is present in the dataset,
- then the Study Day of Visit/Collection/Exam (--DY) should also present in the
- dataset.
+ Version: "1"
+Description: When Date/Time of Collection (--DTC) is present in the dataset, then the Study Day of
+ Visit/Collection/Exam (--DY) should also present in the dataset.
Executability: Fully Executable
Outcome:
- Message: Study Day of Visit/Collection/Exam (--DY) variable is missing when
- Date/Time of Collection (--DTC) is present.
+ Message: Study Day of Visit/Collection/Exam (--DY) variable is missing when Date/Time of
+ Collection (--DTC) is present.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000324/rule.yml b/Published/CORE-000324/rule.yml
index 4ae2d19ae..5c8f4b0a8 100644
--- a/Published/CORE-000324/rule.yml
+++ b/Published/CORE-000324/rule.yml
@@ -4,98 +4,83 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "If the reference time point corresponds to the date of
- collection or assessment: Start values: an observation can
- start BEFORE that time point, can start COINCIDENT with that
- time point, or it is unknown (U) when it started. End values:
- an observation can end BEFORE that time point, can end
- COINCIDENT with that time point, can be known that it didn't
- end but was ONGOING, or it is unknown (U) at all when
- it ended or if it was ongoing. AFTER is not a valid value in
- this case because it would represent an event after the date
- of collection. If the reference time point is prior to the
- date of collection or assessment: Start values:
- an observation can start BEFORE the reference point, can
- start COINCIDENT with the reference point, can start AFTER
- the reference point, or it may not be known (U) when it
- started. End values: an observation can end BEFORE the
- reference point, can end COINCIDENT with the reference point,
- can end AFTER the reference point, can be known that it
- didn't end but was ONGOING, or it is unknown (U) when it ended
- or if it was ongoing."
+ - Cited Guidance:
+ "If the reference time point corresponds to the date of collection or assessment:
+ Start values: an observation can start BEFORE that time point, can start COINCIDENT with that
+ time point, or it is unknown (U) when it started. End values: an observation can end BEFORE
+ that time point, can end COINCIDENT with that time point, can be known that it didn't end but
+ was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a
+ valid value in this case because it would represent an event after the date of collection.
+ If the reference time point is prior to the date of collection or assessment: Start values:
+ an observation can start BEFORE the reference point, can start COINCIDENT with the reference
+ point, can start AFTER the reference point, or it may not be known (U) when it started. End
+ values: an observation can end BEFORE the reference point, can end COINCIDENT with the reference
+ point, can end AFTER the reference point, can be known that it didn't end but was ONGOING,
+ or it is unknown (U) when it ended or if it was ongoing."
Document: IG v3.4
Section: 4.4.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0234
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "If the reference time point corresponds to the date of
- collection or assessment: Start values: an observation can
- start BEFORE that time point, can start COINCIDENT with that
- time point, or it is unknown (U) when it started. End values:
- an observation can end BEFORE that time point, can end
- COINCIDENT with that time point, can be known that it didn't
- end but was ONGOING, or it is unknown (U) at all when it ended
- or if it was ongoing. AFTER is not a valid value in this case
- because it would represent an event after the date of
- collection."
+ - Cited Guidance:
+ "If the reference time point corresponds to the date of collection or assessment:
+ Start values: an observation can start BEFORE that time point, can start COINCIDENT with that
+ time point, or it is unknown (U) when it started. End values: an observation can end BEFORE
+ that time point, can end COINCIDENT with that time point, can be known that it didn't end but
+ was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a
+ valid value in this case because it would represent an event after the date of collection."
Document: IG v3.2
Section: 4.1.4.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0234
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "If the reference time point corresponds to the date of
- collection or assessment: Start values: an observation can
- start BEFORE that time point, can start COINCIDENT with that
- time point, or it is unknown (U) when it started. End values:
- an observation can end BEFORE that time point, can end
- COINCIDENT with that time point, can be known that it didn't
- end but was ONGOING, or it is unknown (U) at all when it ended
- or if it was ongoing. AFTER is not a valid value in this case
- because it would represent an event after the date of
- collection."
+ - Cited Guidance:
+ "If the reference time point corresponds to the date of collection or assessment:
+ Start values: an observation can start BEFORE that time point, can start COINCIDENT with that
+ time point, or it is unknown (U) when it started. End values: an observation can end BEFORE
+ that time point, can end COINCIDENT with that time point, can be known that it didn't end but
+ was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a
+ valid value in this case because it would represent an event after the date of collection."
Document: IG v3.3
Section: 4.4.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0234
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: "If the reference time point corresponds to the date of
- collection or assessment: Start values: an observation can
- start BEFORE that time point, can start COINCIDENT with that
- time point, or it is unknown (U) when it started. End values:
- an observation can end BEFORE that time point, can end
- COINCIDENT with that time point, can be known that it didn't
- end but was ONGOING, or it is unknown (U) at all when it ended
- or if it was ongoing. AFTER is not a valid value in this case
- because it would represent an event after the date of
- collection."
+ - Cited Guidance:
+ "If the reference time point corresponds to the date of collection or assessment:
+ Start values: an observation can start BEFORE that time point, can start COINCIDENT with that
+ time point, or it is unknown (U) when it started. End values: an observation can end BEFORE
+ that time point, can end COINCIDENT with that time point, can be known that it didn't end but
+ was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a
+ valid value in this case because it would represent an event after the date of collection."
Document: TIG 1.0
Item: Num 2
Section: 2.8.7.6
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0443
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
# Variable: --ENRTPT
# Condition: --ENTPT corresponds to the date of collection or assessment.
# Rule: --ENRTPT in ('BEFORE', 'COINCIDENT', 'ONGOING', 'UNKNOWN')
@@ -120,9 +105,8 @@ Check:
Core:
Id: CORE-000324
Status: Published
- Version: '1'
-Description: Trigger error when --ENRTPT is not in ('BEFORE', 'COINCIDENT',
- 'ONGOING', 'UNKNOWN')
+ Version: "1"
+Description: Trigger error when --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'UNKNOWN')
Executability: Partially Executable
Outcome:
Message: --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'UNKNOWN')
diff --git a/Published/CORE-000325/rule.yml b/Published/CORE-000325/rule.yml
index c68d9f55c..cda32fa83 100644
--- a/Published/CORE-000325/rule.yml
+++ b/Published/CORE-000325/rule.yml
@@ -4,81 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ARMCD is limited to 20 characters, but does not have special
- character restrictions.
+ - Cited Guidance:
+ ARMCD is limited to 20 characters, but does not have special character
+ restrictions.
Document: SENDIG v3.0
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND27.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ARMCD is limited to 20 characters, but does not have special
- character restrictions.
+ - Cited Guidance:
+ ARMCD is limited to 20 characters, but does not have special character
+ restrictions.
Document: SENDIG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND27.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ARMCD is limited to 20 characters, but does not have special
- character restrictions.
+ - Cited Guidance:
+ ARMCD is limited to 20 characters, but does not have special character
+ restrictions.
Document: SENDIG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND27.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ARMCD is limited to 20 characters, but does not have special
- character restrictions.
+ - Cited Guidance:
+ ARMCD is limited to 20 characters, but does not have special character
+ restrictions.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND27.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ARMCD is limited to 20 characters, but does not have special
- character restrictions.
+ - Cited Guidance:
+ ARMCD is limited to 20 characters, but does not have special character
+ restrictions.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND27.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: ARMCD is limited to 20 characters, but does not have special
- character restrictions.
+ - Cited Guidance:
+ ARMCD is limited to 20 characters, but does not have special character
+ restrictions.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND27.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
- name: ARMCD
@@ -94,7 +100,7 @@ Check:
Core:
Id: CORE-000325
Status: Published
- Version: '1'
+ Version: "1"
Description: Verify ARMCD value length is <= 20
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000328/rule.yml b/Published/CORE-000328/rule.yml
index 6a2af447e..b2f3e626b 100644
--- a/Published/CORE-000328/rule.yml
+++ b/Published/CORE-000328/rule.yml
@@ -4,143 +4,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3202
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3202
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3202
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3202
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3202
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3202
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3202
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3202
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3202
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3202
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --STDY
@@ -150,13 +150,13 @@ Check:
Core:
Id: CORE-000328
Status: Published
- Version: '1'
-Description: Study Day of Start (--STDY) variable should be included into
- dataset, when Start Study Date/Time (--STDTC) variable is present.
+ Version: "1"
+Description: Study Day of Start (--STDY) variable should be included into dataset, when Start Study
+ Date/Time (--STDTC) variable is present.
Executability: Fully Executable
Outcome:
- Message: The Study Day of Start of Observation (--STDY) is not present in the
- dataset when Start Date/Time of Observation (--STDTC) is present.
+ Message: The Study Day of Start of Observation (--STDY) is not present in the dataset when Start
+ Date/Time of Observation (--STDTC) is present.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000334/rule.yml b/Published/CORE-000334/rule.yml
index 0b3aa0315..59efc38e9 100644
--- a/Published/CORE-000334/rule.yml
+++ b/Published/CORE-000334/rule.yml
@@ -7,189 +7,180 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "When the study does not include the data item for an expected
- variable, however, a null column must still be included in the
- dataset, and a comment must be included in the Define-XML
- document to state that the study does not include the data
- item."
+ - Cited Guidance:
+ "When the study does not include the data item for an expected variable, however,
+ a null column must still be included in the dataset, and a comment must be included in the Define-XML
+ document to state that the study does not include the data item."
Document: SDTM v1.4
Section: 4.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0016
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "When no data has been collected for an expected variable,
- however, a null column must still be included in the dataset,
- and a comment must be included in the define.xml to state that
- data was not collected."
+ - Cited Guidance:
+ "When no data has been collected for an expected variable, however, a null column
+ must still be included in the dataset, and a comment must be included in the define.xml to state
+ that data was not collected."
Document: IG v3.3
Section: 4.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0016
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "When no data has been collected for an expected variable
- however, a null column must still be included in the dataset,
- and a comment must be included in the define.xml to state that
- data was not collected."
+ - Cited Guidance:
+ "When no data has been collected for an expected variable however, a null column
+ must still be included in the dataset, and a comment must be included in the define.xml to state
+ that data was not collected."
Document: IG v3.2
Section: 4.1.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0016
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: All Required and Expected tabulation variables are included as
- columns
+ - Cited Guidance: All Required and Expected tabulation variables are included as columns
Document: TIG v1.0
Item: Table 2 Num
Section: 2.5.
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0301
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: An Expected variable is any variable necessary to make a record
- useful in the context of a specific domain. Columns for
- Expected variables must be present in each submitted dataset
- even if all values are null. Expected variables may contain
- some null values, but in most cases will not contain null
- values for every record.
+ - Cited Guidance:
+ An Expected variable is any variable necessary to make a record useful in
+ the context of a specific domain. Columns for Expected variables must be present in each
+ submitted dataset even if all values are null. Expected variables may contain some null
+ values, but in most cases will not contain null values for every record.
Document: SENDIG v3.0
Item: Text
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND13
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: An Expected variable is any variable necessary to make a record
- useful in the context of a specific domain. Columns for
- Expected variables must be present in each submitted dataset
- even if all values are null. Expected variables may contain
- some null values, but in most cases will not contain null
- values for every record.
+ - Cited Guidance:
+ An Expected variable is any variable necessary to make a record useful in
+ the context of a specific domain. Columns for Expected variables must be present in each
+ submitted dataset even if all values are null. Expected variables may contain some null
+ values, but in most cases will not contain null values for every record.
Document: SENDIG v3.1
Item: Text
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND13
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: An Expected variable is any variable necessary to make a record
- useful in the context of a specific domain. Columns for
- Expected variables must be present in each submitted dataset
- even if all values are null. Expected variables may contain
- some null values, but in most cases will not contain null
- values for every record.
+ - Cited Guidance:
+ An Expected variable is any variable necessary to make a record useful in
+ the context of a specific domain. Columns for Expected variables must be present in each
+ submitted dataset even if all values are null. Expected variables may contain some null
+ values, but in most cases will not contain null values for every record.
Document: SENDIG v3.1.1
Item: Text
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND13
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: An Expected variable is any variable necessary to make a record
- useful in the context of a specific domain. Columns for
- Expected variables must be present in each submitted dataset
- even if all values are null. Expected variables may contain
- some null values, but in most cases will not contain null
- values for every record.
+ - Cited Guidance:
+ An Expected variable is any variable necessary to make a record useful in
+ the context of a specific domain. Columns for Expected variables must be present in each
+ submitted dataset even if all values are null. Expected variables may contain some null
+ values, but in most cases will not contain null values for every record.
Document: SENDIG v3.1.1
Item: Text
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND13
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: An Expected variable is any variable necessary to make a record
- useful in the context of a specific domain. Columns for
- Expected variables must be present in each submitted dataset
- even if all values are null. Expected variables may contain
- some null values, but in most cases will not contain null
- values for every record.
+ - Cited Guidance:
+ An Expected variable is any variable necessary to make a record useful in
+ the context of a specific domain. Columns for Expected variables must be present in each
+ submitted dataset even if all values are null. Expected variables may contain some null
+ values, but in most cases will not contain null values for every record.
Document: SENDIG v3.1
Item: Text
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND13
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: An Expected variable is any variable necessary to make a record
- useful in the context of a specific domain. Columns for
- Expected variables must be present in each submitted dataset
- even if all values are null. Expected variables may contain
- some null values, but in most cases will not contain null
- values for every record.
+ - Cited Guidance:
+ An Expected variable is any variable necessary to make a record useful in
+ the context of a specific domain. Columns for Expected variables must be present in each
+ submitted dataset even if all values are null. Expected variables may contain some null
+ values, but in most cases will not contain null values for every record.
Document: SENDIG v3.1.1
Item: Text
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND13
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Exp for variables which are Expected to be included in the
- resulting dataset, even if all values are null. Such variables
- are considered necessary to make the data record useful in the
- context of the domain.
+ - Cited Guidance: Exp for variables which are Expected to be included in the resulting
+ dataset, even if all values are null. Such variables are considered necessary to make the
+ data record useful in the context of the domain.
Document: TIG v1.0
Item: Table Row 7
Section: 2.8.1 How to Read Domain Specifications
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0065
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: variable_name
@@ -199,7 +190,7 @@ Check:
Core:
Id: CORE-000334
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when an expected variable is not present in the dataset.
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000337/rule.yml b/Published/CORE-000337/rule.yml
index 1a14dd37b..2ab50e73a 100644
--- a/Published/CORE-000337/rule.yml
+++ b/Published/CORE-000337/rule.yml
@@ -7,64 +7,64 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple races are collected then the value of RACE should be
- 'MULTIPLE' and the additional information will be included in
- the Supplemental Qualifiers dataset.
+ - Cited Guidance:
+ If multiple races are collected then the value of RACE should be 'MULTIPLE'
+ and the additional information will be included in the Supplemental Qualifiers dataset.
Document: IG v3.2
Item: Assumption 6
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0140
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple races are collected then the value of RACE should be
- 'MULTIPLE' and the additional information will be included in
- the Supplemental Qualifiers dataset.
+ - Cited Guidance:
+ If multiple races are collected then the value of RACE should be 'MULTIPLE'
+ and the additional information will be included in the Supplemental Qualifiers dataset.
Document: IG v3.3
Item: Assumption 6
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0140
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple races are collected then the value of RACE should be
- 'MULTIPLE' and the additional information will be included in
- the Supplemental Qualifiers dataset.
+ - Cited Guidance:
+ If multiple races are collected then the value of RACE should be 'MULTIPLE'
+ and the additional information will be included in the Supplemental Qualifiers dataset.
Document: IG v3.4
Item: Assumption 6
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0140
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If multiple races are collected then the value of RACE should be
- 'MULTIPLE' and the additional information will be included in
- the Supplemental Qualifiers dataset.
+ - Cited Guidance:
+ If multiple races are collected then the value of RACE should be 'MULTIPLE'
+ and the additional information will be included in the Supplemental Qualifiers dataset.
Document: TIG 1.0
Item: Assumption 6
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0386
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
@@ -86,17 +86,17 @@ Check:
Core:
Id: CORE-000337
Status: Published
- Version: '1'
-Description: 'Raise an error when multiple races are collected in SUPPDM but
- RACE in DM does not equal "MULTIPLE".'
+ Version: "1"
+Description:
+ 'Raise an error when multiple races are collected in SUPPDM but RACE in DM does not equal
+ "MULTIPLE".'
Executability: Fully Executable
Match Datasets:
- Keys:
- USUBJID
Name: DM
Outcome:
- Message: 'Multiple races are collected in SUPPDM but RACE in DM does not equal
- "MULTIPLE".'
+ Message: 'Multiple races are collected in SUPPDM but RACE in DM does not equal "MULTIPLE".'
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000341/rule.yml b/Published/CORE-000341/rule.yml
index 296683e79..6ea8d10e5 100644
--- a/Published/CORE-000341/rule.yml
+++ b/Published/CORE-000341/rule.yml
@@ -4,97 +4,103 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When --ORRES is populated, --STRESC must also be populated,
- regardless of whether the data values are character or numeric
+ - Cited Guidance:
+ When --ORRES is populated, --STRESC must also be populated, regardless of
+ whether the data values are character or numeric
Document: IG v3.0
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND87
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When --ORRES is populated, --STRESC must also be populated,
- regardless of whether the data values are character or numeric
+ - Cited Guidance:
+ When --ORRES is populated, --STRESC must also be populated, regardless of
+ whether the data values are character or numeric
Document: IG v3.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND87
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When --ORRES is populated, --STRESC must also be populated,
- regardless of whether the data values are character or numeric
+ - Cited Guidance:
+ When --ORRES is populated, --STRESC must also be populated, regardless of
+ whether the data values are character or numeric
Document: IG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND87
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When --ORRES is populated, --STRESC must also be populated,
- regardless of whether the data values are character or numeric
+ - Cited Guidance:
+ When --ORRES is populated, --STRESC must also be populated, regardless of
+ whether the data values are character or numeric
Document: IG v3.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND87
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When --ORRES is populated, --STRESC must also be populated,
- regardless of whether the data values are character or numeric
+ - Cited Guidance:
+ When --ORRES is populated, --STRESC must also be populated, regardless of
+ whether the data values are character or numeric
Document: IG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND87
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: When --ORRES is populated, --STRESC must also be populated,
- regardless of whether the data values are character or numeric
+ - Cited Guidance:
+ When --ORRES is populated, --STRESC must also be populated, regardless of
+ whether the data values are character or numeric
Document: IG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND87
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: When --ORRES is populated, --STRESC must also be populated,
- regardless of whether the data values are character or
- numeric.
+ - Cited Guidance:
+ When --ORRES is populated, --STRESC must also be populated, regardless of
+ whether the data values are character or numeric.
Document: TIG v1.0
Item: Text
Section: 2.8.7.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0279
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --ORRES
@@ -104,7 +110,7 @@ Check:
Core:
Id: CORE-000341
Status: Published
- Version: '1'
+ Version: "1"
Description: When --ORRES is populated, --STRESC must also be populated.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000342/rule.yml b/Published/CORE-000342/rule.yml
index a3adb92b4..c55a16b6b 100644
--- a/Published/CORE-000342/rule.yml
+++ b/Published/CORE-000342/rule.yml
@@ -4,196 +4,211 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique
- within the trial.
+ - Cited Guidance:
+ Each Trial Set must be identified by a SETCD which is unique within the
+ trial.
Document: IG v3.0
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND233
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique
- within the trial.
+ - Cited Guidance:
+ Each Trial Set must be identified by a SETCD which is unique within the
+ trial.
Document: IG v3.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND233
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique
- within the trial.
+ - Cited Guidance:
+ Each Trial Set must be identified by a SETCD which is unique within the
+ trial.
Document: IG v3.1.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND233
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique
- within the trial.
+ - Cited Guidance:
+ Each Trial Set must be identified by a SETCD which is unique within the
+ trial.
Document: IG v3.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND233
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique
- within the trial.
+ - Cited Guidance:
+ Each Trial Set must be identified by a SETCD which is unique within the
+ trial.
Document: IG v3.1.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND233
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique
- within the trial.
+ - Cited Guidance:
+ Each Trial Set must be identified by a SETCD which is unique within the
+ trial.
Document: IG v3.1.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND233
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Each Trial Set must be identified by a SETCD that is unique
- within the trial.
+ - Cited Guidance:
+ Each Trial Set must be identified by a SETCD that is unique within the
+ trial.
Document: TIG v1.0
Item: Assumption 2
Section: 2.8.9.28 Assumption 2
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0161
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
- # FDA BUsiness Rule metadata added as both have the same logic
+ Version:
+ "1.0"
+ # FDA BUsiness Rule metadata added as both have the same logic
- Organization: FDA
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Trial set parameter code should be unique for each study set for
- nonclinical data.
+ - Cited Guidance:
+ Trial set parameter code should be unique for each study set for nonclinical
+ data.
Document: FDA
Section: FDAB050
Origin: FDA Business Rules
Rule Identifier:
Id: FB5001
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Trial set parameter code should be unique for each study set for
- nonclinical data.
+ - Cited Guidance:
+ Trial set parameter code should be unique for each study set for nonclinical
+ data.
Document: FDA
Section: FDAB050
Origin: FDA Business Rules
Rule Identifier:
Id: FB5001
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Trial set parameter code should be unique for each study set for
- nonclinical data.
+ - Cited Guidance:
+ Trial set parameter code should be unique for each study set for nonclinical
+ data.
Document: FDA
Section: FDAB050
Origin: FDA Business Rules
Rule Identifier:
Id: FB5001
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Trial set parameter code should be unique for each study set for
- nonclinical data.
+ - Cited Guidance:
+ Trial set parameter code should be unique for each study set for nonclinical
+ data.
Document: FDA
Section: FDAB050
Origin: FDA Business Rules
Rule Identifier:
Id: FB5001
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Trial set parameter code should be unique for each study set for
- nonclinical data.
+ - Cited Guidance:
+ Trial set parameter code should be unique for each study set for nonclinical
+ data.
Document: FDA
Section: FDAB050
Origin: FDA Business Rules
Rule Identifier:
Id: FB5001
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Trial set parameter code should be unique for each study set for
- nonclinical data.
+ - Cited Guidance:
+ Trial set parameter code should be unique for each study set for nonclinical
+ data.
Document: FDA
Section: FDAB050
Origin: FDA Business Rules
Rule Identifier:
Id: FB5001
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Trial set parameter code should be unique for each study set for
- nonclinical data.
+ - Cited Guidance:
+ Trial set parameter code should be unique for each study set for nonclinical
+ data.
Document: FDA
Section: FDAB050
Origin: FDA Business Rules
Rule Identifier:
Id: FB5001
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
# SETCD must be unique for the combination of value in TXPARMCD, TXPARM, TXVAL, and SET
all:
@@ -207,13 +222,11 @@ Check:
Core:
Id: CORE-000342
Status: Published
- Version: '1'
-Description: SETCD must be unique for the combination of value in TXPARMCD,
- TXPARM, TXVAL, and SET
+ Version: "1"
+Description: SETCD must be unique for the combination of value in TXPARMCD, TXPARM, TXVAL, and SET
Executability: Fully Executable
Outcome:
- Message: SETCD is not unique for the combination of value in TXPARMCD, TXPARM,
- TXVAL, and SET
+ Message: SETCD is not unique for the combination of value in TXPARMCD, TXPARM, TXVAL, and SET
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000351/rule.yml b/Published/CORE-000351/rule.yml
index a08a3c9eb..b0c20c981 100644
--- a/Published/CORE-000351/rule.yml
+++ b/Published/CORE-000351/rule.yml
@@ -1,5 +1,5 @@
# Variable: USUBJID
-# Condition:
+# Condition:
# Rule: USUBJID unique within a submission
Authorities:
- Organization: CDISC
@@ -7,67 +7,64 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifier used to uniquely identify a subject across all
- studies for all applications or submissions involving the
- product.
+ - Cited Guidance:
+ Identifier used to uniquely identify a subject across all studies for all
+ applications or submissions involving the product.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0151
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifier used to uniquely identify a subject across all
- studies
+ - Cited Guidance: Identifier used to uniquely identify a subject across all studies
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0151
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifier used to uniquely identify a subject across all
- studies
+ - Cited Guidance: Identifier used to uniquely identify a subject across all studies
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0151
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Identifier used to uniquely identify a subject across all
- studies for all applications or submissions involving the
- product.
+ - Cited Guidance:
+ Identifier used to uniquely identify a subject across all studies for all
+ applications or submissions involving the product.
Document: TIG 1.0
Item: Specification
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0392
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: No more than one animal may have the same USUBJID within a
- submission.
+ - Cited Guidance: No more than one animal may have the same USUBJID within a submission.
Document: SENDIG v3.0
Item: Text
Section: 4.2.3
@@ -80,8 +77,7 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: No more than one animal may have the same USUBJID within a
- submission.
+ - Cited Guidance: No more than one animal may have the same USUBJID within a submission.
Document: SENDIG v3.1
Item: Text
Section: 4.2.3
@@ -94,8 +90,7 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: No more than one animal may have the same USUBJID within a
- submission.
+ - Cited Guidance: No more than one animal may have the same USUBJID within a submission.
Document: SENDIG v3.1.1
Item: Text
Section: 4.2.3
@@ -108,8 +103,7 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: No more than one animal may have the same USUBJID within a
- submission.
+ - Cited Guidance: No more than one animal may have the same USUBJID within a submission.
Document: SENDIG v3.1
Item: Text
Section: 4.2.3
@@ -122,8 +116,7 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: No more than one animal may have the same USUBJID within a
- submission.
+ - Cited Guidance: No more than one animal may have the same USUBJID within a submission.
Document: SENDIG v3.1.1
Item: Text
Section: 4.2.3
@@ -136,8 +129,7 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: No more than one animal may have the same USUBJID within a
- submission.
+ - Cited Guidance: No more than one animal may have the same USUBJID within a submission.
Document: SENDIG v3.1.1
Item: Text
Section: 4.2.3
@@ -150,9 +142,9 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: A sequence of characters used to uniquely identify a subject
- across all studies for all applications or submissions
- involving the product.
+ - Cited Guidance:
+ A sequence of characters used to uniquely identify a subject across all
+ studies for all applications or submissions involving the product.
Document: TIG v1.0
Item: Text
Section: SDTM v2.1, Identifiers for All Classes, USUBJID
@@ -171,7 +163,7 @@ Check:
Core:
Id: CORE-000351
Status: Published
- Version: '1'
+ Version: "1"
Description: USUBJID must be unique across all studies
Executability: Partially Executable
Outcome:
diff --git a/Published/CORE-000352/rule.yml b/Published/CORE-000352/rule.yml
index b0b1b9f0b..b85377dfc 100644
--- a/Published/CORE-000352/rule.yml
+++ b/Published/CORE-000352/rule.yml
@@ -7,82 +7,84 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Since there are, by definition, no gaps between Elements, the
- value of SEENDTC for one Element will always be the same as
- the value of SESTDTC for the next Element.
+ - Cited Guidance:
+ Since there are, by definition, no gaps between Elements, the value of
+ SEENDTC for one Element will always be the same as the value of SESTDTC for the next
+ Element.
Document: IG v3.4
Item: Assumption 8
- Section: '5.3'
+ Section: "5.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0207
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Since there are, by definition, no gaps between Elements, the
- value of SEENDTC for one Element will always be the same as
- the value of SESTDTC for the next Element
+ - Cited Guidance:
+ Since there are, by definition, no gaps between Elements, the value of
+ SEENDTC for one Element will always be the same as the value of SESTDTC for the next
+ Element
Document: IG v3.2
Item: Assumption 10
Section: 5 SE
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0207
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Since there are, by definition, no gaps between Elements, the
- value of SEENDTC for one Element will always be the same as
- the value of SESTDTC for the next Element
+ - Cited Guidance:
+ Since there are, by definition, no gaps between Elements, the value of
+ SEENDTC for one Element will always be the same as the value of SESTDTC for the next
+ Element
Document: IG v3.3
Item: Assumption 8
- Section: '5.3'
+ Section: "5.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0207
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Because there are no time gaps between Elements, the SEENDTC
- value for one element will always be the same as the SESTDTC
- value for the next Element.
+ - Cited Guidance:
+ Because there are no time gaps between Elements, the SEENDTC value for one
+ element will always be the same as the SESTDTC value for the next Element.
Document: IG v3.0
Item: Assumption 1
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND126
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Since there are, by definition, no gaps between Elements, the
- value of SEENDTC for one Element will always be the same as
- the value of SESTDTC for the next Element. Because there are,
- by definition, no gaps between elements, the value of SEENDTC
- for one element will always be the same as the value of
- SESTDTC for the next element.
+ - Cited Guidance:
+ Since there are, by definition, no gaps between Elements, the value of
+ SEENDTC for one Element will always be the same as the value of SESTDTC for the next
+ Element. Because there are, by definition, no gaps between elements, the value of SEENDTC
+ for one element will always be the same as the value of SESTDTC for the next element.
Document: TIG 1.0
Item: Assumption 7
Section: 2.8.10.24
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0427
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SEENDTC
@@ -93,7 +95,7 @@ Check:
Core:
Id: CORE-000352
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error where SEENDTC is not equal to SESTDTC of the next element.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000353/rule.yml b/Published/CORE-000353/rule.yml
index c0b359cad..03867e58c 100644
--- a/Published/CORE-000353/rule.yml
+++ b/Published/CORE-000353/rule.yml
@@ -4,87 +4,93 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Dates or durations represented in TSVAL must be in the
- appropriate ISO 8601 format.
+ - Cited Guidance:
+ Dates or durations represented in TSVAL must be in the appropriate ISO 8601
+ format.
Document: IG v3.0
Item: Specification
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND248.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Dates or durations represented in TSVAL must be in the
- appropriate ISO 8601 format.
+ - Cited Guidance:
+ Dates or durations represented in TSVAL must be in the appropriate ISO 8601
+ format.
Document: IG v3.1
Item: Specification
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND248.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Dates or durations represented in TSVAL must be in the
- appropriate ISO 8601 format.
+ - Cited Guidance:
+ Dates or durations represented in TSVAL must be in the appropriate ISO 8601
+ format.
Document: IG v3.1.1
Item: Specification
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND248.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Dates or durations represented in TSVAL must be in the
- appropriate ISO 8601 format.
+ - Cited Guidance:
+ Dates or durations represented in TSVAL must be in the appropriate ISO 8601
+ format.
Document: IG v3.1
Item: Specification
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND248.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Dates or durations represented in TSVAL must be in the
- appropriate ISO 8601 format.
+ - Cited Guidance:
+ Dates or durations represented in TSVAL must be in the appropriate ISO 8601
+ format.
Document: IG v3.1.1
Item: Specification
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND248.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Dates or durations represented in TSVAL must be in the
- appropriate ISO 8601 format.
+ - Cited Guidance:
+ Dates or durations represented in TSVAL must be in the appropriate ISO 8601
+ format.
Document: IG v3.1.1
Item: Specification
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND248.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
# Applies for:
# date/datetime: TSVAL = EXPENDTC, EXPSTDTC, STSTENDTC, DOSENDTC, DOSSTDTC, or STENDTC
# duration: TRMSAC, INTSAC, SLENGTH, RECSAC
@@ -126,8 +132,9 @@ Check:
operator: equal_to
value: STENDTC
- name: TSVAL
- operator: invalid_date
- # Duration parameter values - P.S. negative durations are allowed
+ operator:
+ invalid_date
+ # Duration parameter values - P.S. negative durations are allowed
- all:
- name: TSPARMCD
operator: equal_to
@@ -182,9 +189,8 @@ Check:
Core:
Id: CORE-000353
Status: Published
- Version: '1'
-Description: Dates or durations represented in TSVAL must be in the appropriate
- ISO 8601 format.
+ Version: "1"
+Description: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 format.
Executability: Fully Executable
Outcome:
Message: Invalid date/datetime or duration format
diff --git a/Published/CORE-000354/rule.yml b/Published/CORE-000354/rule.yml
index 90d353bd0..3576385cf 100644
--- a/Published/CORE-000354/rule.yml
+++ b/Published/CORE-000354/rule.yml
@@ -7,70 +7,69 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) .
- . . are determined by comparing the date portion of the
- respective date/time variables (--DTC, --STDTC, and --ENDTC)
- to the date portion of the Subject Reference Start Date
- (RFSTDTC from the Demographics domain)
+ - Cited Guidance:
+ The permissible Study Day variables (--DY, --STDY, and --ENDY) . . . are
+ determined by comparing the date portion of the respective date/time variables (--DTC,
+ --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC
+ from the Demographics domain)
Document: SDTMIG v3.4
Section: 4.4.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0007
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) .
- . . are determined by comparing the date portion of the
- respective date/time variables (--DTC, --STDTC, and --ENDTC)
- to the date portion of the Subject Reference Start Date
- (RFSTDTC from the Demographics domain).
+ - Cited Guidance:
+ The permissible Study Day variables (--DY, --STDY, and --ENDY) . . . are
+ determined by comparing the date portion of the respective date/time variables (--DTC,
+ --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC
+ from the Demographics domain).
Document: SDTMIG v3.3
Section: 4.4.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0007
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) .
- . . are determined by comparing the date portion of the
- respective date/time variables (--DTC, --STDTC, and --ENDTC)
- to the date portion of the Subject Reference Start Date
- (RFSTDTC from the Demographics domain).
+ - Cited Guidance:
+ The permissible Study Day variables (--DY, --STDY, and --ENDY) . . . are
+ determined by comparing the date portion of the respective date/time variables (--DTC,
+ --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC
+ from the Demographics domain).
Document: SDTMIG v3.2
Section: 4.1.4.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0007
- Version: '1'
- Version: '2.0'
- Version: '3.2'
- - Name: 'TIG'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: Variables --DY, --STDY, and --ENDY represent the timing of
- observations in days relative to the reference start date in
- RFSTDTC where the value of --DY is the relative day of the
- date populated in --DTC for the observation,--STDTC is the
- relative day of the date populated in --STDTC for the
- observation; an--ENDY is the relative day of the of the date
- populated in --ENDTC for the observation.
+ - Cited Guidance:
+ Variables --DY, --STDY, and --ENDY represent the timing of observations in
+ days relative to the reference start date in RFSTDTC where the value of --DY is the
+ relative day of the date populated in --DTC for the observation,--STDTC is the relative
+ day of the date populated in --STDTC for the observation; an--ENDY is the relative day of
+ the of the date populated in --ENDTC for the observation.
Document: TIG 1.0
Section: 2.8.7.6
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0292
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --DY
@@ -83,17 +82,17 @@ Check:
Core:
Id: CORE-000354
Status: Published
- Version: '1'
-Description: Raise an error when the date portion of --DTC is an incomplete date
- or the date portion of DM.RFSTDTC is an incomplete date, but --DY is not empty
+ Version: "1"
+Description: Raise an error when the date portion of --DTC is an incomplete date or the date portion
+ of DM.RFSTDTC is an incomplete date, but --DY is not empty
Executability: Fully Executable
Match Datasets:
- Keys:
- USUBJID
Name: DM
Outcome:
- Message: The date portion of --DTC is not complete date or the date portion of
- DM.RFSTDTC is not complete date, but --DY is not empty
+ Message: The date portion of --DTC is not complete date or the date portion of DM.RFSTDTC is not
+ complete date, but --DY is not empty
Output Variables:
- --DY
- --DTC
diff --git a/Published/CORE-000355/rule.yml b/Published/CORE-000355/rule.yml
index 48c7a95cd..95706e528 100644
--- a/Published/CORE-000355/rule.yml
+++ b/Published/CORE-000355/rule.yml
@@ -7,153 +7,162 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.2
Section: 4.1.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0014
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.3
Section: 4.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0014
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.4
Section: 4.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0014
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.0
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND12
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.1
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND12
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.1.1
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND12
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.1
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND12
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.1.1
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND12
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.1.1
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND12
- Version: '1'
- Version: '5.0'
- Version: '1.0'
- - Name: 'TIG'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: All Required and Expected tabulation variables are included as
- columns in the dataset. Required tabulation variables are
- populated for all records in the dataset.
+ - Cited Guidance:
+ All Required and Expected tabulation variables are included as columns in
+ the dataset. Required tabulation variables are populated for all records in the dataset.
Document: TIG 1.0
Item: Table 2 Num 6
- Section: '2.5'
+ Section: "2.5"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0299
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
- - Name: 'TIG'
+ Version: "1.0"
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: Req for variables which are Required and must be included in the
- resulting dataset and cannot be null for any record. Such
- variables are basic to the identification of a data record or
- are necessary to make the record meaningful.
+ - Cited Guidance:
+ Req for variables which are Required and must be included in the resulting
+ dataset and cannot be null for any record. Such variables are basic to the identification
+ of a data record or are necessary to make the record meaningful.
Document: TIG 1.0
Item: Text
Section: 2.8.1 How to Read Domain Specifications
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0057
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: variable_name
@@ -163,9 +172,8 @@ Check:
Core:
Id: CORE-000355
Status: Published
- Version: '1'
-Description: 'Part A: Raise an error when a Required variable is not present in
- the dataset.'
+ Version: "1"
+Description: "Part A: Raise an error when a Required variable is not present in the dataset."
Executability: Fully Executable
Operations:
- id: $required_variables
diff --git a/Published/CORE-000356/rule.yml b/Published/CORE-000356/rule.yml
index 5574d97b2..19423d949 100644
--- a/Published/CORE-000356/rule.yml
+++ b/Published/CORE-000356/rule.yml
@@ -7,153 +7,162 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.2
Section: 4.1.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0014
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.3
Section: 4.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0014
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.4
Section: 4.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0014
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.0
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND12
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.1
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND12
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.1.1
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND12
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.1
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND12
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.1.1
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND12
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Required variables must always be included in the dataset and
- cannot be null for any record.
+ - Cited Guidance:
+ Required variables must always be included in the dataset and cannot be null
+ for any record.
Document: IG v3.1.1
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND12
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: All Required and Expected tabulation variables are included as
- columns in the dataset. Required tabulation variables are
- populated for all records in the dataset.
+ - Cited Guidance:
+ All Required and Expected tabulation variables are included as columns in
+ the dataset. Required tabulation variables are populated for all records in the dataset.
Document: TIG 1.0
Item: Table 2 Num 6
- Section: '2.5'
+ Section: "2.5"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0299
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Req for variables which are Required and must be included in the
- resulting dataset and cannot be null for any record. Such
- variables are basic to the identification of a data record or
- are necessary to make the record meaningful.
+ - Cited Guidance:
+ Req for variables which are Required and must be included in the resulting
+ dataset and cannot be null for any record. Such variables are basic to the identification
+ of a data record or are necessary to make the record meaningful.
Document: TIG 1.0
Item: Text
Section: 2.8.1 How to Read Domain Specifications
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0057
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: $required_variables
@@ -166,8 +175,8 @@ Check:
Core:
Id: CORE-000356
Status: Published
- Version: '1'
-Description: 'Part B: Raise an error when a Required variable is null.'
+ Version: "1"
+Description: "Part B: Raise an error when a Required variable is null."
Executability: Fully Executable
Operations:
- id: $required_variables
diff --git a/Published/CORE-000357/rule.yml b/Published/CORE-000357/rule.yml
index 71c7cc876..7d08e6764 100644
--- a/Published/CORE-000357/rule.yml
+++ b/Published/CORE-000357/rule.yml
@@ -7,65 +7,68 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Supplemental Qualifier datasets for split domains would also be
- split. The nomenclature would include the additional
- one-to-two characters used to identify the split dataset.
+ - Cited Guidance:
+ Supplemental Qualifier datasets for split domains would also be split. The
+ nomenclature would include the additional one-to-two characters used to identify the split
+ dataset.
Document: IG v3.4
- Item: '7'
+ Item: "7"
Section: 4.1.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0018
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Supplemental Qualifier datasets for split domains would also be
- split. The nomenclature would include the additional
- one-to-two characters used to identify the split dataset.
+ - Cited Guidance:
+ Supplemental Qualifier datasets for split domains would also be split. The
+ nomenclature would include the additional one-to-two characters used to identify the split
+ dataset.
Document: IG v3.2
Item: Rule 7
Section: 4.1.1.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0018
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Supplemental Qualifier datasets for split domains would also be
- split. The nomenclature would include the additional
- one-to-two characters used to identify the split dataset.
+ - Cited Guidance:
+ Supplemental Qualifier datasets for split domains would also be split. The
+ nomenclature would include the additional one-to-two characters used to identify the split
+ dataset.
Document: IG v3.3
Item: Rule 7
Section: 4.1.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0018
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Supplemental Qualifier datasets for split domains would also be
- split. The nomenclature will include the additional one to two
- characters used to identify the split dataset (e.g., SUPPLBHM,
- SUPPFACM).
+ - Cited Guidance:
+ Supplemental Qualifier datasets for split domains would also be split. The
+ nomenclature will include the additional one to two characters used to identify the split
+ dataset (e.g., SUPPLBHM, SUPPFACM).
Document: TIG 1.0
Item: Num 9.3.ii
- Section: '2.6'
+ Section: "2.6"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0303
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: dataset_name
@@ -74,13 +77,13 @@ Check:
Core:
Id: CORE-000357
Status: Published
- Version: '1'
-Description: When a supplemental qualifier dataset is associated with a split
- dataset, the dataset name length must not be greater than 8 characters.
+ Version: "1"
+Description: When a supplemental qualifier dataset is associated with a split dataset, the dataset
+ name length must not be greater than 8 characters.
Executability: Fully Executable
Outcome:
- Message: Supplemental qualifier dataset associated with a split dataset is
- greater than 8 characters in length
+ Message: Supplemental qualifier dataset associated with a split dataset is greater than 8
+ characters in length
Rule Type: Dataset Metadata Check
Scope:
Classes:
diff --git a/Published/CORE-000358/rule.yml b/Published/CORE-000358/rule.yml
index d784d3a64..88c06c2ba 100644
--- a/Published/CORE-000358/rule.yml
+++ b/Published/CORE-000358/rule.yml
@@ -7,33 +7,35 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: --LNKGRP is a grouping identifier used to identify a group of
- records in one domain that is related to a record in another
- domain, often forming a many-to-one relationship.
+ - Cited Guidance:
+ --LNKGRP is a grouping identifier used to identify a group of records in one
+ domain that is related to a record in another domain, often forming a many-to-one
+ relationship.
Document: SDTMIG v3.4
Item: 2.E.2
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0022
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: --LNKGRP is a grouping identifier used to identify a group of
- records in one domain that is related to a record in another
- domain, often forming a many-to-one relationship.
+ - Cited Guidance:
+ --LNKGRP is a grouping identifier used to identify a group of records in one
+ domain that is related to a record in another domain, often forming a many-to-one
+ relationship.
Document: SDTMIG v3.3
Item: 2.E.2
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0022
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -44,34 +46,34 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0022
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: A sequence of characters used to uniquely identify a group of
- records, for a subject, in one domain and link it to 1 or more
- records for that subject in another domain.
+ - Cited Guidance:
+ A sequence of characters used to uniquely identify a group of records, for a
+ subject, in one domain and link it to 1 or more records for that subject in another
+ domain.
Document: SDTM v2.1
Item: --LNKGRP, Definition column
Section: SDTM- 3.1.4 Identifiers for All Classes
- - Cited Guidance: Groups of records can be related by using grouping variables
- such as --LNKID or --LNKGRP in IDVAR. Using --LNKID or
- --LNKGRP can be a more efficient method of representing
- relationships in RELREC when relating a single or group of
- records in one dataset to a group of records in another
- dataset.
+ - Cited Guidance:
+ Groups of records can be related by using grouping variables such as --LNKID
+ or --LNKGRP in IDVAR. Using --LNKID or --LNKGRP can be a more efficient method of
+ representing relationships in RELREC when relating a single or group of records in one
+ dataset to a group of records in another dataset.
Document: SDTM v2.1
Item: --LNKGRP, Definition column
Section: 2.8.5.2
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0306
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --LNKGRP
@@ -82,9 +84,9 @@ Check:
Core:
Id: CORE-000358
Status: Published
- Version: '1'
-Description: Verify that when --LNKGRP is present in one domain it is also
- present in another domain.
+ Version: "1"
+Description: Verify that when --LNKGRP is present in one domain it is also present in another
+ domain.
Executability: Fully Executable
Operations:
- id: $VARIABLE_COUNT
diff --git a/Published/CORE-000359/rule.yml b/Published/CORE-000359/rule.yml
index d4abfcd5b..bf9df5a1c 100644
--- a/Published/CORE-000359/rule.yml
+++ b/Published/CORE-000359/rule.yml
@@ -4,68 +4,73 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The use of an interval of uncertainty, as described in Section
- 4.4.2, cannot be used for DSSTDTC.
+ - Cited Guidance:
+ The use of an interval of uncertainty, as described in Section 4.4.2, cannot
+ be used for DSSTDTC.
Document: IG v3.1
Section: 6.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND317'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND317"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The use of an interval of uncertainty, as described in Section
- 4.4.2, cannot be used for DSSTDTC.
+ - Cited Guidance:
+ The use of an interval of uncertainty, as described in Section 4.4.2, cannot
+ be used for DSSTDTC.
Document: IG v3.1.1
Section: 6.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND317'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND317"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The use of an interval of uncertainty, as described in Section
- 4.4.2, cannot be used for DSSTDTC.
+ - Cited Guidance:
+ The use of an interval of uncertainty, as described in Section 4.4.2, cannot
+ be used for DSSTDTC.
Document: IG v3.1
Section: 6.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND317'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND317"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The use of an interval of uncertainty, as described in Section
- 4.4.2, cannot be used for DSSTDTC.
+ - Cited Guidance:
+ The use of an interval of uncertainty, as described in Section 4.4.2, cannot
+ be used for DSSTDTC.
Document: IG v3.1.1
Section: 6.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND317'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND317"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The use of an interval of uncertainty, as described in Section
- 4.4.2, cannot be used for DSSTDTC.
+ - Cited Guidance:
+ The use of an interval of uncertainty, as described in Section 4.4.2, cannot
+ be used for DSSTDTC.
Document: IG v3.1.1
Section: 6.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND317'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND317"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: DSSTDTC
@@ -76,7 +81,7 @@ Check:
Core:
Id: CORE-000359
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when the value of DSSTDTC contains a slash
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000361/rule.yml b/Published/CORE-000361/rule.yml
index b8b47433b..0d9a49ab6 100644
--- a/Published/CORE-000361/rule.yml
+++ b/Published/CORE-000361/rule.yml
@@ -7,109 +7,114 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There should be a one-to-one relationship between values of
- VISIT and VISITNUM.
+ - Cited Guidance:
+ There should be a one-to-one relationship between values of VISIT and
+ VISITNUM.
Document: IG v3.4
Section: 4.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0035
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There should be a one-to-one relationship between values of
- VISIT and VISITNUM.
+ - Cited Guidance:
+ There should be a one-to-one relationship between values of VISIT and
+ VISITNUM.
Document: IG v3.3
Section: 4.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0035
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There should be a one-to-one relationship between values of
- VISIT and VISITNUM.
+ - Cited Guidance:
+ There should be a one-to-one relationship between values of VISIT and
+ VISITNUM.
Document: IG v3.2
Section: 4.1.4.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0035
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: There will be a one-to-one relationship between values of VISIT
- and VISITNUM in TV.
+ - Cited Guidance:
+ There will be a one-to-one relationship between values of VISIT and VISITNUM
+ in TV.
Document: TIG 1.0
Item: Assumption 6
Section: 2.8.10.31
- - Cited Guidance: Values of VISIT, VISITNUM, and VISITDY will be represented as
- defined in the Trial Visits (TV) dataset.
+ - Cited Guidance:
+ Values of VISIT, VISITNUM, and VISITDY will be represented as defined in the
+ Trial Visits (TV) dataset.
Document: TIG 1.0
Item: Planned Timing table NUM 1
Section: 2.8.7.5
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0316
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0919
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0919
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0919
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: VISITNUM
@@ -121,9 +126,9 @@ Check:
Core:
Id: CORE-000361
Status: Published
- Version: '1'
-Description: When VISITNUM is present in TV, VISIT and VISITNUM should have a
- one-to-one relationship.
+ Version: "1"
+Description: When VISITNUM is present in TV, VISIT and VISITNUM should have a one-to-one
+ relationship.
Executability: Fully Executable
Operations:
- domain: TV
diff --git a/Published/CORE-000363/rule.yml b/Published/CORE-000363/rule.yml
index 998a5194b..45e85b296 100644
--- a/Published/CORE-000363/rule.yml
+++ b/Published/CORE-000363/rule.yml
@@ -4,64 +4,68 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This
- will be the same as the date of informed consent in the
- Disposition domain, if that protocol milestone is documented.
+ - Cited Guidance:
+ Date/time of informed consent in ISO 8601 character format. This will be the
+ same as the date of informed consent in the Disposition domain, if that protocol milestone
+ is documented.
Document: IG v3.4
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0068
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This
- will be the same as the date of informed consent in the
- Disposition domain, if that protocol milestone is documented.
+ - Cited Guidance:
+ Date/time of informed consent in ISO 8601 character format. This will be the
+ same as the date of informed consent in the Disposition domain, if that protocol milestone
+ is documented.
Document: IG v3.2
Item: Specification
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0068
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This
- will be the same as the date of informed consent in the
- Disposition domain, if that protocol milestone is documented.
+ - Cited Guidance:
+ Date/time of informed consent in ISO 8601 character format. This will be the
+ same as the date of informed consent in the Disposition domain, if that protocol milestone
+ is documented.
Document: IG v3.3
Item: Specification
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0068
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This
- will be the same as the date of informed consent in the
- Disposition domain, if that protocol milestone is documented.
+ - Cited Guidance:
+ Date/time of informed consent in ISO 8601 character format. This will be the
+ same as the date of informed consent in the Disposition domain, if that protocol milestone
+ is documented.
Document: TIG 1.0
Item: Specification
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0338
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
# Variable: DSSTDTC
# Condition: Multiple informed consents obtained and DSDECOD = 'INFORMED CONSENT OBTAINED'
# Rule: For each subject, earliest DSSTDTC = DM.RFICDTC
@@ -82,10 +86,9 @@ Check:
Core:
Id: CORE-000363
Status: Published
- Version: '1'
-Description: When there are multiple informed consents obtained and DSDECOD =
- 'INFORMED CONSENT OBTAINED', the earliest DSSTDTC for each subject should be
- equal to DM.RFICDTC.
+ Version: "1"
+Description: When there are multiple informed consents obtained and DSDECOD = 'INFORMED CONSENT
+ OBTAINED', the earliest DSSTDTC for each subject should be equal to DM.RFICDTC.
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -99,8 +102,7 @@ Operations:
name: DSSTDTC
operator: min_date
Outcome:
- Message: The earliest disposition date for "INFORMED CONSENT OBTAINED" is not
- equal to DM.RFICDTC
+ Message: The earliest disposition date for "INFORMED CONSENT OBTAINED" is not equal to DM.RFICDTC
Output Variables:
- RFICDTC
- $min_ds_dsstdtc
diff --git a/Published/CORE-000370/rule.yml b/Published/CORE-000370/rule.yml
index b6a5ea93e..e953a8cba 100644
--- a/Published/CORE-000370/rule.yml
+++ b/Published/CORE-000370/rule.yml
@@ -4,88 +4,82 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: This will be the same as the date of informed consent in the
- Disposition domain, if that protocol milestone is
- documented. Would be null only in studies not collecting the
- date of informed consent.
+ - Cited Guidance:
+ This will be the same as the date of informed consent in the Disposition
+ domain, if that protocol milestone is documented. Would be null only in studies not
+ collecting the date of informed consent.
Document: SDTMIG v3.4
Item: Specification
- Section: '5.2'
- - Cited Guidance: "RFICDTC should correspond to the date of the informed consent
- protocol milestone in DS, if that protocol milestone is
- documented in DS.
-
- \ In the event that there are multiple informed consents, this
- will be the date of the first one."
+ Section: "5.2"
+ - Cited Guidance:
+ "RFICDTC should correspond to the date of the informed consent protocol milestone
+ in DS, if that protocol milestone is documented in DS.\n In the event that there are multiple
+ informed consents, this will be the date of the first one."
Document: SDTMIG v3.4
Item: Assumption 10c
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0143
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Specification[This will be the same as the date of informed
- consent in the Disposition domain, if that protocol milestone
- is documented. Would be null only in studies not collecting
- the date of informed consent.]|Assumption 13[RFICDTC should
- correspond to the date of the informed . . . In the event that
- there are multiple informed consents, this will be the date of
- the first one.]
+ - Cited Guidance:
+ Specification[This will be the same as the date of informed consent in the
+ Disposition domain, if that protocol milestone is documented. Would be null only in
+ studies not collecting the date of informed consent.]|Assumption 13[RFICDTC should
+ correspond to the date of the informed . . . In the event that there are multiple informed
+ consents, this will be the date of the first one.]
Document: IG v3.2
Item: Specification|Assumption 13
- Section: '5'
+ Section: "5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0143
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Specification[This will be the same as the date of informed
- consent in the Disposition domain, if that protocol milestone
- is documented. Would be null only in studies not collecting
- the date of informed consent.]|Assumption 10c[In the event
- that there are multiple informed consents, this will be the
- date of the first one.]
+ - Cited Guidance:
+ Specification[This will be the same as the date of informed consent in the
+ Disposition domain, if that protocol milestone is documented. Would be null only in
+ studies not collecting the date of informed consent.]|Assumption 10c[In the event that
+ there are multiple informed consents, this will be the date of the first one.]
Document: IG v3.3
Item: Specification|Assumption 10c
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0143
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: RFICDTC should correspond to the date of the informed consent
- protocol milestone in Disposition (DS), if that protocol
- milestone is documented in DS. In the event that there are
- multiple informed consents, this will be the date of the
- first. RFPENDTC will be the last date of participation for a
- subject for data included in a submission. This should be the
- last date of any record for the subject in the database at the
- time it is locked for submission. As such, it may not be the
- last date of participation in the study if the submission
- includes interim data.
+ - Cited Guidance:
+ RFICDTC should correspond to the date of the informed consent protocol
+ milestone in Disposition (DS), if that protocol milestone is documented in DS. In the
+ event that there are multiple informed consents, this will be the date of the first.
+ RFPENDTC will be the last date of participation for a subject for data included in a
+ submission. This should be the last date of any record for the subject in the database at
+ the time it is locked for submission. As such, it may not be the last date of
+ participation in the study if the submission includes interim data.
Document: TIG 1.0
Item: Specification|Assumption 10c
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0387
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
# Variable: RFICDTC
# Condition: DS.DSTERM indicates informed consent obtained
# Rule: RFICDTC = earliest DS.DSSTDTC
@@ -103,9 +97,9 @@ Check:
Core:
Id: CORE-000370
Status: Published
- Version: '1'
-Description: DM.RFICDTC must equal the earliest DS.DSSTDTC when DSTERM indicates
- informed consent obtained.
+ Version: "1"
+Description: DM.RFICDTC must equal the earliest DS.DSSTDTC when DSTERM indicates informed consent
+ obtained.
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -119,8 +113,8 @@ Operations:
name: DSSTDTC
operator: min_date
Outcome:
- Message: DM.RFICDTC is not equal to the earliest DSSTDTC, when DSTERM indicates
- Informed consent obtained.
+ Message: DM.RFICDTC is not equal to the earliest DSSTDTC, when DSTERM indicates Informed consent
+ obtained.
Output Variables:
- DSDECOD
- RFICDTC
diff --git a/Published/CORE-000374/rule.yml b/Published/CORE-000374/rule.yml
index 52dacaa8c..2f66d3907 100644
--- a/Published/CORE-000374/rule.yml
+++ b/Published/CORE-000374/rule.yml
@@ -7,70 +7,65 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If disposition events for both study participation and study
- treatment(s) are to be represented, then DSSCAT provides this
- distinction.
+ - Cited Guidance:
+ If disposition events for both study participation and study treatment(s)
+ are to be represented, then DSSCAT provides this distinction.
Document: IG v3.4
Item: Assumption 2.b
Section: 6.2.3
- - Cited Guidance: "ICH E3: Section 10.1 indicates that 'the specific reason for
- discontinuation' should be presented, and that summaries
- should be 'grouped by treatment and by major reason.' The
- CDISC SDS Team interprets this guidance as requiring one
- standardized disposition term (DSDECOD) per disposition event.
- If multiple reasons are reported, the sponsor should identify
- a primary reason and use that to populate DSTERM and DSDECOD.
- Additional reasons should be submitted in SUPPDS."
+ - Cited Guidance:
+ "ICH E3: Section 10.1 indicates that 'the specific reason for discontinuation'
+ should be presented, and that summaries should be 'grouped by treatment and by major reason.'
+ The CDISC SDS Team interprets this guidance as requiring one standardized disposition term (DSDECOD)
+ per disposition event. If multiple reasons are reported, the sponsor should identify a primary
+ reason and use that to populate DSTERM and DSDECOD. Additional reasons should be submitted in
+ SUPPDS."
Document: IG v3.4
Item: Assumption 5
Section: 6.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0537
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "Assumption 2.b[If disposition events for both study
- participation and study treatment(s) are to be represented,
- then DSSCAT provides this distinction]|Assumption 5[ICH E3:
- Section 10.1 indicates that 'the specific reason for
- discontinuation' should be presented, and that summaries
- should be 'grouped by treatment and by major reason.' The
- CDISC SDS Team interprets this guidance as requiring one
- standardized disposition term (DSDECOD) per disposition event.
- If multiple reasons are reported, the sponsor should identify
- a primary reason and use that to populate DSTERM and DSDECOD.
- Additional reasons should be submitted in SUPPDS.]"
+ - Cited Guidance:
+ "Assumption 2.b[If disposition events for both study participation and study treatment(s)
+ are to be represented, then DSSCAT provides this distinction]|Assumption 5[ICH E3: Section 10.1
+ indicates that 'the specific reason for discontinuation' should be presented, and that summaries
+ should be 'grouped by treatment and by major reason.' The CDISC SDS Team interprets this guidance
+ as requiring one standardized disposition term (DSDECOD) per disposition event. If multiple
+ reasons are reported, the sponsor should identify a primary reason and use that to populate
+ DSTERM and DSDECOD. Additional reasons should be submitted in SUPPDS.]"
Document: IG v3.3
Item: Assumption 2.b|Assumption 5
Section: 6.2.3 DS
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0537
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- Cited Guidance: For records with DSCAT = ""DISPOSITION EVENT"", DSSCAT = ""STUDY
- PARTICIPATION"" is used to represent disposition of study
- participation. DSSCAT = ""PRODUCT EXPOSURE"" is used when a
- study has only a single product. If a study has multiple
- products, then DSSCAT should name the individual product."
+ PARTICIPATION"" is used to represent disposition of study participation. DSSCAT =
+ ""PRODUCT EXPOSURE"" is used when a study has only a single product. If a study has
+ multiple products, then DSSCAT should name the individual product."
Document: TIG 1.0
Item: Assumption 2b
Section: 2.8.10.8
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0630
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: DSCAT
@@ -87,7 +82,7 @@ Check:
Core:
Id: CORE-000374
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when there is more than one record per subject per EPOCH
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000376/rule.yml b/Published/CORE-000376/rule.yml
index 446fcdcb7..a45491862 100644
--- a/Published/CORE-000376/rule.yml
+++ b/Published/CORE-000376/rule.yml
@@ -7,85 +7,76 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following variables are exceptions to the philosophy that
- all variable names are prefixed with the Domain Identifier:
- -Required Identifiers (STUDYID, DOMAIN, USUBJID) -Commonly
- used grouping and merge Keys (e.g., VISIT, VISITNUM, VISITDY)
- All Demographics domain (DM) variables other than DMDTC and
- DMDY -All variables in RELREC and SUPPQUAL, and some variables
- in Comments and Trial Design datasets. Required Identifiers
- are not prefixed because they are usually used as keys when
- merging/joining observations. The --SEQ and the optional
- Identifiers --GRPID and --REFID are prefixed because they may
- be used as keys when relating observations across domains.'
+ - Cited Guidance:
+ "The following variables are exceptions to the philosophy that all variable names
+ are prefixed with the Domain Identifier: -Required Identifiers (STUDYID, DOMAIN, USUBJID) -Commonly
+ used grouping and merge Keys (e.g., VISIT, VISITNUM, VISITDY) All Demographics domain (DM) variables
+ other than DMDTC and DMDY -All variables in RELREC and SUPPQUAL, and some variables in Comments
+ and Trial Design datasets. Required Identifiers are not prefixed because they are usually used
+ as keys when merging/joining observations. The --SEQ and the optional Identifiers --GRPID and
+ --REFID are prefixed because they may be used as keys when relating observations across domains."
Document: IG v3.4
Section: 4.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0349
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The philosophy applied to determine which variable names use a
- prefix was that all variable names are prefixed with the
- Domain Identifier in which they originate except the
- following: a. Required Identifiers (STUDYID; DOMAIN; USUBJID).
- b. Commonly used grouping and merge Keys (VISIT; VISITNUM;
- VISITDY); and many of the variables in trial design (such as
- ELEMENT and ARM). c. All Demographics domain (DM) variables
- other than DMDTC and DMDY. d. All variables in RELREC and
- SUPPQUAL; and some variables in Comments and Trial Design
- datasets.'
+ - Cited Guidance:
+ "The philosophy applied to determine which variable names use a prefix was that
+ all variable names are prefixed with the Domain Identifier in which they originate except the
+ following: a. Required Identifiers (STUDYID; DOMAIN; USUBJID). b. Commonly used grouping and
+ merge Keys (VISIT; VISITNUM; VISITDY); and many of the variables in trial design (such as ELEMENT
+ and ARM). c. All Demographics domain (DM) variables other than DMDTC and DMDY. d. All variables
+ in RELREC and SUPPQUAL; and some variables in Comments and Trial Design datasets."
Document: IG v3.2
Section: 4.1.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0349
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The following variables are exceptions to the philosophy that
- all variable names are prefixed with the Domain Identifier: -
- Required Identifiers (STUDYID; DOMAIN; USUBJID). -Commonly
- used grouping and merge Keys (e.g.,VISIT; VISITNUM; VISITDY).
- -All Demographics domain (DM) variables other than DMDTC and
- DMDY. -All variables in RELREC and SUPPQUAL; and some
- variables in Comments and Trial Design datasets. Required
- Identifiers are not prefixed because they are usually used as
- keys when merging/joining observations. The --SEQ and the
- optional Identifiers --GRPID and --REFID are prefixed because
- they may be used as keys when relating observations across
- domains.'
+ - Cited Guidance:
+ "The following variables are exceptions to the philosophy that all variable names
+ are prefixed with the Domain Identifier: - Required Identifiers (STUDYID; DOMAIN; USUBJID).
+ -Commonly used grouping and merge Keys (e.g.,VISIT; VISITNUM; VISITDY). -All Demographics domain
+ (DM) variables other than DMDTC and DMDY. -All variables in RELREC and SUPPQUAL; and some variables
+ in Comments and Trial Design datasets. Required Identifiers are not prefixed because they are
+ usually used as keys when merging/joining observations. The --SEQ and the optional Identifiers
+ --GRPID and --REFID are prefixed because they may be used as keys when relating observations
+ across domains."
Document: IG v3.3
Section: 4.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0349
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 'Apply the domain code to the appropriate variables in the
- domain by replacing all variable prefixes (shown in the SDTM
- as “--“) with the domain code.'
+ - Cited Guidance:
+ "Apply the domain code to the appropriate variables in the domain by replacing
+ all variable prefixes (shown in the SDTM as “--“) with the domain code."
Document: TIG 1.0
Item: 5a
Section: 2.8.3
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0514
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: $domain_is_custom
@@ -124,9 +115,9 @@ Check:
Core:
Id: CORE-000376
Status: Published
- Version: '1'
-Description: Raise an error when the two first characters of a prefixed variable
- within a custom domain do not match the DOMAIN value.
+ Version: "1"
+Description: Raise an error when the two first characters of a prefixed variable within a custom
+ domain do not match the DOMAIN value.
Executability: Fully Executable
Operations:
- id: $domain_list
@@ -135,8 +126,8 @@ Operations:
- id: $domain_is_custom
operator: domain_is_custom
Outcome:
- Message: First 2 characters of prefixed variable within custom domain do not
- match the DOMAIN value.
+ Message: First 2 characters of prefixed variable within custom domain do not match the DOMAIN
+ value.
Output Variables:
- $domain_list
- variable_name
diff --git a/Published/CORE-000381/rule.yml b/Published/CORE-000381/rule.yml
index 2a53a085e..9a3ad9bc0 100644
--- a/Published/CORE-000381/rule.yml
+++ b/Published/CORE-000381/rule.yml
@@ -4,93 +4,93 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.0
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND18
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND18
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND18
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND18
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND18
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND18
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: --TESTCD
@@ -99,7 +99,7 @@ Check:
Core:
Id: CORE-000381
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --TESTCD starts with a number
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000382/rule.yml b/Published/CORE-000382/rule.yml
index bd41e93bc..07ff1f4fb 100644
--- a/Published/CORE-000382/rule.yml
+++ b/Published/CORE-000382/rule.yml
@@ -4,87 +4,93 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per
- subject, Tabulation.
+ - Cited Guidance:
+ dm.xpt, Demographics - Special-Purpose Domains. One record per subject,
+ Tabulation.
Document: IG v3.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND97
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per
- subject, Tabulation.
+ - Cited Guidance:
+ dm.xpt, Demographics - Special-Purpose Domains. One record per subject,
+ Tabulation.
Document: IG v3.1.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND97
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per
- subject, Tabulation.
+ - Cited Guidance:
+ dm.xpt, Demographics - Special-Purpose Domains. One record per subject,
+ Tabulation.
Document: IG v3.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND97
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per
- subject, Tabulation.
+ - Cited Guidance:
+ dm.xpt, Demographics - Special-Purpose Domains. One record per subject,
+ Tabulation.
Document: IG v3.0
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND97
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per
- subject, Tabulation.
+ - Cited Guidance:
+ dm.xpt, Demographics - Special-Purpose Domains. One record per subject,
+ Tabulation.
Document: IG v3.1.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND97
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per
- subject, Tabulation.
+ - Cited Guidance:
+ dm.xpt, Demographics - Special-Purpose Domains. One record per subject,
+ Tabulation.
Document: IG v3.1.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND97
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: USUBJID
@@ -93,7 +99,7 @@ Check:
Core:
Id: CORE-000382
Status: Published
- Version: '1'
+ Version: "1"
Description: DM - One record per subject
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000383/rule.yml b/Published/CORE-000383/rule.yml
index fb131136e..cbfb43fa8 100644
--- a/Published/CORE-000383/rule.yml
+++ b/Published/CORE-000383/rule.yml
@@ -4,73 +4,73 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The SEND Implementation Guide version used for the submission
- containing this dataset. Only a single record should be
- provided in the Trial Summary dataset.
+ - Cited Guidance:
+ The SEND Implementation Guide version used for the submission containing
+ this dataset. Only a single record should be provided in the Trial Summary dataset.
Document: IG v3.1
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND341
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The SEND Implementation Guide version used for the submission
- containing this dataset. Only a single record should be
- provided in the Trial Summary dataset.
+ - Cited Guidance:
+ The SEND Implementation Guide version used for the submission containing
+ this dataset. Only a single record should be provided in the Trial Summary dataset.
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND341
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The SEND Implementation Guide version used for the submission
- containing this dataset. Only a single record should be
- provided in the Trial Summary dataset.
+ - Cited Guidance:
+ The SEND Implementation Guide version used for the submission containing
+ this dataset. Only a single record should be provided in the Trial Summary dataset.
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND341
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The SEND Implementation Guide version used for the submission
- containing this dataset. Only a single record should be
- provided in the Trial Summary dataset.
+ - Cited Guidance:
+ The SEND Implementation Guide version used for the submission containing
+ this dataset. Only a single record should be provided in the Trial Summary dataset.
Document: IG v3.1
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND341
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The SEND Implementation Guide version used for the submission
- containing this dataset. Only a single record should be
- provided in the Trial Summary dataset.
+ - Cited Guidance:
+ The SEND Implementation Guide version used for the submission containing
+ this dataset. Only a single record should be provided in the Trial Summary dataset.
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND341
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: TSPARMCD
@@ -83,7 +83,7 @@ Check:
Core:
Id: CORE-000383
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when there is more than one record with TSPARMCD=SNDIGVER
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000384/rule.yml b/Published/CORE-000384/rule.yml
index 29560cd00..b8dface81 100644
--- a/Published/CORE-000384/rule.yml
+++ b/Published/CORE-000384/rule.yml
@@ -7,31 +7,29 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Two-character abbreviation for the domain of the parent
- record(s). '
+ - Cited Guidance: "Two-character abbreviation for the domain of the parent record(s). "
Document: Model v2.0
Item: RDOMAIN
Section: Related Records
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0374
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Two-character abbreviation for the domain of the parent
- record(s).
+ - Cited Guidance: Two-character abbreviation for the domain of the parent record(s).
Document: Model v1.4
Item: RDOMAIN Description
Section: 4.1.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0374
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -42,24 +40,23 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0374
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Two-character abbreviation for the domain of the parent
- record(s).
+ - Cited Guidance: Two-character abbreviation for the domain of the parent record(s).
Document: SDTM v2.1
Item: RDOMAIN
Section: 6.1 Related Records Dataset
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0538
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: RDOMAIN
@@ -68,7 +65,7 @@ Check:
Core:
Id: CORE-000384
Status: Published
- Version: '1'
+ Version: "1"
Description: RELREC.RDOMAIN must represent a dataset that is present in the study.
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000385/rule.yml b/Published/CORE-000385/rule.yml
index 754fb61e0..ed137ca91 100644
--- a/Published/CORE-000385/rule.yml
+++ b/Published/CORE-000385/rule.yml
@@ -5,103 +5,98 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: In general, all domains based on the three general observation
- classes should have at least one Timing variable. In the
- Events or Interventions general observation class, this could
- be the start date of the event or intervention…This domain
- should contain one record per constant dosing interval per
- subject per administration site (as identified in FOCID). A
- constant dosing interval is sponsor defined and represents a
- specific period of time during which a subject was treated
- with a specific lot at a constant dose level.
+ - Cited Guidance:
+ In general, all domains based on the three general observation classes
+ should have at least one Timing variable. In the Events or Interventions general
+ observation class, this could be the start date of the event or intervention…This domain
+ should contain one record per constant dosing interval per subject per administration site
+ (as identified in FOCID). A constant dosing interval is sponsor defined and represents a
+ specific period of time during which a subject was treated with a specific lot at a
+ constant dose level.
Document: IG v3.1
Section: 4.4|6.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND291'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND291"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: In general, all domains based on the three general observation
- classes should have at least one Timing variable. In the
- Events or Interventions general observation class, this could
- be the start date of the event or intervention…This domain
- should contain one record per constant dosing interval per
- subject per administration site (as identified in FOCID). A
- constant dosing interval is sponsor defined and represents a
- specific period of time during which a subject was treated
- with a specific lot at a constant dose level.
+ - Cited Guidance:
+ In general, all domains based on the three general observation classes
+ should have at least one Timing variable. In the Events or Interventions general
+ observation class, this could be the start date of the event or intervention…This domain
+ should contain one record per constant dosing interval per subject per administration site
+ (as identified in FOCID). A constant dosing interval is sponsor defined and represents a
+ specific period of time during which a subject was treated with a specific lot at a
+ constant dose level.
Document: IG v3.1.1
Section: 4.4|6.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND291'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND291"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: In general, all domains based on the three general observation
- classes should have at least one Timing variable. In the
- Events or Interventions general observation class, this could
- be the start date of the event or intervention…This domain
- should contain one record per constant dosing interval per
- subject per administration site (as identified in FOCID). A
- constant dosing interval is sponsor defined and represents a
- specific period of time during which a subject was treated
- with a specific lot at a constant dose level.
+ - Cited Guidance:
+ In general, all domains based on the three general observation classes
+ should have at least one Timing variable. In the Events or Interventions general
+ observation class, this could be the start date of the event or intervention…This domain
+ should contain one record per constant dosing interval per subject per administration site
+ (as identified in FOCID). A constant dosing interval is sponsor defined and represents a
+ specific period of time during which a subject was treated with a specific lot at a
+ constant dose level.
Document: IG v3.1.1
Section: 4.4|6.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND291'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND291"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: In general, all domains based on the three general observation
- classes should have at least one Timing variable. In the
- Events or Interventions general observation class, this could
- be the start date of the event or intervention…This domain
- should contain one record per constant dosing interval per
- subject per administration site (as identified in FOCID). A
- constant dosing interval is sponsor defined and represents a
- specific period of time during which a subject was treated
- with a specific lot at a constant dose level.
+ - Cited Guidance:
+ In general, all domains based on the three general observation classes
+ should have at least one Timing variable. In the Events or Interventions general
+ observation class, this could be the start date of the event or intervention…This domain
+ should contain one record per constant dosing interval per subject per administration site
+ (as identified in FOCID). A constant dosing interval is sponsor defined and represents a
+ specific period of time during which a subject was treated with a specific lot at a
+ constant dose level.
Document: IG v3.1
Section: 4.4|6.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND291'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND291"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: In general, all domains based on the three general observation
- classes should have at least one Timing variable. In the
- Events or Interventions general observation class, this could
- be the start date of the event or intervention…This domain
- should contain one record per constant dosing interval per
- subject per administration site (as identified in FOCID). A
- constant dosing interval is sponsor defined and represents a
- specific period of time during which a subject was treated
- with a specific lot at a constant dose level.
+ - Cited Guidance:
+ In general, all domains based on the three general observation classes
+ should have at least one Timing variable. In the Events or Interventions general
+ observation class, this could be the start date of the event or intervention…This domain
+ should contain one record per constant dosing interval per subject per administration site
+ (as identified in FOCID). A constant dosing interval is sponsor defined and represents a
+ specific period of time during which a subject was treated with a specific lot at a
+ constant dose level.
Document: IG v3.1.1
Section: 4.4|6.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND291'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND291"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: --STDTC
@@ -111,7 +106,7 @@ Check:
Core:
Id: CORE-000385
Status: Published
- Version: '1'
+ Version: "1"
Description: Either --STDTC or --STDY must be populated.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000386/rule.yml b/Published/CORE-000386/rule.yml
index fc240bd67..b96e0e6e5 100644
--- a/Published/CORE-000386/rule.yml
+++ b/Published/CORE-000386/rule.yml
@@ -4,49 +4,46 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The values of SJSTDTC provide the chronological order of the
- actual subject Stages. SJSEQ should be assigned to be
- consistent with the chronological order of the Stages per
- subject. Note: The requirement that SJSEQ be consistent with
- chronological order is more stringent than in most other
- domains where --SEQ values need only be unique within
- subject."
+ - Cited Guidance:
+ "The values of SJSTDTC provide the chronological order of the actual subject Stages.
+ SJSEQ should be assigned to be consistent with the chronological order of the Stages per subject.
+ Note: The requirement that SJSEQ be consistent with chronological order is more stringent than
+ in most other domains where --SEQ values need only be unique within subject."
Document: IG-DART v1.1
Item: Assumption 7
Section: 4.1.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND354
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The values of SJSTDTC provide the chronological order of the
- actual subject Stages. SJSEQ should be assigned to be
- consistent with the chronological order of the Stages per
- subject. Note: The requirement that SJSEQ be consistent with
- chronological order is more stringent than in most other
- domains where --SEQ values need only be unique within
- subject."
+ - Cited Guidance:
+ "The values of SJSTDTC provide the chronological order of the actual subject Stages.
+ SJSEQ should be assigned to be consistent with the chronological order of the Stages per subject.
+ Note: The requirement that SJSEQ be consistent with chronological order is more stringent than
+ in most other domains where --SEQ values need only be unique within subject."
Document: IG-DART v1.2
Item: Assumption 7
Section: 4.1.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND354
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: SJSEQ
operator: target_is_not_sorted_by
value:
- - name: SJSTDTC
- # What is "null_position" doing?
+ - name:
+ SJSTDTC
+ # What is "null_position" doing?
null_position: last
sort_order: asc
within: USUBJID
@@ -54,9 +51,9 @@ Check:
Core:
Id: CORE-000386
Status: Published
- Version: '1'
-Description: Trigger error when the order of SJSEQ is not chronologically (based
- on SJSTDTC) within USUBJID
+ Version: "1"
+Description: Trigger error when the order of SJSEQ is not chronologically (based on SJSTDTC) within
+ USUBJID
Executability: Fully Executable
Outcome:
Message: SJSEQ is not chronologically (based on SJSTDTC) within USUBJID
diff --git a/Published/CORE-000387/rule.yml b/Published/CORE-000387/rule.yml
index 2cc366eb0..0b0e70f77 100644
--- a/Published/CORE-000387/rule.yml
+++ b/Published/CORE-000387/rule.yml
@@ -5,73 +5,78 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The sequence number must be unique for each record within a
- USUBJID or POOLID, whichever applies for the record.
+ - Cited Guidance:
+ The sequence number must be unique for each record within a USUBJID or
+ POOLID, whichever applies for the record.
Document: IG v3.1
Item: COSEQ CDISC Notes
- Section: '5.2'
+ Section: "5.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND311
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The sequence number must be unique for each record within a
- USUBJID or POOLID, whichever applies for the record.
+ - Cited Guidance:
+ The sequence number must be unique for each record within a USUBJID or
+ POOLID, whichever applies for the record.
Document: IG v3.1.1
Item: COSEQ CDISC Notes
- Section: '5.2'
+ Section: "5.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND311
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The sequence number must be unique for each record within a
- USUBJID or POOLID, whichever applies for the record.
+ - Cited Guidance:
+ The sequence number must be unique for each record within a USUBJID or
+ POOLID, whichever applies for the record.
Document: IG v3.1
Item: COSEQ CDISC Notes
- Section: '5.2'
+ Section: "5.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND311
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The sequence number must be unique for each record within a
- USUBJID or POOLID, whichever applies for the record.
+ - Cited Guidance:
+ The sequence number must be unique for each record within a USUBJID or
+ POOLID, whichever applies for the record.
Document: IG v3.1.1
Item: COSEQ CDISC Notes
- Section: '5.2'
+ Section: "5.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND311
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The sequence number must be unique for each record within a
- USUBJID or POOLID, whichever applies for the record.
+ - Cited Guidance:
+ The sequence number must be unique for each record within a USUBJID or
+ POOLID, whichever applies for the record.
Document: IG v3.1.1
Item: COSEQ CDISC Notes
- Section: '5.2'
+ Section: "5.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND311
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
# case that USUBJID ("expected") is populated
all:
@@ -79,20 +84,21 @@ Check:
operator: non_empty
- name: COSEQ
operator: is_not_unique_set
- value: USUBJID
- # case that USUBJID is not populated
- #- all:
- # - name: USUBJID
- # operator: empty
- # - name: POOLID
- # operator: non_empty
- # - name: COSEQ
- # operator: is_not_unique_set
- # value: POOLID
+ value:
+ USUBJID
+ # case that USUBJID is not populated
+ #- all:
+ # - name: USUBJID
+ # operator: empty
+ # - name: POOLID
+ # operator: non_empty
+ # - name: COSEQ
+ # operator: is_not_unique_set
+ # value: POOLID
Core:
Id: CORE-000387
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when COSEQ is not unique within USUBJID
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000388/rule.yml b/Published/CORE-000388/rule.yml
index 3c472a801..633ecd625 100644
--- a/Published/CORE-000388/rule.yml
+++ b/Published/CORE-000388/rule.yml
@@ -1,92 +1,93 @@
Authorities:
- - Organization: CDISC
- # REMARK: NOT applicable to SENDIG-3.0 (which has similar rule 121)
+ - Organization:
+ CDISC
+ # REMARK: NOT applicable to SENDIG-3.0 (which has similar rule 121)
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL
- are populated; RELTYPE is null)
+ - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are
+ populated; RELTYPE is null)
Document: SENDIG v3.1
Item: Assumption 3
- Section: '8.2.1'
+ Section: "8.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND286'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND286"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL
- are populated; RELTYPE is null)
+ - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are
+ populated; RELTYPE is null)
Document: SENDIG v3.1.1
Item: Assumption 3
- Section: '8.2.1'
+ Section: "8.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND286'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND286"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL
- are populated; RELTYPE is null)
+ - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are
+ populated; RELTYPE is null)
Document: SENDIG v3.1.1
Item: Assumption 3
- Section: '8.2.1'
+ Section: "8.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND286'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND286"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL
- are populated; RELTYPE is null)
+ - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are
+ populated; RELTYPE is null)
Document: SENDIG v3.1
Item: Assumption 3
- Section: '8.2.1'
+ Section: "8.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND286'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND286"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL
- are populated; RELTYPE is null)
+ - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are
+ populated; RELTYPE is null)
Document: SENDIG v3.1.1
Item: Assumption 3
- Section: '8.2.1'
+ Section: "8.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND286'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND286"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL
- are populated; RELTYPE is null)
+ - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are
+ populated; RELTYPE is null)
Document: TIG v1.0
Item: Assumption 3
Section: 2.8.5.2
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0202
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -106,13 +107,13 @@ Check:
Core:
Id: CORE-000388
Status: Published
- Version: '1'
-Description: When USUBJID or POOLID are populated, and IDVARVAL is populated,
- then RELTYPE must be null.
+ Version: "1"
+Description: When USUBJID or POOLID are populated, and IDVARVAL is populated, then RELTYPE must be
+ null.
Executability: Fully Executable
Outcome:
- Message: RELTYPE may not be populated when USUBJID or POOLID is populated, and
- IDVARVAL is populated
+ Message: RELTYPE may not be populated when USUBJID or POOLID is populated, and IDVARVAL is
+ populated
Output Variables:
- RDOMAIN
- USUBJID
diff --git a/Published/CORE-000389/rule.yml b/Published/CORE-000389/rule.yml
index 0cb3d776e..1452a59aa 100644
--- a/Published/CORE-000389/rule.yml
+++ b/Published/CORE-000389/rule.yml
@@ -5,73 +5,78 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The sequence number must be unique for each record within a
- USUBJID or POOLID, whichever applies for the record.
+ - Cited Guidance:
+ The sequence number must be unique for each record within a USUBJID or
+ POOLID, whichever applies for the record.
Document: IG v3.1
Item: COSEQ CDISC Notes
- Section: '5.2'
+ Section: "5.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND312
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The sequence number must be unique for each record within a
- USUBJID or POOLID, whichever applies for the record.
+ - Cited Guidance:
+ The sequence number must be unique for each record within a USUBJID or
+ POOLID, whichever applies for the record.
Document: IG v3.1.1
Item: COSEQ CDISC Notes
- Section: '5.2'
+ Section: "5.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND312
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The sequence number must be unique for each record within a
- USUBJID or POOLID, whichever applies for the record.
+ - Cited Guidance:
+ The sequence number must be unique for each record within a USUBJID or
+ POOLID, whichever applies for the record.
Document: IG v3.1
Item: COSEQ CDISC Notes
- Section: '5.2'
+ Section: "5.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND312
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The sequence number must be unique for each record within a
- USUBJID or POOLID, whichever applies for the record.
+ - Cited Guidance:
+ The sequence number must be unique for each record within a USUBJID or
+ POOLID, whichever applies for the record.
Document: IG v3.1.1
Item: COSEQ CDISC Notes
- Section: '5.2'
+ Section: "5.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND312
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The sequence number must be unique for each record within a
- USUBJID or POOLID, whichever applies for the record.
+ - Cited Guidance:
+ The sequence number must be unique for each record within a USUBJID or
+ POOLID, whichever applies for the record.
Document: IG v3.1
Item: COSEQ CDISC Notes
- Section: '5.2'
+ Section: "5.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND312
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
# case that POOLID ("permissible") is populated
all:
@@ -83,7 +88,7 @@ Check:
Core:
Id: CORE-000389
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when COSEQ is not unique within POOLID
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000390/rule.yml b/Published/CORE-000390/rule.yml
index c79abbd15..b4ef81ca2 100644
--- a/Published/CORE-000390/rule.yml
+++ b/Published/CORE-000390/rule.yml
@@ -5,73 +5,68 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per test per observation time or evaluation interval
- per subject
+ - Cited Guidance: One record per test per observation time or evaluation interval per subject
Document: SENDIG v3.1
Item: Domain Table Header
Section: 6.3.17
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND336
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per test per observation time or evaluation interval
- per subject
+ - Cited Guidance: One record per test per observation time or evaluation interval per subject
Document: SENDIG v3.1.1
Item: Domain Table Header
Section: 6.3.17
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND336
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: One record per test per observation time or evaluation interval
- per subject
+ - Cited Guidance: One record per test per observation time or evaluation interval per subject
Document: SENDIG v3.1
Item: Domain Table Header
Section: 6.3.17
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND336
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: One record per test per observation time or evaluation interval
- per subject
+ - Cited Guidance: One record per test per observation time or evaluation interval per subject
Document: SENDIG v3.1.1
Item: Domain Table Header
Section: 6.3.17
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND336
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: One record per test per observation time or evaluation interval
- per subject
+ - Cited Guidance: One record per test per observation time or evaluation interval per subject
Document: SENDIG v3.1.1
Item: Domain Table Header
Section: 6.3.17
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND336
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
# Implemented as that combination of USUBJID, CVTESTCD and CVDTC must be unique
all:
@@ -83,13 +78,12 @@ Check:
Core:
Id: CORE-000390
Status: Published
- Version: '1'
-Description: Raise an error when there is more than one record present for any
- particular cardiovascular test for a subject and measurement date/time
+ Version: "1"
+Description: Raise an error when there is more than one record present for any particular
+ cardiovascular test for a subject and measurement date/time
Executability: Fully Executable
Outcome:
- Message: The cardiovascular test is not unique for this subject and measurement
- datetime.
+ Message: The cardiovascular test is not unique for this subject and measurement datetime.
Output Variables:
- USUBJID
- CVTESTCD
diff --git a/Published/CORE-000391/rule.yml b/Published/CORE-000391/rule.yml
index efa8c520c..a0f0379f6 100644
--- a/Published/CORE-000391/rule.yml
+++ b/Published/CORE-000391/rule.yml
@@ -4,8 +4,7 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The value in DDTESTCD...In this domain the value should always
- be DEATHD.
+ - Cited Guidance: The value in DDTESTCD...In this domain the value should always be DEATHD.
Document: IG v3.0
Section: 6.3.4
Origin: SEND Conformance Rules
diff --git a/Published/CORE-000393/rule.yml b/Published/CORE-000393/rule.yml
index 5beeb07a1..b4a69c163 100644
--- a/Published/CORE-000393/rule.yml
+++ b/Published/CORE-000393/rule.yml
@@ -4,12 +4,11 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Time points can be represented using the time point variables,
- --TPT, --TPTNUM, --ELTM, and the time point anchors, --TPTREF
- (text description) and --RFTDTC (the date/time).; See also
- --ELTM CDISC Notes in Domain Tables (e.g., "Planned elapsed
- time (in ISO 8601) format relative to the planned fixed
- reference (EXTPTREF).")
+ - Cited Guidance:
+ Time points can be represented using the time point variables, --TPT,
+ --TPTNUM, --ELTM, and the time point anchors, --TPTREF (text description) and --RFTDTC
+ (the date/time).; See also --ELTM CDISC Notes in Domain Tables (e.g., "Planned elapsed
+ time (in ISO 8601) format relative to the planned fixed reference (EXTPTREF).")
Document: IG v3.0
Item: Specification
Section: 4.4.7
@@ -22,11 +21,10 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "--TPTREF: the description of the fixed reference point event or
- anchor from which the planned observation will be made,
- usually the dose ...--ELTM: the planned elapsed time from the
- fixed reference point event (e.g., a dose) to the planned
- observation."
+ - Cited Guidance:
+ "--TPTREF: the description of the fixed reference point event or anchor from which
+ the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from
+ the fixed reference point event (e.g., a dose) to the planned observation."
Document: IG v3.1
Item: Specification
Section: 4.4.7.2.2
@@ -39,11 +37,10 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "--TPTREF: the description of the fixed reference point event or
- anchor from which the planned observation will be made,
- usually the dose ...--ELTM: the planned elapsed time from the
- fixed reference point event (e.g., a dose) to the planned
- observation."
+ - Cited Guidance:
+ "--TPTREF: the description of the fixed reference point event or anchor from which
+ the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from
+ the fixed reference point event (e.g., a dose) to the planned observation."
Document: IG v3.1.1
Item: Specification
Section: 4.4.7.2.2
@@ -56,11 +53,10 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: "--TPTREF: the description of the fixed reference point event or
- anchor from which the planned observation will be made,
- usually the dose ...--ELTM: the planned elapsed time from the
- fixed reference point event (e.g., a dose) to the planned
- observation."
+ - Cited Guidance:
+ "--TPTREF: the description of the fixed reference point event or anchor from which
+ the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from
+ the fixed reference point event (e.g., a dose) to the planned observation."
Document: IG v3.1.1
Item: Specification
Section: 4.4.7.2.2
@@ -73,11 +69,10 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "--TPTREF: the description of the fixed reference point event or
- anchor from which the planned observation will be made,
- usually the dose ...--ELTM: the planned elapsed time from the
- fixed reference point event (e.g., a dose) to the planned
- observation."
+ - Cited Guidance:
+ "--TPTREF: the description of the fixed reference point event or anchor from which
+ the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from
+ the fixed reference point event (e.g., a dose) to the planned observation."
Document: IG v3.1
Item: Specification
Section: 4.4.7.2.2
@@ -90,11 +85,10 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "--TPTREF: the description of the fixed reference point event or
- anchor from which the planned observation will be made,
- usually the dose ...--ELTM: the planned elapsed time from the
- fixed reference point event (e.g., a dose) to the planned
- observation."
+ - Cited Guidance:
+ "--TPTREF: the description of the fixed reference point event or anchor from which
+ the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from
+ the fixed reference point event (e.g., a dose) to the planned observation."
Document: IG v3.1.1
Item: Specification
Section: 4.4.7.2.2
@@ -114,11 +108,12 @@ Authorities:
used:… --TPTREF Represents a description of the fixed
reference point from which the planned observation will be
made. --ELTM Represents the planned elapsed time from the
- fixed timepoint reference to the planned observation.
+ fixed timepoint reference to the planned observation.
Document: TIG v1.0
Item: Table Num 3
- Section: 2.8.7.6 Representing References and Relative Timing, Timing Relative to
- Reference Points
+ Section:
+ 2.8.7.6 Representing References and Relative Timing, Timing Relative to Reference
+ Points
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0195
diff --git a/Published/CORE-000394/rule.yml b/Published/CORE-000394/rule.yml
index 05d5cda65..0f9a55aa2 100644
--- a/Published/CORE-000394/rule.yml
+++ b/Published/CORE-000394/rule.yml
@@ -4,9 +4,10 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The Study Director is the individual responsible for the overall
- conduct of the nonclinical study. The parameter contains the
- name of the specific individual, e.g. 'Dr. William Spock.'
+ - Cited Guidance:
+ The Study Director is the individual responsible for the overall conduct of
+ the nonclinical study. The parameter contains the name of the specific individual, e.g.
+ 'Dr. William Spock.'
Document: IG v3.1
Section: 7.6.3
Origin: SEND Conformance Rules
@@ -18,9 +19,10 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The Study Director is the individual responsible for the overall
- conduct of the nonclinical study. The parameter contains the
- name of the specific individual, e.g. 'Dr. William Spock.'
+ - Cited Guidance:
+ The Study Director is the individual responsible for the overall conduct of
+ the nonclinical study. The parameter contains the name of the specific individual, e.g.
+ 'Dr. William Spock.'
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
@@ -32,9 +34,10 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The Study Director is the individual responsible for the overall
- conduct of the nonclinical study. The parameter contains the
- name of the specific individual, e.g. 'Dr. William Spock.'
+ - Cited Guidance:
+ The Study Director is the individual responsible for the overall conduct of
+ the nonclinical study. The parameter contains the name of the specific individual, e.g.
+ 'Dr. William Spock.'
Document: IG v3.1
Section: 7.6.3
Origin: SEND Conformance Rules
@@ -46,9 +49,10 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The Study Director is the individual responsible for the overall
- conduct of the nonclinical study. The parameter contains the
- name of the specific individual, e.g. 'Dr. William Spock.'
+ - Cited Guidance:
+ The Study Director is the individual responsible for the overall conduct of
+ the nonclinical study. The parameter contains the name of the specific individual, e.g.
+ 'Dr. William Spock.'
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
@@ -60,9 +64,10 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The Study Director is the individual responsible for the overall
- conduct of the nonclinical study. The parameter contains the
- name of the specific individual, e.g. 'Dr. William Spock.'
+ - Cited Guidance:
+ The Study Director is the individual responsible for the overall conduct of
+ the nonclinical study. The parameter contains the name of the specific individual, e.g.
+ 'Dr. William Spock.'
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
diff --git a/Published/CORE-000395/rule.yml b/Published/CORE-000395/rule.yml
index 7b29fce33..452b8e02b 100644
--- a/Published/CORE-000395/rule.yml
+++ b/Published/CORE-000395/rule.yml
@@ -1,12 +1,14 @@
Authorities:
- - Organization: CDISC
- # REMARK: not applicable to SENDIG-3.0
+ - Organization:
+ CDISC
+ # REMARK: not applicable to SENDIG-3.0
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes.
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes.
Document: IG v3.1
Section: 7.6.3
Origin: SEND Conformance Rules
@@ -18,8 +20,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes.
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes.
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
@@ -31,8 +34,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes.
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes.
Document: IG v3.1
Section: 7.6.3
Origin: SEND Conformance Rules
@@ -44,8 +48,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes.
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes.
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
@@ -57,8 +62,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes.
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes.
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
diff --git a/Published/CORE-000396/rule.yml b/Published/CORE-000396/rule.yml
index d2d9d244a..6bd2e955e 100644
--- a/Published/CORE-000396/rule.yml
+++ b/Published/CORE-000396/rule.yml
@@ -4,8 +4,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes
Document: IG v3.1
Section: 7.6.3
Origin: SEND Conformance Rules
@@ -17,8 +18,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
@@ -30,8 +32,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes
Document: IG v3.1
Section: 7.6.3
Origin: SEND Conformance Rules
@@ -43,8 +46,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
@@ -56,8 +60,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
diff --git a/Published/CORE-000398/rule.yml b/Published/CORE-000398/rule.yml
index cf4c8bcd6..134dbcce7 100644
--- a/Published/CORE-000398/rule.yml
+++ b/Published/CORE-000398/rule.yml
@@ -10,14 +10,15 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0303
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all
- standard domains
+ - Cited Guidance:
+ Sponsors must use the predefined SENDIG-standard labels in all standard
+ domains
Document: SENDIG v3.0
Section: "4.2.1"
Origin: SEND Conformance Rules
@@ -29,8 +30,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all
- standard domains
+ - Cited Guidance:
+ Sponsors must use the predefined SENDIG-standard labels in all standard
+ domains
Document: SENDIG v3.1
Section: "4.2.1"
Origin: SEND Conformance Rules
@@ -42,8 +44,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all
- standard domains
+ - Cited Guidance:
+ Sponsors must use the predefined SENDIG-standard labels in all standard
+ domains
Document: SENDIG v3.1.1
Section: "4.2.1"
Origin: SEND Conformance Rules
@@ -55,8 +58,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all
- standard domains
+ - Cited Guidance:
+ Sponsors must use the predefined SENDIG-standard labels in all standard
+ domains
Document: SENDIG v3.1
Section: "4.2.1"
Origin: SEND Conformance Rules
@@ -68,8 +72,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all
- standard domains
+ - Cited Guidance:
+ Sponsors must use the predefined SENDIG-standard labels in all standard
+ domains
Document: SENDIG v3.1.1
Section: "4.2.1"
Origin: SEND Conformance Rules
@@ -81,8 +86,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all
- standard domains
+ - Cited Guidance:
+ Sponsors must use the predefined SENDIG-standard labels in all standard
+ domains
Document: SENDIG v3.1.1
Section: "4.2.1"
Origin: SEND Conformance Rules
@@ -100,8 +106,9 @@ Check:
operator: equal_to
value: library_variable_name
- name: library_variable_label
- operator: non_empty
- # variable label must be equal to that in the CDISC-library
+ operator:
+ non_empty
+ # variable label must be equal to that in the CDISC-library
- name: variable_label
operator: not_equal_to
value: library_variable_label
@@ -109,8 +116,8 @@ Core:
Id: CORE-000398
Status: Published
Version: "1"
-Description: Raise an error when the variable label for an IG-variable does not
- correspond to the variable label in the Implementation Guide.
+Description: Raise an error when the variable label for an IG-variable does not correspond to the
+ variable label in the Implementation Guide.
Executability: Fully Executable
Outcome:
Message: The label of the variable does not correspond to the label in the IG
diff --git a/Published/CORE-000400/rule.yml b/Published/CORE-000400/rule.yml
index 368f18096..6faf21a7c 100644
--- a/Published/CORE-000400/rule.yml
+++ b/Published/CORE-000400/rule.yml
@@ -4,21 +4,21 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If duration will vary (attribute durationWillVary is True) then
- a reason (attribute reasonDurationWillVary) must be given and
- vice versa.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If duration will vary (attribute durationWillVary is True) then a reason (attribute
+ reasonDurationWillVary) must be given and vice versa."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00004'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00004"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'AdministrationDuration'
+ value: "AdministrationDuration"
- any:
- name: durationWillVary
operator: not_equal_to
@@ -33,16 +33,17 @@ Check:
- name: reasonDurationWillVary
operator: non_empty
Core:
- Id: 'CORE-000400'
+ Id: "CORE-000400"
Status: Published
- Version: '1'
-Description: 'If duration will vary (attribute durationWillVary is True) then a
- reason (attribute reasonDurationWillVary) must be given and vice versa.'
+ Version: "1"
+Description:
+ "If duration will vary (attribute durationWillVary is True) then a reason (attribute reasonDurationWillVary)
+ must be given and vice versa."
Executability: Fully Executable
Outcome:
- Message: The administration duration will vary (durationWillVary is not 'false'
- or reasonDurationWillVary is populated), but it is not fully defined
- (durationWillVary is not 'true' or reasonDurationWillVary is missing).
+ Message: The administration duration will vary (durationWillVary is not 'false' or
+ reasonDurationWillVary is populated), but it is not fully defined (durationWillVary is not
+ 'true' or reasonDurationWillVary is missing).
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000401/rule.yml b/Published/CORE-000401/rule.yml
index d9185a2b2..bf82a915d 100644
--- a/Published/CORE-000401/rule.yml
+++ b/Published/CORE-000401/rule.yml
@@ -4,24 +4,24 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Every study version must have exactly one study identifier with
- an identifier scope that references a clinical study sponsor
- organization.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Every study version must have exactly one study identifier with an identifier
+ scope that references a clinical study sponsor organization."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00005'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00005"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyVersion'
+ value: "StudyVersion"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: $num_sponsor_ids
operator: empty
@@ -29,20 +29,21 @@ Check:
operator: not_equal_to
value: 1
Core:
- Id: 'CORE-000401'
+ Id: "CORE-000401"
Status: Published
- Version: '1'
-Description: 'Every study version must have exactly one study identifier with an
- identifier scope that references a clinical study sponsor organization.'
+ Version: "1"
+Description:
+ "Every study version must have exactly one study identifier with an identifier scope that
+ references a clinical study sponsor organization."
Executability: Fully Executable
Operations:
- domain: StudyIdentifier
filter:
- parent_entity: 'StudyVersion'
- parent_rel: 'studyIdentifiers'
- rel_type: 'definition'
- studyIdentifierScope.organizationType.code: 'C70793'
- studyIdentifierScope.organizationType.codeSystem: 'http://www.cdisc.org'
+ parent_entity: "StudyVersion"
+ parent_rel: "studyIdentifiers"
+ rel_type: "definition"
+ studyIdentifierScope.organizationType.code: "C70793"
+ studyIdentifierScope.organizationType.codeSystem: "http://www.cdisc.org"
group:
- parent_id
group_aliases:
@@ -50,9 +51,9 @@ Operations:
id: $num_sponsor_ids
operator: record_count
Outcome:
- Message: 'The study version does not have exactly one sponsor identifier (i.e.,
- a study identifier whose scope is an organization with an type code system
- of "http://www.cdisc.org" and a type code of "C70793")'
+ Message:
+ 'The study version does not have exactly one sponsor identifier (i.e., a study identifier whose
+ scope is an organization with an type code system of "http://www.cdisc.org" and a type code of "C70793")'
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000402/rule.yml b/Published/CORE-000402/rule.yml
index 30a126dc3..a70ff3f09 100644
--- a/Published/CORE-000402/rule.yml
+++ b/Published/CORE-000402/rule.yml
@@ -4,37 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Timing windows must be fully defined, if one of the window
- attributes (i.e., window label, window lower, and window
- upper) is defined then all must be specified.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Timing windows must be fully defined, if one of the window attributes (i.e.,
+ window label, window lower, and window upper) is defined then all must be specified."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00006'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00006"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Timing windows must be fully defined, if one of the window
- attributes (i.e., window label, window lower, and window
- upper) is defined then all must be specified.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Timing windows must be fully defined, if one of the window attributes (i.e.,
+ window label, window lower, and window upper) is defined then all must be specified."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00006'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00006"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Timing'
+ value: "Timing"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: windowLabel
operator: non_empty
@@ -51,16 +51,15 @@ Check:
- name: windowUpper
operator: non_empty
Core:
- Id: 'CORE-000402'
+ Id: "CORE-000402"
Status: Published
- Version: '1'
-Description: 'Timing windows must be fully defined, if one of the window
- attributes (i.e., window label, window lower, and window upper) is defined
- then all must be specified.'
+ Version: "1"
+Description:
+ "Timing windows must be fully defined, if one of the window attributes (i.e., window label,
+ window lower, and window upper) is defined then all must be specified."
Executability: Fully Executable
Outcome:
- Message: 'One or more of the window attributes (windowLabel, windowLower,
- windowUpper) is missing.'
+ Message: "One or more of the window attributes (windowLabel, windowLower, windowUpper) is missing."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000403/rule.yml b/Published/CORE-000403/rule.yml
index a9f7a116d..7e6364299 100644
--- a/Published/CORE-000403/rule.yml
+++ b/Published/CORE-000403/rule.yml
@@ -4,36 +4,36 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If timing type is "Fixed Reference" then it must point to only
- one scheduled instance (e.g. attribute
- relativeToScheduledInstance must be equal to
- relativeFromScheduledInstance or it must be missing).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ 'If timing type is "Fixed Reference" then it must point to only one scheduled
+ instance (e.g. attribute relativeToScheduledInstance must be equal to relativeFromScheduledInstance
+ or it must be missing).'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00007'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00007"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If timing type is "Fixed Reference" then it must point to only
- one scheduled instance (e.g. attribute
- relativeToScheduledInstance must be equal to
- relativeFromScheduledInstance or it must be missing).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ 'If timing type is "Fixed Reference" then it must point to only one scheduled
+ instance (e.g. attribute relativeToScheduledInstance must be equal to relativeFromScheduledInstance
+ or it must be missing).'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00007'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00007"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type.code
operator: equal_to
value: C201358
@@ -47,18 +47,18 @@ Check:
operator: equal_to
value: relativeFromScheduledInstanceId
Core:
- Id: 'CORE-000403'
+ Id: "CORE-000403"
Status: Published
- Version: '1'
-Description: 'If timing type is "Fixed Reference" then it must point to only one
- scheduled instance (e.g. attribute relativeToScheduledInstance must be equal
- to relativeFromScheduledInstance or it must be missing).'
+ Version: "1"
+Description:
+ 'If timing type is "Fixed Reference" then it must point to only one scheduled instance (e.g.
+ attribute relativeToScheduledInstance must be equal to relativeFromScheduledInstance or it must be missing).'
Executability: Fully Executable
Outcome:
- Message: 'The Timing type is "Fixed Reference" (type.code=C201358) but it does
- not point to only one scheduled instance - relativeToScheduledInstanceId is
- not missing and does not contain the same value as
- relativeFromScheduledInstanceId.'
+ Message:
+ 'The Timing type is "Fixed Reference" (type.code=C201358) but it does not point to only one
+ scheduled instance - relativeToScheduledInstanceId is not missing and does not contain the same value
+ as relativeFromScheduledInstanceId.'
Output Variables:
- parent_entity
- parent_id
@@ -73,5 +73,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Timing'
+ - "Timing"
Sensitivity: Record
diff --git a/Published/CORE-000404/rule.yml b/Published/CORE-000404/rule.yml
index 457b489e1..92911d7e5 100644
--- a/Published/CORE-000404/rule.yml
+++ b/Published/CORE-000404/rule.yml
@@ -4,35 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled activity instance must refer to either a default
- condition or a timeline exit, but not both.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A scheduled activity instance must refer to either a default condition or a timeline
+ exit, but not both."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00008'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00008"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled activity instance must refer to either a default
- condition or a timeline exit, but not both.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A scheduled activity instance must refer to either a default condition or a timeline
+ exit, but not both."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00008'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00008"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: instanceType
operator: equal_to
- value: 'ScheduledActivityInstance'
+ value: "ScheduledActivityInstance"
- any:
- all:
- name: defaultConditionId
@@ -45,15 +47,15 @@ Check:
- name: timelineExitId
operator: non_empty
Core:
- Id: 'CORE-000404'
+ Id: "CORE-000404"
Status: Published
- Version: '1'
-Description: 'A scheduled activity instance must refer to either a default
- condition or a timeline exit, but not both.'
+ Version: "1"
+Description:
+ "A scheduled activity instance must refer to either a default condition or a timeline exit,
+ but not both."
Executability: Fully Executable
Outcome:
- Message: 'The defaultConditionId and timelineExitId attributes are either both
- populated or both empty.'
+ Message: "The defaultConditionId and timelineExitId attributes are either both populated or both empty."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000407/rule.yml b/Published/CORE-000407/rule.yml
index 344704764..3c7ff3e9c 100644
--- a/Published/CORE-000407/rule.yml
+++ b/Published/CORE-000407/rule.yml
@@ -4,27 +4,29 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, there must be exactly one scheduled
- timeline which identifies as the main Timeline.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study design, there must be exactly one scheduled timeline which identifies
+ as the main Timeline."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00012'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00012"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, there must be exactly one scheduled
- timeline which identifies as the main Timeline.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study design, there must be exactly one scheduled timeline which identifies
+ as the main Timeline."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00012'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00012"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
$.study.versions.studyDesigns.
{
@@ -37,23 +39,24 @@ Check: |-
~> $map(function($v){$v.id & ($v.name ? " [" & $v.name & "]")})
}[`# Main timelines` != 1][]
Core:
- Id: 'CORE-000407'
+ Id: "CORE-000407"
Status: Published
- Version: '1'
-Description: 'Within a study design, there must be exactly one scheduled
- timeline which identifies as the main Timeline.'
+ Version: "1"
+Description:
+ "Within a study design, there must be exactly one scheduled timeline which identifies as
+ the main Timeline."
Executability: Fully Executable
Outcome:
- Message: 'The study design does not have exactly one main timeline.'
+ Message: "The study design does not have exactly one main timeline."
Output Variables:
- name
- - '# Main timelines'
- - 'Main timelines'
+ - "# Main timelines"
+ - "Main timelines"
Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyDesign'
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "StudyDesign"
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000408/rule.yml b/Published/CORE-000408/rule.yml
index 74befc3f1..d7aa310f3 100644
--- a/Published/CORE-000408/rule.yml
+++ b/Published/CORE-000408/rule.yml
@@ -4,34 +4,34 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a biomedical concept property is required then it must also
- be enabled, while if it is not enabled then it must not be
- required.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If a biomedical concept property is required then it must also be enabled, while
+ if it is not enabled then it must not be required."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00013'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00013"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a biomedical concept property is required then it must also
- be enabled, while if it is not enabled then it must not be
- required.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If a biomedical concept property is required then it must also be enabled, while
+ if it is not enabled then it must not be required."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00013'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00013"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'BiomedicalConceptProperty'
+ value: "BiomedicalConceptProperty"
- any:
- all:
- name: isRequired
@@ -48,16 +48,18 @@ Check:
operator: not_equal_to
value: false
Core:
- Id: 'CORE-000408'
+ Id: "CORE-000408"
Status: Published
- Version: '1'
-Description: 'If a biomedical concept property is required then it must also be
- enabled, while if it is not enabled then it must not be required.'
+ Version: "1"
+Description:
+ "If a biomedical concept property is required then it must also be enabled, while if it is
+ not enabled then it must not be required."
Executability: Fully Executable
Outcome:
- Message: 'A required biomedical concept property (isRequired=true) is not
- enabled (isEnabled is not true), or a disabled biomedical concept property
- (isEnabled=false) is required (isRequired is not false).'
+ Message:
+ "A required biomedical concept property (isRequired=true) is not enabled (isEnabled is not
+ true), or a disabled biomedical concept property (isEnabled=false) is required (isRequired is not
+ false)."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000413/rule.yml b/Published/CORE-000413/rule.yml
index df14dfe2d..cf6edfa2d 100644
--- a/Published/CORE-000413/rule.yml
+++ b/Published/CORE-000413/rule.yml
@@ -1,26 +1,25 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'USDM'
- Document: 'USDM v2.6'
+ - Cited Guidance: "USDM"
+ Document: "USDM v2.6"
Origin: USDM Conformance Rules
Rule Identifier:
- Id: 'DDF00020'
- Version: '1'
- Validator Rule Message: If the reason for a study amendment is 'Other' then this
- must be specified (attribute otherReason must be completed), and
- vice versa.
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00020"
+ Version: "1"
+ Validator Rule Message: If the reason for a study amendment is 'Other' then this must be
+ specified (attribute otherReason must be completed), and vice versa.
+ Version: "1.0"
+ Version: "4.0"
Check:
any:
- all:
- name: code.code
operator: equal_to
- value: 'C17649'
+ value: "C17649"
- any:
- name: otherReason
operator: not_exists
@@ -29,22 +28,21 @@ Check:
- all:
- name: code.code
operator: not_equal_to
- value: 'C17649'
+ value: "C17649"
- name: otherReason
operator: exists
- name: otherReason
operator: non_empty
Core:
- Id: 'CORE-000413'
+ Id: "CORE-000413"
Status: Published
- Version: '1'
-Description: If the reason for a study amendment is 'Other' then this must be
- specified (attribute otherReason must be completed), and vice versa.
+ Version: "1"
+Description: If the reason for a study amendment is 'Other' then this must be specified (attribute
+ otherReason must be completed), and vice versa.
Executability: Fully Executable
Outcome:
- Message: Population of otherReason is not consistent with code - code.code is
- C17649 ('Other') but otherReason is blank, or otherReason is present but
- code.code is not C17649 ('Other').
+ Message: Population of otherReason is not consistent with code - code.code is C17649 ('Other') but
+ otherReason is blank, or otherReason is present but code.code is not C17649 ('Other').
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000414/rule.yml b/Published/CORE-000414/rule.yml
index 144b09c85..9b5197441 100644
--- a/Published/CORE-000414/rule.yml
+++ b/Published/CORE-000414/rule.yml
@@ -4,32 +4,30 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An instance of a class must not refer to itself as its previous
- instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "An instance of a class must not refer to itself as its previous instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00021'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00021"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An instance of a class must not refer to itself as its previous
- instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "An instance of a class must not refer to itself as its previous instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00021'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00021"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: previousId
operator: exists
- name: previousId
@@ -38,11 +36,11 @@ Check:
Core:
Id: CORE-000414
Status: Published
- Version: '1'
-Description: 'An instance of a class must not refer to itself as its previous instance.'
+ Version: "1"
+Description: "An instance of a class must not refer to itself as its previous instance."
Executability: Fully Executable
Outcome:
- Message: 'An instance of a class is referencing itself as its previous instance.'
+ Message: "An instance of a class is referencing itself as its previous instance."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000416/rule.yml b/Published/CORE-000416/rule.yml
index 52878c5d4..4e698be28 100644
--- a/Published/CORE-000416/rule.yml
+++ b/Published/CORE-000416/rule.yml
@@ -4,29 +4,29 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'To ensure consistent ordering, when both previous and next
- attributes are available within an entity the previous id
- value must match the next id value of the referred instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "To ensure consistent ordering, when both previous and next attributes are available
+ within an entity the previous id value must match the next id value of the referred instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00023'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00023"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'To ensure consistent ordering, when both previous and next
- attributes are available within an entity the previous id
- value must match the next id value of the referred instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "To ensure consistent ordering, when both previous and next attributes are available
+ within an entity the previous id value must match the next id value of the referred instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00023'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00023"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: previousId
@@ -35,12 +35,12 @@ Check:
operator: exists
- name: rel_type
operator: equal_to
- value: 'reference'
+ value: "reference"
- any:
- all:
- name: parent_rel
operator: equal_to
- value: 'previousId'
+ value: "previousId"
value_is_literal: true
- name: nextId
operator: not_equal_to
@@ -48,24 +48,24 @@ Check:
- all:
- name: parent_rel
operator: equal_to
- value: 'nextId'
+ value: "nextId"
value_is_literal: true
- name: previousId
operator: not_equal_to
value: parent_id
Core:
- Id: 'CORE-000416'
+ Id: "CORE-000416"
Status: Published
- Version: '1'
-Description: 'To ensure consistent ordering, when both previous and next
- attributes are available within an entity the previous id value must match the
- next id value of the referred instance.'
+ Version: "1"
+Description:
+ "To ensure consistent ordering, when both previous and next attributes are available within
+ an entity the previous id value must match the next id value of the referred instance."
Executability: Fully Executable
Outcome:
- Message: 'The next and previous relationships are not reciprocal - the instance
- is the "previous" instance (parent_rel is "previousId") for an instance that
- is not its "next" instance (nextId is not the same as parent_id), or vice
- versa.'
+ Message:
+ 'The next and previous relationships are not reciprocal - the instance is the "previous" instance
+ (parent_rel is "previousId") for an instance that is not its "next" instance (nextId is not the same
+ as parent_id), or vice versa.'
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000417/rule.yml b/Published/CORE-000417/rule.yml
index a020311fe..f2d937b24 100644
--- a/Published/CORE-000417/rule.yml
+++ b/Published/CORE-000417/rule.yml
@@ -4,35 +4,33 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A window must not be defined for an anchor timing (i.e., type
- is "Fixed Reference").'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: 'A window must not be defined for an anchor timing (i.e., type is "Fixed Reference").'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00025'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00025"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A window must not be defined for an anchor timing (i.e., type
- is "Fixed Reference").'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: 'A window must not be defined for an anchor timing (i.e., type is "Fixed Reference").'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00025'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00025"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type.code
operator: equal_to
- value: 'C201358'
+ value: "C201358"
- any:
- name: windowLabel
operator: non_empty
@@ -43,14 +41,13 @@ Check:
Core:
Id: CORE-000417
Status: Published
- Version: '1'
-Description: 'A window must not be defined for an anchor timing (i.e., type is
- "Fixed Reference").'
+ Version: "1"
+Description: 'A window must not be defined for an anchor timing (i.e., type is "Fixed Reference").'
Executability: Fully Executable
Outcome:
- Message: 'One or more of the window attributes (windowLabel, windowLower,
- windowUpper) contains a value for a Fixed Reference timing
- (type.code=C201358).'
+ Message:
+ "One or more of the window attributes (windowLabel, windowLower, windowUpper) contains a value
+ for a Fixed Reference timing (type.code=C201358)."
Output Variables:
- parent_entity
- parent_id
@@ -66,5 +63,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Timing'
+ - "Timing"
Sensitivity: Record
diff --git a/Published/CORE-000419/rule.yml b/Published/CORE-000419/rule.yml
index da20bf1aa..ce3ff1119 100644
--- a/Published/CORE-000419/rule.yml
+++ b/Published/CORE-000419/rule.yml
@@ -4,32 +4,34 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'To ensure consistent ordering, the same instance must not be
- referenced more than once as previous or next.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "To ensure consistent ordering, the same instance must not be referenced more
+ than once as previous or next."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00027'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00027"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'To ensure consistent ordering, the same instance must not be
- referenced more than once as previous or next.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "To ensure consistent ordering, the same instance must not be referenced more
+ than once as previous or next."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00027'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00027"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- all:
- name: nextId
@@ -50,15 +52,17 @@ Check:
- parent_id
- parent_rel
Core:
- Id: 'CORE-000419'
+ Id: "CORE-000419"
Status: Published
- Version: '1'
-Description: 'To ensure consistent ordering, the same instance must not be
- referenced more than once as previous or next.'
+ Version: "1"
+Description:
+ "To ensure consistent ordering, the same instance must not be referenced more than once as
+ previous or next."
Executability: Fully Executable
Outcome:
- Message: 'The same instance is referenced more than once as previous or next -
- nextId or previousId values are not unique.'
+ Message:
+ "The same instance is referenced more than once as previous or next - nextId or previousId
+ values are not unique."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000423/rule.yml b/Published/CORE-000423/rule.yml
index e341ef2ee..43b53490c 100644
--- a/Published/CORE-000423/rule.yml
+++ b/Published/CORE-000423/rule.yml
@@ -4,38 +4,36 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If timing type is not "Fixed Reference" then it must point to
- two scheduled instances (e.g. the
- relativeFromScheduledInstance and relativeToScheduledInstance
- attributes must not be missing and must not be equal to each
- other).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ 'If timing type is not "Fixed Reference" then it must point to two scheduled instances
+ (e.g. the relativeFromScheduledInstance and relativeToScheduledInstance attributes must not
+ be missing and must not be equal to each other).'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00031'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00031"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If timing type is not "Fixed Reference" then it must point to
- two scheduled instances (e.g. the
- relativeFromScheduledInstance and relativeToScheduledInstance
- attributes must not be missing and must not be equal to each
- other).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ 'If timing type is not "Fixed Reference" then it must point to two scheduled instances
+ (e.g. the relativeFromScheduledInstance and relativeToScheduledInstance attributes must not
+ be missing and must not be equal to each other).'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00031'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00031"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type.code
operator: not_equal_to
value: C201358
@@ -50,19 +48,19 @@ Check:
operator: equal_to
value: relativeToScheduledInstanceId
Core:
- Id: 'CORE-000423'
+ Id: "CORE-000423"
Status: Published
- Version: '1'
-Description: 'If timing type is not "Fixed Reference" then it must point to two
- scheduled instances (e.g. the relativeFromScheduledInstance and
- relativeToScheduledInstance attributes must not be missing and must not be
- equal to each other).'
+ Version: "1"
+Description:
+ 'If timing type is not "Fixed Reference" then it must point to two scheduled instances (e.g.
+ the relativeFromScheduledInstance and relativeToScheduledInstance attributes must not be missing and
+ must not be equal to each other).'
Executability: Fully Executable
Outcome:
- Message: 'The Timing type is not "Fixed Reference" (type.code is not C201358)
- but it does not point to two different scheduled instances -
- relativeFromScheduledInstanceId and/or relativeToScheduledInstanceId is
- missing, or they both contain the same value.'
+ Message:
+ 'The Timing type is not "Fixed Reference" (type.code is not C201358) but it does not point
+ to two different scheduled instances - relativeFromScheduledInstanceId and/or relativeToScheduledInstanceId
+ is missing, or they both contain the same value.'
Output Variables:
- parent_entity
- parent_id
@@ -77,5 +75,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Timing'
+ - "Timing"
Sensitivity: Record
diff --git a/Published/CORE-000424/rule.yml b/Published/CORE-000424/rule.yml
index b0c9df6a1..95cfa20ca 100644
--- a/Published/CORE-000424/rule.yml
+++ b/Published/CORE-000424/rule.yml
@@ -4,38 +4,40 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study version, if more than 1 business therapeutic
- area is defined then they must be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study version, if more than 1 business therapeutic area is defined then
+ they must be distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00032'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00032"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study version, if more than 1 business therapeutic
- area is defined then they must be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study version, if more than 1 business therapeutic area is defined then
+ they must be distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00032'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00032"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Code'
+ value: "Code"
- name: parent_entity
operator: equal_to
- value: 'StudyVersion'
+ value: "StudyVersion"
- name: parent_rel
operator: equal_to
- value: 'businessTherapeuticAreas'
+ value: "businessTherapeuticAreas"
- name: code
operator: is_not_unique_set
value:
@@ -47,14 +49,15 @@ Check:
Core:
Id: CORE-000424
Status: Published
- Version: '1'
-Description: 'Within a study version, if more than 1 business therapeutic area
- is defined then they must be distinct.'
+ Version: "1"
+Description:
+ "Within a study version, if more than 1 business therapeutic area is defined then they must
+ be distinct."
Executability: Fully Executable
Outcome:
- Message: 'The business therapeutic areas of the study version are not unique -
- the same code is used more than once with the same codeSystem and
- codeSystemVersion.'
+ Message:
+ "The business therapeutic areas of the study version are not unique - the same code is used
+ more than once with the same codeSystem and codeSystemVersion."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000427/rule.yml b/Published/CORE-000427/rule.yml
index d381bb933..15d23b3e0 100644
--- a/Published/CORE-000427/rule.yml
+++ b/Published/CORE-000427/rule.yml
@@ -4,32 +4,34 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a code system and corresponding version, a one-to-one
- relationship between code and decode is expected.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a code system and corresponding version, a one-to-one relationship between
+ code and decode is expected."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00035'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00035"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a code system and corresponding version, a one-to-one
- relationship between code and decode is expected.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a code system and corresponding version, a one-to-one relationship between
+ code and decode is expected."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00035'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00035"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Code'
+ value: "Code"
- any:
- name: $num_records_in_codesystemversion_with_code
operator: not_equal_to
@@ -40,9 +42,10 @@ Check:
Core:
Id: CORE-000427
Status: Published
- Version: '1'
-Description: 'Within a code system and corresponding version, a one-to-one
- relationship between code and decode is expected.'
+ Version: "1"
+Description:
+ "Within a code system and corresponding version, a one-to-one relationship between code and
+ decode is expected."
Executability: Partially Executable - Possible Overreporting
Operations:
- group:
@@ -65,8 +68,9 @@ Operations:
id: $num_records_in_codesystemversion_with_code_decode
operator: record_count
Outcome:
- Message: 'There is not a one-to-one relationship between code and decode within
- a codeSytem and corresponding codeSystemVersion'
+ Message:
+ "There is not a one-to-one relationship between code and decode within a codeSytem and corresponding
+ codeSystemVersion"
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000428/rule.yml b/Published/CORE-000428/rule.yml
index 41f1548b2..5375c6b38 100644
--- a/Published/CORE-000428/rule.yml
+++ b/Published/CORE-000428/rule.yml
@@ -4,54 +4,55 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If timing type is "Fixed Reference" then the corresponding
- attribute relativeToFrom must be filled with "Start to
- Start".'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ 'If timing type is "Fixed Reference" then the corresponding attribute relativeToFrom
+ must be filled with "Start to Start".'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00036'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00036"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If timing type is "Fixed Reference" then the corresponding
- attribute relativeToFrom must be filled with "Start to
- Start".'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ 'If timing type is "Fixed Reference" then the corresponding attribute relativeToFrom
+ must be filled with "Start to Start".'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00036'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00036"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type.code
operator: equal_to
- value: 'C201358'
+ value: "C201358"
- any:
- name: relativeToFrom.code
operator: empty
- name: relativeToFrom.code
operator: not_equal_to
- value: 'C201355'
+ value: "C201355"
Core:
Id: CORE-000428
Status: Published
- Version: '1'
-Description: 'If timing type is "Fixed Reference" then the corresponding
- attribute relativeToFrom must be filled with "Start to Start".'
+ Version: "1"
+Description:
+ 'If timing type is "Fixed Reference" then the corresponding attribute relativeToFrom must
+ be filled with "Start to Start".'
Executability: Fully Executable
Outcome:
- Message: 'Type is "Fixed Reference" (type.code=C201358) for the timing but
- relativeToFrom is not "Start to Start" (relativeToFrom.code is not
- C201355).'
+ Message:
+ 'Type is "Fixed Reference" (type.code=C201358) for the timing but relativeToFrom is not "Start
+ to Start" (relativeToFrom.code is not C201355).'
Output Variables:
- parent_entity
- parent_id
@@ -66,5 +67,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Timing'
+ - "Timing"
Sensitivity: Record
diff --git a/Published/CORE-000429/rule.yml b/Published/CORE-000429/rule.yml
index 493186149..4324e0c53 100644
--- a/Published/CORE-000429/rule.yml
+++ b/Published/CORE-000429/rule.yml
@@ -5,32 +5,33 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If the PCORRES result is outside the Limit of Quantification, a.
- PCSTRESN must be null and not populated with the value of zero
- (0).
+ - Cited Guidance:
+ If the PCORRES result is outside the Limit of Quantification, a. PCSTRESN
+ must be null and not populated with the value of zero (0).
Document: IG v3.1.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND329'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND329"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
Check:
all:
- name: PCORRES
operator: not_matches_regex
- value: '[+-]?([0-9]*[.])?[0-9]+$'
- # report an error when either PCORRES does not represent a number - all:
- # and PCSTRESN is populated
+ value:
+ "[+-]?([0-9]*[.])?[0-9]+$"
+ # report an error when either PCORRES does not represent a number - all:
+ # and PCSTRESN is populated
- name: PCSTRESN
operator: non_empty
Core:
Id: CORE-000429
Status: Published
- Version: '1'
-Description: If the PCORRES result is outside the Limit of Quantification, a.
- PCSTRESN must be null and not populated with the value of zero (0).
+ Version: "1"
+Description: If the PCORRES result is outside the Limit of Quantification, a. PCSTRESN must be null
+ and not populated with the value of zero (0).
Executability: Fully Executable
Outcome:
Message: PCORRES does not represent a number but PCSTRESN is populated
diff --git a/Published/CORE-000430/rule.yml b/Published/CORE-000430/rule.yml
index d009c3b8d..0e3f1e962 100644
--- a/Published/CORE-000430/rule.yml
+++ b/Published/CORE-000430/rule.yml
@@ -4,9 +4,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The variable, --STRESC, is derived either by the conversion of
- values in --ORRES to values with standard units, or by the
- assignment of the value of --ORRES.
+ - Cited Guidance:
+ The variable, --STRESC, is derived either by the conversion of values in
+ --ORRES to values with standard units, or by the assignment of the value of --ORRES.
Document: SENDIG v3.0
Item: Text
Section: 4.5.1.1
@@ -19,9 +19,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The variable, --STRESC, is derived either by the conversion of
- values in --ORRES to values with standard units, or by the
- assignment of the value of --ORRES.
+ - Cited Guidance:
+ The variable, --STRESC, is derived either by the conversion of values in
+ --ORRES to values with standard units, or by the assignment of the value of --ORRES.
Document: SENDIG v3.1
Item: Text
Section: 4.5.1.1
@@ -34,9 +34,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The variable, --STRESC, is derived either by the conversion of
- values in --ORRES to values with standard units, or by the
- assignment of the value of --ORRES.
+ - Cited Guidance:
+ The variable, --STRESC, is derived either by the conversion of values in
+ --ORRES to values with standard units, or by the assignment of the value of --ORRES.
Document: SENDIG v3.1.1
Item: Text
Section: 4.5.1.1
@@ -49,9 +49,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The variable, --STRESC, is derived either by the conversion of
- values in --ORRES to values with standard units, or by the
- assignment of the value of --ORRES.
+ - Cited Guidance:
+ The variable, --STRESC, is derived either by the conversion of values in
+ --ORRES to values with standard units, or by the assignment of the value of --ORRES.
Document: SENDIG v3.1
Item: Text
Section: 4.5.1.1
@@ -64,9 +64,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The variable, --STRESC, is derived either by the conversion of
- values in --ORRES to values with standard units, or by the
- assignment of the value of --ORRES.
+ - Cited Guidance:
+ The variable, --STRESC, is derived either by the conversion of values in
+ --ORRES to values with standard units, or by the assignment of the value of --ORRES.
Document: SENDIG v3.1.1
Item: Text
Section: 4.5.1.1
@@ -79,9 +79,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: WThe variable, --STRESC, is derived either by the conversion of
- values in --ORRES to values with standard units, or by the
- assignment of the value of --ORRES.
+ - Cited Guidance:
+ WThe variable, --STRESC, is derived either by the conversion of values in
+ --ORRES to values with standard units, or by the assignment of the value of --ORRES.
Document: SENDIG v3.1.1
Item: Text
Section: 4.5.1.1
@@ -94,9 +94,9 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: Derived by the conversion of numeric values in --ORRES to
- numeric values with standard units. The assigned of the value
- of --ORRES.
+ - Cited Guidance:
+ Derived by the conversion of numeric values in --ORRES to numeric values
+ with standard units. The assigned of the value of --ORRES.
Document: TIG v1.0
Item: Second Table, Num 2
Section: 2.8.7.1 General Guidance
diff --git a/Published/CORE-000432/rule.yml b/Published/CORE-000432/rule.yml
index 10fc61100..98b6bce92 100644
--- a/Published/CORE-000432/rule.yml
+++ b/Published/CORE-000432/rule.yml
@@ -4,8 +4,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter
- described in TXPARM. Maximum 8 characters.
+ - Cited Guidance:
+ TXPARMCD Short character value for the Trial Set parameter described in
+ TXPARM. Maximum 8 characters.
Document: IG v3.0
Item: Specification
Section: 7.4.1
@@ -18,8 +19,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter
- described in TXPARM. Maximum 8 characters.
+ - Cited Guidance:
+ TXPARMCD Short character value for the Trial Set parameter described in
+ TXPARM. Maximum 8 characters.
Document: IG v3.1
Item: Specification
Section: 7.4.1
@@ -32,8 +34,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter
- described in TXPARM. Maximum 8 characters.
+ - Cited Guidance:
+ TXPARMCD Short character value for the Trial Set parameter described in
+ TXPARM. Maximum 8 characters.
Document: IG v3.1.1
Item: Specification
Section: 7.4.1
@@ -46,8 +49,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter
- described in TXPARM. Maximum 8 characters.
+ - Cited Guidance:
+ TXPARMCD Short character value for the Trial Set parameter described in
+ TXPARM. Maximum 8 characters.
Document: IG v3.1
Item: Specification
Section: 7.4.1
@@ -60,8 +64,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter
- described in TXPARM. Maximum 8 characters.
+ - Cited Guidance:
+ TXPARMCD Short character value for the Trial Set parameter described in
+ TXPARM. Maximum 8 characters.
Document: IG v3.1.1
Item: Specification
Section: 7.4.1
@@ -74,8 +79,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter
- described in TXPARM. Maximum 8 characters.
+ - Cited Guidance:
+ TXPARMCD Short character value for the Trial Set parameter described in
+ TXPARM. Maximum 8 characters.
Document: IG v3.1.1
Item: Specification
Section: 7.4.1
@@ -88,8 +94,9 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: Short character value for the Trial Set parameter described in
- TXPARM. Maximum 8 characters.
+ - Cited Guidance:
+ Short character value for the Trial Set parameter described in TXPARM.
+ Maximum 8 characters.
Document: TIG v1.0
Item: TXPARMCD CDISC Notes
Section: 2.8.9.28
@@ -109,8 +116,8 @@ Core:
Id: CORE-000432
Status: Published
Version: "1"
-Description: TXPARMCD Short character value for the Trial Set parameter
- described in TXPARM. Maximum 8 characters.
+Description: TXPARMCD Short character value for the Trial Set parameter described in TXPARM. Maximum
+ 8 characters.
Executability: Fully Executable
Outcome:
Message: TXPARMCD value has more than 8 characters
diff --git a/Published/CORE-000433/rule.yml b/Published/CORE-000433/rule.yml
index a8dade76e..776de468e 100644
--- a/Published/CORE-000433/rule.yml
+++ b/Published/CORE-000433/rule.yml
@@ -4,9 +4,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Unique number for this record within this dataset. (This
- sequence should be unique within the entire dataset because
- there is no USUBJID.)
+ - Cited Guidance:
+ Unique number for this record within this dataset. (This sequence should be
+ unique within the entire dataset because there is no USUBJID.)
Document: IG v3.0
Item: Specification
Section: 7.4.1
@@ -19,9 +19,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Unique number for this record within this dataset. (This
- sequence should be unique within the entire dataset because
- there is no USUBJID.)
+ - Cited Guidance:
+ Unique number for this record within this dataset. (This sequence should be
+ unique within the entire dataset because there is no USUBJID.)
Document: IG v3.1
Item: Specification
Section: 7.4.1
@@ -34,9 +34,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Unique number for this record within this dataset. (This
- sequence should be unique within the entire dataset because
- there is no USUBJID.)
+ - Cited Guidance:
+ Unique number for this record within this dataset. (This sequence should be
+ unique within the entire dataset because there is no USUBJID.)
Document: IG v3.1.1
Item: Specification
Section: 7.4.1
@@ -49,9 +49,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Unique number for this record within this dataset. (This
- sequence should be unique within the entire dataset because
- there is no USUBJID.)
+ - Cited Guidance:
+ Unique number for this record within this dataset. (This sequence should be
+ unique within the entire dataset because there is no USUBJID.)
Document: IG v3.1
Item: Specification
Section: 7.4.1
@@ -64,9 +64,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Unique number for this record within this dataset. (This
- sequence should be unique within the entire dataset because
- there is no USUBJID.)
+ - Cited Guidance:
+ Unique number for this record within this dataset. (This sequence should be
+ unique within the entire dataset because there is no USUBJID.)
Document: IG v3.1.1
Item: Specification
Section: 7.4.1
@@ -79,9 +79,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Unique number for this record within this dataset. (This
- sequence should be unique within the entire dataset because
- there is no USUBJID.)
+ - Cited Guidance:
+ Unique number for this record within this dataset. (This sequence should be
+ unique within the entire dataset because there is no USUBJID.)
Document: IG v3.1.1
Item: Specification
Section: 7.4.1
@@ -94,9 +94,9 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: Unique number for this record within this dataset. (This
- sequence should be unique within the entire dataset because
- there is no USUBJID.)
+ - Cited Guidance:
+ Unique number for this record within this dataset. (This sequence should be
+ unique within the entire dataset because there is no USUBJID.)
Document: TIG v1.0
Item: TXSEQ CDISC Notes
Section: 2.8.9.28
diff --git a/Published/CORE-000436/rule.yml b/Published/CORE-000436/rule.yml
index aba63da57..260c9919a 100644
--- a/Published/CORE-000436/rule.yml
+++ b/Published/CORE-000436/rule.yml
@@ -4,103 +4,103 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day
- --DY = (date portion of --DTC) minus (date portion of RFSTDTC)
- + 1 if --DTC is on or after RFSTDTC.
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day --DY = (date
+ portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC.
Document: SENDIG v3.0
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND74
- Version: '2'
- Version: '5.0'
- Version: '3.0'
+ Version: "2"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day
- --DY = (date portion of --DTC) minus (date portion of RFSTDTC)
- + 1 if --DTC is on or after RFSTDTC.
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day --DY = (date
+ portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC.
Document: SENDIG v3.1
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND74
- Version: '2'
- Version: '5.0'
- Version: '3.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day
- --DY = (date portion of --DTC) minus (date portion of RFSTDTC)
- + 1 if --DTC is on or after RFSTDTC.
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day --DY = (date
+ portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC.
Document: SENDIG v3.1.1
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND74
- Version: '2'
- Version: '5.0'
+ Version: "2"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day
- --DY = (date portion of --DTC) minus (date portion of RFSTDTC)
- + 1 if --DTC is on or after RFSTDTC.
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day --DY = (date
+ portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC.
Document: SENDIG v3.1
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND74
- Version: '2'
- Version: '5.0'
- Version: '1.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day
- --DY = (date portion of --DTC) minus (date portion of RFSTDTC)
- + 1 if --DTC is on or after RFSTDTC.
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day --DY = (date
+ portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC.
Document: SENDIG v3.1.1
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND74
- Version: '2'
- Version: '5.0'
- Version: '1.2'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day
- --DY = (date portion of --DTC) minus (date portion of RFSTDTC)
- + 1 if --DTC is on or after RFSTDTC.
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day --DY = (date
+ portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC.
Document: SENDIG v3.1.1
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND74
- Version: '2'
- Version: '5.0'
- Version: '1.0'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: "All Study Day values are integers. Thus, to calculate Study
- Day: --DY = (date portion of --DTC) - (date portion of
- RFSTDTC) if --DTC precedes RFSTDTC"
+ - Cited Guidance:
+ "All Study Day values are integers. Thus, to calculate Study Day: --DY = (date
+ portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC"
Document: TIG v1.0
Item: Text
Section: 2.8.7.6
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0275
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --DY
@@ -115,11 +115,10 @@ Check:
Core:
Id: CORE-000436
Status: Published
- Version: '1'
-Description: Raise an error when --DY is not calculated as per the study day
- algorithm as a non-zero integer value when the date portion of --DTC is
- complete and the date portion of DM.RFSTDTC is a complete date AND --DY is not
- empty
+ Version: "1"
+Description: Raise an error when --DY is not calculated as per the study day algorithm as a non-zero
+ integer value when the date portion of --DTC is complete and the date portion of DM.RFSTDTC is a
+ complete date AND --DY is not empty
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -130,9 +129,8 @@ Operations:
name: --DTC
operator: dy # does dy op take into acct +1?
Outcome:
- Message: --DY is not calculated correctly even though the date portion of --DTC
- is complete, the date portion of DM.RFSTDTC is a complete date, and --DY is
- not empty.
+ Message: --DY is not calculated correctly even though the date portion of --DTC is complete, the
+ date portion of DM.RFSTDTC is a complete date, and --DY is not empty.
Output Variables:
- --DY
- --DTC
diff --git a/Published/CORE-000438/rule.yml b/Published/CORE-000438/rule.yml
index 3d9127e83..a0353ec7f 100644
--- a/Published/CORE-000438/rule.yml
+++ b/Published/CORE-000438/rule.yml
@@ -7,94 +7,94 @@ Authorities:
- Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL.
Document: IG v3.0
Item: Specification
- Section: '8.5'
+ Section: "8.5"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND257
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL.
Document: IG v3.1
Item: Specification
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND257
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL.
Document: IG v3.1.1
Item: Specification
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND257
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL.
Document: IG v3.1
Item: Specification
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND257
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL.
Document: IG v3.1.1
Item: Specification
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND257
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL.
Document: IG v3.1.1
Item: Specification
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND257
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Result of, response to, or value associated with QNAM. A value
- for this column is required; no records can be in SUPP-- with
- a null value for QVAL.
+ - Cited Guidance:
+ Result of, response to, or value associated with QNAM. A value for this
+ column is required; no records can be in SUPP-- with a null value for QVAL.
Document: TIG v1.0
Item: QVAL CDISC Notes
Section: 2.8.9.27 SEND Supplemental Qualifiers (SUPP--)
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0175
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: QVAL
@@ -102,7 +102,7 @@ Check:
Core:
Id: CORE-000438
Status: Published
- Version: '1'
+ Version: "1"
Description: All records in the SUPP-- datasets must have a value for QVAL.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000440/rule.yml b/Published/CORE-000440/rule.yml
index 6095444c8..75a2e255a 100644
--- a/Published/CORE-000440/rule.yml
+++ b/Published/CORE-000440/rule.yml
@@ -4,103 +4,103 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the
- reason for not completing the evaluation as scheduled in the
- study plan
+ - Cited Guidance:
+ Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not
+ completing the evaluation as scheduled in the study plan
Document: IG v3.0
Section: 6.3.8.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND280'
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Id: "SEND280"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the
- reason for not completing the evaluation as scheduled in the
- study plan
+ - Cited Guidance:
+ Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not
+ completing the evaluation as scheduled in the study plan
Document: IG v3.1
Section: 6.3.8.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND280'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND280"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the
- reason for not completing the evaluation as scheduled in the
- study plan
+ - Cited Guidance:
+ Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not
+ completing the evaluation as scheduled in the study plan
Document: IG v3.1.1
Section: 6.3.8.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND280'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND280"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the
- reason for not completing the evaluation as scheduled in the
- study plan
+ - Cited Guidance:
+ Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not
+ completing the evaluation as scheduled in the study plan
Document: IG v3.1
Section: 6.3.8.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND280'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND280"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the
- reason for not completing the evaluation as scheduled in the
- study plan
+ - Cited Guidance:
+ Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not
+ completing the evaluation as scheduled in the study plan
Document: IG v3.1.1
Section: 6.3.8.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND280'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND280"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the
- reason for not completing the evaluation as scheduled in the
- study plan
+ - Cited Guidance:
+ Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not
+ completing the evaluation as scheduled in the study plan
Document: IG v3.1.1
Section: 6.3.8.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND280'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND280"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the
- reason for not completing the evaluation as described in the
- study plan.
+ - Cited Guidance:
+ Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not
+ completing the evaluation as described in the study plan.
Document: TIG v1.0
Item: Assumption 4.h.ii
Section: 2.8.9.16
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0196
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --STAT
@@ -111,7 +111,7 @@ Check:
Core:
Id: CORE-000440
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when --STAT="NOT DONE" and --REASND is not populated
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000441/rule.yml b/Published/CORE-000441/rule.yml
index a424c28da..214cc85f2 100644
--- a/Published/CORE-000441/rule.yml
+++ b/Published/CORE-000441/rule.yml
@@ -10,10 +10,11 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND201
- Version: '1'
- Version: '5.0'
- # ATTENTION: for SENDIG 3.0 only
- Version: '3.0'
+ Version: "1"
+ Version:
+ "5.0"
+ # ATTENTION: for SENDIG 3.0 only
+ Version: "3.0"
Check:
all:
# Remark: TFTDTREL cannot be null
@@ -29,7 +30,7 @@ Check:
Core:
Id: CORE-000441
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when record is TFDTHREL is not 'N', 'Y' or 'U'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000442/rule.yml b/Published/CORE-000442/rule.yml
index d0f46e33e..0d9bd47c5 100644
--- a/Published/CORE-000442/rule.yml
+++ b/Published/CORE-000442/rule.yml
@@ -4,16 +4,17 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'VSTPTNUM: Numerical version of VSTPT to aid in sorting;
- required if time points are included within the domain.'
+ - Cited Guidance:
+ "VSTPTNUM: Numerical version of VSTPT to aid in sorting; required if time points
+ are included within the domain."
Document: IG v3.0
Section: 6.3.15
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND207
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
Check:
all:
@@ -24,7 +25,7 @@ Check:
Core:
Id: CORE-000442
Status: Published
- Version: '1'
+ Version: "1"
Description: When VSTPT is populated, VSTPTNUM must be populated
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000444/rule.yml b/Published/CORE-000444/rule.yml
index da87527df..91f9a672f 100644
--- a/Published/CORE-000444/rule.yml
+++ b/Published/CORE-000444/rule.yml
@@ -5,68 +5,68 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Results beyond limits of quantitation should be represented with
- the term "BLQ" for results below the limit and "ALQ" for
- results above the limit.
+ - Cited Guidance:
+ Results beyond limits of quantitation should be represented with the term
+ "BLQ" for results below the limit and "ALQ" for results above the limit.
Document: IG v3.1.1
Section: 6.3.11.
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND324'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND324"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Results beyond limits of quantitation should be represented with
- the term "BLQ" for results below the limit and "ALQ" for
- results above the limit.
+ - Cited Guidance:
+ Results beyond limits of quantitation should be represented with the term
+ "BLQ" for results below the limit and "ALQ" for results above the limit.
Document: IG v3.1.1
Section: 6.3.11.
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND324'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND324"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Results beyond limits of quantitation should be represented with
- the term "BLQ" for results below the limit and "ALQ" for
- results above the limit.
+ - Cited Guidance:
+ Results beyond limits of quantitation should be represented with the term
+ "BLQ" for results below the limit and "ALQ" for results above the limit.
Document: IG v3.1.1
Section: 6.3.11.
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND324'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND324"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: PCORRES
operator: not_matches_regex
- value: '[+-]?([0-9]*[.])?[0-9]+$'
- # report an error when either PCORRES is not a number, and PCSTRESC is neither "BLQ" or "ALQ"
+ value:
+ "[+-]?([0-9]*[.])?[0-9]+$"
+ # report an error when either PCORRES is not a number, and PCSTRESC is neither "BLQ" or "ALQ"
- name: PCSTRESC
operator: not_equal_to
- value: 'BLQ'
+ value: "BLQ"
- name: PCSTRESC
operator: not_equal_to
- value: 'ALQ'
+ value: "ALQ"
Core:
Id: CORE-000444
Status: Published
- Version: '1'
-Description: When Result is outside the Limit of Quantification, i.e. it is not
- a number (e.g. <200), then PCSTRESC = "BLQ" or PCSTRESC = "ALQ"
+ Version: "1"
+Description: When Result is outside the Limit of Quantification, i.e. it is not a number (e.g.
+ <200), then PCSTRESC = "BLQ" or PCSTRESC = "ALQ"
Executability: Fully Executable
Outcome:
- Message: The value in PCORRES is not a number (so represents a value outside the
- Limit of Quantification), in which case PCSTRESC must be either "BLQ" or
- "ALQ"
+ Message: The value in PCORRES is not a number (so represents a value outside the Limit of
+ Quantification), in which case PCSTRESC must be either "BLQ" or "ALQ"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000445/rule.yml b/Published/CORE-000445/rule.yml
index bbc103172..462abd691 100644
--- a/Published/CORE-000445/rule.yml
+++ b/Published/CORE-000445/rule.yml
@@ -4,45 +4,48 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If the amount of treatment administered cannot be represented as
- a number and populated in EXDOSE, this field is used to
- describe the amount of treatment administered.
+ - Cited Guidance:
+ If the amount of treatment administered cannot be represented as a number
+ and populated in EXDOSE, this field is used to describe the amount of treatment
+ administered.
Document: IG v3.1
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND314'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND314"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If the amount of treatment administered cannot be represented as
- a number and populated in EXDOSE, this field is used to
- describe the amount of treatment administered.
+ - Cited Guidance:
+ If the amount of treatment administered cannot be represented as a number
+ and populated in EXDOSE, this field is used to describe the amount of treatment
+ administered.
Document: IG v3.1
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND314'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND314"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If the amount of treatment administered cannot be represented as
- a number and populated in EXDOSE, this field is used to
- describe the amount of treatment administered.
+ - Cited Guidance:
+ If the amount of treatment administered cannot be represented as a number
+ and populated in EXDOSE, this field is used to describe the amount of treatment
+ administered.
Document: IG v3.1
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND314'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND314"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
- name: EXDOSTXT
@@ -52,7 +55,7 @@ Check:
Core:
Id: CORE-000445
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when EXDOSE is populated when EXDOSTXT is populated
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000446/rule.yml b/Published/CORE-000446/rule.yml
index 233a66173..04cb47f5c 100644
--- a/Published/CORE-000446/rule.yml
+++ b/Published/CORE-000446/rule.yml
@@ -4,87 +4,93 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: --DTHREL Describes the relationship of a particular finding to
- the death of a subject (Y=caused death, N=did not cause death,
- U=unknown). May be left null if not available.
+ - Cited Guidance:
+ --DTHREL Describes the relationship of a particular finding to the death of
+ a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not
+ available.
Document: SENDIG v3.0
Section: Section 6.3.7-6.3.8
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND183
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: --DTHREL Describes the relationship of a particular finding to
- the death of a subject (Y=caused death, N=did not cause death,
- U=unknown). May be left null if not available.
+ - Cited Guidance:
+ --DTHREL Describes the relationship of a particular finding to the death of
+ a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not
+ available.
Document: SENDIG v3.1
Section: Section 6.3.7-6.3.8
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND183
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: --DTHREL Describes the relationship of a particular finding to
- the death of a subject (Y=caused death, N=did not cause death,
- U=unknown). May be left null if not available.
+ - Cited Guidance:
+ --DTHREL Describes the relationship of a particular finding to the death of
+ a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not
+ available.
Document: SENDIG v3.1.1
Section: Section 6.3.7-6.3.8
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND183
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: --DTHREL Describes the relationship of a particular finding to
- the death of a subject (Y=caused death, N=did not cause death,
- U=unknown). May be left null if not available.
+ - Cited Guidance:
+ --DTHREL Describes the relationship of a particular finding to the death of
+ a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not
+ available.
Document: SENDIG v3.1
Section: Section 6.3.7-6.3.8
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND183
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: --DTHREL Describes the relationship of a particular finding to
- the death of a subject (Y=caused death, N=did not cause death,
- U=unknown). May be left null if not available.
+ - Cited Guidance:
+ --DTHREL Describes the relationship of a particular finding to the death of
+ a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not
+ available.
Document: SENDIG v3.1.1
Section: Section 6.3.7-6.3.8
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND183
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: --DTHREL Describes the relationship of a particular finding to
- the death of a subject (Y=caused death, N=did not cause death,
- U=unknown). May be left null if not available.
+ - Cited Guidance:
+ --DTHREL Describes the relationship of a particular finding to the death of
+ a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not
+ available.
Document: SENDIG v3.1.1
Section: Section 6.3.7-6.3.8
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND183
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: --DTHREL
@@ -101,7 +107,7 @@ Check:
Core:
Id: CORE-000446
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --DTHREL is neither null nor 'Y', 'N' or 'U'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000447/rule.yml b/Published/CORE-000447/rule.yml
index ddd2d9019..c238e2375 100644
--- a/Published/CORE-000447/rule.yml
+++ b/Published/CORE-000447/rule.yml
@@ -4,87 +4,93 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: MASPEC defines the base organ or tissue examined and is required
- when MATEST is 'Gross Pathological Examination'. It should not
- be used when MATEST is 'Clinical Signs Follow-up'.
+ - Cited Guidance:
+ MASPEC defines the base organ or tissue examined and is required when MATEST
+ is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs
+ Follow-up'.
Document: SENDIG v3.0
Section: Section 6.3.7.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND178
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: MASPEC defines the base organ or tissue examined and is required
- when MATEST is 'Gross Pathological Examination'. It should not
- be used when MATEST is 'Clinical Signs Follow-up'.
+ - Cited Guidance:
+ MASPEC defines the base organ or tissue examined and is required when MATEST
+ is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs
+ Follow-up'.
Document: SENDIG v3.1
Section: Section 6.3.7.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND178
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: MASPEC defines the base organ or tissue examined and is required
- when MATEST is 'Gross Pathological Examination'. It should not
- be used when MATEST is 'Clinical Signs Follow-up'.
+ - Cited Guidance:
+ MASPEC defines the base organ or tissue examined and is required when MATEST
+ is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs
+ Follow-up'.
Document: SENDIG v3.1.1
Section: Section 6.3.7.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND178
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: MASPEC defines the base organ or tissue examined and is required
- when MATEST is 'Gross Pathological Examination'. It should not
- be used when MATEST is 'Clinical Signs Follow-up'.
+ - Cited Guidance:
+ MASPEC defines the base organ or tissue examined and is required when MATEST
+ is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs
+ Follow-up'.
Document: SENDIG v3.1
Section: Section 6.3.7.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND178
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: MASPEC defines the base organ or tissue examined and is required
- when MATEST is 'Gross Pathological Examination'. It should not
- be used when MATEST is 'Clinical Signs Follow-up'.
+ - Cited Guidance:
+ MASPEC defines the base organ or tissue examined and is required when MATEST
+ is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs
+ Follow-up'.
Document: SENDIG v3.1.1
Section: Section 6.3.7.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND178
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: MASPEC defines the base organ or tissue examined and is required
- when MATEST is 'Gross Pathological Examination'. It should not
- be used when MATEST is 'Clinical Signs Follow-up'.
+ - Cited Guidance:
+ MASPEC defines the base organ or tissue examined and is required when MATEST
+ is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs
+ Follow-up'.
Document: SENDIG v3.1.1
Section: Section 6.3.7.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND178
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: MATEST
@@ -95,7 +101,7 @@ Check:
Core:
Id: CORE-000447
Status: Published
- Version: '1'
+ Version: "1"
Description: When MATEST is 'Clinical Signs Follow-up' MASPEC should not be used.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000449/rule.yml b/Published/CORE-000449/rule.yml
index c10cacd14..9185b57e0 100644
--- a/Published/CORE-000449/rule.yml
+++ b/Published/CORE-000449/rule.yml
@@ -4,35 +4,33 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Each study element must be referenced by at least one study
- cell.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Each study element must be referenced by at least one study cell."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00040'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00040"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Each study element must be referenced by at least one study
- cell.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Each study element must be referenced by at least one study cell."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00040'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00040"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyElement'
+ value: "StudyElement"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: $num_el_refs
operator: empty
@@ -42,20 +40,20 @@ Check:
Core:
Id: "CORE-000449"
Status: Published
- Version: '1'
-Description: 'Each study element must be referenced by at least one study cell.'
+ Version: "1"
+Description: "Each study element must be referenced by at least one study cell."
Executability: Fully Executable
Operations:
- filter:
- parent_entity: 'StudyCell'
- parent_rel: 'elementIds'
- rel_type: 'reference'
+ parent_entity: "StudyCell"
+ parent_rel: "elementIds"
+ rel_type: "reference"
group:
- id
id: $num_el_refs
operator: record_count
Outcome:
- Message: 'The study element is not referenced by any study cell.'
+ Message: "The study element is not referenced by any study cell."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000451/rule.yml b/Published/CORE-000451/rule.yml
index 0b39e8d90..c2c625b4a 100644
--- a/Published/CORE-000451/rule.yml
+++ b/Published/CORE-000451/rule.yml
@@ -4,210 +4,216 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a
- specific Trial Set, as defined by the sponsor.'
+ - Cited Guidance:
+ "SETCD: Short name of the Trial Set. SET: Long description of a specific Trial
+ Set, as defined by the sponsor."
Document: IG v3.1
Item: Specification
Section: 7.4.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND237'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND237"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'SETCD: Short name of a specific Trial Set. SET: Long
- description of a specific Trial Set, as defined by the
- sponsor.'
+ - Cited Guidance:
+ "SETCD: Short name of a specific Trial Set. SET: Long description of a specific
+ Trial Set, as defined by the sponsor."
Document: IG v3.0
Item: Specification
Section: 7.4.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND237'
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Id: "SEND237"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a
- specific Trial Set, as defined by the sponsor.'
+ - Cited Guidance:
+ "SETCD: Short name of the Trial Set. SET: Long description of a specific Trial
+ Set, as defined by the sponsor."
Document: IG v3.1.1
Item: Specification
Section: 7.4.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND237'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND237"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a
- specific Trial Set, as defined by the sponsor.'
+ - Cited Guidance:
+ "SETCD: Short name of the Trial Set. SET: Long description of a specific Trial
+ Set, as defined by the sponsor."
Document: IG v3.1
Item: Specification
Section: 7.4.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND237'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND237"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a
- specific Trial Set, as defined by the sponsor.'
+ - Cited Guidance:
+ "SETCD: Short name of the Trial Set. SET: Long description of a specific Trial
+ Set, as defined by the sponsor."
Document: IG v3.1.1
Item: Specification
Section: 7.4.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND237'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND237"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a
- specific Trial Set, as defined by the sponsor.'
+ - Cited Guidance:
+ "SETCD: Short name of the Trial Set. SET: Long description of a specific Trial
+ Set, as defined by the sponsor."
Document: IG v3.1.1
Item: Specification
Section: 7.4.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND237'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND237"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a
- specific Trial Set, as defined by the sponsor.'
+ - Cited Guidance:
+ "SETCD: Short name of the Trial Set. SET: Long description of a specific Trial
+ Set, as defined by the sponsor."
Document: TIG v1.0
Item: SETCD CDISC Notes | SET CDISC Notes
Section: 2.8.9.31
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0163
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
- Organization: FDA
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0921
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0921
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0921
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0921
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0921
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0921
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0921
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: SETCD
@@ -216,7 +222,7 @@ Check:
Core:
Id: CORE-000451
Status: Published
- Version: '1'
+ Version: "1"
Description: SET and SETCD should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000454/rule.yml b/Published/CORE-000454/rule.yml
index ddab34829..bab2e8519 100644
--- a/Published/CORE-000454/rule.yml
+++ b/Published/CORE-000454/rule.yml
@@ -4,83 +4,83 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Last date/time of exposure to any protocol-specified treatment
- or therapy, equal to the latest value of EXENDTC (or the
- latest value of EXSTDTC if EXENDTC was not collected or is
- missing).
+ - Cited Guidance:
+ Last date/time of exposure to any protocol-specified treatment or therapy,
+ equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not
+ collected or is missing).
Document: IG v3.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND306
- Version: '2'
- Version: '5.0'
- Version: '3.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Last date/time of exposure to any protocol-specified treatment
- or therapy, equal to the latest value of EXENDTC (or the
- latest value of EXSTDTC if EXENDTC was not collected or is
- missing).
+ - Cited Guidance:
+ Last date/time of exposure to any protocol-specified treatment or therapy,
+ equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not
+ collected or is missing).
Document: IG v3.1.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND306
- Version: '2'
- Version: '5.0'
+ Version: "2"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Last date/time of exposure to any protocol-specified treatment
- or therapy, equal to the latest value of EXENDTC (or the
- latest value of EXSTDTC if EXENDTC was not collected or is
- missing).
+ - Cited Guidance:
+ Last date/time of exposure to any protocol-specified treatment or therapy,
+ equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not
+ collected or is missing).
Document: IG v3.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND306
- Version: '2'
- Version: '5.0'
- Version: '1.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Last date/time of exposure to any protocol-specified treatment
- or therapy, equal to the latest value of EXENDTC (or the
- latest value of EXSTDTC if EXENDTC was not collected or is
- missing).
+ - Cited Guidance:
+ Last date/time of exposure to any protocol-specified treatment or therapy,
+ equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not
+ collected or is missing).
Document: IG v3.1.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND306
- Version: '2'
- Version: '5.0'
- Version: '1.2'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Last date/time of exposure to any protocol-specified treatment
- or therapy, equal to the latest value of EXENDTC (or the
- latest value of EXSTDTC if EXENDTC was not collected or is
- missing).
+ - Cited Guidance:
+ Last date/time of exposure to any protocol-specified treatment or therapy,
+ equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not
+ collected or is missing).
Document: IG v3.1.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND306
- Version: '2'
- Version: '5.0'
- Version: '1.0'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: USUBJID
@@ -95,9 +95,9 @@ Check:
Core:
Id: CORE-000454
Status: Published
- Version: '1'
-Description: Raise an error when EX records are present for subject but RFXENDTC
- does not equal the latest value of EX.EXENDTC
+ Version: "1"
+Description: Raise an error when EX records are present for subject but RFXENDTC does not equal the
+ latest value of EX.EXENDTC
Executability: Fully Executable
Operations:
- domain: EX
@@ -117,8 +117,8 @@ Operations:
name: EXENDTC
operator: max_date
Outcome:
- Message: RFXSTDTC does not equal the latest value of EX.EXENDTC or the latest
- value of EX.EXSTDTC if EX.EXENDTC is not present or not populated.
+ Message: RFXSTDTC does not equal the latest value of EX.EXENDTC or the latest value of EX.EXSTDTC
+ if EX.EXENDTC is not present or not populated.
Output Variables:
- RFXSTDTC
- $max_ex_exendtc
diff --git a/Published/CORE-000455/rule.yml b/Published/CORE-000455/rule.yml
index a23a25edc..28967358e 100644
--- a/Published/CORE-000455/rule.yml
+++ b/Published/CORE-000455/rule.yml
@@ -4,73 +4,78 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: First date/time of exposure to any protocol-specified treatment
- or therapy, equal to the earliest value of EXSTDTC.
+ - Cited Guidance:
+ First date/time of exposure to any protocol-specified treatment or therapy,
+ equal to the earliest value of EXSTDTC.
Document: IG v3.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND305
- Version: '2'
- Version: '5.0'
- Version: '3.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: First date/time of exposure to any protocol-specified treatment
- or therapy, equal to the earliest value of EXSTDTC.
+ - Cited Guidance:
+ First date/time of exposure to any protocol-specified treatment or therapy,
+ equal to the earliest value of EXSTDTC.
Document: IG v3.1.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND305
- Version: '2'
- Version: '5.0'
+ Version: "2"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: First date/time of exposure to any protocol-specified treatment
- or therapy, equal to the earliest value of EXSTDTC.
+ - Cited Guidance:
+ First date/time of exposure to any protocol-specified treatment or therapy,
+ equal to the earliest value of EXSTDTC.
Document: IG v3.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND305
- Version: '2'
- Version: '5.0'
- Version: '1.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: First date/time of exposure to any protocol-specified treatment
- or therapy, equal to the earliest value of EXSTDTC.
+ - Cited Guidance:
+ First date/time of exposure to any protocol-specified treatment or therapy,
+ equal to the earliest value of EXSTDTC.
Document: IG v3.1.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND305
- Version: '2'
- Version: '5.0'
- Version: '1.2'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: First date/time of exposure to any protocol-specified treatment
- or therapy, equal to the earliest value of EXSTDTC.
+ - Cited Guidance:
+ First date/time of exposure to any protocol-specified treatment or therapy,
+ equal to the earliest value of EXSTDTC.
Document: IG v3.1.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND305
- Version: '2'
- Version: '5.0'
- Version: '1.0'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: USUBJID
@@ -82,9 +87,9 @@ Check:
Core:
Id: CORE-000455
Status: Published
- Version: '1'
-Description: Raise an error when EX records are present for subject but RFXSTDTC
- does not equal the earliest value of EX.EXSTDTC
+ Version: "1"
+Description: Raise an error when EX records are present for subject but RFXSTDTC does not equal the
+ earliest value of EX.EXSTDTC
Executability: Fully Executable
Operations:
- domain: EX
diff --git a/Published/CORE-000456/rule.yml b/Published/CORE-000456/rule.yml
index 2ba951230..f166bc2e1 100644
--- a/Published/CORE-000456/rule.yml
+++ b/Published/CORE-000456/rule.yml
@@ -4,93 +4,99 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: MASPEC defines the base organ or tissue examined and is required
- when MATEST is 'Gross Pathological Examination'. It should not
- be used when MATEST is 'Clinical Signs Follow-up'.
+ - Cited Guidance:
+ MASPEC defines the base organ or tissue examined and is required when MATEST
+ is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs
+ Follow-up'.
Document: SENDIG v3.0
Item: Assumption 4.b
Section: Section 6.3.7.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND177
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: MASPEC defines the base organ or tissue examined and is required
- when MATEST is 'Gross Pathological Examination'. It should not
- be used when MATEST is 'Clinical Signs Follow-up'.
+ - Cited Guidance:
+ MASPEC defines the base organ or tissue examined and is required when MATEST
+ is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs
+ Follow-up'.
Document: SENDIG v3.1
Item: Assumption 4.b
Section: Section 6.3.7.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND177
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: MASPEC defines the base organ or tissue examined and is required
- when MATEST is 'Gross Pathological Examination'. It should not
- be used when MATEST is 'Clinical Signs Follow-up'.
+ - Cited Guidance:
+ MASPEC defines the base organ or tissue examined and is required when MATEST
+ is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs
+ Follow-up'.
Document: SENDIG v3.1.1
Item: Assumption 4.b
Section: Section 6.3.7.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND177
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: MASPEC defines the base organ or tissue examined and is required
- when MATEST is 'Gross Pathological Examination'. It should not
- be used when MATEST is 'Clinical Signs Follow-up'.
+ - Cited Guidance:
+ MASPEC defines the base organ or tissue examined and is required when MATEST
+ is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs
+ Follow-up'.
Document: SENDIG v3.1
Item: Assumption 4.b
Section: Section 6.3.7.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND177
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: MASPEC defines the base organ or tissue examined and is required
- when MATEST is 'Gross Pathological Examination'. It should not
- be used when MATEST is 'Clinical Signs Follow-up'.
+ - Cited Guidance:
+ MASPEC defines the base organ or tissue examined and is required when MATEST
+ is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs
+ Follow-up'.
Document: SENDIG v3.1.1
Item: Assumption 4.b
Section: Section 6.3.7.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND177
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: MASPEC defines the base organ or tissue examined and is required
- when MATEST is 'Gross Pathological Examination'. It should not
- be used when MATEST is 'Clinical Signs Follow-up'.
+ - Cited Guidance:
+ MASPEC defines the base organ or tissue examined and is required when MATEST
+ is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs
+ Follow-up'.
Document: SENDIG v3.1.1
Item: Assumption 4.b
Section: Section 6.3.7.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND177
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: MATEST
@@ -101,7 +107,7 @@ Check:
Core:
Id: CORE-000456
Status: Published
- Version: '1'
+ Version: "1"
Description: When MATEST is "Gross Pathological Examination" MASPEC is required.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000457/rule.yml b/Published/CORE-000457/rule.yml
index 10fc9a4fa..d322007de 100644
--- a/Published/CORE-000457/rule.yml
+++ b/Published/CORE-000457/rule.yml
@@ -7,77 +7,74 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There is a one-to-one correspondence between a domain dataset
- and it's Supplemental Qualifier dataset by creating one
- SUPPQUAL for each domain dataset. The single SUPPQUAL dataset
- option that was introduced in SDTMIG v3.1.1 is now
- deprecated. The set of Supplemental Qualifiers for each
- domain is included in a separate dataset with the name SUPP--
- where “--“ denotes the source domain which the supplemental
- Qualifiers relate back to.
+ - Cited Guidance:
+ There is a one-to-one correspondence between a domain dataset and it's
+ Supplemental Qualifier dataset by creating one SUPPQUAL for each domain dataset. The
+ single SUPPQUAL dataset option that was introduced in SDTMIG v3.1.1 is now deprecated. The
+ set of Supplemental Qualifiers for each domain is included in a separate dataset with the
+ name SUPP-- where “--“ denotes the source domain which the supplemental Qualifiers relate
+ back to.
Document: IG v3.2
Section: 8.4.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0373
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There is a one-to-one correspondence between a domain dataset
- and it's Supplemental Qualifier dataset by creating one
- SUPPQUAL for each domain dataset. The single SUPPQUAL dataset
- option that was introduced in SDTMIG v3.1.1 is now deprecated.
- The set of Supplemental Qualifiers for each domain is included
- in a separate dataset with the name SUPP-- where '--' denotes
- the source domain which the supplemental Qualifiers relate
+ - Cited Guidance:
+ There is a one-to-one correspondence between a domain dataset and it's
+ Supplemental Qualifier dataset by creating one SUPPQUAL for each domain dataset. The
+ single SUPPQUAL dataset option that was introduced in SDTMIG v3.1.1 is now deprecated. The
+ set of Supplemental Qualifiers for each domain is included in a separate dataset with the
+ name SUPP-- where '--' denotes the source domain which the supplemental Qualifiers relate
back to.
Document: IG v3.2
Section: 8.4.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0373
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There is a one-to-one correspondence between a domain dataset
- and its Supplemental Qualifier dataset. The single SUPPQUAL
- dataset option that was introduced in SDTMIG v3.1 was
- deprecated. The set of Supplemental Qualifiers for each domain
- is included in a separate dataset with the name SUPP-- where
- "--" denotes the source domain which the Supplemental
- Qualifiers relate back to.
+ - Cited Guidance:
+ There is a one-to-one correspondence between a domain dataset and its
+ Supplemental Qualifier dataset. The single SUPPQUAL dataset option that was introduced in
+ SDTMIG v3.1 was deprecated. The set of Supplemental Qualifiers for each domain is included
+ in a separate dataset with the name SUPP-- where "--" denotes the source domain which the
+ Supplemental Qualifiers relate back to.
Document: IG v3.3
Section: 8.4.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0373
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: There will be only one SUPP-- dataset for a parent dataset.
- Relationships between records in the SUPP-- dataset and
- observations in the parent dataset are specified using the key
- variables STUDYID, RDOMAIN (the domain code of the observation
- in the relationship), USUBJID
+ - Cited Guidance:
+ There will be only one SUPP-- dataset for a parent dataset. Relationships
+ between records in the SUPP-- dataset and observations in the parent dataset are specified
+ using the key variables STUDYID, RDOMAIN (the domain code of the observation in the
+ relationship), USUBJID
Document: TIG 1.0
- Item: ''
+ Item: ""
Section: 2.8.5.3
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0537
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: RDOMAIN
@@ -86,9 +83,8 @@ Check:
Core:
Id: CORE-000457
Status: Published
- Version: '1'
-Description: Trigger error when SUPP--.RDOMAIN does not represent a dataset
- present in the study
+ Version: "1"
+Description: Trigger error when SUPP--.RDOMAIN does not represent a dataset present in the study
Executability: Fully Executable
Operations:
- id: $study_domains
diff --git a/Published/CORE-000458/rule.yml b/Published/CORE-000458/rule.yml
index 66392d21e..2c65d9286 100644
--- a/Published/CORE-000458/rule.yml
+++ b/Published/CORE-000458/rule.yml
@@ -4,102 +4,107 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Sequence number given to ensure uniqueness of subject records
- within a domain. May be any valid number.
+ - Cited Guidance:
+ Sequence number given to ensure uniqueness of subject records within a
+ domain. May be any valid number.
Document: SENDIG v3.0
Item: EXSEQ CDISC Notes
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND138
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a
- record for a given USUBJID within a domain.
+ - Cited Guidance:
+ The Sequence Number (--SEQ) variable uniquely identifies a record for a
+ given USUBJID within a domain.
Document: SENDIG v3.1
Item: Text
- Section: '8'
+ Section: "8"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND138
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a
- record for a given USUBJID within a domain.
+ - Cited Guidance:
+ The Sequence Number (--SEQ) variable uniquely identifies a record for a
+ given USUBJID within a domain.
Document: SENDIG v3.1.1
Item: Text
- Section: '8'
+ Section: "8"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND138
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a
- record for a given USUBJID within a domain.
+ - Cited Guidance:
+ The Sequence Number (--SEQ) variable uniquely identifies a record for a
+ given USUBJID within a domain.
Document: SENDIG v3.1
Item: Text
- Section: '8'
+ Section: "8"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND138
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a
- record for a given USUBJID within a domain.
+ - Cited Guidance:
+ The Sequence Number (--SEQ) variable uniquely identifies a record for a
+ given USUBJID within a domain.
Document: SENDIG v3.1.1
Item: Text
- Section: '8'
+ Section: "8"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND138
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a
- record for a given USUBJID within a domain.
+ - Cited Guidance:
+ The Sequence Number (--SEQ) variable uniquely identifies a record for a
+ given USUBJID within a domain.
Document: SENDIG v3.1.1
Item: Text
- Section: '8'
+ Section: "8"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND138
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: --SEQ Values uniquely identify records for subjects within a
- domain
+ - Cited Guidance: --SEQ Values uniquely identify records for subjects within a domain
Document: TIG v1.0
Item: Table Row 4
Section: 2.8.7.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0074
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -117,9 +122,9 @@ Check:
Core:
Id: CORE-000458
Status: Published
- Version: '1'
-Description: Sequence number given to ensure uniqueness of subject records
- within a domain. May be any valid number.
+ Version: "1"
+Description: Sequence number given to ensure uniqueness of subject records within a domain. May be
+ any valid number.
Executability: Fully Executable
Outcome:
Message: --SEQ is not unique within USUBJID or POOLID
diff --git a/Published/CORE-000459/rule.yml b/Published/CORE-000459/rule.yml
index 418206457..b0b073156 100644
--- a/Published/CORE-000459/rule.yml
+++ b/Published/CORE-000459/rule.yml
@@ -4,97 +4,105 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The units associated with the environmental temperature; only
- "C" or "F" is acceptable.
+ - Cited Guidance:
+ The units associated with the environmental temperature; only "C" or "F" is
+ acceptable.
Document: IG v3.0
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND244.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The units associated with the environmental temperature; only
- "C" or "F" is acceptable.
+ - Cited Guidance:
+ The units associated with the environmental temperature; only "C" or "F" is
+ acceptable.
Document: IG v3.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND244.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The units associated with the environmental temperature; only
- "C" or "F" is acceptable.
+ - Cited Guidance:
+ The units associated with the environmental temperature; only "C" or "F" is
+ acceptable.
Document: IG v3.1.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND244.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The units associated with the environmental temperature; only
- "C" or "F" is acceptable.
+ - Cited Guidance:
+ The units associated with the environmental temperature; only "C" or "F" is
+ acceptable.
Document: IG v3.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND244.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The units associated with the environmental temperature; only
- "C" or "F" is acceptable.
+ - Cited Guidance:
+ The units associated with the environmental temperature; only "C" or "F" is
+ acceptable.
Document: IG v3.1.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND244.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The units associated with the environmental temperature; only
- "C" or "F" is acceptable.
+ - Cited Guidance:
+ The units associated with the environmental temperature; only "C" or "F" is
+ acceptable.
Document: IG v3.1.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND244.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: TXPARMCD
operator: equal_to
- value: ENVTEMPU
- # addition Jozef 2024-03-16
- # pre-condition is that TXVAL is not null
+ value:
+ ENVTEMPU
+ # addition Jozef 2024-03-16
+ # pre-condition is that TXVAL is not null
- name: TXVAL
- operator: non_empty
- # end of addition
+ operator:
+ non_empty
+ # end of addition
- name: TXVAL
operator: not_equal_to
value: C
@@ -104,9 +112,8 @@ Check:
Core:
Id: CORE-000459
Status: Published
- Version: '1'
-Description: The units associated with the environmental temperature; only "C"
- or "F" is acceptable.
+ Version: "1"
+Description: The units associated with the environmental temperature; only "C" or "F" is acceptable.
Executability: Fully Executable
Outcome:
Message: The value of TXVAL may only be "C" or "F" for TXPARMCD=ENTEMPU
diff --git a/Published/CORE-000460/rule.yml b/Published/CORE-000460/rule.yml
index 117689449..79e101381 100644
--- a/Published/CORE-000460/rule.yml
+++ b/Published/CORE-000460/rule.yml
@@ -4,87 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Trial Set Parameters that include dates are required to be
- presented according to the international standard ISO 8601
+ - Cited Guidance: Trial Set Parameters that include dates are required to be presented
+ according to the international standard ISO 8601
Document: IG v3.0
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND243.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Trial Set Parameters that include dates are required to be
- presented according to the international standard ISO 8601
+ - Cited Guidance: Trial Set Parameters that include dates are required to be presented
+ according to the international standard ISO 8601
Document: IG v3.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND243.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Trial Set Parameters that include dates are required to be
- presented according to the international standard ISO 8601
+ - Cited Guidance: Trial Set Parameters that include dates are required to be presented
+ according to the international standard ISO 8601
Document: IG v3.1.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND243.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Trial Set Parameters that include dates are required to be
- presented according to the international standard ISO 8601
+ - Cited Guidance: Trial Set Parameters that include dates are required to be presented
+ according to the international standard ISO 8601
Document: IG v3.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND243.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Trial Set Parameters that include dates are required to be
- presented according to the international standard ISO 8601
+ - Cited Guidance: Trial Set Parameters that include dates are required to be presented
+ according to the international standard ISO 8601
Document: IG v3.1.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND243.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Trial Set Parameters that include dates are required to be
- presented according to the international standard ISO 8601
+ - Cited Guidance: Trial Set Parameters that include dates are required to be presented
+ according to the international standard ISO 8601
Document: IG v3.1.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND243.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- any:
@@ -99,9 +99,9 @@ Check:
Core:
Id: CORE-000460
Status: Published
- Version: '1'
-Description: Trial Set Parameters that include dates are required to be
- presented according to the international standard ISO 8601
+ Version: "1"
+Description: Trial Set Parameters that include dates are required to be presented according to the
+ international standard ISO 8601
Executability: Fully Executable
Outcome:
Message: The value of TXVAL is not in ISO 8601 date/datetime format
diff --git a/Published/CORE-000461/rule.yml b/Published/CORE-000461/rule.yml
index 3be7c2faf..9e6ef1420 100644
--- a/Published/CORE-000461/rule.yml
+++ b/Published/CORE-000461/rule.yml
@@ -4,17 +4,19 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: --SPCUFL describes the usability of the specimen for the test.
- Example, N = the specimen is not usable; otherwise null.
+ - Cited Guidance:
+ --SPCUFL describes the usability of the specimen for the test. Example, N =
+ the specimen is not usable; otherwise null.
Document: SENDIG v3.0
Section: 6.3.7 | 6.3.8
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND182
- Version: '1'
- Version: '5.0'
- # ATTENTION: for SENDIG 3.0, only applicable to MA, MI. Not to LB, PC.
- Version: '3.0'
+ Version: "1"
+ Version:
+ "5.0"
+ # ATTENTION: for SENDIG 3.0, only applicable to MA, MI. Not to LB, PC.
+ Version: "3.0"
Check:
all:
- name: --SPCUFL
@@ -25,7 +27,7 @@ Check:
Core:
Id: CORE-000461
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --SPCUFL is not null and is not equal to 'N'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000462/rule.yml b/Published/CORE-000462/rule.yml
index 2d27e7e6f..91f1495c5 100644
--- a/Published/CORE-000462/rule.yml
+++ b/Published/CORE-000462/rule.yml
@@ -4,68 +4,73 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: --SPCUFL describes the usability of the specimen for the test.
- Example, N = the specimen is not usable; otherwise null.
+ - Cited Guidance:
+ --SPCUFL describes the usability of the specimen for the test. Example, N =
+ the specimen is not usable; otherwise null.
Document: SENDIG v3.1
Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND182.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: --SPCUFL describes the usability of the specimen for the test.
- Example, N = the specimen is not usable; otherwise null.
+ - Cited Guidance:
+ --SPCUFL describes the usability of the specimen for the test. Example, N =
+ the specimen is not usable; otherwise null.
Document: SENDIG v3.1.1
Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND182.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: --SPCUFL describes the usability of the specimen for the test.
- Example, N = the specimen is not usable; otherwise null.
+ - Cited Guidance:
+ --SPCUFL describes the usability of the specimen for the test. Example, N =
+ the specimen is not usable; otherwise null.
Document: SENDIG v3.1
Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND182.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: --SPCUFL describes the usability of the specimen for the test.
- Example, N = the specimen is not usable; otherwise null.
+ - Cited Guidance:
+ --SPCUFL describes the usability of the specimen for the test. Example, N =
+ the specimen is not usable; otherwise null.
Document: SENDIG v3.1.1
Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND182.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: --SPCUFL describes the usability of the specimen for the test.
- Example, N = the specimen is not usable; otherwise null.
+ - Cited Guidance:
+ --SPCUFL describes the usability of the specimen for the test. Example, N =
+ the specimen is not usable; otherwise null.
Document: SENDIG v3.1.1
Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND182.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: --SPCUFL
@@ -76,7 +81,7 @@ Check:
Core:
Id: CORE-000462
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --SPCUFL is not null and is not equal to 'N'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000463/rule.yml b/Published/CORE-000463/rule.yml
index d91a8ae47..94db17fb7 100644
--- a/Published/CORE-000463/rule.yml
+++ b/Published/CORE-000463/rule.yml
@@ -4,96 +4,89 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Used to indicate a derived record. The value should be Y or
- null.
+ - Cited Guidance: Used to indicate a derived record. The value should be Y or null.
Document: SENDIG v3.0
Section: Section 6.3.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND172
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Used to indicate a derived record. The value should be Y or
- null.
+ - Cited Guidance: Used to indicate a derived record. The value should be Y or null.
Document: SENDIG v3.1
Section: Section 6.3.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND172
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Used to indicate a derived record. The value should be Y or
- null.
+ - Cited Guidance: Used to indicate a derived record. The value should be Y or null.
Document: SENDIG v3.1.1
Section: Section 6.3.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND172
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Used to indicate a derived record. The value should be Y or
- null.
+ - Cited Guidance: Used to indicate a derived record. The value should be Y or null.
Document: SENDIG-DART v1.1
Section: Section 6.3.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND172
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Used to indicate a derived record. The value should be Y or
- null.
+ - Cited Guidance: Used to indicate a derived record. The value should be Y or null.
Document: SENDIG-DART v1.2
Section: Section 6.3.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND172
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Used to indicate a derived record. The value should be Y or
- null.
+ - Cited Guidance: Used to indicate a derived record. The value should be Y or null.
Document: SENDIG-GENETOX v1.0
Section: Section 6.3.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND172
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Used to indicate a derived record. The value should be Y or
- null.
+ - Cited Guidance: Used to indicate a derived record. The value should be Y or null.
Document: TIG v1.0
Item: LBDRVFL CDISC Notes
Section: 2.8.9.14
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0102
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --DRVFL
@@ -104,7 +97,7 @@ Check:
Core:
Id: CORE-000463
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --DRVFL is not null and is not equal to 'Y'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000465/rule.yml b/Published/CORE-000465/rule.yml
index fc50987e9..71e12f806 100644
--- a/Published/CORE-000465/rule.yml
+++ b/Published/CORE-000465/rule.yml
@@ -4,48 +4,48 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Time points with collections over a duration also typically
- include the --STINT and --ENINT variables, which specify the
- start and end of the period over which the assessment was
- evaluated, based on the --TPTREF anchor.
+ - Cited Guidance:
+ Time points with collections over a duration also typically include the
+ --STINT and --ENINT variables, which specify the start and end of the period over which
+ the assessment was evaluated, based on the --TPTREF anchor.
Document: IG v3.1
Section: 4.4.7.2.3
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND295'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND295"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Time points with collections over a duration also typically
- include the --STINT and --ENINT variables, which specify the
- start and end of the period over which the assessment was
- evaluated, based on the --TPTREF anchor.
+ - Cited Guidance:
+ Time points with collections over a duration also typically include the
+ --STINT and --ENINT variables, which specify the start and end of the period over which
+ the assessment was evaluated, based on the --TPTREF anchor.
Document: IG v3.1.1
Section: 4.4.7.2.3
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND295'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND295"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Time points with collections over a duration also typically
- include the --STINT and --ENINT variables, which specify the
- start and end of the period over which the assessment was
- evaluated, based on the --TPTREF anchor.
+ - Cited Guidance:
+ Time points with collections over a duration also typically include the
+ --STINT and --ENINT variables, which specify the start and end of the period over which
+ the assessment was evaluated, based on the --TPTREF anchor.
Document: IG v3.1
Section: 4.4.7.2.3
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND295'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND295"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
Check:
any:
- all:
@@ -61,9 +61,8 @@ Check:
Core:
Id: CORE-000465
Status: Published
- Version: '1'
-Description: WHEN --STINT ^= null OR --ENINT ^= null THEN --STINT ^= null AND
- --ENINT ^= null
+ Version: "1"
+Description: WHEN --STINT ^= null OR --ENINT ^= null THEN --STINT ^= null AND --ENINT ^= null
Executability: Fully Executable
Outcome:
Message: --STINT and --ENINT must both be populated or none of them must be populated
diff --git a/Published/CORE-000466/rule.yml b/Published/CORE-000466/rule.yml
index 218d2f777..33f8b9380 100644
--- a/Published/CORE-000466/rule.yml
+++ b/Published/CORE-000466/rule.yml
@@ -5,51 +5,54 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the
- timing of a performed test or observation was not driven by
- the study schedule. | Expected values are Y or null.
+ - Cited Guidance:
+ The Unscheduled Flag (--USCHFL) variable is populated when the timing of a
+ performed test or observation was not driven by the study schedule. | Expected values are
+ Y or null.
Document: IG v3.1
- Section: '4.2.9|6.2.1 '
+ Section: "4.2.9|6.2.1 "
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND303'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND303"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the
- timing of a performed test or observation was not driven by
- the study schedule. | Expected values are Y or null.
+ - Cited Guidance:
+ The Unscheduled Flag (--USCHFL) variable is populated when the timing of a
+ performed test or observation was not driven by the study schedule. | Expected values are
+ Y or null.
Document: IG v3.1.1
- Section: '4.2.9|6.2.1 '
+ Section: "4.2.9|6.2.1 "
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND303'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND303"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the
- timing of a performed test or observation was not driven by
- the study schedule. | Expected values are Y or null.
+ - Cited Guidance:
+ The Unscheduled Flag (--USCHFL) variable is populated when the timing of a
+ performed test or observation was not driven by the study schedule. | Expected values are
+ Y or null.
Document: IG v3.1
- Section: '4.2.9|6.2.1 '
+ Section: "4.2.9|6.2.1 "
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND303'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND303"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the
- timing of a performed test or observation was not driven by
- the study schedule.
+ - Cited Guidance:
+ The Unscheduled Flag (--USCHFL) variable is populated when the timing of a
+ performed test or observation was not driven by the study schedule.
Document: TIG v1.0
Item: Text
Section: 2.8.7.5
@@ -60,10 +63,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0215
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --USCHFL
@@ -74,7 +77,7 @@ Check:
Core:
Id: CORE-000466
Status: Published
- Version: '1'
+ Version: "1"
Description: --USCHFL must be either Y or null
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000471/rule.yml b/Published/CORE-000471/rule.yml
index 977d2031b..4cffa9e61 100644
--- a/Published/CORE-000471/rule.yml
+++ b/Published/CORE-000471/rule.yml
@@ -5,85 +5,91 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should
- be null for records that contain collected or derived data.'
+ - Cited Guidance:
+ "EGEVAL: Role of the person who provided the evaluation. Should be null for records
+ that contain collected or derived data."
Document: IG v3.1
Section: 6.3.16
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND334'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND334"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should
- be null for records that contain collected or derived data.'
+ - Cited Guidance:
+ "EGEVAL: Role of the person who provided the evaluation. Should be null for records
+ that contain collected or derived data."
Document: IG v3.1.1
Section: 6.3.16
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND334'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND334"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should
- be null for records that contain collected or derived data.'
+ - Cited Guidance:
+ "EGEVAL: Role of the person who provided the evaluation. Should be null for records
+ that contain collected or derived data."
Document: IG v3.1
Section: 6.3.16
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND334'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND334"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should
- be null for records that contain collected or derived data.'
+ - Cited Guidance:
+ "EGEVAL: Role of the person who provided the evaluation. Should be null for records
+ that contain collected or derived data."
Document: IG v3.1.1
Section: 6.3.16
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND334'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND334"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should
- be null for records that contain collected or derived data.'
+ - Cited Guidance:
+ "EGEVAL: Role of the person who provided the evaluation. Should be null for records
+ that contain collected or derived data."
Document: IG v3.1.1
Section: 6.3.16
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND334'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND334"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
- # After discussion with SEND team: implemented as that
+ # After discussion with SEND team: implemented as that
# - When EGCAT = MEASUREMENT then EGEVAL is null
- # - When EGORRESU is not null then EGEVAL is null
- # - P.S. Reason for taking EGORRESU (and not EGORRES)
- # is that a value with a unit is not expected to be a subjective value
+ # - When EGORRESU is not null then EGEVAL is null
+ # - P.S. Reason for taking EGORRESU (and not EGORRES)
+ # is that a value with a unit is not expected to be a subjective value
any:
# report an error when EGCAT=MEASUREMENT (case-insensitive) and EGEVAL is populated
# Q: shouldn't be "case-sensitive" as it is under controlled terminology (which is uppercase)
- all:
- name: EGCAT
operator: equal_to_case_insensitive
- value: 'MEASUREMENT'
+ value: "MEASUREMENT"
- name: EGEVAL
- operator: non_empty
- # report an error when EGORRESU is not null and EGEVAL is populated
- # the idea is that evaluations do not have a unit
+ operator:
+ non_empty
+ # report an error when EGORRESU is not null and EGEVAL is populated
+ # the idea is that evaluations do not have a unit
- all:
- name: EGORRESU
operator: non_empty
@@ -92,9 +98,10 @@ Check:
Core:
Id: CORE-000471
Status: Published
- Version: '1'
-Description: 'Report an error when EGCAT=MEASUREMENT (case-insensitive) and
- EGEVAL is populated, or when EGORRESU is not null and EGEVAL is populated'
+ Version: "1"
+Description:
+ "Report an error when EGCAT=MEASUREMENT (case-insensitive) and EGEVAL is populated, or when
+ EGORRESU is not null and EGEVAL is populated"
Executability: Partially Executable
Outcome:
Message: EGEVAL must be null for results that are collected or derived
diff --git a/Published/CORE-000472/rule.yml b/Published/CORE-000472/rule.yml
index 3f9744d9d..d98dc78f9 100644
--- a/Published/CORE-000472/rule.yml
+++ b/Published/CORE-000472/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND150
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND150
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -34,8 +34,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND150
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
@@ -46,9 +46,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND150
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -58,9 +58,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND150
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -70,9 +70,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND150
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: BGDTC
@@ -85,10 +85,9 @@ Check:
Core:
Id: CORE-000472
Status: Published
- Version: '1'
-Description: Raise an error when there is more than one record present for any
- particular Body Weight Gain test, in the BG Domain, for a subject on a
- particular date.
+ Version: "1"
+Description: Raise an error when there is more than one record present for any particular Body
+ Weight Gain test, in the BG Domain, for a subject on a particular date.
Executability: Fully Executable
# The check for this rule was revised to NOT check the records where BGDTC is null
Outcome:
diff --git a/Published/CORE-000474/rule.yml b/Published/CORE-000474/rule.yml
index ddf162186..74e225b74 100644
--- a/Published/CORE-000474/rule.yml
+++ b/Published/CORE-000474/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND208
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND208.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -34,8 +34,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND208.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
@@ -46,9 +46,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND208.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -58,9 +58,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND208.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -70,9 +70,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND208.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: EGTESTCD
@@ -83,9 +83,9 @@ Check:
Core:
Id: CORE-000474
Status: Published
- Version: '1'
-Description: Raise an error when there is more than one record present for any
- particular ECG test for a subject and measurement date/time.
+ Version: "1"
+Description: Raise an error when there is more than one record present for any particular ECG test
+ for a subject and measurement date/time.
Executability: Partially Executable - Possible Underreporting
Outcome:
Message: The ECG test is not unique for this subject and measurement datetime.
diff --git a/Published/CORE-000475/rule.yml b/Published/CORE-000475/rule.yml
index f1b13c466..778c97bcf 100644
--- a/Published/CORE-000475/rule.yml
+++ b/Published/CORE-000475/rule.yml
@@ -4,81 +4,75 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per test per specimen per observation time per
- subject or pool
+ - Cited Guidance: One record per test per specimen per observation time per subject or pool
Document: SENDIG v3.0
Section: 6.3.11
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND192
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per test per specimen per observation time per
- subject or pool
+ - Cited Guidance: One record per test per specimen per observation time per subject or pool
Document: SENDIG v3.1
Section: 6.3.11
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND192
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per test per specimen per observation time per
- subject or pool
+ - Cited Guidance: One record per test per specimen per observation time per subject or pool
Document: SENDIG v3.1.1
Section: 6.3.11
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND192
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: One record per test per specimen per observation time per
- subject or pool
+ - Cited Guidance: One record per test per specimen per observation time per subject or pool
Document: SENDIG v3.1
Section: 6.3.11
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND192
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: One record per test per specimen per observation time per
- subject or pool
+ - Cited Guidance: One record per test per specimen per observation time per subject or pool
Document: SENDIG v3.1.1
Section: 6.3.11
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND192
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: One record per test per specimen per observation time per
- subject or pool
+ - Cited Guidance: One record per test per specimen per observation time per subject or pool
Document: SENDIG v3.1.1
Section: 6.3.11
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND192
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
- all:
@@ -106,14 +100,13 @@ Check:
Core:
Id: CORE-000475
Status: Published
- Version: '1'
-Description: Raise an error when there is more than one record present for any
- particular Pharmacokinetics Concentration, in the PC Domain, for a subject or
- pool on a particular date.
+ Version: "1"
+Description: Raise an error when there is more than one record present for any particular
+ Pharmacokinetics Concentration, in the PC Domain, for a subject or pool on a particular date.
Executability: Fully Executable
Outcome:
- Message: The Pharmacokinetics Concentration test is not unique for this subject
- or pool and specimen and date/time.
+ Message: The Pharmacokinetics Concentration test is not unique for this subject or pool and
+ specimen and date/time.
Output Variables:
- USUBJID
- POOLID
diff --git a/Published/CORE-000476/rule.yml b/Published/CORE-000476/rule.yml
index 8cd8e822d..8405c51ab 100644
--- a/Published/CORE-000476/rule.yml
+++ b/Published/CORE-000476/rule.yml
@@ -1,35 +1,36 @@
Authorities:
- - Organization: CDISC
- # Remark: not applicable to SENDIG-3.1.1, which excludes PC
+ - Organization:
+ CDISC
+ # Remark: not applicable to SENDIG-3.1.1, which excludes PC
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: In the Findings observation class, where data are usually
- collected at multiple study days, either --DTC or --DY must be
- used.
+ - Cited Guidance:
+ In the Findings observation class, where data are usually collected at
+ multiple study days, either --DTC or --DY must be used.
Document: IG v3.1
- Section: '4.4'
+ Section: "4.4"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND289'
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Id: "SEND289"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: In the Findings observation class, where data are usually
- collected at multiple study days, either --DTC or --DY must be
- used.
+ - Cited Guidance:
+ In the Findings observation class, where data are usually collected at
+ multiple study days, either --DTC or --DY must be used.
Document: IG v3.1
- Section: '4.4'
+ Section: "4.4"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND289'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND289"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
- name: --DTC
@@ -39,10 +40,10 @@ Check:
Core:
Id: CORE-000476
Status: Published
- Version: '1'
-Description: When a domain belongs to the Findings General Observation Class,
- and the domain is one in which data are usually collected at multiple study
- days, at least --DTC or --DY must be populated.
+ Version: "1"
+Description: When a domain belongs to the Findings General Observation Class, and the domain is one
+ in which data are usually collected at multiple study days, at least --DTC or --DY must be
+ populated.
Executability: Fully Executable
Outcome:
Message: Neither --DTC nor --DY is populated
diff --git a/Published/CORE-000477/rule.yml b/Published/CORE-000477/rule.yml
index 7748a4c1d..8ec67d752 100644
--- a/Published/CORE-000477/rule.yml
+++ b/Published/CORE-000477/rule.yml
@@ -1,49 +1,50 @@
Authorities:
- - Organization: CDISC
- # Remark: This is the version for SENDIG-3.1.1, which excludes PC
+ - Organization:
+ CDISC
+ # Remark: This is the version for SENDIG-3.1.1, which excludes PC
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: In the Findings observation class, where data are usually
- collected at multiple study days, either --DTC or --DY must be
- used.
+ - Cited Guidance:
+ In the Findings observation class, where data are usually collected at
+ multiple study days, either --DTC or --DY must be used.
Document: IG v3.1.1
- Section: '4.4'
+ Section: "4.4"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND289.1'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND289.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: In the Findings observation class, where data are usually
- collected at multiple study days, either --DTC or --DY must be
- used.
+ - Cited Guidance:
+ In the Findings observation class, where data are usually collected at
+ multiple study days, either --DTC or --DY must be used.
Document: IG v3.1.1
- Section: '4.4'
+ Section: "4.4"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND289.1'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND289.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: In the Findings observation class, where data are usually
- collected at multiple study days, either --DTC or --DY must be
- used.
+ - Cited Guidance:
+ In the Findings observation class, where data are usually collected at
+ multiple study days, either --DTC or --DY must be used.
Document: IG v3.1.1
- Section: '4.4'
+ Section: "4.4"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND289.1'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND289.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: --DTC
@@ -53,10 +54,10 @@ Check:
Core:
Id: CORE-000477
Status: Published
- Version: '1'
-Description: When a domain belongs to the Findings General Observation Class,
- and the domain is one in which data are usually collected at multiple study
- days, at least --DTC or --DY must be populated.
+ Version: "1"
+Description: When a domain belongs to the Findings General Observation Class, and the domain is one
+ in which data are usually collected at multiple study days, at least --DTC or --DY must be
+ populated.
Executability: Fully Executable
Outcome:
Message: Neither --DTC nor --DY is populated
@@ -74,7 +75,7 @@ Scope:
- LB
- OM
- PM
- # REMARK that for SENDIG-3.1.1, PC is not in the list anymore
+ # REMARK that for SENDIG-3.1.1, PC is not in the list anymore
- VS
- EG
- CV
diff --git a/Published/CORE-000478/rule.yml b/Published/CORE-000478/rule.yml
index 1661765cb..ee962c1ae 100644
--- a/Published/CORE-000478/rule.yml
+++ b/Published/CORE-000478/rule.yml
@@ -5,78 +5,78 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Time points with collections over a duration also typically
- include the --STINT and --ENINT variables, which specify the
- start and end of the period over which the assessment was
- evaluated, based on the --TPTREF anchor.
+ - Cited Guidance:
+ Time points with collections over a duration also typically include the
+ --STINT and --ENINT variables, which specify the start and end of the period over which
+ the assessment was evaluated, based on the --TPTREF anchor.
Document: IG v3.1
Section: 4.4.7.2.3
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND294'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND294"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Time points with collections over a duration also typically
- include the --STINT and --ENINT variables, which specify the
- start and end of the period over which the assessment was
- evaluated, based on the --TPTREF anchor.
+ - Cited Guidance:
+ Time points with collections over a duration also typically include the
+ --STINT and --ENINT variables, which specify the start and end of the period over which
+ the assessment was evaluated, based on the --TPTREF anchor.
Document: IG v3.1.1
Section: 4.4.7.2.3
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND294'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND294"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Time points with collections over a duration also typically
- include the --STINT and --ENINT variables, which specify the
- start and end of the period over which the assessment was
- evaluated, based on the --TPTREF anchor.
+ - Cited Guidance:
+ Time points with collections over a duration also typically include the
+ --STINT and --ENINT variables, which specify the start and end of the period over which
+ the assessment was evaluated, based on the --TPTREF anchor.
Document: IG v3.1
Section: 4.4.7.2.3
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND294'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND294"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Time points with collections over a duration also typically
- include the --STINT and --ENINT variables, which specify the
- start and end of the period over which the assessment was
- evaluated, based on the --TPTREF anchor.
+ - Cited Guidance:
+ Time points with collections over a duration also typically include the
+ --STINT and --ENINT variables, which specify the start and end of the period over which
+ the assessment was evaluated, based on the --TPTREF anchor.
Document: IG v3.1.1
Section: 4.4.7.2.3
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND294'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND294"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Time points with collections over a duration also typically
- include the --STINT and --ENINT variables, which specify the
- start and end of the period over which the assessment was
- evaluated, based on the --TPTREF anchor.
+ - Cited Guidance:
+ Time points with collections over a duration also typically include the
+ --STINT and --ENINT variables, which specify the start and end of the period over which
+ the assessment was evaluated, based on the --TPTREF anchor.
Document: IG v3.1.1
Section: 4.4.7.2.3
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND294'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND294"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: --STINT
@@ -88,9 +88,8 @@ Check:
Core:
Id: CORE-000478
Status: Published
- Version: '1'
-Description: Raise an error when --STINT and -ENINT are populated but --TPTREF
- is not populated.
+ Version: "1"
+Description: Raise an error when --STINT and -ENINT are populated but --TPTREF is not populated.
Executability: Fully Executable
Outcome:
Message: --STINT and --ENINT are populated but --TPTREF is not populated
diff --git a/Published/CORE-000479/rule.yml b/Published/CORE-000479/rule.yml
index 3271ff0ab..e8c2f0181 100644
--- a/Published/CORE-000479/rule.yml
+++ b/Published/CORE-000479/rule.yml
@@ -4,8 +4,7 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or
- "N".
+ - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N".
Document: IG v3.0
Item: Specification
Section: 7.6.3
@@ -18,8 +17,7 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or
- "N".
+ - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N".
Document: IG v3.1
Item: Specification
Section: 7.6.3
@@ -32,8 +30,7 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or
- "N".
+ - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N".
Document: IG v3.1.1
Item: Specification
Section: 7.6.2
@@ -46,8 +43,7 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or
- "N".
+ - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N".
Document: IG v3.1
Item: Specification
Section: 7.6.3
@@ -60,8 +56,7 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or
- "N".
+ - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N".
Document: IG v3.1.1
Item: Specification
Section: 7.6.2
@@ -74,8 +69,7 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or
- "N".
+ - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N".
Document: IG v3.1.1
Item: Specification
Section: 7.6.2
diff --git a/Published/CORE-000480/rule.yml b/Published/CORE-000480/rule.yml
index 345fdce43..caa361754 100644
--- a/Published/CORE-000480/rule.yml
+++ b/Published/CORE-000480/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND206
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND206
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -34,8 +34,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND206
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
@@ -46,9 +46,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND206
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -58,9 +58,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND206
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -70,9 +70,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND206
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: VSTESTCD
@@ -83,9 +83,9 @@ Check:
Core:
Id: CORE-000480
Status: Published
- Version: '1'
-Description: Raise an error when there is more than one record present for any
- particular Vital Signs test for a subject and measurement date/time.
+ Version: "1"
+Description: Raise an error when there is more than one record present for any particular Vital
+ Signs test for a subject and measurement date/time.
Executability: Fully Executable
Outcome:
Message: The Vital Signs test is not unique for this subject and measurement datetime.
diff --git a/Published/CORE-000481/rule.yml b/Published/CORE-000481/rule.yml
index 47a6f2646..8ceb4eaa8 100644
--- a/Published/CORE-000481/rule.yml
+++ b/Published/CORE-000481/rule.yml
@@ -4,81 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The reason the result should be excluded from all calculations.
- Used only when BWEXCLFL is Y.
+ - Cited Guidance:
+ The reason the result should be excluded from all calculations. Used only
+ when BWEXCLFL is Y.
Document: IG v3.0
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND149
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The reason the result should be excluded from all calculations.
- Used only when BWEXCLFL is Y.
+ - Cited Guidance:
+ The reason the result should be excluded from all calculations. Used only
+ when BWEXCLFL is Y.
Document: IG v3.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND149
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The reason the result should be excluded from all calculations.
- Used only when BWEXCLFL is Y.
+ - Cited Guidance:
+ The reason the result should be excluded from all calculations. Used only
+ when BWEXCLFL is Y.
Document: IG v3.1.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND149
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The reason the result should be excluded from all calculations.
- Used only when BWEXCLFL is Y.
+ - Cited Guidance:
+ The reason the result should be excluded from all calculations. Used only
+ when BWEXCLFL is Y.
Document: IG v3.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND149
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The reason the result should be excluded from all calculations.
- Used only when BWEXCLFL is Y.
+ - Cited Guidance:
+ The reason the result should be excluded from all calculations. Used only
+ when BWEXCLFL is Y.
Document: IG v3.1.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND149
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The reason the result should be excluded from all calculations.
- Used only when BWEXCLFL is Y.
+ - Cited Guidance:
+ The reason the result should be excluded from all calculations. Used only
+ when BWEXCLFL is Y.
Document: IG v3.1.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND149
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: --EXCLFL
@@ -89,7 +95,7 @@ Check:
Core:
Id: CORE-000481
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when --REASEX is populated and --EXCLFL is not 'Y'
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000482/rule.yml b/Published/CORE-000482/rule.yml
index 7fbd51f07..19c0c909f 100644
--- a/Published/CORE-000482/rule.yml
+++ b/Published/CORE-000482/rule.yml
@@ -4,102 +4,95 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Y if the result should be excluded from all calculations,
- otherwise null.
+ - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null.
Document: SENDIG v3.0
Item: BWEXCLFL Notes
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND148
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Y if the result should be excluded from all calculations,
- otherwise null.
+ - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null.
Document: SENDIG v3.1
Item: BWEXCLFL Notes
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND148
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Y if the result should be excluded from all calculations,
- otherwise null.
+ - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null.
Document: SENDIG v3.1.1
Item: BWEXCLFL Notes
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND148
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Y if the result should be excluded from all calculations,
- otherwise null.
+ - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null.
Document: SENDIG v3.1
Item: BWEXCLFL Notes
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND148
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Y if the result should be excluded from all calculations,
- otherwise null.
+ - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null.
Document: SENDIG v3.1.1
Item: BWEXCLFL Notes
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND148
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Y if the result should be excluded from all calculations,
- otherwise null.
+ - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null.
Document: SENDIG v3.1.1
Item: BWEXCLFL Notes
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND148
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Y if the result should be excluded from all calculations,
- otherwise null.
+ - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null.
Document: TIG v1.0
Item: BWEXCLFL CDISC Notes
Section: 2.8.9.9
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0084
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --EXCLFL
@@ -110,7 +103,7 @@ Check:
Core:
Id: CORE-000482
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when --EXCLFL is populated and the value is different from "Y"
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000484/rule.yml b/Published/CORE-000484/rule.yml
index 8dd92e7f0..c5347ee29 100644
--- a/Published/CORE-000484/rule.yml
+++ b/Published/CORE-000484/rule.yml
@@ -4,62 +4,66 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All records for the same USUBJID that have the same RELID are
- considered "related/associated."
+ - Cited Guidance:
+ All records for the same USUBJID that have the same RELID are considered
+ "related/associated."
Document: IG v3.4
Item: Specification
Section: 8.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0200
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All records for the same USUBJID that have the same RELID are
- considered "related/associated."
+ - Cited Guidance:
+ All records for the same USUBJID that have the same RELID are considered
+ "related/associated."
Document: IG v3.2
Item: Specification
Section: 8.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0200
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All records for the same USUBJID that have the same RELID are
- considered "related/associated."
+ - Cited Guidance:
+ All records for the same USUBJID that have the same RELID are considered
+ "related/associated."
Document: IG v3.3
Item: Specification
Section: 8.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0200
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: All records for the same USUBJID that have the same RELID are
- considered "related/associated."
+ - Cited Guidance:
+ All records for the same USUBJID that have the same RELID are considered
+ "related/associated."
Document: TIG 1.0
Item: Specification-RELID
Section: 2.8.10.21
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0421
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
# Variable: RELID
-# Condition:
+# Condition:
# Rule: Within a subject each unique RELID is present on multiple RELREC records
Check:
all:
@@ -69,9 +73,8 @@ Check:
Core:
Id: CORE-000484
Status: Published
- Version: '1'
-Description: Within a subject, each unique RELID should be present on multiple
- RELREC records
+ Version: "1"
+Description: Within a subject, each unique RELID should be present on multiple RELREC records
Executability: Fully Executable
Outcome:
Message: Unique RELID is NOT present on multiple RELREC records within a subject.
diff --git a/Published/CORE-000485/rule.yml b/Published/CORE-000485/rule.yml
index f0904a96f..35f3608bb 100644
--- a/Published/CORE-000485/rule.yml
+++ b/Published/CORE-000485/rule.yml
@@ -4,108 +4,109 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.0
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND20
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND20
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND20
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND20
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND20
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND20
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The value in QNAM cannot be longer than 8 characters nor can it
- start with a number (e.g., "1TEST" is not valid).
+ - Cited Guidance:
+ The value in QNAM cannot be longer than 8 characters nor can it start with a
+ number (e.g., "1TEST" is not valid).
Document: TIG v1.0
Item: QNAM CDISC Notes
Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP)
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0129
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: QNAM
@@ -114,7 +115,7 @@ Check:
Core:
Id: CORE-000485
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when QNAM > 8 chars
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000486/rule.yml b/Published/CORE-000486/rule.yml
index efa542ba8..07446adb8 100644
--- a/Published/CORE-000486/rule.yml
+++ b/Published/CORE-000486/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND199
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND199
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -34,8 +34,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND199
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
@@ -46,9 +46,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND199
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -58,9 +58,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND199
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -70,9 +70,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND199
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: SCTESTCD
@@ -82,9 +82,9 @@ Check:
Core:
Id: CORE-000486
Status: Published
- Version: '1'
-Description: Raise an error when there is more than one record present for any
- particular Subject Characteristics test for a subject.
+ Version: "1"
+Description: Raise an error when there is more than one record present for any particular Subject
+ Characteristics test for a subject.
Executability: Fully Executable
Outcome:
Message: The Subject Characteristics test is not unique for this subject.
diff --git a/Published/CORE-000487/rule.yml b/Published/CORE-000487/rule.yml
index 95120a3c6..4a76b947b 100644
--- a/Published/CORE-000487/rule.yml
+++ b/Published/CORE-000487/rule.yml
@@ -4,87 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The two-character domain code is limited to A to Z for the first
- character, and A-Z, 0 to 9 for the second character and is
- always represented in uppercase.
+ - Cited Guidance:
+ The two-character domain code is limited to A to Z for the first character,
+ and A-Z, 0 to 9 for the second character and is always represented in uppercase.
Document: IG v3.0
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND33
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The two-character domain code is limited to A to Z for the first
- character, and A-Z, 0 to 9 for the second character and is
- always represented in uppercase.
+ - Cited Guidance:
+ The two-character domain code is limited to A to Z for the first character,
+ and A-Z, 0 to 9 for the second character and is always represented in uppercase.
Document: IG v3.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND33
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The two-character domain code is limited to A to Z for the first
- character, and A-Z, 0 to 9 for the second character and is
- always represented in uppercase.
+ - Cited Guidance:
+ The two-character domain code is limited to A to Z for the first character,
+ and A-Z, 0 to 9 for the second character and is always represented in uppercase.
Document: IG v3.1.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND33
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The two-character domain code is limited to A to Z for the first
- character, and A-Z, 0 to 9 for the second character and is
- always represented in uppercase.
+ - Cited Guidance:
+ The two-character domain code is limited to A to Z for the first character,
+ and A-Z, 0 to 9 for the second character and is always represented in uppercase.
Document: IG v3.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND33
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The two-character domain code is limited to A to Z for the first
- character, and A-Z, 0 to 9 for the second character and is
- always represented in uppercase.
+ - Cited Guidance:
+ The two-character domain code is limited to A to Z for the first character,
+ and A-Z, 0 to 9 for the second character and is always represented in uppercase.
Document: IG v3.1.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND33
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The two-character domain code is limited to A to Z for the first
- character, and A-Z, 0 to 9 for the second character and is
- always represented in uppercase.
+ - Cited Guidance:
+ The two-character domain code is limited to A to Z for the first character,
+ and A-Z, 0 to 9 for the second character and is always represented in uppercase.
Document: IG v3.1.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND33
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: DOMAIN
@@ -93,7 +93,7 @@ Check:
Core:
Id: CORE-000487
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when the value of DOMAIN contains non-uppercase characters
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000490/rule.yml b/Published/CORE-000490/rule.yml
index 00fd0006e..ffc277d1f 100644
--- a/Published/CORE-000490/rule.yml
+++ b/Published/CORE-000490/rule.yml
@@ -4,136 +4,136 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.0
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND23'
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Id: "SEND23"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Organization: CDISC
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND23'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND23"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Organization: CDISC
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND23'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND23"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Organization: CDISC
Standards:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND23'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND23"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Organization: CDISC
Standards:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND23'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND23"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Organization: CDISC
Standards:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND23'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND23"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Organization: CDISC
Standards:
- Name: TIG
References:
- Citations:
- - Cited Guidance: QNAM serves the same purpose as --TESTCD within supplemental
- qualifier datasets, and so values of QNAM are subject to the
- same restrictions as values of --TESTCD
+ - Cited Guidance:
+ QNAM serves the same purpose as --TESTCD within supplemental qualifier
+ datasets, and so values of QNAM are subject to the same restrictions as values of --TESTCD
Document: TIG v1.0
Item: Tabulation Datasets Table, Num 4
Section: 2.6 Guidance for Datasets
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0157
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: When extending a controlled terminology list, the
- case-sensitivity convention of that list should be followed.
+ - Cited Guidance: When extending a controlled terminology list, the case-sensitivity
+ convention of that list should be followed.
Document: TIG v1.0
Item: QNAM CDISC Notes
Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP)
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0157
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: QNAM
@@ -142,7 +142,7 @@ Check:
Core:
Id: CORE-000490
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when QNAM has lowercase characters
Executability: Partially Executable - Possible Overreporting
Outcome:
diff --git a/Published/CORE-000491/rule.yml b/Published/CORE-000491/rule.yml
index 38603b3b0..2736254df 100644
--- a/Published/CORE-000491/rule.yml
+++ b/Published/CORE-000491/rule.yml
@@ -4,93 +4,93 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.0
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND22
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND22
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND22
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND22
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND22
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND22
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: QNAM
@@ -99,13 +99,11 @@ Check:
Core:
Id: CORE-000491
Status: Published
- Version: '1'
-Description: Raise an error when QNAM contains anything else than a letter,
- number or underscore
+ Version: "1"
+Description: Raise an error when QNAM contains anything else than a letter, number or underscore
Executability: Fully Executable
Outcome:
- Message: QNAM value cannot contain characters other than letters, numbers or
- underscores
+ Message: QNAM value cannot contain characters other than letters, numbers or underscores
Output Variables:
- IDVAR
- IDVARVAL
diff --git a/Published/CORE-000492/rule.yml b/Published/CORE-000492/rule.yml
index 4f292ee65..ebc55f44f 100644
--- a/Published/CORE-000492/rule.yml
+++ b/Published/CORE-000492/rule.yml
@@ -4,110 +4,110 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.0
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND21
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND21
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND21
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND21
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND21
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8
- characters, and cannot start with a number, nor can they
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ Values of --TESTCD and QNAM values must be limited to 8 characters, and
+ cannot start with a number, nor can they contain characters other than letters, numbers,
+ or underscores.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND21
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The value in QNAM cannot be longer than 8 characters nor can it
- start with a number (e.g., "1TEST" is not valid). QNAM cannot
- contain characters other than letters, numbers, or
- underscores.
+ - Cited Guidance:
+ The value in QNAM cannot be longer than 8 characters nor can it start with a
+ number (e.g., "1TEST" is not valid). QNAM cannot contain characters other than letters,
+ numbers, or underscores.
Document: TIG v1.0
Item: QNAM CDISC Notes
Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP)
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0137
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: QNAM
@@ -116,7 +116,7 @@ Check:
Core:
Id: CORE-000492
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when QNAM starts with a number
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000493/rule.yml b/Published/CORE-000493/rule.yml
index 35ca7c567..57ae0bce0 100644
--- a/Published/CORE-000493/rule.yml
+++ b/Published/CORE-000493/rule.yml
@@ -4,145 +4,140 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: AGETXT is used to present the age range in situations where the
- exact birthdate is not known. It should be presented in
- number-number format..
+ - Cited Guidance:
+ AGETXT is used to present the age range in situations where the exact
+ birthdate is not known. It should be presented in number-number format..
Document: IG v3.0
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND102
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: AGETXT is used to present the age range in situations where the
- exact birthdate is not known. It should be presented in
- number-number format..
+ - Cited Guidance:
+ AGETXT is used to present the age range in situations where the exact
+ birthdate is not known. It should be presented in number-number format..
Document: IG v3.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND102
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: AGETXT is used to present the age range in situations where the
- exact birthdate is not known. It should be presented in
- number-number format..
+ - Cited Guidance:
+ AGETXT is used to present the age range in situations where the exact
+ birthdate is not known. It should be presented in number-number format..
Document: IG v3.1.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND102
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: AGETXT is used to present the age range in situations where the
- exact birthdate is not known. It should be presented in
- number-number format..
+ - Cited Guidance:
+ AGETXT is used to present the age range in situations where the exact
+ birthdate is not known. It should be presented in number-number format..
Document: IG v3.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND102
- Version: '1'
- Version: '5.0'
- Version: '1.1'
- # FDA Business rule FB5301 is identical, so extending the scope here
- # FB5301 as of SEND 3.1
- - Organization: 'FDA'
+ Version: "1"
+ Version: "5.0"
+ Version:
+ "1.1"
+ # FDA Business rule FB5301 is identical, so extending the scope here
+ # FB5301 as of SEND 3.1
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5301'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB5301"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5301'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB5301"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5301'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB5301"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5301'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB5301"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5301'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB5301"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5301'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB5301"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: AGETXT
@@ -153,9 +148,9 @@ Check:
Core:
Id: CORE-000493
Status: Published
- Version: '1'
-Description: Age Range (AGETXT) should be populated with a number-number format
- when age range is supplied.
+ Version: "1"
+Description: Age Range (AGETXT) should be populated with a number-number format when age range is
+ supplied.
Executability: Fully Executable
Outcome:
Message: AGETXT is not in number - number format.
diff --git a/Published/CORE-000494/rule.yml b/Published/CORE-000494/rule.yml
index dc155f95e..2deac5191 100644
--- a/Published/CORE-000494/rule.yml
+++ b/Published/CORE-000494/rule.yml
@@ -4,12 +4,11 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The Role of the
- variable, which determines how the variable is used in the
- dataset. For SEND Domain. Models, Roles are used to represent
- the categories of variables such as Identifier, Topic, Timing,
- or the five types of Qualifiers"
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The Role of the variable, which determines how the variable is used in the dataset.
+ For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier,
+ Topic, Timing, or the five types of Qualifiers"
Document: IG v3.0
Item: Specification
Section: 3.2.2
@@ -22,12 +21,11 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The Role of the
- variable, which determines how the variable is used in the
- dataset. For SEND Domain. Models, Roles are used to represent
- the categories of variables such as Identifier, Topic, Timing,
- or the five types of Qualifiers"
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The Role of the variable, which determines how the variable is used in the dataset.
+ For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier,
+ Topic, Timing, or the five types of Qualifiers"
Document: IG v3.1
Item: Specification
Section: 3.2.2
@@ -40,12 +38,11 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The Role of the
- variable, which determines how the variable is used in the
- dataset. For SEND Domain. Models, Roles are used to represent
- the categories of variables such as Identifier, Topic, Timing,
- or the five types of Qualifiers"
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The Role of the variable, which determines how the variable is used in the dataset.
+ For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier,
+ Topic, Timing, or the five types of Qualifiers"
Document: IG v3.1.1
Item: Specification
Section: 3.2.2
@@ -58,12 +55,11 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The Role of the
- variable, which determines how the variable is used in the
- dataset. For SEND Domain. Models, Roles are used to represent
- the categories of variables such as Identifier, Topic, Timing,
- or the five types of Qualifiers"
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The Role of the variable, which determines how the variable is used in the dataset.
+ For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier,
+ Topic, Timing, or the five types of Qualifiers"
Document: IG v3.1
Item: Specification
Section: 3.2.2
@@ -76,12 +72,11 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The Role of the
- variable, which determines how the variable is used in the
- dataset. For SEND Domain. Models, Roles are used to represent
- the categories of variables such as Identifier, Topic, Timing,
- or the five types of Qualifiers"
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The Role of the variable, which determines how the variable is used in the dataset.
+ For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier,
+ Topic, Timing, or the five types of Qualifiers"
Document: IG v3.1.1
Item: Specification
Section: 3.2.2
@@ -94,12 +89,11 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The Role of the
- variable, which determines how the variable is used in the
- dataset. For SEND Domain. Models, Roles are used to represent
- the categories of variables such as Identifier, Topic, Timing,
- or the five types of Qualifiers"
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The Role of the variable, which determines how the variable is used in the dataset.
+ For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier,
+ Topic, Timing, or the five types of Qualifiers"
Document: IG v3.1.1
Item: Specification
Section: 3.2.2
@@ -125,12 +119,12 @@ Core:
Id: CORE-000494
Status: Published
Version: "1"
-Description: Raise an error when the role provided in the define.xml does not
- correspond to the role in the IG
+Description: Raise an error when the role provided in the define.xml does not correspond to the role
+ in the IG
Executability: Fully Executable
Outcome:
- Message: The Role of the variable in the define.xml does not correspond to the
- Role given by the Implementation Guide
+ Message: The Role of the variable in the define.xml does not correspond to the Role given by the
+ Implementation Guide
Output Variables:
- define_variable_label
- define_variable_name
diff --git a/Published/CORE-000495/rule.yml b/Published/CORE-000495/rule.yml
index ab0cae137..ef5bee373 100644
--- a/Published/CORE-000495/rule.yml
+++ b/Published/CORE-000495/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND175
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND175
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -34,9 +34,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND175
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -46,9 +46,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND175
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -58,9 +58,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND175
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -70,24 +70,25 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND175
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: ma.xpt, Macroscopic Findings - Findings. One record per finding
- per specimen per subject, Tabulation.
+ - Cited Guidance:
+ ma.xpt, Macroscopic Findings - Findings. One record per finding per specimen
+ per subject, Tabulation.
Document: TIG v1.0
Item: Domain Table Header
Section: 2.8.9.15
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0104
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: MAORRES
@@ -103,10 +104,9 @@ Check:
Core:
Id: CORE-000495
Status: Published
- Version: '1'
-Description: Raise an error when there is more than one record present for any
- particular Macroscopic Finding test and result in the MA Domain, within a
- subject.
+ Version: "1"
+Description: Raise an error when there is more than one record present for any particular
+ Macroscopic Finding test and result in the MA Domain, within a subject.
Executability: Fully Executable
Outcome:
Message: The Macroscopic Finding test result is not unique for this subject and test.
diff --git a/Published/CORE-000496/rule.yml b/Published/CORE-000496/rule.yml
index 8daea794d..8dfd8204d 100644
--- a/Published/CORE-000496/rule.yml
+++ b/Published/CORE-000496/rule.yml
@@ -1,112 +1,126 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per
- interval per subject or pool'
- Document: 'IG v.3.0'
- Item: 'Domain table header'
- Section: '6.3.5'
- # REMARK: Both FWDTC and FWENDTC are "expected" variables
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Food and Water Consumption - Findings. One record per test per interval per subject
+ or pool"
+ Document: "IG v.3.0"
+ Item: "Domain table header"
+ Section:
+ "6.3.5"
+ # REMARK: Both FWDTC and FWENDTC are "expected" variables
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND168'
- Version: '1'
- Version: '5.0'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "SEND168"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per
- interval per subject or pool'
- Document: 'IG v.3.1'
- Item: 'Domain table header'
- Section: '6.3.5'
- # REMARK: Both FWDTC and FWENDTC are "expected" variables
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Food and Water Consumption - Findings. One record per test per interval per subject
+ or pool"
+ Document: "IG v.3.1"
+ Item: "Domain table header"
+ Section:
+ "6.3.5"
+ # REMARK: Both FWDTC and FWENDTC are "expected" variables
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND168'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "SEND168"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per
- interval per subject or pool'
- Document: 'IG v.3.1.1'
- Item: 'Domain table header'
- Section: '6.3.5'
- # REMARK: Both FWDTC and FWENDTC are "expected" variables
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Food and Water Consumption - Findings. One record per test per interval per subject
+ or pool"
+ Document: "IG v.3.1.1"
+ Item: "Domain table header"
+ Section:
+ "6.3.5"
+ # REMARK: Both FWDTC and FWENDTC are "expected" variables
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND168'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "SEND168"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per
- interval per subject or pool'
- Document: 'IG v.3.1'
- Item: 'Domain table header'
- Section: '6.3.5'
- # REMARK: Both FWDTC and FWENDTC are "expected" variables
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Food and Water Consumption - Findings. One record per test per interval per subject
+ or pool"
+ Document: "IG v.3.1"
+ Item: "Domain table header"
+ Section:
+ "6.3.5"
+ # REMARK: Both FWDTC and FWENDTC are "expected" variables
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND168'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "SEND168"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per
- interval per subject or pool'
- Document: 'IG v.3.1.1'
- Item: 'Domain table header'
- Section: '6.3.5'
- # REMARK: Both FWDTC and FWENDTC are "expected" variables
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Food and Water Consumption - Findings. One record per test per interval per subject
+ or pool"
+ Document: "IG v.3.1.1"
+ Item: "Domain table header"
+ Section:
+ "6.3.5"
+ # REMARK: Both FWDTC and FWENDTC are "expected" variables
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND168'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
- - Name: 'SENDIG-GENETOX'
+ Id: "SEND168"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per
- interval per subject or pool'
- Document: 'IG v.3.1'
- Item: 'Domain table header'
- Section: '6.3.5'
- # REMARK: Both FWDTC and FWENDTC are "expected" variables
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Food and Water Consumption - Findings. One record per test per interval per subject
+ or pool"
+ Document: "IG v.3.1"
+ Item: "Domain table header"
+ Section:
+ "6.3.5"
+ # REMARK: Both FWDTC and FWENDTC are "expected" variables
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND168'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND168"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: fw.xpt, Food and Water Consumption - Findings. One record per
- test per interval per subject or pool, Tabulation.
+ - Cited Guidance:
+ fw.xpt, Food and Water Consumption - Findings. One record per test per
+ interval per subject or pool, Tabulation.
Document: TIG v1.0
Item: Domain Table Header
- Section: 2.8.9.12
- # REMARK: Both FWDTC and FWENDTC are "expected" variables
+ Section:
+ 2.8.9.12
+ # REMARK: Both FWDTC and FWENDTC are "expected" variables
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0097
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -114,7 +128,7 @@ Check:
- name: USUBJID
operator: non_empty
- name: FWTESTCD
- operator: 'is_not_unique_set'
+ operator: "is_not_unique_set"
value:
- USUBJID
- FWDTC
@@ -124,7 +138,7 @@ Check:
- name: POOLID
operator: non_empty
- name: FWTESTCD
- operator: 'is_not_unique_set'
+ operator: "is_not_unique_set"
value:
- POOLID
- FWDTC
@@ -132,12 +146,13 @@ Check:
Core:
Id: CORE-000496
Status: Published
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'Structure must be one record per test per interval (as defined by
- FWDTC and FWENDTC) per subject or pool'
+ Message:
+ "Structure must be one record per test per interval (as defined by FWDTC and FWENDTC) per subject
+ or pool"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000498/rule.yml b/Published/CORE-000498/rule.yml
index f735d2b9e..3b08cb0b4 100644
--- a/Published/CORE-000498/rule.yml
+++ b/Published/CORE-000498/rule.yml
@@ -4,93 +4,99 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: AGETXT is used to present the age range in situations where the
- exact birthdate is not known. If AGETXT is included both
- BRTHDTC and AGE should not be populated.
+ - Cited Guidance:
+ AGETXT is used to present the age range in situations where the exact
+ birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be
+ populated.
Document: IG v3.0
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND103
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: AGETXT is used to present the age range in situations where the
- exact birthdate is not known. If AGETXT is included both
- BRTHDTC and AGE should not be populated.
+ - Cited Guidance:
+ AGETXT is used to present the age range in situations where the exact
+ birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be
+ populated.
Document: IG v3.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND103
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: AGETXT is used to present the age range in situations where the
- exact birthdate is not known. If AGETXT is included both
- BRTHDTC and AGE should not be populated.
+ - Cited Guidance:
+ AGETXT is used to present the age range in situations where the exact
+ birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be
+ populated.
Document: IG v3.1.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND103
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: AGETXT is used to present the age range in situations where the
- exact birthdate is not known. If AGETXT is included both
- BRTHDTC and AGE should not be populated.
+ - Cited Guidance:
+ AGETXT is used to present the age range in situations where the exact
+ birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be
+ populated.
Document: IG v3.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND103
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: AGETXT is used to present the age range in situations where the
- exact birthdate is not known. If AGETXT is included both
- BRTHDTC and AGE should not be populated.
+ - Cited Guidance:
+ AGETXT is used to present the age range in situations where the exact
+ birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be
+ populated.
Document: IG v3.1.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND103
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: AGETXT is used to present the age range in situations where the
- exact birthdate is not known. If AGETXT is included both
- BRTHDTC and AGE should not be populated.
+ - Cited Guidance:
+ AGETXT is used to present the age range in situations where the exact
+ birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be
+ populated.
Document: IG v3.1.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND103
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: AGETXT
@@ -103,10 +109,9 @@ Check:
Core:
Id: CORE-000498
Status: Published
- Version: '1'
-Description: AGETXT is used to present the age range in situations where the
- exact birthdate is not known. If AGETXT is included both BRTHDTC and AGE
- should not be populated.
+ Version: "1"
+Description: AGETXT is used to present the age range in situations where the exact birthdate is not
+ known. If AGETXT is included both BRTHDTC and AGE should not be populated.
Executability: Fully Executable
Outcome:
Message: AGETXT is populated, so neither BRTHDTC nor AGE may be populated
diff --git a/Published/CORE-000499/rule.yml b/Published/CORE-000499/rule.yml
index 13e23588d..9b8d2c89b 100644
--- a/Published/CORE-000499/rule.yml
+++ b/Published/CORE-000499/rule.yml
@@ -4,8 +4,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per
- specimen per subject, Tabulation.
+ - Cited Guidance:
+ om.xpt, Organ Measurements - Findings. One record per test per specimen per
+ subject, Tabulation.
Document: SENDIG v3.0
Section: 6.3.9
Origin: SEND Conformance Rules
@@ -17,8 +18,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per
- specimen per subject, Tabulation.
+ - Cited Guidance:
+ om.xpt, Organ Measurements - Findings. One record per test per specimen per
+ subject, Tabulation.
Document: SENDIG v3.1
Section: 6.3.9
Origin: SEND Conformance Rules
@@ -30,8 +32,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per
- specimen per subject, Tabulation.
+ - Cited Guidance:
+ om.xpt, Organ Measurements - Findings. One record per test per specimen per
+ subject, Tabulation.
Document: SENDIG v3.1.1
Section: 6.3.9
Origin: SEND Conformance Rules
@@ -43,8 +46,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per
- specimen per subject, Tabulation.
+ - Cited Guidance:
+ om.xpt, Organ Measurements - Findings. One record per test per specimen per
+ subject, Tabulation.
Document: SENDIG v3.1
Section: 6.3.9
Origin: SEND Conformance Rules
@@ -56,8 +60,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per
- specimen per subject, Tabulation.
+ - Cited Guidance:
+ om.xpt, Organ Measurements - Findings. One record per test per specimen per
+ subject, Tabulation.
Document: SENDIG v3.1.1
Section: 6.3.9
Origin: SEND Conformance Rules
@@ -69,8 +74,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per
- specimen per subject, Tabulation.
+ - Cited Guidance:
+ om.xpt, Organ Measurements - Findings. One record per test per specimen per
+ subject, Tabulation.
Document: SENDIG v3.1.1
Section: 6.3.9
Origin: SEND Conformance Rules
@@ -94,8 +100,8 @@ Core:
Id: CORE-000499
Status: Published
Version: "1"
-Description: Raise an error when there is more than one record present per
- subject for any particular Organ Measurement test in the OM Domain
+Description: Raise an error when there is more than one record present per subject for any
+ particular Organ Measurement test in the OM Domain
Executability: Fully Executable
Outcome:
Message: The Organ Measurement test is not unique for this subject.
diff --git a/Published/CORE-000500/rule.yml b/Published/CORE-000500/rule.yml
index 4eb9f2166..a62be0a05 100644
--- a/Published/CORE-000500/rule.yml
+++ b/Published/CORE-000500/rule.yml
@@ -4,74 +4,69 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter
- per Trial Set
+ - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set
Document: IG v3.0
Item: Specification
Section: 7.4.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND230
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter
- per Trial Set
+ - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set
Document: IG v3.1
Item: Specification
Section: 7.4.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND230
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter
- per Trial Set
+ - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set
Document: IG v3.1.1
Item: Specification
Section: 7.4.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND230
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter
- per Trial Set
+ - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set
Document: IG v3.1
Item: Specification
Section: 7.4.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND230
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter
- per Trial Set.
+ - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set.
Document: TIG v1.0
Item: Domain Table Header
Section: 2.8.9.28
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0158
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: TXPARMCD
@@ -80,7 +75,7 @@ Check:
Core:
Id: CORE-000500
Status: Published
- Version: '1'
+ Version: "1"
Description: Combination of SETCD and TXPARMCD must be unique
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000502/rule.yml b/Published/CORE-000502/rule.yml
index ce549ea4c..212266c80 100644
--- a/Published/CORE-000502/rule.yml
+++ b/Published/CORE-000502/rule.yml
@@ -7,30 +7,30 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Each study must include 1 standardized set of observations in a
- specific structure; this is the Demographics domain described
- here.
+ - Cited Guidance:
+ Each study must include 1 standardized set of observations in a specific
+ structure; this is the Demographics domain described here.
Document: Model v2.0
Item: RDOMAIN
Section: Comments
- - Cited Guidance: Each study must include 1 standardized set of observations in a
- specific structure; this is the Demographics domain described
- here.
+ - Cited Guidance:
+ Each study must include 1 standardized set of observations in a specific
+ structure; this is the Demographics domain described here.
Document: Model v2.0
Item: RDOMAIN
Section: Supplemental Qualifiers
- - Cited Guidance: Each study must incude 1 standardized set of observations in a
- specific structure; this is the Demographics domain described
- here.
+ - Cited Guidance:
+ Each study must incude 1 standardized set of observations in a specific
+ structure; this is the Demographics domain described here.
Document: Model v2.0
Item: RDOMAIN
Section: Related Records
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0369
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -40,9 +40,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0369
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -52,31 +52,31 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0369
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Comments[Each study must include 1 standardized set of
- observations in a specific structure; this is the Demographics
- domain described here.]|Supplemental Qualifiers[Each study
- must include 1 standardized set of observations in a specific
- structure; this is the Demographics domain described
- here.]|Related Records[Each study must include 1 standardized
- set of observations in a specific structure; this is the
+ - Cited Guidance:
+ Comments[Each study must include 1 standardized set of observations in a
+ specific structure; this is the Demographics domain described here.]|Supplemental
+ Qualifiers[Each study must include 1 standardized set of observations in a specific
+ structure; this is the Demographics domain described here.]|Related Records[Each study
+ must include 1 standardized set of observations in a specific structure; this is the
Demographics domain described here.]
Document: SDTM v2.1
Item: RDOMAIN
- Section: 3.2.2 Comments| 6.2 Supplemental Qualifiers Datasets | Section 6.1
- Related Records Dataset
+ Section:
+ 3.2.2 Comments| 6.2 Supplemental Qualifiers Datasets | Section 6.1 Related Records
+ Dataset
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0533
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: RDOMAIN
@@ -87,9 +87,9 @@ Check:
Core:
Id: CORE-000502
Status: Published
- Version: '1'
-Description: Raise an error when RDOMAIN is populated but the referenced RDOMAIN
- doesn't exist as a dataset in the present study
+ Version: "1"
+Description: Raise an error when RDOMAIN is populated but the referenced RDOMAIN doesn't exist as a
+ dataset in the present study
Executability: Fully Executable
Operations:
- id: $study_domains
diff --git a/Published/CORE-000503/rule.yml b/Published/CORE-000503/rule.yml
index ed63ec3d6..273cbb848 100644
--- a/Published/CORE-000503/rule.yml
+++ b/Published/CORE-000503/rule.yml
@@ -4,8 +4,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: QORIG is used to indicate the origin of the data. Possible
- values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
+ - Cited Guidance:
+ QORIG is used to indicate the origin of the data. Possible values are
+ COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
Document: SENDIG v3.0
Item: QORIG CDISC Notes
Section: "8.5"
@@ -18,8 +19,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: QORIG is used to indicate the origin of the data. Possible
- values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
+ - Cited Guidance:
+ QORIG is used to indicate the origin of the data. Possible values are
+ COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
Document: SENDIG v3.1
Item: QORIG CDISC Notes
Section: "8.3"
@@ -32,8 +34,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: QORIG is used to indicate the origin of the data. Possible
- values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
+ - Cited Guidance:
+ QORIG is used to indicate the origin of the data. Possible values are
+ COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
Document: SENDIG v3.1.1
Item: QORIG CDISC Notes
Section: "8.3"
@@ -46,8 +49,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: QORIG is used to indicate the origin of the data. Possible
- values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
+ - Cited Guidance:
+ QORIG is used to indicate the origin of the data. Possible values are
+ COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
Document: SENDIG v3.1
Item: QORIG CDISC Notes
Section: "8.3"
@@ -60,8 +64,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: QORIG is used to indicate the origin of the data. Possible
- values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
+ - Cited Guidance:
+ QORIG is used to indicate the origin of the data. Possible values are
+ COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
Document: SENDIG v3.1.1
Item: QORIG CDISC Notes
Section: "8.3"
@@ -74,8 +79,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: QORIG is used to indicate the origin of the data. Possible
- values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
+ - Cited Guidance:
+ QORIG is used to indicate the origin of the data. Possible values are
+ COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
Document: SENDIG v3.1.1
Item: QORIG CDISC Notes
Section: "8.3"
@@ -88,8 +94,9 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: QORIG is used to indicate the origin of the data. Possible
- values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
+ - Cited Guidance:
+ QORIG is used to indicate the origin of the data. Possible values are
+ COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
Document: TIG v1.0
Item: QORIG CDISC Notes
Section: 2.8.9.27
@@ -117,27 +124,28 @@ Check:
value: OTHER
- name: QORIG
operator: not_equal_to
- value: NOT AVAILABLE
- # Simplification 2024-05-21
- # NO: this is NOT how is_not_contained_by works, it requires a reference to a separate operation
- # see e.g. CG0118
- # - name: QORIG
- # operator: is_not_contained_by
- # value:
- # - COLLECTED
- # - DERIVED
- # - OTHER
- # - NOT AVAILABLE
+ value:
+ NOT AVAILABLE
+ # Simplification 2024-05-21
+ # NO: this is NOT how is_not_contained_by works, it requires a reference to a separate operation
+ # see e.g. CG0118
+ # - name: QORIG
+ # operator: is_not_contained_by
+ # value:
+ # - COLLECTED
+ # - DERIVED
+ # - OTHER
+ # - NOT AVAILABLE
Core:
Id: CORE-000503
Status: Published
Version: "1"
-Description: QORIG is used to indicate the origin of the data. Possible values
- are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.
+Description: QORIG is used to indicate the origin of the data. Possible values are COLLECTED,
+ DERIVED, OTHER, and NOT AVAILABLE.
Executability: Fully Executable
Outcome:
- Message: When populated, the possible values for QORIG are limited to COLLECTED,
- DERIVED, OTHER, and NOT AVAILABLE.
+ Message: When populated, the possible values for QORIG are limited to COLLECTED, DERIVED, OTHER,
+ and NOT AVAILABLE.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000505/rule.yml b/Published/CORE-000505/rule.yml
index eab8f734d..202a8232e 100644
--- a/Published/CORE-000505/rule.yml
+++ b/Published/CORE-000505/rule.yml
@@ -7,187 +7,188 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
- Table 1. TSVAL may have controlled terminology depending on
- the value of TSPARMCD
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0285
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included Appendix
- C1, Trial Summary Codes. TSVAL may have controlled terminology
- depending on the value of TSPARMCD. Conditions for including
- parameters are included in Appendix C1, Trial Summary Codes.
+ - Cited Guidance:
+ Further information about the parameters is included Appendix C1, Trial
+ Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD.
+ Conditions for including parameters are included in Appendix C1, Trial Summary Codes.
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0285
- Version: '1'
- Version: '2.0'
- Version: '3.3'
- ##CGO285 is similar to TRC1734c. Added FDA Business rule.
+ Version: "1"
+ Version: "2.0"
+ Version:
+ "3.3"
+ ##CGO285 is similar to TRC1734c. Added FDA Business rule.
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734c
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734c
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734c
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734c
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734c
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734c
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734c
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734c
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734c
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734c
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
@@ -199,9 +200,9 @@ Check:
Core:
Id: CORE-000505
Status: Published
- Version: '1'
-Description: Study Start Date (SSTDTC) value in the TS dataset should be
- populated in ISO 8601 format.
+ Version: "1"
+Description: Study Start Date (SSTDTC) value in the TS dataset should be populated in ISO 8601
+ format.
Executability: Fully Executable
Outcome:
Message: TSVAL where TSPARMCD = SSTDTC is not in ISO 8601 format.
diff --git a/Published/CORE-000507/rule.yml b/Published/CORE-000507/rule.yml
index 5af21784c..6083cfdf1 100644
--- a/Published/CORE-000507/rule.yml
+++ b/Published/CORE-000507/rule.yml
@@ -4,81 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Metadata in Define-XML document should match both the SENDIG
- label and the label in the .xpt datasets
+ - Cited Guidance:
+ Metadata in Define-XML document should match both the SENDIG label and the
+ label in the .xpt datasets
Document: SENDIG v3.0
Section: 3.2.2 | 4.21
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND6
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Metadata in Define-XML document should match both the SENDIG
- label and the label in the .xpt datasets
+ - Cited Guidance:
+ Metadata in Define-XML document should match both the SENDIG label and the
+ label in the .xpt datasets
Document: SENDIG v3.1
Section: 3.2.2 | 4.21
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND6
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Metadata in Define-XML document should match both the SENDIG
- label and the label in the .xpt datasets
+ - Cited Guidance:
+ Metadata in Define-XML document should match both the SENDIG label and the
+ label in the .xpt datasets
Document: SENDIG v3.1.1
Section: 3.2.2 | 4.21
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND6
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Metadata in Define-XML document should match both the SENDIG
- label and the label in the .xpt datasets
+ - Cited Guidance:
+ Metadata in Define-XML document should match both the SENDIG label and the
+ label in the .xpt datasets
Document: SENDIG v3.1
Section: 3.2.2 | 4.21
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND6
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Metadata in Define-XML document should match both the SENDIG
- label and the label in the .xpt datasets
+ - Cited Guidance:
+ Metadata in Define-XML document should match both the SENDIG label and the
+ label in the .xpt datasets
Document: SENDIG v3.1.1
Section: 3.2.2 | 4.21
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND6
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Metadata in Define-XML document should match both the SENDIG
- label and the label in the .xpt datasets
+ - Cited Guidance:
+ Metadata in Define-XML document should match both the SENDIG label and the
+ label in the .xpt datasets
Document: SENDIG v3.1.1
Section: 3.2.2 | 4.21
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND6
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
# IMPORTANT: Order is important ...
@@ -88,11 +94,11 @@ Check:
Core:
Id: CORE-000507
Status: Published
- Version: '1'
-Description: 'Raise an error when the variable label in the define.xml does not
- correspond to the variable label dataset. NOTE: This rule has been split in
- two parts: A. check define variable label against IG label B. check define
- variable label against the label in the dataset '
+ Version: "1"
+Description:
+ "Raise an error when the variable label in the define.xml does not correspond to the variable
+ label dataset. NOTE: This rule has been split in two parts: A. check define variable label against IG
+ label B. check define variable label against the label in the dataset "
Executability: Fully Executable
Outcome:
Message: The label of the variable is incorrect
diff --git a/Published/CORE-000508/rule.yml b/Published/CORE-000508/rule.yml
index 04840cfb5..f5892ae7d 100644
--- a/Published/CORE-000508/rule.yml
+++ b/Published/CORE-000508/rule.yml
@@ -4,81 +4,75 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per test per palpable mass per observation time per
- subject
+ - Cited Guidance: One record per test per palpable mass per observation time per subject
Document: SENDIG v3.0
Section: 6.3.10
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND191'
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Id: "SEND191"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per test per palpable mass per observation time per
- subject
+ - Cited Guidance: One record per test per palpable mass per observation time per subject
Document: SENDIG v3.1
Section: 6.3.10
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND191'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND191"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per test per palpable mass per observation time per
- subject
+ - Cited Guidance: One record per test per palpable mass per observation time per subject
Document: SENDIG v3.1.1
Section: 6.3.10
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND191'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND191"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: One record per test per palpable mass per observation time per
- subject
+ - Cited Guidance: One record per test per palpable mass per observation time per subject
Document: SENDIG v3.1
Section: 6.3.10
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND191'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND191"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: One record per test per palpable mass per observation time per
- subject
+ - Cited Guidance: One record per test per palpable mass per observation time per subject
Document: SENDIG v3.1.1
Section: 6.3.10
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND191'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND191"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: One record per test per palpable mass per observation time per
- subject
+ - Cited Guidance: One record per test per palpable mass per observation time per subject
Document: SENDIG v3.1.1
Section: 6.3.10
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND191'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND191"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: PMDTC
@@ -92,14 +86,12 @@ Check:
Core:
Id: CORE-000508
Status: Published
- Version: '1'
-Description: Raise an error when there is more than one record present for any
- particular Palpable Mass test per Palpable Mass test in the PM Domain, for a
- subject on a particular date.
+ Version: "1"
+Description: Raise an error when there is more than one record present for any particular Palpable
+ Mass test per Palpable Mass test in the PM Domain, for a subject on a particular date.
Executability: Fully Executable
Outcome:
- Message: The palpable mass test and result is not unique for this subject and
- date/time.
+ Message: The palpable mass test and result is not unique for this subject and date/time.
Output Variables:
- USUBJID
- PMTESTCD
diff --git a/Published/CORE-000509/rule.yml b/Published/CORE-000509/rule.yml
index caef2f70f..b94a78ad8 100644
--- a/Published/CORE-000509/rule.yml
+++ b/Published/CORE-000509/rule.yml
@@ -11,9 +11,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND250
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -23,9 +23,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND250
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -35,9 +35,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND250
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -47,9 +47,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND250
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -59,9 +59,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND250
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -71,9 +71,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND250
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
- all:
@@ -84,9 +84,10 @@ Check:
value: 1
- name: $record_count_AGE
operator: greater_than_or_equal_to
- value: 1
- # NO TSPARMCD=AGE and no TSPARMCD=AGETXT is present
- # Both counts are 0
+ value:
+ 1
+ # NO TSPARMCD=AGE and no TSPARMCD=AGETXT is present
+ # Both counts are 0
- all:
- name: $record_count_AGETXT
operator: equal_to
@@ -98,24 +99,25 @@ Check:
Core:
Id: CORE-000509
Status: Published
- Version: '1'
-Description: Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should
- be present, but not both.
+ Version: "1"
+Description: Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be present, but not
+ both.
Executability: Fully Executable
Operations:
# Record count for TSPARMCD=AGE (for reporting reasons)
- filter:
TSPARMCD: AGE
id: $record_count_AGE
- operator: record_count
- # Record count for TSPARMCD=AGETXT
+ operator:
+ record_count
+ # Record count for TSPARMCD=AGETXT
- filter:
TSPARMCD: AGETXT
id: $record_count_AGETXT
operator: record_count
Outcome:
- Message: Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be
- present, but not both.
+ Message: Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be present, but not
+ both.
Output Variables:
#- TSPARMCD
#- TSVAL
diff --git a/Published/CORE-000511/rule.yml b/Published/CORE-000511/rule.yml
index a8b757c24..67d6dfcbf 100644
--- a/Published/CORE-000511/rule.yml
+++ b/Published/CORE-000511/rule.yml
@@ -5,87 +5,83 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Terminal Body Weight will be recorded in the BW domain and this
- is indicated by the test code (BWTESTCD) of TERMBW.
+ - Cited Guidance:
+ Terminal Body Weight will be recorded in the BW domain and this is indicated
+ by the test code (BWTESTCD) of TERMBW.
Document: IG v3.0
Item: Assumption 2
Section: 6.3.9.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND189
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM
- domain.
+ - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain.
Document: IG v3.1
Item: Assumption 2
Section: 6.3.9.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND189.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM
- domain.
+ - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain.
Document: IG v3.1.1
Item: Assumption 2
Section: 6.3.9.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND189.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM
- domain.
+ - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain.
Document: IG v3.1
Item: Assumption 2
Section: 6.3.9.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND189.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM
- domain.
+ - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain.
Document: IG v3.1.1
Item: Assumption 2
Section: 6.3.9.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND189.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM
- domain.
+ - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain.
Document: IG v3.1.1
Item: Assumption 2
Section: 6.3.9.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND189.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
# implemented as that --TESTCD=TERMBW may only appear for DOMAIN=BWn(in Findings)
@@ -99,7 +95,7 @@ Check:
Core:
Id: CORE-000511
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when --TESTCD=TERMBW is used in another findings domain than BW
Executability: Fully Executable
diff --git a/Published/CORE-000513/rule.yml b/Published/CORE-000513/rule.yml
index f8d20a817..5a975fca6 100644
--- a/Published/CORE-000513/rule.yml
+++ b/Published/CORE-000513/rule.yml
@@ -4,16 +4,17 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: BGENDTC must be populated when BGTESTCD is representing Average
- Body Weight Gain (BWGAINA)
+ - Cited Guidance:
+ BGENDTC must be populated when BGTESTCD is representing Average Body Weight
+ Gain (BWGAINA)
Document: IG v3.0
Section: 6.3.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND152.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
# REMARK: this rule is only applicable to SENDIG-3.0, not to later versions
Check:
all:
@@ -25,7 +26,7 @@ Check:
Core:
Id: CORE-000513
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when BGENDTC is empty when BGTESTCD=BWGAINA
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000514/rule.yml b/Published/CORE-000514/rule.yml
index 654b275dd..3ff3ceaa4 100644
--- a/Published/CORE-000514/rule.yml
+++ b/Published/CORE-000514/rule.yml
@@ -4,16 +4,17 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Date/time of the end of the weight interval in ISO 8601
- format. This must be populated when BGTESTCD is BWGAINA.
+ - Cited Guidance:
+ Date/time of the end of the weight interval in ISO 8601 format. This must
+ be populated when BGTESTCD is BWGAINA.
Document: IG v3.0
Section: 6.3.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND151.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
# REMARK: this rule is only applicable to SENDIG-3.0, not to later versions
Check:
all:
@@ -25,7 +26,7 @@ Check:
Core:
Id: CORE-000514
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when both BGDTC is empty when BGTESTCD=BWGAINA
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000516/rule.yml b/Published/CORE-000516/rule.yml
index 8f9304467..6d7e01e03 100644
--- a/Published/CORE-000516/rule.yml
+++ b/Published/CORE-000516/rule.yml
@@ -4,133 +4,123 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The value for study day should not be negative for exposure
- treatments.
+ - Cited Guidance: The value for study day should not be negative for exposure treatments.
Document: FDA
Section: FDAB036
Origin: FDA Business Rules
Rule Identifier:
Id: FB3601
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The value for study day should not be negative for exposure
- treatments.
+ - Cited Guidance: The value for study day should not be negative for exposure treatments.
Document: FDA
Section: FDAB036
Origin: FDA Business Rules
Rule Identifier:
Id: FB3601
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The value for study day should not be negative for exposure
- treatments.
+ - Cited Guidance: The value for study day should not be negative for exposure treatments.
Document: FDA
Section: FDAB036
Origin: FDA Business Rules
Rule Identifier:
Id: FB3601
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The value for study day should not be negative for exposure
- treatments.
+ - Cited Guidance: The value for study day should not be negative for exposure treatments.
Document: FDA
Section: FDAB036
Origin: FDA Business Rules
Rule Identifier:
Id: FB3601
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The value for study day should not be negative for exposure
- treatments.
+ - Cited Guidance: The value for study day should not be negative for exposure treatments.
Document: FDA
Section: FDAB036
Origin: FDA Business Rules
Rule Identifier:
Id: FB3601
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The value for study day should not be negative for exposure
- treatments.
+ - Cited Guidance: The value for study day should not be negative for exposure treatments.
Document: FDA
Section: FDAB036
Origin: FDA Business Rules
Rule Identifier:
Id: FB3601
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The value for study day should not be negative for exposure
- treatments.
+ - Cited Guidance: The value for study day should not be negative for exposure treatments.
Document: FDA
Section: FDAB036
Origin: FDA Business Rules
Rule Identifier:
Id: FB3601
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The value for study day should not be negative for exposure
- treatments.
+ - Cited Guidance: The value for study day should not be negative for exposure treatments.
Document: FDA
Section: FDAB036
Origin: FDA Business Rules
Rule Identifier:
Id: FB3601
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The value for study day should not be negative for exposure
- treatments.
+ - Cited Guidance: The value for study day should not be negative for exposure treatments.
Document: FDA
Section: FDAB036
Origin: FDA Business Rules
Rule Identifier:
Id: FB3601
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: The value for study day should not be negative for exposure
- treatments.
+ - Cited Guidance: The value for study day should not be negative for exposure treatments.
Document: FDA
Section: FDAB036
Origin: FDA Business Rules
Rule Identifier:
Id: FB3601
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
any:
- name: --STDY
@@ -142,8 +132,10 @@ Check:
Core:
Id: CORE-000516
Status: Published
- Version: '1'
-Description: 'Study Day of Start of Treatment (--STDY) and Study Day of End of Treatment (--ENDY) should not be negative for exposure treatments.'
+ Version: "1"
+Description:
+ "Study Day of Start of Treatment (--STDY) and Study Day of End of Treatment (--ENDY) should
+ not be negative for exposure treatments."
Executability: Fully Executable
Outcome:
Message: Negative value of Study Day variable.
diff --git a/Published/CORE-000517/rule.yml b/Published/CORE-000517/rule.yml
index 1e82c3b0e..f820578ce 100644
--- a/Published/CORE-000517/rule.yml
+++ b/Published/CORE-000517/rule.yml
@@ -12,9 +12,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4003
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -26,9 +26,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4003
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -40,9 +40,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4003
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
@@ -54,9 +54,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4003
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -68,9 +68,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4003
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -82,8 +82,8 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4003
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
@@ -96,9 +96,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4003
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
@@ -110,9 +110,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4003
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -124,9 +124,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4003
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
@@ -138,9 +138,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4003
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --DOSTOT
@@ -149,9 +149,9 @@ Check:
operator: less_than
value: 0
Core:
- Id: 'CORE-000517'
+ Id: "CORE-000517"
Status: Published
- Version: '1'
+ Version: "1"
Description: Total Daily Dose (--DOSTOT) value should not be negative.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000518/rule.yml b/Published/CORE-000518/rule.yml
index 143ebf85c..d34a77247 100644
--- a/Published/CORE-000518/rule.yml
+++ b/Published/CORE-000518/rule.yml
@@ -12,9 +12,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4004
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -26,9 +26,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4004
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -40,9 +40,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4004
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
@@ -54,9 +54,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4004
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -68,9 +68,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4004
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -82,8 +82,8 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4004
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
@@ -96,9 +96,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4004
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
@@ -110,9 +110,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4004
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -124,9 +124,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4004
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
@@ -138,9 +138,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB4004
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --VAMT
@@ -151,7 +151,7 @@ Check:
Core:
Id: CORE-000518
Status: Published
- Version: '1'
+ Version: "1"
Description: Value for Treatment Vehicle Amount (--VAMT) should not be negative.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000519/rule.yml b/Published/CORE-000519/rule.yml
index 23a68fda9..f4ad07911 100644
--- a/Published/CORE-000519/rule.yml
+++ b/Published/CORE-000519/rule.yml
@@ -4,81 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Two character domain identifier used as a prefix in the variable
- is limited to A to Z for the first character
+ - Cited Guidance:
+ Two character domain identifier used as a prefix in the variable is limited
+ to A to Z for the first character
Document: IG v3.0
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND31
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Two character domain identifier used as a prefix in the variable
- is limited to A to Z for the first character
+ - Cited Guidance:
+ Two character domain identifier used as a prefix in the variable is limited
+ to A to Z for the first character
Document: IG v3.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND31
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Two character domain identifier used as a prefix in the variable
- is limited to A to Z for the first character
+ - Cited Guidance:
+ Two character domain identifier used as a prefix in the variable is limited
+ to A to Z for the first character
Document: IG v3.1.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND31
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Two character domain identifier used as a prefix in the variable
- is limited to A to Z for the first character
+ - Cited Guidance:
+ Two character domain identifier used as a prefix in the variable is limited
+ to A to Z for the first character
Document: IG v3.1.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND31
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Two character domain identifier used as a prefix in the variable
- is limited to A to Z for the first character
+ - Cited Guidance:
+ Two character domain identifier used as a prefix in the variable is limited
+ to A to Z for the first character
Document: IG v3.1.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND31
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Two character domain identifier used as a prefix in the variable
- is limited to A to Z for the first character
+ - Cited Guidance:
+ Two character domain identifier used as a prefix in the variable is limited
+ to A to Z for the first character
Document: IG v3.1.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND31
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: DOMAIN
@@ -87,9 +93,9 @@ Check:
Core:
Id: CORE-000519
Status: Published
- Version: '1'
-Description: Raise an error when the value of DOMAIN has a character other than
- A-Z as the first character
+ Version: "1"
+Description: Raise an error when the value of DOMAIN has a character other than A-Z as the first
+ character
Executability: Fully Executable
Outcome:
Message: First character of DOMAIN value must be in the range A-Z
diff --git a/Published/CORE-000520/rule.yml b/Published/CORE-000520/rule.yml
index ff5b3633c..5edd1f202 100644
--- a/Published/CORE-000520/rule.yml
+++ b/Published/CORE-000520/rule.yml
@@ -4,81 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: IG v3.0
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND146
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: IG v3.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND146
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: IG v3.1.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND146
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: IG v3.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND146
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: IG v3.1.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND146
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: IG v3.1.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND146
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
@@ -89,10 +95,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0082
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --STAT
@@ -102,7 +108,7 @@ Check:
Core:
Id: CORE-000520
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when --STAT is not populated and --REASND is populated
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000521/rule.yml b/Published/CORE-000521/rule.yml
index c92391404..533475191 100644
--- a/Published/CORE-000521/rule.yml
+++ b/Published/CORE-000521/rule.yml
@@ -4,103 +4,103 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A baseline indicator may be used to calculate differences or
- changes from baseline. Value should be Y or null. The baseline
- flag is sponsor-defined.
+ - Cited Guidance:
+ A baseline indicator may be used to calculate differences or changes from
+ baseline. Value should be Y or null. The baseline flag is sponsor-defined.
Document: IG v3.0
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND147
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A baseline indicator may be used to calculate differences or
- changes from baseline. Value should be Y or null. The baseline
- flag is sponsor-defined.
+ - Cited Guidance:
+ A baseline indicator may be used to calculate differences or changes from
+ baseline. Value should be Y or null. The baseline flag is sponsor-defined.
Document: IG v3.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND147
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A baseline indicator may be used to calculate differences or
- changes from baseline. Value should be Y or null. The baseline
- flag is sponsor-defined.
+ - Cited Guidance:
+ A baseline indicator may be used to calculate differences or changes from
+ baseline. Value should be Y or null. The baseline flag is sponsor-defined.
Document: IG v3.1.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND147
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: A baseline indicator may be used to calculate differences or
- changes from baseline. Value should be Y or null. The baseline
- flag is sponsor-defined.
+ - Cited Guidance:
+ A baseline indicator may be used to calculate differences or changes from
+ baseline. Value should be Y or null. The baseline flag is sponsor-defined.
Document: IG v3.1.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND147
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A baseline indicator may be used to calculate differences or
- changes from baseline. Value should be Y or null. The baseline
- flag is sponsor-defined.
+ - Cited Guidance:
+ A baseline indicator may be used to calculate differences or changes from
+ baseline. Value should be Y or null. The baseline flag is sponsor-defined.
Document: IG v3.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND147
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A baseline indicator may be used to calculate differences or
- changes from baseline. Value should be Y or null. The baseline
- flag is sponsor-defined.
+ - Cited Guidance:
+ A baseline indicator may be used to calculate differences or changes from
+ baseline. Value should be Y or null. The baseline flag is sponsor-defined.
Document: IG v3.1.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND147
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: A baseline indicator may be used to calculate differences or
- changes from baseline. Value should be Y or null. The baseline
- flag is sponsor-defined.
+ - Cited Guidance:
+ A baseline indicator may be used to calculate differences or changes from
+ baseline. Value should be Y or null. The baseline flag is sponsor-defined.
Document: TIG v1.0
Item: BWBLFL CDISC Notes
Section: 2.8.9.9
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0083
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --BLFL
@@ -111,7 +111,7 @@ Check:
Core:
Id: CORE-000521
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when --BLFL is populated and the value is different from "Y"
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000523/rule.yml b/Published/CORE-000523/rule.yml
index 8577eb316..641617f6c 100644
--- a/Published/CORE-000523/rule.yml
+++ b/Published/CORE-000523/rule.yml
@@ -4,81 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Two character domain identifier used as a prefix in the variable
- is limited to A to Z, 0-9 for the second character
+ - Cited Guidance:
+ Two character domain identifier used as a prefix in the variable is limited
+ to A to Z, 0-9 for the second character
Document: IG v3.0
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND32
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Two character domain identifier used as a prefix in the variable
- is limited to A to Z, 0-9 for the second character
+ - Cited Guidance:
+ Two character domain identifier used as a prefix in the variable is limited
+ to A to Z, 0-9 for the second character
Document: IG v3.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND32
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Two character domain identifier used as a prefix in the variable
- is limited to A to Z, 0-9 for the second character
+ - Cited Guidance:
+ Two character domain identifier used as a prefix in the variable is limited
+ to A to Z, 0-9 for the second character
Document: IG v3.1.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND32
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Two character domain identifier used as a prefix in the variable
- is limited to A to Z, 0-9 for the second character
+ - Cited Guidance:
+ Two character domain identifier used as a prefix in the variable is limited
+ to A to Z, 0-9 for the second character
Document: IG v3.1.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND32
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Two character domain identifier used as a prefix in the variable
- is limited to A to Z, 0-9 for the second character
+ - Cited Guidance:
+ Two character domain identifier used as a prefix in the variable is limited
+ to A to Z, 0-9 for the second character
Document: IG v3.1.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND32
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Two character domain identifier used as a prefix in the variable
- is limited to A to Z, 0-9 for the second character
+ - Cited Guidance:
+ Two character domain identifier used as a prefix in the variable is limited
+ to A to Z, 0-9 for the second character
Document: IG v3.1.1
Section: 4.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND32
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: DOMAIN
@@ -87,13 +93,13 @@ Check:
Core:
Id: CORE-000523
Status: Published
- Version: '1'
-Description: Raise an error when the value of DOMAIN has a character other than
- A-Z as the first character or a character A-Z, 0-9 for the second character
+ Version: "1"
+Description: Raise an error when the value of DOMAIN has a character other than A-Z as the first
+ character or a character A-Z, 0-9 for the second character
Executability: Fully Executable
Outcome:
- Message: First two characters of DOMAIN value must be in the range A-Z for the
- first, and A-Z,0-9 for the second
+ Message: First two characters of DOMAIN value must be in the range A-Z for the first, and A-Z,0-9
+ for the second
Output Variables:
- DOMAIN
Rule Type: Record Data
diff --git a/Published/CORE-000524/rule.yml b/Published/CORE-000524/rule.yml
index 35de9a8ca..eb59cd5a3 100644
--- a/Published/CORE-000524/rule.yml
+++ b/Published/CORE-000524/rule.yml
@@ -4,102 +4,103 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used,
- USUBJID will be null and if a USUBJID is recorded, the POOLID
- will be null.
+ - Cited Guidance:
+ POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will
+ be null and if a USUBJID is recorded, the POOLID will be null.
Document: IG v3.0
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND132
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used,
- USUBJID will be null and if a USUBJID is recorded, the POOLID
- will be null.
+ - Cited Guidance:
+ POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will
+ be null and if a USUBJID is recorded, the POOLID will be null.
Document: IG v3.1
- Section: '8.5'
+ Section: "8.5"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND132
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used,
- USUBJID will be null and if a USUBJID is recorded, the POOLID
- will be null.
+ - Cited Guidance:
+ POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will
+ be null and if a USUBJID is recorded, the POOLID will be null.
Document: IG v3.1.1
- Section: '8.5'
+ Section: "8.5"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND132
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used,
- USUBJID will be null and if a USUBJID is recorded, the POOLID
- will be null.
+ - Cited Guidance:
+ POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will
+ be null and if a USUBJID is recorded, the POOLID will be null.
Document: IG v3.1
- Section: '8.5'
+ Section: "8.5"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND132
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used,
- USUBJID will be null and if a USUBJID is recorded, the POOLID
- will be null.
+ - Cited Guidance:
+ POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will
+ be null and if a USUBJID is recorded, the POOLID will be null.
Document: IG v3.1
- Section: '8.5'
+ Section: "8.5"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND132
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used,
- USUBJID will be null and if a USUBJID is recorded, the POOLID
- will be null.
+ - Cited Guidance:
+ POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will
+ be null and if a USUBJID is recorded, the POOLID will be null.
Document: IG v3.1
- Section: '8.5'
+ Section: "8.5"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND132
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: TIG v1.0
Item: POOLID CDISC Notes
Section: 2.8.9.11
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0068
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: POOLID
@@ -109,7 +110,7 @@ Check:
Core:
Id: CORE-000524
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when both USUBJID and POOLID are populated
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000526/rule.yml b/Published/CORE-000526/rule.yml
index 0cdef4cea..90005b05d 100644
--- a/Published/CORE-000526/rule.yml
+++ b/Published/CORE-000526/rule.yml
@@ -4,87 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per
- pharmacokinetic parameter per time-concentration profile per
- specimen per subject, Tabulation.
+ - Cited Guidance:
+ Pharmacokinetics Parameters - Findings. One record per pharmacokinetic
+ parameter per time-concentration profile per specimen per subject, Tabulation.
Document: IG v3.0
Section: 6.3.12
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND195
- Version: '2'
- Version: '5.0'
- Version: '3.0'
+ Version: "2"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per
- pharmacokinetic parameter per time-concentration profile per
- specimen per subject or pool, Tabulation.
+ - Cited Guidance:
+ Pharmacokinetics Parameters - Findings. One record per pharmacokinetic
+ parameter per time-concentration profile per specimen per subject or pool, Tabulation.
Document: IG v3.0
Section: 6.3.12
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND195.1
- Version: '2'
- Version: '5.0'
- Version: '3.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per
- pharmacokinetic parameter per time-concentration profile per
- specimen per subject or pool, Tabulation.
+ - Cited Guidance:
+ Pharmacokinetics Parameters - Findings. One record per pharmacokinetic
+ parameter per time-concentration profile per specimen per subject or pool, Tabulation.
Document: IG v3.0
Section: 6.3.12
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND195.1
- Version: '2'
- Version: '5.0'
+ Version: "2"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per
- pharmacokinetic parameter per time-concentration profile per
- specimen per subject or pool, Tabulation.
+ - Cited Guidance:
+ Pharmacokinetics Parameters - Findings. One record per pharmacokinetic
+ parameter per time-concentration profile per specimen per subject or pool, Tabulation.
Document: IG v3.1
Section: 6.3.12
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND195.1
- Version: '2'
- Version: '5.0'
- Version: '1.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per
- pharmacokinetic parameter per time-concentration profile per
- specimen per subject or pool, Tabulation.
+ - Cited Guidance:
+ Pharmacokinetics Parameters - Findings. One record per pharmacokinetic
+ parameter per time-concentration profile per specimen per subject or pool, Tabulation.
Document: IG v3.1.1
Section: 6.3.12
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND195.1
- Version: '2'
- Version: '5.0'
- Version: '1.2'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per
- pharmacokinetic parameter per time-concentration profile per
- specimen per subject or pool, Tabulation.
+ - Cited Guidance:
+ Pharmacokinetics Parameters - Findings. One record per pharmacokinetic
+ parameter per time-concentration profile per specimen per subject or pool, Tabulation.
Document: IG v3.1.1
Section: 6.3.12
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND195.1
- Version: '2'
- Version: '5.0'
- Version: '1.0'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.0"
Check:
# "time-concentration profile" is defined the combination of PPCAT and PPTPTREF
# "pharmacokinetic parameter" is defined by PPTESTCD
@@ -98,7 +98,7 @@ Check:
- PPCAT
- PPSPEC
- PPTPTREF
- # Implementation with POOLID
+ # Implementation with POOLID
- name: PPTESTCD
operator: is_not_unique_set
value:
@@ -109,13 +109,12 @@ Check:
Core:
Id: CORE-000526
Status: Published
- Version: '1'
-Description: The combination of POOLID or USUBJID, PPTESTCD, PPCAT, PPSPEC, and
- PPTPTREF must be unique.
+ Version: "1"
+Description: The combination of POOLID or USUBJID, PPTESTCD, PPCAT, PPSPEC, and PPTPTREF must be
+ unique.
Executability: Fully Executable
Outcome:
- Message: The combination of POOLID or USUBJID, PPTESTCD, PPCAT, PPSPEC, and
- PPTPTREF is not unique
+ Message: The combination of POOLID or USUBJID, PPTESTCD, PPCAT, PPSPEC, and PPTPTREF is not unique
Output Variables:
- POOLID
- PPTESTCD
diff --git a/Published/CORE-000527/rule.yml b/Published/CORE-000527/rule.yml
index 270b8cee9..432f74d57 100644
--- a/Published/CORE-000527/rule.yml
+++ b/Published/CORE-000527/rule.yml
@@ -7,108 +7,100 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Since there are, by definition, no gaps between Elements, the
- value of SEENDTC for one Element will always be the same as
- the value of SESTDTC for the next Element. '
+ - Cited Guidance:
+ "Since there are, by definition, no gaps between Elements, the value of SEENDTC
+ for one Element will always be the same as the value of SESTDTC for the next Element. "
Document: IG v3.4
Item: Assumption 8
- Section: '5.3'
- - Cited Guidance: '"Note that SESTDTC is required, although --STDTC is not
- required in any other subject-level dataset. The purpose of
- the dataset is to record the Elements a subject actually
- passed through. We assume that if it is known that a subject
- passed through a particular Element, then there must be some
- information on when it started, even if that information is
- imprecise. Thus, SESTDTC may not be null, although some
- records may not have all the components (e.g., year, month,
- day, hour, minute) of the date/time value collected."'
+ Section: "5.3"
+ - Cited Guidance:
+ '"Note that SESTDTC is required, although --STDTC is not required in any other
+ subject-level dataset. The purpose of the dataset is to record the Elements a subject actually
+ passed through. We assume that if it is known that a subject passed through a particular Element,
+ then there must be some information on when it started, even if that information is imprecise.
+ Thus, SESTDTC may not be null, although some records may not have all the components (e.g.,
+ year, month, day, hour, minute) of the date/time value collected."'
Document: IG v3.4
Item: Assumption 9
- Section: '5.3'
+ Section: "5.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0209
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Assumption 10[Since there are, by definition, no gaps between
- Elements, the value of SEENDTC for one Element will always be
- the same as the value of SESTDTC for the next
- Element.]|Assumption 11[Note that SESTDTC is required,
- although --STDTC is not required in any other subject-level
- dataset. The purpose of the dataset is to record the Elements
- a subject actually passed through. We assume that if it is
- known that a subject passed through a particular Element, then
- there must be some information on when it started, even if
- that information is imprecise. Thus, SESTDTC may not be null,
- although some records may not have all the components (e.g.,
- year, month, day, hour, minute) of the date/time value
- collected.]
+ - Cited Guidance:
+ Assumption 10[Since there are, by definition, no gaps between Elements, the
+ value of SEENDTC for one Element will always be the same as the value of SESTDTC for the
+ next Element.]|Assumption 11[Note that SESTDTC is required, although --STDTC is not
+ required in any other subject-level dataset. The purpose of the dataset is to record the
+ Elements a subject actually passed through. We assume that if it is known that a subject
+ passed through a particular Element, then there must be some information on when it
+ started, even if that information is imprecise. Thus, SESTDTC may not be null, although
+ some records may not have all the components (e.g., year, month, day, hour, minute) of the
+ date/time value collected.]
Document: IG v3.2
Item: Assumption 10|Assumption 11
Section: 5 SE
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0209
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Assumption 8[Since there are, by definition, no gaps between
- Elements, the value of SEENDTC for one Element will always be
- the same as the value of SESTDTC for the next
- Element.]|Assumption 9[Note that SESTDTC is required, although
- --STDTC is not required in any other subject-level dataset.
- The purpose of the dataset is to record the Elements a subject
- actually passed through. We assume that if it is known that a
- subject passed through a particular Element, then there must
- be some information on when it started, even if that
- information is imprecise. Thus, SESTDTC may not be null,
- although some records may not have all the components (e.g.,
- year, month, day, hour, minute) of the date/time value
- collected.]
+ - Cited Guidance:
+ Assumption 8[Since there are, by definition, no gaps between Elements, the
+ value of SEENDTC for one Element will always be the same as the value of SESTDTC for the
+ next Element.]|Assumption 9[Note that SESTDTC is required, although --STDTC is not
+ required in any other subject-level dataset. The purpose of the dataset is to record the
+ Elements a subject actually passed through. We assume that if it is known that a subject
+ passed through a particular Element, then there must be some information on when it
+ started, even if that information is imprecise. Thus, SESTDTC may not be null, although
+ some records may not have all the components (e.g., year, month, day, hour, minute) of the
+ date/time value collected.]
Document: IG v3.3
Item: Assumption 8|Assumption 9
- Section: '5.3'
+ Section: "5.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0209
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Since there are, by definition, no gaps between Elements, the
- value of SEENDTC for one Element will always be the same as
- the value of SESTDTC for the next Element.
+ - Cited Guidance:
+ Since there are, by definition, no gaps between Elements, the value of
+ SEENDTC for one Element will always be the same as the value of SESTDTC for the next
+ Element.
Document: TIG 1.0
Item: Assumption 7
Section: 2.8.10.24
- - Cited Guidance: Note that SESTDTC is required, although --STDTC is not required
- in any other subject-level dataset. The purpose of the dataset
- is to record the Elements a subject actually passed through.
- We assume that if it is known that a subject passed through a
- particular Element, then there must be some information on
- when it started, even if that information is imprecise. Thus,
- SESTDTC may not be null, although some records may not have
- all the components (e.g., year, month, day, hour, minute) of
- the date/time value collected.
+ - Cited Guidance:
+ Note that SESTDTC is required, although --STDTC is not required in any other
+ subject-level dataset. The purpose of the dataset is to record the Elements a subject
+ actually passed through. We assume that if it is known that a subject passed through a
+ particular Element, then there must be some information on when it started, even if that
+ information is imprecise. Thus, SESTDTC may not be null, although some records may not
+ have all the components (e.g., year, month, day, hour, minute) of the date/time value
+ collected.
Document: TIG 1.0
Item: Assumption 8
Section: 2.8.10.24
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0428
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SEENDTC
@@ -118,7 +110,7 @@ Check:
Core:
Id: CORE-000527
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error where element is not the last element and SEENDTC is null.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000529/rule.yml b/Published/CORE-000529/rule.yml
index b261d50dc..427c33728 100644
--- a/Published/CORE-000529/rule.yml
+++ b/Published/CORE-000529/rule.yml
@@ -4,430 +4,431 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The Study Day value is incremented by 1 for each date following
- RFSTDTC. Dates prior to RFSTDTC are decreased by 1, with the
- date preceding RFSTDTC designated as Study Day -1 (there is no
- Study Day 0)....All Study Day values are integers. Thus to
- calculate Study Day, --DY = (date portion of --DTC) - (date
- portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
- = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.
+ - Cited Guidance:
+ The Study Day value is incremented by 1 for each date following RFSTDTC.
+ Dates prior to RFSTDTC are decreased by 1, with the date preceding RFSTDTC designated as
+ Study Day -1 (there is no Study Day 0)....All Study Day values are integers. Thus to
+ calculate Study Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if
+ --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC)
+ if --DTC precedes RFSTDTC. This algorithm should be used across all domains.
Document: SDTMIG v3.4
Section: 4.4.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0006
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'IG v3.2[4.1.4.4][The Study Day value is incremented by 1 for
- each date following RFSTDTC. Dates prior to RFSTDTC are
- decreased by 1, with the date preceding RFSTDTC designated as
- Study Day -1 (there is no Study Day 0). . . . All Study Day
- values are integers.]IG v3.2[4.1.4.4][Thus, to calculate Study
- Day: --DY = (date portion of --DTC) - (date portion of
- RFSTDTC) + 1 if --DTC is on or after RFSTDTC --DY = (date
- portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC This algorithm should be used across all
- domains.]'
+ - Cited Guidance:
+ "IG v3.2[4.1.4.4][The Study Day value is incremented by 1 for each date following
+ RFSTDTC. Dates prior to RFSTDTC are decreased by 1, with the date preceding RFSTDTC designated
+ as Study Day -1 (there is no Study Day 0). . . . All Study Day values are integers.]IG v3.2[4.1.4.4][Thus,
+ to calculate Study Day: --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC
+ is on or after RFSTDTC --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes
+ RFSTDTC This algorithm should be used across all domains.]"
Document: IG v3.2
Section: 4.1.4.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0006
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'IG v3.3[4.4.4][The Study Day value is incremented by 1 for each
- date following RFSTDTC. Dates prior to RFSTDTC are decreased
- by 1, with the date preceding RFSTDTC designated as Study Day
- -1 (there is no Study Day 0). . . . All Study Day values are
- integers.]''IG v3.3[4.4.4][ Thus, to calculate Study
- Day: --DY = (date portion of --DTC) - (date portion of
- RFSTDTC) + 1 if --DTC is on or after RFSTDTC --DY = (date
- portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC This algorithm should be used across all
- domains.]'
+ - Cited Guidance:
+ "IG v3.3[4.4.4][The Study Day value is incremented by 1 for each date following
+ RFSTDTC. Dates prior to RFSTDTC are decreased by 1, with the date preceding RFSTDTC designated
+ as Study Day -1 (there is no Study Day 0). . . . All Study Day values are integers.]'IG v3.3[4.4.4][
+ Thus, to calculate Study Day: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +
+ 1 if --DTC is on or after RFSTDTC --DY = (date portion of --DTC) - (date portion of RFSTDTC)
+ if --DTC precedes RFSTDTC This algorithm should be used across all domains.]"
Document: IG v3.3
Section: 4.4.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0006
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: All relative day values will be integers and there will be no
- study day 0. The reference start date is considered day 1 and
- the study day value is increased by 1 for each date following
- the reference start date and decreased by 1 for each date
- prior to the reference start date, e.g.; --DY = (date portion
- of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or
- after RFSTDTC --DY = (date portion of --DTC) - (date portion
- of RFSTDTC) if --DTC precedes RFSTDTC
+ - Cited Guidance:
+ All relative day values will be integers and there will be no study day 0.
+ The reference start date is considered day 1 and the study day value is increased by 1 for
+ each date following the reference start date and decreased by 1 for each date prior to the
+ reference start date, e.g.; --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1
+ if --DTC is on or after RFSTDTC --DY = (date portion of --DTC) - (date portion of RFSTDTC)
+ if --DTC precedes RFSTDTC
Document: TIG v1.0
Item: Table 1 Num 1
Section: 2.8.7.6
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0291
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day
- --DY = (date portion of --DTC) minus (date portion of RFSTDTC)
- + 1 if --DTC is on or after RFSTDTC.
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day --DY = (date
+ portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC.
Document: SENDIG v3.0
Item: Text
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND73
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day
- --DY = (date portion of --DTC) minus (date portion of RFSTDTC)
- + 1 if --DTC is on or after RFSTDTC.
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day --DY = (date
+ portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC.
Document: SENDIG v3.1
Item: Text
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND73
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day
- --DY = (date portion of --DTC) minus (date portion of RFSTDTC)
- + 1 if --DTC is on or after RFSTDTC.
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day --DY = (date
+ portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC.
Document: SENDIG v3.1.1
Item: Text
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND73
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day
- --DY = (date portion of --DTC) minus (date portion of RFSTDTC)
- + 1 if --DTC is on or after RFSTDTC.
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day --DY = (date
+ portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC.
Document: SENDIG v3.1
Item: Text
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND73
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day
- --DY = (date portion of --DTC) minus (date portion of RFSTDTC)
- + 1 if --DTC is on or after RFSTDTC.
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day --DY = (date
+ portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC.
Document: SENDIG v3.1.1
Item: Text
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND73
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day
- --DY = (date portion of --DTC) minus (date portion of RFSTDTC)
- + 1 if --DTC is on or after RFSTDTC.
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day --DY = (date
+ portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC.
Document: SENDIG v3.1.1
Item: Text
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND73
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: "All Study Day values are integers. Thus, to calculate Study
- Day: --DY = (date portion of --DTC) - (date portion of
- RFSTDTC) + 1 if --DTC is on or after RFSTDTC"
+ - Cited Guidance:
+ "All Study Day values are integers. Thus, to calculate Study Day: --DY = (date
+ portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC"
Document: TIG v1.0
Item: Text
Section: 2.8.7.6
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0274
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day.
- --DY = (date portion of --DTC) - (date portion of RFSTDTC) if
- --DTC precedes RFSTDTC
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day. --DY =
+ (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC
Document: SENDIG v3.0
Item: Text
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND74
- Version: '2'
- Version: '5.0'
- Version: '3.0'
+ Version: "2"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day.
- --DY = (date portion of --DTC) - (date portion of RFSTDTC) if
- --DTC precedes RFSTDTC
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day. --DY =
+ (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC
Document: SENDIG v3.1
Item: Text
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND74
- Version: '2'
- Version: '5.0'
- Version: '3.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day.
- --DY = (date portion of --DTC) - (date portion of RFSTDTC) if
- --DTC precedes RFSTDTC
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day. --DY =
+ (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC
Document: SENDIG v3.1.1
Item: Text
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND74
- Version: '2'
- Version: '5.0'
+ Version: "2"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day.
- --DY = (date portion of --DTC) - (date portion of RFSTDTC) if
- --DTC precedes RFSTDTC
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day. --DY =
+ (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC
Document: SENDIG v3.1
Item: Text
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND74
- Version: '2'
- Version: '5.0'
- Version: '1.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day.
- --DY = (date portion of --DTC) - (date portion of RFSTDTC) if
- --DTC precedes RFSTDTC
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day. --DY =
+ (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC
Document: SENDIG v3.1.1
Item: Text
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND74
- Version: '2'
- Version: '5.0'
- Version: '1.2'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day.
- --DY = (date portion of --DTC) - (date portion of RFSTDTC) if
- --DTC precedes RFSTDTC
+ - Cited Guidance:
+ All Study Day values are integers. Thus, to calculate Study Day. --DY =
+ (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC
Document: SENDIG v3.1.1
Item: Text
Section: 4.4.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND74
- Version: '2'
- Version: '5.0'
- Version: '1.0'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: "All Study Day values are integers. Thus, to calculate Study
- Day: --DY = (date portion of --DTC) - (date portion of
- RFSTDTC) if --DTC precedes RFSTDTC"
+ - Cited Guidance:
+ "All Study Day values are integers. Thus, to calculate Study Day: --DY = (date
+ portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC"
Document: TIG v1.0
Item: Text
Section: 2.8.7.6
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0275
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
- - Organization: 'FDA'
+ Version: "1.0"
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1603
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1603
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1603
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1603
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1603
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1603
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1603
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1603
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1603
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1603
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --DY
@@ -442,11 +443,10 @@ Check:
Core:
Id: CORE-000529
Status: Published
- Version: '1'
-Description: Raise an error when --DY is not calculated as per the study day
- algorithm as a non-zero integer value when the date portion of --DTC is
- complete and the date portion of DM.RFSTDTC is a complete date AND --DY is not
- empty
+ Version: "1"
+Description: Raise an error when --DY is not calculated as per the study day algorithm as a non-zero
+ integer value when the date portion of --DTC is complete and the date portion of DM.RFSTDTC is a
+ complete date AND --DY is not empty
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -457,8 +457,8 @@ Operations:
name: --DTC
operator: dy # does dy op take into acct +1?
Outcome:
- Message: --DY is not correctly calculated even though the date portion of --DTC
- is complete, the date portion of RFSTDTC is complete, and --DY is not empty.
+ Message: --DY is not correctly calculated even though the date portion of --DTC is complete, the
+ date portion of RFSTDTC is complete, and --DY is not empty.
Output Variables:
- $val_dy
- --DY
diff --git a/Published/CORE-000534/rule.yml b/Published/CORE-000534/rule.yml
index f3b52bcec..b82259beb 100644
--- a/Published/CORE-000534/rule.yml
+++ b/Published/CORE-000534/rule.yml
@@ -11,22 +11,22 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0248
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: TAETORD is an integer.
Document: IG v3.2
Item: Assumption 1
- Section: '7.2'
+ Section: "7.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0248
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -37,9 +37,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0248
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SENDIG
References:
- Citations:
@@ -49,9 +49,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND221
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -61,9 +61,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND221
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -73,8 +73,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND221
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
@@ -85,9 +85,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND221
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -97,9 +97,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND221
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -109,9 +109,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND221
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
@@ -122,10 +122,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0452
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
@@ -136,12 +136,12 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0148
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
# Variable: TAETORD
-# Condition:
+# Condition:
# Rule: TAETORD is an integer
Check:
all:
@@ -151,7 +151,7 @@ Check:
Core:
Id: CORE-000534
Status: Published
- Version: '1'
+ Version: "1"
Description: TAETORD must be an integer
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000535/rule.yml b/Published/CORE-000535/rule.yml
index da96aedd4..fdad975f0 100644
--- a/Published/CORE-000535/rule.yml
+++ b/Published/CORE-000535/rule.yml
@@ -1,5 +1,5 @@
# Variable: --SEQ
-# Condition:
+# Condition:
# Rule: --SEQ is in a consistent chronological order
Authorities:
- Organization: CDISC
@@ -7,174 +7,174 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Sequence Number given to ensure uniqueness of subject records
- within a domain. Should be assigned to be consistent
- chronological order.
+ - Cited Guidance:
+ Sequence Number given to ensure uniqueness of subject records within a
+ domain. Should be assigned to be consistent chronological order.
Document: IG v3.2
Item: Specification
Section: 5 SE
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0662
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 5.3[Specification][Sequence number given to ensure uniqueness of
- subject records within a domain. Should be assigned to be
- consistent chronological order.]5.4[Specification][Sequence
- number to ensure uniqueness of subject records. Should be
- assigned to be consistent chronological order.]
+ - Cited Guidance:
+ 5.3[Specification][Sequence number given to ensure uniqueness of subject
+ records within a domain. Should be assigned to be consistent chronological
+ order.]5.4[Specification][Sequence number to ensure uniqueness of subject records. Should
+ be assigned to be consistent chronological order.]
Document: IG v3.3
Item: Specification
Section: 5.3|5.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0620
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 5.3[Specification][Sequence number given to ensure uniqueness of
- subject records within a domain. Should be assigned to be
- consistent chronological order]|5.4[Specification][Sequence
- number to ensure uniqueness of subject records. Should be
- assigned to be consistent chronological order.]
+ - Cited Guidance:
+ 5.3[Specification][Sequence number given to ensure uniqueness of subject
+ records within a domain. Should be assigned to be consistent chronological
+ order]|5.4[Specification][Sequence number to ensure uniqueness of subject records. Should
+ be assigned to be consistent chronological order.]
Document: IG v3.4
Item: Specification
Section: 5.3|5.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0620
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The values of SESTDTC provide the chronological order of the
- actual subject Elements. SESEQ should be assigned to be
- consistent with the chronological order.
+ - Cited Guidance:
+ The values of SESTDTC provide the chronological order of the actual subject
+ Elements. SESEQ should be assigned to be consistent with the chronological order.
Document: IG v3.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND130.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The values of SESTDTC provide the chronological order of the
- actual subject Elements. SESEQ should be assigned to be
- consistent with the chronological order.
+ - Cited Guidance:
+ The values of SESTDTC provide the chronological order of the actual subject
+ Elements. SESEQ should be assigned to be consistent with the chronological order.
Document: IG v3.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND130
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The values of SESTDTC provide the chronological order of the
- actual subject Elements. SESEQ should be assigned to be
- consistent with the chronological order.
+ - Cited Guidance:
+ The values of SESTDTC provide the chronological order of the actual subject
+ Elements. SESEQ should be assigned to be consistent with the chronological order.
Document: IG v3.1.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND130.1
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The values of SESTDTC provide the chronological order of the
- actual subject Elements. SESEQ should be assigned to be
- consistent with the chronological order.
+ - Cited Guidance:
+ The values of SESTDTC provide the chronological order of the actual subject
+ Elements. SESEQ should be assigned to be consistent with the chronological order.
Document: IG v3.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND130.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The values of SESTDTC provide the chronological order of the
- actual subject Elements. SESEQ should be assigned to be
- consistent with the chronological order.
+ - Cited Guidance:
+ The values of SESTDTC provide the chronological order of the actual subject
+ Elements. SESEQ should be assigned to be consistent with the chronological order.
Document: IG v3.1.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND130.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The values of SESTDTC provide the chronological order of the
- actual subject Elements. SESEQ should be assigned to be
- consistent with the chronological order.
+ - Cited Guidance:
+ The values of SESTDTC provide the chronological order of the actual subject
+ Elements. SESEQ should be assigned to be consistent with the chronological order.
Document: IG v3.1.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND130.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The values of SESTDTC provide the chronological order of the
- actual subject elements. SESEQ should be assigned to be
- consistent with the chronological order.
+ - Cited Guidance:
+ The values of SESTDTC provide the chronological order of the actual subject
+ elements. SESEQ should be assigned to be consistent with the chronological order.
Document: TIG v1.0
Item: Assumption 7
Section: 2.8.9.26
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0066
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Sequence number given to ensure uniqueness of subject records
- within a domain. Should be assigned to be consistent
- chronological order.
+ - Cited Guidance:
+ Sequence number given to ensure uniqueness of subject records within a
+ domain. Should be assigned to be consistent chronological order.
Document: TIG v1.0
Item: Specifications
Section: 2.8.10.24
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0661
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --SEQ
@@ -187,9 +187,9 @@ Check:
Core:
Id: CORE-000535
Status: Published
- Version: '1'
-Description: Trigger error when the order of --SEQ is not chronological (based
- on --STDTC) within USUBJID
+ Version: "1"
+Description: Trigger error when the order of --SEQ is not chronological (based on --STDTC) within
+ USUBJID
Executability: Fully Executable
Outcome:
Message: --SEQ is not chronological (based on --STDTC) within USUBJID
diff --git a/Published/CORE-000537/rule.yml b/Published/CORE-000537/rule.yml
index 344accb94..0208dfefe 100644
--- a/Published/CORE-000537/rule.yml
+++ b/Published/CORE-000537/rule.yml
@@ -1,72 +1,78 @@
Authorities:
- - Organization: CDISC
- # REMARK: Rule 342 is not applicable to SENDIG-3.0
+ - Organization:
+ CDISC
+ # REMARK: Rule 342 is not applicable to SENDIG-3.0
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes.
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes.
Document: IG v3.1
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND342'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND342"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes.
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes.
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND342'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND342"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes.
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes.
Document: IG v3.1
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND342'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND342"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes.
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes.
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND342'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND342"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The most appropriate single value, as defined by the sponsor,
- should be included for Trial Summary purposes.
+ - Cited Guidance:
+ The most appropriate single value, as defined by the sponsor, should be
+ included for Trial Summary purposes.
Document: IG v3.1.1
Section: 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND342'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND342"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: TSPARMCD
@@ -79,7 +85,7 @@ Check:
Core:
Id: CORE-000537
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when there is more than record with TSPARMCD=SDESIGN
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000538/rule.yml b/Published/CORE-000538/rule.yml
index ec5d0380f..b97aae66c 100644
--- a/Published/CORE-000538/rule.yml
+++ b/Published/CORE-000538/rule.yml
@@ -4,75 +4,72 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Supplemental Qualifier datasets for split domains would also be
- split. The nomenclature would include the additional
- one-to-two characters used to identify the split dataset
- (e.g., SUPPQS36, SUPPFACM). The value of RDOMAIN in the SUPP--
- datasets would be the two-character domain code (e.g., QS,
- FA).
+ - Cited Guidance:
+ Supplemental Qualifier datasets for split domains would also be split. The
+ nomenclature would include the additional one-to-two characters used to identify the split
+ dataset (e.g., SUPPQS36, SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be
+ the two-character domain code (e.g., QS, FA).
Document: IG v3.4
- Item: '7'
+ Item: "7"
Section: 4.1.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0334
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Supplemental Qualifier datasets for split domains would also be
- split. The nomenclature would include the additional
- one-to-two characters used to identify the split dataset
- (e.g., SUPPQS36; SUPPFACM). The value of RDOMAIN in the SUPP--
- datasets would be the two-character domain code (e.g., QS;
- FA).
+ - Cited Guidance:
+ Supplemental Qualifier datasets for split domains would also be split. The
+ nomenclature would include the additional one-to-two characters used to identify the split
+ dataset (e.g., SUPPQS36; SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be
+ the two-character domain code (e.g., QS; FA).
Document: IG v3.2
- Item: '7'
+ Item: "7"
Section: 4.1.1.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0334
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Supplemental Qualifier datasets for split domains would also be
- split. The nomenclature would include the additional
- one-to-two characters used to identify the split dataset
- (e.g., SUPPQS36; SUPPFACM). The value of RDOMAIN in the SUPP--
- datasets would be the two-character domain code (e.g., QS;
- FA).
+ - Cited Guidance:
+ Supplemental Qualifier datasets for split domains would also be split. The
+ nomenclature would include the additional one-to-two characters used to identify the split
+ dataset (e.g., SUPPQS36; SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be
+ the two-character domain code (e.g., QS; FA).
Document: IG v3.3
- Item: '7'
+ Item: "7"
Section: 4.1.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0334
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Supplemental Qualifier datasets for split domains will also be
- split. The nomenclature will include the additional one to two
- characters used to identify the split dataset (e.g., SUPPLBHM,
- SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would
- be the two-character domain code (e.g., LB, FA).
+ - Cited Guidance:
+ Supplemental Qualifier datasets for split domains will also be split. The
+ nomenclature will include the additional one to two characters used to identify the split
+ dataset (e.g., SUPPLBHM, SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be
+ the two-character domain code (e.g., LB, FA).
Document: TIG 1.0
- Item: 'Num 9.e.ii'
- Section: '2.6'
+ Item: "Num 9.e.ii"
+ Section: "2.6"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0500
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: RDOMAIN
@@ -82,9 +79,9 @@ Check:
Core:
Id: CORE-000538
Status: Published
- Version: '1'
-Description: Trigger error when RDOMAIN does not match characters 5 and 6 of the
- Supplementary dataset name
+ Version: "1"
+Description: Trigger error when RDOMAIN does not match characters 5 and 6 of the Supplementary
+ dataset name
Executability: Fully Executable
Operations:
- id: $dataset_name
diff --git a/Published/CORE-000539/rule.yml b/Published/CORE-000539/rule.yml
index 4aef70606..6f7766e49 100644
--- a/Published/CORE-000539/rule.yml
+++ b/Published/CORE-000539/rule.yml
@@ -7,82 +7,77 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'For domains with two-letter domain codes (i.e., other than
- SUPPxx and RELREC), split dataset names can be up to four
- characters in length. For example, if splitting by --CAT, then
- dataset names would be the domain name plus up to two
- additional characters (e.g., QS36 for SF-36). If splitting
- Findings About by parent domain, then the dataset name would
- be the domain code, "FA", plus the two-character domain code
- for parent domain code (e.g., "FACM"). The four-character
- dataset-name limitation allows the use of a Supplemental
- Qualifier dataset associated with the split dataset. '
+ - Cited Guidance:
+ 'For domains with two-letter domain codes (i.e., other than SUPPxx and RELREC),
+ split dataset names can be up to four characters in length. For example, if splitting by --CAT,
+ then dataset names would be the domain name plus up to two additional characters (e.g., QS36
+ for SF-36). If splitting Findings About by parent domain, then the dataset name would be the
+ domain code, "FA", plus the two-character domain code for parent domain code (e.g., "FACM").
+ The four-character dataset-name limitation allows the use of a Supplemental Qualifier dataset
+ associated with the split dataset. '
Document: IG v3.4
- Item: '6'
+ Item: "6"
Section: 4.1.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0332
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Split dataset names can be up to four characters in length. For
- example; if splitting by --CAT; then dataset names would be
- the domain name plus up to two additional characters (e.g.,
- QS36 for SF-36). If splitting Findings About by parent domain;
- then the dataset name would be the domain name plus the
- two-character domain code describing the parent domain code
- (e.g., FACM). The four-character dataset-name limitation
- allows the use of a Supplemental Qualifier dataset associated
- with the split dataset.
+ - Cited Guidance:
+ Split dataset names can be up to four characters in length. For example; if
+ splitting by --CAT; then dataset names would be the domain name plus up to two additional
+ characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the
+ dataset name would be the domain name plus the two-character domain code describing the
+ parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use
+ of a Supplemental Qualifier dataset associated with the split dataset.
Document: IG v3.2
- Item: '6'
+ Item: "6"
Section: 4.1.1.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0332
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Split dataset names can be up to four characters in length. For
- example; if splitting by --CAT; then dataset names would be
- the domain name plus up to two additional characters (e.g.,
- QS36 for SF-36). If splitting Findings About by parent domain;
- then the dataset name would be the domain name plus the
- two-character domain code describing the parent domain code
- (e.g., FACM). The four-character dataset-name limitation
- allows the use of a Supplemental Qualifier dataset associated
- with the split dataset.
+ - Cited Guidance:
+ Split dataset names can be up to four characters in length. For example; if
+ splitting by --CAT; then dataset names would be the domain name plus up to two additional
+ characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the
+ dataset name would be the domain name plus the two-character domain code describing the
+ parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use
+ of a Supplemental Qualifier dataset associated with the split dataset.
Document: IG v3.3
- Item: '6'
+ Item: "6"
Section: 4.1.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0332
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: For domains with 2-letter domain codes, split dataset names can
- be up to 4 characters in length
+ - Cited Guidance:
+ For domains with 2-letter domain codes, split dataset names can be up to 4
+ characters in length
Document: TIG 1.0
Item: Num 9.e.i
- Section: '2.6'
+ Section: "2.6"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0498
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: dataset_name
@@ -99,9 +94,9 @@ Check:
Core:
Id: CORE-000539
Status: Published
- Version: '1'
-Description: Raise an error when split domains (i.e three/four-letter domain
- name) do not have a two-letter parent domain present in the study.
+ Version: "1"
+Description: Raise an error when split domains (i.e three/four-letter domain name) do not have a
+ two-letter parent domain present in the study.
Executability: Fully Executable
Operations:
- id: $list_dataset_names
diff --git a/Published/CORE-000540/rule.yml b/Published/CORE-000540/rule.yml
index ecad2a536..523992b47 100644
--- a/Published/CORE-000540/rule.yml
+++ b/Published/CORE-000540/rule.yml
@@ -7,79 +7,74 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'If splitting Findings About by parent domain, then the dataset
- name would be the domain code, "FA", plus the two-character
- domain code for parent domain code (e.g., "FACM"). '
+ - Cited Guidance:
+ 'If splitting Findings About by parent domain, then the dataset name would be
+ the domain code, "FA", plus the two-character domain code for parent domain code (e.g., "FACM"). '
Document: IG v3.4
- Item: '6'
+ Item: "6"
Section: 4.1.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0333
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Split dataset names can be up to four characters in length. For
- example; if splitting by --CAT; then dataset names would be
- the domain name plus up to two additional characters (e.g.,
- QS36 for SF-36). If splitting Findings About by parent domain;
- then the dataset name would be the domain name plus the
- two-character domain code describing the parent domain code
- (e.g., FACM). The four-character dataset-name limitation
- allows the use of a Supplemental Qualifier dataset associated
- with the split dataset.
+ - Cited Guidance:
+ Split dataset names can be up to four characters in length. For example; if
+ splitting by --CAT; then dataset names would be the domain name plus up to two additional
+ characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the
+ dataset name would be the domain name plus the two-character domain code describing the
+ parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use
+ of a Supplemental Qualifier dataset associated with the split dataset.
Document: IG v3.2
- Item: '6'
+ Item: "6"
Section: 4.1.1.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0333
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Split dataset names can be up to four characters in length. For
- example; if splitting by --CAT; then dataset names would be
- the domain name plus up to two additional characters (e.g.,
- QS36 for SF-36). If splitting Findings About by parent domain;
- then the dataset name would be the domain name plus the
- two-character domain code describing the parent domain code
- (e.g., FACM). The four-character dataset-name limitation
- allows the use of a Supplemental Qualifier dataset associated
- with the split dataset.
+ - Cited Guidance:
+ Split dataset names can be up to four characters in length. For example; if
+ splitting by --CAT; then dataset names would be the domain name plus up to two additional
+ characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the
+ dataset name would be the domain name plus the two-character domain code describing the
+ parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use
+ of a Supplemental Qualifier dataset associated with the split dataset.
Document: IG v3.3
- Item: '6'
+ Item: "6"
Section: 4.1.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0333
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If splitting Findings About by parent domain, then the dataset
- name would be the domain code, "FA", plus the two-character
- domain code for parent domain code (e.g., "FACM"). The
- four-character dataset-name limitation allows the use of a
- Supplemental Qualifier dataset associated with the split
- dataset.
+ - Cited Guidance:
+ If splitting Findings About by parent domain, then the dataset name would be
+ the domain code, "FA", plus the two-character domain code for parent domain code (e.g.,
+ "FACM"). The four-character dataset-name limitation allows the use of a Supplemental
+ Qualifier dataset associated with the split dataset.
Document: TIG 1.0
Item: Num 9.e.i
- Section: '2.6'
+ Section: "2.6"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0499
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: dataset_name
@@ -88,7 +83,7 @@ Check:
- name: dataset_name
operator: prefix_equal_to
prefix: 2
- value: 'FA'
+ value: "FA"
- name: dataset_name
operator: suffix_is_not_contained_by
suffix: 2
@@ -96,16 +91,15 @@ Check:
Core:
Id: CORE-000540
Status: Published
- Version: '1'
-Description: Raise an error when parent domain referenced in Findings About
- dataset name is not present in the study.
+ Version: "1"
+Description: Raise an error when parent domain referenced in Findings About dataset name is not
+ present in the study.
Executability: Fully Executable
Operations:
- id: $list_dataset_names
operator: dataset_names
Outcome:
- Message: Parent domain referenced in Findings About dataset name is not present
- in the study
+ Message: Parent domain referenced in Findings About dataset name is not present in the study
Output Variables:
- dataset_name
- $list_dataset_names
diff --git a/Published/CORE-000541/rule.yml b/Published/CORE-000541/rule.yml
index 9d2cc9a5d..0545c526b 100644
--- a/Published/CORE-000541/rule.yml
+++ b/Published/CORE-000541/rule.yml
@@ -1,5 +1,5 @@
# Variable: --TESTCD
-# Condition:
+# Condition:
# Rule: --TESTCD <= 8 chars and contains only letters, numbers, and underscores and can not start with a number
Authorities:
- Organization: CDISC
@@ -7,74 +7,74 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot
- start with a number; nor can they contain characters other
- than letters; numbers; or underscores
+ - Cited Guidance:
+ Values of --TESTCD must be limited to 8 characters; and cannot start with a
+ number; nor can they contain characters other than letters; numbers; or underscores
Document: IG v3.4
Section: 4.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0372
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot
- start with a number; nor can they contain characters other
- than letters; numbers; or underscores
+ - Cited Guidance:
+ Values of --TESTCD must be limited to 8 characters; and cannot start with a
+ number; nor can they contain characters other than letters; numbers; or underscores
Document: IG v3.3
Section: 7.4.1
- - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor
- can it start with a number (e.g., '1TEST'). IETESTCD cannot
- contain characters other than letters; numbers; or
- underscores.
+ - Cited Guidance:
+ The value in IETESTCD cannot be longer than 8 characters; nor can it start
+ with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters;
+ numbers; or underscores.
Document: Model v1.7
Section: 3.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0372
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot
- start with a number; nor can they contain characters other
- than letters; numbers; or underscores
+ - Cited Guidance:
+ Values of --TESTCD must be limited to 8 characters; and cannot start with a
+ number; nor can they contain characters other than letters; numbers; or underscores
Document: IG v3.2
Section: 4.1.2.1
- - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor
- can it start with a number (e.g., '1TEST'). IETESTCD cannot
- contain characters other than letters; numbers; or
- underscores.
+ - Cited Guidance:
+ The value in IETESTCD cannot be longer than 8 characters; nor can it start
+ with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters;
+ numbers; or underscores.
Document: Model v1.4
Section: 3.3.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0372
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The value in --TESTCD cannot be longer than 8 characters, nor
- can it start with a number (e.g., "1TEST" is not valid).
- --TESTCD cannot contain characters other than letters,
- numbers, or underscores.
+ - Cited Guidance:
+ The value in --TESTCD cannot be longer than 8 characters, nor can it start
+ with a number (e.g., "1TEST" is not valid). --TESTCD cannot contain characters other than
+ letters, numbers, or underscores.
Document: TIG 1.0
Item: Specifications --TESTCD
Section: Finding Domain Specifications
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0536
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- name: IETESTCD
@@ -83,13 +83,13 @@ Check:
Core:
Id: "CORE-000541"
Status: Published
- Version: '1'
-Description: Part B - Raise an error when IETESTCD > 8 chars or contains more
- than only letters, numbers and underscores, or starts with a number.
+ Version: "1"
+Description: Part B - Raise an error when IETESTCD > 8 chars or contains more than only letters,
+ numbers and underscores, or starts with a number.
Executability: Fully Executable
Outcome:
- Message: IETESTCD > 8 chars or contains more than only letters, numbers,
- underscores, or starts with a number.
+ Message: IETESTCD > 8 chars or contains more than only letters, numbers, underscores, or starts
+ with a number.
Output Variables:
- IETESTCD
Rule Type: Record Data
diff --git a/Published/CORE-000542/rule.yml b/Published/CORE-000542/rule.yml
index f60bc8274..88390a5df 100644
--- a/Published/CORE-000542/rule.yml
+++ b/Published/CORE-000542/rule.yml
@@ -4,238 +4,228 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A further step is necessary when --STRESC contains numeric
- values. These are converted to numeric type and written to
- --STRESN.
+ - Cited Guidance:
+ A further step is necessary when --STRESC contains numeric values. These are
+ converted to numeric type and written to --STRESN.
Document: SENDIG v3.0
Item: Text
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND88
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A further step is necessary when --STRESC contains numeric
- values. These are converted to numeric type and written to
- --STRESN.
+ - Cited Guidance:
+ A further step is necessary when --STRESC contains numeric values. These are
+ converted to numeric type and written to --STRESN.
Document: SENDIG v3.1
Item: Text
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND88
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A further step is necessary when --STRESC contains numeric
- values. These are converted to numeric type and written to
- --STRESN.
+ - Cited Guidance:
+ A further step is necessary when --STRESC contains numeric values. These are
+ converted to numeric type and written to --STRESN.
Document: SENDIG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND88
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A further step is necessary when --STRESC contains numeric
- values. These are converted to numeric type and written to
- --STRESN.
+ - Cited Guidance:
+ A further step is necessary when --STRESC contains numeric values. These are
+ converted to numeric type and written to --STRESN.
Document: SENDIG v3.1
Item: Text
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND88
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A further step is necessary when --STRESC contains numeric
- values. These are converted to numeric type and written to
- --STRESN.
+ - Cited Guidance:
+ A further step is necessary when --STRESC contains numeric values. These are
+ converted to numeric type and written to --STRESN.
Document: SENDIG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND88
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: A further step is necessary when --STRESC contains numeric
- values. These are converted to numeric type and written to
- --STRESN.
+ - Cited Guidance:
+ A further step is necessary when --STRESC contains numeric values. These are
+ converted to numeric type and written to --STRESN.
Document: SENDIG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND88
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: A further step is necessary when --STRESC contains numeric
- values. These are converted to numeric type and written to
- --STRESN.
+ - Cited Guidance:
+ A further step is necessary when --STRESC contains numeric values. These are
+ converted to numeric type and written to --STRESN.
Document: TIG v1.0
Item: Text
Section: 2.8.7.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0280
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
- - Organization: 'FDA'
+ Version: "1.0"
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3102'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB3102"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3102'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB3102"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3102'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB3102"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3102'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB3102"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3102'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB3102"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3102'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3102"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3102'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3102"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3102'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB3102"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3102'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB3102"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3102'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB3102"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --STRESC
@@ -253,9 +243,9 @@ Check:
Core:
Id: CORE-000542
Status: Published
- Version: '1'
-Description: Raise an error when --STRESC is populated with a numeric value, but
- --STRESN is not populated, or --STRESN is not equal to --STRESC.
+ Version: "1"
+Description: Raise an error when --STRESC is populated with a numeric value, but --STRESN is not
+ populated, or --STRESN is not equal to --STRESC.
Executability: Fully Executable
Outcome:
Message: --STRESC is numeric but --STRESN is not populated or not equal to --STRESC.
diff --git a/Published/CORE-000545/rule.yml b/Published/CORE-000545/rule.yml
index 086da8d37..4f1e0d51b 100644
--- a/Published/CORE-000545/rule.yml
+++ b/Published/CORE-000545/rule.yml
@@ -4,84 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.0
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND45
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND45
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND45
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: --STRESN will only contain data values if the data values
- presented in --STRESC are numeric values
+ - Cited Guidance:
+ --STRESN will only contain data values if the data values presented in
+ --STRESC are numeric values
Document: IG v3.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND45
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: --STRESN will only contain data values if the data values
- presented in --STRESC are numeric values
+ - Cited Guidance:
+ --STRESN will only contain data values if the data values presented in
+ --STRESC are numeric values
Document: IG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND45
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: --STRESN will only contain data values if the data values
- presented in --STRESC are numeric values
+ - Cited Guidance:
+ --STRESN will only contain data values if the data values presented in
+ --STRESC are numeric values
Document: IG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND45
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
@@ -106,9 +109,9 @@ Check:
Core:
Id: CORE-000545
Status: Published
- Version: '1'
-Description: Trigger error when --SCAT is not null and --SCAT is equal to
- --DECOD or --SCAT is equal to --BODSYS
+ Version: "1"
+Description: Trigger error when --SCAT is not null and --SCAT is equal to --DECOD or --SCAT is equal
+ to --BODSYS
Executability: Fully Executable
Outcome:
Message: --SCAT is equal to --DECOD, or --SCAT is equal to --BODSYS
diff --git a/Published/CORE-000546/rule.yml b/Published/CORE-000546/rule.yml
index 7dec60f63..37e151727 100644
--- a/Published/CORE-000546/rule.yml
+++ b/Published/CORE-000546/rule.yml
@@ -4,87 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.0
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND47
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND47
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND47
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND47
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND47
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the
- domain or dictionary classification provided by --DECOD and
- --BODSYS.
+ - Cited Guidance:
+ Values for --CAT and --SCAT should not be redundant with the domain or
+ dictionary classification provided by --DECOD and --BODSYS.
Document: IG v.3.1.1
Section: 4.2.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND47
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
# - name: --CAT
@@ -108,9 +108,9 @@ Check:
Core:
Id: CORE-000546
Status: Published
- Version: '1'
-Description: Trigger error when --CAT is not null and --CAT is equal to --DECOD
- or --CAT is equal to --BODSYS
+ Version: "1"
+Description: Trigger error when --CAT is not null and --CAT is equal to --DECOD or --CAT is equal to
+ --BODSYS
Executability: Fully Executable
Outcome:
Message: --CAT is equal to --DECOD, or --CAT is equal to --BODSYS
diff --git a/Published/CORE-000547/rule.yml b/Published/CORE-000547/rule.yml
index 7e7cb649b..6d396765a 100644
--- a/Published/CORE-000547/rule.yml
+++ b/Published/CORE-000547/rule.yml
@@ -5,186 +5,192 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The SENDIG requires dates and times of day to be stored
- according to the international standard ISO 8601
- (http://www.iso.org).
+ - Cited Guidance:
+ The SENDIG requires dates and times of day to be stored according to the
+ international standard ISO 8601 (http://www.iso.org).
Document: SENDIG v3.0
Item: Text
Section: 4.4|4.4.3|4.4.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND66
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The SENDIG requires dates and times of day to be stored
- according to the international standard ISO 8601
- (http://www.iso.org).
+ - Cited Guidance:
+ The SENDIG requires dates and times of day to be stored according to the
+ international standard ISO 8601 (http://www.iso.org).
Document: SENDIG v3.1
Item: Text
Section: 4.4|4.4.3|4.4.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND66
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The SENDIG requires dates and times of day to be stored
- according to the international standard ISO 8601
- (http://www.iso.org).
+ - Cited Guidance:
+ The SENDIG requires dates and times of day to be stored according to the
+ international standard ISO 8601 (http://www.iso.org).
Document: SENDIG v3.1.1
Item: Text
Section: 4.4|4.4.3|4.4.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND66
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The SENDIG requires dates and times of day to be stored
- according to the international standard ISO 8601
- (http://www.iso.org).
+ - Cited Guidance:
+ The SENDIG requires dates and times of day to be stored according to the
+ international standard ISO 8601 (http://www.iso.org).
Document: SENDIG v3.1
Item: Text
Section: 4.4|4.4.3|4.4.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND66
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The SENDIG requires dates and times of day to be stored
- according to the international standard ISO 8601
- (http://www.iso.org).
+ - Cited Guidance:
+ The SENDIG requires dates and times of day to be stored according to the
+ international standard ISO 8601 (http://www.iso.org).
Document: SENDIG v3.1.1
Item: Text
Section: 4.4|4.4.3|4.4.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND66
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The SENDIG requires dates and times of day to be stored
- according to the international standard ISO 8601
- (http://www.iso.org).
+ - Cited Guidance:
+ The SENDIG requires dates and times of day to be stored according to the
+ international standard ISO 8601 (http://www.iso.org).
Document: SENDIG v3.1.1
Item: Text
Section: 4.4|4.4.3|4.4.6
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND66
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The SDTM and SENDIG require use of the ISO 8601 Extended format,
- which requires hyphen delimiters for date components and colon
- delimiters for time components. The ISO 8601 basic format,
- which does not require delimiters, should not be used in SDTM
+ - Cited Guidance:
+ The SDTM and SENDIG require use of the ISO 8601 Extended format, which
+ requires hyphen delimiters for date components and colon delimiters for time components.
+ The ISO 8601 basic format, which does not require delimiters, should not be used in SDTM
datasets.
Document: SENDIG v3.0
Item: Text
- Section: '4.4.1'
+ Section: "4.4.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND67
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The ISO 8601 basic format, which does not require delimiters,
- should not be used.
+ - Cited Guidance:
+ The ISO 8601 basic format, which does not require delimiters, should not be
+ used.
Document: SENDIG v3.1
Item: Text
- Section: '4.4.1'
+ Section: "4.4.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND67
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The ISO 8601 basic format, which does not require delimiters,
- should not be used.
+ - Cited Guidance:
+ The ISO 8601 basic format, which does not require delimiters, should not be
+ used.
Document: SENDIG v3.1.1
Item: Text
- Section: '4.4.1'
+ Section: "4.4.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND67
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The ISO 8601 basic format, which does not require delimiters,
- should not be used.
+ - Cited Guidance:
+ The ISO 8601 basic format, which does not require delimiters, should not be
+ used.
Document: SENDIG v3.1
- Section: '4.4.1'
+ Section: "4.4.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND67
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The ISO 8601 basic format, which does not require delimiters,
- should not be used.
+ - Cited Guidance:
+ The ISO 8601 basic format, which does not require delimiters, should not be
+ used.
Document: SENDIG v3.1.1
Item: Text
- Section: '4.4.1'
+ Section: "4.4.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND67
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The ISO 8601 basic format, which does not require delimiters,
- should not be used.
+ - Cited Guidance:
+ The ISO 8601 basic format, which does not require delimiters, should not be
+ used.
Document: SENDIG v3.1.1
Item: Text
- Section: '4.4.1'
+ Section: "4.4.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND67
- Version: '1'
- Version: '5.0'
- Version: '1.0'
- # SEND68 added here as code for SEND66 and SEND67 also covers SEND68
+ Version: "1"
+ Version: "5.0"
+ Version:
+ "1.0"
+ # SEND68 added here as code for SEND66 and SEND67 also covers SEND68
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When a date is stored with a time in the same variable (as a
- date/time), the date is written in front of the time and the
- time is preceded with "T" using the notation
+ - Cited Guidance:
+ When a date is stored with a time in the same variable (as a date/time), the
+ date is written in front of the time and the time is preceded with "T" using the notation
YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01).
Document: SENDIG v3.0
Item: Text
@@ -192,15 +198,15 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND68
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When a date is stored with a time in the same variable (as a
- date/time), the date is written in front of the time and the
- time is preceded with "T" using the notation
+ - Cited Guidance:
+ When a date is stored with a time in the same variable (as a date/time), the
+ date is written in front of the time and the time is preceded with "T" using the notation
YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01).
Document: SENDIG v3.1
Item: Text
@@ -208,15 +214,15 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND68
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When a date is stored with a time in the same variable (as a
- date/time), the date is written in front of the time and the
- time is preceded with "T" using the notation
+ - Cited Guidance:
+ When a date is stored with a time in the same variable (as a date/time), the
+ date is written in front of the time and the time is preceded with "T" using the notation
YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01).
Document: SENDIG v3.1.1
Item: Text
@@ -224,15 +230,15 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND68
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: When a date is stored with a time in the same variable (as a
- date/time), the date is written in front of the time and the
- time is preceded with "T" using the notation
+ - Cited Guidance:
+ When a date is stored with a time in the same variable (as a date/time), the
+ date is written in front of the time and the time is preceded with "T" using the notation
YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01).
Document: SENDIG v3.1.1
Item: Text
@@ -240,15 +246,15 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND68
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When a date is stored with a time in the same variable (as a
- date/time), the date is written in front of the time and the
- time is preceded with "T" using the notation
+ - Cited Guidance:
+ When a date is stored with a time in the same variable (as a date/time), the
+ date is written in front of the time and the time is preceded with "T" using the notation
YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01).
Document: SENDIG v3.1
Item: Text
@@ -256,15 +262,15 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND68
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When a date is stored with a time in the same variable (as a
- date/time), the date is written in front of the time and the
- time is preceded with "T" using the notation
+ - Cited Guidance:
+ When a date is stored with a time in the same variable (as a date/time), the
+ date is written in front of the time and the time is preceded with "T" using the notation
YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01).
Document: SENDIG v3.1.1
Item: Text
@@ -272,66 +278,63 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND68
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Standards for tabulation and analysis require representation of
- dates and/or times, intervals of time, and durations of time
- in ISO 8601 format as defined by the International
- Organization for Standardization (ISO) (http://www.iso.org).
- The appropriate date and/or time ISO format must be used when
- specified.
+ - Cited Guidance:
+ Standards for tabulation and analysis require representation of dates and/or
+ times, intervals of time, and durations of time in ISO 8601 format as defined by the
+ International Organization for Standardization (ISO) (http://www.iso.org). The appropriate
+ date and/or time ISO format must be used when specified.
Document: TIG v1.0
Item: Text
- Section: '2.3'
+ Section: "2.3"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0267
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Standards for tabulation and analysis require representation of
- dates and/or times, intervals of time, and durations of time
- in ISO 8601 format as defined by the International
- Organization for Standardization (ISO) (http://www.iso.org).
- The appropriate date and/or time ISO format must be used when
- specified.
+ - Cited Guidance:
+ Standards for tabulation and analysis require representation of dates and/or
+ times, intervals of time, and durations of time in ISO 8601 format as defined by the
+ International Organization for Standardization (ISO) (http://www.iso.org). The appropriate
+ date and/or time ISO format must be used when specified.
Document: TIG v1.0
Item: Text
Section: 2.3 Controlled Terminology and Formats
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0268
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Standards for tabulation and analysis require representation of
- dates and/or times, intervals of time, and durations of time
- in ISO 8601 format as defined by the International
- Organization for Standardization (ISO) (http://www.iso.org).
- The appropriate date and/or time ISO format must be used when
- specified.
+ - Cited Guidance:
+ Standards for tabulation and analysis require representation of dates and/or
+ times, intervals of time, and durations of time in ISO 8601 format as defined by the
+ International Organization for Standardization (ISO) (http://www.iso.org). The appropriate
+ date and/or time ISO format must be used when specified.
Document: TIG v1.0
Item: Text
Section: 2.3 Controlled Terminology and Formats
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0269
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- name: RFSTDTC
@@ -351,9 +354,9 @@ Check:
Core:
Id: CORE-000547
Status: Published
- Version: '1'
-Description: Values of variables RFSTDTC, RFENDTC, BRTHDTC, --STDTC, --ENDTC,
- --DTC, --RFTDTC must be correct ISO-8601 dates / datetimes
+ Version: "1"
+Description: Values of variables RFSTDTC, RFENDTC, BRTHDTC, --STDTC, --ENDTC, --DTC, --RFTDTC must
+ be correct ISO-8601 dates / datetimes
Executability: Fully Executable
Outcome:
Message: Variable value is not in correct ISO 8601 date or datetime format
diff --git a/Published/CORE-000548/rule.yml b/Published/CORE-000548/rule.yml
index c94239b2d..6e950a7bc 100644
--- a/Published/CORE-000548/rule.yml
+++ b/Published/CORE-000548/rule.yml
@@ -4,13 +4,12 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Other variables that represent durations or elapsed times
- include --EVLINT and --ELTM. These should be represented in
- accordance with the ISO 8601 standard. Both duration and
- duration units can be represented in a single --DUR variable,
- in accordance with the ISO 8601 standard as follows... For the
- purposes of data submission, an additional format is allowed
- to represent "negative" intervals of time (intervals of time
+ - Cited Guidance:
+ Other variables that represent durations or elapsed times include --EVLINT
+ and --ELTM. These should be represented in accordance with the ISO 8601 standard. Both
+ duration and duration units can be represented in a single --DUR variable, in accordance
+ with the ISO 8601 standard as follows... For the purposes of data submission, an
+ additional format is allowed to represent "negative" intervals of time (intervals of time
preceding a reference point).
Document: IG v3.0
Item: Specification
@@ -18,22 +17,20 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND59.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Duration is frequently used during a review; however, the
- duration timing variable (--DUR) should generally be used in a
- domain if it was collected in lieu of a start date/time
- (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC
- are collected, durations can be calculated by the difference
- in these two values and need not be in the submission dataset.
- Durations and associated units can be provided in a single
- variable, in accordance with the ISO 8601 standard as
- follows...For the purposes of data submission, an additional
- format is allowed to represent "negative" intervals of time
+ - Cited Guidance:
+ Duration is frequently used during a review; however, the duration timing
+ variable (--DUR) should generally be used in a domain if it was collected in lieu of a
+ start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are
+ collected, durations can be calculated by the difference in these two values and need not
+ be in the submission dataset. Durations and associated units can be provided in a single
+ variable, in accordance with the ISO 8601 standard as follows...For the purposes of data
+ submission, an additional format is allowed to represent "negative" intervals of time
(intervals of time preceding a reference point).
Document: IG v3.1
Item: Specification
@@ -41,22 +38,20 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND59.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Duration is frequently used during a review; however, the
- duration timing variable (--DUR) should generally be used in a
- domain if it was collected in lieu of a start date/time
- (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC
- are collected, durations can be calculated by the difference
- in these two values and need not be in the submission dataset.
- Durations and associated units can be provided in a single
- variable, in accordance with the ISO 8601 standard as
- follows...For the purposes of data submission, an additional
- format is allowed to represent "negative" intervals of time
+ - Cited Guidance:
+ Duration is frequently used during a review; however, the duration timing
+ variable (--DUR) should generally be used in a domain if it was collected in lieu of a
+ start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are
+ collected, durations can be calculated by the difference in these two values and need not
+ be in the submission dataset. Durations and associated units can be provided in a single
+ variable, in accordance with the ISO 8601 standard as follows...For the purposes of data
+ submission, an additional format is allowed to represent "negative" intervals of time
(intervals of time preceding a reference point).
Document: IG v3.1.1
Item: Specification
@@ -64,22 +59,20 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND59.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Duration is frequently used during a review; however, the
- duration timing variable (--DUR) should generally be used in a
- domain if it was collected in lieu of a start date/time
- (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC
- are collected, durations can be calculated by the difference
- in these two values and need not be in the submission dataset.
- Durations and associated units can be provided in a single
- variable, in accordance with the ISO 8601 standard as
- follows...For the purposes of data submission, an additional
- format is allowed to represent "negative" intervals of time
+ - Cited Guidance:
+ Duration is frequently used during a review; however, the duration timing
+ variable (--DUR) should generally be used in a domain if it was collected in lieu of a
+ start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are
+ collected, durations can be calculated by the difference in these two values and need not
+ be in the submission dataset. Durations and associated units can be provided in a single
+ variable, in accordance with the ISO 8601 standard as follows...For the purposes of data
+ submission, an additional format is allowed to represent "negative" intervals of time
(intervals of time preceding a reference point).
Document: IG v3.1
Item: Specification
@@ -87,22 +80,20 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND59.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Duration is frequently used during a review; however, the
- duration timing variable (--DUR) should generally be used in a
- domain if it was collected in lieu of a start date/time
- (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC
- are collected, durations can be calculated by the difference
- in these two values and need not be in the submission dataset.
- Durations and associated units can be provided in a single
- variable, in accordance with the ISO 8601 standard as
- follows...For the purposes of data submission, an additional
- format is allowed to represent "negative" intervals of time
+ - Cited Guidance:
+ Duration is frequently used during a review; however, the duration timing
+ variable (--DUR) should generally be used in a domain if it was collected in lieu of a
+ start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are
+ collected, durations can be calculated by the difference in these two values and need not
+ be in the submission dataset. Durations and associated units can be provided in a single
+ variable, in accordance with the ISO 8601 standard as follows...For the purposes of data
+ submission, an additional format is allowed to represent "negative" intervals of time
(intervals of time preceding a reference point).
Document: IG v3.1.1
Item: Specification
@@ -110,22 +101,20 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND59.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Duration is frequently used during a review; however, the
- duration timing variable (--DUR) should generally be used in a
- domain if it was collected in lieu of a start date/time
- (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC
- are collected, durations can be calculated by the difference
- in these two values and need not be in the submission dataset.
- Durations and associated units can be provided in a single
- variable, in accordance with the ISO 8601 standard as
- follows...For the purposes of data submission, an additional
- format is allowed to represent "negative" intervals of time
+ - Cited Guidance:
+ Duration is frequently used during a review; however, the duration timing
+ variable (--DUR) should generally be used in a domain if it was collected in lieu of a
+ start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are
+ collected, durations can be calculated by the difference in these two values and need not
+ be in the submission dataset. Durations and associated units can be provided in a single
+ variable, in accordance with the ISO 8601 standard as follows...For the purposes of data
+ submission, an additional format is allowed to represent "negative" intervals of time
(intervals of time preceding a reference point).
Document: IG v3.1.1
Item: Specification
@@ -133,9 +122,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND59.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
- all:
@@ -168,10 +157,9 @@ Check:
Core:
Id: CORE-000548
Status: Published
- Version: '1'
-Description: --EVLINT, --ELTM, --DUR must be in ISO 8601 duration format,
- including the additional format that allows the representation of "negative"
- intervals of time.
+ Version: "1"
+Description: --EVLINT, --ELTM, --DUR must be in ISO 8601 duration format, including the additional
+ format that allows the representation of "negative" intervals of time.
Executability: Fully Executable
Outcome:
Message: --DUR, --EVLINT or --ELTM is not in ISO 8601 Duration format
diff --git a/Published/CORE-000549/rule.yml b/Published/CORE-000549/rule.yml
index 37cd578b9..dde181a9b 100644
--- a/Published/CORE-000549/rule.yml
+++ b/Published/CORE-000549/rule.yml
@@ -5,31 +5,31 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The value of RSTGCD for an unplanned Stage is 'UNPLAN' and
- SJUPDES should be populated with a description of the
- unplanned Stage.
+ - Cited Guidance:
+ The value of RSTGCD for an unplanned Stage is 'UNPLAN' and SJUPDES should be
+ populated with a description of the unplanned Stage.
Document: IG-DART v1.1
- Section: '4.1.1'
+ Section: "4.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND352
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The value of RSTGCD for an unplanned Stage is 'UNPLAN' and
- SJUPDES should be populated with a description of the
- unplanned Stage.
+ - Cited Guidance:
+ The value of RSTGCD for an unplanned Stage is 'UNPLAN' and SJUPDES should be
+ populated with a description of the unplanned Stage.
Document: IG-DART v1.2
- Section: '4.1.1'
+ Section: "4.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND352
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
@@ -41,7 +41,7 @@ Check:
Core:
Id: CORE-000549
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when RSTGCD is not 'UNPLAN' and SJUPDES is populated
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000550/rule.yml b/Published/CORE-000550/rule.yml
index b911ee9b9..b36314a86 100644
--- a/Published/CORE-000550/rule.yml
+++ b/Published/CORE-000550/rule.yml
@@ -1,9 +1,9 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: Variable = Model List of Allowed Variables for Observation Class
#
# 2025-11-18: SDTMIG-3-3 is implemented in a separate rule, and thus commented out here,
-# as SDTMIG has "domain-specific" variables:
+# as SDTMIG has "domain-specific" variables:
# which are NOT in the "SDTM Model"
Authorities:
- Organization: CDISC
@@ -11,72 +11,74 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Sponsors may not add any variables other than those described in
- the preceding three bullets. . . . Standard variables must not
- be renamed or modified for novel usage.
+ - Cited Guidance: Sponsors may not add any variables other than those described in the
+ preceding three bullets. . . . Standard variables must not be renamed or modified for
+ novel usage.
Document: IG v3.4
- Section: '2.5'
+ Section: "2.5"
- Cited Guidance: Each observation consists of a series of named variables.
Document: Model v2.0
Section: Model Concepts and Terms --Variables
- - Cited Guidance: Domain-specific variables, a concept introduced in SDTM v1.5,
- are for use in a limited number of designated domains and will
- be identified in the appropriate implementation guide.]
+ - Cited Guidance:
+ Domain-specific variables, a concept introduced in SDTM v1.5, are for use in
+ a limited number of designated domains and will be identified in the appropriate
+ implementation guide.]
Document: Model v2.0
Section: The General Observation Classes
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0013
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.2[2.5][Sponsors may not add any other variables. . . .
- Standard variables must not be renamed or modified for novel
- usage. Using SDTM-specified standard variable names.]|Model
- v1.4[3.2.22][Each observation can be described by a series of
- named variables.]
+ - Cited Guidance:
+ IG v3.2[2.5][Sponsors may not add any other variables. . . . Standard
+ variables must not be renamed or modified for novel usage. Using SDTM-specified standard
+ variable names.]|Model v1.4[3.2.22][Each observation can be described by a series of named
+ variables.]
Document: IG v3.2|Model v1.4
Section: IG v3.2[2.5]|Model v1.4[3.2.22]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0013
- Version: '1'
- Version: '2.0'
- Version: '3.2'
- # 2025-11-18: SDTMIG-3-3 is implemented in a separate rule, and thus commented out here,
- # as SDTMIG has "domain-specific" variables:
- # which are NOT in the "SDTM Model"
- # For SDTMIG-3-2 there are none such "domain-specific" variables
- # and for SDTMIG-3-4 they are also present in the "SDTM Model".
- #- Name: SDTMIG
- # References:
- # - Citations:
- # - Cited Guidance: IG v3.3[2.5][Sponsors may not add any other variables. . . .
- # Standard variables must not be renamed or modified for novel
- # usage]|IG v3.3[2.5][[Using SDTM-specified standard variable
- # names]|Model v1.7[3.2.2 2.1][Each observation can be described
- # by a series of named variables. Domain-specific variables, a
- # concept introduced in SDTM v1.5, are for use in a limited
- # number of designated domains and will be identified in the
- # appropriate implementation guide.]
- # Document: IG v3.3|Model v1.7
- # Section: IG v3.3[2.5]|Model v1.7[3.2.2 2.1]
- # Origin: SDTM and SDTMIG Conformance Rules
- # Rule Identifier:
- # Id: CG0013
- # Version: '1'
- # Version: '2.0'
- # Version: '3.3'
- - Name: 'TIG'
+ Version: "1"
+ Version: "2.0"
+ Version:
+ "3.2"
+ # 2025-11-18: SDTMIG-3-3 is implemented in a separate rule, and thus commented out here,
+ # as SDTMIG has "domain-specific" variables:
+ # which are NOT in the "SDTM Model"
+ # For SDTMIG-3-2 there are none such "domain-specific" variables
+ # and for SDTMIG-3-4 they are also present in the "SDTM Model".
+ #- Name: SDTMIG
+ # References:
+ # - Citations:
+ # - Cited Guidance: IG v3.3[2.5][Sponsors may not add any other variables. . . .
+ # Standard variables must not be renamed or modified for novel
+ # usage]|IG v3.3[2.5][[Using SDTM-specified standard variable
+ # names]|Model v1.7[3.2.2 2.1][Each observation can be described
+ # by a series of named variables. Domain-specific variables, a
+ # concept introduced in SDTM v1.5, are for use in a limited
+ # number of designated domains and will be identified in the
+ # appropriate implementation guide.]
+ # Document: IG v3.3|Model v1.7
+ # Section: IG v3.3[2.5]|Model v1.7[3.2.2 2.1]
+ # Origin: SDTM and SDTMIG Conformance Rules
+ # Rule Identifier:
+ # Id: CG0013
+ # Version: '1'
+ # Version: '2.0'
+ # Version: '3.3'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: A dataset is created using a domain specification in this guide
- when the scientific nature or role of the data is within the
- scope of a domain. Domains are extended or custom domain
- specifications are only used when data are different in nature
+ - Cited Guidance:
+ A dataset is created using a domain specification in this guide when the
+ scientific nature or role of the data is within the scope of a domain. Domains are
+ extended or custom domain specifications are only used when data are different in nature
and are not in scope for domains in this guide.
Document: TIG 1.0
Item: Table 2 Num 2
@@ -84,10 +86,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0298
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Organization: CDISC
Standards:
- Name: SDTMIG
@@ -99,9 +101,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0351
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -111,21 +113,22 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0351
- Version: '1'
- Version: '2.0'
- Version: '3.2'
- #- Name: SDTMIG
- # References:
- # - Citations:
- # - Cited Guidance: Using SDTM-specified standard variable names
- # Document: IG v3.3
- # Section: 3.2.2
- # Origin: SDTM and SDTMIG Conformance Rules
- # Rule Identifier:
- # Id: CG0351
- # Version: '1'
- # Version: '2.0'
- # Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version:
+ "3.2"
+ #- Name: SDTMIG
+ # References:
+ # - Citations:
+ # - Cited Guidance: Using SDTM-specified standard variable names
+ # Document: IG v3.3
+ # Section: 3.2.2
+ # Origin: SDTM and SDTMIG Conformance Rules
+ # Rule Identifier:
+ # Id: CG0351
+ # Version: '1'
+ # Version: '2.0'
+ # Version: '3.3'
Check:
all:
- name: variable_name
@@ -134,16 +137,15 @@ Check:
Core:
Id: CORE-000550
Status: Published
- Version: '1'
-Description: Raise an error when a variable is not an allowed variable for an
- Observation Class
+ Version: "1"
+Description: Raise an error when a variable is not an allowed variable for an Observation Class
Executability: Partially Executable - Possible Underreporting
Operations:
- id: $allowed_variables
operator: get_model_column_order
Outcome:
- Message: Variables not listed in the Model List of Allowed Variables for
- Observation Class should be in SUPPQUAL.
+ Message: Variables not listed in the Model List of Allowed Variables for Observation Class should
+ be in SUPPQUAL.
Rule Type: Variable Metadata Check
Scope:
Classes:
diff --git a/Published/CORE-000551/rule.yml b/Published/CORE-000551/rule.yml
index 835c28a64..6dac6f880 100644
--- a/Published/CORE-000551/rule.yml
+++ b/Published/CORE-000551/rule.yml
@@ -5,114 +5,119 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) -
- Relationship Datasets. One record per IDVAR, IDVARVAL, and
- QNAM value per subject per related domain, Tabulation.
+ - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship
+ Datasets. One record per IDVAR, IDVARVAL, and QNAM value per subject per related domain,
+ Tabulation.
Document: IG v3.0
Item: Domain Table Header
- Section: '8.5'
+ Section: "8.5"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND254'
- Version: '1'
- Version: '5.0'
- Version: '3.0'
- # SENDIG-3.1: rule 254.1
+ Id: "SEND254"
+ Version: "1"
+ Version: "5.0"
+ Version:
+ "3.0"
+ # SENDIG-3.1: rule 254.1
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) -
- Relationship Datasets. One record per supplemental qualifier
- per related parent domain record(s), Tabulation.
+ - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship
+ Datasets. One record per supplemental qualifier per related parent domain record(s),
+ Tabulation.
Document: IG v3.1
Item: Domain Table Header
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND254.1'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
- # SENDIG-3.1: rule 254.1
+ Id: "SEND254.1"
+ Version: "1"
+ Version: "5.0"
+ Version:
+ "3.1"
+ # SENDIG-3.1: rule 254.1
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) -
- Relationship Datasets. One record per supplemental qualifier
- per related parent domain record(s), Tabulation.
+ - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship
+ Datasets. One record per supplemental qualifier per related parent domain record(s),
+ Tabulation.
Document: IG v3.1.1
Item: Domain Table Header
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND254.1'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
- # SENDIG-DART-1.1: rule 254.1
+ Id: "SEND254.1"
+ Version: "1"
+ Version: "5.0"
+ Version:
+ "3.1.1"
+ # SENDIG-DART-1.1: rule 254.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) -
- Relationship Datasets. One record per supplemental qualifier
- per related parent domain record(s), Tabulation.
+ - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship
+ Datasets. One record per supplemental qualifier per related parent domain record(s),
+ Tabulation.
Document: IG v3.1
Item: Domain Table Header
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND254.1'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
- # SENDIG-DART-1.2: rule 254.1
+ Id: "SEND254.1"
+ Version: "1"
+ Version: "5.0"
+ Version:
+ "1.1"
+ # SENDIG-DART-1.2: rule 254.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) -
- Relationship Datasets. One record per supplemental qualifier
- per related parent domain record(s), Tabulation.
+ - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship
+ Datasets. One record per supplemental qualifier per related parent domain record(s),
+ Tabulation.
Document: IG v3.1.1
Item: Domain Table Header
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND254.1'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
- # SENDIG-GENETOX-1.0: rule 254.1
+ Id: "SEND254.1"
+ Version: "1"
+ Version: "5.0"
+ Version:
+ "1.2"
+ # SENDIG-GENETOX-1.0: rule 254.1
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) -
- Relationship Datasets. One record per supplemental qualifier
- per related parent domain record(s), Tabulation.
+ - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship
+ Datasets. One record per supplemental qualifier per related parent domain record(s),
+ Tabulation.
Document: IG v3.1.1
Item: Domain Table Header
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND254.1'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND254.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: supp--.xpt, Supplemental Qualifiers for [domain name] —
- Relationship. One record per IDVAR, IDVARVAL, and QNAM value
- per subject per related domain, Tabulation.
+ - Cited Guidance:
+ supp--.xpt, Supplemental Qualifiers for [domain name] — Relationship. One
+ record per IDVAR, IDVARVAL, and QNAM value per subject per related domain, Tabulation.
Document: TIG v1.0
Item: Domain Table Header
Section: 2.8.9.27
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0172
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -138,13 +143,13 @@ Check:
Core:
Id: CORE-000551
Status: Published
- Version: '1'
-Description: There may be only be one record in a SUPP-- dataset with the same
- QNAM value within USUBJID or POOLID, RDOMAIN, IDVAR, IDVARVAL.
+ Version: "1"
+Description: There may be only be one record in a SUPP-- dataset with the same QNAM value within
+ USUBJID or POOLID, RDOMAIN, IDVAR, IDVARVAL.
Executability: Fully Executable
Outcome:
- Message: Duplicate value of the combination of USUBJID or POOLID, RDOMAIN,
- IDVAR, IDVARVAL with QNAM
+ Message: Duplicate value of the combination of USUBJID or POOLID, RDOMAIN, IDVAR, IDVARVAL with
+ QNAM
Output Variables:
- RDOMAIN
- IDVAR
diff --git a/Published/CORE-000552/rule.yml b/Published/CORE-000552/rule.yml
index 03654e5c2..b1236140c 100644
--- a/Published/CORE-000552/rule.yml
+++ b/Published/CORE-000552/rule.yml
@@ -7,97 +7,85 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with
- the reference date as Day 1. They are determined by comparing
- the date portion of the respective date/time
- variables (--DTC, --STDTC, and --ENDTC) to the date portion
- of the Subject Reference Start Date (RFSTDTC from the
- Demographics domain). All Study Day values are
- integers. Thus, to calculate Study Day, --DY = (date portion
- of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or
- after RFSTDTC, --DY = (date portion of --DTC) - (date portion
- of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should
- be used across all domains.
+ - Cited Guidance:
+ The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1. They are
+ determined by comparing the date portion of the respective date/time variables (--DTC,
+ --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC
+ from the Demographics domain). All Study Day values are integers. Thus, to calculate
+ Study Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on
+ or after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
+ precedes RFSTDTC. This algorithm should be used across all domains.
Document: IG v3.4
Section: 4.4.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0220
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1. They are determined by comparing the
- date portion of the respective date/time variables (--DTC,
- --STDTC, and --ENDTC) to the date portion of the Subject
- Reference Start Date (RFSTDTC from the Demographics
- domain).][All Study Day values are integers. Thus, to
- calculate Study Day: --DY = (date portion of --DTC) - (date
- portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
- = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.]'
+ - Cited Guidance:
+ "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1. They are determined
+ by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC)
+ to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All
+ Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across
+ all domains.]"
Document: IG v3.2
Section: 4.1.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0220
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1. They are determined by comparing the
- date portion of the respective date/time variables (--DTC,
- --STDTC, and --ENDTC) to the date portion of the Subject
- Reference Start Date (RFSTDTC from the Demographics
- domain).][All Study Day values are integers. Thus, to
- calculate Study Day: --DY = (date portion of --DTC) - (date
- portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
- = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.]'
+ - Cited Guidance:
+ "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1. They are determined
+ by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC)
+ to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All
+ Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across
+ all domains.]"
Document: IG v3.3
Section: 4.4.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0220
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1. They are determined by comparing the
- date portion of the respective date/time variables (--DTC,
- --STDTC, and --ENDTC) to the date portion of the Subject
- Reference Start Date (RFSTDTC from the Demographics
- domain).][All Study Day values are integers. Thus, to
- calculate Study Day; --DY = (date portion of --DTC) - (date
- portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
- = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.'
+ - Cited Guidance:
+ "The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative
+ day of the observation starting with the reference date as Day 1. They are determined by comparing
+ the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the
+ date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All
+ Study Day values are integers. Thus, to calculate Study Day; --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across
+ all domains."
Document: TIG 1.0
Item: Num 1
Section: 2.8.7.6
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0434
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --STDTC
@@ -110,7 +98,7 @@ Check:
Core:
Id: CORE-000552
Status: Published
- Version: '1'
+ Version: "1"
Description: Study day must be calculated using the algorithm detailed in the SDTMIG.
Executability: Fully Executable
Match Datasets:
diff --git a/Published/CORE-000553/rule.yml b/Published/CORE-000553/rule.yml
index 3bbe557ac..b09517abe 100644
--- a/Published/CORE-000553/rule.yml
+++ b/Published/CORE-000553/rule.yml
@@ -7,97 +7,85 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with
- the reference date as Day 1. They are determined by comparing
- the date portion of the respective date/time variables
- (--DTC, --STDTC, and --ENDTC) to the date portion of the
- Subject Reference Start Date (RFSTDTC from the Demographics
- domain). All Study Day values are integers. Thus, to calculate
- Study Day, --DY = (date portion of --DTC) - (date portion of
- RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date
- portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.
+ - Cited Guidance:
+ The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1. They are
+ determined by comparing the date portion of the respective date/time variables (--DTC,
+ --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC
+ from the Demographics domain). All Study Day values are integers. Thus, to calculate Study
+ Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or
+ after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
+ precedes RFSTDTC. This algorithm should be used across all domains.
Document: IG v3.4
Section: 4.4.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0222
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1. They are determined by comparing the
- date portion of the respective date/time variables (--DTC,
- --STDTC, and --ENDTC) to the date portion of the Subject
- Reference Start Date (RFSTDTC from the Demographics
- domain).][All Study Day values are integers. Thus, to
- calculate Study Day: --DY = (date portion of --DTC) - (date
- portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
- = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.]'
+ - Cited Guidance:
+ "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1. They are determined
+ by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC)
+ to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All
+ Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across
+ all domains.]"
Document: IG v3.2
Section: 4.1.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0222
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1. They are determined by comparing the
- date portion of the respective date/time variables (--DTC,
- --STDTC, and --ENDTC) to the date portion of the Subject
- Reference Start Date (RFSTDTC from the Demographics
- domain).][All Study Day values are integers. Thus, to
- calculate Study Day: --DY = (date portion of --DTC) - (date
- portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
- = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.]'
+ - Cited Guidance:
+ "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1. They are determined
+ by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC)
+ to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All
+ Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across
+ all domains.]"
Document: IG v3.3
Section: 4.4.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0222
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1. They are determined by comparing the
- date portion of the respective date/time variables (--DTC,
- --STDTC, and --ENDTC) to the date portion of the Subject
- Reference Start Date (RFSTDTC from the Demographics
- domain).][All Study Day values are integers. Thus, to
- calculate Study Day; --DY = (date portion of --DTC) - (date
- portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
- = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC
- precedes RFSTDTC. This algorithm should be used across all
- domains.'
+ - Cited Guidance:
+ "The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative
+ day of the observation starting with the reference date as Day 1. They are determined by comparing
+ the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the
+ date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All
+ Study Day values are integers. Thus, to calculate Study Day; --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC)
+ - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across
+ all domains."
Document: TIG 1.0
Item: Num 1
Section: 2.8.7.6
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0436
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
# - name: --ENDY
@@ -112,7 +100,7 @@ Check:
Core:
Id: CORE-000553
Status: Published
- Version: '1'
+ Version: "1"
Description: Study day must be calculated using the algorithm detailed in the SDTMIG.
Executability: Fully Executable
Match Datasets:
diff --git a/Published/CORE-000554/rule.yml b/Published/CORE-000554/rule.yml
index 20630db4e..9e03ed382 100644
--- a/Published/CORE-000554/rule.yml
+++ b/Published/CORE-000554/rule.yml
@@ -6,25 +6,25 @@ Authorities:
- Citations:
- Cited Guidance: If RSTGCD has the value of UNPLAN, then RSTAGE should be null.
Document: IG-DART v1.1
- Section: '4.1.1'
+ Section: "4.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND350
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- Cited Guidance: If RSTGCD has the value of UNPLAN, then RSTAGE should be null.
Document: IG-DART v1.2
- Section: '4.1.1'
+ Section: "4.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND350
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
@@ -36,7 +36,7 @@ Check:
Core:
Id: CORE-000554
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when RSTGCD is 'UNPLAN' and RPHASE is populated
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000555/rule.yml b/Published/CORE-000555/rule.yml
index 8c8584afd..01e567d17 100644
--- a/Published/CORE-000555/rule.yml
+++ b/Published/CORE-000555/rule.yml
@@ -4,81 +4,75 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths
- only)
+ - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only)
Document: SENDIG v3.0
Section: 6.3.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND163
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths
- only)
+ - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only)
Document: SENDIG v3.1
Section: 6.3.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND163
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths
- only)
+ - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only)
Document: SENDIG v3.1.1
Section: 6.3.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND163
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths
- only)
+ - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only)
Document: SENDIG v3.1
Section: 6.3.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND163
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths
- only)
+ - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only)
Document: SENDIG v3.1.1
Section: 6.3.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND163
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths
- only)
+ - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only)
Document: SENDIG v3.1.1
Section: 6.3.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND163
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
# Implemented as uniqueness of DDORRES and/or DDSTRESC per USUBJID
@@ -96,14 +90,13 @@ Check:
Core:
Id: CORE-000555
Status: Published
- Version: '1'
-Description: Raise an error when there is more than one record present the
- combination of USUBJID and DDORRES or for the combination of USUBJID and
- DDSTRESC.
+ Version: "1"
+Description: Raise an error when there is more than one record present the combination of USUBJID
+ and DDORRES or for the combination of USUBJID and DDSTRESC.
Executability: Fully Executable
Outcome:
- Message: There is more than one for the combination of USUBJID and DDORRES or
- the combination of USUBJID and DDSTRESC
+ Message: There is more than one for the combination of USUBJID and DDORRES or the combination of
+ USUBJID and DDSTRESC
Output Variables:
- USUBJID
- DDORRES
diff --git a/Published/CORE-000556/rule.yml b/Published/CORE-000556/rule.yml
index c30c6df74..2a6fb074a 100644
--- a/Published/CORE-000556/rule.yml
+++ b/Published/CORE-000556/rule.yml
@@ -4,81 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One
- record per subject per pool,
+ - Cited Guidance:
+ pooldef.xpt, Pooled Definition - Relationship Datasets. One record per
+ subject per pool,
Document: IG v3.0
Section: 8.7.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND262
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One
- record per subject per pool,
+ - Cited Guidance:
+ pooldef.xpt, Pooled Definition - Relationship Datasets. One record per
+ subject per pool,
Document: IG v3.1
Section: 8.5.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND262.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One
- record per subject per pool,
+ - Cited Guidance:
+ pooldef.xpt, Pooled Definition - Relationship Datasets. One record per
+ subject per pool,
Document: IG v3.1.1
Section: 8.5.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND262.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One
- record per subject per pool,
+ - Cited Guidance:
+ pooldef.xpt, Pooled Definition - Relationship Datasets. One record per
+ subject per pool,
Document: IG v3.1
Section: 8.5.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND262.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One
- record per subject per pool,
+ - Cited Guidance:
+ pooldef.xpt, Pooled Definition - Relationship Datasets. One record per
+ subject per pool,
Document: IG v3.1.1
Section: 8.5.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND262.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One
- record per subject per pool,
+ - Cited Guidance:
+ pooldef.xpt, Pooled Definition - Relationship Datasets. One record per
+ subject per pool,
Document: IG v3.1.1
Section: 8.5.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND262.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: POOLID
@@ -87,12 +93,11 @@ Check:
Core:
Id: CORE-000556
Status: Published
- Version: '1'
-Description: 'Generate a message when the there are duplicate combinations of
- USUBJID and POOLID'
+ Version: "1"
+Description: "Generate a message when the there are duplicate combinations of USUBJID and POOLID"
Executability: Fully Executable
Outcome:
- Message: 'A duplicate combination of USUBJID and POOLID was found'
+ Message: "A duplicate combination of USUBJID and POOLID was found"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000557/rule.yml b/Published/CORE-000557/rule.yml
index 3fc357da9..107627abd 100644
--- a/Published/CORE-000557/rule.yml
+++ b/Published/CORE-000557/rule.yml
@@ -5,105 +5,109 @@ Authorities:
References:
- Citations:
- Cited Guidance: RELTYPE; Identifies the hierarchical level of the records in the
- relationship. Values should be either ONE or MANY, only when
- --SPID is used. However, values are only necessary when
- identifying a relationship between datasets.
+ relationship. Values should be either ONE or MANY, only when --SPID is used. However,
+ values are only necessary when identifying a relationship between datasets.
Document: SENDIG v3.0
Item: RELTYPE CDISC Notes
Section: 8.3.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND253'
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Id: "SEND253"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL
- are null; RELTYPE is populated)
+ - Cited Guidance:
+ Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null;
+ RELTYPE is populated)
Document: SENDIG v3.1
Item: Assumption 4
Section: 8.2.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND253.1'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND253.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL
- are null; RELTYPE is populated)
+ - Cited Guidance:
+ Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null;
+ RELTYPE is populated)
Document: SENDIG v3.1.1
Item: Assumption 4
Section: 8.2.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND253.1'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND253.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL
- are null; RELTYPE is populated)
+ - Cited Guidance:
+ Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null;
+ RELTYPE is populated)
Document: SENDIG v3.1
Item: Assumption 4
Section: 8.2.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND253.1'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND253.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL
- are null; RELTYPE is populated)
+ - Cited Guidance:
+ Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null;
+ RELTYPE is populated)
Document: SENDIG v3.1.1
Item: Assumption 4
Section: 8.2.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND253.1'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND253.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL
- are null; RELTYPE is populated)
+ - Cited Guidance:
+ Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null;
+ RELTYPE is populated)
Document: SENDIG v3.1.1
Item: Assumption 4
Section: 8.2.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND253.1'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND253.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The variable RELTYPE will identify the type of relationship
- between the datasets (e.g., a one-to-one or parent-child
- relationship). The allowable values for RELYPE are ONE and
- MANY per CDISC Controlled Terminology.
+ - Cited Guidance:
+ The variable RELTYPE will identify the type of relationship between the
+ datasets (e.g., a one-to-one or parent-child relationship). The allowable values for
+ RELYPE are ONE and MANY per CDISC Controlled Terminology.
Document: TIG v1.0
Item: Text
Section: 2.8.5.2
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0171
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
# We must take into account that POOLID is "permissible" and may be absent
# USUBJID is "expected" and the column must then always be present
Check:
@@ -121,8 +125,9 @@ Check:
value: ONE
- name: RELTYPE
operator: not_equal_to
- value: MANY
- # Case that the POOLID column is present
+ value:
+ MANY
+ # Case that the POOLID column is present
- all:
- name: USUBJID
operator: empty
@@ -141,13 +146,12 @@ Check:
Core:
Id: CORE-000557
Status: Published
- Version: '1'
-Description: When USUBJID, POOLID, and IDVARVAL are empty, RELTYPE can only be
- "ONE" or "MANY"
+ Version: "1"
+Description: When USUBJID, POOLID, and IDVARVAL are empty, RELTYPE can only be "ONE" or "MANY"
Executability: Fully Executable
Outcome:
- Message: For RELTYPE, only "ONE" and "MANY" are allowed when USUBJID, POOLID,
- and IDVARVAL are null
+ Message: For RELTYPE, only "ONE" and "MANY" are allowed when USUBJID, POOLID, and IDVARVAL are
+ null
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000558/rule.yml b/Published/CORE-000558/rule.yml
index 11ae4803e..198775de1 100644
--- a/Published/CORE-000558/rule.yml
+++ b/Published/CORE-000558/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND72.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND72.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -34,9 +34,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND72.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -46,9 +46,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND72.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -58,9 +58,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND72.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -70,9 +70,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND72.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
@@ -83,10 +83,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0273
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
any:
#- name: --DY
@@ -107,7 +107,7 @@ Check:
Core:
Id: CORE-000558
Status: Published
- Version: '1'
+ Version: "1"
Description: --DY must be a non-zero integer
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000559/rule.yml b/Published/CORE-000559/rule.yml
index cedcfac07..6a538cbfa 100644
--- a/Published/CORE-000559/rule.yml
+++ b/Published/CORE-000559/rule.yml
@@ -4,93 +4,93 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.0
Item: Specification
Section: 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND224
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1
Item: Specification
Section: 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND224
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1.1
Item: Specification
Section: 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND224
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1
Item: Specification
Section: 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND224
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1.1
Item: Specification
Section: 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND224
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1.1
Item: Specification
Section: 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND224
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
- all:
@@ -108,12 +108,11 @@ Check:
Core:
Id: CORE-000559
Status: Published
- Version: '1'
-Description: When study does not use multi-stage arm assignments and ARMCD is
- populated, ARMCD must be present in TA.ARMCD. This rule has been executed to
- identify all cases when ARMCD is not present in TA.ARMCD and therefore
- acknowledges that false positives may be recorded when multi-stage arm
- assignments are in use.
+ Version: "1"
+Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must
+ be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not
+ present in TA.ARMCD and therefore acknowledges that false positives may be recorded when
+ multi-stage arm assignments are in use.
Executability: Fully Executable
Operations:
- domain: TA
diff --git a/Published/CORE-000560/rule.yml b/Published/CORE-000560/rule.yml
index 84f1bf6ee..f1d98c28c 100644
--- a/Published/CORE-000560/rule.yml
+++ b/Published/CORE-000560/rule.yml
@@ -4,83 +4,83 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: ADSL and its related metadata are required in a CDISC-based
- submission of data from a clinical trial even if no other
- analysis datasets are submitted.
+ - Cited Guidance:
+ ADSL and its related metadata are required in a CDISC-based submission of
+ data from a clinical trial even if no other analysis datasets are submitted.
Document: Model v2.1
- Section: '6'
- - Cited Guidance: ADSL contains one record per subject, regardless of the type of
- clinical trial design. The label of the ADSL dataset is
- "Subject-Level Analysis Dataset." In a study, there is only
- one dataset in the class of "SUBJECT LEVEL ANALYSIS DATASET",
- and its name is ADSL.
+ Section: "6"
+ - Cited Guidance:
+ ADSL contains one record per subject, regardless of the type of clinical
+ trial design. The label of the ADSL dataset is "Subject-Level Analysis Dataset." In a
+ study, there is only one dataset in the class of "SUBJECT LEVEL ANALYSIS DATASET", and its
+ name is ADSL.
Document: ADaM IG v1.3
Section: 2.3.1
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '1'
- Version: '1'
- Version: '5.0'
- Version: '1.3'
+ Id: "1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: ADSL and its related metadata are required in a CDISC-based
- submission of data from a clinical trial even if no other
- analysis datasets are submitted.
+ - Cited Guidance:
+ ADSL and its related metadata are required in a CDISC-based submission of
+ data from a clinical trial even if no other analysis datasets are submitted.
Document: Model v2.1
- Section: '6'
- - Cited Guidance: ADSL contains one record per subject, regardless of the type of
- clinical trial design. The label of the ADSL dataset is
- "Subject-Level Analysis Dataset." In a study, there is only
- one dataset in the class of "SUBJECT LEVEL ANALYSIS DATASET",
- and its name is ADSL.
+ Section: "6"
+ - Cited Guidance:
+ ADSL contains one record per subject, regardless of the type of clinical
+ trial design. The label of the ADSL dataset is "Subject-Level Analysis Dataset." In a
+ study, there is only one dataset in the class of "SUBJECT LEVEL ANALYSIS DATASET", and its
+ name is ADSL.
Document: ADaM IG v1.2
Section: 2.3.1
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '1'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: ADSL and its related metadata are required in a CDISC-based
- submission of data from a clinical trial even if no other
- analysis datasets are submitted.
+ - Cited Guidance:
+ ADSL and its related metadata are required in a CDISC-based submission of
+ data from a clinical trial even if no other analysis datasets are submitted.
Document: Model v2.1
- Section: '6'
- - Cited Guidance: ADSL and its related metadata are required in a CDISC-based
- submission of data from a clinical trial even if no other
- analysis datasets are submitted.
+ Section: "6"
+ - Cited Guidance:
+ ADSL and its related metadata are required in a CDISC-based submission of
+ data from a clinical trial even if no other analysis datasets are submitted.
Document: ADaM IG v1.1
Section: 2.3.1
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '1'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: ADSL and its related metadata are required in a CDISC-based
- submission of data from a clinical trial even if no other
- analysis datasets are submitted.
+ - Cited Guidance:
+ ADSL and its related metadata are required in a CDISC-based submission of
+ data from a clinical trial even if no other analysis datasets are submitted.
Document: Model v2.1
- Section: '6'
- - Cited Guidance: ADSL and its related metadata are required in a CDISC-based
- submission of data from a clinical trial even if no other
- analysis datasets are submitted.
+ Section: "6"
+ - Cited Guidance:
+ ADSL and its related metadata are required in a CDISC-based submission of
+ data from a clinical trial even if no other analysis datasets are submitted.
Document: ADaM IG v1.0
Section: 2.3.1
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '1'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: ADSL
@@ -88,7 +88,7 @@ Check:
Core:
Id: CORE-000560
Status: Published
- Version: '1'
+ Version: "1"
Description: The ADSL dataset must exist
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000561/rule.yml b/Published/CORE-000561/rule.yml
index 8745f3767..f860ea678 100644
--- a/Published/CORE-000561/rule.yml
+++ b/Published/CORE-000561/rule.yml
@@ -89,7 +89,7 @@ Check:
- USUBJID
- TFSPEC
- TFANTREG
- # case that TFANTREG is not present
+ # case that TFANTREG is not present
- all:
- name: TFANTREG
operator: not_exists
@@ -103,8 +103,8 @@ Core:
Id: CORE-000561
Status: Published
Version: "1"
-Description: Raise an error when there is more than one record present for any
- particular tumor test result for a subject and specimen.
+Description: Raise an error when there is more than one record present for any particular tumor test
+ result for a subject and specimen.
Executability: Fully Executable
Outcome:
Message: The Tumor Findings test result is not unique for this subject and specimen.
diff --git a/Published/CORE-000567/rule.yml b/Published/CORE-000567/rule.yml
index 51467c0f8..adc680e42 100644
--- a/Published/CORE-000567/rule.yml
+++ b/Published/CORE-000567/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND143
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND143
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -34,8 +34,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND143
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
@@ -46,9 +46,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND143
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
@@ -58,9 +58,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND143
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -70,9 +70,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND143
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: TIG
References:
- Citations:
@@ -83,10 +83,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0079
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --STAT
@@ -97,9 +97,9 @@ Check:
Core:
Id: CORE-000567
Status: Published
- Version: '1'
-Description: Trigger error when --STAT is non-empty and does not contain a value
- from the ND codelist
+ Version: "1"
+Description: Trigger error when --STAT is non-empty and does not contain a value from the ND
+ codelist
Executability: Fully Executable
Outcome:
Message: --STAT does not contain a value from the (ND) codelist
diff --git a/Published/CORE-000568/rule.yml b/Published/CORE-000568/rule.yml
index 092de58cd..84c018181 100644
--- a/Published/CORE-000568/rule.yml
+++ b/Published/CORE-000568/rule.yml
@@ -4,96 +4,103 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: IG v3.0
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND145
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: IG v3.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND145
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: IG v3.1.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND145
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: IG v3.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND145
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: IG v3.1.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND145
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: IG v3.1.1
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND145
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: TIG v1.0
Item: BWSTAT CDISC Notes
Section: 2.8.9.9
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0081
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --ORRES
@@ -103,7 +110,7 @@ Check:
Core:
Id: CORE-000568
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when --ORRES is populated and --STAT is populated
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000569/rule.yml b/Published/CORE-000569/rule.yml
index 994abc608..9a18af75b 100644
--- a/Published/CORE-000569/rule.yml
+++ b/Published/CORE-000569/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND30
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND30
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -34,8 +34,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND30
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
@@ -46,9 +46,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND30
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -58,9 +58,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND30
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -70,9 +70,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND30
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
@@ -83,10 +83,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0212
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: variable_name
@@ -95,7 +95,7 @@ Check:
Core:
Id: CORE-000569
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when variable name is not in uppercase
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000570/rule.yml b/Published/CORE-000570/rule.yml
index ccc1cbc8c..66e6f0dfb 100644
--- a/Published/CORE-000570/rule.yml
+++ b/Published/CORE-000570/rule.yml
@@ -4,87 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier
- (POOLID) is Required in all datasets containing subject-level
- or pool-level data, respectively.
+ - Cited Guidance:
+ The unique subject identifier (USUBJID) or pool identifier (POOLID) is
+ Required in all datasets containing subject-level or pool-level data, respectively.
Document: IG v3.0
Section: 4.2.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND36
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier
- (POOLID) is Required in all datasets containing subject-level
- or pool-level data, respectively.
+ - Cited Guidance:
+ The unique subject identifier (USUBJID) or pool identifier (POOLID) is
+ Required in all datasets containing subject-level or pool-level data, respectively.
Document: IG v3.1
Section: 4.2.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND36
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier
- (POOLID) is Required in all datasets containing subject-level
- or pool-level data, respectively.
+ - Cited Guidance:
+ The unique subject identifier (USUBJID) or pool identifier (POOLID) is
+ Required in all datasets containing subject-level or pool-level data, respectively.
Document: IG v3.1.1
Section: 4.2.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND36
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier
- (POOLID) is Required in all datasets containing subject-level
- or pool-level data, respectively.
+ - Cited Guidance:
+ The unique subject identifier (USUBJID) or pool identifier (POOLID) is
+ Required in all datasets containing subject-level or pool-level data, respectively.
Document: IG v3.1
Section: 4.2.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND36
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier
- (POOLID) is Required in all datasets containing subject-level
- or pool-level data, respectively.
+ - Cited Guidance:
+ The unique subject identifier (USUBJID) or pool identifier (POOLID) is
+ Required in all datasets containing subject-level or pool-level data, respectively.
Document: IG v3.1.1
Section: 4.2.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND36
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier
- (POOLID) is Required in all datasets containing subject-level
- or pool-level data, respectively.
+ - Cited Guidance:
+ The unique subject identifier (USUBJID) or pool identifier (POOLID) is
+ Required in all datasets containing subject-level or pool-level data, respectively.
Document: IG v3.1.1
Section: 4.2.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND36
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: USUBJID
@@ -94,7 +94,7 @@ Check:
Core:
Id: CORE-000570
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when both USUBJID and POOLID are empty
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000571/rule.yml b/Published/CORE-000571/rule.yml
index 7b60669ed..a8a5d3d93 100644
--- a/Published/CORE-000571/rule.yml
+++ b/Published/CORE-000571/rule.yml
@@ -7,71 +7,70 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: --LNKID is a grouping identifier used to identify a record in
- one domain that is related to records in another domain, often
- forming a one-to-many relationship.
+ - Cited Guidance:
+ --LNKID is a grouping identifier used to identify a record in one domain
+ that is related to records in another domain, often forming a one-to-many relationship.
Document: IG v3.4
Item: 2.E.1
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0024
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: --LNKID is a grouping identifier used to identify a record in
- one domain that is related to records in another domain, often
- forming a one-to-many relationship.
+ - Cited Guidance:
+ --LNKID is a grouping identifier used to identify a record in one domain
+ that is related to records in another domain, often forming a one-to-many relationship.
Document: IG v3.3
Item: 2.E.1
Section: 4.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0024
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Identifier used to link related records across domains.
Document: IG v3.2
Item: Specification
- Section: '6.1'
+ Section: "6.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0024
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: A sequence of characters used to uniquely identify a record, for
- a subject, in one domain and link it to 1 or more records for
- that subject in another domain.
+ - Cited Guidance:
+ A sequence of characters used to uniquely identify a record, for a subject,
+ in one domain and link it to 1 or more records for that subject in another domain.
Document: SDTM v2.1
Item: -LNKID, Definition column
Section: SDTM 3.1.4 Identifiers for All Classes
- - Cited Guidance: Groups of records can be related by using grouping variables
- such as --LNKID or --LNKGRP in IDVAR. Using --LNKID or
- --LNKGRP can be a more efficient method of representing
- relationships in RELREC when relating a single or group of
- records in one dataset to a group of records in another
- dataset.
+ - Cited Guidance:
+ Groups of records can be related by using grouping variables such as --LNKID
+ or --LNKGRP in IDVAR. Using --LNKID or --LNKGRP can be a more efficient method of
+ representing relationships in RELREC when relating a single or group of records in one
+ dataset to a group of records in another dataset.
Document: TIG v1.0
Item: -LNKID, Definition column
Section: 2.8.5.2
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0307
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --LNKID
@@ -82,9 +81,8 @@ Check:
Core:
Id: "CORE-000571"
Status: Published
- Version: '1'
-Description: Verify that when --LNKID is present in one domain it is also
- present in another domain.
+ Version: "1"
+Description: Verify that when --LNKID is present in one domain it is also present in another domain.
Executability: Fully Executable
Operations:
- id: $VARIABLE_COUNT
diff --git a/Published/CORE-000572/rule.yml b/Published/CORE-000572/rule.yml
index e7223371e..d70a78f71 100644
--- a/Published/CORE-000572/rule.yml
+++ b/Published/CORE-000572/rule.yml
@@ -4,85 +4,77 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "If the reference time point is prior to the date of collection
- or assessment: Start values: an observation can start BEFORE
- the reference point, can start COINCIDENT with the reference
- point, can start AFTER the reference point, or it may not be
- known (U) when it started. End values: an observation can end
- BEFORE the reference point, can end COINCIDENT with the
- reference point, can end AFTER the reference point, can be
- known that it didn't end but was ONGOING, or it is unknown (U)
- when it ended or if it was ongoing."
+ - Cited Guidance:
+ "If the reference time point is prior to the date of collection or assessment:
+ Start values: an observation can start BEFORE the reference point, can start COINCIDENT with
+ the reference point, can start AFTER the reference point, or it may not be known (U) when it
+ started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with
+ the reference point, can end AFTER the reference point, can be known that it didn't end but
+ was ONGOING, or it is unknown (U) when it ended or if it was ongoing."
Document: IG v3.4
Section: 4.4.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0235
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "If the reference time point is prior to the date of collection
- or assessment: Start values: an observation can start BEFORE
- the reference point, can start COINCIDENT with the reference
- point, can start AFTER the reference point, or it may not be
- known (U) when it started. End values: an observation can end
- BEFORE the reference point, can end COINCIDENT with the
- reference point, can end AFTER the reference point, can be
- known that it didn't end but was ONGOING, or it is unknown (U)
- when it ended or if it was ongoing."
+ - Cited Guidance:
+ "If the reference time point is prior to the date of collection or assessment:
+ Start values: an observation can start BEFORE the reference point, can start COINCIDENT with
+ the reference point, can start AFTER the reference point, or it may not be known (U) when it
+ started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with
+ the reference point, can end AFTER the reference point, can be known that it didn't end but
+ was ONGOING, or it is unknown (U) when it ended or if it was ongoing."
Document: IG v3.2
Section: 4.1.4.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0235
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "If the reference time point is prior to the date of collection
- or assessment: Start values: an observation can start BEFORE
- the reference point, can start COINCIDENT with the reference
- point, can start AFTER the reference point, or it may not be
- known (U) when it started. End values: an observation can end
- BEFORE the reference point, can end COINCIDENT with the
- reference point, can end AFTER the reference point, can be
- known that it didn't end but was ONGOING, or it is unknown (U)
- when it ended or if it was ongoing."
+ - Cited Guidance:
+ "If the reference time point is prior to the date of collection or assessment:
+ Start values: an observation can start BEFORE the reference point, can start COINCIDENT with
+ the reference point, can start AFTER the reference point, or it may not be known (U) when it
+ started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with
+ the reference point, can end AFTER the reference point, can be known that it didn't end but
+ was ONGOING, or it is unknown (U) when it ended or if it was ongoing."
Document: IG v3.3
Section: 4.4.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0235
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: "If the reference time point is prior to the date of collection
- or assessment; Start values; an observation can start BEFORE
- the reference point, can start COINCIDENT with the reference
- point, can start AFTER the reference point, or it may not be
- known (U) when it started. End values; an observation can end
- BEFORE the reference point, can end COINCIDENT with the
- reference point, can end AFTER the reference point, can be
- known that it didn't end but was ONGOING, or it is unknown (U)
- when it ended or if it was ongoing."
+ - Cited Guidance:
+ "If the reference time point is prior to the date of collection or assessment;
+ Start values; an observation can start BEFORE the reference point, can start COINCIDENT with
+ the reference point, can start AFTER the reference point, or it may not be known (U) when it
+ started. End values; an observation can end BEFORE the reference point, can end COINCIDENT with
+ the reference point, can end AFTER the reference point, can be known that it didn't end but
+ was ONGOING, or it is unknown (U) when it ended or if it was ongoing."
Document: TIG 1.0
Item: Num 3
Section: 2.8.7.6
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0444
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
# Variable: --ENRTPT
# Condition: --ENTPT is prior to the date of collection or assessment.
# Rule: --ENRTPT in ('BEFORE', 'COINCIDENT', 'ONGOING', 'AFTER', 'UNKNOWN')
@@ -108,9 +100,9 @@ Check:
Core:
Id: CORE-000572
Status: Published
- Version: '1'
-Description: Trigger error when --ENRTPT is not in ('BEFORE', 'COINCIDENT',
- 'ONGOING', 'AFTER', 'UNKNOWN')
+ Version: "1"
+Description: Trigger error when --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'AFTER',
+ 'UNKNOWN')
Executability: Partially Executable
Outcome:
Message: --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'AFTER', 'UNKNOWN')
diff --git a/Published/CORE-000573/rule.yml b/Published/CORE-000573/rule.yml
index dc183bb1c..d00b62873 100644
--- a/Published/CORE-000573/rule.yml
+++ b/Published/CORE-000573/rule.yml
@@ -4,87 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: In the event that no records are present in a dataset, the empty
- dataset should not be submitted and should not be described in
- the data definition file.
+ - Cited Guidance:
+ In the event that no records are present in a dataset, the empty dataset
+ should not be submitted and should not be described in the data definition file.
Document: SENDIG v3.0
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND278
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: In the event that no records are present in a dataset, the empty
- dataset should not be submitted and should not be described in
- the data definition file.
+ - Cited Guidance:
+ In the event that no records are present in a dataset, the empty dataset
+ should not be submitted and should not be described in the data definition file.
Document: SENDIG v3.1
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND278
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: In the event that no records are present in a dataset, the empty
- dataset should not be submitted and should not be described in
- the data definition file.
+ - Cited Guidance:
+ In the event that no records are present in a dataset, the empty dataset
+ should not be submitted and should not be described in the data definition file.
Document: SENDIG v3.1.1
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND278
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: In the event that no records are present in a dataset, the empty
- dataset should not be submitted and should not be described in
- the data definition file.
+ - Cited Guidance:
+ In the event that no records are present in a dataset, the empty dataset
+ should not be submitted and should not be described in the data definition file.
Document: SENDIG v3.1
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND278
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: In the event that no records are present in a dataset, the empty
- dataset should not be submitted and should not be described in
- the data definition file.
+ - Cited Guidance:
+ In the event that no records are present in a dataset, the empty dataset
+ should not be submitted and should not be described in the data definition file.
Document: SENDIG v3.1.1
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND278
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: In the event that no records are present in a dataset, the empty
- dataset should not be submitted and should not be described in
- the data definition file.
+ - Cited Guidance:
+ In the event that no records are present in a dataset, the empty dataset
+ should not be submitted and should not be described in the data definition file.
Document: SENDIG v3.1.1
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND278
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: $record_count
@@ -93,7 +93,7 @@ Check:
Core:
Id: CORE-000573
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when a dataset has no records
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000575/rule.yml b/Published/CORE-000575/rule.yml
index e15223aef..dc0394f4b 100644
--- a/Published/CORE-000575/rule.yml
+++ b/Published/CORE-000575/rule.yml
@@ -4,68 +4,65 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component
- of all SDTM subject-level domain datasets. In general, all
- domains based on the three general observation classes should
- have at least one Timing variable. In the Events or
- Interventions general observation class, this could be the
- start date of the event or intervention. In the Findings
- observation class, where data are usually collected at
+ - Cited Guidance:
+ Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM
+ subject-level domain datasets. In general, all domains based on the three general
+ observation classes should have at least one Timing variable. In the Events or
+ Interventions general observation class, this could be the start date of the event or
+ intervention. In the Findings observation class, where data are usually collected at
multiple visits, at least one Timing variable must be used.
Document: IG v3.4
- Section: '4.4'
+ Section: "4.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0219
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: In general, all domains based on the three general observation
- classes should have at least one Timing variable. in the
- Events or Interventions general observation class this could
- be the start date of the event or intervention. in the
- Findings observation class where data are usually collected at
- multiple visits, at least one Timing variable must be used.
+ - Cited Guidance:
+ In general, all domains based on the three general observation classes
+ should have at least one Timing variable. in the Events or Interventions general
+ observation class this could be the start date of the event or intervention. in the
+ Findings observation class where data are usually collected at multiple visits, at least
+ one Timing variable must be used.
Document: IG v3.2
Section: 4.1.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0219
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component
- of all SDTM subject-level domain datasets. In general, all
- domains based on the three general observation classes should
- have at least one Timing variable. In the Events or
- Interventions general observation class, this could be the
- start date of the event or intervention. In the Findings
- observation class, where data are usually collected at
+ - Cited Guidance:
+ Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM
+ subject-level domain datasets. In general, all domains based on the three general
+ observation classes should have at least one Timing variable. In the Events or
+ Interventions general observation class, this could be the start date of the event or
+ intervention. In the Findings observation class, where data are usually collected at
multiple visits, at least one Timing variable must be used.
Document: IG v3.3
- Section: '4.4'
+ Section: "4.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0219
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an
- essential component of all SDTM subject-level domain
- datasets. In general, all domains based on the three general
- observation classes should have at least one Timing variable.
- In the Events or Interventions general observation class this
- could be the start date of the event or intervention. In the
- Findings observation class where data are usually collected at
+ - Cited Guidance:
+ Timing variables (SDTM Table 2.2.5) are an essential component of all
+ SDTM subject-level domain datasets. In general, all domains based on the three general
+ observation classes should have at least one Timing variable. In the Events or
+ Interventions general observation class this could be the start date of the event or
+ intervention. In the Findings observation class where data are usually collected at
multiple study days, either --DTC or --DY must beused.
Document: SENDIG v3.0
Item: Text
@@ -73,138 +70,135 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND65
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component
- of all SDTM subject-level domain datasets. In general, all
- domains based on the three general observation classes should
- have at least one Timing variable. In the Events or
- Interventions general observation class this could be the
- start date of the event or intervention. In the Findings
- observation class where data are usually collected at multiple
- study days, either --DTC or --DY must be used.
+ - Cited Guidance:
+ Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM
+ subject-level domain datasets. In general, all domains based on the three general
+ observation classes should have at least one Timing variable. In the Events or
+ Interventions general observation class this could be the start date of the event or
+ intervention. In the Findings observation class where data are usually collected at
+ multiple study days, either --DTC or --DY must be used.
Document: SENDIG v3.1
Item: Text
Section: 4.4.
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND65
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component
- of all SDTM subject-level domain datasets. In general, all
- domains based on the three general observation classes should
- have at least one Timing variable. In the Events or
- Interventions general observation class this could be the
- start date of the event or intervention. In the Findings
- observation class where data are usually collected at multiple
- study days, either --DTC or --DY must be used.
+ - Cited Guidance:
+ Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM
+ subject-level domain datasets. In general, all domains based on the three general
+ observation classes should have at least one Timing variable. In the Events or
+ Interventions general observation class this could be the start date of the event or
+ intervention. In the Findings observation class where data are usually collected at
+ multiple study days, either --DTC or --DY must be used.
Document: SENDIG v3.1.1
Item: Text
Section: 4.4.
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND65
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component
- of all SDTM subject-level domain datasets. In general, all
- domains based on the three general observation classes should
- have at least one Timing variable. In the Events or
- Interventions general observation class this could be the
- start date of the event or intervention. In the Findings
- observation class where data are usually collected at multiple
- study days, either --DTC or --DY must be used.
+ - Cited Guidance:
+ Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM
+ subject-level domain datasets. In general, all domains based on the three general
+ observation classes should have at least one Timing variable. In the Events or
+ Interventions general observation class this could be the start date of the event or
+ intervention. In the Findings observation class where data are usually collected at
+ multiple study days, either --DTC or --DY must be used.
Document: SENDIG v3.1
Item: Text
Section: 4.4.
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND65
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component
- of all SDTM subject-level domain datasets. In general, all
- domains based on the three general observation classes should
- have at least one Timing variable. In the Events or
- Interventions general observation class this could be the
- start date of the event or intervention. In the Findings
- observation class where data are usually collected at multiple
- study days, either --DTC or --DY must be used.
+ - Cited Guidance:
+ Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM
+ subject-level domain datasets. In general, all domains based on the three general
+ observation classes should have at least one Timing variable. In the Events or
+ Interventions general observation class this could be the start date of the event or
+ intervention. In the Findings observation class where data are usually collected at
+ multiple study days, either --DTC or --DY must be used.
Document: SENDIG v3.1.1
Section: 4.4.
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND65
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component
- of all SDTM subject-level domain datasets. In general, all
- domains based on the three general observation classes should
- have at least one Timing variable. In the Events or
- Interventions general observation class this could be the
- start date of the event or intervention. In the Findings
- observation class where data are usually collected at multiple
- study days, either --DTC or --DY must be used.
+ - Cited Guidance:
+ Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM
+ subject-level domain datasets. In general, all domains based on the three general
+ observation classes should have at least one Timing variable. In the Events or
+ Interventions general observation class this could be the start date of the event or
+ intervention. In the Findings observation class where data are usually collected at
+ multiple study days, either --DTC or --DY must be used.
Document: SENDIG v3.1.1
Item: Text
Section: 4.4.
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND65
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Include the applicable SDTM Timing variables. In general, the
- domain must have at least one timing variable.
+ - Cited Guidance:
+ Include the applicable SDTM Timing variables. In general, the domain must
+ have at least one timing variable.
Document: TIG v1.0
Item: 4d
Section: 2.8.3 How to Create New Specifications
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0266
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Include the applicable SDTM Timing variables. In general, the
- domain must have at least one timing variable.
+ - Cited Guidance:
+ Include the applicable SDTM Timing variables. In general, the domain must
+ have at least one timing variable.
Document: TIG v1.0
Item: 4d
Section: 2.8.3
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0433
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: $dataset_variables
@@ -213,9 +207,9 @@ Check:
Core:
Id: CORE-000575
Status: Published
- Version: '1'
-Description: There must be at least one timing variable for any of the domains
- based on the three general observation classes
+ Version: "1"
+Description: There must be at least one timing variable for any of the domains based on the three
+ general observation classes
Executability: Partially Executable - Possible Underreporting
Operations:
- id: $dataset_variables
diff --git a/Published/CORE-000576/rule.yml b/Published/CORE-000576/rule.yml
index e1086c3d6..d878db550 100644
--- a/Published/CORE-000576/rule.yml
+++ b/Published/CORE-000576/rule.yml
@@ -4,118 +4,121 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Numeric representation of the planned test article dose level.
- For dose levels that vary over time within a set, a
- semicolon-delimited string without spaces can be used (e.g.,
- 100;150;7). For more complex dosing regimens, sponsor should
- enter "SEE PROTOCOL".
+ - Cited Guidance:
+ Numeric representation of the planned test article dose level. For dose
+ levels that vary over time within a set, a semicolon-delimited string without spaces can
+ be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE
+ PROTOCOL".
Document: IG v3.0
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND240.1'
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Id: "SEND240.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Numeric representation of the planned test article dose level.
- For dose levels that vary over time within a set, a
- semicolon-delimited string without spaces can be used (e.g.,
- 100;150;7). For more complex dosing regimens, sponsor should
- enter "SEE PROTOCOL".
+ - Cited Guidance:
+ Numeric representation of the planned test article dose level. For dose
+ levels that vary over time within a set, a semicolon-delimited string without spaces can
+ be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE
+ PROTOCOL".
Document: IG v3.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND240.1'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND240.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Numeric representation of the planned test article dose level.
- For dose levels that vary over time within a set, a
- semicolon-delimited string without spaces can be used (e.g.,
- 100;150;7). For more complex dosing regimens, sponsor should
- enter "SEE PROTOCOL".
+ - Cited Guidance:
+ Numeric representation of the planned test article dose level. For dose
+ levels that vary over time within a set, a semicolon-delimited string without spaces can
+ be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE
+ PROTOCOL".
Document: IG v3.1.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND240.1'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND240.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Numeric representation of the planned test article dose level.
- For dose levels that vary over time within a set, a
- semicolon-delimited string without spaces can be used (e.g.,
- 100;150;7). For more complex dosing regimens, sponsor should
- enter "SEE PROTOCOL".
+ - Cited Guidance:
+ Numeric representation of the planned test article dose level. For dose
+ levels that vary over time within a set, a semicolon-delimited string without spaces can
+ be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE
+ PROTOCOL".
Document: IG v3.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND240.1'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND240.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Numeric representation of the planned test article dose level.
- For dose levels that vary over time within a set, a
- semicolon-delimited string without spaces can be used (e.g.,
- 100;150;7). For more complex dosing regimens, sponsor should
- enter "SEE PROTOCOL".
+ - Cited Guidance:
+ Numeric representation of the planned test article dose level. For dose
+ levels that vary over time within a set, a semicolon-delimited string without spaces can
+ be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE
+ PROTOCOL".
Document: IG v3.1.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND240.1'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND240.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Numeric representation of the planned test article dose level.
- For dose levels that vary over time within a set, a
- semicolon-delimited string without spaces can be used (e.g.,
- 100;150;7). For more complex dosing regimens, sponsor should
- enter "SEE PROTOCOL".
+ - Cited Guidance:
+ Numeric representation of the planned test article dose level. For dose
+ levels that vary over time within a set, a semicolon-delimited string without spaces can
+ be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE
+ PROTOCOL".
Document: IG v3.1.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND240.1'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND240.1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: TXPARMCD
operator: equal_to
- value: TRTDOS
- # check whether value is a number
+ value:
+ TRTDOS
+ # check whether value is a number
- name: TXVAL
operator: not_matches_regex
- value: '[+-]?([0-9]*[.])?[0-9]+$'
- # check whether a comma-separated list of values
+ value:
+ "[+-]?([0-9]*[.])?[0-9]+$"
+ # check whether a comma-separated list of values
- name: TXVAL
- operator: not_matches_regex
- # see https://stackoverflow.com/questions/44374088/regex-to-match-comma-separated-numbers-or-stop-full-match-only
+ operator:
+ not_matches_regex
+ # see https://stackoverflow.com/questions/44374088/regex-to-match-comma-separated-numbers-or-stop-full-match-only
value: ^(\s*-?\d+(\.\d+)?)(\s*;\s*-?\d+(\.\d+)?)*$
- name: TXVAL
operator: not_equal_to
@@ -123,15 +126,13 @@ Check:
Core:
Id: CORE-000576
Status: Published
- Version: '1'
-Description: The value of TRTDOS is either a number, a semicolon-delimited
- string containing numbers without spaces, or "SEE PROTOCOL" for more complex
- dosing regimens.
+ Version: "1"
+Description: The value of TRTDOS is either a number, a semicolon-delimited string containing numbers
+ without spaces, or "SEE PROTOCOL" for more complex dosing regimens.
Executability: Fully Executable
Outcome:
- Message: The value of TXVAL for TXPARMCD=TRTDOS is neither a number, a
- semicolon-delimited string containing numbers without spaces, or "SEE
- PROTOCOL"
+ Message: The value of TXVAL for TXPARMCD=TRTDOS is neither a number, a semicolon-delimited string
+ containing numbers without spaces, or "SEE PROTOCOL"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000577/rule.yml b/Published/CORE-000577/rule.yml
index 6c45f3556..25e7221ca 100644
--- a/Published/CORE-000577/rule.yml
+++ b/Published/CORE-000577/rule.yml
@@ -6,25 +6,25 @@ Authorities:
- Citations:
- Cited Guidance: One record per actual Repro Stage per subject
Document: IG-DART v1.1
- Section: '4.1'
+ Section: "4.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND349
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- Cited Guidance: One record per actual Repro Stage per subject
Document: IG-DART v1.2
- Section: '4.1'
+ Section: "4.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND349
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
@@ -35,7 +35,7 @@ Check:
Core:
Id: CORE-000577
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when RSTGCD is not unique within USUBJID
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000578/rule.yml b/Published/CORE-000578/rule.yml
index e259ceb19..8057e2a49 100644
--- a/Published/CORE-000578/rule.yml
+++ b/Published/CORE-000578/rule.yml
@@ -5,54 +5,58 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If the test result in PCORRES is below the Lower Limit of
- Quantitation as indicated in PCSTRESC, then the PCLLOQ must be
- populated and the PCSTRESU populated with the appropriate unit
+ - Cited Guidance:
+ If the test result in PCORRES is below the Lower Limit of Quantitation as
+ indicated in PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with
+ the appropriate unit
Document: IG v3.1.1
Item: Assumption 7.c
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND331'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND331"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: If the test result in PCORRES is below the Lower Limit of
- Quantitation as indicated in PCSTRESC, then the PCLLOQ must be
- populated and the PCSTRESU populated with the appropriate unit
+ - Cited Guidance:
+ If the test result in PCORRES is below the Lower Limit of Quantitation as
+ indicated in PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with
+ the appropriate unit
Document: IG v3.1.1
Item: Assumption 7.c
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND331'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND331"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If the test result in PCORRES is below the Lower Limit of
- Quantitation as indicated in PCSTRESC, then the PCLLOQ must be
- populated and the PCSTRESU populated with the appropriate unit
+ - Cited Guidance:
+ If the test result in PCORRES is below the Lower Limit of Quantitation as
+ indicated in PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with
+ the appropriate unit
Document: IG v3.1.1
Item: Assumption 7.c
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND331'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND331"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: PCSTRESC
operator: equal_to
- value: 'BLQ'
- # report an error when either PCLLOQ is not populated or PCSTRESU is not populated
+ value:
+ "BLQ"
+ # report an error when either PCLLOQ is not populated or PCSTRESU is not populated
- any:
- name: PCLLOQ
operator: empty
@@ -61,14 +65,13 @@ Check:
Core:
Id: CORE-000578
Status: Published
- Version: '1'
-Description: If the test result in PCORRES is below the Lower Limit of
- Quantitation as indicated in PCSTRESC, then the PCLLOQ must be populated and
- the PCSTRESU populated with the appropriate unit
+ Version: "1"
+Description: If the test result in PCORRES is below the Lower Limit of Quantitation as indicated in
+ PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with the appropriate unit
Executability: Fully Executable
Outcome:
- Message: PCSTRESC has value 'BLQ' (Below level of quantitation), so both PCLLOQ
- and PCSTRESU must be populated
+ Message: PCSTRESC has value 'BLQ' (Below level of quantitation), so both PCLLOQ and PCSTRESU must
+ be populated
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000580/rule.yml b/Published/CORE-000580/rule.yml
index 7da4e8091..ee7822700 100644
--- a/Published/CORE-000580/rule.yml
+++ b/Published/CORE-000580/rule.yml
@@ -4,68 +4,67 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Note that Elements that have different start and end rules are
- different Elements and must have different values of ELEMENT
- and ETCD.
+ - Cited Guidance:
+ Note that Elements that have different start and end rules are different
+ Elements and must have different values of ELEMENT and ETCD.
Document: IG v3.4
Item: Assumption 13
Section: 7.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0325
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Specification[Expresses rule for ending Element. Either TEENRL
- or TEDUR must be present for each Element.]|Assumption 15[Note
- that Elements that have different start and end rules are
- different Elements and must have different values of ELEMENT
- and ETCD.]
+ - Cited Guidance:
+ Specification[Expresses rule for ending Element. Either TEENRL or TEDUR must
+ be present for each Element.]|Assumption 15[Note that Elements that have different start
+ and end rules are different Elements and must have different values of ELEMENT and ETCD.]
Document: IG v3.2
Item: Specification|Assumption 15
- Section: '7.2'
+ Section: "7.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0325
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Note that Elements that have different start and end rules are
- different Elements and must have different values of ELEMENT
- and ETCD.
+ - Cited Guidance:
+ Note that Elements that have different start and end rules are different
+ Elements and must have different values of ELEMENT and ETCD.
Document: IG v3.3
Item: Assumption 15
Section: 7.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0325
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Note that elements that have different start and end rules are
- different elements and must have different values of ELEMENT
- and ETCD.
+ - Cited Guidance:
+ Note that elements that have different start and end rules are different
+ elements and must have different values of ELEMENT and ETCD.
Document: TIG 1.0
Item: Assumption 15
Section: 2.8.10.28
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0495
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
# Variable: ETCD
-# Condition:
+# Condition:
# Rule: The combination of ELEMENT, TESTRL, TEENRL, and TEDUR is unique for each ETCD
Check:
any:
@@ -111,7 +110,7 @@ Check:
Core:
Id: CORE-000580
Status: Published
- Version: '1'
+ Version: "1"
Description: The combination of TESTRL, TEENRL, and TEDUR must be unique for each ETCD.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000581/rule.yml b/Published/CORE-000581/rule.yml
index f039cc676..18b5953f5 100644
--- a/Published/CORE-000581/rule.yml
+++ b/Published/CORE-000581/rule.yml
@@ -7,206 +7,213 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Each study must include 1 standardized set of observations in a
- specific structure; this is the Demographics domain described
- here.
+ - Cited Guidance:
+ Each study must include 1 standardized set of observations in a specific
+ structure; this is the Demographics domain described here.
Document: Model v2.0
Section: Demographics
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0368
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Each study must include one standardized set of observations in
- a specific structure; this is the Demographics domain
- described in Table 2.2.6.
+ - Cited Guidance:
+ Each study must include one standardized set of observations in a specific
+ structure; this is the Demographics domain described in Table 2.2.6.
Document: Model v1.4
Section: 2.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0368
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Each study must include one standardized set of observations in
- a specific structure; this is the Demographics domain
- described in Table 2.2.6.
+ - Cited Guidance:
+ Each study must include one standardized set of observations in a specific
+ structure; this is the Demographics domain described in Table 2.2.6.
Document: Model v1.7
Section: 2.2.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0368
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: For studies that assess the impact of tobacco products on the
- health of individuals, DM is required even if no other
- datasets are generated.
+ - Cited Guidance:
+ For studies that assess the impact of tobacco products on the health of
+ individuals, DM is required even if no other datasets are generated.
Document: TIG 1.0
Item: Table 2 Num 3
- Section: '2.5'
+ Section: "2.5"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0532
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For Study Data Tabulation Model (SDTM) data, a DM dataset and
- define.xml must be submitted in Module 5, sections 5.3.1.1,
- 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1,
- 5.3.5.2
+ - Cited Guidance:
+ For Study Data Tabulation Model (SDTM) data, a DM dataset and define.xml
+ must be submitted in Module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3,
+ 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1736
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1736a
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For Study Data Tabulation Model (SDTM) data, a DM dataset and
- define.xml must be submitted in Module 5, sections 5.3.1.1,
- 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1,
- 5.3.5.2
+ - Cited Guidance:
+ For Study Data Tabulation Model (SDTM) data, a DM dataset and define.xml
+ must be submitted in Module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3,
+ 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1736
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1736a
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For Study Data Tabulation Model (SDTM) data, a DM dataset and
- define.xml must be submitted in Module 5, sections 5.3.1.1,
- 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1,
- 5.3.5.2
+ - Cited Guidance:
+ For Study Data Tabulation Model (SDTM) data, a DM dataset and define.xml
+ must be submitted in Module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3,
+ 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1736
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1736a
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a
- Demographic (DM) dataset and define.xml must be submitted in
- Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4
+ - Cited Guidance:
+ For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic
+ (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2,
+ 4.2.3.4
Document: FDA
Section: TRC1736
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1736c
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a
- Demographic (DM) dataset and define.xml must be submitted in
- Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4
+ - Cited Guidance:
+ For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic
+ (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2,
+ 4.2.3.4
Document: FDA
Section: TRC1736
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1736c
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a
- Demographic (DM) dataset and define.xml must be submitted in
- Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4
+ - Cited Guidance:
+ For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic
+ (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2,
+ 4.2.3.4
Document: FDA
Section: TRC1736
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1736c
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a
- Demographic (DM) dataset and define.xml must be submitted in
- Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4
+ - Cited Guidance:
+ For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic
+ (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2,
+ 4.2.3.4
Document: FDA
Section: TRC1736
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1736c
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a
- Demographic (DM) dataset and define.xml must be submitted in
- Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4
+ - Cited Guidance:
+ For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic
+ (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2,
+ 4.2.3.4
Document: FDA
Section: TRC1736
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1736c
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a
- Demographic (DM) dataset and define.xml must be submitted in
- Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4
+ - Cited Guidance:
+ For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic
+ (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2,
+ 4.2.3.4
Document: FDA
Section: TRC1736
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1736c
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a
- Demographic (DM) dataset and define.xml must be submitted in
- Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4
+ - Cited Guidance:
+ For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic
+ (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2,
+ 4.2.3.4
Document: FDA
Section: TRC1736
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1736c
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: DM
@@ -214,7 +221,7 @@ Check:
Core:
Id: CORE-000581
Status: Published
- Version: '1'
+ Version: "1"
Description: DM dataset should be present.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000583/rule.yml b/Published/CORE-000583/rule.yml
index 8e131cc8b..69f515673 100644
--- a/Published/CORE-000583/rule.yml
+++ b/Published/CORE-000583/rule.yml
@@ -1,13 +1,14 @@
Authorities:
- - Organization: CDISC
- # REMARK: NOT applicable to SENDIG-3.0 (which has similar rule xxx)
+ - Organization:
+ CDISC
+ # REMARK: NOT applicable to SENDIG-3.0 (which has similar rule xxx)
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Null flavor for the value of the TSPARMs, which should be
- included according to the trial summary code table below if
- and only if TSVAL is null.
+ - Cited Guidance:
+ Null flavor for the value of the TSPARMs, which should be included according
+ to the trial summary code table below if and only if TSVAL is null.
Document: IG v3.1
Item: Specification
Section: 7.6.1.1
@@ -20,9 +21,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Null flavor for the value of the TSPARMs, which should be
- included according to the trial summary code table below if
- and only if TSVAL is null.
+ - Cited Guidance:
+ Null flavor for the value of the TSPARMs, which should be included according
+ to the trial summary code table below if and only if TSVAL is null.
Document: IG v3.1.1
Item: Specification
Section: 7.6.1.1
@@ -35,9 +36,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Null flavor for the value of the TSPARMs, which should be
- included according to the trial summary code table below if
- and only if TSVAL is null.
+ - Cited Guidance:
+ Null flavor for the value of the TSPARMs, which should be included according
+ to the trial summary code table below if and only if TSVAL is null.
Document: IG v3.1.1
Item: Specification
Section: 7.6.1.1
@@ -50,9 +51,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Null flavor for the value of the TSPARMs, which should be
- included according to the trial summary code table below if
- and only if TSVAL is null.
+ - Cited Guidance:
+ Null flavor for the value of the TSPARMs, which should be included according
+ to the trial summary code table below if and only if TSVAL is null.
Document: IG v3.1
Item: Specification
Section: 7.6.1.1
@@ -65,9 +66,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Null flavor for the value of the TSPARMs, which should be
- included according to the trial summary code table below if
- and only if TSVAL is null.
+ - Cited Guidance:
+ Null flavor for the value of the TSPARMs, which should be included according
+ to the trial summary code table below if and only if TSVAL is null.
Document: IG v3.1.1
Item: Specification
Section: 7.6.1.1
@@ -80,9 +81,9 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: Null flavor for the value of the TSPARMs, which should be
- included according to the trial summary code table below if
- and only if TSVAL is null.
+ - Cited Guidance:
+ Null flavor for the value of the TSPARMs, which should be included according
+ to the trial summary code table below if and only if TSVAL is null.
Document: TIG v1.0
Item: TSVALNF CDISC Notes
Section: 2.8.9.32
@@ -94,7 +95,7 @@ Authorities:
Substandard: SEND
Version: "1.0"
Check:
- # 2024-11-19: after discussion with SEND team, also raise an error
+ # 2024-11-19: after discussion with SEND team, also raise an error
# when NONE of TSVAL and TSVALNF are populated
any:
- all:
@@ -111,8 +112,8 @@ Core:
Id: CORE-000583
Status: Published
Version: "1"
-Description: Either TSVAL or TSVALNF is populated, but not both. Trigger error
- when TSVAL and TSVALNF are populated, or when both variables are empty.
+Description: Either TSVAL or TSVALNF is populated, but not both. Trigger error when TSVAL and
+ TSVALNF are populated, or when both variables are empty.
Executability: Fully Executable
Outcome:
Message: Either both TSVALNF and TSVAL are populated, or both are empty.
diff --git a/Published/CORE-000584/rule.yml b/Published/CORE-000584/rule.yml
index f7aef66a0..5a8063f71 100644
--- a/Published/CORE-000584/rule.yml
+++ b/Published/CORE-000584/rule.yml
@@ -4,103 +4,103 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen
- per observation time per subject or pool, Tabulation.
+ - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per
+ observation time per subject or pool, Tabulation.
Document: SENDIG v3.0
Item: Domain Table Header
Section: 6.3.6
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND169'
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Id: "SEND169"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen
- per observation time per subject or pool, Tabulation.
+ - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per
+ observation time per subject or pool, Tabulation.
Document: SENDIG v3.1
Item: Domain Table Header
Section: 6.3.6
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND169'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND169"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen
- per observation time per subject or pool, Tabulation.
+ - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per
+ observation time per subject or pool, Tabulation.
Document: SENDIG v3.1.1
Item: Domain Table Header
Section: 6.3.6
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND169'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND169"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen
- per observation time per subject or pool, Tabulation.
+ - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per
+ observation time per subject or pool, Tabulation.
Document: SENDIG v3.1
Item: Domain Table Header
Section: 6.3.6
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND169'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND169"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen
- per observation time per subject or pool, Tabulation.
+ - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per
+ observation time per subject or pool, Tabulation.
Document: SENDIG v3.1.1
Item: Domain Table Header
Section: 6.3.6
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND169'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND169"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen
- per observation time per subject or pool, Tabulation.
+ - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per
+ observation time per subject or pool, Tabulation.
Document: SENDIG v3.1.1
Item: Domain Table Header
Section: 6.3.6
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND169'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND169"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: lb.xpt, Laboratory Test Results — Findings. One record per test
- per specimen per observation time per subject or pool,
- Tabulation.
+ - Cited Guidance:
+ lb.xpt, Laboratory Test Results — Findings. One record per test per specimen
+ per observation time per subject or pool, Tabulation.
Document: TIG v1.0
Item: Domain Table Header
Section: 2.8.9.14
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0098
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -128,13 +128,12 @@ Check:
Core:
Id: CORE-000584
Status: Published
- Version: '1'
-Description: Raise an error when there is more than one record present per test
- per specimen, in the LB Domain, for a subject or pool on a particular date.
+ Version: "1"
+Description: Raise an error when there is more than one record present per test per specimen, in the
+ LB Domain, for a subject or pool on a particular date.
Executability: Fully Executable
Outcome:
- Message: The LB test result is not unique per specimen per subject or pool and
- date/time.
+ Message: The LB test result is not unique per specimen per subject or pool and date/time.
Output Variables:
- POOLID
- LBTESTCD
diff --git a/Published/CORE-000590/rule.yml b/Published/CORE-000590/rule.yml
index e6b193457..b3910a056 100644
--- a/Published/CORE-000590/rule.yml
+++ b/Published/CORE-000590/rule.yml
@@ -2,28 +2,26 @@
# Condition: Study of tobacco product(s)
# Rule: TO dataset is required in all studies of tobacco products
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: 'TO is a study reference dataset that provides a consistent
- identifier, the Applicant-defined Tobacco Product Identifier
- (SPTOBID), for a tobacco product in a study. It contains the
- identifying and descriptive characteristics of a tobacco
- product and merges those characteristics on this single
- identifier. This dataset is required for studies of tobacco
- products.'
- Document: 'TIG 1.0'
- Item: 'assumption 1'
- Section: '2.8.8.1'
+ - Cited Guidance:
+ "TO is a study reference dataset that provides a consistent identifier, the Applicant-defined
+ Tobacco Product Identifier (SPTOBID), for a tobacco product in a study. It contains the identifying
+ and descriptive characteristics of a tobacco product and merges those characteristics on this
+ single identifier. This dataset is required for studies of tobacco products."
+ Document: "TIG 1.0"
+ Item: "assumption 1"
+ Section: "2.8.8.1"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0001'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0001"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: TO
@@ -31,9 +29,9 @@ Check:
Core:
Id: CORE-000590
Status: Published
- Version: '1'
-Description: Raise an error when the study is a study of tobacco product(s) but
- the TO dataset is not present.
+ Version: "1"
+Description: Raise an error when the study is a study of tobacco product(s) but the TO dataset is
+ not present.
Executability: Fully Executable
Outcome:
Message: Required TO dataset for study of tobacco product(s) is not present.
diff --git a/Published/CORE-000591/rule.yml b/Published/CORE-000591/rule.yml
index 465b6183a..01c065c3e 100644
--- a/Published/CORE-000591/rule.yml
+++ b/Published/CORE-000591/rule.yml
@@ -1,34 +1,35 @@
# Variable: TOPARMCD
# Rule: TOPARMCD=TBPRDCAT present in dataset
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: A minimally meaningful TO dataset must include at least the
- parameter for tobacco product category (TOPARMCD = TPRDCAT)
- Document: 'TIG 1.0'
- Item: 'assumption 2'
- Section: '2.8.8.1'
+ - Cited Guidance:
+ A minimally meaningful TO dataset must include at least the parameter for
+ tobacco product category (TOPARMCD = TPRDCAT)
+ Document: "TIG 1.0"
+ Item: "assumption 2"
+ Section: "2.8.8.1"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0003'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0003"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: $tbprdcat_count
operator: equal_to
value: 0
Core:
- Status: Published
- Version: '1'
Id: CORE-000591
-Description: Raise an error when there is no record present in TO per SPTOBID
- where TOPARMCD equals TBPRDCAT.
+ Status: Published
+ Version: "1"
+Description: Raise an error when there is no record present in TO per SPTOBID where TOPARMCD equals
+ TBPRDCAT.
Executability: Fully Executable
Operations:
- domain: TO
@@ -40,8 +41,7 @@ Operations:
name: TOPARMCD
operator: record_count
Outcome:
- Message: TO dataset does not include a record for each SPTOBID where TOPARMCD =
- TBPRDCAT.
+ Message: TO dataset does not include a record for each SPTOBID where TOPARMCD = TBPRDCAT.
Output Variables:
- SPTOBID
- $tbprdcat_count
diff --git a/Published/CORE-000592/rule.yml b/Published/CORE-000592/rule.yml
index 5d7e5195a..d2f9e0259 100644
--- a/Published/CORE-000592/rule.yml
+++ b/Published/CORE-000592/rule.yml
@@ -2,23 +2,24 @@
# Condition: TOPARMCD = TBPRDCAT
# Rule: TOVAL ^= null
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: A minimally meaningful TO dataset must include at least the
- parameter for tobacco product category (TOPARMCD = TPRDCAT)
- Document: 'TIG 1.0'
- Item: 'assumption 2'
- Section: '2.8.8.1'
+ - Cited Guidance:
+ A minimally meaningful TO dataset must include at least the parameter for
+ tobacco product category (TOPARMCD = TPRDCAT)
+ Document: "TIG 1.0"
+ Item: "assumption 2"
+ Section: "2.8.8.1"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0004'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0004"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: TOPARMCD
@@ -27,11 +28,10 @@ Check:
- name: TOVAL
operator: empty
Core:
- Status: Published
- Version: '1'
Id: CORE-000592
-Description: Raise an error when TOVAL is not completed for records where
- TOPARMCD equals TBPRDCAT.
+ Status: Published
+ Version: "1"
+Description: Raise an error when TOVAL is not completed for records where TOPARMCD equals TBPRDCAT.
Executability: Fully Executable
Outcome:
Message: TOVAL is not completed when TOPARMCD = TBPRDCAT.
diff --git a/Published/CORE-000593/rule.yml b/Published/CORE-000593/rule.yml
index 6a9cafbea..7d29aa788 100644
--- a/Published/CORE-000593/rule.yml
+++ b/Published/CORE-000593/rule.yml
@@ -2,46 +2,46 @@
# Condition: PTMETHOD = null / PTXFN = null
# Rule: PTXFN ^= null / PTMETHOD ^= null
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: When lab methodology is too complex for the single PTMETHOD
- variable, PTXFN should be used to reference a file name or
- path to a file in the application that describes the
- methodology used. One or the other of PTMETHOD or PTXFN should
- be included in the data.
- Document: 'TIG 1.0'
- Item: 'assumption 6'
- Section: '2.8.8.3'
+ - Cited Guidance:
+ When lab methodology is too complex for the single PTMETHOD variable, PTXFN
+ should be used to reference a file name or path to a file in the application that
+ describes the methodology used. One or the other of PTMETHOD or PTXFN should be included
+ in the data.
+ Document: "TIG 1.0"
+ Item: "assumption 6"
+ Section: "2.8.8.3"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0006'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0006"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
- - Organization: 'CDISC'
+ Version: "1.0"
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: When lab methodology is too complex for the single PTMETHOD
- variable, PTXFN should be used to reference a file name or
- path to a file in the application that describes the
- methodology used. One or the other of PTMETHOD or PTXFN should
- be included in the data.
- Document: 'TIG 1.0'
- Item: 'assumption 6'
- Section: '2.8.8.3'
+ - Cited Guidance:
+ When lab methodology is too complex for the single PTMETHOD variable, PTXFN
+ should be used to reference a file name or path to a file in the application that
+ describes the methodology used. One or the other of PTMETHOD or PTXFN should be included
+ in the data.
+ Document: "TIG 1.0"
+ Item: "assumption 6"
+ Section: "2.8.8.3"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0007'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0007"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: PTMETHOD
@@ -49,9 +49,9 @@ Check:
- name: PTXFN
operator: empty
Core:
- Status: Published
- Version: '1'
Id: CORE-000593
+ Status: Published
+ Version: "1"
Description: Raise an error when PTMETHOD and PTXFN are both not populated.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000594/rule.yml b/Published/CORE-000594/rule.yml
index e2b41857f..91d7c3c33 100644
--- a/Published/CORE-000594/rule.yml
+++ b/Published/CORE-000594/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: Variable labels are in title case
Authorities:
- Organization: CDISC
@@ -7,53 +7,54 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Use title case for all labels (title case means to capitalize
- the first letter of every word except for articles,
- prepositions, and conjunctions).
+ - Cited Guidance:
+ Use title case for all labels (title case means to capitalize the first
+ letter of every word except for articles, prepositions, and conjunctions).
Document: IG v3.4
Item: 3h
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0359
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Use title case for all labels (title case means to capitalize
- the first letter of every word except for articles;
- prepositions; and conjunctions).
+ - Cited Guidance:
+ Use title case for all labels (title case means to capitalize the first
+ letter of every word except for articles; prepositions; and conjunctions).
Document: IG v3.2
Item: 3h
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0359
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Use title case for all labels (title case means to capitalize
- the first letter of every word except for articles;
- prepositions; and conjunctions).
+ - Cited Guidance:
+ Use title case for all labels (title case means to capitalize the first
+ letter of every word except for articles; prepositions; and conjunctions).
Document: IG v3.3
Item: 3h
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0359
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Variable descriptive names (labels), up to 40 characters in
- title case, should be provided as data variable labels.
+ - Cited Guidance:
+ Variable descriptive names (labels), up to 40 characters in title case,
+ should be provided as data variable labels.
Document: IG v3.0
Section: 4.2.1
Origin: SEND Conformance Rules
@@ -65,8 +66,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Variable descriptive names (labels), up to 40 characters in
- title case, should be provided as data variable labels.
+ - Cited Guidance:
+ Variable descriptive names (labels), up to 40 characters in title case,
+ should be provided as data variable labels.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
@@ -78,8 +80,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Variable descriptive names (labels), up to 40 characters in
- title case, should be provided as data variable labels.
+ - Cited Guidance:
+ Variable descriptive names (labels), up to 40 characters in title case,
+ should be provided as data variable labels.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
@@ -91,8 +94,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Variable descriptive names (labels), up to 40 characters in
- title case, should be provided as data variable labels.
+ - Cited Guidance:
+ Variable descriptive names (labels), up to 40 characters in title case,
+ should be provided as data variable labels.
Document: IG v3.1
Section: 4.2.1
Origin: SEND Conformance Rules
@@ -104,8 +108,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Variable descriptive names (labels), up to 40 characters in
- title case, should be provided as data variable labels.
+ - Cited Guidance:
+ Variable descriptive names (labels), up to 40 characters in title case,
+ should be provided as data variable labels.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
@@ -117,8 +122,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Variable descriptive names (labels), up to 40 characters in
- title case, should be provided as data variable labels.
+ - Cited Guidance:
+ Variable descriptive names (labels), up to 40 characters in title case,
+ should be provided as data variable labels.
Document: IG v3.1.1
Section: 4.2.1
Origin: SEND Conformance Rules
@@ -130,50 +136,51 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be
- provided as data variable labels for all variables, including
- Supplemental Qualifier variables. Use title case for all
- labels
+ - Cited Guidance:
+ Descriptive labels per this guide, up to 40 characters, will be provided as
+ data variable labels for all variables, including Supplemental Qualifier variables. Use
+ title case for all labels
Document: TIG 1.0
Item: Tabulation Datasets table NUM 5
Section: 2.6|2.8.2|2.8.3
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0524
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be
- provided as data variable labels for all variables, including
- Supplemental Qualifier variables.
+ - Cited Guidance:
+ Descriptive labels per this guide, up to 40 characters, will be provided as
+ data variable labels for all variables, including Supplemental Qualifier variables.
Document: TIG 1.0
Item: Tabulation Datasets table, Num 5
Section: 2.6 Guidance for Datasets
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0205
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: variable_label
- operator: not_matches_regex
- # value: ^\s*[A-Z]\S*\s*((a|an|the|and|per|to|but|or|for|in|of|on|with|([A-Z]\S*))\s*)*$
- # Updated by Jozef Aerts, added "and/or", "is", "within" and "from"
- # as these appear in existing labels in SDTM Model 2.0 (I did not check in earlier model versions)
- # value: ^\s*[A-Z]\S*\s*((a|an|the|and|per|to|but|or|for|in|of|on|with|and/or|is|within|from|([A-Z]\S*))\s*)*$
- # update 2025-07-24:
+ operator:
+ not_matches_regex
+ # value: ^\s*[A-Z]\S*\s*((a|an|the|and|per|to|but|or|for|in|of|on|with|([A-Z]\S*))\s*)*$
+ # Updated by Jozef Aerts, added "and/or", "is", "within" and "from"
+ # as these appear in existing labels in SDTM Model 2.0 (I did not check in earlier model versions)
+ # value: ^\s*[A-Z]\S*\s*((a|an|the|and|per|to|but|or|for|in|of|on|with|and/or|is|within|from|([A-Z]\S*))\s*)*$
+ # update 2025-07-24:
value: ^\s*[A-Z]\S*\s*((a|an|the|as|and|per|to|but|or|for|in|is|of|on|with|and\/or|is|within|from|([A-Z]\S*))\s*)*$
Core:
Id: CORE-000594
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when a variable label is not in title case
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000595/rule.yml b/Published/CORE-000595/rule.yml
index b0aa7c247..ed91c03a1 100644
--- a/Published/CORE-000595/rule.yml
+++ b/Published/CORE-000595/rule.yml
@@ -2,40 +2,42 @@
# Condition: CASNO = null / UNII = null
# Rule: UNII ^= null / CASNO ^= null
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: At least one of the two permissible variables CASNO or UNII
- should also be provided if available.
- Document: 'TIG 1.0'
- Item: 'assumption 3.d.ii'
- Section: '2.8.8.5'
+ - Cited Guidance:
+ At least one of the two permissible variables CASNO or UNII should also be
+ provided if available.
+ Document: "TIG 1.0"
+ Item: "assumption 3.d.ii"
+ Section: "2.8.8.5"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0010'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0010"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
- - Organization: 'CDISC'
+ Version: "1.0"
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: At least one of the two permissible variables CASNO or UNII
- should also be provided if available.
- Document: 'TIG 1.0'
- Item: 'assumption 3.d.ii'
- Section: '2.8.8.5'
+ - Cited Guidance:
+ At least one of the two permissible variables CASNO or UNII should also be
+ provided if available.
+ Document: "TIG 1.0"
+ Item: "assumption 3.d.ii"
+ Section: "2.8.8.5"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0011'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0011"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -61,12 +63,12 @@ Check:
Core:
Id: CORE-000595
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when UNII and CASNO are both not populated.
Executability: Fully Executable
Outcome:
- Message: At least one of the UNII and CASNO variables should be present and
- populated for each ingredient if available.
+ Message: At least one of the UNII and CASNO variables should be present and populated for each
+ ingredient if available.
Output Variables:
- UNII
- CASNO
diff --git a/Published/CORE-000596/rule.yml b/Published/CORE-000596/rule.yml
index cd5e4cd1c..3c2c863af 100644
--- a/Published/CORE-000596/rule.yml
+++ b/Published/CORE-000596/rule.yml
@@ -2,25 +2,25 @@
# Condition: INGRADE = null AND INPURITY = null
# Rule: TPMF ^= null
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: Ingredient grade (INGRADE) and purity (INPURITY). According to
- the PMTA rule, at least one of these two attributes must be
- included. If the data are proprietary and only available via
- the TPMF, then TPMF should be populated.
- Document: 'TIG 1.0'
- Item: 'assumption 3.f'
- Section: '2.8.8.5'
+ - Cited Guidance:
+ Ingredient grade (INGRADE) and purity (INPURITY). According to the PMTA
+ rule, at least one of these two attributes must be included. If the data are proprietary
+ and only available via the TPMF, then TPMF should be populated.
+ Document: "TIG 1.0"
+ Item: "assumption 3.f"
+ Section: "2.8.8.5"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0012'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0012"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: INGRADE
@@ -33,16 +33,15 @@ Check:
- name: TPMF
operator: not_exists
Core:
- Status: Published
- Version: '1'
Id: CORE-000596
+ Status: Published
+ Version: "1"
Description: Raise an error when INGRADE, INPURITY and TPMF are all not populated.
Executability: Fully Executable
Outcome:
- Message: At least one of INGRADE or INPURITY should be populated. If neither is
- available due to the ingredient being proprietary and originating from a
- third-party supplier, populate TPMF with the Tobacco Product Master File
- number provided by the supplier.
+ Message: At least one of INGRADE or INPURITY should be populated. If neither is available due to
+ the ingredient being proprietary and originating from a third-party supplier, populate TPMF with
+ the Tobacco Product Master File number provided by the supplier.
Output Variables:
- INGRADE
- INPURITY
diff --git a/Published/CORE-000597/rule.yml b/Published/CORE-000597/rule.yml
index d610d5527..82b5ac047 100644
--- a/Published/CORE-000597/rule.yml
+++ b/Published/CORE-000597/rule.yml
@@ -7,68 +7,68 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When a description of Other Medically Important Serious Adverse
- Events category is collected on a CRF, sponsors should place
- the description in the SUPPAE dataset using the standard
- supplemental qualifier name code AESOSP.
+ - Cited Guidance:
+ When a description of Other Medically Important Serious Adverse Events
+ category is collected on a CRF, sponsors should place the description in the SUPPAE
+ dataset using the standard supplemental qualifier name code AESOSP.
Document: IG v3.4
Item: Asumtpion 6c
Section: 6.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0043
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When a description of Other Medically Important Serious Adverse
- Events category is collected on a CRF, sponsors should place
- the description in the SUPPAE dataset using the standard
- supplemental qualifier name code AESOSP.
+ - Cited Guidance:
+ When a description of Other Medically Important Serious Adverse Events
+ category is collected on a CRF, sponsors should place the description in the SUPPAE
+ dataset using the standard supplemental qualifier name code AESOSP.
Document: IG v3.2
Item: Assumption 6c
- Section: '6.2'
+ Section: "6.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0043
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When a description of Other Medically Important Serious Adverse
- Events category is collected on a CRF, sponsors should place
- the description in the SUPPAE dataset using the standard
- supplemental qualifier name code AESOSP.
+ - Cited Guidance:
+ When a description of Other Medically Important Serious Adverse Events
+ category is collected on a CRF, sponsors should place the description in the SUPPAE
+ dataset using the standard supplemental qualifier name code AESOSP.
Document: IG v3.3
Item: Assumption 6c
Section: 6.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0043
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: When a description of "Other Medically Important Serious Adverse
- Events" category is collected on a CRF, applicants should
- place the description in the SUPPAE dataset using the standard
- supplemental qualifier name code AESOSP.
+ - Cited Guidance:
+ When a description of "Other Medically Important Serious Adverse Events"
+ category is collected on a CRF, applicants should place the description in the SUPPAE
+ dataset using the standard supplemental qualifier name code AESOSP.
Document: TIG 1.0
Item: Assumption 7c
Section: 2.8.10.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0322
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: QNAM
@@ -81,7 +81,7 @@ Check:
Core:
Id: CORE-000597
Status: Published
- Version: '1'
+ Version: "1"
Description: When SUPPAE.QNAM=AESOSP is present, a record with AESMIE=Y should be present
Executability: Fully Executable
Match Datasets:
diff --git a/Published/CORE-000598/rule.yml b/Published/CORE-000598/rule.yml
index d81b6da72..a3d304e50 100644
--- a/Published/CORE-000598/rule.yml
+++ b/Published/CORE-000598/rule.yml
@@ -1,5 +1,5 @@
# Variable: DOMAIN
-# Condition:
+# Condition:
# Rule: Dataset name begins with DOMAIN value
Authorities:
- Organization: CDISC
@@ -7,178 +7,168 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Each study subject domain dataset is distinguished by a unique,
- 2-character code that should be used consistently throughout
- the submission. This code, which is stored in the SDTM
- variable named DOMAIN, is used in the dataset name, as the
- value of the DOMAIN variable in that dataset, and as a prefix
- for most variable names in that dataset.
+ - Cited Guidance:
+ Each study subject domain dataset is distinguished by a unique, 2-character
+ code that should be used consistently throughout the submission. This code, which is
+ stored in the SDTM variable named DOMAIN, is used in the dataset name, as the value of the
+ DOMAIN variable in that dataset, and as a prefix for most variable names in that dataset.
Document: Model v2.0
Section: Study Subject Data
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0413
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'This code; which is stored in the SDTM variable named DOMAIN;
- is used in four ways: as the dataset name; the value of the
- DOMAIN variable in that dataset; as a prefix for most variable
- names in that dataset; and as a value in the RDOMAIN variable
- in relationship tables.'
+ - Cited Guidance:
+ "This code; which is stored in the SDTM variable named DOMAIN; is used in four
+ ways: as the dataset name; the value of the DOMAIN variable in that dataset; as a prefix for
+ most variable names in that dataset; and as a value in the RDOMAIN variable in relationship
+ tables."
Document: Model v1.4
- Section: '2.1'
+ Section: "2.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0413
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Each domain dataset is distinguished by a unique; 2-character
- code that should be used consistently throughout the
- submission. This code; which is stored in the SDTM variable
- named DOMAIN; is used in 4 ways: as the dataset name; as the
- value of the DOMAIN variable in that dataset; as a prefix for
- most variable names in that dataset; and as a value in the
- RDOMAIN variable in relationship tables.'
+ - Cited Guidance:
+ "Each domain dataset is distinguished by a unique; 2-character code that should
+ be used consistently throughout the submission. This code; which is stored in the SDTM variable
+ named DOMAIN; is used in 4 ways: as the dataset name; as the value of the DOMAIN variable in
+ that dataset; as a prefix for most variable names in that dataset; and as a value in the RDOMAIN
+ variable in relationship tables."
Document: Model v1.7
- Section: '2.1'
+ Section: "2.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0413
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Each study subject domain dataset is distinguished by a unique
- 2-character code. This code, which is stored in the SDTM
- variable named DOMAIN, is used in the dataset name, as the
- value of the DOMAIN variable in that dataset, and as a prefix
- for most variable names in that dataset.
+ - Cited Guidance:
+ Each study subject domain dataset is distinguished by a unique 2-character
+ code. This code, which is stored in the SDTM variable named DOMAIN, is used in the dataset
+ name, as the value of the DOMAIN variable in that dataset, and as a prefix for most
+ variable names in that dataset.
Document: SDTM v2.1
Item: DOMAIN
Section: Section 3 Study Subject Data
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0568
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: SDTM datasets are normally named to be consistent with the
- domain code.
+ - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code.
Document: SENDIG v3.0
Item: Text
Section: 4.1.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: SDTM datasets are normally named to be consistent with the
- domain code.
+ - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code.
Document: SENDIG v3.1
Item: Text
Section: 4.1.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: SDTM datasets are normally named to be consistent with the
- domain code.
+ - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code.
Document: SENDIG v3.1.1
Item: Text
Section: 4.1.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: SDTM datasets are normally named to be consistent with the
- domain code.
+ - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code.
Document: SENDIG v3.1
Item: Text
Section: 4.1.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: SDTM datasets are normally named to be consistent with the
- domain code.
+ - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code.
Document: SENDIG v3.1.1
Item: Text
Section: 4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: SDTM datasets are normally named to be consistent with the
- domain code.
+ - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code.
Document: SENDIG v3.1.1
Item: Text
Section: 4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Domain datasets based on the SDTM general observations classes
- will be named using the two-character code for the domain or
- using the applicable four-character code when a dataset is
- split. Supplemental Qualifier datasets will be named using
- convention SUPP concatenated with the two-character domain
- code or four-character code when a dataset is split (e.g.,
- SUPPDM, SUPPFA, SUPPFACM). All other datasets will be named
- using the code for the domain or dataset and (e.g., DM,
- RELREC).
+ - Cited Guidance:
+ Domain datasets based on the SDTM general observations classes will be named
+ using the two-character code for the domain or using the applicable four-character code
+ when a dataset is split. Supplemental Qualifier datasets will be named using convention
+ SUPP concatenated with the two-character domain code or four-character code when a dataset
+ is split (e.g., SUPPDM, SUPPFA, SUPPFACM). All other datasets will be named using the code
+ for the domain or dataset and (e.g., DM, RELREC).
Document: TIG v1.0
Item: Tabulation Datasets Table, Num 2
Section: 2.6 Guidance for Datasets
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0037
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: dataset_name
@@ -188,7 +178,7 @@ Check:
Core:
Id: CORE-000598
Status: Published
- Version: '1'
+ Version: "1"
Description: The dataset name must begin with the DOMAIN value.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000599/rule.yml b/Published/CORE-000599/rule.yml
index 388c68edf..7e87e2d68 100644
--- a/Published/CORE-000599/rule.yml
+++ b/Published/CORE-000599/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND134
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND134
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -34,8 +34,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND134
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
@@ -46,9 +46,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND134
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -58,9 +58,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND134
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -70,9 +70,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND134
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
# Remark: In SEND, "no test article (as described in EXTRT) is administered", is depicted as EXDOSE=0
@@ -85,9 +85,9 @@ Check:
Core:
Id: CORE-000599
Status: Published
- Version: '1'
-Description: If no test article (as described in EXTRT) is administered (i.e.,
- EXDOSE is 0), EXLOT is null.
+ Version: "1"
+Description: If no test article (as described in EXTRT) is administered (i.e., EXDOSE is 0), EXLOT
+ is null.
Executability: Fully Executable
Outcome:
Message: EXDOSE is 0, EXLOT may not be populated
diff --git a/Published/CORE-000600/rule.yml b/Published/CORE-000600/rule.yml
index 118a31598..c8108d8ea 100644
--- a/Published/CORE-000600/rule.yml
+++ b/Published/CORE-000600/rule.yml
@@ -1,26 +1,26 @@
# Variable: PARENT
# Rule: For each value in PARENT there must exist one record with REFID value = PARENT value.
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: Every value of PARENT must be defined once and only once. Every
- PARENT must have a unique REFID which may be referenced by
- multiple records with the same PARENT. (Each REFID with a
- PARENT, has only one PARENT and that PARENT is described in a
- unique PARENT record.).
- Document: 'TIG 1.0'
- Item: 'assumption 4'
- Section: '2.8.9.23'
+ - Cited Guidance:
+ Every value of PARENT must be defined once and only once. Every PARENT must
+ have a unique REFID which may be referenced by multiple records with the same PARENT.
+ (Each REFID with a PARENT, has only one PARENT and that PARENT is described in a unique
+ PARENT record.).
+ Document: "TIG 1.0"
+ Item: "assumption 4"
+ Section: "2.8.9.23"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0030'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0030"
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: LEVEL
@@ -35,11 +35,11 @@ Check:
operator: equal_to
value: REFID
Core:
- Status: Published
- Version: '1'
Id: CORE-000600
-Description: Raise an error when a record has a PARENT value but no other record
- exists with REFID value = PARENT value.
+ Status: Published
+ Version: "1"
+Description: Raise an error when a record has a PARENT value but no other record exists with REFID
+ value = PARENT value.
Executability: Fully Executable
Operations:
- domain: RELREF
diff --git a/Published/CORE-000601/rule.yml b/Published/CORE-000601/rule.yml
index 6ce2a73d7..a5cfc159c 100644
--- a/Published/CORE-000601/rule.yml
+++ b/Published/CORE-000601/rule.yml
@@ -1,23 +1,24 @@
# Variable: IQPARENT
# Rule: IQPARENT in IGDCMPID
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: IQPARENT must equal the IDGCMPID of another record in IQ (i.e.,
- the parent ingredient/component must be listed in IQ).
- Document: 'TIG 1.0'
- Item: 'assumption 4.a.i.'
- Section: '2.8.8.6'
+ - Cited Guidance:
+ IQPARENT must equal the IDGCMPID of another record in IQ (i.e., the parent
+ ingredient/component must be listed in IQ).
+ Document: "TIG 1.0"
+ Item: "assumption 4.a.i."
+ Section: "2.8.8.6"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0015'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0015"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IQLEVEL
@@ -32,11 +33,11 @@ Check:
operator: equal_to
value: IGDCMPID
Core:
- Status: Published
- Version: '1'
Id: CORE-000601
-Description: Raise an error when per SPTOBID, the IQPARENT value does not match
- any IGDCMPID value of another record.
+ Status: Published
+ Version: "1"
+Description: Raise an error when per SPTOBID, the IQPARENT value does not match any IGDCMPID value
+ of another record.
Executability: Fully Executable
Operations:
- domain: IQ
@@ -46,8 +47,8 @@ Operations:
name: IGDCMPID
operator: distinct
Outcome:
- Message: IQPARENT value does not match an ingredient represented in another
- records IGDCMPID value.
+ Message: IQPARENT value does not match an ingredient represented in another records IGDCMPID
+ value.
Output Variables:
- SPTOBID
- IGDCMPID
diff --git a/Published/CORE-000602/rule.yml b/Published/CORE-000602/rule.yml
index 67bb8cb1a..f827d87da 100644
--- a/Published/CORE-000602/rule.yml
+++ b/Published/CORE-000602/rule.yml
@@ -2,23 +2,24 @@
# Condition: Record does not have associated PARENT records
# Rule: Value for LEVEL = 1
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: The value for LEVEL must be 1 for a record without a PARENT
- record. This record may or may not have a child record.
- Document: 'TIG 1.0'
- Item: 'assumption 5'
- Section: '2.8.9.23'
+ - Cited Guidance:
+ The value for LEVEL must be 1 for a record without a PARENT record. This
+ record may or may not have a child record.
+ Document: "TIG 1.0"
+ Item: "assumption 5"
+ Section: "2.8.9.23"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0032'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0032"
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: PARENT
@@ -27,11 +28,11 @@ Check:
operator: not_equal_to
value: 1
Core:
- Status: Published
- Version: '1'
Id: CORE-000602
-Description: Raise an error when a record does not have associated PARENT
- records but the value for LEVEL does not equal '1'.
+ Status: Published
+ Version: "1"
+Description: Raise an error when a record does not have associated PARENT records but the value for
+ LEVEL does not equal '1'.
Executability: Fully Executable
Outcome:
Message: Record has no PARENT record in RELREF but LEVEL value does not equal '1'.
diff --git a/Published/CORE-000603/rule.yml b/Published/CORE-000603/rule.yml
index 818f9ff4c..57f14fb0f 100644
--- a/Published/CORE-000603/rule.yml
+++ b/Published/CORE-000603/rule.yml
@@ -1,31 +1,31 @@
# Variable: REFID
# Rule: REFID value is unique
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- Cited Guidance: One record per Reference ID
- Document: 'TIG 1.0'
- Item: 'Domain Table Header'
- Section: '2.8.9.23'
+ Document: "TIG 1.0"
+ Item: "Domain Table Header"
+ Section: "2.8.9.23"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0034'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0034"
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: REFID
operator: is_not_unique_set
value: STUDYID
Core:
- Status: Published
- Version: '1'
Id: CORE-000603
+ Status: Published
+ Version: "1"
Description: Raise an error when the REFID value is not unique.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000604/rule.yml b/Published/CORE-000604/rule.yml
index 5e7fe0dec..41740651b 100644
--- a/Published/CORE-000604/rule.yml
+++ b/Published/CORE-000604/rule.yml
@@ -2,23 +2,24 @@
# Condition: TOPARMCD where TOCAT="NEW PRODUCT" and TOSCAT="PRODUCT DESCRIPTOR"
# Rule: TOPARMCD in PDPARMCD
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: Design parameter data must be included for all new tobacco
- products in the application
- Document: 'TIG 1.0'
- Item: 'assumption 4'
- Section: '2.8.8.2'
+ - Cited Guidance:
+ Design parameter data must be included for all new tobacco products in the
+ application
+ Document: "TIG 1.0"
+ Item: "assumption 4"
+ Section: "2.8.8.2"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0005'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0005"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: TOCAT
@@ -36,10 +37,9 @@ Check:
Core:
Id: CORE-000604
Status: Published
- Version: '1'
-Description: Raise an error when a TOPARMCD in the TO dataset categorized as
- TOCAT = NEW PRODUCT and TOSCAT = PRODUCT DESCRIPTOR does not have a matching
- PDPARMCD in the PD dataset.
+ Version: "1"
+Description: Raise an error when a TOPARMCD in the TO dataset categorized as TOCAT = NEW PRODUCT and
+ TOSCAT = PRODUCT DESCRIPTOR does not have a matching PDPARMCD in the PD dataset.
Executability: Fully Executable
Operations:
- domain: PD
@@ -49,8 +49,8 @@ Operations:
name: PDPARMCD
operator: distinct
Outcome:
- Message: TOPARMCD in TO is categorized as TOCAT = NEW PRODUCT and TOSCAT =
- PRODUCT DESCRIPTOR but does not have a matching PDPARMCD per SPTOBID in PD.
+ Message: TOPARMCD in TO is categorized as TOCAT = NEW PRODUCT and TOSCAT = PRODUCT DESCRIPTOR but
+ does not have a matching PDPARMCD per SPTOBID in PD.
Output Variables:
- SPTOBID
- TOPARMCD
diff --git a/Published/CORE-000605/rule.yml b/Published/CORE-000605/rule.yml
index 835b875ca..0e674fa08 100644
--- a/Published/CORE-000605/rule.yml
+++ b/Published/CORE-000605/rule.yml
@@ -2,42 +2,42 @@
# Condition: IQ domain present in study
# Rule: IGDCMPID in IQ.IGDCMPID
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: When quantifying ingredients in IQ, every ingredient (every
- value of IGDCMPID in IT) must be accounted for in IQ (see IQ
- domain specification and assumptions for more information).
- Document: 'TIG 1.0'
- Item: 'assumption 2b'
- Section: '2.8.8.4'
+ - Cited Guidance: When quantifying ingredients in IQ, every ingredient (every value of
+ IGDCMPID in IT) must be accounted for in IQ (see IQ domain specification and assumptions
+ for more information).
+ Document: "TIG 1.0"
+ Item: "assumption 2b"
+ Section: "2.8.8.4"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0008'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0008"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
- - Organization: 'CDISC'
+ Version: "1.0"
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: When quantifying ingredients in IQ, every ingredient (every
- value of IGDCMPID in IN) must be accounted for in IQ (see IQ
- domain specification and assumptions for more information).
- Document: 'TIG 1.0'
- Item: 'assumption 2b'
- Section: '2.8.8.5'
+ - Cited Guidance: When quantifying ingredients in IQ, every ingredient (every value of
+ IGDCMPID in IN) must be accounted for in IQ (see IQ domain specification and assumptions
+ for more information).
+ Document: "TIG 1.0"
+ Item: "assumption 2b"
+ Section: "2.8.8.5"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0009'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0009"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IGDCMPID
@@ -45,11 +45,11 @@ Check:
value: $iq_igdcmpid
within: SPTOBID
Core:
- Status: Published
- Version: '1'
Id: CORE-000605
-Description: Raise an error when a IGDCMPID in the dataset does not have a
- matching IGDCMPID in the IQ dataset per SPTOBID.
+ Status: Published
+ Version: "1"
+Description: Raise an error when a IGDCMPID in the dataset does not have a matching IGDCMPID in the
+ IQ dataset per SPTOBID.
Executability: Fully Executable
Operations:
- domain: IQ
diff --git a/Published/CORE-000606/rule.yml b/Published/CORE-000606/rule.yml
index 56824240f..455286585 100644
--- a/Published/CORE-000606/rule.yml
+++ b/Published/CORE-000606/rule.yml
@@ -2,25 +2,25 @@
# Condition: IQCAT = TOBACCO INGREDIENT
# Rule: IGDCMPID in IT.IGDCMPID
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: IGDCMPID represents the unique ingredient name established in
- either the Tobacco Ingredients (IT) domain or the Non-Tobacco
- Ingredients (IN) domain. Therefore, every value of IDGCMPID in
- the IQ domain must have an exact match in either IT or IN
- Document: 'TIG 1.0'
- Item: 'assumption 2'
- Section: '2.8.8.6'
+ - Cited Guidance:
+ IGDCMPID represents the unique ingredient name established in either the
+ Tobacco Ingredients (IT) domain or the Non-Tobacco Ingredients (IN) domain. Therefore,
+ every value of IDGCMPID in the IQ domain must have an exact match in either IT or IN
+ Document: "TIG 1.0"
+ Item: "assumption 2"
+ Section: "2.8.8.6"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0013'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0013"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IQCAT
@@ -32,12 +32,11 @@ Check:
value: $it_igdcmpid
within: SPTOBID
Core:
- Status: Published
- Version: '1'
Id: CORE-000606
-Description: Raise an error when IGDCMPID for a tobacco ingredient in the IQ
- dataset (IQCAT = TOBACCO INGREDIENT) does not have a matching IGDCMPID per
- SPTOBID in the IT dataset
+ Status: Published
+ Version: "1"
+Description: Raise an error when IGDCMPID for a tobacco ingredient in the IQ dataset (IQCAT =
+ TOBACCO INGREDIENT) does not have a matching IGDCMPID per SPTOBID in the IT dataset
Executability: Fully Executable
Operations:
- domain: IT
@@ -47,8 +46,8 @@ Operations:
name: IGDCMPID
operator: distinct
Outcome:
- Message: IGDCMPID in IQ categorized as IQCAT = TOBACCO INGREDIENT does not have
- a matching IGDCMPID per SPTOBID in IT.
+ Message: IGDCMPID in IQ categorized as IQCAT = TOBACCO INGREDIENT does not have a matching
+ IGDCMPID per SPTOBID in IT.
Output Variables:
- SPTOBID
- IGDCMPID
diff --git a/Published/CORE-000607/rule.yml b/Published/CORE-000607/rule.yml
index 9408f72d6..5a685b63d 100644
--- a/Published/CORE-000607/rule.yml
+++ b/Published/CORE-000607/rule.yml
@@ -1,35 +1,35 @@
# Variable: STOCONID
# Rule: STOCONID in ES.STOCONID
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: Applicant-defined identifier for a set of storage conditions
- that are represented in the ES domain, where this identifier
- originates.
- Document: 'TIG 1.0'
- Item: 'STOCONID, CDISC Notes column'
- Section: '2.8.8.3'
+ - Cited Guidance:
+ Applicant-defined identifier for a set of storage conditions that are
+ represented in the ES domain, where this identifier originates.
+ Document: "TIG 1.0"
+ Item: "STOCONID, CDISC Notes column"
+ Section: "2.8.8.3"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0017'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0017"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: STOCONID
operator: is_not_contained_by
value: $es_stoconid
Core:
- Status: Published
- Version: '1'
Id: CORE-000607
-Description: Raise an error when value for STOCONID in the PT dataset does not
- match a STOCONID specified in the ES dataset.
+ Status: Published
+ Version: "1"
+Description: Raise an error when value for STOCONID in the PT dataset does not match a STOCONID
+ specified in the ES dataset.
Executability: Fully Executable
Operations:
- domain: ES
diff --git a/Published/CORE-000608/rule.yml b/Published/CORE-000608/rule.yml
index c8ce8a59a..aa47e7a5a 100644
--- a/Published/CORE-000608/rule.yml
+++ b/Published/CORE-000608/rule.yml
@@ -4,68 +4,63 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per test per observation time or evaluation interval
- per subject
+ - Cited Guidance: One record per test per observation time or evaluation interval per subject
Document: SENDIG v3.1
Section: 6.3.18.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND338
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per test per observation time or evaluation interval
- per subject
+ - Cited Guidance: One record per test per observation time or evaluation interval per subject
Document: SENDIG v3.1.1
Section: 6.3.18.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND338
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: One record per test per observation time or evaluation interval
- per subject
+ - Cited Guidance: One record per test per observation time or evaluation interval per subject
Document: SENDIG v3.1
Section: 6.3.18.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND338
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: One record per test per observation time or evaluation interval
- per subject
+ - Cited Guidance: One record per test per observation time or evaluation interval per subject
Document: SENDIG v3.1.1
Section: 6.3.18.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND338
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: One record per test per observation time or evaluation interval
- per subject
+ - Cited Guidance: One record per test per observation time or evaluation interval per subject
Document: SENDIG v3.1.1
Section: 6.3.18.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND338
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: RETESTCD
@@ -82,14 +77,13 @@ Check:
Core:
Id: CORE-000608
Status: Published
- Version: '1'
-Description: Raise an error when there is more than one record present for any
- particular respiratory test for a subject and measurement date/time or
- evaluation interval.
+ Version: "1"
+Description: Raise an error when there is more than one record present for any particular
+ respiratory test for a subject and measurement date/time or evaluation interval.
Executability: Fully Executable
Outcome:
- Message: The respiratory test is not unique for this subject and measurement
- datetime and/or evaluation interval.
+ Message: The respiratory test is not unique for this subject and measurement datetime and/or
+ evaluation interval.
Output Variables:
- USUBJID
- RETESTCD
diff --git a/Published/CORE-000609/rule.yml b/Published/CORE-000609/rule.yml
index a7224394c..727e24f30 100644
--- a/Published/CORE-000609/rule.yml
+++ b/Published/CORE-000609/rule.yml
@@ -1,34 +1,32 @@
# Variable: SETCD
# Rule: RELREF.SETCD = TX.SETCD for a given TX record
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: The SETCD column value must match a SETCD value in the TX
- dataset
- Document: 'TIG 1.0'
- Item: 'assumption 7'
- Section: '2.8.9.23'
+ - Cited Guidance: The SETCD column value must match a SETCD value in the TX dataset
+ Document: "TIG 1.0"
+ Item: "assumption 7"
+ Section: "2.8.9.23"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0033'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0033"
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SETCD
operator: is_not_contained_by
value: $tx_setcd
Core:
- Status: Published
- Version: '1'
Id: CORE-000609
-Description: Raise an error when the SETCD value doesn't match a SETCD value in
- the TX dataset.
+ Status: Published
+ Version: "1"
+Description: Raise an error when the SETCD value doesn't match a SETCD value in the TX dataset.
Executability: Fully Executable
Operations:
- domain: TX
diff --git a/Published/CORE-000610/rule.yml b/Published/CORE-000610/rule.yml
index f7060faf0..5887eeebb 100644
--- a/Published/CORE-000610/rule.yml
+++ b/Published/CORE-000610/rule.yml
@@ -2,34 +2,33 @@
# Condition: REFID value exists in GT domain
# Rule: REFID value exists in RELREF domain
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: Each GTREFID that exists in the GT dataset must exist in the
- RELREF dataset.
- Document: 'TIG 1.0'
- Item: 'assumption 2'
- Section: '2.8.9.23'
+ - Cited Guidance: Each GTREFID that exists in the GT dataset must exist in the RELREF dataset.
+ Document: "TIG 1.0"
+ Item: "assumption 2"
+ Section: "2.8.9.23"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0035'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0035"
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: GTREFID
operator: is_not_contained_by
value: $relref_refid
Core:
- Status: Published
- Version: '1'
Id: CORE-000610
-Description: Raise an error when a REFID value in the GT dataset does not exist
- in the RELREF dataset.
+ Status: Published
+ Version: "1"
+Description: Raise an error when a REFID value in the GT dataset does not exist in the RELREF
+ dataset.
Executability: Fully Executable
Operations:
- domain: RELREF
diff --git a/Published/CORE-000611/rule.yml b/Published/CORE-000611/rule.yml
index 12959eaf5..366b183f1 100644
--- a/Published/CORE-000611/rule.yml
+++ b/Published/CORE-000611/rule.yml
@@ -2,34 +2,33 @@
# Condition: REFID value exists in RELREF domain
# Rule: REFID value exists in GT domain
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: Each REFID that exists in the RELREF dataset must exist in the
- GT dataset.
- Document: 'TIG 1.0'
- Item: 'assumption 3'
- Section: '2.8.9.23'
+ - Cited Guidance: Each REFID that exists in the RELREF dataset must exist in the GT dataset.
+ Document: "TIG 1.0"
+ Item: "assumption 3"
+ Section: "2.8.9.23"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0036'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0036"
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: REFID
operator: is_not_contained_by
value: $gt_refid
Core:
- Status: Published
- Version: '1'
Id: CORE-000611
-Description: Raise an error when a REFID value in the RELREF dataset does not
- exist in the GT dataset.
+ Status: Published
+ Version: "1"
+Description: Raise an error when a REFID value in the RELREF dataset does not exist in the GT
+ dataset.
Executability: Fully Executable
Operations:
- domain: GT
diff --git a/Published/CORE-000612/rule.yml b/Published/CORE-000612/rule.yml
index 6745ab415..ec356ff29 100644
--- a/Published/CORE-000612/rule.yml
+++ b/Published/CORE-000612/rule.yml
@@ -4,143 +4,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Standardized units should be consistent for a given drug or
- metabolite across pharmacokinetic datasets within a
- submission.
+ - Cited Guidance:
+ Standardized units should be consistent for a given drug or metabolite
+ across pharmacokinetic datasets within a submission.
Document: FDA
Section: FDAB070
Origin: FDA Business Rules
Rule Identifier:
Id: FB7001
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Standardized units should be consistent for a given drug or
- metabolite across pharmacokinetic datasets within a
- submission.
+ - Cited Guidance:
+ Standardized units should be consistent for a given drug or metabolite
+ across pharmacokinetic datasets within a submission.
Document: FDA
Section: FDAB070
Origin: FDA Business Rules
Rule Identifier:
Id: FB7001
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Standardized units should be consistent for a given drug or
- metabolite across pharmacokinetic datasets within a
- submission.
+ - Cited Guidance:
+ Standardized units should be consistent for a given drug or metabolite
+ across pharmacokinetic datasets within a submission.
Document: FDA
Section: FDAB070
Origin: FDA Business Rules
Rule Identifier:
Id: FB7001
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Standardized units should be consistent for a given drug or
- metabolite across pharmacokinetic datasets within a
- submission.
+ - Cited Guidance:
+ Standardized units should be consistent for a given drug or metabolite
+ across pharmacokinetic datasets within a submission.
Document: FDA
Section: FDAB070
Origin: FDA Business Rules
Rule Identifier:
Id: FB7001
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Standardized units should be consistent for a given drug or
- metabolite across pharmacokinetic datasets within a
- submission.
+ - Cited Guidance:
+ Standardized units should be consistent for a given drug or metabolite
+ across pharmacokinetic datasets within a submission.
Document: FDA
Section: FDAB070
Origin: FDA Business Rules
Rule Identifier:
Id: FB7001
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Standardized units should be consistent for a given drug or
- metabolite across pharmacokinetic datasets within a
- submission.
+ - Cited Guidance:
+ Standardized units should be consistent for a given drug or metabolite
+ across pharmacokinetic datasets within a submission.
Document: FDA
Section: FDAB070
Origin: FDA Business Rules
Rule Identifier:
Id: FB7001
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Standardized units should be consistent for a given drug or
- metabolite across pharmacokinetic datasets within a
- submission.
+ - Cited Guidance:
+ Standardized units should be consistent for a given drug or metabolite
+ across pharmacokinetic datasets within a submission.
Document: FDA
Section: FDAB070
Origin: FDA Business Rules
Rule Identifier:
Id: FB7001
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Standardized units should be consistent for a given drug or
- metabolite across pharmacokinetic datasets within a
- submission.
+ - Cited Guidance:
+ Standardized units should be consistent for a given drug or metabolite
+ across pharmacokinetic datasets within a submission.
Document: FDA
Section: FDAB070
Origin: FDA Business Rules
Rule Identifier:
Id: FB7001
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Standardized units should be consistent for a given drug or
- metabolite across pharmacokinetic datasets within a
- submission.
+ - Cited Guidance:
+ Standardized units should be consistent for a given drug or metabolite
+ across pharmacokinetic datasets within a submission.
Document: FDA
Section: FDAB070
Origin: FDA Business Rules
Rule Identifier:
Id: FB7001
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Standardized units should be consistent for a given drug or
- metabolite across pharmacokinetic datasets within a
- submission.
+ - Cited Guidance:
+ Standardized units should be consistent for a given drug or metabolite
+ across pharmacokinetic datasets within a submission.
Document: FDA
Section: FDAB070
Origin: FDA Business Rules
Rule Identifier:
Id: FB7001
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
# ONLY for PPSTRESU/PPTESTCD and PCSTRESU/PCTESTCD
@@ -150,11 +150,12 @@ Check:
Core:
Id: CORE-000612
Status: Published
- Version: '1'
-Description: Standardized units (--STRESU) should be consistent per test (--TESTCD) for a given drug or metabolite across pharmacokinetic datasets within a submission.
+ Version: "1"
+Description: Standardized units (--STRESU) should be consistent per test (--TESTCD) for a given drug
+ or metabolite across pharmacokinetic datasets within a submission.
Executability: Fully Executable
Outcome:
- Message: '--STRESU is not consistent per --TESTCD.'
+ Message: "--STRESU is not consistent per --TESTCD."
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000613/rule.yml b/Published/CORE-000613/rule.yml
index 4056bfa17..51c81d0eb 100644
--- a/Published/CORE-000613/rule.yml
+++ b/Published/CORE-000613/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5139
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5139
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5139
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5139
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5139
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5139
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5139
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--ENTPT'
+ - name: "--ENTPT"
operator: exists
Core:
Id: CORE-000613
Status: Published
- Version: '1'
-Description: '--ENTPT must not be in SEND dataset'
+ Version: "1"
+Description: "--ENTPT must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--ENTPT must not be in SEND dataset'
+ Message: "--ENTPT must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000614/rule.yml b/Published/CORE-000614/rule.yml
index 047a94a90..b259d0d31 100644
--- a/Published/CORE-000614/rule.yml
+++ b/Published/CORE-000614/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5138
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5138
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5138
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5138
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5138
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5138
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5138
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--STRTPT'
+ - name: "--STRTPT"
operator: exists
Core:
Id: CORE-000614
Status: Published
- Version: '1'
-Description: '--STRTPT must not be in SEND dataset'
+ Version: "1"
+Description: "--STRTPT must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--STRTPT must not be in SEND dataset'
+ Message: "--STRTPT must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000615/rule.yml b/Published/CORE-000615/rule.yml
index ec7413d4d..d00921423 100644
--- a/Published/CORE-000615/rule.yml
+++ b/Published/CORE-000615/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5137
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5137
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5137
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5137
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5137
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5137
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5137
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--STTPT'
+ - name: "--STTPT"
operator: exists
Core:
Id: CORE-000615
Status: Published
- Version: '1'
-Description: '--STTPT must not be in SEND dataset'
+ Version: "1"
+Description: "--STTPT must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--STTPT must not be in SEND dataset'
+ Message: "--STTPT must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000616/rule.yml b/Published/CORE-000616/rule.yml
index 9a94cb5ef..8abc1e47a 100644
--- a/Published/CORE-000616/rule.yml
+++ b/Published/CORE-000616/rule.yml
@@ -1,129 +1,139 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
# Applicable to SDTMIG versions 3.2, 3.3, 3.4
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4403'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB4403"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4403'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB4403"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4403'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- # REMARK: SENDIG: NOT applicable to SEND 3.0 and 3.1
- - Name: 'SENDIG'
+ Id: "FB4403"
+ Version: "1"
+ Version: "1.5"
+ Version:
+ "3.4"
+ # REMARK: SENDIG: NOT applicable to SEND 3.0 and 3.1
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4403'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4403"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4403'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4403"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4403'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB4403"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4403'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB4403"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4403'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB4403"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
# REMARK: --TPTNUM and --STINT both are usually "permissible"
all:
- - name: '--TPTREF'
+ - name: "--TPTREF"
operator: exists
- - name: '--STINT'
+ - name: "--STINT"
operator: exists
- - name: '--STINT'
- operator: 'non_empty'
- - name: '--TPTREF'
- operator: 'empty'
+ - name: "--STINT"
+ operator: "non_empty"
+ - name: "--TPTREF"
+ operator: "empty"
Core:
Id: CORE-000616
Status: Published
- Version: '1'
-Description: 'When Planned Start of Assessment Interval (--STINT) is populated,
- Time Point Reference (--TPTREF) should also be populated.'
+ Version: "1"
+Description:
+ "When Planned Start of Assessment Interval (--STINT) is populated, Time Point Reference (--TPTREF)
+ should also be populated."
Executability: Fully Executable
Outcome:
Message: --STINT is populated, but --TPTREF is missing.
diff --git a/Published/CORE-000617/rule.yml b/Published/CORE-000617/rule.yml
index 6450aa874..a258d90ae 100644
--- a/Published/CORE-000617/rule.yml
+++ b/Published/CORE-000617/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5136
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5136
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5136
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5136
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5136
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5136
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5136
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--ENRF'
+ - name: "--ENRF"
operator: exists
Core:
Id: CORE-000617
Status: Published
- Version: '1'
-Description: '--ENRF must not be in SEND dataset'
+ Version: "1"
+Description: "--ENRF must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--ENRF must not be in SEND dataset'
+ Message: "--ENRF must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000618/rule.yml b/Published/CORE-000618/rule.yml
index d7b4c1c10..ad9212214 100644
--- a/Published/CORE-000618/rule.yml
+++ b/Published/CORE-000618/rule.yml
@@ -1,135 +1,135 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled
- terminology list, malignancy status in MIRESCAT should align
- with any benign or malignant designation in NEOPLASM. '
- Document: 'FDA'
- Section: 'FDAB085'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy
+ status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. "
+ Document: "FDA"
+ Section: "FDAB085"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB8501'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB8501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled
- terminology list, malignancy status in MIRESCAT should align
- with any benign or malignant designation in NEOPLASM. '
- Document: 'FDA'
- Section: 'FDAB085'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy
+ status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. "
+ Document: "FDA"
+ Section: "FDAB085"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB8501'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB8501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled
- terminology list, malignancy status in MIRESCAT should align
- with any benign or malignant designation in NEOPLASM. '
- Document: 'FDA'
- Section: 'FDAB085'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy
+ status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. "
+ Document: "FDA"
+ Section: "FDAB085"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB8501'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB8501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled
- terminology list, malignancy status in MIRESCAT should align
- with any benign or malignant designation in NEOPLASM. '
- Document: 'FDA'
- Section: 'FDAB085'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy
+ status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. "
+ Document: "FDA"
+ Section: "FDAB085"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB8501'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB8501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled
- terminology list, malignancy status in MIRESCAT should align
- with any benign or malignant designation in NEOPLASM. '
- Document: 'FDA'
- Section: 'FDAB085'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy
+ status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. "
+ Document: "FDA"
+ Section: "FDAB085"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB8501'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB8501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled
- terminology list, malignancy status in MIRESCAT should align
- with any benign or malignant designation in NEOPLASM. '
- Document: 'FDA'
- Section: 'FDAB085'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy
+ status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. "
+ Document: "FDA"
+ Section: "FDAB085"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB8501'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB8501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled
- terminology list, malignancy status in MIRESCAT should align
- with any benign or malignant designation in NEOPLASM. '
- Document: 'FDA'
- Section: 'FDAB085'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy
+ status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. "
+ Document: "FDA"
+ Section: "FDAB085"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB8501'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB8501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
any:
- all:
- - name: 'MISTRESC'
- # 'contains' means 'contains the word'
+ - name:
+ "MISTRESC"
+ # 'contains' means 'contains the word'
operator: contains
- value: 'BENIGN'
- - name: 'MIRESCAT'
+ value: "BENIGN"
+ - name: "MIRESCAT"
operator: not_equal_to
- value: 'BENIGN'
- # Christy Kubin: METASTATIC is allowed for MALIGNANT but not for BENIGN
+ value:
+ "BENIGN"
+ # Christy Kubin: METASTATIC is allowed for MALIGNANT but not for BENIGN
- all:
- - name: 'MISTRESC'
+ - name: "MISTRESC"
operator: contains
- value: 'MALIGNANT'
- - name: 'MIRESCAT'
+ value: "MALIGNANT"
+ - name: "MIRESCAT"
operator: is_not_contained_by
value:
- - 'MALIGNANT'
- - 'METASTATIC'
+ - "MALIGNANT"
+ - "METASTATIC"
Core:
Id: CORE-000618
Status: Published
- Version: '1'
-Description: 'When value of MISTRESC is using the NEOPLASM CT, it should align
- with the value in MIRESCAT.'
+ Version: "1"
+Description: "When value of MISTRESC is using the NEOPLASM CT, it should align with the value in MIRESCAT."
Executability: Fully Executable
Outcome:
# Or should the message be the other way? I.e. that value in MIRESCAT does not match the value in MISTRESC
- Message: Value of MISTRESC is using the NEOPLASM CT and does not align with the
- value in MIRESCAT.
+ Message: Value of MISTRESC is using the NEOPLASM CT and does not align with the value in MIRESCAT.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000619/rule.yml b/Published/CORE-000619/rule.yml
index 2d19a6262..99207066e 100644
--- a/Published/CORE-000619/rule.yml
+++ b/Published/CORE-000619/rule.yml
@@ -1,98 +1,92 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5303'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB5303"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5303'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB5303"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5303'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB5303"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5303'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB5303"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5303'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB5303"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5303'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB5303"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: TXPARMCD
operator: equal_to
- value: 'AGETXT'
+ value: "AGETXT"
- name: TXVAL
operator: not_matches_regex
value: ^[0-9]+-[0-9]+$
Core:
Id: CORE-000619
Status: Published
- Version: '1'
-Description: Value for Age Range (TXVAL when TXPARMCD = 'AGETXT') should be
- populated with a number-number format when age range is supplied.
+ Version: "1"
+Description: Value for Age Range (TXVAL when TXPARMCD = 'AGETXT') should be populated with a
+ number-number format when age range is supplied.
Executability: Fully Executable
Outcome:
Message: TXVAL value when TXPARMCD = AGETXT is not in number - number format.
diff --git a/Published/CORE-000620/rule.yml b/Published/CORE-000620/rule.yml
index 07da5fcd3..2b6cf76de 100644
--- a/Published/CORE-000620/rule.yml
+++ b/Published/CORE-000620/rule.yml
@@ -11,9 +11,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND113.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -24,9 +24,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND113.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -37,8 +37,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND113.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
@@ -50,85 +50,87 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND113.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
- # 2025-01-05: As identical to FDA business rule FB4901, FDA has been added here
+ Version: "1"
+ Version: "5.0"
+ Version:
+ "1.1"
+ # 2025-01-05: As identical to FDA business rule FB4901, FDA has been added here
- Organization: FDA
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Set code should match trial sets for nonclinical data.'
+ - Cited Guidance: "Set code should match trial sets for nonclinical data."
Document: FDA
Section: FDAB049
Origin: FDA Business Rules
Rule Identifier:
Id: FB4901
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Set code should match trial sets for nonclinical data.'
+ - Cited Guidance: "Set code should match trial sets for nonclinical data."
Document: FDA
Section: FDAB049
Origin: FDA Business Rules
Rule Identifier:
Id: FB4901
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Set code should match trial sets for nonclinical data.'
+ - Cited Guidance: "Set code should match trial sets for nonclinical data."
Document: FDA
Section: FDAB049
Origin: FDA Business Rules
Rule Identifier:
Id: FB4901
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Set code should match trial sets for nonclinical data.'
+ - Cited Guidance: "Set code should match trial sets for nonclinical data."
Document: FDA
Section: FDAB049
Origin: FDA Business Rules
Rule Identifier:
Id: FB4901
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Set code should match trial sets for nonclinical data.'
+ - Cited Guidance: "Set code should match trial sets for nonclinical data."
Document: FDA
Section: FDAB049
Origin: FDA Business Rules
Rule Identifier:
Id: FB4901
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Set code should match trial sets for nonclinical data.'
+ - Cited Guidance: "Set code should match trial sets for nonclinical data."
Document: FDA
Section: FDAB049
Origin: FDA Business Rules
Rule Identifier:
Id: FB4901
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- # P.S. NOT applicable to SENDIG-AR
+ Version: "1"
+ Version: "1.5"
+ Version:
+ "1.2"
+ # P.S. NOT applicable to SENDIG-AR
Check:
all:
- name: SETCD
@@ -139,9 +141,8 @@ Check:
Core:
Id: CORE-000620
Status: Published
- Version: '1'
-Description: SETCD value in the DM dataset should match one of the SETCD values
- in the TX dataset.
+ Version: "1"
+Description: SETCD value in the DM dataset should match one of the SETCD values in the TX dataset.
Executability: Fully Executable
Operations:
- domain: TX
diff --git a/Published/CORE-000621/rule.yml b/Published/CORE-000621/rule.yml
index 5417fec1f..fa3b97915 100644
--- a/Published/CORE-000621/rule.yml
+++ b/Published/CORE-000621/rule.yml
@@ -5,108 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5123
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5123
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5123
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5123
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5123
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5123
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5123
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--SDISAB'
+ - name: "--SDISAB"
operator: exists
Core:
Id: CORE-000621
Status: Published
- Version: '1'
-Description: '--SDISAB (Persist or Signif Disability/Incapacity) must not be in
- SEND dataset'
+ Version: "1"
+Description: "--SDISAB (Persist or Signif Disability/Incapacity) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--SDISAB (Persist or Signif Disability/Incapacity) must not be in SEND
- dataset'
+ Message: "--SDISAB (Persist or Signif Disability/Incapacity) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000622/rule.yml b/Published/CORE-000622/rule.yml
index e68ab1619..d482139b1 100644
--- a/Published/CORE-000622/rule.yml
+++ b/Published/CORE-000622/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5124
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5124
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5124
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5124
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5124
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5124
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5124
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--SDTH'
+ - name: "--SDTH"
operator: exists
Core:
Id: CORE-000622
Status: Published
- Version: '1'
-Description: '--SDTH (Results in Death) must not be in SEND dataset'
+ Version: "1"
+Description: "--SDTH (Results in Death) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--SDTH (Results in Death) must not be in SEND dataset'
+ Message: "--SDTH (Results in Death) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000623/rule.yml b/Published/CORE-000623/rule.yml
index 4b21eb7f4..01c7f763e 100644
--- a/Published/CORE-000623/rule.yml
+++ b/Published/CORE-000623/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5125
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5125
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5125
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5125
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5125
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5125
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5125
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--SHOSP'
+ - name: "--SHOSP"
operator: exists
Core:
Id: CORE-000623
Status: Published
- Version: '1'
-Description: '--SHOSP (Requires or Prolongs Hospitalization) must not be in SEND dataset'
+ Version: "1"
+Description: "--SHOSP (Requires or Prolongs Hospitalization) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--SHOSP (Requires or Prolongs Hospitalization) must not be in SEND dataset'
+ Message: "--SHOSP (Requires or Prolongs Hospitalization) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000624/rule.yml b/Published/CORE-000624/rule.yml
index ca81434f3..3eeb2c368 100644
--- a/Published/CORE-000624/rule.yml
+++ b/Published/CORE-000624/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5126
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5126
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5126
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5126
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5126
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5126
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5126
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--SLIFE'
+ - name: "--SLIFE"
operator: exists
Core:
Id: CORE-000624
Status: Published
- Version: '1'
-Description: '--SLIFE (Is Life Threatening) must not be in SEND dataset'
+ Version: "1"
+Description: "--SLIFE (Is Life Threatening) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--SLIFE (Is Life Threatening) must not be in SEND dataset'
+ Message: "--SLIFE (Is Life Threatening) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000625/rule.yml b/Published/CORE-000625/rule.yml
index 779685576..0da826e55 100644
--- a/Published/CORE-000625/rule.yml
+++ b/Published/CORE-000625/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5127
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5127
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5127
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5127
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5127
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5127
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5127
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--SOD'
+ - name: "--SOD"
operator: exists
Core:
Id: CORE-000625
Status: Published
- Version: '1'
-Description: '--SOD (Occurred with Overdose) must not be in SEND dataset'
+ Version: "1"
+Description: "--SOD (Occurred with Overdose) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--SOD (Occurred with Overdose) must not be in SEND dataset'
+ Message: "--SOD (Occurred with Overdose) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000626/rule.yml b/Published/CORE-000626/rule.yml
index a7974184c..ff158849a 100644
--- a/Published/CORE-000626/rule.yml
+++ b/Published/CORE-000626/rule.yml
@@ -5,107 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5128
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5128
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5128
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5128
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5128
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5128
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5128
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--SMIE'
+ - name: "--SMIE"
operator: exists
Core:
Id: CORE-000626
Status: Published
- Version: '1'
-Description: '--SMIE (Other Medically Important Serious Event) must not be in SEND dataset'
+ Version: "1"
+Description: "--SMIE (Other Medically Important Serious Event) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--SMIE (Other Medically Important Serious Event) must not be in SEND
- dataset'
+ Message: "--SMIE (Other Medically Important Serious Event) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000627/rule.yml b/Published/CORE-000627/rule.yml
index a1893a065..762150491 100644
--- a/Published/CORE-000627/rule.yml
+++ b/Published/CORE-000627/rule.yml
@@ -5,107 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5129
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5129
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5129
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5129
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5129
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5129
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5129
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--SOC'
+ - name: "--SOC"
operator: exists
Core:
Id: CORE-000627
Status: Published
- Version: '1'
-Description: '--SOC (Primary System Organ Class) must not be in SEND dataset'
+ Version: "1"
+Description: "--SOC (Primary System Organ Class) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--SOC (Primary System Organ Class) must not be in SEND dataset) must
- not be in SEND dataset'
+ Message: "--SOC (Primary System Organ Class) must not be in SEND dataset) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000628/rule.yml b/Published/CORE-000628/rule.yml
index e70636580..4d4da7f4a 100644
--- a/Published/CORE-000628/rule.yml
+++ b/Published/CORE-000628/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5130
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5130
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5130
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5130
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5130
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5130
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5130
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--SOCCD'
+ - name: "--SOCCD"
operator: exists
Core:
Id: CORE-000628
Status: Published
- Version: '1'
-Description: '--SOCCD (Primary System Organ Class Code) must not be in SEND dataset'
+ Version: "1"
+Description: "--SOCCD (Primary System Organ Class Code) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--SOCCD (Primary System Organ Class Code) must not be in SEND dataset'
+ Message: "--SOCCD (Primary System Organ Class Code) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000629/rule.yml b/Published/CORE-000629/rule.yml
index 8cfaf2b96..74c60d439 100644
--- a/Published/CORE-000629/rule.yml
+++ b/Published/CORE-000629/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5131
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5131
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5131
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5131
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5131
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5131
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5131
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--PRESP'
+ - name: "--PRESP"
operator: exists
Core:
Id: CORE-000629
Status: Published
- Version: '1'
-Description: '--PRESP (Pre-specified) must not be in SEND dataset'
+ Version: "1"
+Description: "--PRESP (Pre-specified) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--PRESP (Pre-specified) must not be in SEND dataset'
+ Message: "--PRESP (Pre-specified) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000630/rule.yml b/Published/CORE-000630/rule.yml
index 20ce33906..2081484b0 100644
--- a/Published/CORE-000630/rule.yml
+++ b/Published/CORE-000630/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5140
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5140
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5140
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5140
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5140
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5140
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5140
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--ENRTPT'
+ - name: "--ENRTPT"
operator: exists
Core:
Id: CORE-000630
Status: Published
- Version: '1'
-Description: '--ENRTPT must not be in SEND dataset'
+ Version: "1"
+Description: "--ENRTPT must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--ENRTPT must not be in SEND dataset'
+ Message: "--ENRTPT must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000631/rule.yml b/Published/CORE-000631/rule.yml
index bacd41e4e..b8b7f38ca 100644
--- a/Published/CORE-000631/rule.yml
+++ b/Published/CORE-000631/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5110
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5110
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5110
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5110
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5110
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5110
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5110
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: 'RFICDTC'
+ - name: "RFICDTC"
operator: exists
Core:
Id: CORE-000631
Status: Published
- Version: '1'
-Description: 'RFICDTC must not be present in SEND dataset'
+ Version: "1"
+Description: "RFICDTC must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: 'RFICDTC must not be present in SEND dataset'
+ Message: "RFICDTC must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000632/rule.yml b/Published/CORE-000632/rule.yml
index 308ef9a37..fdf9305f6 100644
--- a/Published/CORE-000632/rule.yml
+++ b/Published/CORE-000632/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5111
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5111
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5111
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5111
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5111
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5111
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5111
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: 'RFPENDTC'
+ - name: "RFPENDTC"
operator: exists
Core:
Id: CORE-000632
Status: Published
- Version: '1'
-Description: 'RFPENDTC must not be present in SEND dataset'
+ Version: "1"
+Description: "RFPENDTC must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: 'RFPENDTC must not be present in SEND dataset'
+ Message: "RFPENDTC must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000633/rule.yml b/Published/CORE-000633/rule.yml
index 657ab00d1..f2538f623 100644
--- a/Published/CORE-000633/rule.yml
+++ b/Published/CORE-000633/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5109
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5109
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5109
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5109
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5109
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5109
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5109
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: 'RACE'
+ - name: "RACE"
operator: exists
Core:
Id: CORE-000633
Status: Published
- Version: '1'
-Description: 'RACE must not be present in SEND dataset'
+ Version: "1"
+Description: "RACE must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: 'RACE must not be present in SEND dataset'
+ Message: "RACE must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000634/rule.yml b/Published/CORE-000634/rule.yml
index ec4a3b2d1..22e53e852 100644
--- a/Published/CORE-000634/rule.yml
+++ b/Published/CORE-000634/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5108
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5108
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5108
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5108
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5108
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5108
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5108
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: 'INVNAM'
+ - name: "INVNAM"
operator: exists
Core:
Id: CORE-000634
Status: Published
- Version: '1'
-Description: 'INVNAM must not be present in SEND dataset'
+ Version: "1"
+Description: "INVNAM must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: 'INVNAM must not be present in SEND dataset'
+ Message: "INVNAM must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000635/rule.yml b/Published/CORE-000635/rule.yml
index 25b1223d6..268357c42 100644
--- a/Published/CORE-000635/rule.yml
+++ b/Published/CORE-000635/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5107
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5107
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5107
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5107
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5107
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5107
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5107
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: 'INVID'
+ - name: "INVID"
operator: exists
Core:
Id: CORE-000635
Status: Published
- Version: '1'
-Description: 'INVID must not be present in SEND dataset'
+ Version: "1"
+Description: "INVID must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: 'INVID must not be present in SEND dataset'
+ Message: "INVID must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000636/rule.yml b/Published/CORE-000636/rule.yml
index 63ba8878f..861f74fa1 100644
--- a/Published/CORE-000636/rule.yml
+++ b/Published/CORE-000636/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5106
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5106
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5106
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5106
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5106
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5106
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5106
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: 'ETHNIC'
+ - name: "ETHNIC"
operator: exists
Core:
Id: CORE-000636
Status: Published
- Version: '1'
-Description: 'ETHNIC must not be present in SEND dataset'
+ Version: "1"
+Description: "ETHNIC must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: 'ETHNIC must not be present in SEND dataset'
+ Message: "ETHNIC must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000637/rule.yml b/Published/CORE-000637/rule.yml
index f8162e3f5..9f8359bcd 100644
--- a/Published/CORE-000637/rule.yml
+++ b/Published/CORE-000637/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5105
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5105
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5105
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5105
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5105
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5105
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5105
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: 'DTHFL'
+ - name: "DTHFL"
operator: exists
Core:
Id: CORE-000637
Status: Published
- Version: '1'
-Description: 'DTHFL must not be present in SEND dataset'
+ Version: "1"
+Description: "DTHFL must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: 'DTHFL must not be present in SEND dataset'
+ Message: "DTHFL must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000638/rule.yml b/Published/CORE-000638/rule.yml
index 3ca74a32b..654c80acd 100644
--- a/Published/CORE-000638/rule.yml
+++ b/Published/CORE-000638/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5104
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5104
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5104
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5104
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5104
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5104
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5104
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: 'DTHDTC'
+ - name: "DTHDTC"
operator: exists
Core:
Id: CORE-000638
Status: Published
- Version: '1'
-Description: 'DTHDTC must not be present in SEND dataset'
+ Version: "1"
+Description: "DTHDTC must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: 'DTHDTC must not be present in SEND dataset'
+ Message: "DTHDTC must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000639/rule.yml b/Published/CORE-000639/rule.yml
index 3f28655a3..9693dce2a 100644
--- a/Published/CORE-000639/rule.yml
+++ b/Published/CORE-000639/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5103
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5103
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5103
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5103
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5103
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5103
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5103
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: 'COUNTRY'
+ - name: "COUNTRY"
operator: exists
Core:
Id: CORE-000639
Status: Published
- Version: '1'
-Description: 'COUNTRY must not be present in SEND dataset'
+ Version: "1"
+Description: "COUNTRY must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: 'COUNTRY must not be present in SEND dataset'
+ Message: "COUNTRY must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000640/rule.yml b/Published/CORE-000640/rule.yml
index ebf07a327..431f6c371 100644
--- a/Published/CORE-000640/rule.yml
+++ b/Published/CORE-000640/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5102
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5102
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5102
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5102
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5102
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5102
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5102
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: 'ACTARM'
+ - name: "ACTARM"
operator: exists
Core:
Id: CORE-000640
Status: Published
- Version: '1'
-Description: 'ACTARM must not be present in SEND dataset'
+ Version: "1"
+Description: "ACTARM must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: 'ACTARM must not be present in SEND dataset'
+ Message: "ACTARM must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000641/rule.yml b/Published/CORE-000641/rule.yml
index de83109b6..d42a6a297 100644
--- a/Published/CORE-000641/rule.yml
+++ b/Published/CORE-000641/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5101
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5101
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5101
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5101
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5101
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5101
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5101
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: 'ACTARMCD'
+ - name: "ACTARMCD"
operator: exists
Core:
Id: CORE-000641
Status: Published
- Version: '1'
-Description: 'ACTARMCD must not be present in SEND dataset'
+ Version: "1"
+Description: "ACTARMCD must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: 'ACTARMCD must not be present in SEND dataset'
+ Message: "ACTARMCD must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000642/rule.yml b/Published/CORE-000642/rule.yml
index 7be3d414c..27083a923 100644
--- a/Published/CORE-000642/rule.yml
+++ b/Published/CORE-000642/rule.yml
@@ -1,129 +1,139 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
# Applicable to SDTMIG versions 3.2, 3.3, 3.4
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4404'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB4404"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4404'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB4404"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4404'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- # REMARK: SENDIG: NOT applicable to SEND 3.0 and 3.1
- - Name: 'SENDIG'
+ Id: "FB4404"
+ Version: "1"
+ Version: "1.5"
+ Version:
+ "3.4"
+ # REMARK: SENDIG: NOT applicable to SEND 3.0 and 3.1
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4404'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4404"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4404'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4404"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4404'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB4404"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4404'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB4404"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4404'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB4404"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
# REMARK: --TPTNUM and --ENINT both are usually "permissible"
all:
- - name: '--TPTREF'
+ - name: "--TPTREF"
operator: exists
- - name: '--ENINT'
+ - name: "--ENINT"
operator: exists
- - name: '--ENINT'
- operator: 'non_empty'
- - name: '--TPTREF'
- operator: 'empty'
+ - name: "--ENINT"
+ operator: "non_empty"
+ - name: "--TPTREF"
+ operator: "empty"
Core:
Id: CORE-000642
Status: Published
- Version: '1'
-Description: 'When Planned End of Assessment Interval (--ENINT) is populated,
- Time Point Reference (--TPTREF) should also be populated.'
+ Version: "1"
+Description:
+ "When Planned End of Assessment Interval (--ENINT) is populated, Time Point Reference (--TPTREF)
+ should also be populated."
Executability: Fully Executable
Outcome:
Message: --ENINT is populated, but --TPTREF is missing.
diff --git a/Published/CORE-000643/rule.yml b/Published/CORE-000643/rule.yml
index 83840d115..525486d6e 100644
--- a/Published/CORE-000643/rule.yml
+++ b/Published/CORE-000643/rule.yml
@@ -4,147 +4,158 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.'
+ - Cited Guidance:
+ "Records with a baseline flag should have a corresponding standard result with
+ a standardized unit where available."
Document: FDA
Section: FDAB026
Origin: FDA Business Rules
Rule Identifier:
Id: FB2601
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.'
+ - Cited Guidance:
+ "Records with a baseline flag should have a corresponding standard result with
+ a standardized unit where available."
Document: FDA
Section: FDAB026
Origin: FDA Business Rules
Rule Identifier:
Id: FB2601
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.'
+ - Cited Guidance:
+ "Records with a baseline flag should have a corresponding standard result with
+ a standardized unit where available."
Document: FDA
Section: FDAB026
Origin: FDA Business Rules
Rule Identifier:
Id: FB2601
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.'
+ - Cited Guidance:
+ "Records with a baseline flag should have a corresponding standard result with
+ a standardized unit where available."
Document: FDA
Section: FDAB026
Origin: FDA Business Rules
Rule Identifier:
Id: FB2601
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.'
+ - Cited Guidance:
+ "Records with a baseline flag should have a corresponding standard result with
+ a standardized unit where available."
Document: FDA
Section: FDAB026
Origin: FDA Business Rules
Rule Identifier:
Id: FB2601
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.'
+ - Cited Guidance:
+ "Records with a baseline flag should have a corresponding standard result with
+ a standardized unit where available."
Document: FDA
Section: FDAB026
Origin: FDA Business Rules
Rule Identifier:
Id: FB2601
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.'
+ - Cited Guidance:
+ "Records with a baseline flag should have a corresponding standard result with
+ a standardized unit where available."
Document: FDA
Section: FDAB026
Origin: FDA Business Rules
Rule Identifier:
Id: FB2601
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.'
+ - Cited Guidance:
+ "Records with a baseline flag should have a corresponding standard result with
+ a standardized unit where available."
Document: FDA
Section: FDAB026
Origin: FDA Business Rules
Rule Identifier:
Id: FB2601
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.'
+ - Cited Guidance:
+ "Records with a baseline flag should have a corresponding standard result with
+ a standardized unit where available."
Document: FDA
Section: FDAB026
Origin: FDA Business Rules
Rule Identifier:
Id: FB2601
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.'
+ - Cited Guidance:
+ "Records with a baseline flag should have a corresponding standard result with
+ a standardized unit where available."
Document: FDA
Section: FDAB026
Origin: FDA Business Rules
Rule Identifier:
Id: FB2601
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --BLFL
operator: equal_to
- value: 'Y'
+ value: "Y"
- name: --STRESC
operator: empty
Core:
- Id: 'CORE-000643'
+ Id: "CORE-000643"
Status: Published
- Version: '1'
-Description: 'Records with a baseline flag (--BLFL) have a non missing value in
- character standard result variable (--STRESC)'
+ Version: "1"
+Description:
+ "Records with a baseline flag (--BLFL) have a non missing value in character standard result
+ variable (--STRESC)"
Executability: Fully Executable
Outcome:
Message: 'BLFL is set to "Y", but no value for STRESC is provided'
diff --git a/Published/CORE-000645/rule.yml b/Published/CORE-000645/rule.yml
index 2bde23efd..7898a2675 100644
--- a/Published/CORE-000645/rule.yml
+++ b/Published/CORE-000645/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB8601
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB8601
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -34,9 +34,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB8601
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -46,9 +46,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB8601
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
@@ -58,9 +58,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB8601
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -70,9 +70,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB8601
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
@@ -82,9 +82,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB8601
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
# throw an error when both AGE and AGETXT are not present in DM
@@ -96,7 +96,7 @@ Check:
Core:
Id: CORE-000645
Status: Published
- Version: '1'
+ Version: "1"
Description: At least one of variables AGE or AGETXT is present in the DM dataset.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000648/rule.yml b/Published/CORE-000648/rule.yml
index ec122a63a..213a4ebf4 100644
--- a/Published/CORE-000648/rule.yml
+++ b/Published/CORE-000648/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB8602
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB8602
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -34,9 +34,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB8602
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -46,9 +46,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB8602
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
@@ -58,9 +58,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB8602
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -70,9 +70,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB8602
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
@@ -82,9 +82,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB8602
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
any:
# Commented out 2025-05-05: See Jora comment Nick de Donder https://jira.cdisc.org/browse/CORERULES-9331
@@ -104,7 +104,7 @@ Check:
Core:
Id: CORE-000648
Status: Published
- Version: '1'
+ Version: "1"
Description: AGE or AGETXT should be populated in the DM dataset.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000649/rule.yml b/Published/CORE-000649/rule.yml
index 0f574406c..36a5f3407 100644
--- a/Published/CORE-000649/rule.yml
+++ b/Published/CORE-000649/rule.yml
@@ -5,108 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5112
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5112
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5112
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5112
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5112
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5112
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5112
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--BDSYCD'
+ - name: "--BDSYCD"
operator: exists
Core:
Id: CORE-000649
Status: Published
- Version: '1'
-Description: '--BDSYCD (Body System or Organ Class Code) must not be present in
- SEND dataset'
+ Version: "1"
+Description: "--BDSYCD (Body System or Organ Class Code) must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--BDSYCD (Body System or Organ Class Code) must not be present in SEND
- dataset'
+ Message: "--BDSYCD (Body System or Organ Class Code) must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000650/rule.yml b/Published/CORE-000650/rule.yml
index 3c1196ae5..8d8324800 100644
--- a/Published/CORE-000650/rule.yml
+++ b/Published/CORE-000650/rule.yml
@@ -4,81 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: --ORRES is an Expected variable and should always be populated
- except when --STAT = 'NOT DONE'
+ - Cited Guidance:
+ --ORRES is an Expected variable and should always be populated except when
+ --STAT = 'NOT DONE'
Document: IG v3.0
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND86.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: --ORRES is an Expected variable and should always be populated
- except when --STAT = 'NOT DONE'
+ - Cited Guidance:
+ --ORRES is an Expected variable and should always be populated except when
+ --STAT = 'NOT DONE'
Document: IG v3.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND86.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: --ORRES is an Expected variable and should always be populated
- except when --STAT = 'NOT DONE'
+ - Cited Guidance:
+ --ORRES is an Expected variable and should always be populated except when
+ --STAT = 'NOT DONE'
Document: IG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND86.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: --ORRES is an Expected variable and should always be populated
- except when --STAT = 'NOT DONE'
+ - Cited Guidance:
+ --ORRES is an Expected variable and should always be populated except when
+ --STAT = 'NOT DONE'
Document: IG v3.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND86.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: --ORRES is an Expected variable and should always be populated
- except when --STAT = 'NOT DONE'
+ - Cited Guidance:
+ --ORRES is an Expected variable and should always be populated except when
+ --STAT = 'NOT DONE'
Document: IG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND86.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: --ORRES is an Expected variable and should always be populated
- except when --STAT = 'NOT DONE'
+ - Cited Guidance:
+ --ORRES is an Expected variable and should always be populated except when
+ --STAT = 'NOT DONE'
Document: IG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND86.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: --STAT
@@ -89,7 +95,7 @@ Check:
Core:
Id: CORE-000650
Status: Published
- Version: '1'
+ Version: "1"
Description: Data should not be presented in the --ORRES variable if --STAT = "NOT DONE".
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000651/rule.yml b/Published/CORE-000651/rule.yml
index 4dcdd266a..86538589a 100644
--- a/Published/CORE-000651/rule.yml
+++ b/Published/CORE-000651/rule.yml
@@ -1,214 +1,205 @@
Authorities:
- - Organization: CDISC
- # REMARK: not applicable to SENDIG-3.0
+ - Organization:
+ CDISC
+ # REMARK: not applicable to SENDIG-3.0
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1
- Section: '4.4.7.2.1'
+ Section: "4.4.7.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND290'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND290"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1.1
- Section: '4.4.7.2.1'
+ Section: "4.4.7.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND290'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND290"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1
- Section: '4.4.7.2.1'
+ Section: "4.4.7.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND290'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND290"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1.1
- Section: '4.4.7.2.1'
+ Section: "4.4.7.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND290'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND290"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1.1
- Section: '4.4.7.2.1'
+ Section: "4.4.7.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND290'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND290"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Organization: FDA
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0926
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0926
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0913
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0913
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0913
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0913
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0913
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# The implementation only checks 1:1 relationship between --TPT and --TPTNUM
Check:
all:
@@ -226,7 +217,7 @@ Check:
Core:
Id: CORE-000651
Status: Published
- Version: '1'
+ Version: "1"
Description: --TPT and --TPTNUM should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000652/rule.yml b/Published/CORE-000652/rule.yml
index 7d99fbc74..cea51f4a7 100644
--- a/Published/CORE-000652/rule.yml
+++ b/Published/CORE-000652/rule.yml
@@ -1,21 +1,21 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Only animals on the study are included, negative and/or positive
- controls from another study are not included in the
- domain. Study data are not typically directly compared
- against the positive control data.
+ - Cited Guidance:
+ Only animals on the study are included, negative and/or positive controls
+ from another study are not included in the domain. Study data are not typically directly
+ compared against the positive control data.
Document: SENDIG-GENETOX
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND410
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
- all:
@@ -25,16 +25,18 @@ Check:
- all:
- name: USUBJID
operator: is_not_contained_by
- value: $ex_usubjid
- # TODO?: no record in EX is expected when the subject is an "Untreated Control",
- # i.e. DM.SETCD has a value from TX.TXVAL='Untreated Control' for TXPARMCD=TCNTRL
- # After discussion with SEND team: we will NOT implement the second part "except when the subject is an untreated control", as this may cause false positives.
+ value:
+ $ex_usubjid
+ # TODO?: no record in EX is expected when the subject is an "Untreated Control",
+ # i.e. DM.SETCD has a value from TX.TXVAL='Untreated Control' for TXPARMCD=TCNTRL
+ # After discussion with SEND team: we will NOT implement the second part "except when the subject is an untreated control", as this may cause false positives.
Core:
Id: CORE-000652
Status: Published
- Version: '1'
-Description: 'Only animals on the study are included, negative and/or positive
- controls from another study are not included in the domain'
+ Version: "1"
+Description:
+ "Only animals on the study are included, negative and/or positive controls from another study
+ are not included in the domain"
Executability: Partially Executable - Possible Overreporting
Operations:
- domain: DM
@@ -46,7 +48,7 @@ Operations:
name: USUBJID
operator: distinct
Outcome:
- Message: 'No record for USUBJID is found in DM or EC'
+ Message: "No record for USUBJID is found in DM or EC"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000653/negative/01/results/results.csv b/Published/CORE-000653/negative/01/results/results.csv
index 72c2cb74f..5e2636035 100644
--- a/Published/CORE-000653/negative/01/results/results.csv
+++ b/Published/CORE-000653/negative/01/results/results.csv
@@ -7,5 +7,3 @@ DS,5,DSDTC,2018-05-08T09:13
DS,5,DSENDTC,2018-05-08T08:00
DS,6,DSDTC,2018-09-21
DS,6,DSENDTC,2018-09-04
-DS,8,DSDTC,2018-09-21T09:21
-DS,8,DSENDTC,2018-09-21
diff --git a/Published/CORE-000653/rule.yml b/Published/CORE-000653/rule.yml
index 809abb483..15730e638 100644
--- a/Published/CORE-000653/rule.yml
+++ b/Published/CORE-000653/rule.yml
@@ -4,98 +4,104 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be
- calculated by the difference in these two values...
+ - Cited Guidance:
+ If both --DTC and --ENDTC are collected, durations can be calculated by the
+ difference in these two values...
Document: IG v3.0
Section: 4.4.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND58
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be
- calculated by the difference in these two values...
+ - Cited Guidance:
+ If both --DTC and --ENDTC are collected, durations can be calculated by the
+ difference in these two values...
Document: IG v3.1
Section: 4.4.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND58
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be
- calculated by the difference in these two values...
+ - Cited Guidance:
+ If both --DTC and --ENDTC are collected, durations can be calculated by the
+ difference in these two values...
Document: IG v3.1.1
Section: 4.4.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND58
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be
- calculated by the difference in these two values...
+ - Cited Guidance:
+ If both --DTC and --ENDTC are collected, durations can be calculated by the
+ difference in these two values...
Document: IG v3.1
Section: 4.4.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND58
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be
- calculated by the difference in these two values...
+ - Cited Guidance:
+ If both --DTC and --ENDTC are collected, durations can be calculated by the
+ difference in these two values...
Document: IG v3.1.1
Section: 4.4.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND58
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be
- calculated by the difference in these two values...
+ - Cited Guidance:
+ If both --DTC and --ENDTC are collected, durations can be calculated by the
+ difference in these two values...
Document: IG v3.1.1
Section: 4.4.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND58
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: "The length of time an observation continues, i.e., the duration
- of the observation, is represented using variables - --DTC or
- --STDTC for the start of the observation and --ENDTC for the
- end of the observation when date/times are collected."
+ - Cited Guidance:
+ "The length of time an observation continues, i.e., the duration of the observation,
+ is represented using variables - --DTC or --STDTC for the start of the observation and --ENDTC
+ for the end of the observation when date/times are collected."
Document: TIG v1.0
Item: Text
Section: 2.8.7.5 Representing Planned and Actual Timing
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0264
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --ENDTC
@@ -108,7 +114,7 @@ Check:
Core:
Id: CORE-000653
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when --ENDTC before --DTC
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000654/rule.yml b/Published/CORE-000654/rule.yml
index 9a56a193f..3f9961474 100644
--- a/Published/CORE-000654/rule.yml
+++ b/Published/CORE-000654/rule.yml
@@ -5,103 +5,93 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND292'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND292"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND292'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND292"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND292'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND292"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND292'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND292"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND292'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND292"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: --TPTNUM
@@ -118,9 +108,8 @@ Check:
Core:
Id: CORE-000654
Status: Published
- Version: '1'
-Description: There must be a one-to-one relationship between the values of --TPT
- and --TPTNUM
+ Version: "1"
+Description: There must be a one-to-one relationship between the values of --TPT and --TPTNUM
Executability: Fully Executable
Outcome:
Message: The relationship between --TPT and --TPTNUM is not a one-to-one relationship
diff --git a/Published/CORE-000660/negative/01/data/.env b/Published/CORE-000660/negative/01/data/.env
index 3eef46d54..2d7f67aab 100644
--- a/Published/CORE-000660/negative/01/data/.env
+++ b/Published/CORE-000660/negative/01/data/.env
@@ -1,4 +1,3 @@
PRODUCT=TIG
VERSION=1-0
-SUBSTANDARD=SEND
-USE_CASE=NONCLIN
+SUBSTANDARD=sdtm
diff --git a/Published/CORE-000660/rule.yml b/Published/CORE-000660/rule.yml
index 018895647..9d4ec9259 100644
--- a/Published/CORE-000660/rule.yml
+++ b/Published/CORE-000660/rule.yml
@@ -1,39 +1,38 @@
# Variable: SPTOBID
# Rule: SPTOBID in TO.SPTOBID
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: SPTOBID is used in the Product Design (PD), Tobacco Ingredients
- (IT), Non-Tobacco Ingredients (IN), and Ingredient Quantities
- by Component (IQ) domains, as well as any domain in the
- general observation classes where there are records pertaining
- to the tobacco product it identifies/describes (e.g., PT).
- Every value of SPTOBID in any dataset must correspond to a
- product described in the TO dataset.
- Document: 'TIG 1.0'
- Item: 'assumption 1b'
- Section: '2.8.8.1'
+ - Cited Guidance:
+ SPTOBID is used in the Product Design (PD), Tobacco Ingredients (IT),
+ Non-Tobacco Ingredients (IN), and Ingredient Quantities by Component (IQ) domains, as well
+ as any domain in the general observation classes where there are records pertaining to the
+ tobacco product it identifies/describes (e.g., PT). Every value of SPTOBID in any dataset
+ must correspond to a product described in the TO dataset.
+ Document: "TIG 1.0"
+ Item: "assumption 1b"
+ Section: "2.8.8.1"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0002'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0002"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SPTOBID
operator: is_not_contained_by
value: $to_sptobid
Core:
- Status: Published
- Version: '1'
Id: CORE-000660
-Description: Part A - Raise an error when the value of SPTOBID in the dataset
- does not correspond to a SPTOBID value present in TO.
+ Status: Published
+ Version: "1"
+Description: Part A - Raise an error when the value of SPTOBID in the dataset does not correspond to
+ a SPTOBID value present in TO.
Executability: Fully Executable
Operations:
- domain: TO
diff --git a/Published/CORE-000661/rule.yml b/Published/CORE-000661/rule.yml
index af5fe12a2..18c9fb732 100644
--- a/Published/CORE-000661/rule.yml
+++ b/Published/CORE-000661/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5113
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5113
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5113
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5113
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5113
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5113
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5113
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--HLT'
+ - name: "--HLT"
operator: exists
Core:
Id: CORE-000661
Status: Published
- Version: '1'
-Description: '--HLT (High Level Term) must not be present in SEND dataset'
+ Version: "1"
+Description: "--HLT (High Level Term) must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--HLT (High Level Term) must not be present in SEND dataset'
+ Message: "--HLT (High Level Term) must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000662/rule.yml b/Published/CORE-000662/rule.yml
index b574ad3d6..03153aef2 100644
--- a/Published/CORE-000662/rule.yml
+++ b/Published/CORE-000662/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5114
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5114
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5114
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5114
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5114
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5114
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5114
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--HLTCD'
+ - name: "--HLTCD"
operator: exists
Core:
Id: CORE-000662
Status: Published
- Version: '1'
-Description: '--HLTCD (High Level Term Code) must not be in SEND dataset'
+ Version: "1"
+Description: "--HLTCD (High Level Term Code) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--HLTCD (High Level Term Code) must not be in SEND dataset'
+ Message: "--HLTCD (High Level Term Code) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000663/rule.yml b/Published/CORE-000663/rule.yml
index 2b7c8f474..a9f25d6d3 100644
--- a/Published/CORE-000663/rule.yml
+++ b/Published/CORE-000663/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5115
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5115
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5115
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5115
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5115
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5115
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5115
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--HLGT'
+ - name: "--HLGT"
operator: exists
Core:
Id: CORE-000663
Status: Published
- Version: '1'
-Description: '--HLGT (High Level Group Term) must not be in SEND dataset'
+ Version: "1"
+Description: "--HLGT (High Level Group Term) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--HLGT (High Level Group Term) must not be in SEND dataset'
+ Message: "--HLGT (High Level Group Term) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000664/rule.yml b/Published/CORE-000664/rule.yml
index f37c31fa3..c2dcb28f8 100644
--- a/Published/CORE-000664/rule.yml
+++ b/Published/CORE-000664/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5116
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5116
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5116
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5116
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5116
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5116
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5116
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--LLT'
+ - name: "--LLT"
operator: exists
Core:
Id: CORE-000664
Status: Published
- Version: '1'
-Description: '--LLT (Lower Level Term) must not be in SEND dataset'
+ Version: "1"
+Description: "--LLT (Lower Level Term) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--LLT (Lower Level Term) must not be in SEND dataset'
+ Message: "--LLT (Lower Level Term) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000665/rule.yml b/Published/CORE-000665/rule.yml
index d60910ae8..5d6cd0876 100644
--- a/Published/CORE-000665/rule.yml
+++ b/Published/CORE-000665/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5117
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5117
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5117
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5117
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5117
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5117
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5117
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--LLTCD'
+ - name: "--LLTCD"
operator: exists
Core:
Id: CORE-000665
Status: Published
- Version: '1'
-Description: '--LLTCD (Lower Level Term Code) must not be in SEND dataset'
+ Version: "1"
+Description: "--LLTCD (Lower Level Term Code) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--LLTCD (Lower Level Term Code) must not be in SEND dataset'
+ Message: "--LLTCD (Lower Level Term Code) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000667/rule.yml b/Published/CORE-000667/rule.yml
index 71ece93dc..e4a61b120 100644
--- a/Published/CORE-000667/rule.yml
+++ b/Published/CORE-000667/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5118
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5118
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5118
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5118
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5118
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5118
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5118
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--PARTY'
+ - name: "--PARTY"
operator: exists
Core:
Id: CORE-000667
Status: Published
- Version: '1'
-Description: '--PARTY (Accountable Party) must not be in SEND dataset'
+ Version: "1"
+Description: "--PARTY (Accountable Party) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--PARTY (Accountable Party) must not be in SEND dataset'
+ Message: "--PARTY (Accountable Party) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000668/rule.yml b/Published/CORE-000668/rule.yml
index dd741a0ac..4829c7196 100644
--- a/Published/CORE-000668/rule.yml
+++ b/Published/CORE-000668/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5119
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5119
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5119
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5119
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5119
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5119
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5119
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--PRTYID'
+ - name: "--PRTYID"
operator: exists
Core:
Id: CORE-000668
Status: Published
- Version: '1'
-Description: '--PRTYID (Identification of Accountable Party) must not be in SEND dataset'
+ Version: "1"
+Description: "--PRTYID (Identification of Accountable Party) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--PRTYID (Identification of Accountable Party) must not be in SEND dataset'
+ Message: "--PRTYID (Identification of Accountable Party) must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000669/rule.yml b/Published/CORE-000669/rule.yml
index c532fefab..4569a563b 100644
--- a/Published/CORE-000669/rule.yml
+++ b/Published/CORE-000669/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5135
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5135
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5135
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5135
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5135
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5135
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5135
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--STRF'
+ - name: "--STRF"
operator: exists
Core:
Id: CORE-000669
Status: Published
- Version: '1'
-Description: '--STRF must not be in SEND dataset'
+ Version: "1"
+Description: "--STRF must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--STRF must not be in SEND dataset'
+ Message: "--STRF must not be in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000670/rule.yml b/Published/CORE-000670/rule.yml
index 605d0f38a..e3ef189ba 100644
--- a/Published/CORE-000670/rule.yml
+++ b/Published/CORE-000670/rule.yml
@@ -1,60 +1,62 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'The DD domain should only be utilized for subjects with an
- unscheduled death'
+ - Cited Guidance: "The DD domain should only be utilized for subjects with an unscheduled death"
Document: SENDIG v3.0
- Section: '6.3.4.1'
- Origin: 'SEND Conformance Rules'
+ Section: "6.3.4.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND167'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '3.0'
+ Id: "SEND167"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "3.0"
Check:
all:
- - name: 'DDTESTCD'
- operator: non_empty
- # For SENDIG-3.0, there is no DDUSCHFL, so a check is done on DSDECOD
- # which has ACCIDENTAL DEATH, FOUND DEAD, MORIBUND SACRIFICE, NON-MORIBUND SACRIFICE
- # for "unscheduled"
- - name: 'DSDECOD'
- # "is_not_contained_by" gives an error "'list' object has no attribute 'startswith'"
- # WHY?
- #operator: is_not_contained_by
- #value:
- # - 'ACCIDENTAL DEATH'
- # - 'FOUND DEAD'
- # - 'MORIBUND SACRIFICE'
- # - 'NON-MORIBUND SACRIFICE'
+ - name: "DDTESTCD"
+ operator:
+ non_empty
+ # For SENDIG-3.0, there is no DDUSCHFL, so a check is done on DSDECOD
+ # which has ACCIDENTAL DEATH, FOUND DEAD, MORIBUND SACRIFICE, NON-MORIBUND SACRIFICE
+ # for "unscheduled"
+ - name:
+ "DSDECOD"
+ # "is_not_contained_by" gives an error "'list' object has no attribute 'startswith'"
+ # WHY?
+ #operator: is_not_contained_by
+ #value:
+ # - 'ACCIDENTAL DEATH'
+ # - 'FOUND DEAD'
+ # - 'MORIBUND SACRIFICE'
+ # - 'NON-MORIBUND SACRIFICE'
operator: not_equal_to
- value: 'ACCIDENTAL DEATH'
- - name: 'DSDECOD'
+ value: "ACCIDENTAL DEATH"
+ - name: "DSDECOD"
operator: not_equal_to
- value: 'FOUND DEAD'
- - name: 'DSDECOD'
+ value: "FOUND DEAD"
+ - name: "DSDECOD"
operator: not_equal_to
- value: 'MORIBUND SACRIFICE'
- - name: 'DSDECOD'
+ value: "MORIBUND SACRIFICE"
+ - name: "DSDECOD"
operator: not_equal_to
- value: 'NON-MORIBUND SACRIFICE'
+ value: "NON-MORIBUND SACRIFICE"
Core:
Id: CORE-000670
Status: Published
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Match Datasets:
- Keys:
- USUBJID
Name: DS
Outcome:
- Message: 'Record does not have DDSTRESC=ACCIDENTAL DEATH,FOUND DEAD,MORIBUND
- SACRIFICE,NON-MORIBUND SACRIFICE indicating unscheduled death'
+ Message:
+ "Record does not have DDSTRESC=ACCIDENTAL DEATH,FOUND DEAD,MORIBUND SACRIFICE,NON-MORIBUND
+ SACRIFICE indicating unscheduled death"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000671/rule.yml b/Published/CORE-000671/rule.yml
index b3895472b..a7aae5323 100644
--- a/Published/CORE-000671/rule.yml
+++ b/Published/CORE-000671/rule.yml
@@ -1,95 +1,90 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'The DD domain should only be utilized for subjects with an
- unscheduled death'
+ - Cited Guidance: "The DD domain should only be utilized for subjects with an unscheduled death"
Document: SENDIG v3.1
- Section: '6.3.4.1'
- Origin: 'SEND Conformance Rules'
+ Section: "6.3.4.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND167'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "SEND167"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'The DD domain should only be utilized for subjects with an
- unscheduled death'
+ - Cited Guidance: "The DD domain should only be utilized for subjects with an unscheduled death"
Document: SENDIG v3.1.1
- Section: '6.3.4.1'
- Origin: 'SEND Conformance Rules'
+ Section: "6.3.4.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND167'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "SEND167"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'The DD domain should only be utilized for subjects with an
- unscheduled death'
+ - Cited Guidance: "The DD domain should only be utilized for subjects with an unscheduled death"
Document: SENDIG v3.1
- Section: '6.3.4.1'
- Origin: 'SEND Conformance Rules'
+ Section: "6.3.4.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND167'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "SEND167"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'The DD domain should only be utilized for subjects with an
- unscheduled death'
+ - Cited Guidance: "The DD domain should only be utilized for subjects with an unscheduled death"
Document: SENDIG v3.1.1
- Section: '6.3.4.1'
- Origin: 'SEND Conformance Rules'
+ Section: "6.3.4.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND167'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
- - Name: 'SENDIG-GENETOX'
+ Id: "SEND167"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'The DD domain should only be utilized for subjects with an
- unscheduled death'
+ - Cited Guidance: "The DD domain should only be utilized for subjects with an unscheduled death"
Document: SENDIG v3.1.1
- Section: '6.3.4.1'
- Origin: 'SEND Conformance Rules'
+ Section: "6.3.4.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND167'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND167"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- - name: 'DDTESTCD'
+ - name: "DDTESTCD"
operator: non_empty
- - name: 'DSUSCHFL'
+ - name: "DSUSCHFL"
operator: not_equal_to
- value: 'Y'
+ value: "Y"
Core:
Id: CORE-000671
Status: Published
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Match Datasets:
- Keys:
- USUBJID
Name: DS
Outcome:
- Message: 'Record does not have DSUSCHFL=Y in DS'
+ Message: "Record does not have DSUSCHFL=Y in DS"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000672/rule.yml b/Published/CORE-000672/rule.yml
index e6bf30e90..1ce232d5d 100644
--- a/Published/CORE-000672/rule.yml
+++ b/Published/CORE-000672/rule.yml
@@ -1,136 +1,146 @@
Authorities:
- Organization: FDA
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3901'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB3901"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3901'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB3901"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3901'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB3901"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3901'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB3901"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3901'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB3901"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3901'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3901"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3901'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3901"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3901'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB3901"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3901'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-AR'
+ Id: "FB3901"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3901'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB3901"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --STNRHI
@@ -143,9 +153,9 @@ Check:
Core:
Id: CORE-000672
Status: Published
- Version: '1'
-Description: Normal Range Upper Limit-Standard Units (--STNRHI) should be
- greater than the Normal Range Lower Limit-Standard Units (--STNRLO).
+ Version: "1"
+Description: Normal Range Upper Limit-Standard Units (--STNRHI) should be greater than the Normal
+ Range Lower Limit-Standard Units (--STNRLO).
Executability: Fully Executable
Outcome:
Message: --STNRHI is less than or equal to --STNRLO.
diff --git a/Published/CORE-000673/negative/01/data/iq.csv b/Published/CORE-000673/negative/01/data/iq.csv
index 255de2f14..4bb16ceee 100644
--- a/Published/CORE-000673/negative/01/data/iq.csv
+++ b/Published/CORE-000673/negative/01/data/iq.csv
@@ -1,6 +1,6 @@
STUDYID,DOMAIN,SPTOBID,IGDCMPID,IQCAT,IQPARENT,IQLEVEL,IQFUNCT,IQVALTRG,IQVALMIN,IQVALMAX,IQVALU
-TOB07,IQ,CIG01A,Tobacco Filler,TOBACCO INGREDIENT,,1,,683.71,661.3,683.7,mg/cigarette
+TOB07,IQ,CIG01A,Tobacco Filler,TOBACCO INGREDIENT,,1,,603.71,661.3,683.7,mg/cigarette
TOB07,IQ,CIG01A,Bright Tobacco,TOBACCO INGREDIENT,Tobacco Filler,2,,306,295,305,mg/cigarette
TOB07,IQ,CIG01A,Oriental Tobacco,TOBACCO INGREDIENT,Tobacco Filler,2,,118,,117,mg/cigarette
TOB07,IQ,CIG01A,Cationic Starch,NON-TOBACCO INGREDIENT,FSC Paper B,2,Binder,0.46,,0.45,mg/cigarette
-TOB07,IQ,CIG01A,Seam Adhesive,NON-TOBACCO INGREDIENT,FSC Paper B,2,Adhesive,-0.24,-1.75,-0.25,mg/cigarette
+TOB07,IQ,CIG01A,Seam Adhesive,NON-TOBACCO INGREDIENT,FSC Paper B,2,Adhesive,-2.24,-1.75,-0.25,mg/cigarette
diff --git a/Published/CORE-000673/negative/01/results/results.csv b/Published/CORE-000673/negative/01/results/results.csv
new file mode 100644
index 000000000..590c8919c
--- /dev/null
+++ b/Published/CORE-000673/negative/01/results/results.csv
@@ -0,0 +1,9 @@
+Dataset,Record,Variable,Value
+IQ,1,IGDCMPID,Tobacco Filler
+IQ,1,IQVALMIN,661.3
+IQ,1,IQVALTRG,603.71
+IQ,1,SPTOBID,CIG01A
+IQ,5,IGDCMPID,Seam Adhesive
+IQ,5,IQVALMIN,-1.75
+IQ,5,IQVALTRG,-2.24
+IQ,5,SPTOBID,CIG01A
diff --git a/Published/CORE-000673/rule.yml b/Published/CORE-000673/rule.yml
index 5534ecf6e..08c46cdfa 100644
--- a/Published/CORE-000673/rule.yml
+++ b/Published/CORE-000673/rule.yml
@@ -2,22 +2,22 @@
# Condition: --VALTRG is a number
# Rule: --VALMIN <= --VALTRG <= --VALMAX
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- Cited Guidance: No specific guidance; this is a simple mathematical definition
- Document: 'TIG 1.0'
- Item: 'Specification Table: IQVALTRG | IQVALMIN | IQVALMAX'
- Section: '2.8.8.6'
+ Document: "TIG 1.0"
+ Item: "Specification Table: IQVALTRG | IQVALMIN | IQVALMAX"
+ Section: "2.8.8.6"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0016a'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0016a"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --VALTRG
@@ -30,11 +30,11 @@ Check:
operator: less_than
value: --VALMIN
Core:
- Status: Published
- Version: '1'
Id: CORE-000673
-Description: Part A - Raise an error when --VALTRG is a number and is less than
- the specified --VALMIN value.
+ Status: Published
+ Version: "1"
+Description: Part A - Raise an error when --VALTRG is a number and is less than the specified
+ --VALMIN value.
Executability: Fully Executable
Outcome:
Message: --VALTRG is not equal to or greater than the --VALMIN value.
diff --git a/Published/CORE-000674/negative/01/data/_datasets.csv b/Published/CORE-000674/negative/01/data/_datasets.csv
index 2f28eb4c1..8829a8a4b 100644
--- a/Published/CORE-000674/negative/01/data/_datasets.csv
+++ b/Published/CORE-000674/negative/01/data/_datasets.csv
@@ -1,2 +1,2 @@
Filename,Label
-iq,Ingredient Quantities by Component
+pd,Product Design Parameters
diff --git a/Published/CORE-000674/negative/01/data/_variables.csv b/Published/CORE-000674/negative/01/data/_variables.csv
index 4d51d0d4d..be4a7a9e2 100644
--- a/Published/CORE-000674/negative/01/data/_variables.csv
+++ b/Published/CORE-000674/negative/01/data/_variables.csv
@@ -1,13 +1,10 @@
dataset,variable,label,type,length
-iq,STUDYID,Study Identifier,Char,50
-iq,DOMAIN,Domain Abbreviation,Char,50
-iq,SPTOBID,Applicant-Defined Tobacco Product ID,Char,50
-iq,IGDCMPID,Ingredient or Component Identifier,Char,50
-iq,IQCAT,Category of Ingredient or Component,Char,50
-iq,IQPARENT,Parent of Ingredient or Component,Char,50
-iq,IQLEVEL,Ingredient Level in Hierarchy,Num,50
-iq,IQFUNCT,Ingredient Function,Char,50
-iq,IQVALTRG,Ingredient Target Value,Num,50
-iq,IQVALMIN,Ingredient Minimum Value,Num,50
-iq,IQVALMAX,Ingredient Maximum Value,Num,50
-iq,IQVALU,Ingredient Value Unit,Char,50
+pd,STUDYID,Study Identifier,Char,200
+pd,DOMAIN,Domain Abbreviation,Char,200
+pd,SPTOBID,Applicant-Defined Tobacco Product ID,Char,40
+pd,PDSEQ,Sequence Number,Num,10
+pd,PDPARMCD,Design Parameter Element Short Name,Char,8
+pd,PDPARM,Design Parameter Element Name,Char,40
+pd,PDVALTRG,Design Parameter Element Target Value,Char,50
+pd,PDVALMAX,Design Parameter Element Maximum Value,Char,50
+pd,PDVALU,Design Parameter Element Value Unit,Char,50
diff --git a/Published/CORE-000674/negative/01/data/pd.csv b/Published/CORE-000674/negative/01/data/pd.csv
new file mode 100644
index 000000000..1ebb0b6fa
--- /dev/null
+++ b/Published/CORE-000674/negative/01/data/pd.csv
@@ -0,0 +1,12 @@
+STUDYID,DOMAIN,SPTOBID,PDSEQ,PDPARMCD,PDPARM,PDVALTRG,PDVALMAX,PDVALU
+TOB09,PD,VAPE-Z27,2,PUFCNT,Puff Count,311,310,
+TOB09,PD,VAPE-Z27,3,CRTVOL,Cartridge Volume,3,2.9,mL
+TOB09,PD,VAPE-Z27,4,HTELNUM,Number of Heating Elements,-1.1,-2.1,
+TOB09,PD,VAPE-Z27,5,HTELGTH,Heating Element Length,3.4,3.3,mm
+TOB09,PD,VAPE-Z27,9,HTELCFG,Heating Element Configuration,SPIRAL,SPIRAL,
+TOB09,PD,VAPE-Z27,10,BTVLTORG,Battery Voltage Operating Range,4.5,4,V
+TOB09,PD,VAPE-Z27,11,BTCRTORG,Battery Current Operating Range,1601,1600.99,mAh
+TOB09,PD,VAPE-Z27,21,PDUVOR,PDU Voltage Operating Range,4.3,4.2,V
+TOB09,PD,VAPE-Z27,22,PDUCOR,PDU Current Operating Range,YES,NO,
+TOB09,PD,VAPE-Z27,23,PDUTCTOF,PDU Temperature Cut-off,70,69,C
+TOB09,PD,VAPE-Z27,24,AIRFLRT,Airflow Rate,800,740,L/min
diff --git a/Published/CORE-000674/negative/01/results/results.csv b/Published/CORE-000674/negative/01/results/results.csv
index 243a5867d..5a36682f3 100644
--- a/Published/CORE-000674/negative/01/results/results.csv
+++ b/Published/CORE-000674/negative/01/results/results.csv
@@ -1,21 +1,37 @@
Dataset,Record,Variable,Value
-IQ,1,IGDCMPID,Tobacco Filler
-IQ,1,IQVALMAX,683.7
-IQ,1,IQVALTRG,683.71
-IQ,1,SPTOBID,CIG01A
-IQ,2,IGDCMPID,Bright Tobacco
-IQ,2,IQVALMAX,305.0
-IQ,2,IQVALTRG,306.0
-IQ,2,SPTOBID,CIG01A
-IQ,3,IGDCMPID,Oriental Tobacco
-IQ,3,IQVALMAX,117.0
-IQ,3,IQVALTRG,118.0
-IQ,3,SPTOBID,CIG01A
-IQ,4,IGDCMPID,Cationic Starch
-IQ,4,IQVALMAX,0.45
-IQ,4,IQVALTRG,0.46
-IQ,4,SPTOBID,CIG01A
-IQ,5,IGDCMPID,Seam Adhesive
-IQ,5,IQVALMAX,-0.25
-IQ,5,IQVALTRG,-0.24
-IQ,5,SPTOBID,CIG01A
+PD,1,PDPARMCD,PUFCNT
+PD,1,PDVALMAX,310
+PD,1,PDVALTRG,311
+PD,1,SPTOBID,VAPE-Z27
+PD,2,PDPARMCD,CRTVOL
+PD,2,PDVALMAX,2.9
+PD,2,PDVALTRG,3
+PD,2,SPTOBID,VAPE-Z27
+PD,3,PDPARMCD,HTELNUM
+PD,3,PDVALMAX,-2.1
+PD,3,PDVALTRG,-1.1
+PD,3,SPTOBID,VAPE-Z27
+PD,4,PDPARMCD,HTELGTH
+PD,4,PDVALMAX,3.3
+PD,4,PDVALTRG,3.4
+PD,4,SPTOBID,VAPE-Z27
+PD,6,PDPARMCD,BTVLTORG
+PD,6,PDVALMAX,4
+PD,6,PDVALTRG,4.5
+PD,6,SPTOBID,VAPE-Z27
+PD,7,PDPARMCD,BTCRTORG
+PD,7,PDVALMAX,1600.99
+PD,7,PDVALTRG,1601
+PD,7,SPTOBID,VAPE-Z27
+PD,8,PDPARMCD,PDUVOR
+PD,8,PDVALMAX,4.2
+PD,8,PDVALTRG,4.3
+PD,8,SPTOBID,VAPE-Z27
+PD,10,PDPARMCD,PDUTCTOF
+PD,10,PDVALMAX,69
+PD,10,PDVALTRG,70
+PD,10,SPTOBID,VAPE-Z27
+PD,11,PDPARMCD,AIRFLRT
+PD,11,PDVALMAX,740
+PD,11,PDVALTRG,800
+PD,11,SPTOBID,VAPE-Z27
diff --git a/Published/CORE-000674/negative/02/data/.env b/Published/CORE-000674/negative/02/data/.env
new file mode 100644
index 000000000..0ce633d09
--- /dev/null
+++ b/Published/CORE-000674/negative/02/data/.env
@@ -0,0 +1,4 @@
+PRODUCT=TIG
+VERSION=1-0
+SUBSTANDARD=SDTM
+USE_CASE=PROD
diff --git a/Published/CORE-000674/negative/02/data/_datasets.csv b/Published/CORE-000674/negative/02/data/_datasets.csv
new file mode 100644
index 000000000..8829a8a4b
--- /dev/null
+++ b/Published/CORE-000674/negative/02/data/_datasets.csv
@@ -0,0 +1,2 @@
+Filename,Label
+pd,Product Design Parameters
diff --git a/Published/CORE-000674/negative/02/data/_variables.csv b/Published/CORE-000674/negative/02/data/_variables.csv
new file mode 100644
index 000000000..948838ab0
--- /dev/null
+++ b/Published/CORE-000674/negative/02/data/_variables.csv
@@ -0,0 +1,9 @@
+dataset,variable,label,type,length
+pd,STUDYID,Study Identifier,Char,200
+pd,DOMAIN,Domain Abbreviation,Char,200
+pd,SPTOBID,Applicant-Defined Tobacco Product ID,Char,40
+pd,PDSEQ,Sequence Number,Num,10
+pd,PDPARM,Design Parameter Element Name,Char,40
+pd,PDVALTRG,Design Parameter Element Target Value,Char,50
+pd,PDVALMAX,Design Parameter Element Maximum Value,Char,50
+pd,PDVALU,Design Parameter Element Value Unit,Char,50
diff --git a/Published/CORE-000674/negative/02/data/pd.csv b/Published/CORE-000674/negative/02/data/pd.csv
new file mode 100644
index 000000000..9e02de392
--- /dev/null
+++ b/Published/CORE-000674/negative/02/data/pd.csv
@@ -0,0 +1,12 @@
+STUDYID,DOMAIN,SPTOBID,PDSEQ,PDPARM,PDVALTRG,PDVALMAX,PDVALU
+TOB09,PD,VAPE-Z27,2,Puff Count,300,310,
+TOB09,PD,VAPE-Z27,3,Cartridge Volume,3,2.9,mL
+TOB09,PD,VAPE-Z27,4,Number of Heating Elements,,,
+TOB09,PD,VAPE-Z27,5,Heating Element Length,,3.3,mm
+TOB09,PD,VAPE-Z27,9,Heating Element Configuration,SPIRAL,SPIRAL,
+TOB09,PD,VAPE-Z27,10,Battery Voltage Operating Range,4.5,4,V
+TOB09,PD,VAPE-Z27,11,Battery Current Operating Range,1601,,mAh
+TOB09,PD,VAPE-Z27,21,PDU Voltage Operating Range,3,4.2,V
+TOB09,PD,VAPE-Z27,22,PDU Current Operating Range,YES,NO,
+TOB09,PD,VAPE-Z27,23,PDU Temperature Cut-off,70,69,C
+TOB09,PD,VAPE-Z27,24,Airflow Rate,699,740,L/min
diff --git a/Published/CORE-000674/negative/02/results/results.csv b/Published/CORE-000674/negative/02/results/results.csv
new file mode 100644
index 000000000..18a66d21d
--- /dev/null
+++ b/Published/CORE-000674/negative/02/results/results.csv
@@ -0,0 +1,13 @@
+Dataset,Record,Variable,Value
+PD,2,PDPARMCD,Not in dataset
+PD,2,PDVALMAX,2.9
+PD,2,PDVALTRG,3
+PD,2,SPTOBID,VAPE-Z27
+PD,6,PDPARMCD,Not in dataset
+PD,6,PDVALMAX,4
+PD,6,PDVALTRG,4.5
+PD,6,SPTOBID,VAPE-Z27
+PD,10,PDPARMCD,Not in dataset
+PD,10,PDVALMAX,69
+PD,10,PDVALTRG,70
+PD,10,SPTOBID,VAPE-Z27
diff --git a/Published/CORE-000674/negative/03/data/.env b/Published/CORE-000674/negative/03/data/.env
new file mode 100644
index 000000000..0ce633d09
--- /dev/null
+++ b/Published/CORE-000674/negative/03/data/.env
@@ -0,0 +1,4 @@
+PRODUCT=TIG
+VERSION=1-0
+SUBSTANDARD=SDTM
+USE_CASE=PROD
diff --git a/Published/CORE-000674/negative/03/data/_datasets.csv b/Published/CORE-000674/negative/03/data/_datasets.csv
new file mode 100644
index 000000000..2f28eb4c1
--- /dev/null
+++ b/Published/CORE-000674/negative/03/data/_datasets.csv
@@ -0,0 +1,2 @@
+Filename,Label
+iq,Ingredient Quantities by Component
diff --git a/Published/CORE-000674/negative/03/data/_variables.csv b/Published/CORE-000674/negative/03/data/_variables.csv
new file mode 100644
index 000000000..4d51d0d4d
--- /dev/null
+++ b/Published/CORE-000674/negative/03/data/_variables.csv
@@ -0,0 +1,13 @@
+dataset,variable,label,type,length
+iq,STUDYID,Study Identifier,Char,50
+iq,DOMAIN,Domain Abbreviation,Char,50
+iq,SPTOBID,Applicant-Defined Tobacco Product ID,Char,50
+iq,IGDCMPID,Ingredient or Component Identifier,Char,50
+iq,IQCAT,Category of Ingredient or Component,Char,50
+iq,IQPARENT,Parent of Ingredient or Component,Char,50
+iq,IQLEVEL,Ingredient Level in Hierarchy,Num,50
+iq,IQFUNCT,Ingredient Function,Char,50
+iq,IQVALTRG,Ingredient Target Value,Num,50
+iq,IQVALMIN,Ingredient Minimum Value,Num,50
+iq,IQVALMAX,Ingredient Maximum Value,Num,50
+iq,IQVALU,Ingredient Value Unit,Char,50
diff --git a/Published/CORE-000674/negative/01/data/iq.csv b/Published/CORE-000674/negative/03/data/iq.csv
similarity index 100%
rename from Published/CORE-000674/negative/01/data/iq.csv
rename to Published/CORE-000674/negative/03/data/iq.csv
diff --git a/Published/CORE-000674/negative/03/results/results.csv b/Published/CORE-000674/negative/03/results/results.csv
new file mode 100644
index 000000000..243a5867d
--- /dev/null
+++ b/Published/CORE-000674/negative/03/results/results.csv
@@ -0,0 +1,21 @@
+Dataset,Record,Variable,Value
+IQ,1,IGDCMPID,Tobacco Filler
+IQ,1,IQVALMAX,683.7
+IQ,1,IQVALTRG,683.71
+IQ,1,SPTOBID,CIG01A
+IQ,2,IGDCMPID,Bright Tobacco
+IQ,2,IQVALMAX,305.0
+IQ,2,IQVALTRG,306.0
+IQ,2,SPTOBID,CIG01A
+IQ,3,IGDCMPID,Oriental Tobacco
+IQ,3,IQVALMAX,117.0
+IQ,3,IQVALTRG,118.0
+IQ,3,SPTOBID,CIG01A
+IQ,4,IGDCMPID,Cationic Starch
+IQ,4,IQVALMAX,0.45
+IQ,4,IQVALTRG,0.46
+IQ,4,SPTOBID,CIG01A
+IQ,5,IGDCMPID,Seam Adhesive
+IQ,5,IQVALMAX,-0.25
+IQ,5,IQVALTRG,-0.24
+IQ,5,SPTOBID,CIG01A
diff --git a/Published/CORE-000674/rule.yml b/Published/CORE-000674/rule.yml
index 79f4fb6fd..2a70a2042 100644
--- a/Published/CORE-000674/rule.yml
+++ b/Published/CORE-000674/rule.yml
@@ -2,22 +2,22 @@
# Condition: --VALTRG is a number
# Rule: --VALMIN <= --VALTRG <= --VALMAX
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- Cited Guidance: No specific guidance; this is a simple mathematical definition
- Document: 'TIG 1.0'
- Item: 'Specification Table: IQVALTRG | IQVALMIN | IQVALMAX'
- Section: '2.8.8.6'
+ Document: "TIG 1.0"
+ Item: "Specification Table: IQVALTRG | IQVALMIN | IQVALMAX"
+ Section: "2.8.8.6"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0016a'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0016a"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --VALTRG
@@ -30,11 +30,11 @@ Check:
operator: greater_than
value: --VALMAX
Core:
- Status: Published
- Version: '1'
Id: CORE-000674
-Description: Part B - Raise an error when --VALTRG is a number and is greater
- than the specified --VALMAX value.
+ Status: Published
+ Version: "1"
+Description: Part B - Raise an error when --VALTRG is a number and is greater than the specified
+ --VALMAX value.
Executability: Fully Executable
Outcome:
Message: --VALTRG is not equal to or less than the --VALMAX value.
diff --git a/Published/CORE-000675/rule.yml b/Published/CORE-000675/rule.yml
index 9c0ac25cb..e764c947b 100644
--- a/Published/CORE-000675/rule.yml
+++ b/Published/CORE-000675/rule.yml
@@ -4,134 +4,134 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Section: FDAB042
Origin: FDA Business Rules
Rule Identifier:
Id: FB4201
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Origin: FDA Business Rules
Rule Identifier:
Id: FB4201
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Origin: FDA Business Rules
Rule Identifier:
Id: FB4201
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Origin: FDA Business Rules
Rule Identifier:
Id: FB4201
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Origin: FDA Business Rules
Rule Identifier:
Id: FB4201
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Origin: FDA Business Rules
Rule Identifier:
Id: FB4201
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Origin: FDA Business Rules
Rule Identifier:
Id: FB4201
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Origin: FDA Business Rules
Rule Identifier:
Id: FB4201
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Origin: FDA Business Rules
Rule Identifier:
Id: FB4201
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Origin: FDA Business Rules
Rule Identifier:
Id: FB4201
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --STAT
@@ -148,11 +148,12 @@ Check:
Core:
Id: CORE-000675
Status: Published
- Version: '1'
-Description: When a test is not done (--STAT = 'NOT DONE'), the result variables (--ORRES and --STRESC) should not be populated.
+ Version: "1"
+Description: When a test is not done (--STAT = 'NOT DONE'), the result variables (--ORRES and
+ --STRESC) should not be populated.
Executability: Fully Executable
Outcome:
- Message: '--STAT = NOT DONE, but a result variable (--ORRES, --STRESC and/or --STRESN) is populated.'
+ Message: "--STAT = NOT DONE, but a result variable (--ORRES, --STRESC and/or --STRESN) is populated."
Output Variables:
- --TESTCD
- --ORRES
diff --git a/Published/CORE-000676/rule.yml b/Published/CORE-000676/rule.yml
index 53d9b5fe6..8e2adb17a 100644
--- a/Published/CORE-000676/rule.yml
+++ b/Published/CORE-000676/rule.yml
@@ -1,28 +1,27 @@
# Variable: SPTOBID
# Rule: SPTOBID in TO.SPTOBID
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: SPTOBID is used in the Product Design (PD), Tobacco Ingredients
- (IT), Non-Tobacco Ingredients (IN), and Ingredient Quantities
- by Component (IQ) domains, as well as any domain in the
- general observation classes where there are records pertaining
- to the tobacco product it identifies/describes (e.g., PT).
- Every value of SPTOBID in any dataset must correspond to a
- product described in the TO dataset.
- Document: 'TIG 1.0'
- Item: 'assumption 1b'
- Section: '2.8.8.1'
+ - Cited Guidance:
+ SPTOBID is used in the Product Design (PD), Tobacco Ingredients (IT),
+ Non-Tobacco Ingredients (IN), and Ingredient Quantities by Component (IQ) domains, as well
+ as any domain in the general observation classes where there are records pertaining to the
+ tobacco product it identifies/describes (e.g., PT). Every value of SPTOBID in any dataset
+ must correspond to a product described in the TO dataset.
+ Document: "TIG 1.0"
+ Item: "assumption 1b"
+ Section: "2.8.8.1"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0002'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0002"
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: TXPARMCD
@@ -33,12 +32,11 @@ Check:
operator: is_not_contained_by
value: $to_sptobid
Core:
- Status: Published
- Version: '1'
Id: CORE-000676
-Description: Part B - Raise an error when the value of TXVAL for TXPARMCD =
- SPTOBID in the TX dataset does not correspond to a SPTOBID value present in
- TO.
+ Status: Published
+ Version: "1"
+Description: Part B - Raise an error when the value of TXVAL for TXPARMCD = SPTOBID in the TX
+ dataset does not correspond to a SPTOBID value present in TO.
Executability: Fully Executable
Operations:
- domain: TO
@@ -46,8 +44,8 @@ Operations:
name: SPTOBID
operator: distinct
Outcome:
- Message: Value in TXVAL for TXPARMCD = SPTOBID in the TX dataset does not
- correspond to a SPTOBID value in TO.
+ Message: Value in TXVAL for TXPARMCD = SPTOBID in the TX dataset does not correspond to a SPTOBID
+ value in TO.
Output Variables:
- TXVAL
- $to_sptobid
diff --git a/Published/CORE-000677/negative/01/data/_datasets.csv b/Published/CORE-000677/negative/01/data/_datasets.csv
index 71f47d966..17424bac4 100644
--- a/Published/CORE-000677/negative/01/data/_datasets.csv
+++ b/Published/CORE-000677/negative/01/data/_datasets.csv
@@ -1,3 +1,2 @@
Filename,Label
vs,Vital Signs
-pooldef,Pool Definition
diff --git a/Published/CORE-000677/negative/01/data/_variables.csv b/Published/CORE-000677/negative/01/data/_variables.csv
index d4eebc7a9..1ddac9181 100644
--- a/Published/CORE-000677/negative/01/data/_variables.csv
+++ b/Published/CORE-000677/negative/01/data/_variables.csv
@@ -4,6 +4,3 @@ vs,DOMAIN,Domain Abbreviation,Char,2
vs,USUBJID,Unique Subject Identifier,Char,8
vs,POOLID,Pool Identfier,Char,8
vs,VSSEQ,Sequence Number,Num,8
-pooldef,STUDYID,Study Identifier,Char,12
-pooldef,POOLID,Pool Identfier,Char,8
-pooldef,USUBJID,Unique Subject Identifier,Char,8
diff --git a/Published/CORE-000677/negative/01/data/pooldef.csv b/Published/CORE-000677/negative/01/data/pooldef.csv
deleted file mode 100644
index b20d93d12..000000000
--- a/Published/CORE-000677/negative/01/data/pooldef.csv
+++ /dev/null
@@ -1,7 +0,0 @@
-STUDYID,POOLID,USUBJID
-CDISCPILOT01,POOL1,
-CDISCPILOT01,POOL1,
-CDISCPILOT01,POOL1,
-CDISCPILOT01,POOL2,
-CDISCPILOT01,POOL2,
-CDISCPILOT01,POOL2,
diff --git a/Published/CORE-000677/negative/02/data/_datasets.csv b/Published/CORE-000677/negative/02/data/_datasets.csv
index 71f47d966..996df63ae 100644
--- a/Published/CORE-000677/negative/02/data/_datasets.csv
+++ b/Published/CORE-000677/negative/02/data/_datasets.csv
@@ -1,3 +1,2 @@
Filename,Label
-vs,Vital Signs
-pooldef,Pool Definition
+vs,Vital Signs
\ No newline at end of file
diff --git a/Published/CORE-000677/negative/02/data/_variables.csv b/Published/CORE-000677/negative/02/data/_variables.csv
index d4eebc7a9..1ddac9181 100644
--- a/Published/CORE-000677/negative/02/data/_variables.csv
+++ b/Published/CORE-000677/negative/02/data/_variables.csv
@@ -4,6 +4,3 @@ vs,DOMAIN,Domain Abbreviation,Char,2
vs,USUBJID,Unique Subject Identifier,Char,8
vs,POOLID,Pool Identfier,Char,8
vs,VSSEQ,Sequence Number,Num,8
-pooldef,STUDYID,Study Identifier,Char,12
-pooldef,POOLID,Pool Identfier,Char,8
-pooldef,USUBJID,Unique Subject Identifier,Char,8
diff --git a/Published/CORE-000677/positive/02/data/_datasets.csv b/Published/CORE-000677/positive/02/data/_datasets.csv
index 17424bac4..71f47d966 100644
--- a/Published/CORE-000677/positive/02/data/_datasets.csv
+++ b/Published/CORE-000677/positive/02/data/_datasets.csv
@@ -1,2 +1,3 @@
Filename,Label
vs,Vital Signs
+pooldef,Pool Definition
diff --git a/Published/CORE-000677/positive/02/data/_variables.csv b/Published/CORE-000677/positive/02/data/_variables.csv
index ec37b34c8..c8529fb82 100644
--- a/Published/CORE-000677/positive/02/data/_variables.csv
+++ b/Published/CORE-000677/positive/02/data/_variables.csv
@@ -23,3 +23,6 @@ vs,VSDTC,Date/Time of Measurements,Char,10
vs,VSDY,Study Day of Vital Signs,Num,8
vs,VSTPT,Planned Time Point Name,Char,200
vs,VSTPTNUM,Planned Time Point Number,Num,8
+pooldef,STUDYID,Study Identifier,Char,12
+pooldef,POOLID,Pool Identfier,Char,8
+pooldef,USUBJID,Unique Subject Identifier,Char,8
\ No newline at end of file
diff --git a/Published/CORE-000677/negative/02/data/pooldef.csv b/Published/CORE-000677/positive/02/data/pooldef.csv
similarity index 100%
rename from Published/CORE-000677/negative/02/data/pooldef.csv
rename to Published/CORE-000677/positive/02/data/pooldef.csv
diff --git a/Published/CORE-000677/rule.yml b/Published/CORE-000677/rule.yml
index d60b6fc18..f9cf1f44e 100644
--- a/Published/CORE-000677/rule.yml
+++ b/Published/CORE-000677/rule.yml
@@ -4,102 +4,109 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: SENDIG v3.0
Item: POOLID CDISC Notes
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND139
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: SENDIG v3.1
Item: POOLID CDISC Notes
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND139
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: SENDIG v3.1.1
Item: POOLID CDISC Notes
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND139
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: SENDIG v3.1
Item: POOLID CDISC Notes
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND139
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: SENDIG v3.1.1
Item: POOLID CDISC Notes
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND139
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: SENDIG v3.1.1
Item: POOLID CDISC Notes
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND139
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: TIG v1.0
Item: POOLID CDISC Notes
Section: 2.8.9.22
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0075
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: $poolid_exists
@@ -110,9 +117,8 @@ Check:
Core:
Id: CORE-000677
Status: Published
- Version: '1'
-Description: Part A - Raise error when POOLID exists in the dataset but POOLDEF
- does not exist.
+ Version: "1"
+Description: Part A - Raise error when POOLID exists in the dataset but POOLDEF does not exist.
Executability: Fully Executable
Operations:
- id: $poolid_exists
diff --git a/Published/CORE-000678/rule.yml b/Published/CORE-000678/rule.yml
index 36d5961c1..a6bc94625 100644
--- a/Published/CORE-000678/rule.yml
+++ b/Published/CORE-000678/rule.yml
@@ -4,102 +4,109 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: SENDIG v3.0
Item: POOLID CDISC Notes
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND139
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: SENDIG v3.1
Item: POOLID CDISC Notes
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND139
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: SENDIG v3.1.1
Item: POOLID CDISC Notes
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND139
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: SENDIG v3.1
Item: POOLID CDISC Notes
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND139
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: SENDIG v3.1.1
Item: POOLID CDISC Notes
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND139
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: SENDIG v3.1.1
Item: POOLID CDISC Notes
Section: 6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND139
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each
- subject and the USUBJID must be null.
+ - Cited Guidance:
+ If POOLID is entered, POOLDEF records must exist for each subject and the
+ USUBJID must be null.
Document: TIG v1.0
Item: POOLID CDISC Notes
Section: 2.8.9.22
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0075
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: POOLID
@@ -110,9 +117,9 @@ Check:
Core:
Id: CORE-000678
Status: Published
- Version: '1'
-Description: Part B - Raise error when value for POOLID in the dataset is not a
- POOLID value in POOLDEF.
+ Version: "1"
+Description: Part B - Raise error when value for POOLID in the dataset is not a POOLID value in
+ POOLDEF.
Executability: Fully Executable
Operations:
- domain: POOLDEF
diff --git a/Published/CORE-000680/rule.yml b/Published/CORE-000680/rule.yml
index a08a21e5e..ec93f4306 100644
--- a/Published/CORE-000680/rule.yml
+++ b/Published/CORE-000680/rule.yml
@@ -4,28 +4,29 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A unit must not be specified for a planned enrollment number or
- a planned completion number.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A unit must not be specified for a planned enrollment number or a planned completion
+ number."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00043'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00043"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Range'
+ value: "Range"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: parent_rel
operator: is_contained_by
value:
- - 'plannedCompletionNumber'
- - 'plannedEnrollmentNumber'
+ - "plannedCompletionNumber"
+ - "plannedEnrollmentNumber"
- not:
any:
- name: unit
@@ -36,15 +37,13 @@ Check:
- name: unit
operator: not_exists
Core:
- Id: 'CORE-000680'
+ Id: "CORE-000680"
Status: Published
- Version: '1'
-Description: 'A unit must not be specified for a planned enrollment number or a
- planned completion number.'
+ Version: "1"
+Description: "A unit must not be specified for a planned enrollment number or a planned completion number."
Executability: Fully Executable
Outcome:
- Message: 'A unit is specified for a planned enrollment number or a planned
- completion number.'
+ Message: "A unit is specified for a planned enrollment number or a planned completion number."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000681/rule.yml b/Published/CORE-000681/rule.yml
index 213f9cca6..ac9ed17e6 100644
--- a/Published/CORE-000681/rule.yml
+++ b/Published/CORE-000681/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'At least one attribute must be specified for an address.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "At least one attribute must be specified for an address."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00045'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00045"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Address'
+ value: "Address"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: text
operator: not_exists
@@ -59,13 +59,13 @@ Check:
operator: equal_to
value: false
Core:
- Id: 'CORE-000681'
+ Id: "CORE-000681"
Status: Published
- Version: '1'
-Description: 'At least one attribute must be specified for an address.'
+ Version: "1"
+Description: "At least one attribute must be specified for an address."
Executability: Fully Executable
Outcome:
- Message: 'All attributes of the address are blank.'
+ Message: "All attributes of the address are blank."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000682/rule.yml b/Published/CORE-000682/rule.yml
index bc2bfbeb1..10fd94888 100644
--- a/Published/CORE-000682/rule.yml
+++ b/Published/CORE-000682/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled decision instance is not expected to refer to a
- timeline exit.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A scheduled decision instance is not expected to refer to a timeline exit."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00064'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00064"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'ScheduledDecisionInstance'
+ value: "ScheduledDecisionInstance"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- not:
any:
- name: timelineExitId
@@ -28,13 +27,13 @@ Check:
- name: timelineExitId
operator: empty
Core:
- Id: 'CORE-000682'
+ Id: "CORE-000682"
Status: Published
- Version: '1'
-Description: 'A scheduled decision instance is not expected to refer to a timeline exit.'
+ Version: "1"
+Description: "A scheduled decision instance is not expected to refer to a timeline exit."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The scheduled decision instance refers to a timeline exit.'
+ Message: "The scheduled decision instance refers to a timeline exit."
Output Variables:
- parent_entity
- parent_id
@@ -46,5 +45,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ScheduledDecisionInstance'
+ - "ScheduledDecisionInstance"
Sensitivity: Record
diff --git a/Published/CORE-000683/rule.yml b/Published/CORE-000683/rule.yml
index 536c4bb36..751598c24 100644
--- a/Published/CORE-000683/rule.yml
+++ b/Published/CORE-000683/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled decision instance is not expected to have a
- sub-timeline.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A scheduled decision instance is not expected to have a sub-timeline."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00065'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00065"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'ScheduledDecisionInstance'
+ value: "ScheduledDecisionInstance"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- not:
any:
- name: timelineId
@@ -28,13 +27,13 @@ Check:
- name: timelineId
operator: empty
Core:
- Id: 'CORE-000683'
+ Id: "CORE-000683"
Status: Published
- Version: '1'
-Description: 'A scheduled decision instance is not expected to have a sub-timeline.'
+ Version: "1"
+Description: "A scheduled decision instance is not expected to have a sub-timeline."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The scheduled decision instance has a sub-timeline.'
+ Message: "The scheduled decision instance has a sub-timeline."
Output Variables:
- parent_entity
- parent_id
@@ -46,5 +45,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ScheduledDecisionInstance'
+ - "ScheduledDecisionInstance"
Sensitivity: Record
diff --git a/Published/CORE-000684/rule.yml b/Published/CORE-000684/rule.yml
index bdd3acd66..2c9278b44 100644
--- a/Published/CORE-000684/rule.yml
+++ b/Published/CORE-000684/rule.yml
@@ -4,36 +4,35 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The minimum value of a range must be less than or equal to the
- maximum value of the range.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "The minimum value of a range must be less than or equal to the maximum value
+ of the range."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00070'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00070"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Range'
+ value: "Range"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: minValue
operator: greater_than
value: maxValue
Core:
- Id: 'CORE-000684'
+ Id: "CORE-000684"
Status: Published
- Version: '1'
-Description: 'The minimum value of a range must be less than or equal to the
- maximum value of the range.'
+ Version: "1"
+Description: "The minimum value of a range must be less than or equal to the maximum value of the range."
Executability: Fully Executable
Outcome:
- Message: 'The minimum value of the range is not less than or equal to the
- maximum value.'
+ Message: "The minimum value of the range is not less than or equal to the maximum value."
Output Variables:
- parent_entity
- parent_id
@@ -45,5 +44,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Range'
+ - "Range"
Sensitivity: Record
diff --git a/Published/CORE-000690/rule.yml b/Published/CORE-000690/rule.yml
index 2b5490a0c..3133700ed 100644
--- a/Published/CORE-000690/rule.yml
+++ b/Published/CORE-000690/rule.yml
@@ -4,8 +4,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which
- should be unique for each variable in the dataset.
+ - Cited Guidance:
+ A descriptive Variable Label, using up to 40 characters, which should be
+ unique for each variable in the dataset.
Document: SENDIG v3.0
Item: Text
Section: 3.2.2
@@ -18,8 +19,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which
- should be unique for each variable in the dataset.
+ - Cited Guidance:
+ A descriptive Variable Label, using up to 40 characters, which should be
+ unique for each variable in the dataset.
Document: SENDIG v3.1
Item: Text
Section: 3.2.2
@@ -32,8 +34,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which
- should be unique for each variable in the dataset.
+ - Cited Guidance:
+ A descriptive Variable Label, using up to 40 characters, which should be
+ unique for each variable in the dataset.
Document: SENDIG v3.1.1
Item: Text
Section: 3.2.2
@@ -46,8 +49,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which
- should be unique for each variable in the dataset.
+ - Cited Guidance:
+ A descriptive Variable Label, using up to 40 characters, which should be
+ unique for each variable in the dataset.
Document: SENDIG v3.1
Item: Text
Section: 3.2.2
@@ -60,8 +64,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which
- should be unique for each variable in the dataset.
+ - Cited Guidance:
+ A descriptive Variable Label, using up to 40 characters, which should be
+ unique for each variable in the dataset.
Document: SENDIG v3.1.1
Item: Text
Section: 3.2.2
@@ -74,8 +79,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which
- should be unique for each variable in the dataset.
+ - Cited Guidance:
+ A descriptive Variable Label, using up to 40 characters, which should be
+ unique for each variable in the dataset.
Document: SENDIG v3.1.1
Item: Text
Section: 3.2.2
@@ -88,9 +94,9 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be
- provided as data variable labels for all variables, including
- Supplemental Qualifier variables
+ - Cited Guidance:
+ Descriptive labels per this guide, up to 40 characters, will be provided as
+ data variable labels for all variables, including Supplemental Qualifier variables
Document: TIG v1.0
Item: Text
Section: 2.6 Guidance for Datasets, Tabulation Dataset, Num 5
@@ -107,11 +113,10 @@ Check:
operator: is_not_unique_relationship
value: variable_label
Core:
- Status: Published
- Version: '1'
Id: CORE-000690
-Description: Raise an error when the variable label is not unique for each
- variable in the dataset
+ Status: Published
+ Version: "1"
+Description: Raise an error when the variable label is not unique for each variable in the dataset
Executability: Fully Executable
Outcome:
Message: Variable label is not unique for each variable in the dataset.
diff --git a/Published/CORE-000691/rule.yml b/Published/CORE-000691/rule.yml
index f6e797a6b..16079a851 100644
--- a/Published/CORE-000691/rule.yml
+++ b/Published/CORE-000691/rule.yml
@@ -4,26 +4,25 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within an encounter there must be no duplicate environmental
- settings.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within an encounter there must be no duplicate environmental settings."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00053'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00053"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Code'
+ value: "Code"
- name: parent_entity
operator: equal_to
- value: 'Encounter'
+ value: "Encounter"
- name: parent_rel
operator: equal_to
- value: 'environmentalSetting'
+ value: "environmentalSetting"
value_is_literal: true
- name: code
operator: is_not_unique_set
@@ -36,8 +35,8 @@ Check:
Core:
Id: "CORE-000691"
Status: Published
- Version: '1'
-Description: 'Within an encounter there must be no duplicate environmental settings.'
+ Version: "1"
+Description: "Within an encounter there must be no duplicate environmental settings."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -46,8 +45,9 @@ Match Datasets:
- rel_type
Name: Encounter
Outcome:
- Message: 'The environmental settings of the encounter are not unique - the same
- code is used more than once with the same codeSystem and codeSystemVersion.'
+ Message:
+ "The environmental settings of the encounter are not unique - the same code is used more than
+ once with the same codeSystem and codeSystemVersion."
Output Variables:
- name
- parent_entity
diff --git a/Published/CORE-000692/rule.yml b/Published/CORE-000692/rule.yml
index f66ad7cfe..e4eca406e 100644
--- a/Published/CORE-000692/rule.yml
+++ b/Published/CORE-000692/rule.yml
@@ -4,26 +4,25 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, if more trial types are defined, they
- must be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within a study design, if more trial types are defined, they must be distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00055'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00055"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Code'
+ value: "Code"
- name: parent_entity
operator: equal_to
- value: 'StudyDesign'
+ value: "StudyDesign"
- name: parent_rel
operator: equal_to
- value: 'trialTypes'
+ value: "trialTypes"
value_is_literal: true
- name: code
operator: is_not_unique_set
@@ -36,9 +35,8 @@ Check:
Core:
Id: "CORE-000692"
Status: Published
- Version: '1'
-Description: 'Within a study design, if more trial types are defined, they must
- be distinct.'
+ Version: "1"
+Description: "Within a study design, if more trial types are defined, they must be distinct."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -47,8 +45,9 @@ Match Datasets:
- rel_type
Name: StudyDesign
Outcome:
- Message: 'The trial types of the study design are not unique - the same code is
- used more than once with the same codeSystem and codeSystemVersion.'
+ Message:
+ "The trial types of the study design are not unique - the same code is used more than once
+ with the same codeSystem and codeSystemVersion."
Output Variables:
- name
- parent_entity
diff --git a/Published/CORE-000693/rule.yml b/Published/CORE-000693/rule.yml
index f477904a7..0e71fcd6d 100644
--- a/Published/CORE-000693/rule.yml
+++ b/Published/CORE-000693/rule.yml
@@ -4,26 +4,25 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, if more therapeutic areas are defined,
- they must be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within a study design, if more therapeutic areas are defined, they must be distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00056'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00056"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Code'
+ value: "Code"
- name: parent_entity
operator: equal_to
- value: 'StudyDesign'
+ value: "StudyDesign"
- name: parent_rel
operator: equal_to
- value: 'therapeuticAreas'
+ value: "therapeuticAreas"
value_is_literal: true
- name: code
operator: is_not_unique_set
@@ -36,9 +35,8 @@ Check:
Core:
Id: "CORE-000693"
Status: Published
- Version: '1'
-Description: 'Within a study design, if more therapeutic areas are defined, they
- must be distinct.'
+ Version: "1"
+Description: "Within a study design, if more therapeutic areas are defined, they must be distinct."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -47,8 +45,9 @@ Match Datasets:
- rel_type
Name: StudyDesign
Outcome:
- Message: 'The therapeutic areas of the study design are not unique - the same
- code is used more than once with the same codeSystem and codeSystemVersion.'
+ Message:
+ "The therapeutic areas of the study design are not unique - the same code is used more than
+ once with the same codeSystem and codeSystemVersion."
Output Variables:
- name
- parent_entity
diff --git a/Published/CORE-000694/rule.yml b/Published/CORE-000694/rule.yml
index bc53bcd5a..65d009049 100644
--- a/Published/CORE-000694/rule.yml
+++ b/Published/CORE-000694/rule.yml
@@ -4,26 +4,25 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, if more trial intent types are defined,
- they must be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within a study design, if more trial intent types are defined, they must be distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00057'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00057"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Code'
+ value: "Code"
- name: parent_entity
operator: equal_to
- value: 'StudyDesign'
+ value: "StudyDesign"
- name: parent_rel
operator: equal_to
- value: 'trialIntentTypes'
+ value: "trialIntentTypes"
value_is_literal: true
- name: code
operator: is_not_unique_set
@@ -36,9 +35,8 @@ Check:
Core:
Id: "CORE-000694"
Status: Published
- Version: '1'
-Description: 'Within a study design, if more trial intent types are defined,
- they must be distinct.'
+ Version: "1"
+Description: "Within a study design, if more trial intent types are defined, they must be distinct."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -47,8 +45,9 @@ Match Datasets:
- rel_type
Name: StudyDesign
Outcome:
- Message: 'The trial intent types of the study design are not unique - the same
- code is used more than once with the same codeSystem and codeSystemVersion.'
+ Message:
+ "The trial intent types of the study design are not unique - the same code is used more than
+ once with the same codeSystem and codeSystemVersion."
Output Variables:
- name
- parent_entity
diff --git a/Published/CORE-000695/rule.yml b/Published/CORE-000695/rule.yml
index 20cd07097..467b0d1d3 100644
--- a/Published/CORE-000695/rule.yml
+++ b/Published/CORE-000695/rule.yml
@@ -4,26 +4,25 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, if more characteristics are defined,
- they must be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within a study design, if more characteristics are defined, they must be distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00134'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00134"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Code'
+ value: "Code"
- name: parent_entity
operator: equal_to
- value: 'StudyDesign'
+ value: "StudyDesign"
- name: parent_rel
operator: equal_to
- value: 'characteristics'
+ value: "characteristics"
value_is_literal: true
- name: code
operator: is_not_unique_set
@@ -36,9 +35,8 @@ Check:
Core:
Id: "CORE-000695"
Status: Published
- Version: '1'
-Description: 'Within a study design, if more characteristics are defined, they
- must be distinct.'
+ Version: "1"
+Description: "Within a study design, if more characteristics are defined, they must be distinct."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -47,8 +45,9 @@ Match Datasets:
- rel_type
Name: StudyDesign
Outcome:
- Message: 'The characteristics of the study design are not unique - the same code
- is used more than once with the same codeSystem and codeSystemVersion.'
+ Message:
+ "The characteristics of the study design are not unique - the same code is used more than once
+ with the same codeSystem and codeSystemVersion."
Output Variables:
- name
- parent_entity
diff --git a/Published/CORE-000696/rule.yml b/Published/CORE-000696/rule.yml
index 90d4ad10a..83eb76df7 100644
--- a/Published/CORE-000696/rule.yml
+++ b/Published/CORE-000696/rule.yml
@@ -4,38 +4,35 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Every identifier must be unique within the scope of an
- identified organization.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Every identifier must be unique within the scope of an identified organization."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00138'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00138"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyIdentifier'
+ value: "StudyIdentifier"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: studyIdentifier
operator: is_not_unique_set
value:
- studyIdentifierScope.identifierScheme
- studyIdentifierScope.identifier
Core:
- Id: 'CORE-000696'
+ Id: "CORE-000696"
Status: Published
- Version: '1'
-Description: 'Every identifier must be unique within the scope of an identified
- organization.'
+ Version: "1"
+Description: "Every identifier must be unique within the scope of an identified organization."
Executability: Fully Executable
Outcome:
- Message: 'The identifier is not unique within the scope of the identified
- organization.'
+ Message: "The identifier is not unique within the scope of the identified organization."
Output Variables:
- parent_entity
- parent_id
@@ -49,5 +46,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyIdentifier'
+ - "StudyIdentifier"
Sensitivity: Record
diff --git a/Published/CORE-000697/rule.yml b/Published/CORE-000697/rule.yml
index 53b80ffe0..3e1e1ea95 100644
--- a/Published/CORE-000697/rule.yml
+++ b/Published/CORE-000697/rule.yml
@@ -4,37 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An identified organization is not expected to have more than
- one identifier for the study.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An identified organization is not expected to have more than one identifier for
+ the study."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00139'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00139"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyIdentifier'
+ value: "StudyIdentifier"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: studyIdentifierScope.identifier
operator: is_not_unique_set
value:
- parent_id
- studyIdentifierScope.identifierScheme
Core:
- Id: 'CORE-000697'
+ Id: "CORE-000697"
Status: Published
- Version: '1'
-Description: 'An identified organization is not expected to have more than one
- identifier for the study.'
+ Version: "1"
+Description: "An identified organization is not expected to have more than one identifier for the study."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The identified organization has more than one identifier for the study.'
+ Message: "The identified organization has more than one identifier for the study."
Output Variables:
- parent_entity
- parent_id
@@ -48,5 +48,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyIdentifier'
+ - "StudyIdentifier"
Sensitivity: Record
diff --git a/Published/CORE-000698/negative/01/results/results.csv b/Published/CORE-000698/negative/01/results/results.csv
index 5a36682f3..b81404c1c 100644
--- a/Published/CORE-000698/negative/01/results/results.csv
+++ b/Published/CORE-000698/negative/01/results/results.csv
@@ -1,37 +1,37 @@
Dataset,Record,Variable,Value
PD,1,PDPARMCD,PUFCNT
-PD,1,PDVALMAX,310
-PD,1,PDVALTRG,311
+PD,1,PDVALMIN,300.01
+PD,1,PDVALTRG,300
PD,1,SPTOBID,VAPE-Z27
PD,2,PDPARMCD,CRTVOL
-PD,2,PDVALMAX,2.9
-PD,2,PDVALTRG,3
+PD,2,PDVALMIN,1
+PD,2,PDVALTRG,0
PD,2,SPTOBID,VAPE-Z27
PD,3,PDPARMCD,HTELNUM
-PD,3,PDVALMAX,-2.1
-PD,3,PDVALTRG,-1.1
+PD,3,PDVALMIN,0
+PD,3,PDVALTRG,-1
PD,3,SPTOBID,VAPE-Z27
PD,4,PDPARMCD,HTELGTH
-PD,4,PDVALMAX,3.3
-PD,4,PDVALTRG,3.4
+PD,4,PDVALMIN,3
+PD,4,PDVALTRG,2
PD,4,SPTOBID,VAPE-Z27
PD,6,PDPARMCD,BTVLTORG
-PD,6,PDVALMAX,4
-PD,6,PDVALTRG,4.5
+PD,6,PDVALMIN,-4.5
+PD,6,PDVALTRG,-4.6
PD,6,SPTOBID,VAPE-Z27
PD,7,PDPARMCD,BTCRTORG
-PD,7,PDVALMAX,1600.99
+PD,7,PDVALMIN,1602
PD,7,PDVALTRG,1601
PD,7,SPTOBID,VAPE-Z27
PD,8,PDPARMCD,PDUVOR
-PD,8,PDVALMAX,4.2
-PD,8,PDVALTRG,4.3
+PD,8,PDVALMIN,3.2
+PD,8,PDVALTRG,3
PD,8,SPTOBID,VAPE-Z27
PD,10,PDPARMCD,PDUTCTOF
-PD,10,PDVALMAX,69
-PD,10,PDVALTRG,70
+PD,10,PDVALMIN,55
+PD,10,PDVALTRG,54.99
PD,10,SPTOBID,VAPE-Z27
PD,11,PDPARMCD,AIRFLRT
-PD,11,PDVALMAX,740
-PD,11,PDVALTRG,800
+PD,11,PDVALMIN,700
+PD,11,PDVALTRG,699
PD,11,SPTOBID,VAPE-Z27
diff --git a/Published/CORE-000698/negative/02/data/_datasets.csv b/Published/CORE-000698/negative/02/data/_datasets.csv
new file mode 100644
index 000000000..8829a8a4b
--- /dev/null
+++ b/Published/CORE-000698/negative/02/data/_datasets.csv
@@ -0,0 +1,2 @@
+Filename,Label
+pd,Product Design Parameters
diff --git a/Published/CORE-000698/negative/02/data/results.csv b/Published/CORE-000698/negative/02/data/results.csv
deleted file mode 100644
index 7a371d5e3..000000000
--- a/Published/CORE-000698/negative/02/data/results.csv
+++ /dev/null
@@ -1,2 +0,0 @@
-Filename,Label
-pd.csv,Product Design Parameters
diff --git a/Published/CORE-000698/negative/02/results/results.csv b/Published/CORE-000698/negative/02/results/results.csv
index 18a66d21d..4592b8c22 100644
--- a/Published/CORE-000698/negative/02/results/results.csv
+++ b/Published/CORE-000698/negative/02/results/results.csv
@@ -1,13 +1,21 @@
Dataset,Record,Variable,Value
-PD,2,PDPARMCD,Not in dataset
-PD,2,PDVALMAX,2.9
-PD,2,PDVALTRG,3
-PD,2,SPTOBID,VAPE-Z27
-PD,6,PDPARMCD,Not in dataset
-PD,6,PDVALMAX,4
-PD,6,PDVALTRG,4.5
-PD,6,SPTOBID,VAPE-Z27
-PD,10,PDPARMCD,Not in dataset
-PD,10,PDVALMAX,69
-PD,10,PDVALTRG,70
-PD,10,SPTOBID,VAPE-Z27
+PD,1,PDPARMCD,Not in dataset
+PD,1,PDVALMIN,310
+PD,1,PDVALTRG,300
+PD,1,SPTOBID,VAPE-Z27
+PD,3,PDPARMCD,Not in dataset
+PD,3,PDVALMIN,5
+PD,3,PDVALTRG,-1
+PD,3,SPTOBID,VAPE-Z27
+PD,4,PDPARMCD,Not in dataset
+PD,4,PDVALMIN,3.3
+PD,4,PDVALTRG,2
+PD,4,SPTOBID,VAPE-Z27
+PD,8,PDPARMCD,Not in dataset
+PD,8,PDVALMIN,4.2
+PD,8,PDVALTRG,3
+PD,8,SPTOBID,VAPE-Z27
+PD,11,PDPARMCD,Not in dataset
+PD,11,PDVALMIN,740
+PD,11,PDVALTRG,699
+PD,11,SPTOBID,VAPE-Z27
diff --git a/Published/CORE-000698/rule.yml b/Published/CORE-000698/rule.yml
index 96fca69d2..b266af95e 100644
--- a/Published/CORE-000698/rule.yml
+++ b/Published/CORE-000698/rule.yml
@@ -2,22 +2,22 @@
# Condition: --VALTRG is a number
# Rule: --VALMIN <= --VALTRG <= --VALMAX
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- Cited Guidance: No specific guidance; this is a simple mathematical definition
- Document: 'TIG 1.0'
- Item: 'Specification Table: PDVALTRG | PDVALMIN | PDVALMAX'
- Section: '2.8.8.2'
+ Document: "TIG 1.0"
+ Item: "Specification Table: PDVALTRG | PDVALMIN | PDVALMAX"
+ Section: "2.8.8.2"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0016'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0016"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --VALTRG
@@ -30,11 +30,11 @@ Check:
operator: less_than
value: --VALMIN
Core:
- Status: Published
- Version: '1'
Id: CORE-000698
-Description: Part A - Raise an error when --VALTRG is a number and is less than
- the specified --VALMIN value.
+ Status: Published
+ Version: "1"
+Description: Part A - Raise an error when --VALTRG is a number and is less than the specified
+ --VALMIN value.
Executability: Fully Executable
Outcome:
Message: --VALTRG is not equal to or greater than the --VALMIN value.
diff --git a/Published/CORE-000699/rule.yml b/Published/CORE-000699/rule.yml
index 8083d91b9..ec2d13c2b 100644
--- a/Published/CORE-000699/rule.yml
+++ b/Published/CORE-000699/rule.yml
@@ -4,143 +4,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Standard units should be consistent within the same assessment
- (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
- values).
+ - Cited Guidance:
+ Standard units should be consistent within the same assessment (having the
+ same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Standard units should be consistent within the same assessment
- (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
- values).
+ - Cited Guidance:
+ Standard units should be consistent within the same assessment (having the
+ same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Standard units should be consistent within the same assessment
- (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
- values).
+ - Cited Guidance:
+ Standard units should be consistent within the same assessment (having the
+ same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Standard units should be consistent within the same assessment
- (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
- values).
+ - Cited Guidance:
+ Standard units should be consistent within the same assessment (having the
+ same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Standard units should be consistent within the same assessment
- (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
- values).
+ - Cited Guidance:
+ Standard units should be consistent within the same assessment (having the
+ same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Standard units should be consistent within the same assessment
- (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
- values).
+ - Cited Guidance:
+ Standard units should be consistent within the same assessment (having the
+ same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Standard units should be consistent within the same assessment
- (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
- values).
+ - Cited Guidance:
+ Standard units should be consistent within the same assessment (having the
+ same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Standard units should be consistent within the same assessment
- (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
- values).
+ - Cited Guidance:
+ Standard units should be consistent within the same assessment (having the
+ same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Standard units should be consistent within the same assessment
- (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
- values).
+ - Cited Guidance:
+ Standard units should be consistent within the same assessment (having the
+ same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Standard units should be consistent within the same assessment
- (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
- values).
+ - Cited Guidance:
+ Standard units should be consistent within the same assessment (having the
+ same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --STRESU
@@ -155,13 +155,13 @@ Check:
Core:
Id: CORE-000699
Status: Published
- Version: '1'
-Description: Standard units should be consistent within the same assessment
- (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values)
+ Version: "1"
+Description: Standard units should be consistent within the same assessment (having the same
+ --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values)
Executability: Fully Executable
Outcome:
- Message: Standards units are inconsistent within the same test (category,
- sub-category, specimen and method)
+ Message: Standards units are inconsistent within the same test (category, sub-category, specimen
+ and method)
Output Variables:
- --STRESU
- --TESTCD
diff --git a/Published/CORE-000700/rule.yml b/Published/CORE-000700/rule.yml
index 857b58a50..88e919f63 100644
--- a/Published/CORE-000700/rule.yml
+++ b/Published/CORE-000700/rule.yml
@@ -4,143 +4,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3204
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3204
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3204
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3204
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3204
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3204
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3204
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3204
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3204
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3204
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --DY
@@ -150,10 +150,9 @@ Check:
Core:
Id: CORE-000700
Status: Published
- Version: '1'
-Description: When Study Day of Visit/Collection/Exam (--DY) is present in the
- dataset, then the Date/Time of Collection (--DTC) should also be present in
- the dataset
+ Version: "1"
+Description: When Study Day of Visit/Collection/Exam (--DY) is present in the dataset, then the
+ Date/Time of Collection (--DTC) should also be present in the dataset
Executability: Fully Executable
Outcome:
Message: Date/Time of Collection (--DTC) variable is missing when Study Day of
diff --git a/Published/CORE-000702/rule.yml b/Published/CORE-000702/rule.yml
index 7c22c51fc..e48c807b6 100644
--- a/Published/CORE-000702/rule.yml
+++ b/Published/CORE-000702/rule.yml
@@ -4,36 +4,35 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled decision instance is expected to refer to a default
- condition.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A scheduled decision instance is expected to refer to a default condition."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00066'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00066"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'ScheduledDecisionInstance'
+ value: "ScheduledDecisionInstance"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: defaultConditionId
operator: not_exists
- name: defaultConditionId
operator: empty
Core:
- Id: 'CORE-000702'
+ Id: "CORE-000702"
Status: Published
- Version: '1'
-Description: 'A scheduled decision instance is expected to refer to a default condition.'
+ Version: "1"
+Description: "A scheduled decision instance is expected to refer to a default condition."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The scheduled decision instance does not refer to a default condition.'
+ Message: "The scheduled decision instance does not refer to a default condition."
Output Variables:
- parent_entity
- parent_id
@@ -45,5 +44,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ScheduledDecisionInstance'
+ - "ScheduledDecisionInstance"
Sensitivity: Record
diff --git a/Published/CORE-000703/rule.yml b/Published/CORE-000703/rule.yml
index c80fb32d8..57ababddd 100644
--- a/Published/CORE-000703/rule.yml
+++ b/Published/CORE-000703/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study cell must refer to at least one element.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A study cell must refer to at least one element."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00067'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00067"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyCell'
+ value: "StudyCell"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: elementIds
operator: not_exists
@@ -29,13 +29,13 @@ Check:
operator: equal_to
value: false
Core:
- Id: 'CORE-000703'
+ Id: "CORE-000703"
Status: Published
- Version: '1'
-Description: 'A study cell must refer to at least one element.'
+ Version: "1"
+Description: "A study cell must refer to at least one element."
Executability: Fully Executable
Outcome:
- Message: 'The study cell does not refer to any elements.'
+ Message: "The study cell does not refer to any elements."
Output Variables:
- parent_entity
- parent_id
@@ -46,5 +46,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyCell'
+ - "StudyCell"
Sensitivity: Record
diff --git a/Published/CORE-000704/rule.yml b/Published/CORE-000704/rule.yml
index 67ae6f4fc..dc4a5d274 100644
--- a/Published/CORE-000704/rule.yml
+++ b/Published/CORE-000704/rule.yml
@@ -2,22 +2,22 @@
# Condition: --VALTRG is a number
# Rule: --VALMIN <= --VALTRG <= --VALMAX
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- Cited Guidance: No specific guidance; this is a simple mathematical definition
- Document: 'TIG 1.0'
- Item: 'Specification Table: PDVALTRG | PDVALMIN | PDVALMAX'
- Section: '2.8.8.2'
+ Document: "TIG 1.0"
+ Item: "Specification Table: PDVALTRG | PDVALMIN | PDVALMAX"
+ Section: "2.8.8.2"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0016'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0016"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --VALTRG
@@ -30,11 +30,11 @@ Check:
operator: greater_than
value: --VALMAX
Core:
- Status: Published
- Version: '1'
Id: CORE-000704
-Description: Part B - Raise an error when --VALTRG is a number and is greater
- than the specified --VALMAX value.
+ Status: Published
+ Version: "1"
+Description: Part B - Raise an error when --VALTRG is a number and is greater than the specified
+ --VALMAX value.
Executability: Fully Executable
Outcome:
Message: --VALTRG is not equal to or less than the --VALMAX value.
diff --git a/Published/CORE-000707/rule.yml b/Published/CORE-000707/rule.yml
index d9eb0eeff..cb1d5e44e 100644
--- a/Published/CORE-000707/rule.yml
+++ b/Published/CORE-000707/rule.yml
@@ -7,143 +7,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3208
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3208
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3208
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3208
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3208
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3208
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3208
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3208
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3208
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3208
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --DY
@@ -160,9 +160,9 @@ Check:
Core:
Id: CORE-000707
Status: Published
- Version: '1'
-Description: Study Day of Visit/Collection/Exam (--DY) should be less than or
- equal to Study Day of End of Observation (--ENDY).
+ Version: "1"
+Description: Study Day of Visit/Collection/Exam (--DY) should be less than or equal to Study Day of
+ End of Observation (--ENDY).
Executability: Fully Executable
Outcome:
Message: --DY is greater than --ENDY.
diff --git a/Published/CORE-000708/rule.yml b/Published/CORE-000708/rule.yml
index f9fb04a4c..b8a3eefa3 100644
--- a/Published/CORE-000708/rule.yml
+++ b/Published/CORE-000708/rule.yml
@@ -7,143 +7,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3207
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3207
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3207
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3207
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3207
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3207
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3207
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3207
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3207
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3207
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --STDY
@@ -156,10 +156,9 @@ Check:
Core:
Id: CORE-000708
Status: Published
- Version: '1'
-Description: When Study Day of End of Observation (--ENDY) is present in the
- dataset, then the End Date/Time of Observation (--ENDTC) should also be
- present in the dataset.
+ Version: "1"
+Description: When Study Day of End of Observation (--ENDY) is present in the dataset, then the End
+ Date/Time of Observation (--ENDTC) should also be present in the dataset.
Executability: Fully Executable
Outcome:
Message: --STDY is greater than --ENDY.
diff --git a/Published/CORE-000710/rule.yml b/Published/CORE-000710/rule.yml
index 53c96e768..e5e3a6359 100644
--- a/Published/CORE-000710/rule.yml
+++ b/Published/CORE-000710/rule.yml
@@ -4,86 +4,77 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "If the reference time point is prior to the date of collection
- or assessment: Start values: an observation can start BEFORE
- the reference point, can start COINCIDENT with the reference
- point, can start AFTER the reference point, or it may not be
- known (U) when it started. End values: an observation can end
- BEFORE the reference point, can end COINCIDENT with the
- reference point, can end AFTER the reference point, can be
- known that it didn't end but was ONGOING, or it is unknown (U)
- when it ended or if it was ongoing."
+ - Cited Guidance:
+ "If the reference time point is prior to the date of collection or assessment:
+ Start values: an observation can start BEFORE the reference point, can start COINCIDENT with
+ the reference point, can start AFTER the reference point, or it may not be known (U) when it
+ started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with
+ the reference point, can end AFTER the reference point, can be known that it didn't end but
+ was ONGOING, or it is unknown (U) when it ended or if it was ongoing."
Document: IG v3.4
Section: 4.4.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0233
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "If the reference time point is prior to the date of collection
- or assessment: Start values: an observation can start BEFORE
- the reference point, can start COINCIDENT with the reference
- point, can start AFTER the reference point, or it may not be
- known (U) when it started. End values: an observation can end
- BEFORE the reference point, can end COINCIDENT with the
- reference point, can end AFTER the reference point, can be
- known that it didn't end but was ONGOING, or it is unknown (U)
- when it ended or if it was ongoing."
+ - Cited Guidance:
+ "If the reference time point is prior to the date of collection or assessment:
+ Start values: an observation can start BEFORE the reference point, can start COINCIDENT with
+ the reference point, can start AFTER the reference point, or it may not be known (U) when it
+ started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with
+ the reference point, can end AFTER the reference point, can be known that it didn't end but
+ was ONGOING, or it is unknown (U) when it ended or if it was ongoing."
Document: IG v3.2
Section: 4.1.4.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0233
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "If the reference time point is prior to the date of collection
- or assessment: Start values: an observation can start BEFORE
- the reference point, can start COINCIDENT with the reference
- point, can start AFTER the reference point, or it may not be
- known (U) when it started. End values: an observation can end
- BEFORE the reference point, can end COINCIDENT with the
- reference point, can end AFTER the reference point, can be
- known that it didn't end but was ONGOING, or it is unknown (U)
- when it ended or if it was ongoing."
+ - Cited Guidance:
+ "If the reference time point is prior to the date of collection or assessment:
+ Start values: an observation can start BEFORE the reference point, can start COINCIDENT with
+ the reference point, can start AFTER the reference point, or it may not be known (U) when it
+ started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with
+ the reference point, can end AFTER the reference point, can be known that it didn't end but
+ was ONGOING, or it is unknown (U) when it ended or if it was ongoing."
Document: IG v3.3
Section: 4.4.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0233
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: 'If the reference time point is prior to the date of collection
- or assessment: Start values: an observation can start
- BEFORE the reference point, can start COINCIDENT with the
- reference point, can start AFTER the reference point, or it
- may not be known (U) when it started. End values: an
- observation can end BEFORE the reference point, can end
- COINCIDENT with the reference point, can end AFTER the
- reference point, can be known that it didn''t end but was
- ONGOING, or it is unknown (U) when it ended or if it was
- ongoing.'
+ - Cited Guidance:
+ "If the reference time point is prior to the date of collection or assessment:
+ Start values: an observation can start BEFORE the reference point, can start COINCIDENT
+ with the reference point, can start AFTER the reference point, or it may not be known (U) when
+ it started. End values: an observation can end BEFORE the reference point, can end COINCIDENT
+ with the reference point, can end AFTER the reference point, can be known that it didn't end
+ but was ONGOING, or it is unknown (U) when it ended or if it was ongoing."
Document: TIG 1.0
Item: Num 3
Section: 2.8.7.6
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0442
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
# Variable: --STRTPT
# Condition: --STTPT is prior to the date of collection or assessment.
# Rule: --STRTPT in ('BEFORE', 'COINCIDENT', 'AFTER', 'UNKNOWN')
@@ -106,11 +97,10 @@ Check:
Core:
Id: CORE-000710
Status: Published
- Version: '1'
+ Version: "1"
-Description: Trigger error when --STRTPT is not in ('BEFORE', 'COINCIDENT',
- 'AFTER', 'UNKNOWN') and --STTPT is prior to the date of collection or
- assessment.
+Description: Trigger error when --STRTPT is not in ('BEFORE', 'COINCIDENT', 'AFTER', 'UNKNOWN') and
+ --STTPT is prior to the date of collection or assessment.
Executability: Partially Executable
Outcome:
Message: --STRTPT is not in ('BEFORE', 'COINCIDENT', 'AFTER', 'UNKNOWN')
diff --git a/Published/CORE-000711/rule.yml b/Published/CORE-000711/rule.yml
index 10792afe4..949d258ae 100644
--- a/Published/CORE-000711/rule.yml
+++ b/Published/CORE-000711/rule.yml
@@ -7,133 +7,123 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3404
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3404
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3404
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3404
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3404
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3404
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3404
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3404
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3404
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3404
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: RFSTDTC
@@ -146,9 +136,9 @@ Check:
Core:
Id: CORE-000711
Status: Published
- Version: '1'
-Description: Subject Reference Start Date/Time (RFSTDTC) should be prior or
- equal to the Subject Reference End Date/Time (RFENDTC).
+ Version: "1"
+Description: Subject Reference Start Date/Time (RFSTDTC) should be prior or equal to the Subject
+ Reference End Date/Time (RFENDTC).
Executability: Fully Executable
Outcome:
Message: RFSTDTC falls after RFENDTC.
diff --git a/Published/CORE-000712/rule.yml b/Published/CORE-000712/rule.yml
index 573901c16..5c6ec3bc1 100644
--- a/Published/CORE-000712/rule.yml
+++ b/Published/CORE-000712/rule.yml
@@ -7,82 +7,86 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies.
Document: Model v2.0
Item: IDVAR
Section: Comments
- - Cited Guidance: Name of the identifying variable in the
- general-observation-class dataset that identifies the related
- record(s).
+ - Cited Guidance:
+ Name of the identifying variable in the general-observation-class dataset
+ that identifies the related record(s).
Document: Model v2.0
Item: IDVAR
Section: Supplemental Qualifiers
- - Cited Guidance: Name of the identifying variable in the
- general-observation-class dataset that identifies the related
- record(s).
+ - Cited Guidance:
+ Name of the identifying variable in the general-observation-class dataset
+ that identifies the related record(s).
Document: Model v2.0
Item: IDVAR
Section: Related Records
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0370
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies.
Document: Model v1.4
Section: 2.2.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0370
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies.
Document: Model v1.7
Section: 2.2.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0370
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies.
Document: SDTM v2.1
Item: IDVAR
Section: 3.2.2 Comments
- - Cited Guidance: Name of the identifying variable in the
- general-observation-class dataset that identifies the related
- record(s).
+ - Cited Guidance:
+ Name of the identifying variable in the general-observation-class dataset
+ that identifies the related record(s).
Document: SDTM v2.1
Item: IDVAR
Section: 6.2 Supplemental Qualifiers Datasets
- - Cited Guidance: Name of the identifying variable in the
- general-observation-class dataset that identifies the related
- record(s).
+ - Cited Guidance:
+ Name of the identifying variable in the general-observation-class dataset
+ that identifies the related record(s).
Document: SDTM v2.1
Item: IDVAR
Section: Section 6.1 Related Records Dataset
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0534
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: RDOMAIN
@@ -95,9 +99,9 @@ Check:
Core:
Id: CORE-000712
Status: Published
- Version: '1'
-Description: Part A - Raise and error when IDVAR in SUPP-- is not populated with
- a valid variable from the dataset referenced in RDOMAIN.
+ Version: "1"
+Description: Part A - Raise and error when IDVAR in SUPP-- is not populated with a valid variable
+ from the dataset referenced in RDOMAIN.
Executability: Fully Executable
Match Datasets:
- Child: true
@@ -113,8 +117,8 @@ Operations:
operator: distinct
value_is_reference: true
Outcome:
- Message: Value for IDVAR in SUPP-- does not represent a variable present in the
- dataset referenced in RDOMAIN.
+ Message: Value for IDVAR in SUPP-- does not represent a variable present in the dataset referenced
+ in RDOMAIN.
Output Variables:
- IDVAR
Rule Type: Record Data
diff --git a/Published/CORE-000714/rule.yml b/Published/CORE-000714/rule.yml
index 2e01127b5..3710f7420 100644
--- a/Published/CORE-000714/rule.yml
+++ b/Published/CORE-000714/rule.yml
@@ -7,120 +7,111 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3408
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3408
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3408
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3408
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3408
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3408
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3408
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3408
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3408
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: RFXSTDTC
@@ -133,9 +124,9 @@ Check:
Core:
Id: CORE-000714
Status: Published
- Version: '1'
-Description: Date/Time of First Study Treatment (RFXSTDTC) variable value should
- be prior or equal to the Date/Time of Last Study Treatment (RFXENDTC).
+ Version: "1"
+Description: Date/Time of First Study Treatment (RFXSTDTC) variable value should be prior or equal
+ to the Date/Time of Last Study Treatment (RFXENDTC).
Executability: Fully Executable
Outcome:
Message: RFXSTDTC falls after RFXENDTC.
diff --git a/Published/CORE-000715/rule.yml b/Published/CORE-000715/rule.yml
index b9d4c6c6e..b50c4ec42 100644
--- a/Published/CORE-000715/rule.yml
+++ b/Published/CORE-000715/rule.yml
@@ -4,102 +4,109 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: SENDIG v3.0
Item: BWSTAT CDISC Notes
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND144
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: SENDIG v3.1
Item: BWSTAT CDISC Notes
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND144
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: SENDIG v3.1.1
Item: BWSTAT CDISC Notes
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND144
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: SENDIG v3.1
Item: BWSTAT CDISC Notes
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND144
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: SENDIG v3.1.1
Item: BWSTAT CDISC Notes
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND144
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: SENDIG v3.1.1
Item: BWSTAT CDISC Notes
Section: 6.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND144
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Used to indicate when a test is not done or result is missing.
- Should be null if a result exists in BWORRES.
+ - Cited Guidance:
+ Used to indicate when a test is not done or result is missing. Should be
+ null if a result exists in BWORRES.
Document: TIG v1.0
Item: BWSTAT CDISC Notes
Section: 2.8.9.9
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0080
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --ORRES
@@ -109,7 +116,7 @@ Check:
Core:
Id: CORE-000715
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when --ORRES is not populated and --STAT is not populated
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000718/rule.yml b/Published/CORE-000718/rule.yml
index 47dfd0ca0..57ce3c190 100644
--- a/Published/CORE-000718/rule.yml
+++ b/Published/CORE-000718/rule.yml
@@ -7,143 +7,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3209
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3209
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3209
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3209
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3209
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3209
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3209
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3209
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3209
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3209
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --STDTC
@@ -156,9 +156,9 @@ Check:
Core:
Id: CORE-000718
Status: Published
- Version: '1'
-Description: Start Date/Time of Observation (--STDTC) should be prior or equal
- to the End Date/Time of Observation (--ENDTC).
+ Version: "1"
+Description: Start Date/Time of Observation (--STDTC) should be prior or equal to the End Date/Time
+ of Observation (--ENDTC).
Executability: Fully Executable
Outcome:
Message: --STDTC falls after --ENDTC.
diff --git a/Published/CORE-000721/rule.yml b/Published/CORE-000721/rule.yml
index 6b208e86b..3ca64d061 100644
--- a/Published/CORE-000721/rule.yml
+++ b/Published/CORE-000721/rule.yml
@@ -1,5 +1,5 @@
# Variable: ARM
-# Condition:
+# Condition:
# Rule: ARM not in ('Screen Failure', 'Not Assigned', 'Unplanned Product Exposure', 'Not Exposed to Product')
Authorities:
- Organization: CDISC
@@ -14,10 +14,10 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0654
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ARM
@@ -30,13 +30,13 @@ Check:
Core:
Id: "CORE-000721"
Status: Published
- Version: '1'
-Description: Raise an error when ARM is 'Screen Failure', 'Not Assigned',
- 'Unplanned Product Exposure', or 'Not Exposed to Product'
+ Version: "1"
+Description: Raise an error when ARM is 'Screen Failure', 'Not Assigned', 'Unplanned Product
+ Exposure', or 'Not Exposed to Product'
Executability: Fully Executable
Outcome:
- Message: ARM cannot be equal to 'Screen Failure', 'Not Assigned', 'Unplanned
- Product Exposure' or 'Not Exposed to Product'.
+ Message: ARM cannot be equal to 'Screen Failure', 'Not Assigned', 'Unplanned Product Exposure' or
+ 'Not Exposed to Product'.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000722/rule.yml b/Published/CORE-000722/rule.yml
index ee2835fb0..e51b54ca6 100644
--- a/Published/CORE-000722/rule.yml
+++ b/Published/CORE-000722/rule.yml
@@ -4,87 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If the PCORRES result is less than the Lower Limit of
- Quantification (LLQ), then PCSTRESN should be null and not
- populated with the value of zero (0).
+ - Cited Guidance:
+ If the PCORRES result is less than the Lower Limit of Quantification (LLQ),
+ then PCSTRESN should be null and not populated with the value of zero (0).
Document: IG v3.0
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND194
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If the PCORRES result is less than the Lower Limit of
- Quantification (LLQ), then PCSTRESN should be null and not
- populated with the value of zero (0).
+ - Cited Guidance:
+ If the PCORRES result is less than the Lower Limit of Quantification (LLQ),
+ then PCSTRESN should be null and not populated with the value of zero (0).
Document: IG v3.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND194
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If the PCORRES result is less than the Lower Limit of
- Quantification (LLQ), then PCSTRESN should be null and not
- populated with the value of zero (0).
+ - Cited Guidance:
+ If the PCORRES result is less than the Lower Limit of Quantification (LLQ),
+ then PCSTRESN should be null and not populated with the value of zero (0).
Document: IG v3.1.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND194
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If the PCORRES result is less than the Lower Limit of
- Quantification (LLQ), then PCSTRESN should be null and not
- populated with the value of zero (0).
+ - Cited Guidance:
+ If the PCORRES result is less than the Lower Limit of Quantification (LLQ),
+ then PCSTRESN should be null and not populated with the value of zero (0).
Document: IG v3.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND194
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If the PCORRES result is less than the Lower Limit of
- Quantification (LLQ), then PCSTRESN should be null and not
- populated with the value of zero (0).
+ - Cited Guidance:
+ If the PCORRES result is less than the Lower Limit of Quantification (LLQ),
+ then PCSTRESN should be null and not populated with the value of zero (0).
Document: IG v3.1.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND194
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: If the PCORRES result is less than the Lower Limit of
- Quantification (LLQ), then PCSTRESN should be null and not
- populated with the value of zero (0).
+ - Cited Guidance:
+ If the PCORRES result is less than the Lower Limit of Quantification (LLQ),
+ then PCSTRESN should be null and not populated with the value of zero (0).
Document: IG v3.1.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND194
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
# Attention: -ORRES is "char", -STRESN is "num"
@@ -96,10 +96,9 @@ Check:
Core:
Id: CORE-000722
Status: Published
- Version: '1'
-Description: If the PCORRES result is less than the Lower Limit of
- Quantification, then PCSTRESN should be null and not populated with the value
- of zero (0).
+ Version: "1"
+Description: If the PCORRES result is less than the Lower Limit of Quantification, then PCSTRESN
+ should be null and not populated with the value of zero (0).
Executability: Fully Executable
Outcome:
Message: PCSTRESN may not be populated as PCORRES is less than PCLLOQ
diff --git a/Published/CORE-000727/rule.yml b/Published/CORE-000727/rule.yml
index 10bd75230..34630e37c 100644
--- a/Published/CORE-000727/rule.yml
+++ b/Published/CORE-000727/rule.yml
@@ -2,25 +2,25 @@
# Condition: IQCAT = NON-TOBACCO INGREDIENT
# Rule: IGDCMPID in IN.IGDCMPID
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: IGDCMPID represents the unique ingredient name established in
- either the Tobacco Ingredients (IT) domain or the Non-Tobacco
- Ingredients (IN) domain. Therefore, every value of IDGCMPID in
- the IQ domain must have an exact match in either IT or IN
- Document: 'TIG 1.0'
- Item: 'assumption 2'
- Section: '2.8.8.6'
+ - Cited Guidance:
+ IGDCMPID represents the unique ingredient name established in either the
+ Tobacco Ingredients (IT) domain or the Non-Tobacco Ingredients (IN) domain. Therefore,
+ every value of IDGCMPID in the IQ domain must have an exact match in either IT or IN
+ Document: "TIG 1.0"
+ Item: "assumption 2"
+ Section: "2.8.8.6"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0014'
- Version: '1'
- Version: '1.0'
+ Id: "TIG0014"
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IQCAT
@@ -32,12 +32,11 @@ Check:
value: $in_igdcmpid
within: SPTOBID
Core:
- Status: Published
- Version: '1'
Id: CORE-000727
-Description: Raise an error when IGDCMPID for a non-tobacco ingredient in the IQ
- dataset (IQCAT = NON-TOBACCO INGREDIENT) does not have a matching IGDCMPID per
- SPTOBID in the IN dataset.
+ Status: Published
+ Version: "1"
+Description: Raise an error when IGDCMPID for a non-tobacco ingredient in the IQ dataset (IQCAT =
+ NON-TOBACCO INGREDIENT) does not have a matching IGDCMPID per SPTOBID in the IN dataset.
Executability: Fully Executable
Operations:
- domain: IN
@@ -47,8 +46,8 @@ Operations:
name: IGDCMPID
operator: distinct
Outcome:
- Message: IGDCMPID in IQ categorized as IQCAT = NON-TOBACCO INGREDIENT does not
- have a matching IGDCMPID per SPTOBID in IN.
+ Message: IGDCMPID in IQ categorized as IQCAT = NON-TOBACCO INGREDIENT does not have a matching
+ IGDCMPID per SPTOBID in IN.
Output Variables:
- SPTOBID
- IGDCMPID
diff --git a/Published/CORE-000732/rule.yml b/Published/CORE-000732/rule.yml
index 60b96ca65..e9410f132 100644
--- a/Published/CORE-000732/rule.yml
+++ b/Published/CORE-000732/rule.yml
@@ -2,138 +2,128 @@
# Condition:
# Rule: --STRESC is not populated with a numeric value, but --STRESN is not empty
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3103'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB3103"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3103'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB3103"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3103'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB3103"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3103'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB3103"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3103'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB3103"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3103'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3103"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3103'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3103"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3103'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB3103"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3103'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB3103"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3103'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB3103"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --STRESC
@@ -146,11 +136,11 @@ Check:
Core:
Id: CORE-000732
Status: Published
- Version: '1'
-Description: '--STRESC is not populated with a numeric value, but --STRESN is not empty.'
+ Version: "1"
+Description: "--STRESC is not populated with a numeric value, but --STRESN is not empty."
Executability: Fully Executable
Outcome:
- Message: '--STRESC is not numeric but --STRESN is not empty'
+ Message: "--STRESC is not numeric but --STRESN is not empty"
Output Variables:
- --STRESC
- --STRESN
diff --git a/Published/CORE-000736/rule.yml b/Published/CORE-000736/rule.yml
index b31304f20..6b9410c2f 100644
--- a/Published/CORE-000736/rule.yml
+++ b/Published/CORE-000736/rule.yml
@@ -1,118 +1,119 @@
# Variable: TSPARMCD
-# Condition:
+# Condition:
# Rule: Either 'AGE' or 'AGETXT' is in the list of TSPARAMCDs with TSVAL populated, not both.
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1116'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB1116"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1116'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- # SEND-IGs added Jozef
- - Name: 'SENDIG'
+ Id: "FB1116"
+ Version: "1"
+ Version: "1.5"
+ Version:
+ "3.4"
+ # SEND-IGs added Jozef
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1116'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB1116"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1116'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB1116"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1116'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB1116"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1116'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB1116"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1116'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB1116"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1116'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB1116"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1116'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB1116"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- any:
@@ -133,9 +134,8 @@ Check:
Core:
Id: CORE-000736
Status: Published
- Version: '1'
-Description: 'Either AGE or AGETXT is in the list of TSPARMCDs with TSVAL
- populated, not both.'
+ Version: "1"
+Description: "Either AGE or AGETXT is in the list of TSPARMCDs with TSVAL populated, not both."
Executability: Fully Executable
Operations:
- domain: TS
@@ -151,7 +151,7 @@ Operations:
name: TSPARMCD
operator: record_count
Outcome:
- Message: 'AGE and AGETXT are in the list of TSPARAMCDs with TSVAL populated.'
+ Message: "AGE and AGETXT are in the list of TSPARAMCDs with TSVAL populated."
Output Variables:
- TSPARMCD
- TSVAL
diff --git a/Published/CORE-000744/rule.yml b/Published/CORE-000744/rule.yml
index c67a8d391..3f641fd3e 100644
--- a/Published/CORE-000744/rule.yml
+++ b/Published/CORE-000744/rule.yml
@@ -7,68 +7,65 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If an FA record does have a parent record, the value in FAOBJ
- should match the value in --TERM or --TRT, unless the parent
- domain is dictionary coded or subject to controlled
- terminology, in which case FAOBJ should match the value in
- --DECOD.
+ - Cited Guidance:
+ If an FA record does have a parent record, the value in FAOBJ should match
+ the value in --TERM or --TRT, unless the parent domain is dictionary coded or subject to
+ controlled terminology, in which case FAOBJ should match the value in --DECOD.
Document: IG v3.4
Section: 6.4.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0174
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: In general, the value in FAOBJ should match the value in --TERM
- or --TRT, unless the parent domain is dictionary coded or
- subject to controlled terminology, in which case FAOBJ should
- then match the value in --DECOD.
+ - Cited Guidance:
+ In general, the value in FAOBJ should match the value in --TERM or --TRT,
+ unless the parent domain is dictionary coded or subject to controlled terminology, in
+ which case FAOBJ should then match the value in --DECOD.
Document: IG v3.3
Section: 6.4.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0174
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: In general, the value in FAOBJ should match the value in --TERM
- or --TRT, unless the parent domain is dictionary coded or
- subject to controlled terminology, in which case FAOBJ should
- then match the value in --DECOD.
+ - Cited Guidance:
+ In general, the value in FAOBJ should match the value in --TERM or --TRT,
+ unless the parent domain is dictionary coded or subject to controlled terminology, in
+ which case FAOBJ should then match the value in --DECOD.
Document: IG v3.2
Section: 6.4.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0174
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: A record in FA may or may not have a parent record in an events
- or interventions domain. If an FA record does have a parent
- record, the value in FAOBJ should match the value in --TERM or
- --TRT, unless the parent domain is dictionary coded or subject
- to controlled terminology. In such cases, the value
- represented in FAOBJ will match the value represented in
- --DECOD.
+ - Cited Guidance: A record in FA may or may not have a parent record in an events or
+ interventions domain. If an FA record does have a parent record, the value in FAOBJ should
+ match the value in --TERM or --TRT, unless the parent domain is dictionary coded or
+ subject to controlled terminology. In such cases, the value represented in FAOBJ will
+ match the value represented in --DECOD.
Document: TIG 1.0
Section: 2.8.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0403
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: FAOBJ
@@ -83,16 +80,15 @@ Check:
Core:
Id: CORE-000744
Status: Published
- Version: '1'
-Description: Raise an error when a related record is present in the parent
- domain dataset but FAOBJ is not equal to the --TERM, --TRT or --DECOD of the
- parent domain.
+ Version: "1"
+Description: Raise an error when a related record is present in the parent domain dataset but FAOBJ
+ is not equal to the --TERM, --TRT or --DECOD of the parent domain.
Executability: Fully Executable
Match Datasets:
- Name: RELREC
Outcome:
- Message: Related record is present in the parent domain dataset but FAOBJ is not
- equal to the "TERM", "TRT" or "DECOD" of the parent domain.
+ Message: Related record is present in the parent domain dataset but FAOBJ is not equal to the
+ "TERM", "TRT" or "DECOD" of the parent domain.
Output Variables:
- FAOBJ
- RELREC.**TERM
diff --git a/Published/CORE-000749/rule.yml b/Published/CORE-000749/rule.yml
index 857b59cad..3a000aa09 100644
--- a/Published/CORE-000749/rule.yml
+++ b/Published/CORE-000749/rule.yml
@@ -4,102 +4,109 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial
- Summary parameter value, Tabulation.
+ - Cited Guidance:
+ ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter
+ value, Tabulation.
Document: SENDIG v3.0
Item: Domain Table Header
Section: 7.6.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND245
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial
- Summary parameter value, Tabulation.
+ - Cited Guidance:
+ ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter
+ value, Tabulation.
Document: SENDIG v3.1
Item: Domain Table Header
Section: 7.6.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND245
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial
- Summary parameter value, Tabulation.
+ - Cited Guidance:
+ ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter
+ value, Tabulation.
Document: SENDIG v3.1.1
Item: Domain Table Header
Section: 7.6.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND245
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial
- Summary parameter value, Tabulation.
+ - Cited Guidance:
+ ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter
+ value, Tabulation.
Document: SENDIG v3.1
Item: Domain Table Header
Section: 7.6.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND245
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial
- Summary parameter value, Tabulation.
+ - Cited Guidance:
+ ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter
+ value, Tabulation.
Document: SENDIG v3.1.1
Item: Domain Table Header
Section: 7.6.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND245
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial
- Summary parameter value, Tabulation.
+ - Cited Guidance:
+ ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter
+ value, Tabulation.
Document: SENDIG v3.1.1
Item: Domain Table Header
Section: 7.6.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND245
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial
- Summary parameter value, Tabulation.
+ - Cited Guidance:
+ ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter
+ value, Tabulation.
Document: TIG v1.0
Item: Domain Table Header
Section: 2.8.9.32
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0166
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: TSVAL
@@ -108,7 +115,7 @@ Check:
Core:
Id: CORE-000749
Status: Published
- Version: '1'
+ Version: "1"
Description: TSVAL must be unique within each distinct value of TSPARMCD
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000750/rule.yml b/Published/CORE-000750/rule.yml
index f7522d1d4..32e247ce3 100644
--- a/Published/CORE-000750/rule.yml
+++ b/Published/CORE-000750/rule.yml
@@ -7,20 +7,20 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: A number used to uniquely identify records for a subject within
- a domain. The Trial Summary domain does not contain subject
- data, and TSSEQ is a sequence number to ensure uniqueness
- within the dataset.
+ - Cited Guidance:
+ A number used to uniquely identify records for a subject within a domain.
+ The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to
+ ensure uniqueness within the dataset.
Document: SDTM v2.1
Item: --SEQ
- Section: '3.1.4 Identifiers for All Classes'
+ Section: "3.1.4 Identifiers for All Classes"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0310
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -46,14 +46,14 @@ Check:
Core:
Id: "CORE-000750"
Status: Published
- Version: '1'
-Description: Part A - Excluding TS.TSSEQ, raise an error when --SEQ is not a
- unique number per USUBJID per domain, or not a unique number per POOLID per
- domain, including when the domain is split into multiple files.
+ Version: "1"
+Description: Part A - Excluding TS.TSSEQ, raise an error when --SEQ is not a unique number per
+ USUBJID per domain, or not a unique number per POOLID per domain, including when the domain is
+ split into multiple files.
Executability: Fully Executable
Outcome:
- Message: --SEQ is not a unique number per one of the following identifier
- variables, per domain; USUBJID or POOLID.
+ Message: --SEQ is not a unique number per one of the following identifier variables, per domain;
+ USUBJID or POOLID.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000751/rule.yml b/Published/CORE-000751/rule.yml
index f27ccfc4a..db0801fc4 100644
--- a/Published/CORE-000751/rule.yml
+++ b/Published/CORE-000751/rule.yml
@@ -4,20 +4,20 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: A number used to uniquely identify records for a subject within
- a domain. The Trial Summary domain does not contain subject
- data, and TSSEQ is a sequence number to ensure uniqueness
- within the dataset.
+ - Cited Guidance:
+ A number used to uniquely identify records for a subject within a domain.
+ The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to
+ ensure uniqueness within the dataset.
Document: SDTM v2.1
Item: --SEQ
- Section: '3.1.4 Identifiers for All Classes'
+ Section: "3.1.4 Identifiers for All Classes"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0310
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
any:
- all:
@@ -53,13 +53,13 @@ Check:
Core:
Id: CORE-000751
Status: Published
- Version: '1'
-Description: Part B - Raise an error when --SEQ is not a unique number per one
- of the following identifier variables, per domain; USUBJID, POOLID or SPDEVID.
+ Version: "1"
+Description: Part B - Raise an error when --SEQ is not a unique number per one of the following
+ identifier variables, per domain; USUBJID, POOLID or SPDEVID.
Executability: Fully Executable
Outcome:
- Message: --SEQ is not a unique number per one of the following identifier
- variables, per domain; USUBJID, POOLID or SPDEVID.
+ Message: --SEQ is not a unique number per one of the following identifier variables, per domain;
+ USUBJID, POOLID or SPDEVID.
Output Variables:
- SPDEVID
- USUBJID
diff --git a/Published/CORE-000752/rule.yml b/Published/CORE-000752/rule.yml
index c95f761b7..0819ecd1c 100644
--- a/Published/CORE-000752/rule.yml
+++ b/Published/CORE-000752/rule.yml
@@ -4,20 +4,20 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: A number used to uniquely identify records for a subject within
- a domain. The Trial Summary domain does not contain subject
- data, and TSSEQ is a sequence number to ensure uniqueness
- within the dataset.
+ - Cited Guidance:
+ A number used to uniquely identify records for a subject within a domain.
+ The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to
+ ensure uniqueness within the dataset.
Document: SDTM v2.1
Item: --SEQ
- Section: '3.1.4 Identifiers for All Classes'
+ Section: "3.1.4 Identifiers for All Classes"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0310
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SPTOBID
@@ -32,9 +32,9 @@ Check:
Core:
Id: CORE-000752
Status: Published
- Version: '1'
-Description: Part C - Raise an error when --SEQ is not a unique number per one
- of the following identifier variables, per domain; SPTOBID.
+ Version: "1"
+Description: Part C - Raise an error when --SEQ is not a unique number per one of the following
+ identifier variables, per domain; SPTOBID.
Executability: Fully Executable
Outcome:
Message: --SEQ is not a unique number per SPTOBID per domain.
diff --git a/Published/CORE-000753/rule.yml b/Published/CORE-000753/rule.yml
index 678687669..7e13e2fb7 100644
--- a/Published/CORE-000753/rule.yml
+++ b/Published/CORE-000753/rule.yml
@@ -4,20 +4,20 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: A number used to uniquely identify records for a subject within
- a domain. The Trial Summary domain does not contain subject
- data, and TSSEQ is a sequence number to ensure uniqueness
- within the dataset.
+ - Cited Guidance:
+ A number used to uniquely identify records for a subject within a domain.
+ The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to
+ ensure uniqueness within the dataset.
Document: SDTM v2.1
Item: --SEQ
- Section: '3.1.4 Identifiers for All Classes'
+ Section: "3.1.4 Identifiers for All Classes"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0310
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: SPTOBID
@@ -32,9 +32,9 @@ Check:
Core:
Id: CORE-000753
Status: Published
- Version: '1'
-Description: Part D - Raise an error when --SEQ is not a unique number per one
- of the following identifier variables, per domain; SPTOBID.
+ Version: "1"
+Description: Part D - Raise an error when --SEQ is not a unique number per one of the following
+ identifier variables, per domain; SPTOBID.
Executability: Fully Executable
Outcome:
Message: --SEQ is not a unique number per SPTOBID per domain.
diff --git a/Published/CORE-000754/rule.yml b/Published/CORE-000754/rule.yml
index ca5b378e2..449a71f6c 100644
--- a/Published/CORE-000754/rule.yml
+++ b/Published/CORE-000754/rule.yml
@@ -4,20 +4,20 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: A number used to uniquely identify records for a subject within
- a domain. The Trial Summary domain does not contain subject
- data, and TSSEQ is a sequence number to ensure uniqueness
- within the dataset.
+ - Cited Guidance:
+ A number used to uniquely identify records for a subject within a domain.
+ The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to
+ ensure uniqueness within the dataset.
Document: SDTM v2.1
Item: --SEQ
- Section: '3.1.4 Identifiers for All Classes'
+ Section: "3.1.4 Identifiers for All Classes"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0310
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: STOCONID
@@ -32,9 +32,9 @@ Check:
Core:
Id: CORE-000754
Status: Published
- Version: '1'
-Description: Part E - Raise an error when --SEQ is not a unique number per one
- of the following identifier variables, per domain; SPTOBID.
+ Version: "1"
+Description: Part E - Raise an error when --SEQ is not a unique number per one of the following
+ identifier variables, per domain; SPTOBID.
Executability: Fully Executable
Outcome:
Message: --SEQ is not a unique number per STOCONID per domain.
diff --git a/Published/CORE-000755/rule.yml b/Published/CORE-000755/rule.yml
index d7ccff759..32ddc93d0 100644
--- a/Published/CORE-000755/rule.yml
+++ b/Published/CORE-000755/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: STUDYID, DOMAIN, and --SEQ exist and at least one of USUBJID, APID, SPDEVID, or POOLID
Authorities:
- Organization: CDISC
@@ -7,23 +7,23 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: STUDYID, DOMAIN, and --SEQ are required in all domains based on
- one of the 3 general observation classes. Each general class
- domain must also include at least one of the following subject
- identifiers - SUBJID, SPDEVID, or POOLID.
+ - Cited Guidance:
+ STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3
+ general observation classes. Each general class domain must also include at least one of
+ the following subject identifiers - SUBJID, SPDEVID, or POOLID.
Document: SDTM v2.1
Section: Section 3.1.4 Identifiers For All Classes
- - Cited Guidance: The Associated Persons Identifier (APID) will be required in all
- AP datasets, and will identify records as AP data.
+ - Cited Guidance: The Associated Persons Identifier (APID) will be required in all AP
+ datasets, and will identify records as AP data.
Document: SDTM v2.1
Section: Section 4.0 Associated Persons Data
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0642
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: DOMAIN
@@ -35,7 +35,7 @@ Check:
Core:
Id: "CORE-000755"
Status: Published
- Version: '1'
+ Version: "1"
Description: Raise an error when STUDYID and DOMAIN exist but SPTOBID does not exist.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000756/rule.yml b/Published/CORE-000756/rule.yml
index a24cf8deb..6cfbd4ddd 100644
--- a/Published/CORE-000756/rule.yml
+++ b/Published/CORE-000756/rule.yml
@@ -4,131 +4,117 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Occasionally data that are intended to be numeric are collected
- with characters attached that cause the character-to numeric
- conversion to fail. For example, numeric cell counts in the
- source data may be specified with a greater than (>) or less
- than (<) sign attached (e.g., >10,000 or <1). These values
- should have a null result in the --STRESN column since only
- numeric values can be represented in the --STRESN field.
+ - Cited Guidance: Occasionally data that are intended to be numeric are collected with
+ characters attached that cause the character-to numeric conversion to fail. For example,
+ numeric cell counts in the source data may be specified with a greater than (>) or less
+ than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in
+ the --STRESN column since only numeric values can be represented in the --STRESN field.
Document: IG v3.0
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND91
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Occasionally data that are intended to be numeric are collected
- with characters attached that cause the character-to numeric
- conversion to fail. For example, numeric cell counts in the
- source data may be specified with a greater than (>) or less
- than (<) sign attached (e.g., >10,000 or <1). These values
- should have a null result in the --STRESN column since only
- numeric values can be represented in the --STRESN field.
+ - Cited Guidance: Occasionally data that are intended to be numeric are collected with
+ characters attached that cause the character-to numeric conversion to fail. For example,
+ numeric cell counts in the source data may be specified with a greater than (>) or less
+ than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in
+ the --STRESN column since only numeric values can be represented in the --STRESN field.
Document: IG v3.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND91
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Occasionally data that are intended to be numeric are collected
- with characters attached that cause the character-to numeric
- conversion to fail. For example, numeric cell counts in the
- source data may be specified with a greater than (>) or less
- than (<) sign attached (e.g., >10,000 or <1). These values
- should have a null result in the --STRESN column since only
- numeric values can be represented in the --STRESN field.
+ - Cited Guidance: Occasionally data that are intended to be numeric are collected with
+ characters attached that cause the character-to numeric conversion to fail. For example,
+ numeric cell counts in the source data may be specified with a greater than (>) or less
+ than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in
+ the --STRESN column since only numeric values can be represented in the --STRESN field.
Document: IG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND91
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Occasionally data that are intended to be numeric are collected
- with characters attached that cause the character-to numeric
- conversion to fail. For example, numeric cell counts in the
- source data may be specified with a greater than (>) or less
- than (<) sign attached (e.g., >10,000 or <1). These values
- should have a null result in the --STRESN column since only
- numeric values can be represented in the --STRESN field.
+ - Cited Guidance: Occasionally data that are intended to be numeric are collected with
+ characters attached that cause the character-to numeric conversion to fail. For example,
+ numeric cell counts in the source data may be specified with a greater than (>) or less
+ than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in
+ the --STRESN column since only numeric values can be represented in the --STRESN field.
Document: IG v3.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND91
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Occasionally data that are intended to be numeric are collected
- with characters attached that cause the character-to numeric
- conversion to fail. For example, numeric cell counts in the
- source data may be specified with a greater than (>) or less
- than (<) sign attached (e.g., >10,000 or <1). These values
- should have a null result in the --STRESN column since only
- numeric values can be represented in the --STRESN field.
+ - Cited Guidance: Occasionally data that are intended to be numeric are collected with
+ characters attached that cause the character-to numeric conversion to fail. For example,
+ numeric cell counts in the source data may be specified with a greater than (>) or less
+ than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in
+ the --STRESN column since only numeric values can be represented in the --STRESN field.
Document: IG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND91
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Occasionally data that are intended to be numeric are collected
- with characters attached that cause the character-to numeric
- conversion to fail. For example, numeric cell counts in the
- source data may be specified with a greater than (>) or less
- than (<) sign attached (e.g., >10,000 or <1). These values
- should have a null result in the --STRESN column since only
- numeric values can be represented in the --STRESN field.
+ - Cited Guidance: Occasionally data that are intended to be numeric are collected with
+ characters attached that cause the character-to numeric conversion to fail. For example,
+ numeric cell counts in the source data may be specified with a greater than (>) or less
+ than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in
+ the --STRESN column since only numeric values can be represented in the --STRESN field.
Document: IG v3.1.1
Section: 4.5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND91
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Occasionally data that are intended to be numeric are collected
- with characters attached that cause the character-to numeric
- conversion to fail. For example, numeric cell counts in the
- source data may be specified with a greater than (>) or less
- than (<) sign attached (e.g., >10,000 or <1). These values
- should have a null result in the --STRESN column since only
- numeric values can be represented in the --STRESN field.
+ - Cited Guidance: Occasionally data that are intended to be numeric are collected with
+ characters attached that cause the character-to numeric conversion to fail. For example,
+ numeric cell counts in the source data may be specified with a greater than (>) or less
+ than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in
+ the --STRESN column since only numeric values can be represented in the --STRESN field.
Document: TIG v1.0
Item: Text
Section: 2.8.7.1
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0281
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --ORRES
@@ -139,13 +125,12 @@ Check:
Core:
Id: CORE-000756
Status: Published
- Version: '1'
-Description: When --ORRES is representing numeric data with special characters
- like '<' and '>', , --STRESN may not be populated.
+ Version: "1"
+Description: When --ORRES is representing numeric data with special characters like '<' and '>', ,
+ --STRESN may not be populated.
Executability: Partially Executable # See JIRA
Outcome:
- Message: --STRESN may not be populated as --ORRES does not represent a pure
- numeric value.
+ Message: --STRESN may not be populated as --ORRES does not represent a pure numeric value.
Output Variables:
- --ORRES
- --STRESN
diff --git a/Published/CORE-000757/rule.yml b/Published/CORE-000757/rule.yml
index 235e5be50..5062a4735 100644
--- a/Published/CORE-000757/rule.yml
+++ b/Published/CORE-000757/rule.yml
@@ -4,36 +4,36 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When findings are collected about an event or intervention, and
- the name of the event or intervention is collected in an
- "Other, specify" CRF field, the value in --OBJ variable
- depends on whether the FA record has a parent record and
- whether the "Other, specify" value was coded.
+ - Cited Guidance:
+ When findings are collected about an event or intervention, and the name of
+ the event or intervention is collected in an "Other, specify" CRF field, the value in
+ --OBJ variable depends on whether the FA record has a parent record and whether the
+ "Other, specify" value was coded.
Document: IG v3.4
- Section: '4.2.7.4'
+ Section: "4.2.7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0602
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- - Cited Guidance: When findings are collected about an event or intervention, and
- the name of the event or intervention is collected in an
- "Other, specify" CRF field, the value in --OBJ variable
- depends on whether the FA record has a parent record and
- whether the "Other, specify" value was coded.
+ - Cited Guidance:
+ When findings are collected about an event or intervention, and the name of
+ the event or intervention is collected in an "Other, specify" CRF field, the value in
+ --OBJ variable depends on whether the FA record has a parent record and whether the
+ "Other, specify" value was coded.
Document: TIG 1.0
Section: 2.8.7.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0656
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --DECOD
@@ -46,17 +46,15 @@ Check:
Core:
Id: CORE-000757
Status: Published
- Version: '1'
-Description: When findings are collected about an intervention, and the
- interventions parent record exists and --DECOD = null, FAOBJ should be equal
- to --TRT.
+ Version: "1"
+Description: When findings are collected about an intervention, and the interventions parent record
+ exists and --DECOD = null, FAOBJ should be equal to --TRT.
Executability: Fully Executable
Match Datasets:
- Name: RELREC
Wildcard: FA
Outcome:
- Message: Interventions parent record exists and --DECOD = null, but FAOBJ is not
- equal to --TRT.
+ Message: Interventions parent record exists and --DECOD = null, but FAOBJ is not equal to --TRT.
Output Variables:
- RELREC.FAOBJ
- --TRT
diff --git a/Published/CORE-000758/rule.yml b/Published/CORE-000758/rule.yml
index 1eeb7995e..34329c55c 100644
--- a/Published/CORE-000758/rule.yml
+++ b/Published/CORE-000758/rule.yml
@@ -7,90 +7,80 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Reference Start Date/time for the subject in ISO 8601 character
- format. Usually equivalent to date/time when subject was first
- exposed to study treatment. See Assumption 9 for additional
- detail on when RFSTDTC may be null.
+ - Cited Guidance:
+ Reference Start Date/time for the subject in ISO 8601 character format.
+ Usually equivalent to date/time when subject was first exposed to study treatment. See
+ Assumption 9 for additional detail on when RFSTDTC may be null.
Document: IG v3.3
Item: Specification
- Section: '5.2'
- - Cited Guidance: ARMNRS is populated with "UNPLANNED TREATMENT", ACTARMUD should
- be populated with a description of the unplanned treatment
- received.
+ Section: "5.2"
+ - Cited Guidance:
+ ARMNRS is populated with "UNPLANNED TREATMENT", ACTARMUD should be populated
+ with a description of the unplanned treatment received.
Document: IG v3.3
Item: Assumption 4.a.4
- Section: '5.2'
- - Cited Guidance: As described in Section 4.1.4, Order of the Variables, RFSTDTC
- is used to calculate study day variables. RFSTDTC is usually
- defined as the date/time when a subject was first exposed to
- study drug. This definition applies for most interventional
- studies, when the start of treatment is the natural and
- preferred starting point for study day variables and thus the
- logical value for RFSTDTC. In such studies, when data are
- submitted for subjects who are ineligible for treatment (e.g.,
- screen failures with ARMNRS = "SCREEN FAILURE"), subjects who
- were enrolled but not assigned to an arm (e.g., ARMNRS = "NOT
- ASSIGNED"), or subjects who were randomized but not treated
- (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will be null. For
- studies with designs that include a substantial portion of
- subjects who are not expected to be treated, a different
- protocol milestone may be chosen as the starting point for
- study day variables. Some examples include non-interventional
- or observational studies, studies with a no-treatment arm, or
- studies where there is a delay between randomization and
- treatment.
+ Section: "5.2"
+ - Cited Guidance:
+ As described in Section 4.1.4, Order of the Variables, RFSTDTC is used to
+ calculate study day variables. RFSTDTC is usually defined as the date/time when a subject
+ was first exposed to study drug. This definition applies for most interventional studies,
+ when the start of treatment is the natural and preferred starting point for study day
+ variables and thus the logical value for RFSTDTC. In such studies, when data are submitted
+ for subjects who are ineligible for treatment (e.g., screen failures with ARMNRS = "SCREEN
+ FAILURE"), subjects who were enrolled but not assigned to an arm (e.g., ARMNRS = "NOT
+ ASSIGNED"), or subjects who were randomized but not treated (e.g., ARMNRS = "NOT
+ TREATED"), RFSTDTC will be null. For studies with designs that include a substantial
+ portion of subjects who are not expected to be treated, a different protocol milestone may
+ be chosen as the starting point for study day variables. Some examples include
+ non-interventional or observational studies, studies with a no-treatment arm, or studies
+ where there is a delay between randomization and treatment.
Document: IG v3.3
Item: Assumption 9
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0534
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Reference Start Date/time for the subject in ISO 8601 character
- format. Usually equivalent to date/time when subject was first
- exposed to study treatment. See Assumption 9 for additional
- detail on when RFSTDTC may be null.
+ - Cited Guidance:
+ Reference Start Date/time for the subject in ISO 8601 character format.
+ Usually equivalent to date/time when subject was first exposed to study treatment. See
+ Assumption 9 for additional detail on when RFSTDTC may be null.
Document: IG v3.4
Item: Specification
- Section: '5.2'
- - Cited Guidance: RFSTDTC is used to calculate study day variables. RFSTDTC is
- usually defined as the date/time when a subject was first
- exposed to study drug. This definition applies for most
- interventional studies, when the start of treatment is the
- natural and preferred starting point for study day variables
- and thus the logical value for RFSTDTC. In such studies, when
- data are submitted for subjects who are ineligible for
- treatment (e.g., screen failures with ARMNRS = "SCREEN
- FAILURE"), subjects who were enrolled but not assigned to an
- arm (e.g., ARMNRS = "NOT ASSIGNED"), or subjects who were
- randomized but not treated (e.g., ARMNRS = "NOT TREATED"),
- RFSTDTC will be null. For studies with designs that include a
- substantial portion of subjects who are not expected to be
- treated, a different protocol milestone may be chosen as the
- starting point for study day variables. Some examples include
- non-interventional or observational studies, studies with a
- no-treatment Arm, or studies where there is a delay between
- randomization and treatment.
+ Section: "5.2"
+ - Cited Guidance:
+ RFSTDTC is used to calculate study day variables. RFSTDTC is usually defined
+ as the date/time when a subject was first exposed to study drug. This definition applies
+ for most interventional studies, when the start of treatment is the natural and preferred
+ starting point for study day variables and thus the logical value for RFSTDTC. In such
+ studies, when data are submitted for subjects who are ineligible for treatment (e.g.,
+ screen failures with ARMNRS = "SCREEN FAILURE"), subjects who were enrolled but not
+ assigned to an arm (e.g., ARMNRS = "NOT ASSIGNED"), or subjects who were randomized but
+ not treated (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will be null. For studies with designs
+ that include a substantial portion of subjects who are not expected to be treated, a
+ different protocol milestone may be chosen as the starting point for study day variables.
+ Some examples include non-interventional or observational studies, studies with a
+ no-treatment Arm, or studies where there is a delay between randomization and treatment.
Document: IG v3.4
Item: Assumption 9
- Section: '5.2'
+ Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0534
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- - Cited Guidance: RFSTDTC Reference start date/time for the subject in ISO 8601
- character format. Usually equivalent to date/time when subject
- was first exposed to study product
+ - Cited Guidance:
+ RFSTDTC Reference start date/time for the subject in ISO 8601 character
+ format. Usually equivalent to date/time when subject was first exposed to study product
Document: TIG 1.0
Item: Specification
Section: 2.8.10.4
@@ -101,32 +91,32 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0627
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: ARMNRS
operator: non_empty
- name: ARMNRS
operator: not_equal_to
- value: 'UNPLANNED TREATMENT'
+ value: "UNPLANNED TREATMENT"
value_is_literal: true
- name: RFSTDTC
operator: non_empty
Core:
- Id: 'CORE-000758'
+ Id: "CORE-000758"
Status: Published
- Version: '1'
-Description: 'Raise an error when milestone associated with RFSTDTC is start of
- treatment and ARMNRS is not null and different from ''UNPLANNED TREATMENT'',
- but RFSTDTC is not null.'
+ Version: "1"
+Description:
+ "Raise an error when milestone associated with RFSTDTC is start of treatment and ARMNRS is
+ not null and different from 'UNPLANNED TREATMENT', but RFSTDTC is not null."
Executability: Partially Executable
Outcome:
- Message: 'Milestone associated with RFSTDTC is start of treatment and ARMNRS is
- not null and different from ''UNPLANNED TREATMENT'', but RFSTDTC is not
- empty.'
+ Message:
+ "Milestone associated with RFSTDTC is start of treatment and ARMNRS is not null and different
+ from 'UNPLANNED TREATMENT', but RFSTDTC is not empty."
Output Variables:
- ARMNRS
- RFSTDTC
diff --git a/Published/CORE-000760/rule.yml b/Published/CORE-000760/rule.yml
index 915bc4700..22bded515 100644
--- a/Published/CORE-000760/rule.yml
+++ b/Published/CORE-000760/rule.yml
@@ -7,29 +7,27 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3413
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3413
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: RFCSTDTC
@@ -42,9 +40,9 @@ Check:
Core:
Id: CORE-000760
Status: Published
- Version: '1'
-Description: Date/Time of First Challenge Agent Admin (RFCSTDTC) should be prior
- or equal to the Date/Time of Last Challenge Agent Admin (RFCENDTC).
+ Version: "1"
+Description: Date/Time of First Challenge Agent Admin (RFCSTDTC) should be prior or equal to the
+ Date/Time of Last Challenge Agent Admin (RFCENDTC).
Executability: Fully Executable
Outcome:
Message: RFCSTDTC falls after RFCENDTC.
diff --git a/Published/CORE-000762/rule.yml b/Published/CORE-000762/rule.yml
index bd6986d2d..ce29b0869 100644
--- a/Published/CORE-000762/rule.yml
+++ b/Published/CORE-000762/rule.yml
@@ -5,8 +5,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "Variables intended only for human studies should not be
- included in nonclinical data."
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
@@ -18,8 +19,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "Variables intended only for human studies should not be
- included in nonclinical data."
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
@@ -31,8 +33,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "Variables intended only for human studies should not be
- included in nonclinical data."
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
@@ -44,8 +47,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: "Variables intended only for human studies should not be
- included in nonclinical data."
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
@@ -57,8 +61,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "Variables intended only for human studies should not be
- included in nonclinical data."
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
@@ -70,8 +75,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "Variables intended only for human studies should not be
- included in nonclinical data."
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
@@ -83,8 +89,9 @@ Authorities:
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: "Variables intended only for human studies should not be
- included in nonclinical data."
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
diff --git a/Published/CORE-000763/rule.yml b/Published/CORE-000763/rule.yml
index 598014f03..712adeb17 100644
--- a/Published/CORE-000763/rule.yml
+++ b/Published/CORE-000763/rule.yml
@@ -4,89 +4,77 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "If the reference time point corresponds to the date of
- collection or assessment: Start values: an observation can
- start BEFORE that time point, can start COINCIDENT with that
- time point, or it is unknown (U) when it started. End values:
- an observation can end BEFORE that time point, can end
- COINCIDENT with that time point, can be known that it didn't
- end but was ONGOING, or it is unknown (U) at all when
- it ended or if it was ongoing. AFTER is not a valid value in
- this case because it would represent an event after the date
- of collection."
+ - Cited Guidance:
+ "If the reference time point corresponds to the date of collection or assessment:
+ Start values: an observation can start BEFORE that time point, can start COINCIDENT with that
+ time point, or it is unknown (U) when it started. End values: an observation can end BEFORE
+ that time point, can end COINCIDENT with that time point, can be known that it didn't end but
+ was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not
+ a valid value in this case because it would represent an event after the date of collection."
Document: IG v3.4
Section: 4.4.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0232
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "If the reference time point corresponds to the date of
- collection or assessment: Start values: an observation can
- start BEFORE that time point, can start COINCIDENT with that
- time point, or it is unknown (U) when it started. End values:
- an observation can end BEFORE that time point, can end
- COINCIDENT with that time point, can be known that it didn't
- end but was ONGOING, or it is unknown (U) at all when it ended
- or if it was ongoing. AFTER is not a valid value in this case
- because it would represent an event after the date of
- collection."
+ - Cited Guidance:
+ "If the reference time point corresponds to the date of collection or assessment:
+ Start values: an observation can start BEFORE that time point, can start COINCIDENT with that
+ time point, or it is unknown (U) when it started. End values: an observation can end BEFORE
+ that time point, can end COINCIDENT with that time point, can be known that it didn't end but
+ was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a
+ valid value in this case because it would represent an event after the date of collection."
Document: IG v3.2
Section: 4.1.4.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0232
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "If the reference time point corresponds to the date of
- collection or assessment: Start values: an observation can
- start BEFORE that time point, can start COINCIDENT with that
- time point, or it is unknown (U) when it started. End values:
- an observation can end BEFORE that time point, can end
- COINCIDENT with that time point, can be known that it didn't
- end but was ONGOING, or it is unknown (U) at all when it ended
- or if it was ongoing. AFTER is not a valid value in this case
- because it would represent an event after the date of
- collection."
+ - Cited Guidance:
+ "If the reference time point corresponds to the date of collection or assessment:
+ Start values: an observation can start BEFORE that time point, can start COINCIDENT with that
+ time point, or it is unknown (U) when it started. End values: an observation can end BEFORE
+ that time point, can end COINCIDENT with that time point, can be known that it didn't end but
+ was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a
+ valid value in this case because it would represent an event after the date of collection."
Document: IG v3.3
Section: 4.4.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0232
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If the reference time point corresponds to the date of
- collection or assessment; Start values; an observation can
- start BEFORE that time point, can start COINCIDENT with that
- time point, or it is unknown (U) when it started. End values;
- an observation can end BEFORE that time point, can end
- COINCIDENT with that time point, can be known that it didn't
- end but was ONGOING, or it is unknown (U) at all when it ended
- or if it was ongoing. AFTER is not a valid value in this case
- because it would represent an event after the date of
- collection.
+ - Cited Guidance: If the reference time point corresponds to the date of collection or
+ assessment; Start values; an observation can start BEFORE that time point, can start
+ COINCIDENT with that time point, or it is unknown (U) when it started. End values; an
+ observation can end BEFORE that time point, can end COINCIDENT with that time point, can
+ be known that it didn't end but was ONGOING, or it is unknown (U) at all when it ended or
+ if it was ongoing. AFTER is not a valid value in this case because it would represent an
+ event after the date of collection.
Document: TIG 1.0
Item: Num 1
Section: 2.8.7.6
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0441
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
# Variable: --STRTPT
# Condition: --STTPT corresponds to the date of collection or assessment.
# Rule: --STRTPT in ('BEFORE', 'COINCIDENT', 'UNKNOWN')
@@ -110,12 +98,12 @@ Check:
Core:
Id: CORE-000763
Status: Published
- Version: '1'
+ Version: "1"
Description: Trigger error when --STRTPT is not in ('BEFORE', 'COINCIDENT', 'UNKNOWN')
Executability: Partially Executable
Outcome:
- Message: --STTPT is equal to the date of collection or assessment but --STRTPT
- is not in ('BEFORE', 'COINCIDENT', 'UNKNOWN').
+ Message: --STTPT is equal to the date of collection or assessment but --STRTPT is not in
+ ('BEFORE', 'COINCIDENT', 'UNKNOWN').
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000764/rule.yml b/Published/CORE-000764/rule.yml
index c022a3b25..05639e1e8 100644
--- a/Published/CORE-000764/rule.yml
+++ b/Published/CORE-000764/rule.yml
@@ -1,22 +1,22 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: DSSCAT = "PRODUCT EXPOSURE" is used when a study has only a
- single product|2.b.iii If a study has multiple products, then
- DSSCAT should name the individual product.
+ - Cited Guidance: DSSCAT = "PRODUCT EXPOSURE" is used when a study has only a single
+ product|2.b.iii If a study has multiple products, then DSSCAT should name the individual
+ product.
Document: TIG v1.0
Item: 2.b.ii
Section: 2.8.10.8
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0632
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: $disposition_event_count
@@ -32,12 +32,11 @@ Check:
- USUBJID
- EPOCH
Core:
- Status: Published
- Version: '1'
Id: CORE-000764
-Description: Trigger error when subject has more than one record per Epoch with
- DSCAT = 'DISPOSITION EVENT' and more than one record where DSSCAT = PRODUCT
- EXPOSURE'
+ Status: Published
+ Version: "1"
+Description: Trigger error when subject has more than one record per Epoch with DSCAT = 'DISPOSITION
+ EVENT' and more than one record where DSSCAT = PRODUCT EXPOSURE'
Executability: Fully Executable
Operations:
- domain: DS
@@ -50,8 +49,8 @@ Operations:
name: DSCAT
operator: record_count
Outcome:
- Message: More than 1 record exists per subject per EPOCH with DSCAT =
- 'DISPOSITION EVENT' and DSSCAT = 'PRODUCT EXPOSURE'.
+ Message: More than 1 record exists per subject per EPOCH with DSCAT = 'DISPOSITION EVENT' and
+ DSSCAT = 'PRODUCT EXPOSURE'.
Output Variables:
- USUBJID
- DSCAT
diff --git a/Published/CORE-000765/rule.yml b/Published/CORE-000765/rule.yml
index 0a209e7b8..42aced21e 100644
--- a/Published/CORE-000765/rule.yml
+++ b/Published/CORE-000765/rule.yml
@@ -1,5 +1,5 @@
# Variable: dataset_size
-# Condition:
+# Condition:
# Rule: dataset_size is not greater than 5GB
Authorities:
- Organization: FDA
@@ -7,133 +7,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Large datasets should be split into smaller datasets no larger
- than 5 GB in size.
+ - Cited Guidance:
+ Large datasets should be split into smaller datasets no larger than 5 GB in
+ size.
Document: FDA
Section: FDAB024
Origin: FDA Business Rules
Rule Identifier:
Id: FB2401
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Large datasets should be split into smaller datasets no larger
- than 5 GB in size.
+ - Cited Guidance:
+ Large datasets should be split into smaller datasets no larger than 5 GB in
+ size.
Document: FDA
Section: FDAB024
Origin: FDA Business Rules
Rule Identifier:
Id: FB2401
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Large datasets should be split into smaller datasets no larger
- than 5 GB in size.
+ - Cited Guidance:
+ Large datasets should be split into smaller datasets no larger than 5 GB in
+ size.
Document: FDA
Section: FDAB024
Origin: FDA Business Rules
Rule Identifier:
Id: FB2401
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Large datasets should be split into smaller datasets no larger
- than 5 GB in size.
+ - Cited Guidance:
+ Large datasets should be split into smaller datasets no larger than 5 GB in
+ size.
Document: FDA
Section: FDAB024
Origin: FDA Business Rules
Rule Identifier:
Id: FB2401
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Large datasets should be split into smaller datasets no larger
- than 5 GB in size.
+ - Cited Guidance:
+ Large datasets should be split into smaller datasets no larger than 5 GB in
+ size.
Document: FDA
Section: FDAB024
Origin: FDA Business Rules
Rule Identifier:
Id: FB2401
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Large datasets should be split into smaller datasets no larger
- than 5 GB in size.
+ - Cited Guidance:
+ Large datasets should be split into smaller datasets no larger than 5 GB in
+ size.
Document: FDA
Section: FDAB024
Origin: FDA Business Rules
Rule Identifier:
Id: FB2401
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Large datasets should be split into smaller datasets no larger
- than 5 GB in size.
+ - Cited Guidance:
+ Large datasets should be split into smaller datasets no larger than 5 GB in
+ size.
Document: FDA
Section: FDAB024
Origin: FDA Business Rules
Rule Identifier:
Id: FB2401
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Large datasets should be split into smaller datasets no larger
- than 5 GB in size.
+ - Cited Guidance:
+ Large datasets should be split into smaller datasets no larger than 5 GB in
+ size.
Document: FDA
Section: FDAB024
Origin: FDA Business Rules
Rule Identifier:
Id: FB2401
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Large datasets should be split into smaller datasets no larger
- than 5 GB in size.
+ - Cited Guidance:
+ Large datasets should be split into smaller datasets no larger than 5 GB in
+ size.
Document: FDA
Section: FDAB024
Origin: FDA Business Rules
Rule Identifier:
Id: FB2401
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Large datasets should be split into smaller datasets no larger
- than 5 GB in size.
+ - Cited Guidance:
+ Large datasets should be split into smaller datasets no larger than 5 GB in
+ size.
Document: FDA
Section: FDAB024
Origin: FDA Business Rules
Rule Identifier:
Id: FB2401
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: $dataset_size
@@ -142,7 +152,7 @@ Check:
Core:
Id: CORE-000765
Status: Published
- Version: '1'
+ Version: "1"
Description: The submitted dataset is larger than 5 GB
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000768/rule.yml b/Published/CORE-000768/rule.yml
index e7f2524a9..599332d09 100644
--- a/Published/CORE-000768/rule.yml
+++ b/Published/CORE-000768/rule.yml
@@ -11,9 +11,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND235
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -24,9 +24,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND235
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -37,8 +37,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND235
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
@@ -50,9 +50,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND235
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
@@ -63,9 +63,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND235
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -76,9 +76,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND235
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
# There may be only 1 record for TXPARMCD=ARMCD per group of SETCD values
@@ -89,18 +89,20 @@ Check:
Core:
Id: CORE-000768
Status: Published
- Version: '1'
+ Version: "1"
Description: Every Trial Set should have only one ARMCD.
Executability: Fully Executable
Operations:
- - domain: TX
- # only keep the records with TXPARMCD=ARMCD
+ - domain:
+ TX
+ # only keep the records with TXPARMCD=ARMCD
filter:
- TXPARMCD: ARMCD
- # group the records by value of TXSETCD
+ TXPARMCD:
+ ARMCD
+ # group the records by value of TXSETCD
group:
- SETCD
- # within the filtered and grouped records, count the number of TXVAL records
+ # within the filtered and grouped records, count the number of TXVAL records
id: $armcd_count
name: TXVAL
operator: record_count
diff --git a/Published/CORE-000769/rule.yml b/Published/CORE-000769/rule.yml
index fe17458b3..efabda69c 100644
--- a/Published/CORE-000769/rule.yml
+++ b/Published/CORE-000769/rule.yml
@@ -1,97 +1,91 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5302'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB5302"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5302'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB5302"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5302'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB5302"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5302'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB5302"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5302'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB5302"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'If an age range is supplied, it should be in number-number
- format.'
- Document: 'FDA'
- Section: 'FDAB053'
+ - Cited Guidance: "If an age range is supplied, it should be in number-number format."
+ Document: "FDA"
+ Section: "FDAB053"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB5302'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB5302"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: TSPARMCD
operator: equal_to
- value: 'AGETXT'
+ value: "AGETXT"
- name: TSVAL
operator: not_matches_regex
value: ^[0-9]+-[0-9]+$
Core:
Id: CORE-000769
Status: Published
- Version: '1'
-Description: 'The value of TSVAL for TSPARMCD=AGETXT must be in number-number format'
+ Version: "1"
+Description: "The value of TSVAL for TSPARMCD=AGETXT must be in number-number format"
Executability: Fully Executable
Outcome:
Message: TSVAL value when TSPARMCD = AGETXT is not in number - number format.
diff --git a/Published/CORE-000770/negative/01/data/tx.csv b/Published/CORE-000770/negative/01/data/tx.csv
index 5b6d0f3e7..c50dd4d6c 100644
--- a/Published/CORE-000770/negative/01/data/tx.csv
+++ b/Published/CORE-000770/negative/01/data/tx.csv
@@ -5,4 +5,5 @@ CDISCPILOT01,TX,SET1,"Control Group, Vehicle Control once daily ",3,TCNTRL,Contr
CDISCPILOT01,TX,SET2,"Low-Dose Group, 100 mg/kg Drug a once daily ",4,ARMCD,Arm Code,ARM2
CDISCPILOT01,TX,SET2,"Low-Dose Group, 100 mg/kg Drug a once daily ",5,XXSPGRPCD,Sponsor-defined Group Code,GRP2
CDISCPILOT01,TX,SET2,"Low-Dose Group, 100 mg/kg Drug a once daily ",6,GRPLBL,Group Label,Label 2
-CDISCPILOT01,TX,SET3,"Low-Dose Group, 100 mg/kg Drug a once daily ",6,ARMCD,Arm Code,ARM3
+CDISCPILOT01,TX,SET3,"Low-Dose Group, 100 mg/kg Drug a once daily ",7,ARMCD,Arm Code,ARM3
+CDISCPILOT01,TX,SET3,"Low-Dose Group, 100 mg/kg Drug a once daily ",8,TCNTRL,Control Type,Vehicle Control
diff --git a/Published/CORE-000770/rule.yml b/Published/CORE-000770/rule.yml
index 4afd8034f..f9e77b39f 100644
--- a/Published/CORE-000770/rule.yml
+++ b/Published/CORE-000770/rule.yml
@@ -10,185 +10,182 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND234
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with
- corresponding parameter value under TXVAL.
+ - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding
+ parameter value under TXVAL.
Document: IG v3.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND234
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with
- corresponding parameter value under TXVAL.
+ - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding
+ parameter value under TXVAL.
Document: IG v3.1.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND234
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with
- corresponding parameter value under TXVAL.
+ - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding
+ parameter value under TXVAL.
Document: IG v3.1.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND234
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with
- corresponding parameter value under TXVAL.
+ - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding
+ parameter value under TXVAL.
Document: IG v3.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND234
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with
- corresponding parameter value under TXVAL.
+ - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding
+ parameter value under TXVAL.
Document: IG v3.1.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND234
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with
- corresponding parameter value under TXVAL.
+ - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding
+ parameter value under TXVAL.
Document: TIG v1.0
Item: Assumption 3
Section: 2.8.9.28
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0162
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
- # FDA rule FB4602 added (SEND-only)
+ Version:
+ "1.0"
+ # FDA rule FB4602 added (SEND-only)
- Organization: FDA
Standards:
# Applicable to SENDIG as of version 3.1
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
Document: FDA
Section: FDAB046
Origin: FDA Business Rules
Rule Identifier:
Id: FB4602
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
Document: FDA
Section: FDAB046
Origin: FDA Business Rules
Rule Identifier:
Id: FB4602
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
Document: FDA
Section: FDAB046
Origin: FDA Business Rules
Rule Identifier:
Id: FB4602
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
Document: FDA
Section: FDAB046
Origin: FDA Business Rules
Rule Identifier:
Id: FB4602
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
Document: FDA
Section: FDAB046
Origin: FDA Business Rules
Rule Identifier:
Id: FB4602
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
Document: FDA
Section: FDAB046
Origin: FDA Business Rules
Rule Identifier:
Id: FB4602
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
# 2025-03-13: REMARK that only the first violation is reported when Sensitivity is set to "Dataset"
# See Github issue https://github.com/cdisc-org/cdisc-rules-engine/issues/831
- - name: '$txgroupsbysetcd'
- operator: 'does_not_contain'
- value: 'SPGRPCD'
- # TODO???: also check the TXVAL is populated for TXPARMCD=SPGRPCD, this however seems not to be part of the rule
+ - name: "$txgroupsbysetcd"
+ operator: "does_not_contain"
+ value:
+ "SPGRPCD"
+ # TODO???: also check the TXVAL is populated for TXPARMCD=SPGRPCD, this however seems not to be part of the rule
Core:
Id: CORE-000770
Status: Published
- Version: '1'
-Description: 'For each Trial Set (SETCD) in the TX dataset exactly one
- Sponsor-Defined Group Code (SPGRPCD) record should be included.'
+ Version: "1"
+Description:
+ "For each Trial Set (SETCD) in the TX dataset exactly one Sponsor-Defined Group Code (SPGRPCD)
+ record should be included."
Executability: Fully Executable
Operations:
- domain: TX
diff --git a/Published/CORE-000771/rule.yml b/Published/CORE-000771/rule.yml
index 88e6c9c4a..e39a1e917 100644
--- a/Published/CORE-000771/rule.yml
+++ b/Published/CORE-000771/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND156
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND156
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -34,8 +34,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND156
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
@@ -46,9 +46,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND156
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -58,9 +58,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND156
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -70,9 +70,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND156
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
- all:
@@ -98,15 +98,13 @@ Check:
Core:
Id: CORE-000771
Status: Published
- Version: '1'
-Description: Raise an error when there is more than one record present for any
- particular Result or Findings as Collected, in the CL Domain, for a subject or
- pool on a particular date.
+ Version: "1"
+Description: Raise an error when there is more than one record present for any particular Result or
+ Findings as Collected, in the CL Domain, for a subject or pool on a particular date.
Executability: Fully Executable
# The check for this rule was revised to NOT check the records where CLDTC is null
Outcome:
- Message: The Clinical Observation test result is not unique for this subject and
- date/time.
+ Message: The Clinical Observation test result is not unique for this subject and date/time.
Output Variables:
- USUBJID
- POOLID
diff --git a/Published/CORE-000772/rule.yml b/Published/CORE-000772/rule.yml
index 88383f139..630cca3ad 100644
--- a/Published/CORE-000772/rule.yml
+++ b/Published/CORE-000772/rule.yml
@@ -4,99 +4,99 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set
- with a Trial Arm as defined in the Trial Arms table. Each
- Trial Set should only have one ARMCD parameter, but more than
- one Trial Set may have the same value of the ARMCD parameter.
+ - Cited Guidance:
+ The ARMCD parameter should be used to associate each Trial Set with a Trial
+ Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD
+ parameter, but more than one Trial Set may have the same value of the ARMCD parameter.
Document: IG v3.0
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND236.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set
- with a Trial Arm as defined in the Trial Arms table. Each
- Trial Set should only have one ARMCD parameter, but more than
- one Trial Set may have the same value of the ARMCD parameter.
+ - Cited Guidance:
+ The ARMCD parameter should be used to associate each Trial Set with a Trial
+ Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD
+ parameter, but more than one Trial Set may have the same value of the ARMCD parameter.
Document: IG v3.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND236.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set
- with a Trial Arm as defined in the Trial Arms table. Each
- Trial Set should only have one ARMCD parameter, but more than
- one Trial Set may have the same value of the ARMCD parameter.
+ - Cited Guidance:
+ The ARMCD parameter should be used to associate each Trial Set with a Trial
+ Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD
+ parameter, but more than one Trial Set may have the same value of the ARMCD parameter.
Document: IG v3.1.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND236.1
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set
- with a Trial Arm as defined in the Trial Arms table. Each
- Trial Set should only have one ARMCD parameter, but more than
- one Trial Set may have the same value of the ARMCD parameter.
+ - Cited Guidance:
+ The ARMCD parameter should be used to associate each Trial Set with a Trial
+ Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD
+ parameter, but more than one Trial Set may have the same value of the ARMCD parameter.
Document: IG v3.1.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND236.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set
- with a Trial Arm as defined in the Trial Arms table. Each
- Trial Set should only have one ARMCD parameter, but more than
- one Trial Set may have the same value of the ARMCD parameter.
+ - Cited Guidance:
+ The ARMCD parameter should be used to associate each Trial Set with a Trial
+ Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD
+ parameter, but more than one Trial Set may have the same value of the ARMCD parameter.
Document: IG v3.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND236.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set
- with a Trial Arm as defined in the Trial Arms table. Each
- Trial Set should only have one ARMCD parameter, but more than
- one Trial Set may have the same value of the ARMCD parameter.
+ - Cited Guidance:
+ The ARMCD parameter should be used to associate each Trial Set with a Trial
+ Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD
+ parameter, but more than one Trial Set may have the same value of the ARMCD parameter.
Document: IG v3.1.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND236.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: TXPARMCD
@@ -107,10 +107,10 @@ Check:
operator: is_not_contained_by
value: $ta_armcd
Core:
- Status: Published
- Version: '1'
Id: CORE-000772
-Description: ''
+ Status: Published
+ Version: "1"
+Description: ""
Executability: Fully Executable
Operations:
- domain: TA
@@ -118,7 +118,7 @@ Operations:
name: ARMCD
operator: distinct
Outcome:
- Message: 'The value of TXVAL for TXPARMCD=ARMCD cannot be found in the TA dataset'
+ Message: "The value of TXVAL for TXPARMCD=ARMCD cannot be found in the TA dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000773/rule.yml b/Published/CORE-000773/rule.yml
index 0a8436c87..f72de3acd 100644
--- a/Published/CORE-000773/rule.yml
+++ b/Published/CORE-000773/rule.yml
@@ -4,68 +4,73 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: For a specimen collected or observed post mortem, this is the
- date/time of subject disposition in ISO 8601 format
+ - Cited Guidance:
+ For a specimen collected or observed post mortem, this is the date/time of
+ subject disposition in ISO 8601 format
Document: IG v3.1
Section: 6.3.7 | 6.3.8 | 6.3.14
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND320'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND320"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: For a specimen collected or observed post mortem, this is the
- date/time of subject disposition in ISO 8601 format
+ - Cited Guidance:
+ For a specimen collected or observed post mortem, this is the date/time of
+ subject disposition in ISO 8601 format
Document: IG v3.1.1
Section: 6.3.7 | 6.3.8 | 6.3.14
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND320'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND320"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: For a specimen collected or observed post mortem, this is the
- date/time of subject disposition in ISO 8601 format
+ - Cited Guidance:
+ For a specimen collected or observed post mortem, this is the date/time of
+ subject disposition in ISO 8601 format
Document: IG v3.1.1
Section: 6.3.7 | 6.3.8 | 6.3.14
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND320'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND320"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: For a specimen collected or observed post mortem, this is the
- date/time of subject disposition in ISO 8601 format
+ - Cited Guidance:
+ For a specimen collected or observed post mortem, this is the date/time of
+ subject disposition in ISO 8601 format
Document: IG v3.1
Section: 6.3.7 | 6.3.8 | 6.3.14
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND320'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND320"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: For a specimen collected or observed post mortem, this is the
- date/time of subject disposition in ISO 8601 format
+ - Cited Guidance:
+ For a specimen collected or observed post mortem, this is the date/time of
+ subject disposition in ISO 8601 format
Document: IG v3.1.1
Section: 6.3.7 | 6.3.8 | 6.3.14
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND320'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND320"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: --DTC
@@ -76,7 +81,7 @@ Check:
Core:
Id: CORE-000773
Status: Published
- Version: '1'
+ Version: "1"
Description: --DTC may not be later than DS.DSSTDTC
Executability: Fully Executable
Operations:
diff --git a/Published/CORE-000774/rule.yml b/Published/CORE-000774/rule.yml
index d6252cca8..cb2b9bcf7 100644
--- a/Published/CORE-000774/rule.yml
+++ b/Published/CORE-000774/rule.yml
@@ -4,143 +4,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Section: FDAB042
Origin: FDA Business Rules
Rule Identifier:
Id: FB4202
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Section: FDAB042
Origin: FDA Business Rules
Rule Identifier:
Id: FB4202
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Section: FDAB042
Origin: FDA Business Rules
Rule Identifier:
Id: FB4202
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Section: FDAB042
Origin: FDA Business Rules
Rule Identifier:
Id: FB4202
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Section: FDAB042
Origin: FDA Business Rules
Rule Identifier:
Id: FB4202
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Section: FDAB042
Origin: FDA Business Rules
Rule Identifier:
Id: FB4202
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Section: FDAB042
Origin: FDA Business Rules
Rule Identifier:
Id: FB4202
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Section: FDAB042
Origin: FDA Business Rules
Rule Identifier:
Id: FB4202
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Section: FDAB042
Origin: FDA Business Rules
Rule Identifier:
Id: FB4202
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: When a test is not done, the result variable should not be
- populated, and the reason not done should be provided in the
- appropriate variable.
+ - Cited Guidance:
+ When a test is not done, the result variable should not be populated, and
+ the reason not done should be provided in the appropriate variable.
Document: FDA
Section: FDAB042
Origin: FDA Business Rules
Rule Identifier:
Id: FB4202
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --STAT
@@ -155,9 +155,9 @@ Check:
Core:
Id: CORE-000774
Status: Published
- Version: '1'
-Description: When a test is not done (--STAT = NOT DONE), the Reason Not Done
- (--REASND) should be populated.
+ Version: "1"
+Description: When a test is not done (--STAT = NOT DONE), the Reason Not Done (--REASND) should be
+ populated.
Executability: Partially Executable - Possible Overreporting
Outcome:
Message: --STAT = NOT DONE, but --REASND is missing.
diff --git a/Published/CORE-000775/rule.yml b/Published/CORE-000775/rule.yml
index 3958e5c5d..605148f98 100644
--- a/Published/CORE-000775/rule.yml
+++ b/Published/CORE-000775/rule.yml
@@ -4,89 +4,95 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "TRTDOSU: For more complex dosing regimens, sponsor should enter
- 'SEE PROTOCOL' to match the associated TRTDOS value."
+ - Cited Guidance:
+ "TRTDOSU: For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL'
+ to match the associated TRTDOS value."
Document: IG v3.0
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND241.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE
- PROTOCOL' to match the associated TRTDOS value."
+ - Cited Guidance:
+ "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match
+ the associated TRTDOS value."
Document: IG v3.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND241.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE
- PROTOCOL' to match the associated TRTDOS value."
+ - Cited Guidance:
+ "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match
+ the associated TRTDOS value."
Document: IG v3.1.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND241.1
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE
- PROTOCOL' to match the associated TRTDOS value."
+ - Cited Guidance:
+ "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match
+ the associated TRTDOS value."
Document: IG v3.1.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND241.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE
- PROTOCOL' to match the associated TRTDOS value."
+ - Cited Guidance:
+ "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match
+ the associated TRTDOS value."
Document: IG v3.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND241.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE
- PROTOCOL' to match the associated TRTDOS value."
+ - Cited Guidance:
+ "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match
+ the associated TRTDOS value."
Document: IG v3.1.1
Item: Specification
Section: 7.4.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND241.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
- # With thanks to Richard Marshall 2025-03-16
+ # With thanks to Richard Marshall 2025-03-16
all:
- name: TXPARMCD
operator: is_contained_by
@@ -100,34 +106,35 @@ Check:
operator: not_equal_to
value: 1
Core:
- Status: Published
- Version: '1'
Id: CORE-000775
-Description: ''
+ Status: Published
+ Version: "1"
+Description: ""
Executability: Fully Executable
# Group by value of SETCD
Operations:
- # With thanks to Richard Marshall 2025-03-16
+ # With thanks to Richard Marshall 2025-03-16
# counts the records with TRTDOS='SEE PROTOCOL' within the group
- filter:
TXPARMCD: TRTDOS
- TXVAL: 'SEE PROTOCOL'
+ TXVAL: "SEE PROTOCOL"
group:
- SETCD
id: $num_trtdos_see_protocol
- operator: record_count
- # counts the records with TRTDOSU='SEE PROTOCOL' within the group
+ operator:
+ record_count
+ # counts the records with TRTDOSU='SEE PROTOCOL' within the group
- filter:
TXPARMCD: TRTDOSU
- TXVAL: 'SEE PROTOCOL'
+ TXVAL: "SEE PROTOCOL"
group:
- SETCD
id: $num_trtdosu_see_protocol
operator: record_count
Outcome:
- Message: "Within a single set, when TXPARMCD='TRTDOS' with the value for
- TXVAL='SEE PROTOCOL', then for the record with TXPARMCD=TRTDOSU in the same
- set, the value for TXVAL must also be 'SEE PROTOCOL'"
+ Message:
+ "Within a single set, when TXPARMCD='TRTDOS' with the value for TXVAL='SEE PROTOCOL', then
+ for the record with TXPARMCD=TRTDOSU in the same set, the value for TXVAL must also be 'SEE PROTOCOL'"
Output Variables:
- STUDYID
- $num_trtdos_see_protocol
diff --git a/Published/CORE-000776/rule.yml b/Published/CORE-000776/rule.yml
index ea6039bd2..a59c5c552 100644
--- a/Published/CORE-000776/rule.yml
+++ b/Published/CORE-000776/rule.yml
@@ -4,143 +4,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3203
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3203
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3203
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3203
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3203
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3203
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3203
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3203
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3203
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3203
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --ENDY
@@ -150,14 +150,13 @@ Check:
Core:
Id: CORE-000776
Status: Published
- Version: '1'
-Description: When End Date/Time of Observation (--ENDTC) is present in the
- dataset, then the Study Day of End of Observation (--ENDY) should also be
- present in the dataset
+ Version: "1"
+Description: When End Date/Time of Observation (--ENDTC) is present in the dataset, then the Study
+ Day of End of Observation (--ENDY) should also be present in the dataset
Executability: Fully Executable
Outcome:
- Message: Study Day of End of Observation (--ENDY) variable is missing when End
- Date/Time of Observation (--ENDTC) is present.
+ Message: Study Day of End of Observation (--ENDY) variable is missing when End Date/Time of
+ Observation (--ENDTC) is present.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000780/rule.yml b/Published/CORE-000780/rule.yml
index 3b63d5396..dfb415011 100644
--- a/Published/CORE-000780/rule.yml
+++ b/Published/CORE-000780/rule.yml
@@ -1,96 +1,102 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When the comment text is longer than 200 characters, the first
- 200 characters of the comment will be in COVAL, the next 200
- in COVAL1, and additional text stored as needed to COVALn.'
- Document: 'IG v.3.0'
- Item: 'Specification'
- Section: '5.2.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "When the comment text is longer than 200 characters, the first 200 characters
+ of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed
+ to COVALn."
+ Document: "IG v.3.0"
+ Item: "Specification"
+ Section: "5.2.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND119'
- Version: '1'
- Version: '5.0'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "SEND119"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When the comment text is longer than 200 characters, the first
- 200 characters of the comment will be in COVAL, the next 200
- in COVAL1, and additional text stored as needed to COVALn.'
- Document: 'IG v.3.1'
- Item: 'Specification'
- Section: '5.2.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "When the comment text is longer than 200 characters, the first 200 characters
+ of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed
+ to COVALn."
+ Document: "IG v.3.1"
+ Item: "Specification"
+ Section: "5.2.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND119'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "SEND119"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When the comment text is longer than 200 characters, the first
- 200 characters of the comment will be in COVAL, the next 200
- in COVAL1, and additional text stored as needed to COVALn.'
- Document: 'IG v.3.1.1'
- Item: 'Specification'
- Section: '5.2.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "When the comment text is longer than 200 characters, the first 200 characters
+ of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed
+ to COVALn."
+ Document: "IG v.3.1.1"
+ Item: "Specification"
+ Section: "5.2.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND119'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "SEND119"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'When the comment text is longer than 200 characters, the first
- 200 characters of the comment will be in COVAL, the next 200
- in COVAL1, and additional text stored as needed to COVALn.'
- Document: 'IG v.3.1.1'
- Item: 'Specification'
- Section: '5.2.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "When the comment text is longer than 200 characters, the first 200 characters
+ of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed
+ to COVALn."
+ Document: "IG v.3.1.1"
+ Item: "Specification"
+ Section: "5.2.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND119'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "SEND119"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'When the comment text is longer than 200 characters, the first
- 200 characters of the comment will be in COVAL, the next 200
- in COVAL1, and additional text stored as needed to COVALn.'
- Document: 'IG v.3.1'
- Item: 'Specification'
- Section: '5.2.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "When the comment text is longer than 200 characters, the first 200 characters
+ of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed
+ to COVALn."
+ Document: "IG v.3.1"
+ Item: "Specification"
+ Section: "5.2.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND119'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "SEND119"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'When the comment text is longer than 200 characters, the first
- 200 characters of the comment will be in COVAL, the next 200
- in COVAL1, and additional text stored as needed to COVALn.'
- Document: 'IG v.3.1.1'
- Item: 'Specification'
- Section: '5.2.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "When the comment text is longer than 200 characters, the first 200 characters
+ of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed
+ to COVALn."
+ Document: "IG v.3.1.1"
+ Item: "Specification"
+ Section: "5.2.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND119'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND119"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
any:
#- all:
@@ -106,12 +112,11 @@ Check:
Core:
Id: CORE-000780
Status: Published
- Version: '1'
-Description: 'Correct order of population in COVALn variables check'
+ Version: "1"
+Description: "Correct order of population in COVALn variables check"
Executability: Partially Executable - Possible Underreporting
Outcome:
- Message: 'Correct order of population in COVAL variables must be COVAL, COVAL1,
- COVAL2 ...'
+ Message: "Correct order of population in COVAL variables must be COVAL, COVAL1, COVAL2 ..."
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000781/rule.yml b/Published/CORE-000781/rule.yml
index c3854fed0..0ebd083a5 100644
--- a/Published/CORE-000781/rule.yml
+++ b/Published/CORE-000781/rule.yml
@@ -2,98 +2,104 @@
# Condition: TXPARMCD = SPECIES
# Rule: One Trail Set cannot contain more than one species
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND307'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "SEND307"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND307'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND307"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND307'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND307"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND307'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND307"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND307'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND307"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: $species_count
operator: greater_than
value: 1
Core:
- Status: Published
- Version: '1'
Id: CORE-000781
-Description: 'Trial Sets (TX) can have multiple species and/or strains if they
- are different by set.'
+ Status: Published
+ Version: "1"
+Description: "Trial Sets (TX) can have multiple species and/or strains if they are different by set."
Executability: Fully Executable
Operations:
- - domain: TX
- # only keep the records with TXPARMCD=SPECIES
+ - domain:
+ TX
+ # only keep the records with TXPARMCD=SPECIES
filter:
- TXPARMCD: SPECIES
- # group the records by value of TXSETCD
+ TXPARMCD:
+ SPECIES
+ # group the records by value of TXSETCD
group:
- SETCD
- # within the filtered and grouped records, count the number of records
+ # within the filtered and grouped records, count the number of records
id: $species_count
operator: record_count
Outcome:
- Message: 'One Trial Set cannot contain more than one species for the same SETCD.'
+ Message: "One Trial Set cannot contain more than one species for the same SETCD."
Output Variables:
- SETCD
- $species_count
diff --git a/Published/CORE-000782/rule.yml b/Published/CORE-000782/rule.yml
index 09f9372a0..dd19638b6 100644
--- a/Published/CORE-000782/rule.yml
+++ b/Published/CORE-000782/rule.yml
@@ -2,98 +2,104 @@
# Condition: TXPARMCD = STRAIN
# Rule: One Trail Set cannot contain more than one strain
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND308'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "SEND308"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND308'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND308"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND308'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND308"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND308'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND308"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND308'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND308"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: $strain_count
operator: greater_than
value: 1
Core:
- Status: Published
- Version: '1'
Id: CORE-000782
-Description: 'Trial Sets (TX) can have multiple species and/or strains if they
- are different by set.'
+ Status: Published
+ Version: "1"
+Description: "Trial Sets (TX) can have multiple species and/or strains if they are different by set."
Executability: Fully Executable
Operations:
- - domain: TX
- # only keep the records with TXPARMCD=STRAIN
+ - domain:
+ TX
+ # only keep the records with TXPARMCD=STRAIN
filter:
- TXPARMCD: STRAIN
- # group the records by value of TXSETCD
+ TXPARMCD:
+ STRAIN
+ # group the records by value of TXSETCD
group:
- SETCD
- # within the filtered and grouped records, count the number of records
+ # within the filtered and grouped records, count the number of records
id: $strain_count
operator: record_count
Outcome:
- Message: 'One Trial Set cannot contain more than one strain.'
+ Message: "One Trial Set cannot contain more than one strain."
Output Variables:
- SETCD
- $strain_count
diff --git a/Published/CORE-000783/rule.yml b/Published/CORE-000783/rule.yml
index 441609e51..08b3b881c 100644
--- a/Published/CORE-000783/rule.yml
+++ b/Published/CORE-000783/rule.yml
@@ -4,136 +4,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The SDTM allows for the inclusion of a sponsor's non-SDTM
- variables using the Supplemental Qualifiers special-purpose
- dataset structure
+ - Cited Guidance:
+ The SDTM allows for the inclusion of a sponsor's non-SDTM variables using
+ the Supplemental Qualifiers special-purpose dataset structure
Document: IG v3.4
Item: NA
- Section: '2.5'
+ Section: "2.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0314
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The SDTM allows for the inclusion of the sponsors non-SDTM
- variables using the Supplemental Qualifiers special-purpose
- dataset structure, described in Section 8; 8.4, Relating
- Non-Standard Variables Values To A Parent Domain.'
+ - Cited Guidance:
+ "The SDTM allows for the inclusion of the sponsors non-SDTM variables using the
+ Supplemental Qualifiers special-purpose dataset structure, described in Section 8; 8.4, Relating
+ Non-Standard Variables Values To A Parent Domain."
Document: IG v3.2
- Section: '2.5'
+ Section: "2.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0314
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The SDTM allows for the inclusion of a sponsor's non-SDTM
- variables using the Supplemental Qualifiers special purpose
- dataset structure, described in Section 8.4, Relating
- Non-Standard Variables Values to a Parent Domain.
+ - Cited Guidance:
+ The SDTM allows for the inclusion of a sponsor's non-SDTM variables using
+ the Supplemental Qualifiers special purpose dataset structure, described in Section 8.4,
+ Relating Non-Standard Variables Values to a Parent Domain.
Document: IG v3.3
- Section: '2.5'
- - Cited Guidance: New sponsor-defined variables must not be added, and existing
- variables must not be renamed or modified for novel usage.
+ Section: "2.5"
+ - Cited Guidance:
+ New sponsor-defined variables must not be added, and existing variables must
+ not be renamed or modified for novel usage.
Document: Model v1.7
- Section: '2.1'
+ Section: "2.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0314
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The value in QNAM may not be the same as any variable name
- defined in another domain or the SDTM.
+ - Cited Guidance:
+ The value in QNAM may not be the same as any variable name defined in
+ another domain or the SDTM.
Document: SENDIG v3.0
Item: QNAM CDISC Notes
- Section: '8.5'
+ Section: "8.5"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND274
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The value in QNAM may not be the same as any variable name
- defined in another domain or the SDTM.
+ - Cited Guidance:
+ The value in QNAM may not be the same as any variable name defined in
+ another domain or the SDTM.
Document: SENDIG v3.1
Item: QNAM CDISC Notes
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND274.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The value in QNAM may not be the same as any variable name
- defined in another domain or the SDTM.
+ - Cited Guidance:
+ The value in QNAM may not be the same as any variable name defined in
+ another domain or the SDTM.
Document: SENDIG v3.1.1
Item: QNAM CDISC Notes
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND274.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The value in QNAM may not be the same as any variable name
- defined in another domain or the SDTM.
+ - Cited Guidance:
+ The value in QNAM may not be the same as any variable name defined in
+ another domain or the SDTM.
Document: SENDIG v3.1.1
Item: QNAM CDISC Notes
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND274.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The value in QNAM may not be the same as any variable name
- defined in another domain or the SDTM.
+ - Cited Guidance:
+ The value in QNAM may not be the same as any variable name defined in
+ another domain or the SDTM.
Document: SENDIG v3.1
Item: QNAM CDISC Notes
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND274.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The value in QNAM may not be the same as any variable name
- defined in another domain or the SDTM.
+ - Cited Guidance:
+ The value in QNAM may not be the same as any variable name defined in
+ another domain or the SDTM.
Document: SENDIG v3.1.1
Item: QNAM CDISC Notes
- Section: '8.3'
+ Section: "8.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND274.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
# Variable: QNAM
# Condition: SUPP--.QNAM present in dataset
# Rule: Value of SUPP--.QNAM ^= any variable name defined in the corresponding SDTM version
@@ -145,17 +152,16 @@ Check:
Core:
Id: CORE-000783
Status: Published
- Version: '1'
-Description: Raise an error when SUPP--.QNAM is present in dataset, but value of
- SUPP--.QNAM is equal to a variable name defined in the corresponding SDTM
- version.
+ Version: "1"
+Description: Raise an error when SUPP--.QNAM is present in dataset, but value of SUPP--.QNAM is
+ equal to a variable name defined in the corresponding SDTM version.
Executability: Fully Executable
Operations:
- id: $model_variables
operator: get_parent_model_column_order
Outcome:
- Message: SUPP--.QNAM is present in the dataset, but the value of SUPP--.QNAM
- equals a variable name defined in the corresponding SDTM version.
+ Message: SUPP--.QNAM is present in the dataset, but the value of SUPP--.QNAM equals a variable
+ name defined in the corresponding SDTM version.
Output Variables:
- QNAM
- $model_variables
diff --git a/Published/CORE-000784/rule.yml b/Published/CORE-000784/rule.yml
index d8fbde9a4..ce84bb0f2 100644
--- a/Published/CORE-000784/rule.yml
+++ b/Published/CORE-000784/rule.yml
@@ -7,24 +7,25 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those
- at the start of the visit.
+ - Cited Guidance:
+ If TAETORD and/or EPOCH are added, then the values must be those at the
+ start of the visit.
Document: IG v3.4
Item: Assumption 11
- Section: '5.5'
+ Section: "5.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0217
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those
- at the start of the visit.It would be inappropriate to add the
- variables that support time points (--TPT, --TPTNUM, --ELTM,
- --TPTREF, and --RFTDTC), since the topic of this dataset is
+ - Cited Guidance:
+ If TAETORD and/or EPOCH are added, then the values must be those at the
+ start of the visit.It would be inappropriate to add the variables that support time points
+ (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is
visits.
Document: IG v3.2
Item: Assumption 11
@@ -32,41 +33,42 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0217
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those
- at the start of the visit.It would be inappropriate to add the
- variables that support time points (--TPT, --TPTNUM, --ELTM,
- --TPTREF, and --RFTDTC), since the topic of this dataset is
+ - Cited Guidance:
+ If TAETORD and/or EPOCH are added, then the values must be those at the
+ start of the visit.It would be inappropriate to add the variables that support time points
+ (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is
visits.
Document: IG v3.3
Item: Assumption 11
- Section: '5.5'
+ Section: "5.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0217
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those
- at the start of the visit.
+ - Cited Guidance:
+ If TAETORD and/or EPOCH are added, then the values must be those at the
+ start of the visit.
Document: TIG 1.0
Item: Assumption 11
Section: 2.8.10.25
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0431
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: TAETORD
@@ -83,17 +85,17 @@ Check:
Core:
Id: CORE-000784
Status: Published
- Version: '1'
-Description: Raise an error when variable TAETORD values don't match between
- Subject Visits (SV) and Subject Elements (SE) datasets.
+ Version: "1"
+Description: Raise an error when variable TAETORD values don't match between Subject Visits (SV) and
+ Subject Elements (SE) datasets.
Executability: Fully Executable
Match Datasets:
- Keys:
- USUBJID
Name: SE
Outcome:
- Message: TAETORD values don't match between Subject Visits (SV) and Subject
- Elements (SE) datasets.
+ Message: TAETORD values don't match between Subject Visits (SV) and Subject Elements (SE)
+ datasets.
Output Variables:
- SESTDTC
- SEENDTC
diff --git a/Published/CORE-000785/rule.yml b/Published/CORE-000785/rule.yml
index 97f2399ff..54f9b3ad8 100644
--- a/Published/CORE-000785/rule.yml
+++ b/Published/CORE-000785/rule.yml
@@ -7,30 +7,30 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: Model v2.0
Item: --SCAT
Section: Interventions
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: Model v2.0
Item: --SCAT
Section: Events
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: Model v2.0
Item: --SCAT
Section: Findings
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0429
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -40,50 +40,46 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0429
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '2.2.1[Table 3.2.1 --SCAT][Used to define a further
- categorization of --CAT values.]|2.2.2[Table 3.2.2
- --SCAT][Used to define a further categorization of --CAT
- values.]|2.2.3[Table 3.2.3 --SCAT][Used to define a further
- categorization of --CAT values.]'
+ - Cited Guidance:
+ "2.2.1[Table 3.2.1 --SCAT][Used to define a further categorization of --CAT values.]|2.2.2[Table
+ 3.2.2 --SCAT][Used to define a further categorization of --CAT values.]|2.2.3[Table 3.2.3 --SCAT][Used
+ to define a further categorization of --CAT values.]"
Document: Model v1.7
- Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3:
- --SCAT]'
+ Item: "2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]"
Section: 2.2.1|2.2.2|2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0429
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Interventions[A further grouping or classification of the
- category for the topic of the finding, event, or intervention.
- The category is in --CAT.]|Events[A further grouping or
- classification of the category for the topic of the finding,
- event, or intervention. The category is in --CAT.]|Findings[A
- further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.]
+ - Cited Guidance:
+ Interventions[A further grouping or classification of the category for the
+ topic of the finding, event, or intervention. The category is in --CAT.]|Events[A further
+ grouping or classification of the category for the topic of the finding, event, or
+ intervention. The category is in --CAT.]|Findings[A further grouping or classification of
+ the category for the topic of the finding, event, or intervention. The category is in
+ --CAT.]
Document: SDTM v2.1
Item: Specifications --SCAT
- Section: Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The
- Events Observation Class Section|3.1.3 The Findings
- Observation Class
+ Section: Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The Events
+ Observation Class Section|3.1.3 The Findings Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0583
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IESCAT
@@ -93,7 +89,7 @@ Check:
Core:
Id: CORE-000785
Status: Published
- Version: '1'
+ Version: "1"
Description: Part B - Raise an error when IESCAT is not empty, but IECAT is empty.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000786/negative/01/data/_datasets.csv b/Published/CORE-000786/negative/01/data/_datasets.csv
index 87639a89d..18280d3ae 100644
--- a/Published/CORE-000786/negative/01/data/_datasets.csv
+++ b/Published/CORE-000786/negative/01/data/_datasets.csv
@@ -14,3 +14,4 @@ mh,Medical History
da,Product Accountability
eg,ECG Test Results
fa,Findings About Events or Interventions
+ti,Trial Inclusion/Exclusion Criteria
\ No newline at end of file
diff --git a/Published/CORE-000786/negative/01/data/_variables.csv b/Published/CORE-000786/negative/01/data/_variables.csv
index d5bd786ee..1c9c2fe22 100644
--- a/Published/CORE-000786/negative/01/data/_variables.csv
+++ b/Published/CORE-000786/negative/01/data/_variables.csv
@@ -104,3 +104,9 @@ fa,FATESTCD,Findings About Test Short Name,Char,8
fa,FATEST,Findings About Test Name,Char,40
fa,FAOBJ,Object of the Observation,Char,50
fa,FASCAT,Subcategory for Findings About,Char,50
+ti,STUDYID,Study Identifier,Char,12
+ti,DOMAIN,Domain Abbreviation,Char,2
+ti,IETESTCD,Incl/Excl Criterion Short Name,Char,7
+ti,IETEST,Inclusion/Exclusion Criterion,Char,196
+ti,IESCAT,Inclusion/Exclusion Subcategory,Char,9
+ti,TIVERS,Protocol Criteria Versions,Char,200
diff --git a/Published/CORE-000786/negative/01/data/ti.csv b/Published/CORE-000786/negative/01/data/ti.csv
new file mode 100644
index 000000000..0d64f6420
--- /dev/null
+++ b/Published/CORE-000786/negative/01/data/ti.csv
@@ -0,0 +1,9 @@
+STUDYID,DOMAIN,IETESTCD,IETEST,IESCAT,TIVERS
+CDISCPILOT01,TI,INCL01,Males and postmenopausal females at least 50 years of age.,INCLUSION,ORIGINAL
+CDISCPILOT01,TI,INCL02,Diagnosis of probable AD as defined by NINCDS and the ADRDA guidelines.,INCLUSION,ORIGINAL
+CDISCPILOT01,TI,INCL03,MMSE score of 10 to 23.,,ORIGINAL
+CDISCPILOT01,TI,EXCL11,Serious illness which required hospitalization within 3 months of screening.,EXCLUSION,ORIGINAL
+CDISCPILOT01,TI,EXCL14,"A history within the last 5 years of the following: a) Schizophrenia b) Bipolar Disease c) Ethanol or psychoactive drug abuse or dependence.",EXCLUSION,AMENDMENT 1
+CDISCPILOT01,TI,EXCL15,A history of syncope within the last 5 years.,,AMENDMENT 1
+CDISCPILOT01,TI,EXCL16,"Evidence from ECG recording at screening of any of the following conditions: a) Left bundle branch block b) Bradycardia <50 beats per minute c) Sinus pauses >2 seconds (See Protocol for Remainder)",EXCLUSION,AMENDMENT 1
+CDISCPILOT01,TI,EXCL17,"A history within the last 5 years of a serious cardiovascular disorder, including a) Clinically significant arrhythmia (See Protocol for Remainder)",EXCLUSION,AMENDMENT 1
diff --git a/Published/CORE-000786/rule.yml b/Published/CORE-000786/rule.yml
index 2cc0f8944..fcf6db017 100644
--- a/Published/CORE-000786/rule.yml
+++ b/Published/CORE-000786/rule.yml
@@ -7,30 +7,30 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: Model v2.0
Item: --SCAT
Section: Interventions
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: Model v2.0
Item: --SCAT
Section: Events
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: Model v2.0
Item: --SCAT
Section: Findings
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0430
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -40,51 +40,50 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0430
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Used to define a further categorization of --CAT values.]'
Document: Model v1.7
- Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3:
- --SCAT]'
+ Item: "2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]"
Section: 2.2.1|2.2.2|2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0430
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: SDTM v2.1
Item: Specifications --SCAT
Section: Section 3.1.1 The Interventions Observation Class
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: SDTM v2.1
Item: Specifications --SCAT
Section: Section 3.1.2 The Events Observation Class Section
- - Cited Guidance: A further grouping or classification of the category for the
- topic of the finding, event, or intervention. The category is
- in --CAT.
+ - Cited Guidance:
+ A further grouping or classification of the category for the topic of the
+ finding, event, or intervention. The category is in --CAT.
Document: SDTM v2.1
Item: Specifications --SCAT
Section: 3.1.3 The Findings Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0584
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: IESCAT
@@ -94,9 +93,8 @@ Check:
Core:
Id: CORE-000786
Status: Published
- Version: '1'
-Description: Part B - Raise an error when IESCAT exists in a dataset, but IECAT
- does not exist.
+ Version: "1"
+Description: Part B - Raise an error when IESCAT exists in a dataset, but IECAT does not exist.
Executability: Fully Executable
Outcome:
Message: IESCAT exists in a dataset, but IECAT does not exist.
diff --git a/Published/CORE-000788/rule.yml b/Published/CORE-000788/rule.yml
index 9e4970fa7..0626fdb51 100644
--- a/Published/CORE-000788/rule.yml
+++ b/Published/CORE-000788/rule.yml
@@ -5,107 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5133
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5133
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5133
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5133
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5133
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5133
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5133
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: 'TSVCDREF'
+ - name: "TSVCDREF"
operator: exists
Core:
- Status: Published
- Version: '1'
Id: CORE-000788
-Description: 'TSVCDREF (Name of Reference Terminology) must not be present in SEND dataset'
+ Status: Published
+ Version: "1"
+Description: "TSVCDREF (Name of Reference Terminology) must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: 'TSVCDREF (Name of Reference Terminology) must not be present in SEND
- dataset'
+ Message: "TSVCDREF (Name of Reference Terminology) must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000789/rule.yml b/Published/CORE-000789/rule.yml
index 6540a2064..bf8b282e8 100644
--- a/Published/CORE-000789/rule.yml
+++ b/Published/CORE-000789/rule.yml
@@ -5,107 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5134
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5134
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5134
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5134
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5134
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5134
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5134
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: 'TSVCDVER'
+ - name: "TSVCDVER"
operator: exists
Core:
- Status: Published
- Version: '1'
Id: CORE-000789
-Description: 'TSVCDVER (Version of the Reference Terminology) must not be
- present in SEND dataset'
+ Status: Published
+ Version: "1"
+Description: "TSVCDVER (Version of the Reference Terminology) must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: 'TSVCDVER must not be present in SEND dataset'
+ Message: "TSVCDVER must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000791/rule.yml b/Published/CORE-000791/rule.yml
index dfa375c09..fcf536526 100644
--- a/Published/CORE-000791/rule.yml
+++ b/Published/CORE-000791/rule.yml
@@ -4,153 +4,153 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0903
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0903
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0903
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0903
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0903
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0903
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0903
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0903
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0903
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: All paired variables should have a one-to-one relationship.
- Examples include short name and name of test; parameter name
- and parameter code or number; variable name and variable
- label, etc.
+ - Cited Guidance:
+ All paired variables should have a one-to-one relationship. Examples include
+ short name and name of test; parameter name and parameter code or number; variable name
+ and variable label, etc.
Document: FDA
Section: FDAB009
Origin: FDA Business Rules
Rule Identifier:
Id: FB0903
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: ACTARM
@@ -159,7 +159,7 @@ Check:
Core:
Id: CORE-000791
Status: Published
- Version: '1'
+ Version: "1"
Description: ACTARMCD and ACTARM should have a one-to-one relationship.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000793/rule.yml b/Published/CORE-000793/rule.yml
index 4f96a78eb..8ffccfab2 100644
--- a/Published/CORE-000793/rule.yml
+++ b/Published/CORE-000793/rule.yml
@@ -1,136 +1,146 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1601
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1601
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1601
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1601
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1601
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1601
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1601
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1601
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1601
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1601
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --DTC
@@ -142,13 +152,11 @@ Check:
Core:
Id: CORE-000793
Status: Published
- Version: '1'
-Description: 'Collection study day (--DY) should be present when date/time of
- collection (--DTC) is populated'
+ Version: "1"
+Description: "Collection study day (--DY) should be present when date/time of collection (--DTC) is populated"
Executability: Fully Executable
Outcome:
- Message: Collection study day (--DY) is missing when date/time of collection
- (--DTC) is populated.
+ Message: Collection study day (--DY) is missing when date/time of collection (--DTC) is populated.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000794/rule.yml b/Published/CORE-000794/rule.yml
index 7f2b852fc..9cc163710 100644
--- a/Published/CORE-000794/rule.yml
+++ b/Published/CORE-000794/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5120
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5120
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5120
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5120
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5120
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5120
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5120
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--PTCD'
+ - name: "--PTCD"
operator: exists
Core:
- Status: Published
- Version: '1'
Id: CORE-000794
-Description: '--PTCD (Preferred Term Code) must not be in SEND dataset'
+ Status: Published
+ Version: "1"
+Description: "--PTCD (Preferred Term Code) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--PTCD (Preferred Term Code) must not be present in SEND dataset'
+ Message: "--PTCD (Preferred Term Code) must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000796/rule.yml b/Published/CORE-000796/rule.yml
index 3ca371318..29b652f6d 100644
--- a/Published/CORE-000796/rule.yml
+++ b/Published/CORE-000796/rule.yml
@@ -4,21 +4,21 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A specified condition for assessments must apply to at least to
- a procedure, biomedical concept, biomedical concept surrogate,
- biomedical concept category or a whole activity.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A specified condition for assessments must apply to at least to a procedure,
+ biomedical concept, biomedical concept surrogate, biomedical concept category or a whole activity."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00016'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00016"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Condition'
+ value: "Condition"
- any:
- name: appliesToIds
operator: not_exists
@@ -26,17 +26,17 @@ Check:
operator: not_equal_to
value: true
Core:
- Id: 'CORE-000796'
+ Id: "CORE-000796"
Status: Published
- Version: '1'
-Description: 'A specified condition for assessments must apply to at least to a
- procedure, biomedical concept, biomedical concept surrogate, biomedical
- concept category or a whole activity.'
+ Version: "1"
+Description:
+ "A specified condition for assessments must apply to at least to a procedure, biomedical
+ concept, biomedical concept surrogate, biomedical concept category or a whole activity."
Executability: Fully Executable
Outcome:
- Message: 'The condition does not apply to a procedure, biomedical concept,
- biomedical concept surrogate, biomedical concept category or a whole
- activity.'
+ Message:
+ "The condition does not apply to a procedure, biomedical concept, biomedical concept surrogate,
+ biomedical concept category or a whole activity."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000797/rule.yml b/Published/CORE-000797/rule.yml
index 5415b57e6..615afad08 100644
--- a/Published/CORE-000797/rule.yml
+++ b/Published/CORE-000797/rule.yml
@@ -4,19 +4,19 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Each StudyArm must have one StudyCell for each StudyEpoch.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Each StudyArm must have one StudyCell for each StudyEpoch."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00068'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00068"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyArm'
+ value: "StudyArm"
- name: id.StudyEpoch
operator: is_unique_set
value: id
@@ -24,34 +24,34 @@ Check:
- all:
- name: parent_entity
operator: equal_to
- value: 'StudyDesign'
+ value: "StudyDesign"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: parent_rel
operator: equal_to
- value: 'arms'
+ value: "arms"
- name: parent_rel.StudyEpoch
operator: equal_to
- value: 'epochs'
+ value: "epochs"
- all:
- name: parent_entity
operator: equal_to
- value: 'StudyCell'
+ value: "StudyCell"
- name: rel_type
operator: equal_to
- value: 'reference'
+ value: "reference"
- name: parent_rel
operator: equal_to
- value: 'armId'
+ value: "armId"
- name: parent_rel.StudyEpoch
operator: equal_to
- value: 'epochId'
+ value: "epochId"
Core:
- Id: 'CORE-000797'
+ Id: "CORE-000797"
Status: Published
- Version: '1'
-Description: 'Each StudyArm must have one StudyCell for each StudyEpoch.'
+ Version: "1"
+Description: "Each StudyArm must have one StudyCell for each StudyEpoch."
Executability: Fully Executable
Match Datasets:
- Join Type: left
@@ -61,7 +61,7 @@ Match Datasets:
- rel_type
Name: StudyEpoch
Outcome:
- Message: 'The StudyArm does not have a StudyCell for the StudyEpoch.'
+ Message: "The StudyArm does not have a StudyCell for the StudyEpoch."
Output Variables:
- parent_entity
- parent_id
@@ -74,5 +74,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyArm'
+ - "StudyArm"
Sensitivity: Record
diff --git a/Published/CORE-000798/rule.yml b/Published/CORE-000798/rule.yml
index 2f15c9a4c..3bb98a729 100644
--- a/Published/CORE-000798/rule.yml
+++ b/Published/CORE-000798/rule.yml
@@ -4,40 +4,40 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A procedure must only reference a study intervention that is
- defined within the same study design as the activity within
- which the procedure is defined.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A procedure must only reference a study intervention that is defined within the
+ same study design as the activity within which the procedure is defined."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00048'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00048"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Procedure'
+ value: "Procedure"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: rel_type.StudyIntervention
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: rel_type.Activity
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: parent_id.StudyIntervention
operator: not_equal_to
value: parent_id.Activity
Core:
- Id: 'CORE-000798'
+ Id: "CORE-000798"
Status: Published
- Version: '1'
-Description: 'A procedure must only reference a study intervention that is
- defined within the same study design as the activity within which the
- procedure is defined.'
+ Version: "1"
+Description:
+ "A procedure must only reference a study intervention that is defined within the same study
+ design as the activity within which the procedure is defined."
Executability: Fully Executable
Match Datasets:
- Join Type: left
@@ -51,11 +51,10 @@ Match Datasets:
Right: id
Name: Activity
Outcome:
- Message: 'The procedure references a study intervention that is not defined
- within the same study design as the activity within which the procedure is
- defined: the parent_id of the study intervention
- (parent_id.StudyIntervention) is not the same as the parent_id of the
- activity (parent_id.Activity).'
+ Message:
+ "The procedure references a study intervention that is not defined within the same study design
+ as the activity within which the procedure is defined: the parent_id of the study intervention (parent_id.StudyIntervention)
+ is not the same as the parent_id of the activity (parent_id.Activity)."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000799/rule.yml b/Published/CORE-000799/rule.yml
index 2b4cd2942..a831be822 100644
--- a/Published/CORE-000799/rule.yml
+++ b/Published/CORE-000799/rule.yml
@@ -4,39 +4,41 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study arm must only reference populations that are defined
- within the same study design as the study arm.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study arm must only reference populations that are defined within the same
+ study design as the study arm."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00049'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00049"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyDesignPopulation'
+ value: "StudyDesignPopulation"
- name: rel_type
operator: equal_to
- value: 'reference'
+ value: "reference"
- name: parent_rel
operator: equal_to
- value: 'populationIds'
+ value: "populationIds"
value_is_literal: true
- name: rel_type.StudyArm
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: parent_id.StudyArm
operator: is_not_contained_by
value: $parent_of_population
Core:
- Id: 'CORE-000799'
+ Id: "CORE-000799"
Status: Published
- Version: '1'
-Description: 'A study arm must only reference populations that are defined
- within the same study design as the study arm.'
+ Version: "1"
+Description:
+ "A study arm must only reference populations that are defined within the same study design
+ as the study arm."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -54,10 +56,10 @@ Operations:
name: parent_id
operator: distinct
Outcome:
- Message: 'The study population is referenced by a study arm but was not defined
- within the same study design as the study arm: the parent_id of the study
- population ($parent_of_population) is not the same as parent_id of the study
- arm (parent_id.StudyArm).'
+ Message:
+ "The study population is referenced by a study arm but was not defined within the same study
+ design as the study arm: the parent_id of the study population ($parent_of_population) is not the
+ same as parent_id of the study arm (parent_id.StudyArm)."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000800/rule.yml b/Published/CORE-000800/rule.yml
index 9906479ab..4db484238 100644
--- a/Published/CORE-000800/rule.yml
+++ b/Published/CORE-000800/rule.yml
@@ -4,30 +4,30 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If geographic scope type is global then no codes are expected
- to specify the specific area within scope while if it is not
- global then at least one code is expected to specify the
- specific area within scope.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If geographic scope type is global then no codes are expected to specify the
+ specific area within scope while if it is not global then at least one code is expected to specify
+ the specific area within scope."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00077'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00077"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'GeographicScope'
+ value: "GeographicScope"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- all:
- name: type.code
operator: equal_to
- value: 'C68846'
+ value: "C68846"
- name: code
operator: exists
- name: code
@@ -36,7 +36,7 @@ Check:
- all:
- name: type.code
operator: not_equal_to
- value: 'C68846'
+ value: "C68846"
- any:
- name: code
operator: not_exists
@@ -46,17 +46,18 @@ Check:
operator: equal_to
value: false
Core:
- Id: 'CORE-000800'
+ Id: "CORE-000800"
Status: Published
- Version: '1'
-Description: 'If geographic scope type is global then no codes are expected to
- specify the specific area within scope while if it is not global then at least
- one code is expected to specify the specific area within scope.'
+ Version: "1"
+Description:
+ "If geographic scope type is global then no codes are expected to specify the specific area
+ within scope while if it is not global then at least one code is expected to specify the specific area
+ within scope."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The geographic scope is global (type.code = C68846) and a code has
- been specified or the geographic scope is not global (type.code is not
- C68846) and no code has been specified.'
+ Message:
+ "The geographic scope is global (type.code = C68846) and a code has been specified or the geographic
+ scope is not global (type.code is not C68846) and no code has been specified."
Output Variables:
- parent_entity
- parent_id
@@ -71,5 +72,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'GeographicScope'
+ - "GeographicScope"
Sensitivity: Record
diff --git a/Published/CORE-000801/rule.yml b/Published/CORE-000801/rule.yml
index 40702561a..64d875490 100644
--- a/Published/CORE-000801/rule.yml
+++ b/Published/CORE-000801/rule.yml
@@ -4,31 +4,31 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study protocol document version, if a date of a
- specific type exists with a global geographic scope then no
- other dates are expected with the same type.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study protocol document version, if a date of a specific type exists
+ with a global geographic scope then no other dates are expected with the same type."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00095'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00095"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'GeographicScope'
+ value: "GeographicScope"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: type.code
operator: equal_to
- value: 'C68846'
+ value: "C68846"
- name: type.decode
operator: equal_to_case_insensitive
- value: 'Global'
+ value: "Global"
- any:
- name: $num_geographic_scopes_for_this_date
operator: greater_than
@@ -37,12 +37,12 @@ Check:
operator: greater_than
value: 1
Core:
- Id: 'CORE-000801'
+ Id: "CORE-000801"
Status: Published
- Version: '1'
-Description: 'Within a study protocol document version, if a date of a specific
- type exists with a global geographic scope then no other dates are expected
- with the same type.'
+ Version: "1"
+Description:
+ "Within a study protocol document version, if a date of a specific type exists with a global
+ geographic scope then no other dates are expected with the same type."
Executability: Partially Executable - Possible Overreporting
Match Datasets:
- Keys:
@@ -70,9 +70,9 @@ Operations:
id: $num_dates_of_this_type
operator: record_count
Outcome:
- Message: 'The study protocol document version has a type of governance date with
- a global geographic scope and either another date of the same type or
- additional geographic scope(s) defined for the date.'
+ Message:
+ "The study protocol document version has a type of governance date with a global geographic
+ scope and either another date of the same type or additional geographic scope(s) defined for the date."
Output Variables:
- parent_entity.StudyProtocolDocumentVersion
- parent_id.StudyProtocolDocumentVersion
@@ -90,5 +90,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'GeographicScope'
+ - "GeographicScope"
Sensitivity: Record
diff --git a/Published/CORE-000802/rule.yml b/Published/CORE-000802/rule.yml
index 2d12793a5..cba493bdc 100644
--- a/Published/CORE-000802/rule.yml
+++ b/Published/CORE-000802/rule.yml
@@ -4,23 +4,24 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If the duration of an administration will vary, a quantity is
- not expected for the administration duration and vice versa.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If the duration of an administration will vary, a quantity is not expected for
+ the administration duration and vice versa."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00003'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00003"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'AdministrationDuration'
+ value: "AdministrationDuration"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- all:
- name: durationWillVary
@@ -44,15 +45,17 @@ Check:
operator: equal_to
value: false
Core:
- Id: 'CORE-000802'
+ Id: "CORE-000802"
Status: Published
- Version: '1'
-Description: 'If the duration of an administration will vary, a quantity is not
- expected for the administration duration and vice versa.'
+ Version: "1"
+Description:
+ "If the duration of an administration will vary, a quantity is not expected for the administration
+ duration and vice versa."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'A duration quantity has been specified when the duration will vary, or
- a duration quantity has not been specified when the duration will not vary.'
+ Message:
+ "A duration quantity has been specified when the duration will vary, or a duration quantity
+ has not been specified when the duration will not vary."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000803/rule.yml b/Published/CORE-000803/rule.yml
index 4bd272530..f8112570c 100644
--- a/Published/CORE-000803/rule.yml
+++ b/Published/CORE-000803/rule.yml
@@ -4,36 +4,38 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a synonym is specified then it is not expected to be equal
- to the name of the biomedical concept (case insensitive).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If a synonym is specified then it is not expected to be equal to the name of
+ the biomedical concept (case insensitive)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00079'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00079"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'BiomedicalConcept'
+ value: "BiomedicalConcept"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: parent_rel.string
operator: equal_to
- value: 'synonyms'
+ value: "synonyms"
value_is_literal: true
- name: value
operator: equal_to_case_insensitive
value: name
Core:
- Id: 'CORE-000803'
+ Id: "CORE-000803"
Status: Published
- Version: '1'
-Description: 'If a synonym is specified then it is not expected to be equal to
- the name of the biomedical concept (case insensitive).'
+ Version: "1"
+Description:
+ "If a synonym is specified then it is not expected to be equal to the name of the biomedical
+ concept (case insensitive)."
Executability: Partially Executable - Possible Overreporting
Match Datasets:
- Keys:
@@ -42,8 +44,7 @@ Match Datasets:
- rel_type
Name: string
Outcome:
- Message: 'The biomedical concept synonym value is the same as the biomedical
- concept name (case insensitive).'
+ Message: "The biomedical concept synonym value is the same as the biomedical concept name (case insensitive)."
Output Variables:
- parent_entity
- parent_id
@@ -56,5 +57,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'BiomedicalConcept'
+ - "BiomedicalConcept"
Sensitivity: Record
diff --git a/Published/CORE-000804/negative/01/data/ScheduledDecisionInstance.csv b/Published/CORE-000804/negative/01/data/ScheduledDecisionInstance.csv
index b31f894d6..75d4ed31f 100644
--- a/Published/CORE-000804/negative/01/data/ScheduledDecisionInstance.csv
+++ b/Published/CORE-000804/negative/01/data/ScheduledDecisionInstance.csv
@@ -1,4 +1,4 @@
parent_entity,parent_id,parent_rel,rel_type,id,name,description,label,defaultConditionId,epochId,timelineId,timelineExitId,instanceType,conditionAssignments
-ScheduleTimeline,ScheduleTimeline_4,instances,definition,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,ConditionAssignment_1
-ScheduleTimeline,ScheduleTimeline_4,entryId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,ConditionAssignment_1
-Timing,Timing_6,relativeToScheduledInstanceId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,ConditionAssignment_1
+ScheduleTimeline,ScheduleTimeline_4,instances,definition,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,True
+ScheduleTimeline,ScheduleTimeline_4,entryId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,True
+Timing,Timing_6,relativeToScheduledInstanceId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,True
diff --git a/Published/CORE-000804/positive/01/data/ScheduledDecisionInstance.csv b/Published/CORE-000804/positive/01/data/ScheduledDecisionInstance.csv
index 50efb5ea1..bb5f2ac0a 100644
--- a/Published/CORE-000804/positive/01/data/ScheduledDecisionInstance.csv
+++ b/Published/CORE-000804/positive/01/data/ScheduledDecisionInstance.csv
@@ -1,4 +1,4 @@
parent_entity,parent_id,parent_rel,rel_type,id,name,description,label,defaultConditionId,epochId,timelineId,timelineExitId,instanceType,conditionAssignments
-ScheduleTimeline,ScheduleTimeline_1,instances,definition,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,ConditionAssignment_1
-ScheduleTimeline,ScheduleTimeline_1,entryId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,ConditionAssignment_1
-Timing,Timing_6,relativeToScheduledInstanceId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,ConditionAssignment_1
+ScheduleTimeline,ScheduleTimeline_1,instances,definition,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,True
+ScheduleTimeline,ScheduleTimeline_1,entryId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,True
+Timing,Timing_6,relativeToScheduledInstanceId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,True
diff --git a/Published/CORE-000804/rule.yml b/Published/CORE-000804/rule.yml
index 3afeb9e1b..692c5d589 100644
--- a/Published/CORE-000804/rule.yml
+++ b/Published/CORE-000804/rule.yml
@@ -4,63 +4,63 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A timing must only be specified as being relative to/from a
- scheduled activity/decision instance that is defined within
- the same timeline as the timing.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A timing must only be specified as being relative to/from a scheduled activity/decision
+ instance that is defined within the same timeline as the timing."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00046'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00046"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A timing must only be specified as being relative to/from a
- scheduled activity/decision instance that is defined within
- the same timeline as the timing.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A timing must only be specified as being relative to/from a scheduled activity/decision
+ instance that is defined within the same timeline as the timing."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00046'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00046"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- any:
- name: instanceType
operator: equal_to
- value: 'ScheduledActivityInstance'
+ value: "ScheduledActivityInstance"
- name: instanceType
operator: equal_to
- value: 'ScheduledDecisionInstance'
+ value: "ScheduledDecisionInstance"
- name: rel_type
operator: equal_to
- value: 'reference'
+ value: "reference"
- any:
- name: parent_rel
operator: equal_to
- value: 'relativeToScheduledInstanceId'
+ value: "relativeToScheduledInstanceId"
value_is_literal: true
- name: parent_rel
operator: equal_to
- value: 'relativeFromScheduledInstanceId'
+ value: "relativeFromScheduledInstanceId"
value_is_literal: true
- name: rel_type.Timing
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: parent_id.Timing
operator: is_not_contained_by
value: $parent_of_scheduled_instance
Core:
- Id: 'CORE-000804'
+ Id: "CORE-000804"
Status: Published
- Version: '1'
-Description: 'A timing must only be specified as being relative to/from a
- scheduled activity/decision instance that is defined within the same timeline
- as the timing.'
+ Version: "1"
+Description:
+ "A timing must only be specified as being relative to/from a scheduled activity/decision
+ instance that is defined within the same timeline as the timing."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -78,10 +78,10 @@ Operations:
name: parent_id
operator: distinct
Outcome:
- Message: 'The relative to/from scheduled instance of a timing was not defined
- within the same timeline as the timing: the parent_id of the scheduled
- instance ($parent_of_scheduled_instance) is not the same as parent_id of the
- timing (parent_id.Timing).'
+ Message:
+ "The relative to/from scheduled instance of a timing was not defined within the same timeline
+ as the timing: the parent_id of the scheduled instance ($parent_of_scheduled_instance) is not the
+ same as parent_id of the timing (parent_id.Timing)."
Output Variables:
- parent_entity
- parent_id
@@ -94,6 +94,6 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ScheduledActivityInstance'
- - 'ScheduledDecisionInstance'
+ - "ScheduledActivityInstance"
+ - "ScheduledDecisionInstance"
Sensitivity: Record
diff --git a/Published/CORE-000805/rule.yml b/Published/CORE-000805/rule.yml
index 91a461ec2..487ff36e8 100644
--- a/Published/CORE-000805/rule.yml
+++ b/Published/CORE-000805/rule.yml
@@ -4,49 +4,47 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The range specified for a planned age is not expected to be
- approximate.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "The range specified for a planned age is not expected to be approximate."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00042'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00042"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The range specified for a planned age is not expected to be
- approximate.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "The range specified for a planned age is not expected to be approximate."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00042'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00042"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Range'
+ value: "Range"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: parent_rel
operator: equal_to
- value: 'plannedAge'
+ value: "plannedAge"
- name: isApproximate
operator: equal_to
value: true
Core:
- Id: 'CORE-000805'
+ Id: "CORE-000805"
Status: Published
- Version: '1'
-Description: 'The range specified for a planned age is not expected to be approximate.'
+ Version: "1"
+Description: "The range specified for a planned age is not expected to be approximate."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The planned age range is marked as approximate, which is not expected.'
+ Message: "The planned age range is marked as approximate, which is not expected."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000806/rule.yml b/Published/CORE-000806/rule.yml
index c697bb66c..6b4fdca42 100644
--- a/Published/CORE-000806/rule.yml
+++ b/Published/CORE-000806/rule.yml
@@ -4,41 +4,43 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within subject enrollment, the quantity must be a number or a
- percentage (i.e. the unit must be empty or %).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within subject enrollment, the quantity must be a number or a percentage (i.e.
+ the unit must be empty or %)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00017'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00017"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within subject enrollment, the quantity must be a number or a
- percentage (i.e. the unit must be empty or %).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within subject enrollment, the quantity must be a number or a percentage (i.e.
+ the unit must be empty or %)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00017'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00017"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Quantity'
+ value: "Quantity"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: parent_entity
operator: equal_to
- value: 'SubjectEnrollment'
+ value: "SubjectEnrollment"
- name: parent_rel
operator: equal_to
- value: 'quantity'
+ value: "quantity"
- not:
any:
- name: unit
@@ -51,23 +53,25 @@ Check:
- all:
- name: unit.standardCode.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: unit.standardCode.code
operator: equal_to
- value: 'C25613'
+ value: "C25613"
- name: unit.standardCode.decode
operator: equal_to
- value: '%'
+ value: "%"
Core:
- Id: 'CORE-000806'
+ Id: "CORE-000806"
Status: Published
- Version: '1'
-Description: 'Within subject enrollment, the quantity must be a number or a
- percentage (i.e. the unit must be empty or %).'
+ Version: "1"
+Description:
+ "Within subject enrollment, the quantity must be a number or a percentage (i.e. the unit
+ must be empty or %)."
Executability: Fully Executable
Outcome:
- Message: 'The unit for a subject enrollement quantity is not empty or coded as %
- (codeSystem = http://www.cdisc.org, code = C25613 and decode = %).'
+ Message:
+ "The unit for a subject enrollement quantity is not empty or coded as % (codeSystem = http://www.cdisc.org,
+ code = C25613 and decode = %)."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000807/rule.yml b/Published/CORE-000807/rule.yml
index 4b7aafa87..974e9f596 100644
--- a/Published/CORE-000807/rule.yml
+++ b/Published/CORE-000807/rule.yml
@@ -4,43 +4,44 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'At least one scheduled activity instance within a timeline must
- point to a timeline exit.'
- Document: 'USDM_CORE_Rules.xlsx'
+ - Cited Guidance:
+ "At least one scheduled activity instance within a timeline must point to a timeline
+ exit."
+ Document: "USDM_CORE_Rules.xlsx"
Origin: USDM Conformance Rules
Rule Identifier:
- Id: 'DDF00037'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00037"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'At least one scheduled activity instance within a timeline must
- point to a timeline exit.'
- Document: 'USDM_CORE_Rules.xlsx'
+ - Cited Guidance:
+ "At least one scheduled activity instance within a timeline must point to a timeline
+ exit."
+ Document: "USDM_CORE_Rules.xlsx"
Origin: USDM Conformance Rules
Rule Identifier:
- Id: 'DDF00037'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00037"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'ScheduleTimeline'
+ value: "ScheduleTimeline"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: $timeline_exits
operator: empty
Core:
- Status: Published
- Version: '1'
Id: CORE-000807
-Description: 'At least one scheduled activity instance within a timeline must
- point to a timeline exit.'
+ Status: Published
+ Version: "1"
+Description: "At least one scheduled activity instance within a timeline must point to a timeline exit."
Executability: Fully Executable
Operations:
- domain: ScheduledActivityInstance
@@ -52,8 +53,9 @@ Operations:
name: timelineExitId
operator: distinct
Outcome:
- Message: 'The schedule timeline does not have a defined exit: none of its
- scheduled activity instances has a timeline exit.'
+ Message:
+ "The schedule timeline does not have a defined exit: none of its scheduled activity instances
+ has a timeline exit."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000808/rule.yml b/Published/CORE-000808/rule.yml
index 9cf5434cb..c808b2dc2 100644
--- a/Published/CORE-000808/rule.yml
+++ b/Published/CORE-000808/rule.yml
@@ -4,32 +4,30 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Only one version of any code system is expected to be used
- within a study version.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Only one version of any code system is expected to be used within a study version."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00073'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00073"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Only one version of any code system is expected to be used
- within a study version.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Only one version of any code system is expected to be used within a study version."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00073'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00073"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: $min_codeSystemVersion
operator: not_equal_to
value: $max_codeSystemVersion
@@ -37,11 +35,10 @@ Check:
operator: equal_to
value: $min_id_for_codeSystemVersion
Core:
- Id: 'CORE-000808'
+ Id: "CORE-000808"
Status: Published
- Version: '1'
-Description: 'Only one version of any code system is expected to be used within
- a study version.'
+ Version: "1"
+Description: "Only one version of any code system is expected to be used within a study version."
Executability: Partially Executable - Possible Overreporting
Operations:
- group:
@@ -67,7 +64,7 @@ Operations:
name: codeSystemVersion
operator: record_count
Outcome:
- Message: 'More than one code system version is used for the code system.'
+ Message: "More than one code system version is used for the code system."
Output Variables:
- codeSystem
- codeSystemVersion
@@ -76,5 +73,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Code'
+ - "Code"
Sensitivity: Record
diff --git a/Published/CORE-000809/rule.yml b/Published/CORE-000809/rule.yml
index b4040a616..8106edd95 100644
--- a/Published/CORE-000809/rule.yml
+++ b/Published/CORE-000809/rule.yml
@@ -4,51 +4,54 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study cell must only reference elements that are defined
- within the same study design as the study cell.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study cell must only reference elements that are defined within the same study
+ design as the study cell."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00047'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00047"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study cell must only reference elements that are defined
- within the same study design as the study cell.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study cell must only reference elements that are defined within the same study
+ design as the study cell."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00047'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00047"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyElement'
+ value: "StudyElement"
- name: rel_type
operator: equal_to
- value: 'reference'
+ value: "reference"
- name: parent_rel
operator: equal_to
- value: 'elementIds'
+ value: "elementIds"
value_is_literal: true
- name: rel_type.StudyCell
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: parent_id.StudyCell
operator: is_not_contained_by
value: $parent_of_study_element
Core:
- Id: 'CORE-000809'
+ Id: "CORE-000809"
Status: Published
- Version: '1'
-Description: 'A study cell must only reference elements that are defined within
- the same study design as the study cell.'
+ Version: "1"
+Description:
+ "A study cell must only reference elements that are defined within the same study design
+ as the study cell."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -66,10 +69,10 @@ Operations:
name: parent_id
operator: distinct
Outcome:
- Message: 'The study element is referenced by a study cell but was not defined
- within the same study design as the study cell: the parent_id of the study
- element ($parent_of_study_element) is not the same as parent_id of the study
- cell (parent_id.StudyCell).'
+ Message:
+ "The study element is referenced by a study cell but was not defined within the same study
+ design as the study cell: the parent_id of the study element ($parent_of_study_element) is not the
+ same as parent_id of the study cell (parent_id.StudyCell)."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000810/rule.yml b/Published/CORE-000810/rule.yml
index 69a8b17f2..0e6ce0597 100644
--- a/Published/CORE-000810/rule.yml
+++ b/Published/CORE-000810/rule.yml
@@ -4,24 +4,24 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An activity is expected to refer to at least one procedure,
- biomedical concept, biomedical concept category or biomedical
- concept surrogate.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An activity is expected to refer to at least one procedure, biomedical concept,
+ biomedical concept category or biomedical concept surrogate."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00075'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00075"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Activity'
+ value: "Activity"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: definedProcedures
operator: not_exists
@@ -55,16 +55,17 @@ Check:
operator: equal_to
value: false
Core:
- Id: 'CORE-000810'
+ Id: "CORE-000810"
Status: Published
- Version: '1'
-Description: 'An activity is expected to refer to at least one procedure,
- biomedical concept, biomedical concept category or biomedical concept
- surrogate.'
+ Version: "1"
+Description:
+ "An activity is expected to refer to at least one procedure, biomedical concept, biomedical
+ concept category or biomedical concept surrogate."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The activity does not refer to any procedure, biomedical concept,
- biomedical concept category or biomedical concept surrogate.'
+ Message:
+ "The activity does not refer to any procedure, biomedical concept, biomedical concept category
+ or biomedical concept surrogate."
Output Variables:
- parent_entity
- parent_id
@@ -79,5 +80,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Activity'
+ - "Activity"
Sensitivity: Record
diff --git a/Published/CORE-000811/rule.yml b/Published/CORE-000811/rule.yml
index 283d42abe..9c9fcddb8 100644
--- a/Published/CORE-000811/rule.yml
+++ b/Published/CORE-000811/rule.yml
@@ -4,44 +4,46 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The same Biomedical Concept Category must not be referenced
- more than once from the same activity.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "The same Biomedical Concept Category must not be referenced more than once from
+ the same activity."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00090'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00090"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The same Biomedical Concept Category must not be referenced
- more than once from the same activity.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "The same Biomedical Concept Category must not be referenced more than once from
+ the same activity."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00090'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00090"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'BiomedicalConceptCategory'
+ value: "BiomedicalConceptCategory"
- name: rel_type
operator: equal_to
- value: 'reference'
+ value: "reference"
- name: rel_type.Activity
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: parent_entity
operator: equal_to
- value: 'Activity'
+ value: "Activity"
- name: parent_rel
operator: equal_to
- value: 'bcCategoryIds'
+ value: "bcCategoryIds"
value_is_literal: true
- name: id
operator: is_not_unique_set
@@ -51,11 +53,12 @@ Check:
- parent_rel
- rel_type.Activity
Core:
- Id: 'CORE-000811'
+ Id: "CORE-000811"
Status: Published
- Version: '1'
-Description: 'The same Biomedical Concept Category must not be referenced more
- than once from the same activity.'
+ Version: "1"
+Description:
+ "The same Biomedical Concept Category must not be referenced more than once from the same
+ activity."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -65,8 +68,7 @@ Match Datasets:
Right: instanceType
Name: Activity
Outcome:
- Message: 'The biomedical concept category is referenced more than once from the
- same activity.'
+ Message: "The biomedical concept category is referenced more than once from the same activity."
Output Variables:
- parent_entity
- parent_id
@@ -78,5 +80,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'BiomedicalConceptCategory'
+ - "BiomedicalConceptCategory"
Sensitivity: Record
diff --git a/Published/CORE-000812/rule.yml b/Published/CORE-000812/rule.yml
index 3704552b1..2c5624a63 100644
--- a/Published/CORE-000812/rule.yml
+++ b/Published/CORE-000812/rule.yml
@@ -4,35 +4,33 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A biomedical concept category is expected to have at least a
- member or a child.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A biomedical concept category is expected to have at least a member or a child."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00014'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00014"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A biomedical concept category is expected to have at least a
- member or a child.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A biomedical concept category is expected to have at least a member or a child."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00014'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00014"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'BiomedicalConceptCategory'
+ value: "BiomedicalConceptCategory"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- all:
- name: memberIds
@@ -54,14 +52,13 @@ Check:
operator: equal_to
value: true
Core:
- Id: 'CORE-000812'
+ Id: "CORE-000812"
Status: Published
- Version: '1'
-Description: 'A biomedical concept category is expected to have at least a
- member or a child.'
+ Version: "1"
+Description: "A biomedical concept category is expected to have at least a member or a child."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The biomedical concept category does not have any members or children.'
+ Message: "The biomedical concept category does not have any members or children."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000813/rule.yml b/Published/CORE-000813/rule.yml
index 04efe7061..1f54ba9af 100644
--- a/Published/CORE-000813/rule.yml
+++ b/Published/CORE-000813/rule.yml
@@ -4,38 +4,40 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'All standard code aliases referenced by an instance of the
- alias code class must be unique.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "All standard code aliases referenced by an instance of the alias code class must
+ be unique."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00052'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00052"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'All standard code aliases referenced by an instance of the
- alias code class must be unique.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "All standard code aliases referenced by an instance of the alias code class must
+ be unique."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00052'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00052"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Code'
+ value: "Code"
- name: parent_entity
operator: equal_to
- value: 'AliasCode'
+ value: "AliasCode"
- name: parent_rel
operator: equal_to
- value: 'standardCodeAliases'
+ value: "standardCodeAliases"
value_is_literal: true
- name: code
operator: is_not_unique_set
@@ -48,9 +50,8 @@ Check:
Core:
Id: "CORE-000813"
Status: Published
- Version: '1'
-Description: 'All standard code aliases referenced by an instance of the alias
- code class must be unique.'
+ Version: "1"
+Description: "All standard code aliases referenced by an instance of the alias code class must be unique."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -58,8 +59,9 @@ Match Datasets:
Right: id
Name: AliasCode
Outcome:
- Message: 'The standard code aliases of the alias code are not unique - the same
- code is used more than once with the same codeSystem and codeSystemVersion.'
+ Message:
+ "The standard code aliases of the alias code are not unique - the same code is used more than
+ once with the same codeSystem and codeSystemVersion."
Output Variables:
- parent_entity.AliasCode
- parent_id.AliasCode
diff --git a/Published/CORE-000814/rule.yml b/Published/CORE-000814/rule.yml
index e35532af1..6c700015a 100644
--- a/Published/CORE-000814/rule.yml
+++ b/Published/CORE-000814/rule.yml
@@ -4,44 +4,44 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study version, if a date of a specific type exists
- with a global geographic scope then no other dates are
- expected with the same type.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study version, if a date of a specific type exists with a global geographic
+ scope then no other dates are expected with the same type."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00094'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00094"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study version, if a date of a specific type exists
- with a global geographic scope then no other dates are
- expected with the same type.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study version, if a date of a specific type exists with a global geographic
+ scope then no other dates are expected with the same type."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00094'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00094"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'GeographicScope'
+ value: "GeographicScope"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: type.code
operator: equal_to
- value: 'C68846'
+ value: "C68846"
- name: type.decode
operator: equal_to_case_insensitive
- value: 'Global'
+ value: "Global"
- any:
- name: $num_geographic_scopes_for_this_date
operator: greater_than
@@ -50,11 +50,12 @@ Check:
operator: greater_than
value: 1
Core:
- Id: 'CORE-000814'
+ Id: "CORE-000814"
Status: Published
- Version: '1'
-Description: 'Within a study version, if a date of a specific type exists with a
- global geographic scope then no other dates are expected with the same type.'
+ Version: "1"
+Description:
+ "Within a study version, if a date of a specific type exists with a global geographic scope
+ then no other dates are expected with the same type."
Executability: Partially Executable - Possible Overreporting
Match Datasets:
- Keys:
@@ -82,9 +83,9 @@ Operations:
id: $num_dates_of_this_type
operator: record_count
Outcome:
- Message: 'The study version has a type of governance date with a global
- geographic scope and either another date of the same type or additional
- geographic scope(s) defined for the date.'
+ Message:
+ "The study version has a type of governance date with a global geographic scope and either
+ another date of the same type or additional geographic scope(s) defined for the date."
Output Variables:
- parent_entity.StudyVersion
- parent_id.StudyVersion
@@ -102,5 +103,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'GeographicScope'
+ - "GeographicScope"
Sensitivity: Record
diff --git a/Published/CORE-000815/rule.yml b/Published/CORE-000815/rule.yml
index 541903263..9ac995fdc 100644
--- a/Published/CORE-000815/rule.yml
+++ b/Published/CORE-000815/rule.yml
@@ -4,35 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, the planned age range must be specified
- either in the study population or in all cohorts.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study design, the planned age range must be specified either in the
+ study population or in all cohorts."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00097'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00097"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, the planned age range must be specified
- either in the study population or in all cohorts.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study design, the planned age range must be specified either in the
+ study population or in all cohorts."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00097'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00097"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyDesignPopulation'
+ value: "StudyDesignPopulation"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- all:
- any:
@@ -59,11 +61,12 @@ Check:
operator: equal_to
value: true
Core:
- Id: 'CORE-000815'
+ Id: "CORE-000815"
Status: Published
- Version: '1'
-Description: 'Within a study design, the planned age range must be specified
- either in the study population or in all cohorts.'
+ Version: "1"
+Description:
+ "Within a study design, the planned age range must be specified either in the study population
+ or in all cohorts."
Executability: Fully Executable
Match Datasets:
- Join Type: left
@@ -75,8 +78,9 @@ Match Datasets:
- rel_type
Name: StudyCohort
Outcome:
- Message: 'Planned age has not been specified for either the study population or
- the cohort, or it has been specified for both.'
+ Message:
+ "Planned age has not been specified for either the study population or the cohort, or it has
+ been specified for both."
Output Variables:
- parent_entity
- parent_id
@@ -97,5 +101,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyDesignPopulation'
+ - "StudyDesignPopulation"
Sensitivity: Record
diff --git a/Published/CORE-000816/rule.yml b/Published/CORE-000816/rule.yml
index 83a294ad2..7ef074b66 100644
--- a/Published/CORE-000816/rule.yml
+++ b/Published/CORE-000816/rule.yml
@@ -4,45 +4,43 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'All epochs are expected to be referred to from a scheduled
- Activity Instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "All epochs are expected to be referred to from a scheduled Activity Instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00099'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00099"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'All epochs are expected to be referred to from a scheduled
- Activity Instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "All epochs are expected to be referred to from a scheduled Activity Instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00099'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00099"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyEpoch'
+ value: "StudyEpoch"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: epochId
operator: not_exists
- name: epochId
operator: empty
Core:
- Id: 'CORE-000816'
+ Id: "CORE-000816"
Status: Published
- Version: '1'
-Description: 'All epochs are expected to be referred to from a scheduled Activity Instance.'
+ Version: "1"
+Description: "All epochs are expected to be referred to from a scheduled Activity Instance."
Executability: Partially Executable - Possible Overreporting
Match Datasets:
- Join Type: left
@@ -52,7 +50,7 @@ Match Datasets:
- rel_type
Name: ScheduledActivityInstance
Outcome:
- Message: 'The epoch is not referenced by any scheduled activity instances.'
+ Message: "The epoch is not referenced by any scheduled activity instances."
Output Variables:
- parent_entity
- parent_id
@@ -63,5 +61,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyEpoch'
+ - "StudyEpoch"
Sensitivity: Record
diff --git a/Published/CORE-000817/rule.yml b/Published/CORE-000817/rule.yml
index 5f0de85d6..4f3370a52 100644
--- a/Published/CORE-000817/rule.yml
+++ b/Published/CORE-000817/rule.yml
@@ -4,35 +4,33 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study version, there must be no more than one title of
- each type.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within a study version, there must be no more than one title of each type."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00100'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00100"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study version, there must be no more than one title of
- each type.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within a study version, there must be no more than one title of each type."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00100'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00100"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyTitle'
+ value: "StudyTitle"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: type.code
operator: is_not_unique_set
@@ -43,13 +41,13 @@ Check:
value:
- parent_id
Core:
- Id: 'CORE-000817'
+ Id: "CORE-000817"
Status: Published
- Version: '1'
-Description: 'Within a study version, there must be no more than one title of each type.'
+ Version: "1"
+Description: "Within a study version, there must be no more than one title of each type."
Executability: Fully Executable
Outcome:
- Message: 'There is more than one title of the same type code or decode.'
+ Message: "There is more than one title of the same type code or decode."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000818/rule.yml b/Published/CORE-000818/rule.yml
index 733afe3a2..310047067 100644
--- a/Published/CORE-000818/rule.yml
+++ b/Published/CORE-000818/rule.yml
@@ -4,53 +4,53 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled activity instance must not point (via the
- "timeline" relationship) to the timeline in which it is
- specified.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ 'A scheduled activity instance must not point (via the "timeline" relationship)
+ to the timeline in which it is specified.'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00026'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00026"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled activity instance must not point (via the
- "timeline" relationship) to the timeline in which it is
- specified.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ 'A scheduled activity instance must not point (via the "timeline" relationship)
+ to the timeline in which it is specified.'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00026'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00026"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'ScheduledActivityInstance'
+ value: "ScheduledActivityInstance"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: parent_rel
operator: equal_to
- value: 'instances'
+ value: "instances"
- name: timelineId
operator: equal_to
value: parent_id
Core:
Id: CORE-000818
Status: Published
- Version: '1'
-Description: 'A scheduled activity instance must not point (via the "timeline"
- relationship) to the timeline in which it is specified.'
+ Version: "1"
+Description:
+ 'A scheduled activity instance must not point (via the "timeline" relationship) to the timeline
+ in which it is specified.'
Executability: Fully Executable
Outcome:
- Message: 'The scheduled activity instance is referencing its parent timeline as
- its sub-timeline.'
+ Message: "The scheduled activity instance is referencing its parent timeline as its sub-timeline."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000819/rule.yml b/Published/CORE-000819/rule.yml
index 7d7f90278..5ea199b1f 100644
--- a/Published/CORE-000819/rule.yml
+++ b/Published/CORE-000819/rule.yml
@@ -4,49 +4,49 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled activity instance must only reference a timeline
- exit that is defined within the same schedule timeline as the
- scheduled activity instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A scheduled activity instance must only reference a timeline exit that is defined
+ within the same schedule timeline as the scheduled activity instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00102'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00102"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled activity instance must only reference a timeline
- exit that is defined within the same schedule timeline as the
- scheduled activity instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A scheduled activity instance must only reference a timeline exit that is defined
+ within the same schedule timeline as the scheduled activity instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00102'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00102"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'ScheduledActivityInstance'
+ value: "ScheduledActivityInstance"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: timelineExitId
operator: non_empty
- name: parent_id.ScheduleTimelineExit
operator: not_equal_to
value: parent_id
Core:
- Id: 'CORE-000819'
+ Id: "CORE-000819"
Status: Published
- Version: '1'
-Description: 'A scheduled activity instance must only reference a timeline exit
- that is defined within the same schedule timeline as the scheduled activity
- instance.'
+ Version: "1"
+Description:
+ "A scheduled activity instance must only reference a timeline exit that is defined within
+ the same schedule timeline as the scheduled activity instance."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -55,9 +55,9 @@ Match Datasets:
- rel_type
Name: ScheduleTimelineExit
Outcome:
- Message: 'The scheduled activity instance references a timeline exit that is not
- defined within the same schedule timeline as the scheduled activity
- instance.'
+ Message:
+ "The scheduled activity instance references a timeline exit that is not defined within the
+ same schedule timeline as the scheduled activity instance."
Output Variables:
- parent_entity
- parent_id
@@ -70,5 +70,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ScheduledActivityInstance'
+ - "ScheduledActivityInstance"
Sensitivity: Record
diff --git a/Published/CORE-000820/rule.yml b/Published/CORE-000820/rule.yml
index c5e905d4f..7c2b1643c 100644
--- a/Published/CORE-000820/rule.yml
+++ b/Published/CORE-000820/rule.yml
@@ -4,35 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The value for each timing must be a non-negative duration
- specified in ISO 8601 format.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "The value for each timing must be a non-negative duration specified in ISO 8601
+ format."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00060'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00060"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The value for each timing must be a non-negative duration
- specified in ISO 8601 format.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "The value for each timing must be a non-negative duration specified in ISO 8601
+ format."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00060'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00060"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Timing'
+ value: "Timing"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: value
operator: exists
- name: value
@@ -41,15 +43,13 @@ Check:
negative: false
operator: invalid_duration
Core:
- Id: 'CORE-000820'
+ Id: "CORE-000820"
Status: Published
- Version: '1'
-Description: 'The value for each timing must be a non-negative duration
- specified in ISO 8601 format.'
+ Version: "1"
+Description: "The value for each timing must be a non-negative duration specified in ISO 8601 format."
Executability: Fully Executable
Outcome:
- Message: 'The value attribute of the timing is not a non-negative duration in
- ISO 8601 format.'
+ Message: "The value attribute of the timing is not a non-negative duration in ISO 8601 format."
Output Variables:
- parent_entity
- parent_id
@@ -62,5 +62,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Timing'
+ - "Timing"
Sensitivity: Record
diff --git a/Published/CORE-000821/rule.yml b/Published/CORE-000821/rule.yml
index 7238d6ab3..e94283faa 100644
--- a/Published/CORE-000821/rule.yml
+++ b/Published/CORE-000821/rule.yml
@@ -4,41 +4,41 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The target for a condition must not be equal to its parent.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "The target for a condition must not be equal to its parent."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00044'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00044"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The target for a condition must not be equal to its parent.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "The target for a condition must not be equal to its parent."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00044'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00044"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'ConditionAssignment'
- - name: 'rel_type'
+ value: "ConditionAssignment"
+ - name: "rel_type"
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: conditionTargetId
operator: equal_to
value: parent_id
Core:
- Id: 'CORE-000821'
+ Id: "CORE-000821"
Status: Published
- Version: '1'
-Description: 'The target for a condition must not be equal to its parent.'
+ Version: "1"
+Description: "The target for a condition must not be equal to its parent."
Executability: Fully Executable
Outcome:
Message: "The condition assignment's target is the same as its parent."
diff --git a/Published/CORE-000822/rule.yml b/Published/CORE-000822/rule.yml
index 2314ee9b7..cfc88235d 100644
--- a/Published/CORE-000822/rule.yml
+++ b/Published/CORE-000822/rule.yml
@@ -4,37 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "There must be at least one exit defined for each timeline
- (i.e., at least one instance of StudyTimelineExit linked via
- the 'exits' relationship)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "There must be at least one exit defined for each timeline (i.e., at least one
+ instance of StudyTimelineExit linked via the 'exits' relationship)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00108'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00108"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: "There must be at least one exit defined for each timeline
- (i.e., at least one instance of StudyTimelineExit linked via
- the 'exits' relationship)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "There must be at least one exit defined for each timeline (i.e., at least one
+ instance of StudyTimelineExit linked via the 'exits' relationship)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00108'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00108"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'ScheduleTimeline'
+ value: "ScheduleTimeline"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: exits
operator: not_exists
@@ -44,15 +44,15 @@ Check:
operator: equal_to
value: false
Core:
- Id: 'CORE-000822'
+ Id: "CORE-000822"
Status: Published
- Version: '1'
-Description: "There must be at least one exit defined for each timeline (i.e.,
- at least one instance of StudyTimelineExit linked via the 'exits'
- relationship)."
+ Version: "1"
+Description:
+ "There must be at least one exit defined for each timeline (i.e., at least one instance of
+ StudyTimelineExit linked via the 'exits' relationship)."
Executability: Fully Executable
Outcome:
- Message: 'There is no exit defined for the timeline.'
+ Message: "There is no exit defined for the timeline."
Output Variables:
- parent_entity
- parent_id
@@ -64,5 +64,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ScheduleTimeline'
+ - "ScheduleTimeline"
Sensitivity: Record
diff --git a/Published/CORE-000823/rule.yml b/Published/CORE-000823/rule.yml
index 07105a5b5..422fe19f6 100644
--- a/Published/CORE-000823/rule.yml
+++ b/Published/CORE-000823/rule.yml
@@ -4,45 +4,43 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Every study version must have a title of type "Official Study
- Title".'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: 'Every study version must have a title of type "Official Study Title".'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00115'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00115"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Every study version must have a title of type "Official Study
- Title".'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: 'Every study version must have a title of type "Official Study Title".'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00115'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00115"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyVersion'
+ value: "StudyVersion"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: $study_title_type_codes
operator: does_not_contain_case_insensitive
- value: 'C207616'
+ value: "C207616"
- name: $study_title_type_decodes
operator: does_not_contain_case_insensitive
- value: 'Official Study Title'
+ value: "Official Study Title"
Core:
- Id: 'CORE-000823'
+ Id: "CORE-000823"
Status: Published
- Version: '1'
+ Version: "1"
Description: 'Every study version must have a title of type "Official Study Title".'
Executability: Fully Executable
Operations:
@@ -69,9 +67,9 @@ Operations:
name: type.decode
operator: distinct
Outcome:
- Message: 'The study version does not have a title of type "Official Study Title"
- (type.code = C207616 or type.decode = "Official Study Title", both case
- insensitive).'
+ Message:
+ 'The study version does not have a title of type "Official Study Title" (type.code = C207616
+ or type.decode = "Official Study Title", both case insensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -84,5 +82,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyVersion'
+ - "StudyVersion"
Sensitivity: Record
diff --git a/Published/CORE-000824/rule.yml b/Published/CORE-000824/rule.yml
index 183c2b68d..60cf4758f 100644
--- a/Published/CORE-000824/rule.yml
+++ b/Published/CORE-000824/rule.yml
@@ -4,50 +4,50 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled activity/decision instance must not refer to itself
- as its default condition.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A scheduled activity/decision instance must not refer to itself as its default
+ condition."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00019'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00019"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled activity/decision instance must not refer to itself
- as its default condition.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A scheduled activity/decision instance must not refer to itself as its default
+ condition."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00019'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00019"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: is_contained_by
value:
- - 'ScheduledActivityInstance'
- - 'ScheduledDecisionInstance'
+ - "ScheduledActivityInstance"
+ - "ScheduledDecisionInstance"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: defaultConditionId
operator: equal_to
value: id
Core:
Id: CORE-000824
Status: Published
- Version: '1'
-Description: 'A scheduled activity/decision instance must not refer to itself as
- its default condition.'
+ Version: "1"
+Description: "A scheduled activity/decision instance must not refer to itself as its default condition."
Executability: Fully Executable
Outcome:
- Message: 'A scheduled activity/decision instance is referencing itself as its
- default condition.'
+ Message: "A scheduled activity/decision instance is referencing itself as its default condition."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000825/rule.yml b/Published/CORE-000825/rule.yml
index 14531bac9..4705c9228 100644
--- a/Published/CORE-000825/rule.yml
+++ b/Published/CORE-000825/rule.yml
@@ -4,35 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'When specified, the lower limit of a timing window must be a
- non-negative duration in ISO 8601 format.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "When specified, the lower limit of a timing window must be a non-negative duration
+ in ISO 8601 format."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00061'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00061"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'When specified, the lower limit of a timing window must be a
- non-negative duration in ISO 8601 format.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "When specified, the lower limit of a timing window must be a non-negative duration
+ in ISO 8601 format."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00061'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00061"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Timing'
+ value: "Timing"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: windowLower
operator: exists
- name: windowLower
@@ -41,15 +43,17 @@ Check:
negative: false
operator: invalid_duration
Core:
- Id: 'CORE-000825'
+ Id: "CORE-000825"
Status: Published
- Version: '1'
-Description: 'When specified, the lower limit of a timing window must be a
- non-negative duration in ISO 8601 format.'
+ Version: "1"
+Description:
+ "When specified, the lower limit of a timing window must be a non-negative duration in ISO
+ 8601 format."
Executability: Fully Executable
Outcome:
- Message: 'The lower limit of the timing window (windowLower) is not a
- non-negative duration in ISO 8601 format.'
+ Message:
+ "The lower limit of the timing window (windowLower) is not a non-negative duration in ISO 8601
+ format."
Output Variables:
- parent_entity
- parent_id
@@ -62,5 +66,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Timing'
+ - "Timing"
Sensitivity: Record
diff --git a/Published/CORE-000826/rule.yml b/Published/CORE-000826/rule.yml
index 3946e3b5d..bce610738 100644
--- a/Published/CORE-000826/rule.yml
+++ b/Published/CORE-000826/rule.yml
@@ -4,35 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'When specified, the upper limit of a timing window must be a
- non-negative duration in ISO 8601 format.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "When specified, the upper limit of a timing window must be a non-negative duration
+ in ISO 8601 format."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00062'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00062"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'When specified, the upper limit of a timing window must be a
- non-negative duration in ISO 8601 format.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "When specified, the upper limit of a timing window must be a non-negative duration
+ in ISO 8601 format."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00062'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00062"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Timing'
+ value: "Timing"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: windowUpper
operator: exists
- name: windowUpper
@@ -41,15 +43,17 @@ Check:
negative: false
operator: invalid_duration
Core:
- Id: 'CORE-000826'
+ Id: "CORE-000826"
Status: Published
- Version: '1'
-Description: 'When specified, the upper limit of a timing window must be a
- non-negative duration in ISO 8601 format.'
+ Version: "1"
+Description:
+ "When specified, the upper limit of a timing window must be a non-negative duration in ISO
+ 8601 format."
Executability: Fully Executable
Outcome:
- Message: 'The upper limit of the timing window (windowUpper) is not a
- non-negative duration in ISO 8601 format.'
+ Message:
+ "The upper limit of the timing window (windowUpper) is not a non-negative duration in ISO 8601
+ format."
Output Variables:
- parent_entity
- parent_id
@@ -62,5 +66,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Timing'
+ - "Timing"
Sensitivity: Record
diff --git a/Published/CORE-000827/rule.yml b/Published/CORE-000827/rule.yml
index 17e9c4fc4..09ce90642 100644
--- a/Published/CORE-000827/rule.yml
+++ b/Published/CORE-000827/rule.yml
@@ -4,46 +4,49 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An encounter must only be scheduled at a timing that is defined
- within the same study design as the encounter.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An encounter must only be scheduled at a timing that is defined within the same
+ study design as the encounter."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00127'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00127"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An encounter must only be scheduled at a timing that is defined
- within the same study design as the encounter.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An encounter must only be scheduled at a timing that is defined within the same
+ study design as the encounter."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00127'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00127"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Encounter'
+ value: "Encounter"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: scheduledAtId
operator: non_empty
- name: parent_id
operator: not_equal_to
value: parent_id.ScheduleTimeline
Core:
- Id: 'CORE-000827'
+ Id: "CORE-000827"
Status: Published
- Version: '1'
-Description: 'An encounter must only be scheduled at a timing that is defined
- within the same study design as the encounter.'
+ Version: "1"
+Description:
+ "An encounter must only be scheduled at a timing that is defined within the same study design
+ as the encounter."
Executability: Fully Executable
Match Datasets:
- Join Type: left
@@ -59,10 +62,10 @@ Match Datasets:
- rel_type
Name: ScheduleTimeline
Outcome:
- Message: 'The encounter is scheduled at a timing that either is not defined in
- the same study design (the parent_id of the timing''s parent schedule
- timeline does not match the parent_id of the encounter) or is invalid
- (schedulateAtId does not match the id of any timing).'
+ Message:
+ "The encounter is scheduled at a timing that either is not defined in the same study design
+ (the parent_id of the timing's parent schedule timeline does not match the parent_id of the encounter)
+ or is invalid (schedulateAtId does not match the id of any timing)."
Output Variables:
- parent_entity
- parent_id
@@ -76,5 +79,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Encounter'
+ - "Encounter"
Sensitivity: Record
diff --git a/Published/CORE-000828/rule.yml b/Published/CORE-000828/rule.yml
index 582bea199..68c8c21e5 100644
--- a/Published/CORE-000828/rule.yml
+++ b/Published/CORE-000828/rule.yml
@@ -4,37 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A standard code alias is not expected to be equal to the
- standard code (e.g. no equal code or decode for the same
- coding system version is expected).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A standard code alias is not expected to be equal to the standard code (e.g.
+ no equal code or decode for the same coding system version is expected)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00063'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00063"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A standard code alias is not expected to be equal to the
- standard code (e.g. no equal code or decode for the same
- coding system version is expected).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A standard code alias is not expected to be equal to the standard code (e.g.
+ no equal code or decode for the same coding system version is expected)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00063'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00063"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'AliasCode'
+ value: "AliasCode"
- name: parent_rel.Code
operator: equal_to
- value: 'standardCodeAliases'
+ value: "standardCodeAliases"
value_is_literal: true
- name: standardCode.codeSystem
operator: equal_to_case_insensitive
@@ -50,12 +50,12 @@ Check:
operator: equal_to_case_insensitive
value: decode
Core:
- Id: 'CORE-000828'
+ Id: "CORE-000828"
Status: Published
- Version: '1'
-Description: 'A standard code alias is not expected to be equal to the standard
- code (e.g. no equal code or decode for the same coding system version is
- expected).'
+ Version: "1"
+Description:
+ "A standard code alias is not expected to be equal to the standard code (e.g. no equal code
+ or decode for the same coding system version is expected)."
Executability: Partially Executable - Possible Overreporting
Match Datasets:
- Keys:
@@ -65,10 +65,10 @@ Match Datasets:
Right: parent_entity
Name: Code
Outcome:
- Message: 'The standard code alias is the same as the standard code - the same
- combination of code system, code system version and either code or decode is
- used for both the standard code and the standard code alias (case
- insensitive).'
+ Message:
+ "The standard code alias is the same as the standard code - the same combination of code system,
+ code system version and either code or decode is used for both the standard code and the standard
+ code alias (case insensitive)."
Output Variables:
- parent_entity
- parent_id
@@ -86,5 +86,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'AliasCode'
+ - "AliasCode"
Sensitivity: Record
diff --git a/Published/CORE-000829/rule.yml b/Published/CORE-000829/rule.yml
index 921102a98..1c1830622 100644
--- a/Published/CORE-000829/rule.yml
+++ b/Published/CORE-000829/rule.yml
@@ -4,36 +4,36 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within an encounter there must be no duplicate contact modes.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within an encounter there must be no duplicate contact modes."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00054'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00054"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within an encounter there must be no duplicate contact modes.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within an encounter there must be no duplicate contact modes."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00054'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00054"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Code'
+ value: "Code"
- name: parent_entity
operator: equal_to
- value: 'Encounter'
+ value: "Encounter"
- name: parent_rel
operator: equal_to
- value: 'contactModes'
+ value: "contactModes"
value_is_literal: true
- name: code
operator: is_not_unique_set
@@ -46,8 +46,8 @@ Check:
Core:
Id: "CORE-000829"
Status: Published
- Version: '1'
-Description: 'Within an encounter there must be no duplicate contact modes.'
+ Version: "1"
+Description: "Within an encounter there must be no duplicate contact modes."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -56,8 +56,9 @@ Match Datasets:
- rel_type
Name: Encounter
Outcome:
- Message: 'The contact modes of the encounter are not unique - the same code is
- used more than once with the same codeSystem and codeSystemVersion.'
+ Message:
+ "The contact modes of the encounter are not unique - the same code is used more than once with
+ the same codeSystem and codeSystemVersion."
Output Variables:
- name
- parent_entity
diff --git a/Published/CORE-000830/rule.yml b/Published/CORE-000830/rule.yml
index b994a2942..8eaf8440b 100644
--- a/Published/CORE-000830/rule.yml
+++ b/Published/CORE-000830/rule.yml
@@ -4,37 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Anchor timings (e.g. type is "Fixed Reference") must be related
- to a scheduled activity instance via a
- relativeFromScheduledInstance relationship.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ 'Anchor timings (e.g. type is "Fixed Reference") must be related to a scheduled
+ activity instance via a relativeFromScheduledInstance relationship.'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00011'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00011"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Anchor timings (e.g. type is "Fixed Reference") must be related
- to a scheduled activity instance via a
- relativeFromScheduledInstance relationship.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ 'Anchor timings (e.g. type is "Fixed Reference") must be related to a scheduled
+ activity instance via a relativeFromScheduledInstance relationship.'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00011'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00011"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type.code
operator: equal_to
- value: 'C201358'
+ value: "C201358"
- any:
- name: relativeFromScheduledInstanceId
operator: empty
@@ -43,12 +43,12 @@ Check:
- name: id.ScheduledActivityInstance
operator: empty
Core:
- Id: 'CORE-000830'
+ Id: "CORE-000830"
Status: Published
- Version: '1'
-Description: 'Anchor timings (e.g. type is "Fixed Reference") must be related to
- a scheduled activity instance via a relativeFromScheduledInstance
- relationship.'
+ Version: "1"
+Description:
+ 'Anchor timings (e.g. type is "Fixed Reference") must be related to a scheduled activity
+ instance via a relativeFromScheduledInstance relationship.'
Executability: Fully Executable
Match Datasets:
- Join Type: left
@@ -59,11 +59,10 @@ Match Datasets:
Right: parent_entity
Name: ScheduledActivityInstance
Outcome:
- Message: 'The timing has a type of "Fixed Reference" (type.code=C201358) but it
- is not related to a scheduled activity instance via a
- relativeFromScheduledInstance relationship - the value of
- relativeFromScheduledInstanceId is missing or it does not match the id value
- of a ScheduledActivityInstance.'
+ Message:
+ 'The timing has a type of "Fixed Reference" (type.code=C201358) but it is not related to a
+ scheduled activity instance via a relativeFromScheduledInstance relationship - the value of relativeFromScheduledInstanceId
+ is missing or it does not match the id value of a ScheduledActivityInstance.'
Output Variables:
- parent_entity
- parent_id
@@ -78,5 +77,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Timing'
+ - "Timing"
Sensitivity: Record
diff --git a/Published/CORE-000831/rule.yml b/Published/CORE-000831/rule.yml
index 1e51e4e30..48630013d 100644
--- a/Published/CORE-000831/rule.yml
+++ b/Published/CORE-000831/rule.yml
@@ -4,38 +4,36 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within an indication, if more indication codes are defined,
- they must be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within an indication, if more indication codes are defined, they must be distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00058'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00058"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within an indication, if more indication codes are defined,
- they must be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within an indication, if more indication codes are defined, they must be distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00058'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00058"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Code'
+ value: "Code"
- name: parent_entity
operator: equal_to
- value: 'Indication'
+ value: "Indication"
- name: parent_rel
operator: equal_to
- value: 'codes'
+ value: "codes"
value_is_literal: true
- name: code
operator: is_not_unique_set
@@ -48,9 +46,8 @@ Check:
Core:
Id: "CORE-000831"
Status: Published
- Version: '1'
-Description: 'Within an indication, if more indication codes are defined, they
- must be distinct.'
+ Version: "1"
+Description: "Within an indication, if more indication codes are defined, they must be distinct."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -59,8 +56,9 @@ Match Datasets:
- rel_type
Name: Indication
Outcome:
- Message: 'The codes of the indication are not unique - the same code is used
- more than once with the same codeSystem and codeSystemVersion.'
+ Message:
+ "The codes of the indication are not unique - the same code is used more than once with the
+ same codeSystem and codeSystemVersion."
Output Variables:
- name
- parent_entity
diff --git a/Published/CORE-000832/negative/01/data/StudyIntervention.csv b/Published/CORE-000832/negative/01/data/StudyIntervention.csv
index a7385c2d1..eeccd371b 100644
--- a/Published/CORE-000832/negative/01/data/StudyIntervention.csv
+++ b/Published/CORE-000832/negative/01/data/StudyIntervention.csv
@@ -1,3 +1,2 @@
parent_entity,parent_id,parent_rel,rel_type,id,description,name,label,instanceType,administrations,type,type.id,type.code,type.codeSystem,type.codeSystemVersion,type.decode,role,role.id,role.code,role.codeSystem,role.codeSystemVersion,role.decode,productDesignation,productDesignation.id,productDesignation.code,productDesignation.codeSystem,productDesignation.codeSystemVersion,productDesignation.decode,pharmacologicClass,pharmacologicClass.id,pharmacologicClass.code,pharmacologicClass.codeSystem,pharmacologicClass.codeSystemVersion,pharmacologicClass.decode,codes,minimumResponseDuration,minimumResponseDuration.id,minimumResponseDuration.value,minimumResponseDuration.unit,minimumResponseDuration.unit.id,minimumResponseDuration.unit.standardCode,minimumResponseDuration.unit.standardCode.id,minimumResponseDuration.unit.standardCode.code,minimumResponseDuration.unit.standardCode.codeSystem,minimumResponseDuration.unit.standardCode.codeSystemVersion,minimumResponseDuration.unit.standardCode.decode,minimumResponseDuration.unit.standardCodeAliases
-parent_entity,parent_id,parent_rel,rel_type,id,description,name,label,instanceType,administrations,type,type.id,type.code,type.codeSystem,type.codeSystemVersion,type.decode,role,role.id,role.code,role.codeSystem,role.codeSystemVersion,role.decode,productDesignation,productDesignation.id,productDesignation.code,productDesignation.codeSystem,productDesignation.codeSystemVersion,productDesignation.decode,pharmacologicClass,pharmacologicClass.id,pharmacologicClass.code,pharmacologicClass.codeSystem,pharmacologicClass.codeSystemVersion,pharmacologicClass.decode,codes,minimumResponseDuration,minimumResponseDuration.id,minimumResponseDuration.value,minimumResponseDuration.unit,minimumResponseDuration.unit.id,minimumResponseDuration.unit.standardCode,minimumResponseDuration.unit.standardCode.id,minimumResponseDuration.unit.standardCode.code,minimumResponseDuration.unit.standardCode.codeSystem,minimumResponseDuration.unit.standardCode.codeSystemVersion,minimumResponseDuration.unit.standardCode.decode,minimumResponseDuration.unit.standardCodeAliases
StudyDesign,StudyDesign_1,studyInterventions,definition,StudyIntervention_1,LY900018,LY,LY900018,StudyIntervention,True,True,Code_478,C1909,http://www.cdisc.org,2023-12-15,Pharmacologic Substance,True,Code_477,C41161,http://www.cdisc.org,2023-12-15,Experimental Intervention,True,Code_480,C99909x1,http://www.cdisc.org,2023-12-15,IMP,True,Code_479,A,FDA,None set,B,True,True,Quantity_4,1,True,AliasCode_209,True,Code_481,C25301,http://www.cdisc.org,2023-12-15,Day,False
diff --git a/Published/CORE-000832/rule.yml b/Published/CORE-000832/rule.yml
index 02d6ef57f..5da31ed58 100644
--- a/Published/CORE-000832/rule.yml
+++ b/Published/CORE-000832/rule.yml
@@ -4,38 +4,40 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study intervention, if more intervention codes are
- defined, they must be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study intervention, if more intervention codes are defined, they must
+ be distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00059'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00059"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study intervention, if more intervention codes are
- defined, they must be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study intervention, if more intervention codes are defined, they must
+ be distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00059'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00059"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Code'
+ value: "Code"
- name: parent_entity
operator: equal_to
- value: 'StudyIntervention'
+ value: "StudyIntervention"
- name: parent_rel
operator: equal_to
- value: 'codes'
+ value: "codes"
value_is_literal: true
- name: code
operator: is_not_unique_set
@@ -48,9 +50,8 @@ Check:
Core:
Id: "CORE-000832"
Status: Published
- Version: '1'
-Description: 'Within a study intervention, if more intervention codes are
- defined, they must be distinct.'
+ Version: "1"
+Description: "Within a study intervention, if more intervention codes are defined, they must be distinct."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -59,8 +60,9 @@ Match Datasets:
- rel_type
Name: StudyIntervention
Outcome:
- Message: 'The codes of the study intervention are not unique - the same code is
- used more than once with the same codeSystem and codeSystemVersion.'
+ Message:
+ "The codes of the study intervention are not unique - the same code is used more than once
+ with the same codeSystem and codeSystemVersion."
Output Variables:
- name
- parent_entity
diff --git a/Published/CORE-000833/rule.yml b/Published/CORE-000833/rule.yml
index d96bfcb49..151b96284 100644
--- a/Published/CORE-000833/rule.yml
+++ b/Published/CORE-000833/rule.yml
@@ -13,13 +13,13 @@ Authorities:
'attribute="attributeName"/>' in any order (where "klassName"
and "attributeName" contain only letters in upper or lower
case).
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00137'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00137"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
@@ -32,33 +32,31 @@ Authorities:
'attribute="attributeName"/>' in any order (where "klassName"
and "attributeName" contain only letters in upper or lower
case).
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00137'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00137"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'ParameterMap'
+ value: "ParameterMap"
- name: rel_type
operator: equal_to
value: definition
- name: reference
operator: contains
- value: 'usdm:ref'
+ value: "usdm:ref"
- name: reference
operator: not_matches_regex
- value: '^]* klass=\"[a-zA-Z]+\")(?=[^>]*
- id=\"([^\"]+)\")(?=[^>]*
- attribute=\"[a-zA-Z]+\")[^>]*)(\/>|><\/usdm:ref>)$'
+ value: '^]* klass=\"[a-zA-Z]+\")(?=[^>]* id=\"([^\"]+)\")(?=[^>]* attribute=\"[a-zA-Z]+\")[^>]*)(\/>|><\/usdm:ref>)$'
Core:
- Id: 'CORE-000833'
+ Id: "CORE-000833"
Status: Published
- Version: '1'
+ Version: "1"
Description: >-
References must be a fixed value or a reference to items stored elsewhere in
the data model which must be specified in the correct format. They must start
@@ -68,8 +66,9 @@ Description: >-
lower case).
Executability: Fully Executable
Outcome:
- Message: 'The reference is not a fixed value (it contains "usdm:ref") but it is
- not specified in the correct format.'
+ Message:
+ 'The reference is not a fixed value (it contains "usdm:ref") but it is not specified in the
+ correct format.'
Output Variables:
- parent_entity
- parent_id
@@ -81,5 +80,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ParameterMap'
+ - "ParameterMap"
Sensitivity: Record
diff --git a/Published/CORE-000834/rule.yml b/Published/CORE-000834/rule.yml
index 2ce2f93e0..86294d549 100644
--- a/Published/CORE-000834/rule.yml
+++ b/Published/CORE-000834/rule.yml
@@ -4,51 +4,52 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If geographic scope type is global then there must be only one
- geographic scope specified.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If geographic scope type is global then there must be only one geographic scope
+ specified."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00151'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00151"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If geographic scope type is global then there must be only one
- geographic scope specified.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If geographic scope type is global then there must be only one geographic scope
+ specified."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00151'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00151"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'GovernanceDate'
+ value: "GovernanceDate"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: $num_of_geographic_scopes
operator: greater_than
value: 1
- any:
- name: $geographic_scope_type_codes
operator: contains_case_insensitive
- value: 'C68846'
+ value: "C68846"
- name: $geographic_scope_type_decodes
operator: contains_case_insensitive
- value: 'Global'
+ value: "Global"
Core:
- Id: 'CORE-000834'
+ Id: "CORE-000834"
Status: Published
- Version: '1'
-Description: 'If geographic scope type is global then there must be only one
- geographic scope specified.'
+ Version: "1"
+Description: "If geographic scope type is global then there must be only one geographic scope specified."
Executability: Fully Executable
Operations:
- domain: GeographicScope
@@ -78,9 +79,9 @@ Operations:
name: type.decode
operator: distinct
Outcome:
- Message: 'The governance date has more than one geographic scope defined, at
- least one of which has type of "Global" (type.code = C68846 or type.decode =
- "Global", both case insensitive).'
+ Message:
+ 'The governance date has more than one geographic scope defined, at least one of which has
+ type of "Global" (type.code = C68846 or type.decode = "Global", both case insensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -95,5 +96,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'GovernanceDate'
+ - "GovernanceDate"
Sensitivity: Record
diff --git a/Published/CORE-000835/rule.yml b/Published/CORE-000835/rule.yml
index bd4001165..ab3a04af0 100644
--- a/Published/CORE-000835/rule.yml
+++ b/Published/CORE-000835/rule.yml
@@ -4,47 +4,50 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study cell must only reference an arm that is defined within
- the same study design as the study cell.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study cell must only reference an arm that is defined within the same study
+ design as the study cell."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00071'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00071"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study cell must only reference an arm that is defined within
- the same study design as the study cell.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study cell must only reference an arm that is defined within the same study
+ design as the study cell."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00071'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00071"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyCell'
+ value: "StudyCell"
- name: parent_entity
operator: equal_to
- value: 'StudyDesign'
+ value: "StudyDesign"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: parent_id
operator: not_equal_to
value: parent_id.StudyArm
Core:
- Id: 'CORE-000835'
+ Id: "CORE-000835"
Status: Published
- Version: '1'
-Description: 'A study cell must only reference an arm that is defined within the
- same study design as the study cell.'
+ Version: "1"
+Description:
+ "A study cell must only reference an arm that is defined within the same study design as
+ the study cell."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -54,8 +57,9 @@ Match Datasets:
- rel_type
Name: StudyArm
Outcome:
- Message: 'The study cell references an arm that is not defined within the same
- study design as the study cell.'
+ Message:
+ "The study cell references an arm that is not defined within the same study design as the study
+ cell."
Output Variables:
- parent_entity
- parent_id
@@ -67,5 +71,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyCell'
+ - "StudyCell"
Sensitivity: Record
diff --git a/Published/CORE-000836/rule.yml b/Published/CORE-000836/rule.yml
index c380e1b40..431b458ff 100644
--- a/Published/CORE-000836/rule.yml
+++ b/Published/CORE-000836/rule.yml
@@ -4,47 +4,50 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study cell must only reference an epoch that is defined
- within the same study design as the study cell.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study cell must only reference an epoch that is defined within the same study
+ design as the study cell."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00072'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00072"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study cell must only reference an epoch that is defined
- within the same study design as the study cell.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study cell must only reference an epoch that is defined within the same study
+ design as the study cell."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00072'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00072"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyCell'
+ value: "StudyCell"
- name: parent_entity
operator: equal_to
- value: 'StudyDesign'
+ value: "StudyDesign"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: parent_id
operator: not_equal_to
value: parent_id.StudyEpoch
Core:
- Id: 'CORE-000836'
+ Id: "CORE-000836"
Status: Published
- Version: '1'
-Description: 'A study cell must only reference an epoch that is defined within
- the same study design as the study cell.'
+ Version: "1"
+Description:
+ "A study cell must only reference an epoch that is defined within the same study design as
+ the study cell."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -54,8 +57,9 @@ Match Datasets:
- rel_type
Name: StudyEpoch
Outcome:
- Message: 'The study cell references an epoch that is not defined within the same
- study design as the study cell.'
+ Message:
+ "The study cell references an epoch that is not defined within the same study design as the
+ study cell."
Output Variables:
- parent_entity
- parent_id
@@ -67,5 +71,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyCell'
+ - "StudyCell"
Sensitivity: Record
diff --git a/Published/CORE-000837/negative/01/data/Activity.csv b/Published/CORE-000837/negative/01/data/Activity.csv
index 2195e58ec..6cfd625e9 100644
--- a/Published/CORE-000837/negative/01/data/Activity.csv
+++ b/Published/CORE-000837/negative/01/data/Activity.csv
@@ -1,5 +1,4 @@
parent_entity,parent_id,parent_rel,rel_type,id,name,description,label,instanceType,definedProcedures,biomedicalConceptIds,nextId,timelineId,previousId,bcSurrogateIds,bcCategoryIds
-parent_entity,parent_id,parent_rel,rel_type,id,name,description,label,instanceType,definedProcedures,biomedicalConceptIds,nextId,timelineId,previousId,bcSurrogateIds,bcCategoryIds
StudyDesign,StudyDesign_1,activities,definition,Activity_1,Informed consent,,Informed consent,Activity,False,False,Activity_2,,,False,False
StudyDesign,StudyDesign_1,activities,definition,Activity_2,Inclusion/exclusion criteria,,Inclusion and exclusion criteria,Activity,False,False,Activity_3,,Activity_1,False,False
StudyDesign,StudyDesign_2,activities,definition,Activity_3,Patient number assigned,,Patient number assigned,Activity,False,False,,,Activity_2,False,False
diff --git a/Published/CORE-000837/rule.yml b/Published/CORE-000837/rule.yml
index 279fe2e2e..6357e38ce 100644
--- a/Published/CORE-000837/rule.yml
+++ b/Published/CORE-000837/rule.yml
@@ -4,35 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An activity must only reference activities that are specified
- within the same study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An activity must only reference activities that are specified within the same
+ study design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00028'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00028"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An activity must only reference activities that are specified
- within the same study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An activity must only reference activities that are specified within the same
+ study design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00028'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00028"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Activity'
+ value: "Activity"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- all:
- name: previousId
@@ -51,11 +53,10 @@ Check:
operator: is_not_contained_by
value: $activity_ids_for_study_design
Core:
- Id: 'CORE-000837'
+ Id: "CORE-000837"
Status: Published
- Version: '1'
-Description: 'An activity must only reference activities that are specified
- within the same study design.'
+ Version: "1"
+Description: "An activity must only reference activities that are specified within the same study design."
Executability: Fully Executable
Operations:
- group:
@@ -65,8 +66,9 @@ Operations:
name: id
operator: distinct
Outcome:
- Message: 'The activity references a previous or next activity that is not
- specified within the same study design.'
+ Message:
+ "The activity references a previous or next activity that is not specified within the same
+ study design."
Output Variables:
- parent_entity
- parent_id
@@ -80,5 +82,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Activity'
+ - "Activity"
Sensitivity: Record
diff --git a/Published/CORE-000838/rule.yml b/Published/CORE-000838/rule.yml
index cff43fe7a..33a647fef 100644
--- a/Published/CORE-000838/rule.yml
+++ b/Published/CORE-000838/rule.yml
@@ -4,35 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An encounter must only reference encounters that are specified
- within the same study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An encounter must only reference encounters that are specified within the same
+ study design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00029'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00029"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An encounter must only reference encounters that are specified
- within the same study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An encounter must only reference encounters that are specified within the same
+ study design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00029'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00029"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Encounter'
+ value: "Encounter"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- all:
- name: previousId
@@ -51,11 +53,10 @@ Check:
operator: is_not_contained_by
value: $encounter_ids_for_study_design
Core:
- Id: 'CORE-000838'
+ Id: "CORE-000838"
Status: Published
- Version: '1'
-Description: 'An encounter must only reference encounters that are specified
- within the same study design.'
+ Version: "1"
+Description: "An encounter must only reference encounters that are specified within the same study design."
Executability: Fully Executable
Operations:
- group:
@@ -65,8 +66,9 @@ Operations:
name: id
operator: distinct
Outcome:
- Message: 'The encounter references a previous or next encounter that is not
- specified within the same study design.'
+ Message:
+ "The encounter references a previous or next encounter that is not specified within the same
+ study design."
Output Variables:
- parent_entity
- parent_id
@@ -80,5 +82,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Encounter'
+ - "Encounter"
Sensitivity: Record
diff --git a/Published/CORE-000839/rule.yml b/Published/CORE-000839/rule.yml
index 963df33b6..776ae4127 100644
--- a/Published/CORE-000839/rule.yml
+++ b/Published/CORE-000839/rule.yml
@@ -4,35 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An epoch must only reference epochs that are specified within
- the same study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An epoch must only reference epochs that are specified within the same study
+ design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00024'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00024"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An epoch must only reference epochs that are specified within
- the same study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An epoch must only reference epochs that are specified within the same study
+ design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00024'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00024"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyEpoch'
+ value: "StudyEpoch"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- all:
- name: previousId
@@ -51,11 +53,10 @@ Check:
operator: is_not_contained_by
value: $epoch_ids_for_study_design
Core:
- Id: 'CORE-000839'
+ Id: "CORE-000839"
Status: Published
- Version: '1'
-Description: 'An epoch must only reference epochs that are specified within the
- same study design.'
+ Version: "1"
+Description: "An epoch must only reference epochs that are specified within the same study design."
Executability: Fully Executable
Operations:
- group:
@@ -65,8 +66,9 @@ Operations:
name: id
operator: distinct
Outcome:
- Message: 'The epoch references a previous or next epoch that is not specified
- within the same study design.'
+ Message:
+ "The epoch references a previous or next epoch that is not specified within the same study
+ design."
Output Variables:
- parent_entity
- parent_id
@@ -80,5 +82,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyEpoch'
+ - "StudyEpoch"
Sensitivity: Record
diff --git a/Published/CORE-000840/rule.yml b/Published/CORE-000840/rule.yml
index 5c5e391d4..21c300a98 100644
--- a/Published/CORE-000840/rule.yml
+++ b/Published/CORE-000840/rule.yml
@@ -4,35 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An activity must only reference timelines that are specified
- within the same study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An activity must only reference timelines that are specified within the same
+ study design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00152'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00152"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An activity must only reference timelines that are specified
- within the same study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An activity must only reference timelines that are specified within the same
+ study design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00152'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00152"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Activity'
+ value: "Activity"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: timelineId
operator: exists
- name: timelineId
@@ -41,11 +43,10 @@ Check:
operator: is_not_contained_by
value: $timeline_ids_for_study_design
Core:
- Id: 'CORE-000840'
+ Id: "CORE-000840"
Status: Published
- Version: '1'
-Description: 'An activity must only reference timelines that are specified
- within the same study design.'
+ Version: "1"
+Description: "An activity must only reference timelines that are specified within the same study design."
Executability: Fully Executable
Operations:
- domain: ScheduleTimeline
@@ -56,8 +57,7 @@ Operations:
name: id
operator: distinct
Outcome:
- Message: 'The activity references a timeline that is not specified within the
- same study design.'
+ Message: "The activity references a timeline that is not specified within the same study design."
Output Variables:
- parent_entity
- parent_id
@@ -70,5 +70,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Activity'
+ - "Activity"
Sensitivity: Record
diff --git a/Published/CORE-000847/rule.yml b/Published/CORE-000847/rule.yml
index a6b6ec014..5e5b671b8 100644
--- a/Published/CORE-000847/rule.yml
+++ b/Published/CORE-000847/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5121
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5121
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5121
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5121
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5121
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5121
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5121
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--SCAN'
+ - name: "--SCAN"
operator: exists
Core:
- Status: Published
- Version: '1'
Id: CORE-000847
-Description: '--SCAN must not be present in SEND dataset'
+ Status: Published
+ Version: "1"
+Description: "--SCAN must not be present in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--SCAN must not be present in SEND dataset'
+ Message: "--SCAN must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000848/rule.yml b/Published/CORE-000848/rule.yml
index 676fd6f48..a60279dd3 100644
--- a/Published/CORE-000848/rule.yml
+++ b/Published/CORE-000848/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5122
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5122
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5122
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5122
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5122
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5122
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5122
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '--SCONG'
+ - name: "--SCONG"
operator: exists
Core:
- Status: Published
- Version: '1'
Id: CORE-000848
-Description: '--SCONG (Congenital Anomaly or Birth Defect) must not be in SEND dataset'
+ Status: Published
+ Version: "1"
+Description: "--SCONG (Congenital Anomaly or Birth Defect) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: '--SCONG must not be present in SEND dataset'
+ Message: "--SCONG must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000849/rule.yml b/Published/CORE-000849/rule.yml
index 4cfd82434..7e4b85366 100644
--- a/Published/CORE-000849/rule.yml
+++ b/Published/CORE-000849/rule.yml
@@ -4,32 +4,30 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An instance of a class must not refer to itself as its next
- instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "An instance of a class must not refer to itself as its next instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00022'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00022"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An instance of a class must not refer to itself as its next
- instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "An instance of a class must not refer to itself as its next instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00022'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00022"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: nextId
operator: exists
- name: nextId
@@ -38,11 +36,11 @@ Check:
Core:
Id: CORE-000849
Status: Published
- Version: '1'
-Description: 'An instance of a class must not refer to itself as its next instance.'
+ Version: "1"
+Description: "An instance of a class must not refer to itself as its next instance."
Executability: Fully Executable
Outcome:
- Message: 'An instance of a class is referencing itself as its next instance.'
+ Message: "An instance of a class is referencing itself as its next instance."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000850/rule.yml b/Published/CORE-000850/rule.yml
index 1edb5281e..aacb4baa5 100644
--- a/Published/CORE-000850/rule.yml
+++ b/Published/CORE-000850/rule.yml
@@ -4,25 +4,24 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a transition start rule is defined then an end rule is
- expected and vice versa.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "If a transition start rule is defined then an end rule is expected and vice versa."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00078'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00078"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: is_contained_by
value:
- - 'Encounter'
- - 'StudyElement'
+ - "Encounter"
+ - "StudyElement"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- all:
- name: transitionStartRule
@@ -57,15 +56,13 @@ Check:
operator: equal_to
value: false
Core:
- Id: 'CORE-000850'
+ Id: "CORE-000850"
Status: Published
- Version: '1'
-Description: 'If a transition start rule is defined then an end rule is expected
- and vice versa.'
+ Version: "1"
+Description: "If a transition start rule is defined then an end rule is expected and vice versa."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'A transition start rule is defined but an end rule is missing, or vice
- versa.'
+ Message: "A transition start rule is defined but an end rule is missing, or vice versa."
Output Variables:
- parent_entity
- parent_id
@@ -82,6 +79,6 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Encounter'
- - 'StudyElement'
+ - "Encounter"
+ - "StudyElement"
Sensitivity: Record
diff --git a/Published/CORE-000851/rule.yml b/Published/CORE-000851/rule.yml
index ff0a4222a..51e28fb13 100644
--- a/Published/CORE-000851/rule.yml
+++ b/Published/CORE-000851/rule.yml
@@ -4,37 +4,35 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An instance of a class must not reference itself as one of its
- own children.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "An instance of a class must not reference itself as one of its own children."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00018'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00018"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An instance of a class must not reference itself as one of its
- own children.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "An instance of a class must not reference itself as one of its own children."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00018'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00018"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'reference'
+ value: "reference"
- name: childIds
operator: exists
- name: parent_rel
operator: equal_to
- value: 'childIds'
+ value: "childIds"
value_is_literal: true
- name: parent_id
operator: equal_to
@@ -42,11 +40,11 @@ Check:
Core:
Id: CORE-000851
Status: Published
- Version: '1'
-Description: 'An instance of a class must not reference itself as one of its own children.'
+ Version: "1"
+Description: "An instance of a class must not reference itself as one of its own children."
Executability: Fully Executable
Outcome:
- Message: 'An instance of a class is being referenced as one of its own children.'
+ Message: "An instance of a class is being referenced as one of its own children."
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000852/positive/01/data/se.csv b/Published/CORE-000852/positive/01/data/se.csv
index 20f436457..0be00fd50 100644
--- a/Published/CORE-000852/positive/01/data/se.csv
+++ b/Published/CORE-000852/positive/01/data/se.csv
@@ -1,2 +1,2 @@
-,STUDYID,DOMAIN,USUBJID,SESEQ,ETCD,ELEMENT,EPOCH,SESTDTC,SEENDTC,SESTDY,SEENDY
-,CDISCPILOT01,SE,CDISC001,1,SCREEN,Screening,SCREENING,2012-11-23,2012-11-30,-7,1
+STUDYID,DOMAIN,USUBJID,SESEQ,ETCD,ELEMENT,EPOCH,SESTDTC,SEENDTC,SESTDY,SEENDY
+CDISCPILOT01,SE,CDISC001,1,SCREEN,Screening,SCREENING,2012-11-23,2012-11-30,-7,1
diff --git a/Published/CORE-000852/rule.yml b/Published/CORE-000852/rule.yml
index 724cc0be2..8073c9984 100644
--- a/Published/CORE-000852/rule.yml
+++ b/Published/CORE-000852/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: Variables are ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables are ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.3.1, 2.2.4, and 2.2.5
Authorities:
- Organization: CDISC
@@ -7,196 +7,180 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Variables for the three general observation classes must be
- ordered with Identifiers first; followed by the Topic;
- Qualifier; and Timing variables. Within each role; variables
- must be ordered as shown in SDTM: Tables 2.2.1; 2.2.2; 2.2.3;
- 2.2.3.1; 2.2.4; and 2.2.5'
+ - Cited Guidance:
+ "Variables for the three general observation classes must be ordered with Identifiers
+ first; followed by the Topic; Qualifier; and Timing variables. Within each role; variables must
+ be ordered as shown in SDTM: Tables 2.2.1; 2.2.2; 2.2.3; 2.2.3.1; 2.2.4; and 2.2.5"
Document: IG v3.2
Section: 4.1.1.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0330
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Variables for the three general observation classes must be
- ordered with Identifiers first; followed by the Topic;
- Qualifier; and Timing variables. Within each role; variables
- must be ordered as shown in SDTM: Tables 2.2.1; 2.2.2; 2.2.3;
- 2.2.3.1; 2.2.4; and 2.2.5'
+ - Cited Guidance:
+ "Variables for the three general observation classes must be ordered with Identifiers
+ first; followed by the Topic; Qualifier; and Timing variables. Within each role; variables must
+ be ordered as shown in SDTM: Tables 2.2.1; 2.2.2; 2.2.3; 2.2.3.1; 2.2.4; and 2.2.5"
Document: IG v3.3
Section: 4.1.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0330
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Variables for the 3 general observation classes must be ordered
- with Identifiers variables first, followed by Topic,
- Qualifier, and Timing variables. Within each role, variables
- must be ordered as shown in SDTM Sections 3.1.1, The
- Interventions Observation Class; 3.1.2, The Events Observation
- Class; 3.1.3, The Findings Observation Class; 3.1.3.1,
- Findings About Events or Interventions; 3.1.4, Identifiers for
- All Classes; and 3.1.5, Timing Variables for All Classes.
+ - Cited Guidance: Variables for the 3 general observation classes must be ordered with
+ Identifiers variables first, followed by Topic, Qualifier, and Timing variables. Within
+ each role, variables must be ordered as shown in SDTM Sections 3.1.1, The Interventions
+ Observation Class; 3.1.2, The Events Observation Class; 3.1.3, The Findings Observation
+ Class; 3.1.3.1, Findings About Events or Interventions; 3.1.4, Identifiers for All
+ Classes; and 3.1.5, Timing Variables for All Classes.
Document: IG v3.4
Section: 4.1.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0664
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Dataset variables will be ordered per guidance in the SDTM Model
- v1.2. Variable order in TIG Domain Specifications aligns with
- variable order in the SDTM.
+ - Cited Guidance:
+ Dataset variables will be ordered per guidance in the SDTM Model v1.2.
+ Variable order in TIG Domain Specifications aligns with variable order in the SDTM.
Document: TIG 1.0
Item: Tabulation Datasets Num 3
- Section: '2.6'
+ Section: "2.6"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0698
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The order of variables in the data definition file should
- reflect the order of variables in the dataset. The order of
- variables in the SDTM domain models has been chosen to
- facilitate the review of the models and application of the
- models. Variables for the three general observation classes
- should be ordered with Identifiers first, followed by the
- Topic Qualifier, and Timing variables. Within each role,
- variables are ordered as shown in Tables 2.2.1-2.2.5 of the
- SDTM.
+ - Cited Guidance:
+ The order of variables in the data definition file should reflect the order
+ of variables in the dataset. The order of variables in the SDTM domain models has been
+ chosen to facilitate the review of the models and application of the models. Variables for
+ the three general observation classes should be ordered with Identifiers first, followed
+ by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as
+ shown in Tables 2.2.1-2.2.5 of the SDTM.
Document: SENDIG v3.0
Item: Text
Section: 4.1.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND48
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The order of variables in the data definition file should
- reflect the order of variables in the dataset. The order of
- variables in the SDTM domain models has been chosen to
- facilitate the review of the models and application of the
- models. Variables for the three general observation classes
- should be ordered with Identifiers first, followed by the
- Topic Qualifier, and Timing variables. Within each role,
- variables are ordered as shown in Tables 2.2.1-2.2.5 of the
- SDTM.
+ - Cited Guidance:
+ The order of variables in the data definition file should reflect the order
+ of variables in the dataset. The order of variables in the SDTM domain models has been
+ chosen to facilitate the review of the models and application of the models. Variables for
+ the three general observation classes should be ordered with Identifiers first, followed
+ by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as
+ shown in Tables 2.2.1-2.2.5 of the SDTM.
Document: SENDIG v3.1
Item: Text
Section: 4.1.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND48
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The order of variables in the data definition file should
- reflect the order of variables in the dataset. The order of
- variables in the SDTM domain models has been chosen to
- facilitate the review of the models and application of the
- models. Variables for the three general observation classes
- should be ordered with Identifiers first, followed by the
- Topic Qualifier, and Timing variables. Within each role,
- variables are ordered as shown in Tables 2.2.1-2.2.5 of the
- SDTM.
+ - Cited Guidance:
+ The order of variables in the data definition file should reflect the order
+ of variables in the dataset. The order of variables in the SDTM domain models has been
+ chosen to facilitate the review of the models and application of the models. Variables for
+ the three general observation classes should be ordered with Identifiers first, followed
+ by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as
+ shown in Tables 2.2.1-2.2.5 of the SDTM.
Document: SENDIG v3.1.1
Item: Text
Section: 4.1.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND48
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The order of variables in the data definition file should
- reflect the order of variables in the dataset. The order of
- variables in the SDTM domain models has been chosen to
- facilitate the review of the models and application of the
- models. Variables for the three general observation classes
- should be ordered with Identifiers first, followed by the
- Topic Qualifier, and Timing variables. Within each role,
- variables are ordered as shown in Tables 2.2.1-2.2.5 of the
- SDTM.
+ - Cited Guidance:
+ The order of variables in the data definition file should reflect the order
+ of variables in the dataset. The order of variables in the SDTM domain models has been
+ chosen to facilitate the review of the models and application of the models. Variables for
+ the three general observation classes should be ordered with Identifiers first, followed
+ by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as
+ shown in Tables 2.2.1-2.2.5 of the SDTM.
Document: SENDIG v3.1.1
Item: Text
Section: 4.1.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND48
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The order of variables in the data definition file should
- reflect the order of variables in the dataset. The order of
- variables in the SDTM domain models has been chosen to
- facilitate the review of the models and application of the
- models. Variables for the three general observation classes
- should be ordered with Identifiers first, followed by the
- Topic Qualifier, and Timing variables. Within each role,
- variables are ordered as shown in Tables 2.2.1-2.2.5 of the
- SDTM.
+ - Cited Guidance:
+ The order of variables in the data definition file should reflect the order
+ of variables in the dataset. The order of variables in the SDTM domain models has been
+ chosen to facilitate the review of the models and application of the models. Variables for
+ the three general observation classes should be ordered with Identifiers first, followed
+ by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as
+ shown in Tables 2.2.1-2.2.5 of the SDTM.
Document: SENDIG v3.1
Item: Text
Section: 4.1.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND48
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The order of variables in the data definition file should
- reflect the order of variables in the dataset. The order of
- variables in the SDTM domain models has been chosen to
- facilitate the review of the models and application of the
- models. Variables for the three general observation classes
- should be ordered with Identifiers first, followed by the
- Topic Qualifier, and Timing variables. Within each role,
- variables are ordered as shown in Tables 2.2.1-2.2.5 of the
- SDTM.
+ - Cited Guidance:
+ The order of variables in the data definition file should reflect the order
+ of variables in the dataset. The order of variables in the SDTM domain models has been
+ chosen to facilitate the review of the models and application of the models. Variables for
+ the three general observation classes should be ordered with Identifiers first, followed
+ by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as
+ shown in Tables 2.2.1-2.2.5 of the SDTM.
Document: SENDIG v3.1.1
Item: Text
Section: 4.1.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND48
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: $column_order_from_dataset
@@ -205,19 +189,19 @@ Check:
Core:
Id: CORE-000852
Status: Published
- Version: '1'
-Description: 'Raise an error when variables are not in the specified order'
+ Version: "1"
+Description: "Raise an error when variables are not in the specified order"
Executability: Fully Executable
Operations:
# variable order in CDISC-Library
- id: $column_order_from_library
- operator: get_column_order_from_library
- # variable order in dataset
+ operator:
+ get_column_order_from_library
+ # variable order in dataset
- id: $column_order_from_dataset
operator: get_column_order_from_dataset
Outcome:
- Message: Variables are not in the correct order as shown in SDTM for the
- observation class.
+ Message: Variables are not in the correct order as shown in SDTM for the observation class.
Output Variables:
- $column_order_from_dataset
- $column_order_from_library
diff --git a/Published/CORE-000853/rule.yml b/Published/CORE-000853/rule.yml
index ac2f65927..496fa58ea 100644
--- a/Published/CORE-000853/rule.yml
+++ b/Published/CORE-000853/rule.yml
@@ -1,136 +1,146 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1602
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1602
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1602
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1602
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1602
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1602
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1602
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1602
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1602
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: Collection study day should be populated when date/time of
- collection is available.
+ - Cited Guidance:
+ Collection study day should be populated when date/time of collection is
+ available.
Document: FDA
Section: FDAB016
Origin: FDA Business Rules
Rule Identifier:
Id: FB1602
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --DTC
@@ -146,17 +156,17 @@ Check:
Core:
Id: "CORE-000853"
Status: Published
- Version: '1'
-Description: Collection study day (--DY) should be populated when date/time of
- collection (--DTC) is populated
+ Version: "1"
+Description: Collection study day (--DY) should be populated when date/time of collection (--DTC) is
+ populated
Executability: Fully Executable
Match Datasets:
- Keys:
- USUBJID
Name: DM
Outcome:
- Message: Collection study day (--DY) is not populated when date/time of
- collection (--DTC) is populated.
+ Message: Collection study day (--DY) is not populated when date/time of collection (--DTC) is
+ populated.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000854/rule.yml b/Published/CORE-000854/rule.yml
index 02016ee23..4111edd65 100644
--- a/Published/CORE-000854/rule.yml
+++ b/Published/CORE-000854/rule.yml
@@ -4,32 +4,34 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An eligibility criterion''s category must be specified using
- the Category of Inclusion/Exclusion (C66797) SDTM codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An eligibility criterion's category must be specified using the Category of Inclusion/Exclusion
+ (C66797) SDTM codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00110'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00110"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An eligibility criterion''s category must be specified using
- the Category of Inclusion/Exclusion (C66797) SDTM codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An eligibility criterion's category must be specified using the Category of Inclusion/Exclusion
+ (C66797) SDTM codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00110'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00110"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: category
operator: equal_to
value: true
@@ -37,7 +39,7 @@ Check:
all:
- name: category.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: category.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -79,11 +81,12 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000854'
+ Id: "CORE-000854"
Status: Published
- Version: '1'
-Description: 'An eligibility criterion''s category must be specified using the
- Category of Inclusion/Exclusion (C66797) SDTM codelist.'
+ Version: "1"
+Description:
+ "An eligibility criterion's category must be specified using the Category of Inclusion/Exclusion
+ (C66797) SDTM codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -128,13 +131,12 @@ Operations:
term_value: category.decode
version: category.codeSystemVersion
Outcome:
- Message: 'The eligibility criterion''s category is not specified using the
- Category of Inclusion/Exclusion (C66797) SDTM codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, the code or decode (either as preferred term or as submission value)
- is found in the codelist (case insensitive) but the corresponding decode or
- code does not match the codelist value (case sensitive), and/or neither code
- nor decode is found in the codelist.'
+ Message:
+ 'The eligibility criterion''s category is not specified using the Category of Inclusion/Exclusion
+ (C66797) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
+ terminology package date, the code or decode (either as preferred term or as submission value) is
+ found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist
+ value (case sensitive), and/or neither code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -155,5 +157,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'EligibilityCriterion'
+ - "EligibilityCriterion"
Sensitivity: Record
diff --git a/Published/CORE-000855/rule.yml b/Published/CORE-000855/rule.yml
index 58c2240cd..2793f9126 100644
--- a/Published/CORE-000855/rule.yml
+++ b/Published/CORE-000855/rule.yml
@@ -4,32 +4,34 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study intervention''s type must be specified using the
- Intervention Type Response (C99078) SDTM codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study intervention's type must be specified using the Intervention Type Response
+ (C99078) SDTM codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00128'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00128"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study intervention''s type must be specified using the
- Intervention Type Response (C99078) SDTM codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study intervention's type must be specified using the Intervention Type Response
+ (C99078) SDTM codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00128'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00128"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type
operator: equal_to
value: true
@@ -37,7 +39,7 @@ Check:
all:
- name: type.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: type.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -79,11 +81,12 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000855'
+ Id: "CORE-000855"
Status: Published
- Version: '1'
-Description: 'A study intervention''s type must be specified using the
- Intervention Type Response (C99078) SDTM codelist.'
+ Version: "1"
+Description:
+ "A study intervention's type must be specified using the Intervention Type Response (C99078)
+ SDTM codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -128,13 +131,12 @@ Operations:
term_value: type.decode
version: type.codeSystemVersion
Outcome:
- Message: 'The study intervention''s type is not specified using the Intervention
- Type Response (C99078) SDTM codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, the code or decode (either as preferred term or as submission value)
- is found in the codelist (case insensitive) but the corresponding decode or
- code does not match the codelist value (case sensitive), and/or neither code
- nor decode is found in the codelist.'
+ Message:
+ 'The study intervention''s type is not specified using the Intervention Type Response (C99078)
+ SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
+ package date, the code or decode (either as preferred term or as submission value) is found in the
+ codelist (case insensitive) but the corresponding decode or code does not match the codelist value
+ (case sensitive), and/or neither code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -155,5 +157,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyIntervention'
+ - "StudyIntervention"
Sensitivity: Record
diff --git a/Published/CORE-000856/rule.yml b/Published/CORE-000856/rule.yml
index 5079e885d..ac99305d1 100644
--- a/Published/CORE-000856/rule.yml
+++ b/Published/CORE-000856/rule.yml
@@ -4,36 +4,36 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An encounter's contact modes must be specified according to the
- extensible Mode of Subject Contact (C171445) SDTM codelist
- (e.g. an entry with a code or decode used from the codelist
- should be consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An encounter's contact modes must be specified according to the extensible Mode
+ of Subject Contact (C171445) SDTM codelist (e.g. an entry with a code or decode used from the
+ codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00136'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00136"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An encounter's contact modes must be specified according to the
- extensible Mode of Subject Contact (C171445) SDTM codelist
- (e.g. an entry with a code or decode used from the codelist
- should be consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An encounter's contact modes must be specified according to the extensible Mode
+ of Subject Contact (C171445) SDTM codelist (e.g. an entry with a code or decode used from the
+ codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00136'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00136"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: contactModes
operator: exists
- name: contactModes
@@ -41,13 +41,13 @@ Check:
value: true
- name: parent_rel.Code
operator: equal_to
- value: 'contactModes'
+ value: "contactModes"
value_is_literal: true
- not:
all:
- name: codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -89,13 +89,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000856'
+ Id: "CORE-000856"
Status: Published
- Version: '1'
-Description: "An encounter's contact modes must be specified according to the
- extensible Mode of Subject Contact (C171445) SDTM codelist (e.g. an entry with
- a code or decode used from the codelist should be consistent with the full
- entry in the codelist)."
+ Version: "1"
+Description:
+ "An encounter's contact modes must be specified according to the extensible Mode of Subject
+ Contact (C171445) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be
+ consistent with the full entry in the codelist)."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -109,7 +109,7 @@ Operations:
- id: $codelist_code
map:
- output: C171445
- parent_rel.Code: 'contactModes'
+ parent_rel.Code: "contactModes"
operator: map
- ct_package_types:
- SDTM
@@ -149,13 +149,12 @@ Operations:
term_value: decode
version: codeSystemVersion
Outcome:
- Message: 'The encounter''s contact mode is not specified according to the
- extensible Mode of Subject Contact (C171445) SDTM codelist - codeSystem is
- not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
- package date, and/or the code or decode (either as preferred term or as
- submission value) is found in the codelist (case insensitive) but the
- corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The encounter''s contact mode is not specified according to the extensible Mode of Subject
+ Contact (C171445) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not
+ a valid terminology package date, and/or the code or decode (either as preferred term or as submission
+ value) is found in the codelist (case insensitive) but the corresponding decode or code does not match
+ the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -176,5 +175,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Encounter'
+ - "Encounter"
Sensitivity: Record
diff --git a/Published/CORE-000857/rule.yml b/Published/CORE-000857/rule.yml
index 46991f33b..0be98184b 100644
--- a/Published/CORE-000857/rule.yml
+++ b/Published/CORE-000857/rule.yml
@@ -4,44 +4,42 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A planned sex must be specified using the Sex of Participants
- (C66732) SDTM codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A planned sex must be specified using the Sex of Participants (C66732) SDTM codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00141'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00141"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A planned sex must be specified using the Sex of Participants
- (C66732) SDTM codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A planned sex must be specified using the Sex of Participants (C66732) SDTM codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00141'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00141"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: plannedSex
operator: equal_to
value: true
- name: parent_rel.Code
operator: equal_to
- value: 'plannedSex'
+ value: "plannedSex"
value_is_literal: true
- not:
all:
- name: codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -83,11 +81,10 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000857'
+ Id: "CORE-000857"
Status: Published
- Version: '1'
-Description: 'A planned sex must be specified using the Sex of Participants
- (C66732) SDTM codelist.'
+ Version: "1"
+Description: "A planned sex must be specified using the Sex of Participants (C66732) SDTM codelist."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -101,7 +98,7 @@ Operations:
- id: $codelist_code
map:
- output: C66732
- parent_rel.Code: 'plannedSex'
+ parent_rel.Code: "plannedSex"
operator: map
- ct_package_types:
- SDTM
@@ -141,13 +138,12 @@ Operations:
term_value: decode
version: codeSystemVersion
Outcome:
- Message: 'The planned sex is not specified using the Sex of Participants
- (C66732) SDTM codelist - codeSystem is not "http://www.cdisc.org",
- codeSystemVersion is not a valid terminology package date, the code or
- decode (either as preferred term or as submission value) is found in the
- codelist (case insensitive) but the corresponding decode or code does not
- match the codelist value (case sensitive), and/or neither code nor decode is
- found in the codelist.'
+ Message:
+ 'The planned sex is not specified using the Sex of Participants (C66732) SDTM codelist - codeSystem
+ is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code
+ or decode (either as preferred term or as submission value) is found in the codelist (case insensitive)
+ but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither
+ code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -168,6 +164,6 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyDesignPopulation'
- - 'StudyCohort'
+ - "StudyDesignPopulation"
+ - "StudyCohort"
Sensitivity: Record
diff --git a/Published/CORE-000858/rule.yml b/Published/CORE-000858/rule.yml
index a20c45af9..5c6c78f35 100644
--- a/Published/CORE-000858/rule.yml
+++ b/Published/CORE-000858/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An encounter's environmental settings must be specified
- according to the extensible Environmental Setting (C127262)
- SDTM codelist (e.g. an entry with a code or decode used from
- the codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An encounter's environmental settings must be specified according to the extensible
+ Environmental Setting (C127262) SDTM codelist (e.g. an entry with a code or decode used from
+ the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00157'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00157"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: environmentalSettings
operator: exists
- name: environmentalSettings
@@ -28,13 +27,13 @@ Check:
value: true
- name: parent_rel.Code
operator: equal_to
- value: 'environmentalSettings'
+ value: "environmentalSettings"
value_is_literal: true
- not:
all:
- name: codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -76,13 +75,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000858'
+ Id: "CORE-000858"
Status: Published
- Version: '1'
-Description: "An encounter's environmental settings must be specified according
- to the extensible Environmental Setting (C127262) SDTM codelist (e.g. an entry
- with a code or decode used from the codelist should be consistent with the
- full entry in the codelist)."
+ Version: "1"
+Description:
+ "An encounter's environmental settings must be specified according to the extensible Environmental
+ Setting (C127262) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be
+ consistent with the full entry in the codelist)."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -96,7 +95,7 @@ Operations:
- id: $codelist_code
map:
- output: C127262
- parent_rel.Code: 'environmentalSettings'
+ parent_rel.Code: "environmentalSettings"
operator: map
- ct_package_types:
- SDTM
@@ -136,12 +135,11 @@ Operations:
term_value: decode
version: codeSystemVersion
Outcome:
- Message: 'The encounter''s environmental setting is not specified according to
- the extensible Environmental Setting (C127262) SDTM codelist - codeSystem is
- not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
- package date, and/or the code or decode is found in the codelist (case
- insensitive) but the corresponding decode or code does not match the
- codelist value (case sensitive).'
+ Message:
+ 'The encounter''s environmental setting is not specified according to the extensible Environmental
+ Setting (C127262) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not
+ a valid terminology package date, and/or the code or decode is found in the codelist (case insensitive)
+ but the corresponding decode or code does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -162,5 +160,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Encounter'
+ - "Encounter"
Sensitivity: Record
diff --git a/Published/CORE-000859/rule.yml b/Published/CORE-000859/rule.yml
index c2438b434..d05e086a3 100644
--- a/Published/CORE-000859/rule.yml
+++ b/Published/CORE-000859/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An administration's frequency must be specified according to
- the extensible Frequency (C71113) SDTM codelist (e.g. an entry
- with a code or decode used from the codelist should be
+ - Cited Guidance:
+ "An administration's frequency must be specified according to the extensible Frequency
+ (C71113) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be
consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00175'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00175"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: frequency.standardCode
operator: exists
- name: frequency.standardCode
@@ -29,7 +29,7 @@ Check:
all:
- name: frequency.standardCode.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: frequency.standardCode.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -71,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000859'
+ Id: "CORE-000859"
Status: Published
- Version: '1'
-Description: "An administration's frequency must be specified according to the
- extensible Frequency (C71113) SDTM codelist (e.g. an entry with a code or
- decode used from the codelist should be consistent with the full entry in the
- codelist)."
+ Version: "1"
+Description:
+ "An administration's frequency must be specified according to the extensible Frequency (C71113)
+ SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with
+ the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -122,12 +122,11 @@ Operations:
term_value: frequency.standardCode.decode
version: frequency.standardCode.codeSystemVersion
Outcome:
- Message: 'The administration''s frequency is not specified according to the
- extensible Frequency (C71113) SDTM codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, and/or the code or decode is found in the codelist (case insensitive)
- but the corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The administration''s frequency is not specified according to the extensible Frequency (C71113)
+ SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
+ package date, and/or the code or decode is found in the codelist (case insensitive) but the corresponding
+ decode or code does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -148,5 +147,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Administration'
+ - "Administration"
Sensitivity: Record
diff --git a/Published/CORE-000860/rule.yml b/Published/CORE-000860/rule.yml
index bfd87b9d5..df7174a34 100644
--- a/Published/CORE-000860/rule.yml
+++ b/Published/CORE-000860/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An administration's route must be specified according to the
- extensible Route of Administration Response (C66729) SDTM
- codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An administration's route must be specified according to the extensible Route
+ of Administration Response (C66729) SDTM codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00176'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00176"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: route.standardCode
operator: exists
- name: route.standardCode
@@ -30,7 +29,7 @@ Check:
all:
- name: route.standardCode.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: route.standardCode.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000860'
+ Id: "CORE-000860"
Status: Published
- Version: '1'
-Description: "An administration's route must be specified according to the
- extensible Route of Administration Response (C66729) SDTM codelist (e.g. an
- entry with a code or decode used from the codelist should be consistent with
- the full entry in the codelist)."
+ Version: "1"
+Description:
+ "An administration's route must be specified according to the extensible Route of Administration
+ Response (C66729) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be
+ consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +122,12 @@ Operations:
term_value: route.standardCode.decode
version: route.standardCode.codeSystemVersion
Outcome:
- Message: 'The administration''s route is not specified according to the
- extensible Route of Administration Response (C66729) SDTM codelist -
- codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
- terminology package date, and/or the code or decode (either as preferred
- term or as submission value) is found in the codelist (case insensitive) but
- the corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The administration''s route is not specified according to the extensible Route of Administration
+ Response (C66729) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not
+ a valid terminology package date, and/or the code or decode (either as preferred term or as submission
+ value) is found in the codelist (case insensitive) but the corresponding decode or code does not match
+ the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Administration'
+ - "Administration"
Sensitivity: Record
diff --git a/Published/CORE-000861/rule.yml b/Published/CORE-000861/rule.yml
index 663fbabeb..c2dca3df8 100644
--- a/Published/CORE-000861/rule.yml
+++ b/Published/CORE-000861/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An administrable dose form must be specified according to the
- extensible Pharmaceutical Dosage Form (C66726) SDTM codelist
- (e.g. an entry with a code or decode used from the codelist
+ - Cited Guidance:
+ "An administrable dose form must be specified according to the extensible Pharmaceutical
+ Dosage Form (C66726) SDTM codelist (e.g. an entry with a code or decode used from the codelist
should be consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00179'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00179"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: administrableDoseForm.standardCode
operator: exists
- name: administrableDoseForm.standardCode
@@ -29,7 +29,7 @@ Check:
all:
- name: administrableDoseForm.standardCode.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: administrableDoseForm.standardCode.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +72,13 @@ Check:
value: $value_for_code
Core:
- Id: 'CORE-000861'
+ Id: "CORE-000861"
Status: Published
- Version: '1'
-Description: "An administrable dose form must be specified according to the
- extensible Pharmaceutical Dosage Form (C66726) SDTM codelist (e.g. an entry
- with a code or decode used from the codelist should be consistent with the
- full entry in the codelist)."
+ Version: "1"
+Description:
+ "An administrable dose form must be specified according to the extensible Pharmaceutical
+ Dosage Form (C66726) SDTM codelist (e.g. an entry with a code or decode used from the codelist should
+ be consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +123,12 @@ Operations:
term_value: administrableDoseForm.standardCode.decode
version: administrableDoseForm.standardCode.codeSystemVersion
Outcome:
- Message: 'The administrable dose form is not specified according to the
- extensible Pharmaceutical Dosage Form (C66726) SDTM codelist - codeSystem is
- not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
- package date, and/or the code or decode (either as preferred term or as
- submission value) is found in the codelist (case insensitive) but the
- corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The administrable dose form is not specified according to the extensible Pharmaceutical Dosage
+ Form (C66726) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a
+ valid terminology package date, and/or the code or decode (either as preferred term or as submission
+ value) is found in the codelist (case insensitive) but the corresponding decode or code does not match
+ the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +149,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'AdministrableProduct'
+ - "AdministrableProduct"
Sensitivity: Record
diff --git a/Published/CORE-000862/rule.yml b/Published/CORE-000862/rule.yml
index 9b0bf4211..f715d5a84 100644
--- a/Published/CORE-000862/rule.yml
+++ b/Published/CORE-000862/rule.yml
@@ -4,143 +4,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3205
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3205
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3205
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3205
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3205
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3205
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3205
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3205
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3205
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3205
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --STDY
@@ -150,14 +150,13 @@ Check:
Core:
Id: CORE-000862
Status: Published
- Version: '1'
-Description: When Study Day of Start of Observation (--STDY) is present in the
- dataset, then the Start Date/Time of Observation (--STDTC) is also present in
- the dataset.
+ Version: "1"
+Description: When Study Day of Start of Observation (--STDY) is present in the dataset, then the
+ Start Date/Time of Observation (--STDTC) is also present in the dataset.
Executability: Fully Executable
Outcome:
- Message: Start Date/Time of Observation (--STDTC) variable is missing when Study
- Day of Start of Observation (--STDY) is present.
+ Message: Start Date/Time of Observation (--STDTC) variable is missing when Study Day of Start of
+ Observation (--STDY) is present.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000863/rule.yml b/Published/CORE-000863/rule.yml
index c93178476..354f44aa3 100644
--- a/Published/CORE-000863/rule.yml
+++ b/Published/CORE-000863/rule.yml
@@ -1,136 +1,126 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3101'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB3101"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3101'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB3101"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3101'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB3101"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3101'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB3101"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3101'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB3101"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3101'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3101"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3101'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3101"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3101'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB3101"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3101'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB3101"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'Standardized Result in Numeric Format should be populated
- whenever it is applicable.'
- Document: 'FDA'
- Section: 'FDAB031'
+ - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable."
+ Document: "FDA"
+ Section: "FDAB031"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3101'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB3101"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --STRESC
@@ -143,7 +133,7 @@ Check:
Core:
Id: CORE-000863
Status: Published
- Version: '1'
+ Version: "1"
Description: When --STRESC is populated with a numeric value, --STRESN should be populated.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000864/rule.yml b/Published/CORE-000864/rule.yml
index 9458f858d..3aaee0d30 100644
--- a/Published/CORE-000864/rule.yml
+++ b/Published/CORE-000864/rule.yml
@@ -4,143 +4,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3206
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3206
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3206
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3206
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3206
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3206
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
Version: 3.1.1
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3206
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3206
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3206
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3206
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --ENDY
@@ -150,14 +150,13 @@ Check:
Core:
Id: CORE-000864
Status: Published
- Version: '1'
-Description: When Study Day of End of Observation (--ENDY) is present in the
- dataset, then the End Date/Time of Observation (--ENDTC) is also present in
- the dataset
+ Version: "1"
+Description: When Study Day of End of Observation (--ENDY) is present in the dataset, then the End
+ Date/Time of Observation (--ENDTC) is also present in the dataset
Executability: Fully Executable
Outcome:
- Message: End Date/Time of Observation (--ENDTC) variable is missing when Study
- Day of End of Observation (--ENDY) is present.
+ Message: End Date/Time of Observation (--ENDTC) variable is missing when Study Day of End of
+ Observation (--ENDY) is present.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000865/negative/01/data/lb.csv b/Published/CORE-000865/negative/01/data/lb.csv
index 51b9f0808..804ba04c2 100644
--- a/Published/CORE-000865/negative/01/data/lb.csv
+++ b/Published/CORE-000865/negative/01/data/lb.csv
@@ -2,4 +2,4 @@ STUDYID,DOMAIN,USUBJID,LBSEQ,LBTESTCD,LBTEST,LBCAT,LBORRES,LBORRESU,LBORNRLO,LBO
CDISCPILOT01,LB,CDISC001,1,ALB,Albumin,CHEMISTRY,3.9,g/dL,3.5,4.6,39,39,g/L,35,46,NORMAL,,,Y,1,SCREENING 1,SCREENING,2012-11-23T11:20,-7,,3,TP1,1,PT05M,PT08M,Day 1 dose,PT05M
CDISCPILOT01,LB,CDISC001,2,ALP,Alkaline Phosphatase,CHEMISTRY,93,U/L,35,115,93,93,U/L,35,115,NORMAL,,,Y,1,SCREENING 1,SCREENING,2012-11-23T11:20,-7,,2,TP2,2,PT05M,PT08M,,PT05M
CDISCPILOT01,LB,CDISC002,3,ALP,Alkaline Phosphatase,CHEMISTRY,93,U/L,35,115,93,93,U/L,35,115,NORMAL,,,Y,1,SCREENING 1,SCREENING,2012-11-23T11:20,-7,,Grade II,TP3,3,PT05M,PT08M,Day 1 dose,PT05M
-CDISCPILOT01,LB,CDISC002,4,ALP,Alkaline Phosphatase,CHEMISTRY,,,,,,,,,,,NOT DONE,sample broken,,1,SCREENING 1,SCREENING,2012-11-23T17:21,-7,,,TP1,1,PT05M,PT08M,Day 1 dose,
+CDISCPILOT01,LB,CDISC002,4,ALP,Alkaline Phosphatase,CHEMISTRY,,,,,,,,,,,NOT DONE,sample broken,,1,SCREENING 1,SCREENING,2012-11-23T17:21,-7,,,TP1,1,PT05M,PT08M,,
diff --git a/Published/CORE-000865/positive/01/data/_datasets.csv b/Published/CORE-000865/positive/01/data/_datasets.csv
new file mode 100644
index 000000000..f54881356
--- /dev/null
+++ b/Published/CORE-000865/positive/01/data/_datasets.csv
@@ -0,0 +1,3 @@
+Filename,Label
+lb,Laboratory Test Results
+pp,Pharmacokinetics Parameters
diff --git a/Published/CORE-000865/positive/01/data/_variables.csv b/Published/CORE-000865/positive/01/data/_variables.csv
new file mode 100644
index 000000000..39379eec4
--- /dev/null
+++ b/Published/CORE-000865/positive/01/data/_variables.csv
@@ -0,0 +1,42 @@
+dataset,variable,label,type,length
+lb,STUDYID,Study Identifier,Char,12
+lb,DOMAIN,Domain Abbreviation,Char,2
+lb,USUBJID,Unique Subject Identifier,Char,8
+lb,LBSEQ,Sequence Number,Num,8
+lb,LBTESTCD,Lab Test or Examination Short Name,Char,7
+lb,LBTEST,Lab Test or Examination Name,Char,39
+lb,LBCAT,Category for Lab Test,Char,10
+lb,LBORRES,Result or Finding in Original Units,Char,6
+lb,LBORRESU,Original Units,Char,7
+lb,LBORNRLO,Reference Range Lower Limit in Orig Unit,Char,200
+lb,LBORNRHI,Reference Range Upper Limit in Orig Unit,Char,200
+lb,LBSTRESC,Character Result/Finding in Std Format,Char,8
+lb,LBSTRESN,Numeric Result/Finding in Standard Units,Num,8
+lb,LBSTRESU,Standard Units,Char,7
+lb,LBSTNRLO,Reference Range Lower Limit-Std Units,Num,8
+lb,LBSTNRHI,Reference Range Upper Limit-Std Units,Num,8
+lb,LBNRIND,Reference Range Indicator,Char,8
+lb,LBSTAT,Completion Status,Char,8
+lb,LBREASND,Reason Not Done,Char,50
+lb,LBLOBXFL,Last Observation Before Exposure Flag,Char,1
+lb,VISITNUM,Visit Number,Num,8
+lb,VISIT,Visit Name,Char,200
+lb,EPOCH,Epoch,Char,9
+lb,LBDTC,Date/Time of Specimen Collection,Char,19
+lb,LBDY,Study Day of Specimen Collection,Num,8
+lb,LBTOX,Toxicity,Char,50
+lb,LBTOXGR,Standard Toxicity Grade,Char,50
+lb,LBTPT,Planned Time Point Name ,Char,50
+lb,LBTPTNUM,Planned Time Point Number,Num,8
+lb,LBSTINT,Planned Start of Assessment Interval ,Char,20
+lb,LBENINT,Planned End of Assessment Interval ,Char,20
+lb,LBTPTREF,Time Point Reference,Char,100
+lb,LBELTM,Planned Elapsed Time from Time Point Ref,char,30
+pp,STUDYID,Study Identifier,Char,12
+pp,DOMAIN,Domain Abbreviation,Char,2
+pp,USUBJID,Unique Subject Identifier,Char,8
+pp,PPSEQ,Sequence Number,Num,8
+pp,PPTESTCD,Parameter Short Name ,Char,7
+pp,PPTEST,Parameter Name ,Char,39
+pp,PPSPEC,Specimen Material Type ,Char,200
+pp,PPTPTREF,Time Point Reference,Char,20
diff --git a/Published/CORE-000865/positive/01/data/lb.csv b/Published/CORE-000865/positive/01/data/lb.csv
new file mode 100644
index 000000000..3045afe3d
--- /dev/null
+++ b/Published/CORE-000865/positive/01/data/lb.csv
@@ -0,0 +1,5 @@
+STUDYID,DOMAIN,USUBJID,LBSEQ,LBTESTCD,LBTEST,LBCAT,LBORRES,LBORRESU,LBORNRLO,LBORNRHI,LBSTRESC,LBSTRESN,LBSTRESU,LBSTNRLO,LBSTNRHI,LBNRIND,LBSTAT,LBREASND,LBLOBXFL,VISITNUM,VISIT,EPOCH,LBDTC,LBDY,LBTOX,LBTOXGR,LBTPT,LBTPTNUM,LBSTINT,LBENINT,LBTPTREF,LBELTM
+CDISCPILOT01,LB,CDISC001,1,ALB,Albumin,CHEMISTRY,3.9,g/dL,3.5,4.6,39,39,g/L,35,46,NORMAL,,,Y,1,SCREENING 1,SCREENING,2012-11-23T11:20,-7,,3,TP1,1,PT05M,PT08M,Day 1 dose,PT05M
+CDISCPILOT01,LB,CDISC001,2,ALP,Alkaline Phosphatase,CHEMISTRY,93,U/L,35,115,93,93,U/L,35,115,NORMAL,,,Y,1,SCREENING 1,SCREENING,2012-11-23T11:20,-7,,2,TP2,2,PT05M,PT08M,Day 1 dose,PT05M
+CDISCPILOT01,LB,CDISC002,2,ALP,Alkaline Phosphatase,CHEMISTRY,93,U/L,35,115,93,93,U/L,35,115,NORMAL,,,Y,1,SCREENING 1,SCREENING,2012-11-23T11:20,-7,,Grade II,TP3,3,PT05M,PT08M,Day 1 dose,PT05M
+CDISCPILOT01,LB,CDISC002,2,ALP,Alkaline Phosphatase,CHEMISTRY,,,,,,,,,,,NOT DONE,sample broken,,1,SCREENING 1,SCREENING,2012-11-23T17:21,-7,,,TP1,1,PT05M,PT08M,Day 1 dose,PT05M
diff --git a/Published/CORE-000865/positive/01/data/pp.csv b/Published/CORE-000865/positive/01/data/pp.csv
new file mode 100644
index 000000000..974413e30
--- /dev/null
+++ b/Published/CORE-000865/positive/01/data/pp.csv
@@ -0,0 +1,5 @@
+STUDYID,DOMAIN,USUBJID,PPSEQ,PPTESTCD,PPTEST,PPSPEC,PPTPTREF
+CDISCPILOT01,PP,CDISC001,1,TMAX,Time of CMAX ,ABDOMINAL WALL,Day 1 dose
+CDISCPILOT01,PP,CDISC001,2,,,"ADIPOSE TISSUE, BROWN",Day 1 dose
+CDISCPILOT01,PP,CDISC001,3,,,"ABDOMINAL WALL;ADIPOSE TISSUE, BROWN",Day 1 dose
+CDISCPILOT01,PP,CDISC001,4,,,"ABDOMINAL WALL;ADIPOSE TISSUE, BROWN;AIR SAC",Day 1 dose
diff --git a/Published/CORE-000865/rule.yml b/Published/CORE-000865/rule.yml
index 27a67e54a..f976bb838 100644
--- a/Published/CORE-000865/rule.yml
+++ b/Published/CORE-000865/rule.yml
@@ -1,159 +1,171 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
# Applicable to SDTMIG versions 3.2, 3.3, 3.4
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4405'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB4405"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4405'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB4405"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4405'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB4405"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4405'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB4405"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4405'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB4405"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4405'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4405"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4405'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4405"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4405'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB4405"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4405'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB4405"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'When timing info is provided as a reference to a particular
- timepoint, the timepoint should be also populated.'
- Document: 'FDA'
- Section: 'FDAB044'
+ - Cited Guidance:
+ "When timing info is provided as a reference to a particular timepoint, the timepoint
+ should be also populated."
+ Document: "FDA"
+ Section: "FDAB044"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4405'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB4405"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
# REMARK: --TPTNUM and --ELTM both are usually "permissible"
all:
- - name: '--TPTREF'
+ - name: "--TPTREF"
operator: exists
- - name: '--ELTM'
- operator: exists
- #- name: '--TPTREF'
- # operator: 'non_empty'
- #- name: '--ELTM'
- # operator: 'empty'
- # Correction 2025-09-05
- - name: '--ELTM'
- operator: 'non_empty'
- - name: '--TPTREF'
- operator: 'empty'
+ - name: "--ELTM"
+ operator:
+ exists
+ #- name: '--TPTREF'
+ # operator: 'non_empty'
+ #- name: '--ELTM'
+ # operator: 'empty'
+ # Correction 2025-09-05
+ - name: "--ELTM"
+ operator: "non_empty"
+ - name: "--TPTREF"
+ operator: "empty"
Core:
Id: CORE-000865
Status: Published
- Version: '1'
-Description: 'When Planned Elapsed Time from Time Point Ref (--ELTM) is
- populated, Time Point Reference (--TPTREF) should also be populated.'
+ Version: "1"
+Description:
+ "When Planned Elapsed Time from Time Point Ref (--ELTM) is populated, Time Point Reference
+ (--TPTREF) should also be populated."
Executability: Fully Executable
Outcome:
Message: --ELTM is populated, but --TPTREF is missing.
diff --git a/Published/CORE-000866/rule.yml b/Published/CORE-000866/rule.yml
index afcbf7c01..eb7ea9aec 100644
--- a/Published/CORE-000866/rule.yml
+++ b/Published/CORE-000866/rule.yml
@@ -7,143 +7,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3210
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3210
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3210
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3210
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3210
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3210
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3210
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3210
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3210
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3210
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --DTC
@@ -155,14 +155,14 @@ Check:
- name: --ENDTC
operator: non_empty
- name: --DTC
- operator: date_greater_than
+ operator: date_greater_than_or_equal_to
value: --ENDTC
Core:
Id: CORE-000866
Status: Published
- Version: '1'
-Description: Date/Time of Collection (--DTC) should be prior or equal to the End
- Date/Time of Observation (--ENDTC)
+ Version: "1"
+Description: Date/Time of Collection (--DTC) should be prior or equal to the End Date/Time of
+ Observation (--ENDTC)
Executability: Fully Executable
Outcome:
Message: --DTC falls after --ENDTC.
diff --git a/Published/CORE-000867/rule.yml b/Published/CORE-000867/rule.yml
index 9b9b69cff..b0f4d2f0b 100644
--- a/Published/CORE-000867/rule.yml
+++ b/Published/CORE-000867/rule.yml
@@ -1,136 +1,126 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1501'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB1501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1501'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB1501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1501'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB1501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1501'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB1501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1501'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB1501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1501'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB1501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1501'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB1501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1501'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB1501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1501'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB1501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1501'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB1501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: variable_data_type
@@ -142,7 +132,7 @@ Check:
Core:
Id: CORE-000867
Status: Published
- Version: '1'
+ Version: "1"
Description: Text variable in submitted dataset should not contain leading spaces ' '.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000868/rule.yml b/Published/CORE-000868/rule.yml
index ed27dfc55..b5c72994d 100644
--- a/Published/CORE-000868/rule.yml
+++ b/Published/CORE-000868/rule.yml
@@ -4,39 +4,39 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Each schedule timeline must contain at least one anchor (fixed
- time) - i.e., at least one scheduled activity instance that is
- referenced by a Fixed Reference timing.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Each schedule timeline must contain at least one anchor (fixed time) - i.e.,
+ at least one scheduled activity instance that is referenced by a Fixed Reference timing."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00009'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00009"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Organization: CDISC
Standards:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Each schedule timeline must contain at least one anchor (fixed
- time) - i.e., at least one scheduled activity instance that is
- referenced by a Fixed Reference timing.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Each schedule timeline must contain at least one anchor (fixed time) - i.e.,
+ at least one scheduled activity instance that is referenced by a Fixed Reference timing."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00009'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00009"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'ScheduleTimeline'
+ value: "ScheduleTimeline"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: $fixed_ref_sched_ins
operator: empty
@@ -46,18 +46,18 @@ Check:
operator: shares_no_elements_with
value: $instances
Core:
- Id: 'CORE-000868'
+ Id: "CORE-000868"
Status: Published
- Version: '1'
-Description: 'Each schedule timeline must contain at least one anchor (fixed
- time) - i.e., at least one scheduled activity instance that is referenced by a
- Fixed Reference timing.'
+ Version: "1"
+Description:
+ "Each schedule timeline must contain at least one anchor (fixed time) - i.e., at least one
+ scheduled activity instance that is referenced by a Fixed Reference timing."
Executability: Fully Executable
Operations:
- domain: Timing
filter:
- rel_type: 'definition'
- type.code: 'C201358'
+ rel_type: "definition"
+ type.code: "C201358"
group:
- parent_id
group_aliases:
@@ -67,7 +67,7 @@ Operations:
operator: distinct
- domain: ScheduledActivityInstance
filter:
- rel_type: 'definition'
+ rel_type: "definition"
group:
- parent_id
group_aliases:
@@ -76,8 +76,9 @@ Operations:
name: id
operator: distinct
Outcome:
- Message: 'The schedule timeline does not contain an anchor (i.e., a scheduled
- activity instance that is referenced by a Fixed Reference timing).'
+ Message:
+ "The schedule timeline does not contain an anchor (i.e., a scheduled activity instance that
+ is referenced by a Fixed Reference timing)."
Output Variables:
- parent_entity
- parent_id
@@ -88,5 +89,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ScheduleTimeline'
+ - "ScheduleTimeline"
Sensitivity: Record
diff --git a/Published/CORE-000869/rule.yml b/Published/CORE-000869/rule.yml
index 237a44a4a..791a7bb5f 100644
--- a/Published/CORE-000869/rule.yml
+++ b/Published/CORE-000869/rule.yml
@@ -4,21 +4,21 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If duration will vary (attribute durationWillVary is True) then
- a reason (attribute reasonDurationWillVary) must be given and
- vice versa.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If duration will vary (attribute durationWillVary is True) then a reason (attribute
+ reasonDurationWillVary) must be given and vice versa."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00034'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00034"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Duration'
+ value: "Duration"
- any:
- name: durationWillVary
operator: not_equal_to
@@ -37,16 +37,17 @@ Check:
- name: reasonDurationWillVary
operator: empty
Core:
- Id: 'CORE-000869'
+ Id: "CORE-000869"
Status: Published
- Version: '1'
-Description: 'If duration will vary (attribute durationWillVary is True) then a
- reason (attribute reasonDurationWillVary) must be given and vice versa.'
+ Version: "1"
+Description:
+ "If duration will vary (attribute durationWillVary is True) then a reason (attribute reasonDurationWillVary)
+ must be given and vice versa."
Executability: Fully Executable
Outcome:
- Message: The duration will vary (durationWillVary is not 'false' or
- reasonDurationWillVary is populated), but it is not fully defined
- (durationWillVary is not 'true' or reasonDurationWillVary is missing).
+ Message: The duration will vary (durationWillVary is not 'false' or reasonDurationWillVary is
+ populated), but it is not fully defined (durationWillVary is not 'true' or
+ reasonDurationWillVary is missing).
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000870/rule.yml b/Published/CORE-000870/rule.yml
index 14712162d..d4dc73a87 100644
--- a/Published/CORE-000870/rule.yml
+++ b/Published/CORE-000870/rule.yml
@@ -4,32 +4,34 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'All scheduled activity instances in the main timeline are
- expected to refer to an epoch.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "All scheduled activity instances in the main timeline are expected to refer to
+ an epoch."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00080'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00080"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'All scheduled activity instances in the main timeline are
- expected to refer to an epoch.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "All scheduled activity instances in the main timeline are expected to refer to
+ an epoch."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00080'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00080"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: mainTimeline
operator: equal_to
value: true
@@ -39,11 +41,10 @@ Check:
- name: epochId
operator: empty
Core:
- Id: 'CORE-000870'
+ Id: "CORE-000870"
Status: Published
- Version: '1'
-Description: 'All scheduled activity instances in the main timeline are expected
- to refer to an epoch.'
+ Version: "1"
+Description: "All scheduled activity instances in the main timeline are expected to refer to an epoch."
Executability: Partially Executable - Possible Overreporting
Match Datasets:
- Keys:
@@ -54,8 +55,7 @@ Match Datasets:
- rel_type
Name: ScheduleTimeline
Outcome:
- Message: 'The scheduled activity instance is in the main timeline but does not
- refer to an epoch.'
+ Message: "The scheduled activity instance is in the main timeline but does not refer to an epoch."
Output Variables:
- parent_entity
- parent_id
@@ -68,5 +68,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ScheduledActivityInstance'
+ - "ScheduledActivityInstance"
Sensitivity: Record
diff --git a/Published/CORE-000871/rule.yml b/Published/CORE-000871/rule.yml
index 18c778d5b..4d9f0f593 100644
--- a/Published/CORE-000871/rule.yml
+++ b/Published/CORE-000871/rule.yml
@@ -4,32 +4,34 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "Within a study design there is expected to be exactly one
- objective with level 'Primary Objective'."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study design there is expected to be exactly one objective with level
+ 'Primary Objective'."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00084'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00084"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: "Within a study design there is expected to be exactly one
- objective with level 'Primary Objective'."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study design there is expected to be exactly one objective with level
+ 'Primary Objective'."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00084'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00084"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- not:
all:
- name: $num_primary_obj
@@ -38,17 +40,18 @@ Check:
operator: equal_to
value: 1
Core:
- Id: 'CORE-000871'
+ Id: "CORE-000871"
Status: Published
- Version: '1'
-Description: "Within a study design there is expected to be exactly one
- objective with level 'Primary Objective'."
+ Version: "1"
+Description:
+ "Within a study design there is expected to be exactly one objective with level 'Primary
+ Objective'."
Executability: Partially Executable - Possible Overreporting
Operations:
- domain: Objective
filter:
- level.code: 'C85826'
- rel_type: 'definition'
+ level.code: "C85826"
+ rel_type: "definition"
group:
- parent_id
- rel_type
@@ -58,8 +61,8 @@ Operations:
operator: record_count
- domain: Objective
filter:
- level.code: 'C85826'
- rel_type: 'definition'
+ level.code: "C85826"
+ rel_type: "definition"
group:
- parent_id
- rel_type
@@ -69,8 +72,7 @@ Operations:
name: text
operator: distinct
Outcome:
- Message: "There is not exactly one objective with a level of 'Primary Objective'
- within the study design."
+ Message: "There is not exactly one objective with a level of 'Primary Objective' within the study design."
Output Variables:
- parent_entity
- parent_id
@@ -83,7 +85,7 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyDesign'
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "StudyDesign"
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000872/rule.yml b/Published/CORE-000872/rule.yml
index 21b8fffde..9bfefba5d 100644
--- a/Published/CORE-000872/rule.yml
+++ b/Published/CORE-000872/rule.yml
@@ -4,24 +4,24 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Date values associated to a study protocol document version
- must be unique regarding the combination of type and
- geographic scopes of the date.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Date values associated to a study protocol document version must be unique regarding
+ the combination of type and geographic scopes of the date."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00092'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00092"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyProtocolDocumentVersion'
+ value: "StudyProtocolDocumentVersion"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- all:
- name: code.standardCode.code
@@ -41,12 +41,12 @@ Check:
- type.code
- type.code.GeographicScope
Core:
- Id: 'CORE-000872'
+ Id: "CORE-000872"
Status: Published
- Version: '1'
-Description: 'Date values associated to a study protocol document version must
- be unique regarding the combination of type and geographic scopes of the
- date.'
+ Version: "1"
+Description:
+ "Date values associated to a study protocol document version must be unique regarding the
+ combination of type and geographic scopes of the date."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -60,8 +60,9 @@ Match Datasets:
- rel_type
Name: GeographicScope
Outcome:
- Message: 'The study protocol document version has more than one governance date
- with the same type and geographic scope.'
+ Message:
+ "The study protocol document version has more than one governance date with the same type and
+ geographic scope."
Output Variables:
- parent_entity
- parent_id
@@ -81,5 +82,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyProtocolDocumentVersion'
+ - "StudyProtocolDocumentVersion"
Sensitivity: Record
diff --git a/Published/CORE-000873/rule.yml b/Published/CORE-000873/rule.yml
index be4b9afe4..e0a3535c4 100644
--- a/Published/CORE-000873/rule.yml
+++ b/Published/CORE-000873/rule.yml
@@ -4,37 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Date values associated to a study version must be unique
- regarding the combination of type and geographic scopes of the
- date.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Date values associated to a study version must be unique regarding the combination
+ of type and geographic scopes of the date."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00093'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00093"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Date values associated to a study version must be unique
- regarding the combination of type and geographic scopes of the
- date.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Date values associated to a study version must be unique regarding the combination
+ of type and geographic scopes of the date."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00093'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00093"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyVersion'
+ value: "StudyVersion"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- all:
- name: code.standardCode.code
@@ -54,11 +54,12 @@ Check:
- type.code
- type.code.GeographicScope
Core:
- Id: 'CORE-000873'
+ Id: "CORE-000873"
Status: Published
- Version: '1'
-Description: 'Date values associated to a study version must be unique regarding
- the combination of type and geographic scopes of the date.'
+ Version: "1"
+Description:
+ "Date values associated to a study version must be unique regarding the combination of type
+ and geographic scopes of the date."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -72,8 +73,7 @@ Match Datasets:
- rel_type
Name: GeographicScope
Outcome:
- Message: 'The study version has more than one governance date with the same type
- and geographic scope.'
+ Message: "The study version has more than one governance date with the same type and geographic scope."
Output Variables:
- parent_entity
- parent_id
@@ -93,5 +93,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyVersion'
+ - "StudyVersion"
Sensitivity: Record
diff --git a/Published/CORE-000874/rule.yml b/Published/CORE-000874/rule.yml
index 07a18aecc..e9cc4b016 100644
--- a/Published/CORE-000874/rule.yml
+++ b/Published/CORE-000874/rule.yml
@@ -4,43 +4,41 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'All primary endpoints must be referenced by a primary
- objective.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "All primary endpoints must be referenced by a primary objective."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00096'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00096"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'All primary endpoints must be referenced by a primary
- objective.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "All primary endpoints must be referenced by a primary objective."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00096'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00096"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: level.code
operator: equal_to
- value: 'C94496'
+ value: "C94496"
- name: level.code.Objective
operator: not_equal_to
- value: 'C85826'
+ value: "C85826"
Core:
- Id: 'CORE-000874'
+ Id: "CORE-000874"
Status: Published
- Version: '1'
-Description: 'All primary endpoints must be referenced by a primary objective.'
+ Version: "1"
+Description: "All primary endpoints must be referenced by a primary objective."
Executability: Fully Executable
Match Datasets:
- Join Type: left
@@ -50,8 +48,9 @@ Match Datasets:
- rel_type
Name: Objective
Outcome:
- Message: 'The primary endpoint (level.code = C94496) is not referenced by a
- primary objective (level.code.Objective = C85826).'
+ Message:
+ "The primary endpoint (level.code = C94496) is not referenced by a primary objective (level.code.Objective
+ = C85826)."
Output Variables:
- parent_entity
- parent_id
@@ -67,5 +66,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Endpoint'
+ - "Endpoint"
Sensitivity: Record
diff --git a/Published/CORE-000875/rule.yml b/Published/CORE-000875/rule.yml
index 4b6519c80..14bb95105 100644
--- a/Published/CORE-000875/rule.yml
+++ b/Published/CORE-000875/rule.yml
@@ -4,35 +4,37 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, the planned sex must be specified either
- in the study population or in all cohorts.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study design, the planned sex must be specified either in the study
+ population or in all cohorts."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00098'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00098"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, the planned sex must be specified either
- in the study population or in all cohorts.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study design, the planned sex must be specified either in the study
+ population or in all cohorts."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00098'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00098"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyDesignPopulation'
+ value: "StudyDesignPopulation"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- all:
- any:
@@ -59,11 +61,12 @@ Check:
operator: equal_to
value: true
Core:
- Id: 'CORE-000875'
+ Id: "CORE-000875"
Status: Published
- Version: '1'
-Description: 'Within a study design, the planned sex must be specified either in
- the study population or in all cohorts.'
+ Version: "1"
+Description:
+ "Within a study design, the planned sex must be specified either in the study population
+ or in all cohorts."
Executability: Fully Executable
Match Datasets:
- Join Type: left
@@ -75,8 +78,9 @@ Match Datasets:
- rel_type
Name: StudyCohort
Outcome:
- Message: 'Planned sex has not been specified for either the study population or
- the cohort, or it has been specified for both.'
+ Message:
+ "Planned sex has not been specified for either the study population or the cohort, or it has
+ been specified for both."
Output Variables:
- parent_entity
- parent_id
@@ -93,5 +97,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyDesignPopulation'
+ - "StudyDesignPopulation"
Sensitivity: Record
diff --git a/Published/CORE-000876/rule.yml b/Published/CORE-000876/rule.yml
index 47343c21a..524eb9d2f 100644
--- a/Published/CORE-000876/rule.yml
+++ b/Published/CORE-000876/rule.yml
@@ -4,23 +4,24 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a document version, the specified section numbers for
- narrative content must be unique.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a document version, the specified section numbers for narrative content
+ must be unique."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00103'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00103"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'NarrativeContent'
+ value: "NarrativeContent"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: sectionNumber
operator: non_empty
- name: sectionNumber
@@ -29,11 +30,10 @@ Check:
- parent_entity
- parent_id
Core:
- Id: 'CORE-000876'
+ Id: "CORE-000876"
Status: Published
- Version: '1'
-Description: 'Within a document version, the specified section numbers for
- narrative content must be unique.'
+ Version: "1"
+Description: "Within a document version, the specified section numbers for narrative content must be unique."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -47,7 +47,7 @@ Match Datasets:
- rel_type
Name: StudyProtocolDocument
Outcome:
- Message: 'The section number is not unique within the document version.'
+ Message: "The section number is not unique within the document version."
Output Variables:
- parent_entity
- parent_id
@@ -61,5 +61,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'NarrativeContent'
+ - "NarrativeContent"
Sensitivity: Record
diff --git a/Published/CORE-000877/rule.yml b/Published/CORE-000877/rule.yml
index bedbda514..597c84047 100644
--- a/Published/CORE-000877/rule.yml
+++ b/Published/CORE-000877/rule.yml
@@ -4,48 +4,49 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled activity instance must only have a sub-timeline
- that is defined within the same study design as the scheduled
- activity instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A scheduled activity instance must only have a sub-timeline that is defined within
+ the same study design as the scheduled activity instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00107'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00107"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled activity instance must only have a sub-timeline
- that is defined within the same study design as the scheduled
- activity instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A scheduled activity instance must only have a sub-timeline that is defined within
+ the same study design as the scheduled activity instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00107'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00107"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'ScheduledActivityInstance'
+ value: "ScheduledActivityInstance"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: timelineId
operator: non_empty
- name: $study_design_id_for_subtimeline
operator: not_equal_to
value: $study_design_id_for_scheduled_instance
Core:
- Id: 'CORE-000877'
+ Id: "CORE-000877"
Status: Published
- Version: '1'
-Description: 'A scheduled activity instance must only have a sub-timeline that
- is defined within the same study design as the scheduled activity instance.'
+ Version: "1"
+Description:
+ "A scheduled activity instance must only have a sub-timeline that is defined within the same
+ study design as the scheduled activity instance."
Executability: Fully Executable
Operations:
- domain: ScheduleTimeline
@@ -67,8 +68,9 @@ Operations:
name: parent_id
operator: distinct
Outcome:
- Message: 'The scheduled activity instance has a sub-timeline that is not defined
- within the same study design.'
+ Message:
+ "The scheduled activity instance has a sub-timeline that is not defined within the same study
+ design."
Output Variables:
- parent_entity
- parent_id
@@ -82,5 +84,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ScheduledActivityInstance'
+ - "ScheduledActivityInstance"
Sensitivity: Record
diff --git a/Published/CORE-000878/rule.yml b/Published/CORE-000878/rule.yml
index 45b92428e..a8a85909a 100644
--- a/Published/CORE-000878/rule.yml
+++ b/Published/CORE-000878/rule.yml
@@ -4,43 +4,44 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If specified, the context of a condition must point to a valid
- instance in the activity or scheduled activity instance
- class.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If specified, the context of a condition must point to a valid instance in the
+ activity or scheduled activity instance class."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00114'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00114"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If specified, the context of a condition must point to a valid
- instance in the activity or scheduled activity instance
- class.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If specified, the context of a condition must point to a valid instance in the
+ activity or scheduled activity instance class."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00114'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00114"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: parent_rel
operator: equal_to
- value: 'contextIds'
+ value: "contextIds"
value_is_literal: true
- name: $condition_count
operator: non_empty
Core:
- Id: 'CORE-000878'
+ Id: "CORE-000878"
Status: Published
- Version: '1'
-Description: 'If specified, the context of a condition must point to a valid
- instance in the activity or scheduled activity instance class.'
+ Version: "1"
+Description:
+ "If specified, the context of a condition must point to a valid instance in the activity
+ or scheduled activity instance class."
Executability: Fully Executable
Operations:
- domain: Condition
@@ -124,11 +125,10 @@ Operations:
rel_type: definition
operator: map
Outcome:
- Message: 'The specified context of the condition is not a valid instance of
- either the Activity or ScheduledActivityInstance class (the value of the
- condition''s contextIds attribute either matches the id of an instance that
- is not an Activity or ScheduledActivityInstance, or it does not match the id
- of any class instance).'
+ Message:
+ "The specified context of the condition is not a valid instance of either the Activity or ScheduledActivityInstance
+ class (the value of the condition's contextIds attribute either matches the id of an instance that
+ is not an Activity or ScheduledActivityInstance, or it does not match the id of any class instance)."
Output Variables:
- $condition_parent_entity
- $condition_parent_id
@@ -147,8 +147,8 @@ Rule Type: Record Data
Scope:
Entities:
Exclude:
- - 'Activity'
- - 'ScheduledActivityInstance'
+ - "Activity"
+ - "ScheduledActivityInstance"
Include:
- ALL
Sensitivity: Record
diff --git a/Published/CORE-000879/rule.yml b/Published/CORE-000879/rule.yml
index 72f26c1f2..a92e4b05c 100644
--- a/Published/CORE-000879/rule.yml
+++ b/Published/CORE-000879/rule.yml
@@ -4,44 +4,44 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "For CDISC codelist references (where the code system is
- 'http://www.cdisc.org'), the code system version must be a
- valid CDISC terminology release date in ISO 8601 date format."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "For CDISC codelist references (where the code system is 'http://www.cdisc.org'),
+ the code system version must be a valid CDISC terminology release date in ISO 8601 date format."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00155'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00155"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: "For CDISC codelist references (where the code system is
- 'http://www.cdisc.org'), the code system version must be a
- valid CDISC terminology release date in ISO 8601 date format."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "For CDISC codelist references (where the code system is 'http://www.cdisc.org'),
+ the code system version must be a valid CDISC terminology release date in ISO 8601 date format."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00155'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00155"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: codeSystemVersion
operator: is_not_contained_by
value: $valid_versions
Core:
- Id: 'CORE-000879'
+ Id: "CORE-000879"
Status: Published
- Version: '1'
-Description: "For CDISC codelist references (where the code system is
- 'http://www.cdisc.org'), the code system version must be a valid CDISC
- terminology release date in ISO 8601 date format."
+ Version: "1"
+Description:
+ "For CDISC codelist references (where the code system is 'http://www.cdisc.org'), the code
+ system version must be a valid CDISC terminology release date in ISO 8601 date format."
Executability: Fully Executable
Operations:
- ct_package_types:
@@ -51,8 +51,9 @@ Operations:
id: $valid_versions
operator: valid_codelist_dates
Outcome:
- Message: 'The code system is "http://www.cdisc.org" but the code system version
- is not a valid CDISC terminology release date in ISO 8601 date format.'
+ Message:
+ 'The code system is "http://www.cdisc.org" but the code system version is not a valid CDISC
+ terminology release date in ISO 8601 date format.'
Output Variables:
- parent_entity
- parent_id
@@ -66,5 +67,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Code'
+ - "Code"
Sensitivity: Record
diff --git a/Published/CORE-000881/rule.yml b/Published/CORE-000881/rule.yml
index 11d2fd5a8..9d13e6e8d 100644
--- a/Published/CORE-000881/rule.yml
+++ b/Published/CORE-000881/rule.yml
@@ -5,31 +5,31 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Required timing variables for identification of the day on
- which group summaries (group means and incidences) are
- calculated should be populated for nonclinical data.'
+ - Cited Guidance:
+ "Required timing variables for identification of the day on which group summaries
+ (group means and incidences) are calculated should be populated for nonclinical data."
Document: FDA
Section: FDAB047
Origin: FDA Business Rules
Rule Identifier:
Id: FB4701
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Required timing variables for identification of the day on
- which group summaries (group means and incidences) are
- calculated should be populated for nonclinical data.'
+ - Cited Guidance:
+ "Required timing variables for identification of the day on which group summaries
+ (group means and incidences) are calculated should be populated for nonclinical data."
Document: FDA
Section: FDAB047
Origin: FDA Business Rules
Rule Identifier:
Id: FB4701
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
Check:
all:
# - name: DSTERM
@@ -41,17 +41,16 @@ Check:
- "REMOVED FROM STUDY ALIVE"
- "TERMINAL SACRIFICE"
- name: VISITDY
- operator: 'empty'
+ operator: "empty"
- name: DSNOMDY
- operator: 'empty'
+ operator: "empty"
Core:
Id: CORE-000881
Status: Published
- Version: '1'
-Description: VISITDY or DSNOMDY is populated in the DS dataset for scheduled
- disposition records as these are required timing variables for identification
- of the day on which group summaries (Group Means and Incidences) are
- calculated for post mortem data.
+ Version: "1"
+Description: VISITDY or DSNOMDY is populated in the DS dataset for scheduled disposition records as
+ these are required timing variables for identification of the day on which group summaries (Group
+ Means and Incidences) are calculated for post mortem data.
Executability: Fully Executable
Outcome:
Message: Missing VISITDY or DSNOMDY values for scheduled disposition record.
diff --git a/Published/CORE-000882/rule.yml b/Published/CORE-000882/rule.yml
index 3dddbce1a..d5a26c7c7 100644
--- a/Published/CORE-000882/rule.yml
+++ b/Published/CORE-000882/rule.yml
@@ -6,22 +6,22 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Required timing variables for identification of the day on
- which group summaries (group means and incidences) are
- calculated should be populated for nonclinical data.'
+ - Cited Guidance:
+ "Required timing variables for identification of the day on which group summaries
+ (group means and incidences) are calculated should be populated for nonclinical data."
Document: FDA
Section: FDAB047
Origin: FDA Business Rules
Rule Identifier:
Id: FB4703
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
Check:
all:
# - name: DSTERM
- # "DSTERM" changed in "DSDECOD" - see comment Keith Moseley
+ # "DSTERM" changed in "DSDECOD" - see comment Keith Moseley
# https://jira.cdisc.org/browse/CORERULES-9244
- name: DSDECOD
operator: is_contained_by
@@ -31,16 +31,15 @@ Check:
- "REMOVED FROM STUDY ALIVE"
- "TERMINAL SACRIFICE"
- name: VISITDY
- operator: 'empty'
+ operator: "empty"
Core:
Id: CORE-000882
Status: Published
- Version: '1'
-Description: VISITDY should be populated in the DS dataset for disposition
- records where DSTERM has been mapped to one of 'INTERIM SACRIFICE', 'RECOVERY
- SACRIFICE', 'REMOVED FROM STUDY ALIVE', or 'TERMINAL SACRIFICE', as these are
- required timing variables for identification of the day on which group
- summaries (Group Means and Incidences) are calculated for post mortem data.
+ Version: "1"
+Description: VISITDY should be populated in the DS dataset for disposition records where DSTERM has
+ been mapped to one of 'INTERIM SACRIFICE', 'RECOVERY SACRIFICE', 'REMOVED FROM STUDY ALIVE', or
+ 'TERMINAL SACRIFICE', as these are required timing variables for identification of the day on
+ which group summaries (Group Means and Incidences) are calculated for post mortem data.
Executability: Fully Executable
Outcome:
Message: Missing VISITDY value for scheduled disposition record.
diff --git a/Published/CORE-000883/rule.yml b/Published/CORE-000883/rule.yml
index cb923a31c..8fb20c0e1 100644
--- a/Published/CORE-000883/rule.yml
+++ b/Published/CORE-000883/rule.yml
@@ -12,9 +12,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND104.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -25,9 +25,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND104.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -38,8 +38,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND104.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
@@ -50,9 +50,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND104.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -62,9 +62,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND104.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -74,9 +74,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND104.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
# For DM: AGE, AGETXT and AGEU are variables
@@ -94,10 +94,10 @@ Check:
Core:
Id: CORE-000883
Status: Published
- Version: '1'
-Description: AGEU is the unit associated with AGE or AGETXT. If either of those
- variables is populated, AGEU should be populated. This applies to both DM (as
- variables) as to TS (as parameters)
+ Version: "1"
+Description: AGEU is the unit associated with AGE or AGETXT. If either of those variables is
+ populated, AGEU should be populated. This applies to both DM (as variables) as to TS (as
+ parameters)
Executability: Fully Executable
Outcome:
Message: AGE or AGETXT is populated, but AGEU is not populated
diff --git a/Published/CORE-000884/rule.yml b/Published/CORE-000884/rule.yml
index 33d3d8bc8..ceede6457 100644
--- a/Published/CORE-000884/rule.yml
+++ b/Published/CORE-000884/rule.yml
@@ -11,9 +11,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND104.2
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -24,9 +24,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND104.2
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -37,8 +37,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND104.2
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
@@ -49,9 +49,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND104.2
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -61,9 +61,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND104.2
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -73,9 +73,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND104.2
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
# For DM: AGE, AGETXT and AGEU are variables
@@ -89,8 +89,9 @@ Check:
- name: AGETXT
operator: non_empty
- name: AGE
- operator: non_empty
- # for TS, they are parameters (values in TSPARMCD)
+ operator:
+ non_empty
+ # for TS, they are parameters (values in TSPARMCD)
- all:
- name: DOMAIN
operator: equal_to
@@ -102,20 +103,22 @@ Check:
Core:
Id: CORE-000884
Status: Published
- Version: '1'
-Description: AGEU is the unit associated with AGE or AGETXT. If either of those
- variables is populated, AGEU should be populated. This applies to both DM (as
- variables) as to TS (as parameters)
+ Version: "1"
+Description: AGEU is the unit associated with AGE or AGETXT. If either of those variables is
+ populated, AGEU should be populated. This applies to both DM (as variables) as to TS (as
+ parameters)
Executability: Fully Executable
Operations:
- - domain: TS
- # only keep the records with TSPARMCD=AGEU
+ - domain:
+ TS
+ # only keep the records with TSPARMCD=AGEU
filter:
- TSPARMCD: AGEU
- # group the records by value of TXSETCD
- #group:
- # - SETCD
- # within the filtered and grouped records, count the number of TXVAL records
+ TSPARMCD:
+ AGEU
+ # group the records by value of TXSETCD
+ #group:
+ # - SETCD
+ # within the filtered and grouped records, count the number of TXVAL records
id: $ageu_count
name: TSVAL
operator: record_count
@@ -124,10 +127,10 @@ Outcome:
Output Variables:
- DOMAIN
- $ageu_count
- #- USUBJID
- #- AGETXT
- #- AGE
- #- AGEU
+ #- USUBJID
+ #- AGETXT
+ #- AGE
+ #- AGEU
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000888/rule.yml b/Published/CORE-000888/rule.yml
index 14bc4df89..59c79cb21 100644
--- a/Published/CORE-000888/rule.yml
+++ b/Published/CORE-000888/rule.yml
@@ -1,108 +1,101 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4608'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB4608"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4608'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB4608"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4608'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB4608"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4608'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB4608"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4608'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4608"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4608'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB4608"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4608'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB4608"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '$txparmcd'
- operator: 'does_not_contain'
- value: 'PLANFSUB'
+ - name: "$txparmcd"
+ operator: "does_not_contain"
+ value: "PLANFSUB"
Core:
Id: CORE-000888
Status: Published
- Version: '1'
-Description: For each Trial Set (SETCD) in the TX dataset exactly one Planned
- Number of Female Subjects (PLANFSUB) record should be included.
+ Version: "1"
+Description: For each Trial Set (SETCD) in the TX dataset exactly one Planned Number of Female
+ Subjects (PLANFSUB) record should be included.
Executability: Fully Executable
Grouping_Variables:
- SETCD
diff --git a/Published/CORE-000889/rule.yml b/Published/CORE-000889/rule.yml
index fa161bd65..2fbd4f68b 100644
--- a/Published/CORE-000889/rule.yml
+++ b/Published/CORE-000889/rule.yml
@@ -1,136 +1,146 @@
Authorities:
- Organization: FDA
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3902'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB3902"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3902'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB3902"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3902'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB3902"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3902'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB3902"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3902'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB3902"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3902'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3902"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3902'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3902"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3902'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB3902"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3902'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-AR'
+ Id: "FB3902"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: Upper limit of reference range should be greater than lower
- limit, whenever both are submitted.
- Document: 'FDA'
- Section: 'FDAB039'
+ - Cited Guidance:
+ Upper limit of reference range should be greater than lower limit, whenever
+ both are submitted.
+ Document: "FDA"
+ Section: "FDAB039"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3902'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB3902"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --ORNRLO
@@ -149,9 +159,10 @@ Check:
Core:
Id: CORE-000889
Status: Published
- Version: '1'
-Description: 'Normal Range Upper Limit-Original Units (--ORNRHI) is greater than
- the Normal Range Lower Limit-Original Units (--ORNRLO).'
+ Version: "1"
+Description:
+ "Normal Range Upper Limit-Original Units (--ORNRHI) is greater than the Normal Range Lower
+ Limit-Original Units (--ORNRLO)."
Executability: Partially Executable - Possible Underreporting
Outcome:
Message: --ORNRHI is less than or equal to --ORNRLO.
diff --git a/Published/CORE-000890/rule.yml b/Published/CORE-000890/rule.yml
index bc7767cd3..0bd12ce77 100644
--- a/Published/CORE-000890/rule.yml
+++ b/Published/CORE-000890/rule.yml
@@ -1,136 +1,126 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1502'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB1502"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1502'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB1502"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1502'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB1502"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1502'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB1502"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1502'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB1502"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1502'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB1502"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1502'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB1502"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1502'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB1502"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1502'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB1502"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'Character values should not have leading spaces or only have a
- period character.'
- Document: 'FDA'
- Section: 'FDAB015'
+ - Cited Guidance: "Character values should not have leading spaces or only have a period character."
+ Document: "FDA"
+ Section: "FDAB015"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB1502'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB1502"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: variable_data_type
@@ -140,12 +130,12 @@ Check:
operator: non_empty
- name: variable_value
operator: equal_to
- value: '.'
+ value: "."
value_is_literal: true
Core:
Id: CORE-000890
Status: Published
- Version: '1'
+ Version: "1"
Description: Text variable in submitted dataset should not contain '.' as an entire value.
Executability: Fully Executable
Outcome:
diff --git a/Published/CORE-000891/rule.yml b/Published/CORE-000891/rule.yml
index 5dd15561a..ef4808812 100644
--- a/Published/CORE-000891/rule.yml
+++ b/Published/CORE-000891/rule.yml
@@ -1,108 +1,101 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4603'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB4603"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4603'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB4603"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4603'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB4603"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4603'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB4603"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4603'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4603"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4603'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB4603"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4603'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB4603"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '$txparmcd'
- operator: 'does_not_contain'
- value: 'ARMCD'
+ - name: "$txparmcd"
+ operator: "does_not_contain"
+ value: "ARMCD"
Core:
Id: CORE-000891
Status: Published
- Version: '1'
-Description: For each Trial Set (SETCD) in the TX dataset an Arm Code (ARMCD)
- record should be included.
+ Version: "1"
+Description: For each Trial Set (SETCD) in the TX dataset an Arm Code (ARMCD) record should be
+ included.
Executability: Fully Executable # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD
Operations:
- domain: TX
diff --git a/Published/CORE-000892/rule.yml b/Published/CORE-000892/rule.yml
index 7ae0d8ace..587d66b28 100644
--- a/Published/CORE-000892/rule.yml
+++ b/Published/CORE-000892/rule.yml
@@ -1,136 +1,146 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When end timepoint is provided, then a related start timepoint
- should also be provided.'
- Document: 'FDA'
- Section: 'FDAB041'
+ - Cited Guidance:
+ "When end timepoint is provided, then a related start timepoint should also be
+ provided."
+ Document: "FDA"
+ Section: "FDAB041"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4301'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB4301"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When end timepoint is provided, then a related start timepoint
- should also be provided.'
- Document: 'FDA'
- Section: 'FDAB041'
+ - Cited Guidance:
+ "When end timepoint is provided, then a related start timepoint should also be
+ provided."
+ Document: "FDA"
+ Section: "FDAB041"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4301'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB4301"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'When end timepoint is provided, then a related start timepoint
- should also be provided.'
- Document: 'FDA'
- Section: 'FDAB041'
+ - Cited Guidance:
+ "When end timepoint is provided, then a related start timepoint should also be
+ provided."
+ Document: "FDA"
+ Section: "FDAB041"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4301'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB4301"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When end timepoint is provided, then a related start timepoint
- should also be provided.'
- Document: 'FDA'
- Section: 'FDAB041'
+ - Cited Guidance:
+ "When end timepoint is provided, then a related start timepoint should also be
+ provided."
+ Document: "FDA"
+ Section: "FDAB041"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4301'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB4301"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When end timepoint is provided, then a related start timepoint
- should also be provided.'
- Document: 'FDA'
- Section: 'FDAB041'
+ - Cited Guidance:
+ "When end timepoint is provided, then a related start timepoint should also be
+ provided."
+ Document: "FDA"
+ Section: "FDAB041"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4301'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB4301"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'When end timepoint is provided, then a related start timepoint
- should also be provided.'
- Document: 'FDA'
- Section: 'FDAB041'
+ - Cited Guidance:
+ "When end timepoint is provided, then a related start timepoint should also be
+ provided."
+ Document: "FDA"
+ Section: "FDAB041"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4301'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB4301"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'When end timepoint is provided, then a related start timepoint
- should also be provided.'
- Document: 'FDA'
- Section: 'FDAB041'
+ - Cited Guidance:
+ "When end timepoint is provided, then a related start timepoint should also be
+ provided."
+ Document: "FDA"
+ Section: "FDAB041"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4301'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB4301"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'When end timepoint is provided, then a related start timepoint
- should also be provided.'
- Document: 'FDA'
- Section: 'FDAB041'
+ - Cited Guidance:
+ "When end timepoint is provided, then a related start timepoint should also be
+ provided."
+ Document: "FDA"
+ Section: "FDAB041"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4301'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4301"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'When end timepoint is provided, then a related start timepoint
- should also be provided.'
- Document: 'FDA'
- Section: 'FDAB041'
+ - Cited Guidance:
+ "When end timepoint is provided, then a related start timepoint should also be
+ provided."
+ Document: "FDA"
+ Section: "FDAB041"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4301'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB4301"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'When end timepoint is provided, then a related start timepoint
- should also be provided.'
- Document: 'FDA'
- Section: 'FDAB041'
+ - Cited Guidance:
+ "When end timepoint is provided, then a related start timepoint should also be
+ provided."
+ Document: "FDA"
+ Section: "FDAB041"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB4301'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB4301"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
# TODO: FAILS when e.g. --ENRF and --STDTC columns are absent
all:
@@ -138,65 +148,76 @@ Check:
# Case ENDTC populated: check that one of --STDTC, --STRF or --STRTPT is populated
- all:
- name: --ENDTC
- operator: non_empty
- # we need to take into account that the column --STDTC may be absent
+ operator:
+ non_empty
+ # we need to take into account that the column --STDTC may be absent
- any:
- name: --STDTC
operator: not_exists
- name: --STDTC
- operator: empty
- # we need to take into account that the column --STRF may be absent
+ operator:
+ empty
+ # we need to take into account that the column --STRF may be absent
- any:
- name: --STRF
operator: not_exists
- name: --STRF
- operator: empty
- # we need to take into account that the column --STRTPT may be absent
+ operator:
+ empty
+ # we need to take into account that the column --STRTPT may be absent
- any:
- name: --STRTPT
operator: not_exists
- name: --STRTPT
- operator: empty
- # Case ENRF populated: check that one of --STDTC, --STRF or --STRTPT is populated
+ operator:
+ empty
+ # Case ENRF populated: check that one of --STDTC, --STRF or --STRTPT is populated
- all:
- name: --ENRF
- operator: non_empty
- # we need to take into account that the column --STDTC may be absent
+ operator:
+ non_empty
+ # we need to take into account that the column --STDTC may be absent
- any:
- name: --STDTC
operator: not_exists
- name: --STDTC
- operator: empty
- # we need to take into account that the column --STRF may be absent
+ operator:
+ empty
+ # we need to take into account that the column --STRF may be absent
- any:
- name: --STRF
operator: not_exists
- name: --STRF
- operator: empty
- # we need to take into account that the column --STRTPT may be absent
+ operator:
+ empty
+ # we need to take into account that the column --STRTPT may be absent
- any:
- name: --STRTPT
operator: not_exists
- name: --STRTPT
- operator: empty
+ operator:
+ empty
- # Case ENRTPT populated: check that one of --STDTC, --STRF or --STRTPT is populated
+ # Case ENRTPT populated: check that one of --STDTC, --STRF or --STRTPT is populated
- all:
- name: --ENRTPT
- operator: non_empty
- # we need to take into account that the column --STDTC may be absent
+ operator:
+ non_empty
+ # we need to take into account that the column --STDTC may be absent
- any:
- name: --STDTC
operator: not_exists
- name: --STDTC
- operator: empty
- # we need to take into account that the column --STRF may be absent
+ operator:
+ empty
+ # we need to take into account that the column --STRF may be absent
- any:
- name: --STRF
operator: not_exists
- name: --STRF
- operator: empty
- # we need to take into account that the column --STRTPT may be absent
+ operator:
+ empty
+ # we need to take into account that the column --STRTPT may be absent
- any:
- name: --STRTPT
operator: not_exists
@@ -206,9 +227,9 @@ Check:
Core:
Id: CORE-000892
Status: Published
- Version: '1'
-Description: When Eed timepoint (--ENDTC, --ENRF or --ENRTPT) is populated,
- related start timepoint (--STDTC, --STRF or --STRTPT should also be populated.
+ Version: "1"
+Description: When Eed timepoint (--ENDTC, --ENRF or --ENRTPT) is populated, related start timepoint
+ (--STDTC, --STRF or --STRTPT should also be populated.
Executability: Fully Executable
Outcome:
Message: End timepoint is populated but start timepoint is missing.
diff --git a/Published/CORE-000893/rule.yml b/Published/CORE-000893/rule.yml
index 0e879ef10..def4469d2 100644
--- a/Published/CORE-000893/rule.yml
+++ b/Published/CORE-000893/rule.yml
@@ -1,108 +1,101 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4604'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB4604"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4604'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB4604"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4604'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB4604"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4604'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB4604"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4604'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4604"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4604'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB4604"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4604'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB4604"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '$txparmcd'
- operator: 'does_not_contain'
- value: 'GRPLBL'
+ - name: "$txparmcd"
+ operator: "does_not_contain"
+ value: "GRPLBL"
Core:
Id: CORE-000893
Status: Published
- Version: '1'
-Description: For each Trial Set (SETCD) in the TX dataset exactly one Group
- Label (GRPLBL) record should be included.
+ Version: "1"
+Description: For each Trial Set (SETCD) in the TX dataset exactly one Group Label (GRPLBL) record
+ should be included.
Executability: Fully Executable
# We make a list of the distinct values of TXPARMCD within each group with same value for SETCD
Operations:
diff --git a/Published/CORE-000894/rule.yml b/Published/CORE-000894/rule.yml
index 915ebb4aa..a388b989a 100644
--- a/Published/CORE-000894/rule.yml
+++ b/Published/CORE-000894/rule.yml
@@ -1,108 +1,101 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4605'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB4605"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4605'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB4605"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4605'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB4605"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4605'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB4605"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4605'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4605"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4605'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB4605"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4605'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB4605"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '$txparmcd'
- operator: 'does_not_contain'
- value: 'TRTDOS'
+ - name: "$txparmcd"
+ operator: "does_not_contain"
+ value: "TRTDOS"
Core:
Id: CORE-000894
Status: Published
- Version: '1'
-Description: For each Trial Set (SETCD) in the TX dataset a Dose Level (TRTDOS)
- record should be included.
+ Version: "1"
+Description: For each Trial Set (SETCD) in the TX dataset a Dose Level (TRTDOS) record should be
+ included.
Executability: Fully Executable
# We make a list of the distinct values of TXPARMCD within each group with same value for SETCD
Operations:
@@ -113,7 +106,7 @@ Operations:
name: TXPARMCD
operator: distinct
Outcome:
- Message: 'TX dataset should include a TXPARMCD = TRTDOS record per SETCD.'
+ Message: "TX dataset should include a TXPARMCD = TRTDOS record per SETCD."
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000895/rule.yml b/Published/CORE-000895/rule.yml
index ccf5f90a8..cfcd2983b 100644
--- a/Published/CORE-000895/rule.yml
+++ b/Published/CORE-000895/rule.yml
@@ -1,108 +1,101 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4606'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB4606"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4606'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB4606"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4606'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB4606"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4606'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB4606"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4606'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4606"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4606'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB4606"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4606'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB4606"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '$txparmcd'
- operator: 'does_not_contain'
- value: 'TRTDOSU'
+ - name: "$txparmcd"
+ operator: "does_not_contain"
+ value: "TRTDOSU"
Core:
Id: CORE-000895
Status: Published
- Version: '1'
-Description: For each Trial Set (SETCD) in the TX dataset a Dose Units (TRTDOSU)
- record should be included.
+ Version: "1"
+Description: For each Trial Set (SETCD) in the TX dataset a Dose Units (TRTDOSU) record should be
+ included.
Executability: Fully Executable
# We make a list of the distinct values of TXPARMCD within each group with same value for SETCD
Operations:
diff --git a/Published/CORE-000896/rule.yml b/Published/CORE-000896/rule.yml
index c611a2cf6..9befa36bc 100644
--- a/Published/CORE-000896/rule.yml
+++ b/Published/CORE-000896/rule.yml
@@ -5,87 +5,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.'
+ - Cited Guidance: "Pool ID should match pool definition for nonclinical data."
Document: FDA
Section: FDAB054
Origin: FDA Business Rules
Rule Identifier:
Id: FB5401
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.'
+ - Cited Guidance: "Pool ID should match pool definition for nonclinical data."
Document: FDA
Section: FDAB054
Origin: FDA Business Rules
Rule Identifier:
Id: FB5401
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.'
+ - Cited Guidance: "Pool ID should match pool definition for nonclinical data."
Document: FDA
Section: FDAB054
Origin: FDA Business Rules
Rule Identifier:
Id: FB5401
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.'
+ - Cited Guidance: "Pool ID should match pool definition for nonclinical data."
Document: FDA
Section: FDAB054
Origin: FDA Business Rules
Rule Identifier:
Id: FB5401
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.'
+ - Cited Guidance: "Pool ID should match pool definition for nonclinical data."
Document: FDA
Section: FDAB054
Origin: FDA Business Rules
Rule Identifier:
Id: FB5401
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.'
+ - Cited Guidance: "Pool ID should match pool definition for nonclinical data."
Document: FDA
Section: FDAB054
Origin: FDA Business Rules
Rule Identifier:
Id: FB5401
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.'
+ - Cited Guidance: "Pool ID should match pool definition for nonclinical data."
Document: FDA
Section: FDAB054
Origin: FDA Business Rules
Rule Identifier:
Id: FB5401
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: POOLID
@@ -96,9 +96,8 @@ Check:
Core:
Id: CORE-000896
Status: Published
- Version: '1'
-Description: 'POOLID value in the dataset should match one of the POOLID values
- in the POOLDEF dataset'
+ Version: "1"
+Description: "POOLID value in the dataset should match one of the POOLID values in the POOLDEF dataset"
Executability: Fully Executable
Operations:
- domain: POOLDEF
@@ -106,7 +105,7 @@ Operations:
name: POOLID
operator: distinct
Outcome:
- Message: 'POOLID value does not match a POOLID value in the POOLDEF dataset.'
+ Message: "POOLID value does not match a POOLID value in the POOLDEF dataset."
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000897/rule.yml b/Published/CORE-000897/rule.yml
index ce6e1f2e7..14f74d473 100644
--- a/Published/CORE-000897/rule.yml
+++ b/Published/CORE-000897/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study version's study phase must be specified according to
- the extensible Trial Phase Response (C66737) SDTM codelist
- (e.g. an entry with a code or decode used from the codelist
+ - Cited Guidance:
+ "A study version's study phase must be specified according to the extensible Trial
+ Phase Response (C66737) SDTM codelist (e.g. an entry with a code or decode used from the codelist
should be consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00015'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00015"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: studyPhase.standardCode
operator: exists
- name: studyPhase.standardCode
@@ -29,7 +29,7 @@ Check:
all:
- name: studyPhase.standardCode.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: studyPhase.standardCode.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -71,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000897'
+ Id: "CORE-000897"
Status: Published
- Version: '1'
-Description: "A study version's study phase must be specified according to the
- extensible Trial Phase Response (C66737) SDTM codelist (e.g. an entry with a
- code or decode used from the codelist should be consistent with the full entry
- in the codelist)."
+ Version: "1"
+Description:
+ "A study version's study phase must be specified according to the extensible Trial Phase
+ Response (C66737) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be
+ consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -122,12 +122,12 @@ Operations:
term_value: studyPhase.standardCode.decode
version: studyPhase.standardCode.codeSystemVersion
Outcome:
- Message: 'The study version''s study phase is not specified according to the
- extensible Trial Phase Response (C66737) SDTM codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, and/or the code or decode (either as preferred term or as submission
- value) is found in the codelist (case insensitive) but the corresponding
- decode or code does not match the codelist value (case sensitive).'
+ Message:
+ 'The study version''s study phase is not specified according to the extensible Trial Phase
+ Response (C66737) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not
+ a valid terminology package date, and/or the code or decode (either as preferred term or as submission
+ value) is found in the codelist (case insensitive) but the corresponding decode or code does not match
+ the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -148,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyVersion'
+ - "StudyVersion"
Sensitivity: Record
diff --git a/Published/CORE-000898/rule.yml b/Published/CORE-000898/rule.yml
index 81b82251c..cbe011bee 100644
--- a/Published/CORE-000898/rule.yml
+++ b/Published/CORE-000898/rule.yml
@@ -7,25 +7,25 @@ Authorities:
- Citations:
- Cited Guidance: One record per implantation site per fetus per subject.
Document: IG-DART v1.1
- Section: '5.1.1'
+ Section: "5.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND355
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- Cited Guidance: One record per implantation site per fetus per subject.
Document: IG-DART v1.2
- Section: '5.1.1'
+ Section: "5.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND355
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
@@ -37,9 +37,8 @@ Check:
Core:
Id: CORE-000898
Status: Published
- Version: '1'
-Description: Raise an error when the combination of USUBJID, ICIMPLBL and
- FETUSID in not unique
+ Version: "1"
+Description: Raise an error when the combination of USUBJID, ICIMPLBL and FETUSID in not unique
Executability: Fully Executable
Outcome:
Message: The value of ICIMPLBL is not unique within FETUSID and USUBJID
diff --git a/Published/CORE-000899/rule.yml b/Published/CORE-000899/rule.yml
index d366145d2..567b4ea58 100644
--- a/Published/CORE-000899/rule.yml
+++ b/Published/CORE-000899/rule.yml
@@ -4,56 +4,56 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The ICIMPLBL must be populated for each result, i.e. for each
- implantation site. In the situation where the implantations
- were not evaluated (ICSTAT = NOT DONE) per protocol, the
- artificial label, ALL, is used to represent missing results
- (see Example 5).
+ - Cited Guidance:
+ The ICIMPLBL must be populated for each result, i.e. for each implantation
+ site. In the situation where the implantations were not evaluated (ICSTAT = NOT DONE) per
+ protocol, the artificial label, ALL, is used to represent missing results (see Example 5).
Document: DART-IG v1.1
- Section: '5.1.2'
+ Section: "5.1.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND363
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The ICIMPLBL must be populated for each result, i.e. for each
- implantation site. In the situation where the implantations
- were not evaluated (ICSTAT = NOT DONE) per protocol, the
- artificial label, ALL, is used to represent missing results
- (see Example 5).
+ - Cited Guidance:
+ The ICIMPLBL must be populated for each result, i.e. for each implantation
+ site. In the situation where the implantations were not evaluated (ICSTAT = NOT DONE) per
+ protocol, the artificial label, ALL, is used to represent missing results (see Example 5).
Document: DART-IG v1.2
- Section: '5.1.2'
+ Section: "5.1.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND363
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
- # Rule has 2 parts:
+ # Rule has 2 parts:
# a) number of records for this subject = 1
- # b) when ICSTAT='NOT DONE', ICIMPLBL = "ALL"
+ # b) when ICSTAT='NOT DONE', ICIMPLBL = "ALL"
all:
- name: $record_count_USUBJID
operator: equal_to
value: 1
- name: ICSTAT
operator: equal_to
- value: 'NOT DONE'
- # Raise issue when ICIMPLBL is not "ALL"
+ value:
+ "NOT DONE"
+ # Raise issue when ICIMPLBL is not "ALL"
- name: ICIMPLBL
operator: not_equal_to
value: ALL
Core:
Id: CORE-000899
Status: Published
- Version: '1'
-Description: "Raise an issue when there is only one record for this subject in
- IC, LBSTAT='NOT DONE', and ICIMPLBL is not 'ALL'"
+ Version: "1"
+Description:
+ "Raise an issue when there is only one record for this subject in IC, LBSTAT='NOT DONE',
+ and ICIMPLBL is not 'ALL'"
Executability: Fully Executable
Operations:
# This counts the number of records for the current USUBJID
@@ -62,8 +62,7 @@ Operations:
id: $record_count_USUBJID
operator: record_count
Outcome:
- Message: "ICIMPLBL must be 'ALL' when there is only one record for the subject
- and ICSTAT is 'NOT DONE'"
+ Message: "ICIMPLBL must be 'ALL' when there is only one record for the subject and ICSTAT is 'NOT DONE'"
Output Variables:
- $record_count_USUBJID
- ICSTAT
diff --git a/Published/CORE-000900/rule.yml b/Published/CORE-000900/rule.yml
index 33a71b799..7ee1ceb93 100644
--- a/Published/CORE-000900/rule.yml
+++ b/Published/CORE-000900/rule.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within an encounter, if more environmental settings are
- defined, they must be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within an encounter, if more environmental settings are defined, they must be
+ distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00156'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00156"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'Code'
+ value: "Code"
- name: parent_entity
operator: equal_to
- value: 'Encounter'
+ value: "Encounter"
- name: parent_rel
operator: equal_to
- value: 'environmentalSettings'
+ value: "environmentalSettings"
value_is_literal: true
- name: code
operator: is_not_unique_set
@@ -34,11 +35,10 @@ Check:
- codeSystem
- codeSystemVersion
Core:
- Id: 'CORE-000900'
+ Id: "CORE-000900"
Status: Published
- Version: '1'
-Description: 'Within an encounter, if more environmental settings are defined,
- they must be distinct.'
+ Version: "1"
+Description: "Within an encounter, if more environmental settings are defined, they must be distinct."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -47,8 +47,9 @@ Match Datasets:
- rel_type
Name: Encounter
Outcome:
- Message: 'The environmental settings of the encounter are not unique - the same
- code is used more than once with the same codeSystem and codeSystemVersion.'
+ Message:
+ "The environmental settings of the encounter are not unique - the same code is used more than
+ once with the same codeSystem and codeSystemVersion."
Output Variables:
- name
- parent_entity
diff --git a/Published/CORE-000901/rule.yml b/Published/CORE-000901/rule.yml
index 60e2b6840..c65ce949f 100644
--- a/Published/CORE-000901/rule.yml
+++ b/Published/CORE-000901/rule.yml
@@ -4,133 +4,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be
- consistent with naming in other datasets across a submission.
+ - Cited Guidance:
+ Drugs and metabolite names in pharmacokinetic datasets should be consistent
+ with naming in other datasets across a submission.
Document: FDA
Section: FDAB069
Origin: FDA Business Rules
Rule Identifier:
Id: FB6901
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be
- consistent with naming in other datasets across a submission.
+ - Cited Guidance:
+ Drugs and metabolite names in pharmacokinetic datasets should be consistent
+ with naming in other datasets across a submission.
Document: FDA
Section: FDAB069
Origin: FDA Business Rules
Rule Identifier:
Id: FB6901
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be
- consistent with naming in other datasets across a submission.
+ - Cited Guidance:
+ Drugs and metabolite names in pharmacokinetic datasets should be consistent
+ with naming in other datasets across a submission.
Document: FDA
Section: FDAB069
Origin: FDA Business Rules
Rule Identifier:
Id: FB6901
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be
- consistent with naming in other datasets across a submission.
+ - Cited Guidance:
+ Drugs and metabolite names in pharmacokinetic datasets should be consistent
+ with naming in other datasets across a submission.
Document: FDA
Section: FDAB069
Origin: FDA Business Rules
Rule Identifier:
Id: FB6901
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be
- consistent with naming in other datasets across a submission.
+ - Cited Guidance:
+ Drugs and metabolite names in pharmacokinetic datasets should be consistent
+ with naming in other datasets across a submission.
Document: FDA
Section: FDAB069
Origin: FDA Business Rules
Rule Identifier:
Id: FB6901
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be
- consistent with naming in other datasets across a submission.
+ - Cited Guidance:
+ Drugs and metabolite names in pharmacokinetic datasets should be consistent
+ with naming in other datasets across a submission.
Document: FDA
Section: FDAB069
Origin: FDA Business Rules
Rule Identifier:
Id: FB6901
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be
- consistent with naming in other datasets across a submission.
+ - Cited Guidance:
+ Drugs and metabolite names in pharmacokinetic datasets should be consistent
+ with naming in other datasets across a submission.
Document: FDA
Section: FDAB069
Origin: FDA Business Rules
Rule Identifier:
Id: FB6901
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be
- consistent with naming in other datasets across a submission.
+ - Cited Guidance:
+ Drugs and metabolite names in pharmacokinetic datasets should be consistent
+ with naming in other datasets across a submission.
Document: FDA
Section: FDAB069
Origin: FDA Business Rules
Rule Identifier:
Id: FB6901
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be
- consistent with naming in other datasets across a submission.
+ - Cited Guidance:
+ Drugs and metabolite names in pharmacokinetic datasets should be consistent
+ with naming in other datasets across a submission.
Document: FDA
Section: FDAB069
Origin: FDA Business Rules
Rule Identifier:
Id: FB6901
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be
- consistent with naming in other datasets across a submission.
+ - Cited Guidance:
+ Drugs and metabolite names in pharmacokinetic datasets should be consistent
+ with naming in other datasets across a submission.
Document: FDA
Section: FDAB069
Origin: FDA Business Rules
Rule Identifier:
Id: FB6901
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: PPCAT
@@ -144,16 +154,16 @@ Check:
operator: not_equal_to
value: RELREC.PCTEST
Core:
- Status: Published
- Version: '1'
Id: CORE-000901
-Description: 'The values of PPCAT and PCTEST do not match at the same reference timepoint'
+ Status: Published
+ Version: "1"
+Description: "The values of PPCAT and PCTEST do not match at the same reference timepoint"
Executability: Partially Executable
Match Datasets:
- Name: RELREC
Wildcard: PC
Outcome:
- Message: 'The values of PPCAT and PCTEST do not match at the same reference timepoint'
+ Message: "The values of PPCAT and PCTEST do not match at the same reference timepoint"
Output Variables:
- PPCAT
- PPRFTDTC
diff --git a/Published/CORE-000902/rule.yml b/Published/CORE-000902/rule.yml
index c7e8f6e15..79467ca0c 100644
--- a/Published/CORE-000902/rule.yml
+++ b/Published/CORE-000902/rule.yml
@@ -6,219 +6,216 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: New variables (other than that are from the same general
- observation class) must not be added, and existing variables
- must not be renamed or modified for novel usage.
+ - Cited Guidance:
+ New variables (other than that are from the same general observation class)
+ must not be added, and existing variables must not be renamed or modified for novel usage.
Document: IG v3.0
Item: Specification
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND268
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When preparing datasets based on the SENDIG domain models,
- sponsors must not add any variables other than specified
- Identifier variables (SDTM (http://www.cdisc.org/sdtm) Table
- 2.2.4), Timing variables (SDTM Table 2.2.5), or Qualifier
- variables from the same general observation class (described
- in SDTM Tables 2.2.1-2.2.3). The addition of non-standard
- variables will compromise the ability to use the datasets
- (e.g., to populate a data repository and/or use standard
- tools). See Appendix E for a list of SDTM variables that
- should never be used in SEND.
+ - Cited Guidance:
+ When preparing datasets based on the SENDIG domain models, sponsors must not
+ add any variables other than specified Identifier variables (SDTM
+ (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or
+ Qualifier variables from the same general observation class (described in SDTM Tables
+ 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use
+ the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix
+ E for a list of SDTM variables that should never be used in SEND.
Document: IG v3.1
Item: Specification
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND268.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When preparing datasets based on the SENDIG domain models,
- sponsors must not add any variables other than specified
- Identifier variables (SDTM (http://www.cdisc.org/sdtm) Table
- 2.2.4), Timing variables (SDTM Table 2.2.5), or Qualifier
- variables from the same general observation class (described
- in SDTM Tables 2.2.1-2.2.3). The addition of non-standard
- variables will compromise the ability to use the datasets
- (e.g., to populate a data repository and/or use standard
- tools). See Appendix E for a list of SDTM variables that
- should never be used in SEND.
+ - Cited Guidance:
+ When preparing datasets based on the SENDIG domain models, sponsors must not
+ add any variables other than specified Identifier variables (SDTM
+ (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or
+ Qualifier variables from the same general observation class (described in SDTM Tables
+ 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use
+ the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix
+ E for a list of SDTM variables that should never be used in SEND.
Document: IG v3.1.1
Item: Specification
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND268.1
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: When preparing datasets based on the SENDIG domain models,
- sponsors must not add any variables other than specified
- Identifier variables (SDTM (http://www.cdisc.org/sdtm) Table
- 2.2.4), Timing variables (SDTM Table 2.2.5), or Qualifier
- variables from the same general observation class (described
- in SDTM Tables 2.2.1-2.2.3). The addition of non-standard
- variables will compromise the ability to use the datasets
- (e.g., to populate a data repository and/or use standard
- tools). See Appendix E for a list of SDTM variables that
- should never be used in SEND.
+ - Cited Guidance:
+ When preparing datasets based on the SENDIG domain models, sponsors must not
+ add any variables other than specified Identifier variables (SDTM
+ (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or
+ Qualifier variables from the same general observation class (described in SDTM Tables
+ 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use
+ the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix
+ E for a list of SDTM variables that should never be used in SEND.
Document: IG v3.1.1
Item: Specification
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND268.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When preparing datasets based on the SENDIG domain models,
- sponsors must not add any variables other than specified
- Identifier variables (SDTM (http://www.cdisc.org/sdtm) Table
- 2.2.4), Timing variables (SDTM Table 2.2.5), or Qualifier
- variables from the same general observation class (described
- in SDTM Tables 2.2.1-2.2.3). The addition of non-standard
- variables will compromise the ability to use the datasets
- (e.g., to populate a data repository and/or use standard
- tools). See Appendix E for a list of SDTM variables that
- should never be used in SEND.
+ - Cited Guidance:
+ When preparing datasets based on the SENDIG domain models, sponsors must not
+ add any variables other than specified Identifier variables (SDTM
+ (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or
+ Qualifier variables from the same general observation class (described in SDTM Tables
+ 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use
+ the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix
+ E for a list of SDTM variables that should never be used in SEND.
Document: IG v3.1
Item: Specification
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND268.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When preparing datasets based on the SENDIG domain models,
- sponsors must not add any variables other than specified
- Identifier variables (SDTM (http://www.cdisc.org/sdtm) Table
- 2.2.4), Timing variables (SDTM Table 2.2.5), or Qualifier
- variables from the same general observation class (described
- in SDTM Tables 2.2.1-2.2.3). The addition of non-standard
- variables will compromise the ability to use the datasets
- (e.g., to populate a data repository and/or use standard
- tools). See Appendix E for a list of SDTM variables that
- should never be used in SEND.
+ - Cited Guidance:
+ When preparing datasets based on the SENDIG domain models, sponsors must not
+ add any variables other than specified Identifier variables (SDTM
+ (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or
+ Qualifier variables from the same general observation class (described in SDTM Tables
+ 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use
+ the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix
+ E for a list of SDTM variables that should never be used in SEND.
Document: IG v3.1.1
Item: Specification
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND268.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
- # Part 2: SEND269/269.1
+ Version: "1"
+ Version: "5.0"
+ Version:
+ "1.2"
+ # Part 2: SEND269/269.1
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: New variables (other than those that are from the same general
- observation class) must not be added, and existing variables
- must not be renamed or modified for novel usage.
+ - Cited Guidance:
+ New variables (other than those that are from the same general observation
+ class) must not be added, and existing variables must not be renamed or modified for novel
+ usage.
Document: IG v3.0
Item: Specification
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND269
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: New variables (other than those that are from the same general
- observation class) must not be added, and existing variables
- must not be renamed or modified for novel usage.
+ - Cited Guidance:
+ New variables (other than those that are from the same general observation
+ class) must not be added, and existing variables must not be renamed or modified for novel
+ usage.
Document: IG v3.1
Item: Specification
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND269.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: New variables (other than those that are from the same general
- observation class) must not be added, and existing variables
- must not be renamed or modified for novel usage.
+ - Cited Guidance:
+ New variables (other than those that are from the same general observation
+ class) must not be added, and existing variables must not be renamed or modified for novel
+ usage.
Document: IG v3.1.1
Item: Specification
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND269.1
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: New variables (other than those that are from the same general
- observation class) must not be added, and existing variables
- must not be renamed or modified for novel usage.
+ - Cited Guidance:
+ New variables (other than those that are from the same general observation
+ class) must not be added, and existing variables must not be renamed or modified for novel
+ usage.
Document: IG v3.1.1
Item: Specification
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND269.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: New variables (other than those that are from the same general
- observation class) must not be added, and existing variables
- must not be renamed or modified for novel usage.
+ - Cited Guidance:
+ New variables (other than those that are from the same general observation
+ class) must not be added, and existing variables must not be renamed or modified for novel
+ usage.
Document: IG v3.1
Item: Specification
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND269.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: New variables (other than those that are from the same general
- observation class) must not be added, and existing variables
- must not be renamed or modified for novel usage.
+ - Cited Guidance:
+ New variables (other than those that are from the same general observation
+ class) must not be added, and existing variables must not be renamed or modified for novel
+ usage.
Document: IG v3.1.1
Item: Specification
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND269.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
# The code is the same as for CG0013, but the scope is slightly different
# (for SEND, the scope is limited to Interventions, Events and Findings)
@@ -230,16 +227,14 @@ Check:
Core:
Id: CORE-000902
Status: Published
- Version: '1'
-Description: 'Trigger error when variable is not an allowed variable for the
- underlying Observation Class'
+ Version: "1"
+Description: "Trigger error when variable is not an allowed variable for the underlying Observation Class"
Executability: Fully Executable
Operations:
- id: $allowed_variables
operator: get_model_column_order
Outcome:
- Message: 'The variable is not an allowed variable for the underlying Observation
- Class'
+ Message: "The variable is not an allowed variable for the underlying Observation Class"
Rule Type: Variable Metadata Check against Library Metadata
Scope:
Classes:
diff --git a/Published/CORE-000903/rule.yml b/Published/CORE-000903/rule.yml
index ef83668f4..fdb2e24f4 100644
--- a/Published/CORE-000903/rule.yml
+++ b/Published/CORE-000903/rule.yml
@@ -4,59 +4,61 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure; ..Demographics (DM), Comments
- (CO), and Subject Elements (SE) include study data that do not
- conform to one of the three general observation classes. These
- are described in Section 5"
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure; ..Demographics (DM), Comments (CO), and Subject Elements (SE) include study
+ data that do not conform to one of the three general observation classes. These are described
+ in Section 5"
Document: SENDIG v3.1
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND297
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure; ..Demographics (DM), Comments
- (CO), and Subject Elements (SE) include study data that do not
- conform to one of the three general observation classes. These
- are described in Section 5"
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure; ..Demographics (DM), Comments (CO), and Subject Elements (SE) include study
+ data that do not conform to one of the three general observation classes. These are described
+ in Section 5"
Document: SENDIG v3.1
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND297
- Version: '1'
- Version: '5.0'
- Version: '1.1'
- # P.S. Not applicable to SENDIG-3.1.1, DART-1.2 and GENETOX
+ Version: "1"
+ Version: "5.0"
+ Version:
+ "1.1"
+ # P.S. Not applicable to SENDIG-3.1.1, DART-1.2 and GENETOX
Check:
all:
# select variable (is present) in dataset
- name: variable_name
- operator: exists
- # check whether the variable is known in the CDISC Library
+ operator:
+ exists
+ # check whether the variable is known in the CDISC Library
- name: variable_name
operator: not_equal_to
value: library_variable_name
Core:
Id: CORE-000903
Status: Published
- Version: '1'
-Description: "Additional variables not specified in the SENDIG description of
- the domain (including both the domain table and assumptions) may not be added
- to DM, CO, or SE"
+ Version: "1"
+Description:
+ "Additional variables not specified in the SENDIG description of the domain (including both
+ the domain table and assumptions) may not be added to DM, CO, or SE"
Executability: Fully Executable
Outcome:
- Message: The variable is not allowed in this domain as it is not specified in
- the SENDIG for the specific domain
+ Message: The variable is not allowed in this domain as it is not specified in the SENDIG for the
+ specific domain
Output Variables:
- variable_name
- # - library_variable_name
+ # - library_variable_name
Rule Type: Variable Metadata Check against Library Metadata
Scope:
Classes:
diff --git a/Published/CORE-000904/rule.yml b/Published/CORE-000904/rule.yml
index 9214aa1a4..8e6d84226 100644
--- a/Published/CORE-000904/rule.yml
+++ b/Published/CORE-000904/rule.yml
@@ -4,32 +4,34 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A timing''s type must be specified using the Timing Type Value
- Set Terminology (C201264) DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A timing's type must be specified using the Timing Type Value Set Terminology
+ (C201264) DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00051'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00051"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A timing''s type must be specified using the Timing Type Value
- Set Terminology (C201264) DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A timing's type must be specified using the Timing Type Value Set Terminology
+ (C201264) DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00051'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00051"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type
operator: equal_to
value: true
@@ -37,7 +39,7 @@ Check:
all:
- name: type.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: type.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -79,11 +81,12 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000904'
+ Id: "CORE-000904"
Status: Published
- Version: '1'
-Description: 'A timing''s type must be specified using the Timing Type Value Set
- Terminology (C201264) DDF codelist.'
+ Version: "1"
+Description:
+ "A timing's type must be specified using the Timing Type Value Set Terminology (C201264)
+ DDF codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -128,13 +131,12 @@ Operations:
term_value: type.decode
version: type.codeSystemVersion
Outcome:
- Message: 'The timing''s type is not specified using the Timing Type Value Set
- Terminology (C201264) DDF codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, the code or decode (either as preferred term or as submission value)
- is found in the codelist (case insensitive) but the corresponding decode or
- code does not match the codelist value (case sensitive), and/or neither code
- nor decode is found in the codelist.'
+ Message:
+ 'The timing''s type is not specified using the Timing Type Value Set Terminology (C201264)
+ DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
+ package date, the code or decode (either as preferred term or as submission value) is found in the
+ codelist (case insensitive) but the corresponding decode or code does not match the codelist value
+ (case sensitive), and/or neither code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -155,5 +157,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Timing'
+ - "Timing"
Sensitivity: Record
diff --git a/Published/CORE-000905/rule.yml b/Published/CORE-000905/rule.yml
index 3e2d575a3..311e1a854 100644
--- a/Published/CORE-000905/rule.yml
+++ b/Published/CORE-000905/rule.yml
@@ -4,34 +4,34 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A timing''s relative to/from property must be specified using
- the Timing Relative To From Value Set Terminology (C201265)
- DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A timing's relative to/from property must be specified using the Timing Relative
+ To From Value Set Terminology (C201265) DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00104'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00104"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A timing''s relative to/from property must be specified using
- the Timing Relative To From Value Set Terminology (C201265)
- DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A timing's relative to/from property must be specified using the Timing Relative
+ To From Value Set Terminology (C201265) DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00104'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00104"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: relativeToFrom
operator: equal_to
value: true
@@ -39,7 +39,7 @@ Check:
all:
- name: relativeToFrom.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: relativeToFrom.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -81,11 +81,12 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000905'
+ Id: "CORE-000905"
Status: Published
- Version: '1'
-Description: 'A timing''s relative to/from property must be specified using the
- Timing Relative To From Value Set Terminology (C201265) DDF codelist.'
+ Version: "1"
+Description:
+ "A timing's relative to/from property must be specified using the Timing Relative To From
+ Value Set Terminology (C201265) DDF codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -130,13 +131,12 @@ Operations:
term_value: relativeToFrom.decode
version: relativeToFrom.codeSystemVersion
Outcome:
- Message: 'The timing''s relative to/from property is not specified using the
- Timing Relative To From Value Set Terminology (C201265) DDF codelist -
- codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
- terminology package date, the code or decode (either as preferred term or as
- submission value) is found in the codelist (case insensitive) but the
- corresponding decode or code does not match the codelist value (case
- sensitive), and/or neither code nor decode is found in the codelist.'
+ Message:
+ 'The timing''s relative to/from property is not specified using the Timing Relative To From
+ Value Set Terminology (C201265) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, the code or decode (either as preferred term or as submission
+ value) is found in the codelist (case insensitive) but the corresponding decode or code does not match
+ the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -157,5 +157,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Timing'
+ - "Timing"
Sensitivity: Record
diff --git a/Published/CORE-000906/rule.yml b/Published/CORE-000906/rule.yml
index 12cf02aa4..b85b35569 100644
--- a/Published/CORE-000906/rule.yml
+++ b/Published/CORE-000906/rule.yml
@@ -4,8 +4,9 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "The unit of a planned age is expected to be specified using
- terms from the Age Unit (C66781) SDTM codelist."
+ - Cited Guidance:
+ "The unit of a planned age is expected to be specified using terms from the Age
+ Unit (C66781) SDTM codelist."
Document: "USDM_CORE_Rules.xlsx"
Origin: "USDM Conformance Rules"
Rule Identifier:
@@ -70,8 +71,9 @@ Core:
Id: "CORE-000906"
Status: Published
Version: "1"
-Description: "The unit of a planned age is expected to be specified using terms
- from the Age Unit (C66781) SDTM codelist."
+Description:
+ "The unit of a planned age is expected to be specified using terms from the Age Unit (C66781)
+ SDTM codelist."
Executability: Partially Executable - Possible Overreporting
Operations:
- id: $codelist_code
@@ -116,13 +118,12 @@ Operations:
term_value: plannedAge.unit.decode
version: plannedAge.unit.codeSystemVersion
Outcome:
- Message: 'The unit of the planned age is not specified using the Age Unit
- (C66781) SDTM codelist - codeSystem is not "http://www.cdisc.org",
- codeSystemVersion is not a valid terminology package date, the code or
- decode (either as preferred term or as submission value) is found in the
- codelist (case insensitive) but the corresponding decode or code does not
- match the codelist value (case sensitive), and/or neither code nor decode is
- found in the codelist.'
+ Message:
+ 'The unit of the planned age is not specified using the Age Unit (C66781) SDTM codelist - codeSystem
+ is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code
+ or decode (either as preferred term or as submission value) is found in the codelist (case insensitive)
+ but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither
+ code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
diff --git a/Published/CORE-000907/rule.yml b/Published/CORE-000907/rule.yml
index f0a1594a3..8850d9153 100644
--- a/Published/CORE-000907/rule.yml
+++ b/Published/CORE-000907/rule.yml
@@ -4,32 +4,34 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study intervention''s role must be specified using the study
- intervention role (C207417) DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study intervention's role must be specified using the study intervention role
+ (C207417) DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00112'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00112"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study intervention''s role must be specified using the study
- intervention role (C207417) DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study intervention's role must be specified using the study intervention role
+ (C207417) DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00112'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00112"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: role
operator: equal_to
value: true
@@ -37,7 +39,7 @@ Check:
all:
- name: role.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: role.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -79,11 +81,12 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000907'
+ Id: "CORE-000907"
Status: Published
- Version: '1'
-Description: 'A study intervention''s role must be specified using the study
- intervention role (C207417) DDF codelist.'
+ Version: "1"
+Description:
+ "A study intervention's role must be specified using the study intervention role (C207417)
+ DDF codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -128,13 +131,12 @@ Operations:
term_value: role.decode
version: role.codeSystemVersion
Outcome:
- Message: 'The study intervention''s role is not specified using the study
- intervention role (C207417) DDF codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, the code or decode (either as preferred term or as submission value)
- is found in the codelist (case insensitive) but the corresponding decode or
- code does not match the codelist value (case sensitive), and/or neither code
- nor decode is found in the codelist.'
+ Message:
+ 'The study intervention''s role is not specified using the study intervention role (C207417)
+ DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
+ package date, the code or decode (either as preferred term or as submission value) is found in the
+ codelist (case insensitive) but the corresponding decode or code does not match the codelist value
+ (case sensitive), and/or neither code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -155,5 +157,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyIntervention'
+ - "StudyIntervention"
Sensitivity: Record
diff --git a/Published/CORE-000908/rule.yml b/Published/CORE-000908/rule.yml
index 6f6729920..94ce02362 100644
--- a/Published/CORE-000908/rule.yml
+++ b/Published/CORE-000908/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An agent administration's frequency must be specified according
- to the extensible Frequency (C71113) SDTM codelist (e.g. an
- entry with a code or decode used from the codelist should be
- consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An agent administration's frequency must be specified according to the extensible
+ Frequency (C71113) SDTM codelist (e.g. an entry with a code or decode used from the codelist
+ should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00113'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00113"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: frequency.standardCode
operator: exists
- name: frequency.standardCode
@@ -29,7 +29,7 @@ Check:
all:
- name: frequency.standardCode.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: frequency.standardCode.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -71,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000908'
+ Id: "CORE-000908"
Status: Published
- Version: '1'
-Description: "An agent administration's frequency must be specified according to
- the extensible Frequency (C71113) SDTM codelist (e.g. an entry with a code or
- decode used from the codelist should be consistent with the full entry in the
- codelist)."
+ Version: "1"
+Description:
+ "An agent administration's frequency must be specified according to the extensible Frequency
+ (C71113) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent
+ with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -122,12 +122,12 @@ Operations:
term_value: frequency.standardCode.decode
version: frequency.standardCode.codeSystemVersion
Outcome:
- Message: 'The agent administration''s frequency is not specified according to
- the extensible Frequency (C71113) SDTM codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, and/or the code or decode (either as preferred term or as submission
- value) is found in the codelist (case insensitive) but the corresponding
- decode or code does not match the codelist value (case sensitive).'
+ Message:
+ 'The agent administration''s frequency is not specified according to the extensible Frequency
+ (C71113) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
+ terminology package date, and/or the code or decode (either as preferred term or as submission value)
+ is found in the codelist (case insensitive) but the corresponding decode or code does not match the
+ codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -148,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'AgentAdministration'
+ - "AgentAdministration"
Sensitivity: Record
diff --git a/Published/CORE-000909/rule.yml b/Published/CORE-000909/rule.yml
index 256493068..1c6458f0b 100644
--- a/Published/CORE-000909/rule.yml
+++ b/Published/CORE-000909/rule.yml
@@ -4,20 +4,21 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study version''s study type must be specified using the Study
- Type Response (C99077) SDTM codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study version's study type must be specified using the Study Type Response
+ (C99077) SDTM codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00116'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00116"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: studyType
operator: equal_to
value: true
@@ -25,7 +26,7 @@ Check:
all:
- name: studyType.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: studyType.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -67,11 +68,12 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000909'
+ Id: "CORE-000909"
Status: Published
- Version: '1'
-Description: 'A study version''s study type must be specified using the Study
- Type Response (C99077) SDTM codelist.'
+ Version: "1"
+Description:
+ "A study version's study type must be specified using the Study Type Response (C99077) SDTM
+ codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -116,13 +118,12 @@ Operations:
term_value: studyType.decode
version: studyType.codeSystemVersion
Outcome:
- Message: 'The study version''s study type is not specified using the Study Type
- Response (C99077) SDTM codelist - codeSystem is not "http://www.cdisc.org",
- codeSystemVersion is not a valid terminology package date, the code or
- decode (either as preferred term or as submission value) is found in the
- codelist (case insensitive) but the corresponding decode or code does not
- match the codelist value (case sensitive), and/or neither code nor decode is
- found in the codelist.'
+ Message:
+ 'The study version''s study type is not specified using the Study Type Response (C99077) SDTM
+ codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
+ package date, the code or decode (either as preferred term or as submission value) is found in the
+ codelist (case insensitive) but the corresponding decode or code does not match the codelist value
+ (case sensitive), and/or neither code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -143,5 +144,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyVersion'
+ - "StudyVersion"
Sensitivity: Record
diff --git a/Published/CORE-000910/rule.yml b/Published/CORE-000910/rule.yml
index 6bd837cf3..7d95f61aa 100644
--- a/Published/CORE-000910/rule.yml
+++ b/Published/CORE-000910/rule.yml
@@ -4,21 +4,21 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study protocol document version''s protocol status must be
- specified using the Protocol Status Value Set Terminology
- (C188723) DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study protocol document version's protocol status must be specified using the
+ Protocol Status Value Set Terminology (C188723) DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00117'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00117"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: protocolStatus
operator: equal_to
value: true
@@ -26,7 +26,7 @@ Check:
all:
- name: protocolStatus.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: protocolStatus.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -68,12 +68,12 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000910'
+ Id: "CORE-000910"
Status: Published
- Version: '1'
-Description: 'A study protocol document version''s protocol status must be
- specified using the Protocol Status Value Set Terminology (C188723) DDF
- codelist.'
+ Version: "1"
+Description:
+ "A study protocol document version's protocol status must be specified using the Protocol
+ Status Value Set Terminology (C188723) DDF codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -118,14 +118,12 @@ Operations:
term_value: protocolStatus.decode
version: protocolStatus.codeSystemVersion
Outcome:
- Message: 'The study protocol document version''s protocol status is not
- specified using the Protocol Status Value Set Terminology (C188723) DDF
- codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is
- not a valid terminology package date, the code or decode (either as
- preferred term or as submission value) is found in the codelist (case
- insensitive) but the corresponding decode or code does not match the
- codelist value (case sensitive), and/or neither code nor decode is found in
- the codelist.'
+ Message:
+ 'The study protocol document version''s protocol status is not specified using the Protocol
+ Status Value Set Terminology (C188723) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, the code or decode (either as preferred term or as submission
+ value) is found in the codelist (case insensitive) but the corresponding decode or code does not match
+ the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -146,5 +144,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyProtocolDocumentVersion'
+ - "StudyProtocolDocumentVersion"
Sensitivity: Record
diff --git a/Published/CORE-000911/rule.yml b/Published/CORE-000911/rule.yml
index cbd087e52..544840dc0 100644
--- a/Published/CORE-000911/rule.yml
+++ b/Published/CORE-000911/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study design's trial intent types must be specified according
- to the extensible Trial Intent Type Response (C66736) SDTM
- codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study design's trial intent types must be specified according to the extensible
+ Trial Intent Type Response (C66736) SDTM codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00118'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00118"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: trialIntentTypes
operator: exists
- name: trialIntentTypes
@@ -28,13 +27,13 @@ Check:
value: true
- name: parent_rel.Code
operator: equal_to
- value: 'trialIntentTypes'
+ value: "trialIntentTypes"
value_is_literal: true
- not:
all:
- name: codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -76,13 +75,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000911'
+ Id: "CORE-000911"
Status: Published
- Version: '1'
-Description: "A study design's trial intent types must be specified according to
- the extensible Trial Intent Type Response (C66736) SDTM codelist (e.g. an
- entry with a code or decode used from the codelist should be consistent with
- the full entry in the codelist)."
+ Version: "1"
+Description:
+ "A study design's trial intent types must be specified according to the extensible Trial
+ Intent Type Response (C66736) SDTM codelist (e.g. an entry with a code or decode used from the codelist
+ should be consistent with the full entry in the codelist)."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -96,7 +95,7 @@ Operations:
- id: $codelist_code
map:
- output: C66736
- parent_rel.Code: 'trialIntentTypes'
+ parent_rel.Code: "trialIntentTypes"
operator: map
- ct_package_types:
- SDTM
@@ -136,13 +135,12 @@ Operations:
term_value: decode
version: codeSystemVersion
Outcome:
- Message: 'The study design''s trial intent type is not specified according to
- the extensible Trial Intent Type Response (C66736) SDTM codelist -
- codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
- terminology package date, and/or the code or decode (either as preferred
- term or as submission value) is found in the codelist (case insensitive) but
- the corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The study design''s trial intent type is not specified according to the extensible Trial Intent
+ Type Response (C66736) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, and/or the code or decode (either as preferred term or as
+ submission value) is found in the codelist (case insensitive) but the corresponding decode or code
+ does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -163,5 +161,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyDesign'
+ - "StudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000912/rule.yml b/Published/CORE-000912/rule.yml
index 4ffdd9c48..9243104e9 100644
--- a/Published/CORE-000912/rule.yml
+++ b/Published/CORE-000912/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study design's trial types must be specified according to the
- extensible Trial Type Response (C66739) SDTM codelist (e.g. an
- entry with a code or decode used from the codelist should be
- consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study design's trial types must be specified according to the extensible Trial
+ Type Response (C66739) SDTM codelist (e.g. an entry with a code or decode used from the codelist
+ should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00119'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00119"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: trialTypes
operator: exists
- name: trialTypes
@@ -27,13 +27,13 @@ Check:
value: true
- name: parent_rel.Code
operator: equal_to
- value: 'trialTypes'
+ value: "trialTypes"
value_is_literal: true
- not:
all:
- name: codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -75,13 +75,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000912'
+ Id: "CORE-000912"
Status: Published
- Version: '1'
-Description: "A study design's trial types must be specified according to the
- extensible Trial Type Response (C66739) SDTM codelist (e.g. an entry with a
- code or decode used from the codelist should be consistent with the full entry
- in the codelist)."
+ Version: "1"
+Description:
+ "A study design's trial types must be specified according to the extensible Trial Type Response
+ (C66739) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent
+ with the full entry in the codelist)."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -95,7 +95,7 @@ Operations:
- id: $codelist_code
map:
- output: C66739
- parent_rel.Code: 'trialTypes'
+ parent_rel.Code: "trialTypes"
operator: map
- ct_package_types:
- SDTM
@@ -135,12 +135,12 @@ Operations:
term_value: decode
version: codeSystemVersion
Outcome:
- Message: 'The study design''s trial type is not specified according to the
- extensible Trial Type Response (C66739) SDTM codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, and/or the code or decode (either as preferred term or as submission
- value) is found in the codelist (case insensitive) but the corresponding
- decode or code does not match the codelist value (case sensitive).'
+ Message:
+ 'The study design''s trial type is not specified according to the extensible Trial Type Response
+ (C66739) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
+ terminology package date, and/or the code or decode (either as preferred term or as submission value)
+ is found in the codelist (case insensitive) but the corresponding decode or code does not match the
+ codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -161,5 +161,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyDesign'
+ - "StudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000914/rule.yml b/Published/CORE-000914/rule.yml
index 2edd77f52..e75c9b916 100644
--- a/Published/CORE-000914/rule.yml
+++ b/Published/CORE-000914/rule.yml
@@ -2,145 +2,155 @@
# Condition: --BLFL="Y" and '--STRESC ^= Null
# Rule: 'Only one --BLFL per record having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.
- Document: 'FDA'
- Section: 'FDAB026'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ Records with a baseline flag should have a corresponding standard result
+ with a standardized unit where available.
+ Document: "FDA"
+ Section: "FDAB026"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB2603'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB2603"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.
- Document: 'FDA'
- Section: 'FDAB026'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ Records with a baseline flag should have a corresponding standard result
+ with a standardized unit where available.
+ Document: "FDA"
+ Section: "FDAB026"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB2603'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB2603"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.
- Document: 'FDA'
- Section: 'FDAB026'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ Records with a baseline flag should have a corresponding standard result
+ with a standardized unit where available.
+ Document: "FDA"
+ Section: "FDAB026"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB2603'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB2603"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.
- Document: 'FDA'
- Section: 'FDAB026'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ Records with a baseline flag should have a corresponding standard result
+ with a standardized unit where available.
+ Document: "FDA"
+ Section: "FDAB026"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB2603'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB2603"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.
- Document: 'FDA'
- Section: 'FDAB026'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ Records with a baseline flag should have a corresponding standard result
+ with a standardized unit where available.
+ Document: "FDA"
+ Section: "FDAB026"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB2603'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB2603"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.
- Document: 'FDA'
- Section: 'FDAB026'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ Records with a baseline flag should have a corresponding standard result
+ with a standardized unit where available.
+ Document: "FDA"
+ Section: "FDAB026"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB2603'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB2603"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.
- Document: 'FDA'
- Section: 'FDAB026'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ Records with a baseline flag should have a corresponding standard result
+ with a standardized unit where available.
+ Document: "FDA"
+ Section: "FDAB026"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB2603'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB2603"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.
- Document: 'FDA'
- Section: 'FDAB026'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ Records with a baseline flag should have a corresponding standard result
+ with a standardized unit where available.
+ Document: "FDA"
+ Section: "FDAB026"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB2603'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB2603"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.
- Document: 'FDA'
- Section: 'FDAB026'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ Records with a baseline flag should have a corresponding standard result
+ with a standardized unit where available.
+ Document: "FDA"
+ Section: "FDAB026"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB2603'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB2603"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: Records with a baseline flag should have a corresponding
- standard result with a standardized unit where available.
- Document: 'FDA'
- Section: 'FDAB026'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ Records with a baseline flag should have a corresponding standard result
+ with a standardized unit where available.
+ Document: "FDA"
+ Section: "FDAB026"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB2603'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB2603"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --STRESC
operator: non_empty
- name: --BLFL
operator: equal_to
- value: 'Y'
+ value: "Y"
value_is_literal: true
- name: --BLFL
operator: is_not_unique_set
@@ -152,12 +162,11 @@ Check:
- --METHOD
- USUBJID
Core:
- Status: Published
- Version: '1'
Id: CORE-000914
-Description: There should be only one record with a baseline flag and non
- missing character standard result value having the same --TESTCD, --CAT,
- --SCAT, --SPEC, --METHOD values.
+ Status: Published
+ Version: "1"
+Description: There should be only one record with a baseline flag and non missing character standard
+ result value having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values.
Executability: Fully Executable
Outcome:
Message: There are multiple records per assigned baseline flag (--BLFL).
diff --git a/Published/CORE-000916/rule.yml b/Published/CORE-000916/rule.yml
index 1c55e84af..d6009a04b 100644
--- a/Published/CORE-000916/rule.yml
+++ b/Published/CORE-000916/rule.yml
@@ -7,82 +7,86 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies.
Document: Model v2.0
Item: IDVAR
Section: Comments
- - Cited Guidance: Name of the identifying variable in the
- general-observation-class dataset that identifies the related
- record(s).
+ - Cited Guidance:
+ Name of the identifying variable in the general-observation-class dataset
+ that identifies the related record(s).
Document: Model v2.0
Item: IDVAR
Section: Supplemental Qualifiers
- - Cited Guidance: Name of the identifying variable in the
- general-observation-class dataset that identifies the related
- record(s).
+ - Cited Guidance:
+ Name of the identifying variable in the general-observation-class dataset
+ that identifies the related record(s).
Document: Model v2.0
Item: IDVAR
Section: Related Records
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0370
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies.
Document: Model v1.4
Section: 2.2.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0370
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies.
Document: Model v1.7
Section: 2.2.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0370
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies.
Document: SDTM v2.1
Item: IDVAR
Section: 3.2.2 Comments
- - Cited Guidance: Name of the identifying variable in the
- general-observation-class dataset that identifies the related
- record(s).
+ - Cited Guidance:
+ Name of the identifying variable in the general-observation-class dataset
+ that identifies the related record(s).
Document: SDTM v2.1
Item: IDVAR
Section: 6.2 Supplemental Qualifiers Datasets
- - Cited Guidance: Name of the identifying variable in the
- general-observation-class dataset that identifies the related
- record(s).
+ - Cited Guidance:
+ Name of the identifying variable in the general-observation-class dataset
+ that identifies the related record(s).
Document: SDTM v2.1
Item: IDVAR
Section: Section 6.1 Related Records Dataset
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0534
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: RDOMAIN
@@ -95,9 +99,9 @@ Check:
Core:
Id: CORE-000916
Status: Published
- Version: '1'
-Description: Part B - Raise and error when IDVAR in RELREC is not populated with
- a valid variable from the dataset referenced in RDOMAIN.
+ Version: "1"
+Description: Part B - Raise and error when IDVAR in RELREC is not populated with a valid variable
+ from the dataset referenced in RDOMAIN.
Executability: Fully Executable
Match Datasets:
- Child: true
@@ -113,8 +117,8 @@ Operations:
operator: distinct
value_is_reference: true
Outcome:
- Message: Value for IDVAR in RELREC does not represent a variable present in the
- dataset referenced in RDOMAIN.
+ Message: Value for IDVAR in RELREC does not represent a variable present in the dataset referenced
+ in RDOMAIN.
Output Variables:
- IDVAR
Rule Type: Record Data
diff --git a/Published/CORE-000917/rule.yml b/Published/CORE-000917/rule.yml
index f03836d2f..debb9779a 100644
--- a/Published/CORE-000917/rule.yml
+++ b/Published/CORE-000917/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study design's intervention model must be specified according
- to the extensible Intervention Model Response (C99076) SDTM
- codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study design's intervention model must be specified according to the extensible
+ Intervention Model Response (C99076) SDTM codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00120'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00120"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: interventionModel
operator: exists
- name: interventionModel
@@ -30,7 +29,7 @@ Check:
all:
- name: interventionModel.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: interventionModel.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000917'
+ Id: "CORE-000917"
Status: Published
- Version: '1'
-Description: "A study design's intervention model must be specified according to
- the extensible Intervention Model Response (C99076) SDTM codelist (e.g. an
- entry with a code or decode used from the codelist should be consistent with
- the full entry in the codelist)."
+ Version: "1"
+Description:
+ "A study design's intervention model must be specified according to the extensible Intervention
+ Model Response (C99076) SDTM codelist (e.g. an entry with a code or decode used from the codelist should
+ be consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +122,12 @@ Operations:
term_value: interventionModel.decode
version: interventionModel.codeSystemVersion
Outcome:
- Message: 'The study design''s intervention model is not specified according to
- the extensible Intervention Model Response (C99076) SDTM codelist -
- codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
- terminology package date, and/or the code or decode (either as preferred
- term or as submission value) is found in the codelist (case insensitive) but
- the corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The study design''s intervention model is not specified according to the extensible Intervention
+ Model Response (C99076) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, and/or the code or decode (either as preferred term or as
+ submission value) is found in the codelist (case insensitive) but the corresponding decode or code
+ does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyDesign'
+ - "StudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000918/rule.yml b/Published/CORE-000918/rule.yml
index 33e3a786f..f39b44ab7 100644
--- a/Published/CORE-000918/rule.yml
+++ b/Published/CORE-000918/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study design's blinding schema must be specified according to
- the extensible Trial Blinding Schema Response (C66735) SDTM
- codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study design's blinding schema must be specified according to the extensible
+ Trial Blinding Schema Response (C66735) SDTM codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00121'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00121"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: blindingSchema
operator: exists
- name: blindingSchema
@@ -30,7 +29,7 @@ Check:
all:
- name: blindingSchema.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: blindingSchema.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000918'
+ Id: "CORE-000918"
Status: Published
- Version: '1'
-Description: "A study design's blinding schema must be specified according to
- the extensible Trial Blinding Schema Response (C66735) SDTM codelist (e.g. an
- entry with a code or decode used from the codelist should be consistent with
- the full entry in the codelist)."
+ Version: "1"
+Description:
+ "A study design's blinding schema must be specified according to the extensible Trial Blinding
+ Schema Response (C66735) SDTM codelist (e.g. an entry with a code or decode used from the codelist should
+ be consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +122,12 @@ Operations:
term_value: blindingSchema.decode
version: blindingSchema.codeSystemVersion
Outcome:
- Message: 'The study design''s blinding schema is not specified according to the
- extensible Trial Blinding Schema Response (C66735) SDTM codelist -
- codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
- terminology package date, and/or the code or decode (either as preferred
- term or as submission value) is found in the codelist (case insensitive) but
- the corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The study design''s blinding schema is not specified according to the extensible Trial Blinding
+ Schema Response (C66735) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, and/or the code or decode (either as preferred term or as
+ submission value) is found in the codelist (case insensitive) but the corresponding decode or code
+ does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyDesign'
+ - "StudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000919/rule.yml b/Published/CORE-000919/rule.yml
index ce577545c..7148f2038 100644
--- a/Published/CORE-000919/rule.yml
+++ b/Published/CORE-000919/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study design's characteristics must be specified according to
- the extensible Study Design Characteristics Value Set
- Terminology (C207416) DDF codelist (e.g. an entry with a code
- or decode used from the codelist should be consistent with the
- full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study design's characteristics must be specified according to the extensible
+ Study Design Characteristics Value Set Terminology (C207416) DDF codelist (e.g. an entry with
+ a code or decode used from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00122'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00122"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: characteristics
operator: exists
- name: characteristics
@@ -28,13 +27,13 @@ Check:
value: true
- name: parent_rel.Code
operator: equal_to
- value: 'characteristics'
+ value: "characteristics"
value_is_literal: true
- not:
all:
- name: codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -76,13 +75,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000919'
+ Id: "CORE-000919"
Status: Published
- Version: '1'
-Description: "A study design's characteristics must be specified according to
- the extensible Study Design Characteristics Value Set Terminology (C207416)
- DDF codelist (e.g. an entry with a code or decode used from the codelist
- should be consistent with the full entry in the codelist)."
+ Version: "1"
+Description:
+ "A study design's characteristics must be specified according to the extensible Study Design
+ Characteristics Value Set Terminology (C207416) DDF codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -96,7 +95,7 @@ Operations:
- id: $codelist_code
map:
- output: C207416
- parent_rel.Code: 'characteristics'
+ parent_rel.Code: "characteristics"
operator: map
- ct_package_types:
- DDF
@@ -136,13 +135,12 @@ Operations:
term_value: decode
version: codeSystemVersion
Outcome:
- Message: 'The study design''s characteristic is not specified according to the
- extensible Study Design Characteristics Value Set Terminology (C207416) DDF
- codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is
- not a valid terminology package date, and/or the code or decode (either as
- preferred term or as submission value) is found in the codelist (case
- insensitive) but the corresponding decode or code does not match the
- codelist value (case sensitive).'
+ Message:
+ 'The study design''s characteristic is not specified according to the extensible Study Design
+ Characteristics Value Set Terminology (C207416) DDF codelist - codeSystem is not "http://www.cdisc.org",
+ codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred
+ term or as submission value) is found in the codelist (case insensitive) but the corresponding decode
+ or code does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -163,5 +161,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyDesign'
+ - "StudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000920/rule.yml b/Published/CORE-000920/rule.yml
index 7f1407f85..d4215edda 100644
--- a/Published/CORE-000920/rule.yml
+++ b/Published/CORE-000920/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A masking role must be specified according to the extensible
- masking role (C207414) DDF codelist (e.g. an entry with a code
- or decode used from the codelist should be consistent with the
- full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A masking role must be specified according to the extensible masking role (C207414)
+ DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent
+ with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00123'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00123"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: role
operator: exists
- name: role
@@ -29,7 +29,7 @@ Check:
all:
- name: role.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: role.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -71,12 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000920'
+ Id: "CORE-000920"
Status: Published
- Version: '1'
-Description: "A masking role must be specified according to the extensible
- masking role (C207414) DDF codelist (e.g. an entry with a code or decode used
- from the codelist should be consistent with the full entry in the codelist)."
+ Version: "1"
+Description:
+ "A masking role must be specified according to the extensible masking role (C207414) DDF
+ codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full
+ entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -121,12 +122,11 @@ Operations:
term_value: role.decode
version: role.codeSystemVersion
Outcome:
- Message: 'The masking role is not specified according to the extensible masking
- role (C207414) DDF codelist - codeSystem is not "http://www.cdisc.org",
- codeSystemVersion is not a valid terminology package date, and/or the code
- or decode (either as preferred term or as submission value) is found in the
- codelist (case insensitive) but the corresponding decode or code does not
- match the codelist value (case sensitive).'
+ Message:
+ 'The masking role is not specified according to the extensible masking role (C207414) DDF codelist
+ - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date,
+ and/or the code or decode (either as preferred term or as submission value) is found in the codelist
+ (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -147,5 +147,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Masking'
+ - "Masking"
Sensitivity: Record
diff --git a/Published/CORE-000921/rule.yml b/Published/CORE-000921/rule.yml
index dac59959c..ba5b89233 100644
--- a/Published/CORE-000921/rule.yml
+++ b/Published/CORE-000921/rule.yml
@@ -4,20 +4,21 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study intervention''s product designation must be specified
- using the product designation (C207418) DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study intervention's product designation must be specified using the product
+ designation (C207418) DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00129'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00129"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: productDesignation
operator: equal_to
value: true
@@ -25,7 +26,7 @@ Check:
all:
- name: productDesignation.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: productDesignation.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -67,11 +68,12 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000921'
+ Id: "CORE-000921"
Status: Published
- Version: '1'
-Description: 'A study intervention''s product designation must be specified
- using the product designation (C207418) DDF codelist.'
+ Version: "1"
+Description:
+ "A study intervention's product designation must be specified using the product designation
+ (C207418) DDF codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -116,13 +118,12 @@ Operations:
term_value: productDesignation.decode
version: productDesignation.codeSystemVersion
Outcome:
- Message: 'The study intervention''s product designation is not specified using
- the product designation (C207418) DDF codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, the code or decode (either as preferred term or as submission value)
- is found in the codelist (case insensitive) but the corresponding decode or
- code does not match the codelist value (case sensitive), and/or neither code
- nor decode is found in the codelist.'
+ Message:
+ 'The study intervention''s product designation is not specified using the product designation
+ (C207418) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
+ terminology package date, the code or decode (either as preferred term or as submission value) is
+ found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist
+ value (case sensitive), and/or neither code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -143,5 +144,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyIntervention'
+ - "StudyIntervention"
Sensitivity: Record
diff --git a/Published/CORE-000922/rule.yml b/Published/CORE-000922/rule.yml
index c9485dd64..33ab05593 100644
--- a/Published/CORE-000922/rule.yml
+++ b/Published/CORE-000922/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An agent administration's route must be specified according to
- the extensible Route of Administration Response (C66729) SDTM
- codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An agent administration's route must be specified according to the extensible
+ Route of Administration Response (C66729) SDTM codelist (e.g. an entry with a code or decode
+ used from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00130'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00130"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: route.standardCode
operator: exists
- name: route.standardCode
@@ -30,7 +29,7 @@ Check:
all:
- name: route.standardCode.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: route.standardCode.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000922'
+ Id: "CORE-000922"
Status: Published
- Version: '1'
-Description: "An agent administration's route must be specified according to the
- extensible Route of Administration Response (C66729) SDTM codelist (e.g. an
- entry with a code or decode used from the codelist should be consistent with
- the full entry in the codelist)."
+ Version: "1"
+Description:
+ "An agent administration's route must be specified according to the extensible Route of Administration
+ Response (C66729) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be
+ consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +122,12 @@ Operations:
term_value: route.standardCode.decode
version: route.standardCode.codeSystemVersion
Outcome:
- Message: 'The agent administration''s route is not specified according to the
- extensible Route of Administration Response (C66729) SDTM codelist -
- codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
- terminology package date, and/or the code or decode (either as preferred
- term or as submission value) is found in the codelist (case insensitive) but
- the corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The agent administration''s route is not specified according to the extensible Route of Administration
+ Response (C66729) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not
+ a valid terminology package date, and/or the code or decode (either as preferred term or as submission
+ value) is found in the codelist (case insensitive) but the corresponding decode or code does not match
+ the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'AgentAdministration'
+ - "AgentAdministration"
Sensitivity: Record
diff --git a/Published/CORE-000923/rule.yml b/Published/CORE-000923/rule.yml
index 19a7b0b49..4f054db4b 100644
--- a/Published/CORE-000923/rule.yml
+++ b/Published/CORE-000923/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An encounter's environmental setting must be specified
- according to the extensible Environmental Setting (C127262)
- SDTM codelist (e.g. an entry with a code or decode used from
- the codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An encounter's environmental setting must be specified according to the extensible
+ Environmental Setting (C127262) SDTM codelist (e.g. an entry with a code or decode used from
+ the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00135'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00135"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: environmentalSetting
operator: exists
- name: environmentalSetting
@@ -28,13 +27,13 @@ Check:
value: true
- name: parent_rel.Code
operator: equal_to
- value: 'environmentalSetting'
+ value: "environmentalSetting"
value_is_literal: true
- not:
all:
- name: codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -76,13 +75,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000923'
+ Id: "CORE-000923"
Status: Published
- Version: '1'
-Description: "An encounter's environmental setting must be specified according
- to the extensible Environmental Setting (C127262) SDTM codelist (e.g. an entry
- with a code or decode used from the codelist should be consistent with the
- full entry in the codelist)."
+ Version: "1"
+Description:
+ "An encounter's environmental setting must be specified according to the extensible Environmental
+ Setting (C127262) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be
+ consistent with the full entry in the codelist)."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -96,7 +95,7 @@ Operations:
- id: $codelist_code
map:
- output: C127262
- parent_rel.Code: 'environmentalSetting'
+ parent_rel.Code: "environmentalSetting"
operator: map
- ct_package_types:
- SDTM
@@ -136,13 +135,12 @@ Operations:
term_value: decode
version: codeSystemVersion
Outcome:
- Message: 'The encounter''s environmental setting is not specified according to
- the extensible Environmental Setting (C127262) SDTM codelist - codeSystem is
- not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
- package date, and/or the code or decode (either as preferred term or as
- submission value) is found in the codelist (case insensitive) but the
- corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The encounter''s environmental setting is not specified according to the extensible Environmental
+ Setting (C127262) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not
+ a valid terminology package date, and/or the code or decode (either as preferred term or as submission
+ value) is found in the codelist (case insensitive) but the corresponding decode or code does not match
+ the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -163,5 +161,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Encounter'
+ - "Encounter"
Sensitivity: Record
diff --git a/Published/CORE-000924/rule.yml b/Published/CORE-000924/rule.yml
index 5c0d293ba..9b3c55dd9 100644
--- a/Published/CORE-000924/rule.yml
+++ b/Published/CORE-000924/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An organization type must be specified according to the
- extensible organization type (C188724) DDF codelist (e.g. an
- entry with a code or decode used from the codelist should be
- consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An organization type must be specified according to the extensible organization
+ type (C188724) DDF codelist (e.g. an entry with a code or decode used from the codelist should
+ be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00140'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00140"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: organizationType
operator: exists
- name: organizationType
@@ -29,7 +29,7 @@ Check:
all:
- name: organizationType.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: organizationType.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -39,7 +39,7 @@ Check:
value: true
- name: $codelist_extensible_override
operator: equal_to
- value: 'Y'
+ value: "Y"
- any:
- all:
- name: $code_for_decode_pref_term
@@ -75,13 +75,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000924'
+ Id: "CORE-000924"
Status: Published
- Version: '1'
-Description: "An organization type must be specified according to the extensible
- organization type (C188724) DDF codelist (e.g. an entry with a code or decode
- used from the codelist should be consistent with the full entry in the
- codelist)."
+ Version: "1"
+Description:
+ "An organization type must be specified according to the extensible organization type (C188724)
+ DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the
+ full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -96,24 +96,25 @@ Operations:
ct_package_type: DDF
id: $codelist_extensible
operator: codelist_extensible
- version: organizationType.codeSystemVersion
- # DDF codelist extensibility was not defined in earlier CT packages and
- # defaults to false, so assigning an override:
+ version:
+ organizationType.codeSystemVersion
+ # DDF codelist extensibility was not defined in earlier CT packages and
+ # defaults to false, so assigning an override:
- id: $codelist_extensible_override
map:
- - organizationType.codeSystemVersion: '2022-09-30'
+ - organizationType.codeSystemVersion: "2022-09-30"
output: "Y"
- - organizationType.codeSystemVersion: '2022-12-16'
+ - organizationType.codeSystemVersion: "2022-12-16"
output: "Y"
- - organizationType.codeSystemVersion: '2023-03-31'
+ - organizationType.codeSystemVersion: "2023-03-31"
output: "Y"
- - organizationType.codeSystemVersion: '2023-06-30'
+ - organizationType.codeSystemVersion: "2023-06-30"
output: "Y"
- - organizationType.codeSystemVersion: '2023-09-29'
+ - organizationType.codeSystemVersion: "2023-09-29"
output: "Y"
- - organizationType.codeSystemVersion: '2023-12-15'
+ - organizationType.codeSystemVersion: "2023-12-15"
output: "Y"
- - organizationType.codeSystemVersion: '2024-03-29'
+ - organizationType.codeSystemVersion: "2024-03-29"
output: "Y"
operator: map
- codelist_code: $codelist_code
@@ -145,12 +146,12 @@ Operations:
term_value: organizationType.decode
version: organizationType.codeSystemVersion
Outcome:
- Message: 'The organization type is not specified according to the extensible
- organization type (C188724) DDF codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, and/or the code or decode (either as preferred term or as submission
- value) is found in the codelist (case insensitive) but the corresponding
- decode or code does not match the codelist value (case sensitive).'
+ Message:
+ 'The organization type is not specified according to the extensible organization type (C188724)
+ DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
+ package date, and/or the code or decode (either as preferred term or as submission value) is found
+ in the codelist (case insensitive) but the corresponding decode or code does not match the codelist
+ value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -172,6 +173,6 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Organization'
- - 'ResearchOrganization'
+ - "Organization"
+ - "ResearchOrganization"
Sensitivity: Record
diff --git a/Published/CORE-000925/rule.yml b/Published/CORE-000925/rule.yml
index bebdada45..42bb22635 100644
--- a/Published/CORE-000925/rule.yml
+++ b/Published/CORE-000925/rule.yml
@@ -4,36 +4,36 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A governance date type must be specified according to the
- extensible governance date type (C207413) DDF codelist (e.g.
- an entry with a code or decode used from the codelist should
- be consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A governance date type must be specified according to the extensible governance
+ date type (C207413) DDF codelist (e.g. an entry with a code or decode used from the codelist
+ should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00142'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00142"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A governance date type must be specified according to the
- extensible governance date type (C207413) DDF codelist (e.g.
- an entry with a code or decode used from the codelist should
- be consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A governance date type must be specified according to the extensible governance
+ date type (C207413) DDF codelist (e.g. an entry with a code or decode used from the codelist
+ should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00142'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00142"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type
operator: exists
- name: type
@@ -43,7 +43,7 @@ Check:
all:
- name: type.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: type.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -85,13 +85,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000925'
+ Id: "CORE-000925"
Status: Published
- Version: '1'
-Description: "A governance date type must be specified according to the
- extensible governance date type (C207413) DDF codelist (e.g. an entry with a
- code or decode used from the codelist should be consistent with the full entry
- in the codelist)."
+ Version: "1"
+Description:
+ "A governance date type must be specified according to the extensible governance date type
+ (C207413) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent
+ with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -136,12 +136,12 @@ Operations:
term_value: type.decode
version: type.codeSystemVersion
Outcome:
- Message: 'The governance date type is not specified according to the extensible
- governance date type (C207413) DDF codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, and/or the code or decode (either as preferred term or as submission
- value) is found in the codelist (case insensitive) but the corresponding
- decode or code does not match the codelist value (case sensitive).'
+ Message:
+ 'The governance date type is not specified according to the extensible governance date type
+ (C207413) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
+ terminology package date, and/or the code or decode (either as preferred term or as submission value)
+ is found in the codelist (case insensitive) but the corresponding decode or code does not match the
+ codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -162,5 +162,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'GovernanceDate'
+ - "GovernanceDate"
Sensitivity: Record
diff --git a/Published/CORE-000926/rule.yml b/Published/CORE-000926/rule.yml
index 31259ada4..2aad3c41a 100644
--- a/Published/CORE-000926/rule.yml
+++ b/Published/CORE-000926/rule.yml
@@ -1,38 +1,38 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: In Vivo Micronucleus is represented at the subject level, not
- the slide level.
+ - Cited Guidance:
+ In Vivo Micronucleus is represented at the subject level, not the slide
+ level.
Document: SENDIG-GENETOX
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND409
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
# In Vivo Micronucleus is represented at the subject level, not the slide level.
# i.e. when GVCAT = 'IN VIVO MICRONUCLEUS' then USUBJID must be populated, not POOLID
# REMARK: but USUBJID = "required" anyway
Check:
all:
- - name: 'GVCAT'
+ - name: "GVCAT"
operator: equal_to
- value: 'IN VIVO MICRONUCLEUS'
- - name: 'USUBJID'
+ value: "IN VIVO MICRONUCLEUS"
+ - name: "USUBJID"
operator: empty
Core:
Id: CORE-000926
Status: Published
- Version: '1'
+ Version: "1"
Description: In Vivo Micronucleus is represented at the subject level, not the slide level.
Executability: Fully Executable
Outcome:
- Message: When GVCAT = 'IN VIVO MICRONUCLEUS' then USUBJID must be populated, not
- POOLID
+ Message: When GVCAT = 'IN VIVO MICRONUCLEUS' then USUBJID must be populated, not POOLID
Rule Type: Record Data
Scope:
Classes:
diff --git a/Published/CORE-000929/rule.yml b/Published/CORE-000929/rule.yml
index 45e8ffb11..14e0d05a6 100644
--- a/Published/CORE-000929/rule.yml
+++ b/Published/CORE-000929/rule.yml
@@ -4,72 +4,68 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Using SDTM-specified standard domain names and prefixes where
- applicable.
+ - Cited Guidance: Using SDTM-specified standard domain names and prefixes where applicable.
Document: SDTMIG v3.4
Section: 3.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0001
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Check the CDISC Controlled Terminology [see Appendix C -
- Controlled Terminology] for reserved two-character domain
- identifiers or abbreviations. If one has not been assigned by
- CDISC, then the sponsor may select the unique two-character
- domain code to be used consistently throughout the submission.
+ - Cited Guidance: Check the CDISC Controlled Terminology [see Appendix C - Controlled
+ Terminology] for reserved two-character domain identifiers or abbreviations. If one has
+ not been assigned by CDISC, then the sponsor may select the unique two-character domain
+ code to be used consistently throughout the submission.
Document: IG v3.2
Item: 3.d
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0001
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Determine the domain code, one that is not a domain code in the
- CDISC Controlled Terminology codelist "SDTM Domain
- Abbreviations" available at
- http://www.cancer.gov/research/resources/terminology/cdisc. If
- it desired to have this domain code as part of CDISC
- controlled terminology, then submit a request to
- https://ncitermform.nci.nih.gov/ncitermform/?version=cdisc.
- The sponsor-selected, two-character domain code should be used
- consistently throughout the submission.
+ - Cited Guidance:
+ Determine the domain code, one that is not a domain code in the CDISC
+ Controlled Terminology codelist "SDTM Domain Abbreviations" available at
+ http://www.cancer.gov/research/resources/terminology/cdisc. If it desired to have this
+ domain code as part of CDISC controlled terminology, then submit a request to
+ https://ncitermform.nci.nih.gov/ncitermform/?version=cdisc. The sponsor-selected,
+ two-character domain code should be used consistently throughout the submission.
Document: IG v3.3
Item: 3.e
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0001
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: A dataset is created using a domain specification in this guide
- when the scientific nature or role of the data is within the
- scope of a domain. Domains are extended or custom domain
- specifications are only used when data are different in nature
+ - Cited Guidance:
+ A dataset is created using a domain specification in this guide when the
+ scientific nature or role of the data is within the scope of a domain. Domains are
+ extended or custom domain specifications are only used when data are different in nature
and are not in scope for domains in this guide.
Document: TIG 1.0
Item: Table 2 Num 2
- Section: '2.5'
+ Section: "2.5"
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0289
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
- Name: SENDIG
References:
- Citations:
@@ -80,9 +76,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND16
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -93,9 +89,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND16
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -106,8 +102,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND16
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
@@ -119,9 +115,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND16
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -132,9 +128,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND16
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -145,25 +141,25 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND16
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: TIG
References:
- Citations:
- - Cited Guidance: To support implementation of standards, controlled terminology
- will be used to name domain datasets and variables in datasets
- when applicable.
+ - Cited Guidance:
+ To support implementation of standards, controlled terminology will be used
+ to name domain datasets and variables in datasets when applicable.
Document: TIG v1.0
Item: Standards for Tabulation
Section: 2.3.
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0090
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
# Variable: DOMAIN
# Condition: Not custom domain
# Rule: DOMAIN = valid Domain Code published by CDISC
@@ -181,9 +177,8 @@ Check:
Core:
Id: CORE-000929
Status: Published
- Version: '1'
-Description: Raise and error when the DOMAIN Code is not a valid Domain Code
- published by CDISC.
+ Version: "1"
+Description: Raise and error when the DOMAIN Code is not a valid Domain Code published by CDISC.
Executability: Fully Executable
Operations:
- id: $domain_is_custom
diff --git a/Published/CORE-000930/rule.yml b/Published/CORE-000930/rule.yml
index 17c966f30..70757de4c 100644
--- a/Published/CORE-000930/rule.yml
+++ b/Published/CORE-000930/rule.yml
@@ -4,32 +4,34 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study amendment reason must be coded using the study
- amendment reason (C207415) DDF codelist."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study amendment reason must be coded using the study amendment reason (C207415)
+ DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00143'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00143"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study amendment reason must be coded using the study
- amendment reason (C207415) DDF codelist."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study amendment reason must be coded using the study amendment reason (C207415)
+ DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00143'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00143"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: code
operator: exists
- name: code
@@ -39,7 +41,7 @@ Check:
all:
- name: code.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: code.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -81,11 +83,10 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000930'
+ Id: "CORE-000930"
Status: Published
- Version: '1'
-Description: "A study amendment reason must be coded using the study amendment
- reason (C207415) DDF codelist."
+ Version: "1"
+Description: "A study amendment reason must be coded using the study amendment reason (C207415) DDF codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -130,12 +131,11 @@ Operations:
term_value: code.decode
version: code.codeSystemVersion
Outcome:
- Message: 'The study amendment reason is not coded using the study amendment
- reason (C207415) DDF codelist - codeSystem is not "http://www.cdisc.org",
- codeSystemVersion is not a valid terminology package date, and/or the code
- or decode (either as preferred term or as submission value) is found in the
- codelist (case insensitive) but the corresponding decode or code does not
- match the codelist value (case sensitive).'
+ Message:
+ 'The study amendment reason is not coded using the study amendment reason (C207415) DDF codelist
+ - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date,
+ and/or the code or decode (either as preferred term or as submission value) is found in the codelist
+ (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -156,5 +156,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyAmendmentReason'
+ - "StudyAmendmentReason"
Sensitivity: Record
diff --git a/Published/CORE-000931/rule.yml b/Published/CORE-000931/rule.yml
index 65a3bc828..6bbf26dde 100644
--- a/Published/CORE-000931/rule.yml
+++ b/Published/CORE-000931/rule.yml
@@ -4,32 +4,34 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study geographic scope type must be specified using the
- geographic scope type (C207412) DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study geographic scope type must be specified using the geographic scope type
+ (C207412) DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00144'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00144"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study geographic scope type must be specified using the
- geographic scope type (C207412) DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study geographic scope type must be specified using the geographic scope type
+ (C207412) DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00144'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00144"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type
operator: equal_to
value: true
@@ -37,7 +39,7 @@ Check:
all:
- name: type.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: type.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -79,11 +81,12 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000931'
+ Id: "CORE-000931"
Status: Published
- Version: '1'
-Description: 'A study geographic scope type must be specified using the
- geographic scope type (C207412) DDF codelist.'
+ Version: "1"
+Description:
+ "A study geographic scope type must be specified using the geographic scope type (C207412)
+ DDF codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -128,13 +131,12 @@ Operations:
term_value: type.decode
version: type.codeSystemVersion
Outcome:
- Message: 'The study geographic scope type is not specified using the geographic
- scope type (C207412) DDF codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, the code or decode (either as preferred term or as submission value)
- is found in the codelist (case insensitive) but the corresponding decode or
- code does not match the codelist value (case sensitive), and/or neither code
- nor decode is found in the codelist.'
+ Message:
+ 'The study geographic scope type is not specified using the geographic scope type (C207412)
+ DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
+ package date, the code or decode (either as preferred term or as submission value) is found in the
+ codelist (case insensitive) but the corresponding decode or code does not match the codelist value
+ (case sensitive), and/or neither code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -154,5 +156,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'GeographicScope'
+ - "GeographicScope"
Sensitivity: Record
diff --git a/Published/CORE-000932/rule.yml b/Published/CORE-000932/rule.yml
index e6dbf5c1c..6a4d211e1 100644
--- a/Published/CORE-000932/rule.yml
+++ b/Published/CORE-000932/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A quantity's unit must be coded according to the extensible
- unit (C71620) SDTM codelist (e.g. an entry with a code or
- decode used from the codelist should be consistent with the
- full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A quantity's unit must be coded according to the extensible unit (C71620) SDTM
+ codelist (e.g. an entry with a code or decode used from the codelist should be consistent with
+ the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00145'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00145"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: unit
operator: exists
- name: unit
@@ -29,7 +29,7 @@ Check:
all:
- name: unit.standardCode.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: unit.standardCode.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,12 +72,13 @@ Check:
value: $value_for_code
Core:
- Id: 'CORE-000932'
+ Id: "CORE-000932"
Status: Published
- Version: '1'
-Description: "A quantity's unit must be coded according to the extensible unit
- (C71620) SDTM codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the codelist)."
+ Version: "1"
+Description:
+ "A quantity's unit must be coded according to the extensible unit (C71620) SDTM codelist
+ (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry
+ in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -122,12 +123,11 @@ Operations:
term_value: unit.standardCode.decode
version: unit.standardCode.codeSystemVersion
Outcome:
- Message: 'The quantity''s unit is not specified according to the extensible unit
- (C71620) SDTM codelist - codeSystem is not "http://www.cdisc.org",
- codeSystemVersion is not a valid terminology package date, and/or the code
- or decode (either as preferred term or as submission value) is found in the
- codelist (case insensitive) but the corresponding decode or code does not
- match the codelist value (case sensitive).'
+ Message:
+ 'The quantity''s unit is not specified according to the extensible unit (C71620) SDTM codelist
+ - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date,
+ and/or the code or decode (either as preferred term or as submission value) is found in the codelist
+ (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -148,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Quantity'
+ - "Quantity"
Sensitivity: Record
diff --git a/Published/CORE-000933/rule.yml b/Published/CORE-000933/rule.yml
index 504e1c45c..58de78ff5 100644
--- a/Published/CORE-000933/rule.yml
+++ b/Published/CORE-000933/rule.yml
@@ -4,32 +4,34 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study title type must be specified using the study title type
- (C207419) DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study title type must be specified using the study title type (C207419) DDF
+ codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00146'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00146"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study title type must be specified using the study title type
- (C207419) DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study title type must be specified using the study title type (C207419) DDF
+ codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00146'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00146"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type
operator: equal_to
value: true
@@ -37,7 +39,7 @@ Check:
all:
- name: type.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: type.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -79,11 +81,10 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000933'
+ Id: "CORE-000933"
Status: Published
- Version: '1'
-Description: 'A study title type must be specified using the study title type
- (C207419) DDF codelist.'
+ Version: "1"
+Description: "A study title type must be specified using the study title type (C207419) DDF codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -128,13 +129,12 @@ Operations:
term_value: type.decode
version: type.codeSystemVersion
Outcome:
- Message: 'The study title type is not specified using the study title type
- (C207419) DDF codelist - codeSystem is not "http://www.cdisc.org",
- codeSystemVersion is not a valid terminology package date, the code or
- decode (either as preferred term or as submission value) is found in the
- codelist (case insensitive) but the corresponding decode or code does not
- match the codelist value (case sensitive), and/or neither code nor decode is
- found in the codelist.'
+ Message:
+ 'The study title type is not specified using the study title type (C207419) DDF codelist -
+ codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date,
+ the code or decode (either as preferred term or as submission value) is found in the codelist (case
+ insensitive) but the corresponding decode or code does not match the codelist value (case sensitive),
+ and/or neither code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -155,5 +155,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyTitle'
+ - "StudyTitle"
Sensitivity: Record
diff --git a/Published/CORE-000934/rule.yml b/Published/CORE-000934/rule.yml
index d80554ced..2d06cc512 100644
--- a/Published/CORE-000934/rule.yml
+++ b/Published/CORE-000934/rule.yml
@@ -4,11 +4,10 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "Defines the type of specimen used for a measurement. Examples:
- SERUM, PLASMA, URINE. If multiple specimen types are used for
- a calculation (e.g., serum and urine for creatinine
- clearance), then refer to Section 4.3.6.2 for guidance on how
- to populate."
+ - Cited Guidance:
+ "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA,
+ URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine
+ clearance), then refer to Section 4.3.6.2 for guidance on how to populate."
Document: IG v3.1
Item: PPSPEC CDISC Notes
Section: 6.3.12
@@ -21,11 +20,10 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "Defines the type of specimen used for a measurement. Examples:
- SERUM, PLASMA, URINE. If multiple specimen types are used for
- a calculation (e.g., serum and urine for creatinine
- clearance), then refer to Section 4.3.6.2 for guidance on how
- to populate."
+ - Cited Guidance:
+ "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA,
+ URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine
+ clearance), then refer to Section 4.3.6.2 for guidance on how to populate."
Document: IG v3.1.1
Item: PPSPEC CDISC Notes
Section: 6.3.12
@@ -38,11 +36,10 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "Defines the type of specimen used for a measurement. Examples:
- SERUM, PLASMA, URINE. If multiple specimen types are used for
- a calculation (e.g., serum and urine for creatinine
- clearance), then refer to Section 4.3.6.2 for guidance on how
- to populate."
+ - Cited Guidance:
+ "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA,
+ URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine
+ clearance), then refer to Section 4.3.6.2 for guidance on how to populate."
Document: IG v3.1
Item: PPSPEC CDISC Notes
Section: 6.3.12
@@ -55,11 +52,10 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "Defines the type of specimen used for a measurement. Examples:
- SERUM, PLASMA, URINE. If multiple specimen types are used for
- a calculation (e.g., serum and urine for creatinine
- clearance), then refer to Section 4.3.6.2 for guidance on how
- to populate."
+ - Cited Guidance:
+ "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA,
+ URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine
+ clearance), then refer to Section 4.3.6.2 for guidance on how to populate."
Document: IG v3.1.1
Item: PPSPEC CDISC Notes
Section: 6.3.12
@@ -72,11 +68,10 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: "Defines the type of specimen used for a measurement. Examples:
- SERUM, PLASMA, URINE. If multiple specimen types are used for
- a calculation (e.g., serum and urine for creatinine
- clearance), then refer to Section 4.3.6.2 for guidance on how
- to populate."
+ - Cited Guidance:
+ "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA,
+ URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine
+ clearance), then refer to Section 4.3.6.2 for guidance on how to populate."
Document: IG v3.1.1
Item: PPSPEC CDISC Notes
Section: 6.3.12
@@ -101,28 +96,29 @@ Check:
# TODO: check whether each "splitted part follows the CT for "SPEC" (codelist)
- name: PPSPEC
operator: contains
- value: ';'
- # 2025-11-19: part that iterates of the "splitted parts" and checks each of them
- #- name: $ppspec_value
- # operator: not_contains_all
- # value: $ppspec_codelist
- # TRYING JUST THE OTHER WAY AROUND - THIS SEEMS TO BE THE RIGHT WAY
+ value:
+ ";"
+ # 2025-11-19: part that iterates of the "splitted parts" and checks each of them
+ #- name: $ppspec_value
+ # operator: not_contains_all
+ # value: $ppspec_codelist
+ # TRYING JUST THE OTHER WAY AROUND - THIS SEEMS TO BE THE RIGHT WAY
- name: $ppspec_codelist
operator: not_contains_all
- value: $ppspec_value
- # operator: not_equal_to
- # value: 'TEST'
+ value:
+ $ppspec_value
+ # operator: not_equal_to
+ # value: 'TEST'
Core:
Id: CORE-000934
Status: Published
Version: "1"
-Description: If multiple specimen types are used for a calculation (e.g., serum
- and urine for creatinine clearance), then this field should be populated with
- values from the (SPEC) Controlled Terminology codelist delimited by a
- semicolon.
+Description: If multiple specimen types are used for a calculation (e.g., serum and urine for
+ creatinine clearance), then this field should be populated with values from the (SPEC) Controlled
+ Terminology codelist delimited by a semicolon.
Executability: Fully Executable
Operations:
- - delimiter: ';'
+ - delimiter: ";"
id: $ppspec_value
name: PPSPEC
operator: split_by
diff --git a/Published/CORE-000935/rule.yml b/Published/CORE-000935/rule.yml
index 45d20a150..2e7b8d4ba 100644
--- a/Published/CORE-000935/rule.yml
+++ b/Published/CORE-000935/rule.yml
@@ -4,41 +4,44 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Data types of attributes (string, number, boolean) must conform
- with the USDM schema based on the API specification.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Data types of attributes (string, number, boolean) must conform with the USDM
+ schema based on the API specification."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00082'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00082"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Data types of attributes (string, number, boolean) must conform
- with the USDM schema based on the API specification.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Data types of attributes (string, number, boolean) must conform with the USDM
+ schema based on the API specification."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00082'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00082"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: validator
operator: equal_to
- value: 'type'
+ value: "type"
Core:
- Id: 'CORE-000935'
+ Id: "CORE-000935"
Status: Published
- Version: '1'
-Description: 'Data types of attributes (string, number, boolean) must conform
- with the USDM schema based on the API specification.'
+ Version: "1"
+Description:
+ "Data types of attributes (string, number, boolean) must conform with the USDM schema based
+ on the API specification."
Executability: Fully Executable
Outcome:
- Message: 'The datatype of the attribute does not conform with the USDM schema.'
+ Message: "The datatype of the attribute does not conform with the USDM schema."
Output Variables:
- error_attribute
- message
@@ -46,5 +49,5 @@ Rule Type: JSON Schema Check
Scope:
Entities:
Include:
- - 'ALL'
+ - "ALL"
Sensitivity: Record
diff --git a/Published/CORE-000936/rule.yml b/Published/CORE-000936/rule.yml
index 03ba90218..4eb3b7917 100644
--- a/Published/CORE-000936/rule.yml
+++ b/Published/CORE-000936/rule.yml
@@ -4,26 +4,26 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Syntax template text is expected to be HTML formatted.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Syntax template text is expected to be HTML formatted."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00086'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00086"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: $xhtml_errors
operator: non_empty
Core:
- Id: 'CORE-000936'
+ Id: "CORE-000936"
Status: Published
- Version: '1'
-Description: 'Syntax template text is expected to be HTML formatted.'
+ Version: "1"
+Description: "Syntax template text is expected to be HTML formatted."
Executability: Partially Executable - Possible Overreporting
Operations:
- id: $xhtml_errors
@@ -31,7 +31,7 @@ Operations:
namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0
operator: get_xhtml_errors
Outcome:
- Message: 'The text attribute contains non-conformant XHTML.'
+ Message: "The text attribute contains non-conformant XHTML."
Output Variables:
- parent_entity
- parent_id
@@ -42,9 +42,9 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Characteristic'
- - 'Condition'
- - 'EligibilityCriterion'
- - 'Endpoint'
- - 'Objective'
+ - "Characteristic"
+ - "Condition"
+ - "EligibilityCriterion"
+ - "Endpoint"
+ - "Objective"
Sensitivity: Record
diff --git a/Published/CORE-000937/rule.yml b/Published/CORE-000937/rule.yml
index 00c375b2f..38a9d6d2f 100644
--- a/Published/CORE-000937/rule.yml
+++ b/Published/CORE-000937/rule.yml
@@ -4,52 +4,53 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Attributes must be included as defined in the USDM schema based
- on the API specification (i.e., all required properties are
- present and no additional attributes are present).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Attributes must be included as defined in the USDM schema based on the API specification
+ (i.e., all required properties are present and no additional attributes are present)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00125'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00125"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Attributes must be included as defined in the USDM schema based
- on the API specification (i.e., all required properties are
- present and no additional attributes are present).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Attributes must be included as defined in the USDM schema based on the API specification
+ (i.e., all required properties are present and no additional attributes are present)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00125'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00125"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: validator
operator: is_contained_by
value:
- - 'required'
- - 'additionalProperties'
+ - "required"
+ - "additionalProperties"
Core:
- Id: 'CORE-000937'
+ Id: "CORE-000937"
Status: Published
- Version: '1'
-Description: 'Attributes must be included as defined in the USDM schema based on
- the API specification (i.e., all required properties are present and no
- additional attributes are present).'
+ Version: "1"
+Description:
+ "Attributes must be included as defined in the USDM schema based on the API specification
+ (i.e., all required properties are present and no additional attributes are present)."
Executability: Fully Executable
Outcome:
- Message: 'Attributes are not included as defined in the USDM schema - required
- properties are missing or additional properties are present.'
+ Message:
+ "Attributes are not included as defined in the USDM schema - required properties are missing
+ or additional properties are present."
Output Variables:
- message
Rule Type: JSON Schema Check
Scope:
Entities:
Include:
- - 'ALL'
+ - "ALL"
Sensitivity: Record
diff --git a/Published/CORE-000938/rule.yml b/Published/CORE-000938/rule.yml
index 152dbc3e2..61e987312 100644
--- a/Published/CORE-000938/rule.yml
+++ b/Published/CORE-000938/rule.yml
@@ -4,50 +4,50 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Cardinalities must be as defined in the USDM schema based on
- the API specification (i.e., required properties have at least
- one value and single-value properties are not lists).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Cardinalities must be as defined in the USDM schema based on the API specification
+ (i.e., required properties have at least one value and single-value properties are not lists)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00126'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00126"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Cardinalities must be as defined in the USDM schema based on
- the API specification (i.e., required properties have at least
- one value and single-value properties are not lists).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Cardinalities must be as defined in the USDM schema based on the API specification
+ (i.e., required properties have at least one value and single-value properties are not lists)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00126'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00126"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: validator
operator: is_contained_by
value:
- - 'minLength'
- - 'minItems'
- - 'maxItems'
+ - "minLength"
+ - "minItems"
+ - "maxItems"
Core:
- Id: 'CORE-000938'
+ Id: "CORE-000938"
Status: Published
- Version: '1'
-Description: 'Cardinalities must be as defined in the USDM schema based on the
- API specification (i.e., required properties have at least one value and
- single-value properties are not lists).'
+ Version: "1"
+Description:
+ "Cardinalities must be as defined in the USDM schema based on the API specification (i.e.,
+ required properties have at least one value and single-value properties are not lists)."
Executability: Fully Executable
Outcome:
- Message: 'The cardinality of the attribute is not as defined in the USDM schema
- - the attribute is required but does not have a value (the value is too
- short), or the attribute is a list and has either too few entries (the list
- is too short) or too many entries (the list is too long).'
+ Message:
+ "The cardinality of the attribute is not as defined in the USDM schema - the attribute is required
+ but does not have a value (the value is too short), or the attribute is a list and has either too
+ few entries (the list is too short) or too many entries (the list is too long)."
Output Variables:
- error_attribute
- message
@@ -55,5 +55,5 @@ Rule Type: JSON Schema Check
Scope:
Entities:
Include:
- - 'ALL'
+ - "ALL"
Sensitivity: Record
diff --git a/Published/CORE-000939/rule.yml b/Published/CORE-000939/rule.yml
index 01e20b7fd..abe034870 100644
--- a/Published/CORE-000939/rule.yml
+++ b/Published/CORE-000939/rule.yml
@@ -4,32 +4,34 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An objective level must be specified using the objective level
- (C188725) DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An objective level must be specified using the objective level (C188725) DDF
+ codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00147'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00147"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An objective level must be specified using the objective level
- (C188725) DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An objective level must be specified using the objective level (C188725) DDF
+ codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00147'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00147"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: level
operator: equal_to
value: true
@@ -37,7 +39,7 @@ Check:
all:
- name: level.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: level.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -79,11 +81,10 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000939'
+ Id: "CORE-000939"
Status: Published
- Version: '1'
-Description: 'An objective level must be specified using the objective level
- (C188725) DDF codelist.'
+ Version: "1"
+Description: "An objective level must be specified using the objective level (C188725) DDF codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -128,13 +129,12 @@ Operations:
term_value: level.decode
version: level.codeSystemVersion
Outcome:
- Message: 'The objective level is not specified using the objective level
- (C188725) DDF codelist - codeSystem is not "http://www.cdisc.org",
- codeSystemVersion is not a valid terminology package date, the code or
- decode (either as preferred term or as submission value) is found in the
- codelist (case insensitive) but the corresponding decode or code does not
- match the codelist value (case sensitive), and/or neither code nor decode is
- found in the codelist.'
+ Message:
+ 'The objective level is not specified using the objective level (C188725) DDF codelist - codeSystem
+ is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code
+ or decode (either as preferred term or as submission value) is found in the codelist (case insensitive)
+ but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither
+ code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -155,5 +155,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Objective'
+ - "Objective"
Sensitivity: Record
diff --git a/Published/CORE-000940/rule.yml b/Published/CORE-000940/rule.yml
index 210645ce4..3dcb88e29 100644
--- a/Published/CORE-000940/rule.yml
+++ b/Published/CORE-000940/rule.yml
@@ -4,32 +4,30 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An endpoint level must be specified using the endpoint level
- (C188726) DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "An endpoint level must be specified using the endpoint level (C188726) DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00148'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00148"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An endpoint level must be specified using the endpoint level
- (C188726) DDF codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "An endpoint level must be specified using the endpoint level (C188726) DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00148'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00148"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: level
operator: equal_to
value: true
@@ -37,7 +35,7 @@ Check:
all:
- name: level.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: level.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -79,11 +77,10 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000940'
+ Id: "CORE-000940"
Status: Published
- Version: '1'
-Description: 'An endpoint level must be specified using the endpoint level
- (C188726) DDF codelist.'
+ Version: "1"
+Description: "An endpoint level must be specified using the endpoint level (C188726) DDF codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -128,13 +125,12 @@ Operations:
term_value: level.decode
version: level.codeSystemVersion
Outcome:
- Message: 'The endpoint level is not specified using the endpoint level (C188726)
- DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
- is not a valid terminology package date, the code or decode (either as
- preferred term or as submission value) is found in the codelist (case
- insensitive) but the corresponding decode or code does not match the
- codelist value (case sensitive), and/or neither code nor decode is found in
- the codelist.'
+ Message:
+ 'The endpoint level is not specified using the endpoint level (C188726) DDF codelist - codeSystem
+ is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code
+ or decode (either as preferred term or as submission value) is found in the codelist (case insensitive)
+ but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither
+ code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -155,5 +151,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Endpoint'
+ - "Endpoint"
Sensitivity: Record
diff --git a/Published/CORE-000941/rule.yml b/Published/CORE-000941/rule.yml
index 16329e83c..e9d60f51e 100644
--- a/Published/CORE-000941/rule.yml
+++ b/Published/CORE-000941/rule.yml
@@ -4,36 +4,36 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study arm data origin type must be specified according to the
- extensible data origin type (C188727) DDF codelist (e.g. an
- entry with a code or decode used from the codelist should be
- consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study arm data origin type must be specified according to the extensible data
+ origin type (C188727) DDF codelist (e.g. an entry with a code or decode used from the codelist
+ should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00149'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00149"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study arm data origin type must be specified according to the
- extensible data origin type (C188727) DDF codelist (e.g. an
- entry with a code or decode used from the codelist should be
- consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study arm data origin type must be specified according to the extensible data
+ origin type (C188727) DDF codelist (e.g. an entry with a code or decode used from the codelist
+ should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00149'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00149"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: dataOriginType
operator: exists
- name: dataOriginType
@@ -43,7 +43,7 @@ Check:
all:
- name: dataOriginType.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: dataOriginType.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -53,7 +53,7 @@ Check:
value: true
- name: $codelist_extensible_override
operator: equal_to
- value: 'Y'
+ value: "Y"
- any:
- all:
- name: $code_for_decode_pref_term
@@ -89,13 +89,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000941'
+ Id: "CORE-000941"
Status: Published
- Version: '1'
-Description: "A study arm data origin type must be specified according to the
- extensible data origin type (C188727) DDF codelist (e.g. an entry with a code
- or decode used from the codelist should be consistent with the full entry in
- the codelist)."
+ Version: "1"
+Description:
+ "A study arm data origin type must be specified according to the extensible data origin type
+ (C188727) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent
+ with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -110,24 +110,25 @@ Operations:
ct_package_type: DDF
id: $codelist_extensible
operator: codelist_extensible
- version: dataOriginType.codeSystemVersion
- # DDF codelist extensibility was not defined in earlier CT packages and
- # defaults to false, so assigning an override:
+ version:
+ dataOriginType.codeSystemVersion
+ # DDF codelist extensibility was not defined in earlier CT packages and
+ # defaults to false, so assigning an override:
- id: $codelist_extensible_override
map:
- - dataOriginType.codeSystemVersion: '2022-09-30'
+ - dataOriginType.codeSystemVersion: "2022-09-30"
output: "Y"
- - dataOriginType.codeSystemVersion: '2022-12-16'
+ - dataOriginType.codeSystemVersion: "2022-12-16"
output: "Y"
- - dataOriginType.codeSystemVersion: '2023-03-31'
+ - dataOriginType.codeSystemVersion: "2023-03-31"
output: "Y"
- - dataOriginType.codeSystemVersion: '2023-06-30'
+ - dataOriginType.codeSystemVersion: "2023-06-30"
output: "Y"
- - dataOriginType.codeSystemVersion: '2023-09-29'
+ - dataOriginType.codeSystemVersion: "2023-09-29"
output: "Y"
- - dataOriginType.codeSystemVersion: '2023-12-15'
+ - dataOriginType.codeSystemVersion: "2023-12-15"
output: "Y"
- - dataOriginType.codeSystemVersion: '2024-03-29'
+ - dataOriginType.codeSystemVersion: "2024-03-29"
output: "Y"
operator: map
- codelist_code: $codelist_code
@@ -159,12 +160,12 @@ Operations:
term_value: dataOriginType.decode
version: dataOriginType.codeSystemVersion
Outcome:
- Message: 'The study arm data origin type is not specified according to the
- extensible data origin type (C188727) DDF codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, and/or the code or decode (either as preferred term or as submission
- value) is found in the codelist (case insensitive) but the corresponding
- decode or code does not match the codelist value (case sensitive).'
+ Message:
+ 'The study arm data origin type is not specified according to the extensible data origin type
+ (C188727) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
+ terminology package date, and/or the code or decode (either as preferred term or as submission value)
+ is found in the codelist (case insensitive) but the corresponding decode or code does not match the
+ codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -186,5 +187,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyArm'
+ - "StudyArm"
Sensitivity: Record
diff --git a/Published/CORE-000942/rule.yml b/Published/CORE-000942/rule.yml
index 146f9695b..88c6d5248 100644
--- a/Published/CORE-000942/rule.yml
+++ b/Published/CORE-000942/rule.yml
@@ -4,36 +4,36 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An encounter type must be specified according to the extensible
- encounter type (C188728) DDF codelist (e.g. an entry with a
- code or decode used from the codelist should be consistent
- with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An encounter type must be specified according to the extensible encounter type
+ (C188728) DDF codelist (e.g. an entry with a code or decode used from the codelist should be
+ consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00150'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00150"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An encounter type must be specified according to the extensible
- encounter type (C188728) DDF codelist (e.g. an entry with a
- code or decode used from the codelist should be consistent
- with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An encounter type must be specified according to the extensible encounter type
+ (C188728) DDF codelist (e.g. an entry with a code or decode used from the codelist should be
+ consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00150'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00150"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type
operator: exists
- name: type
@@ -43,7 +43,7 @@ Check:
all:
- name: type.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: type.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -53,7 +53,7 @@ Check:
value: true
- name: $codelist_extensible_override
operator: equal_to
- value: 'Y'
+ value: "Y"
- any:
- all:
- name: $code_for_decode_pref_term
@@ -89,13 +89,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000942'
+ Id: "CORE-000942"
Status: Published
- Version: '1'
-Description: "An encounter type must be specified according to the extensible
- encounter type (C188728) DDF codelist (e.g. an entry with a code or decode
- used from the codelist should be consistent with the full entry in the
- codelist)."
+ Version: "1"
+Description:
+ "An encounter type must be specified according to the extensible encounter type (C188728)
+ DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the
+ full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -110,25 +110,26 @@ Operations:
ct_package_type: DDF
id: $codelist_extensible
operator: codelist_extensible
- version: type.codeSystemVersion
- # DDF codelist extensibility was not defined in earlier CT packages and
- # defaults to false, so assigning an override:
+ version:
+ type.codeSystemVersion
+ # DDF codelist extensibility was not defined in earlier CT packages and
+ # defaults to false, so assigning an override:
- id: $codelist_extensible_override
map:
- output: "Y"
- type.codeSystemVersion: '2022-09-30'
+ type.codeSystemVersion: "2022-09-30"
- output: "Y"
- type.codeSystemVersion: '2022-12-16'
+ type.codeSystemVersion: "2022-12-16"
- output: "Y"
- type.codeSystemVersion: '2023-03-31'
+ type.codeSystemVersion: "2023-03-31"
- output: "Y"
- type.codeSystemVersion: '2023-06-30'
+ type.codeSystemVersion: "2023-06-30"
- output: "Y"
- type.codeSystemVersion: '2023-09-29'
+ type.codeSystemVersion: "2023-09-29"
- output: "Y"
- type.codeSystemVersion: '2023-12-15'
+ type.codeSystemVersion: "2023-12-15"
- output: "Y"
- type.codeSystemVersion: '2024-03-29'
+ type.codeSystemVersion: "2024-03-29"
operator: map
- codelist_code: $codelist_code
ct_package_type: DDF
@@ -159,12 +160,12 @@ Operations:
term_value: type.decode
version: type.codeSystemVersion
Outcome:
- Message: 'The encounter type is not specified according to the extensible
- encounter type (C188728) DDF codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, and/or the code or decode (either as preferred term or as submission
- value) is found in the codelist (case insensitive) but the corresponding
- decode or code does not match the codelist value (case sensitive).'
+ Message:
+ 'The encounter type is not specified according to the extensible encounter type (C188728) DDF
+ codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
+ package date, and/or the code or decode (either as preferred term or as submission value) is found
+ in the codelist (case insensitive) but the corresponding decode or code does not match the codelist
+ value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -186,5 +187,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Encounter'
+ - "Encounter"
Sensitivity: Record
diff --git a/Published/CORE-000943/rule.yml b/Published/CORE-000943/rule.yml
index 3094b88ce..097feca60 100644
--- a/Published/CORE-000943/rule.yml
+++ b/Published/CORE-000943/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study definition document type must be specified according to
- the extensible study definition document type (C215477) DDF
- codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study definition document type must be specified according to the extensible
+ study definition document type (C215477) DDF codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00166'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00166"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type
operator: exists
- name: type
@@ -30,7 +29,7 @@ Check:
all:
- name: type.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: type.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000943'
+ Id: "CORE-000943"
Status: Published
- Version: '1'
-Description: "A study definition document type must be specified according to
- the extensible study definition document type (C215477) DDF codelist (e.g. an
- entry with a code or decode used from the codelist should be consistent with
- the full entry in the codelist)."
+ Version: "1"
+Description:
+ "A study definition document type must be specified according to the extensible study definition
+ document type (C215477) DDF codelist (e.g. an entry with a code or decode used from the codelist should
+ be consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +122,12 @@ Operations:
term_value: type.decode
version: type.codeSystemVersion
Outcome:
- Message: 'The study definition document type is not specified according to the
- extensible study definition document type (C215477) DDF codelist -
- codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
- terminology package date, and/or the code or decode (either as preferred
- term or as submission value) is found in the codelist (case insensitive) but
- the corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The study definition document type is not specified according to the extensible study definition
+ document type (C215477) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, and/or the code or decode (either as preferred term or as
+ submission value) is found in the codelist (case insensitive) but the corresponding decode or code
+ does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyDefinitionDocument'
+ - "StudyDefinitionDocument"
Sensitivity: Record
diff --git a/Published/CORE-000944/rule.yml b/Published/CORE-000944/rule.yml
index 558e50f54..158385bc6 100644
--- a/Published/CORE-000944/rule.yml
+++ b/Published/CORE-000944/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A piece of narrative content must only reference narrative
- content items that have been defined within the study.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A piece of narrative content must only reference narrative content items that
+ have been defined within the study."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00168'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00168"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**.study)@$s.$s.documentedBy@$sd.
$sd.versions@$sv.
@@ -40,15 +41,17 @@ Check: |-
]
[check=true]
Core:
- Id: 'CORE-000944'
+ Id: "CORE-000944"
Status: Published
- Version: '1'
-Description: 'A piece of narrative content must only reference narrative content
- items that have been defined within the study.'
+ Version: "1"
+Description:
+ "A piece of narrative content must only reference narrative content items that have been
+ defined within the study."
Executability: Fully Executable
Outcome:
- Message: 'The reference to the narrative content item is not targetting a
- narrative content item that has been defined within the study.'
+ Message:
+ "The reference to the narrative content item is not targetting a narrative content item that
+ has been defined within the study."
Output Variables:
- StudyDefinitionDocument.id
- StudyDefinitionDocument.name
@@ -61,5 +64,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'NarrativeContent'
+ - "NarrativeContent"
Sensitivity: Record
diff --git a/Published/CORE-000945/rule.yml b/Published/CORE-000945/rule.yml
index 34955845b..2fcc63496 100644
--- a/Published/CORE-000945/rule.yml
+++ b/Published/CORE-000945/rule.yml
@@ -4,26 +4,26 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Syntax template text is expected to be HTML formatted.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Syntax template text is expected to be HTML formatted."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00247'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00247"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: $xhtml_errors
operator: non_empty
Core:
- Id: 'CORE-000945'
+ Id: "CORE-000945"
Status: Published
- Version: '1'
-Description: 'Syntax template text is expected to be HTML formatted.'
+ Version: "1"
+Description: "Syntax template text is expected to be HTML formatted."
Executability: Partially Executable - Possible Overreporting
Operations:
- id: $xhtml_errors
@@ -31,7 +31,7 @@ Operations:
namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0
operator: get_xhtml_errors
Outcome:
- Message: 'The text attribute contains non-conformant XHTML.'
+ Message: "The text attribute contains non-conformant XHTML."
Output Variables:
- parent_entity
- parent_id
@@ -42,10 +42,10 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Characteristic'
- - 'Condition'
- - 'EligibilityCriterionItem'
- - 'Endpoint'
- - 'IntercurrentEvent'
- - 'Objective'
+ - "Characteristic"
+ - "Condition"
+ - "EligibilityCriterionItem"
+ - "Endpoint"
+ - "IntercurrentEvent"
+ - "Objective"
Sensitivity: Record
diff --git a/Published/CORE-000946/rule.yml b/Published/CORE-000946/rule.yml
index a1421bb77..a33160d68 100644
--- a/Published/CORE-000946/rule.yml
+++ b/Published/CORE-000946/rule.yml
@@ -4,29 +4,27 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: RPHASE variable is required when any Repro Phase day variable is
- used
+ - Cited Guidance: RPHASE variable is required when any Repro Phase day variable is used
Document: IG-DART v1.1
- Section: '4.1.1'
+ Section: "4.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND351
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: RPHASE variable is required when any Repro Phase day variable is
- used
+ - Cited Guidance: RPHASE variable is required when any Repro Phase day variable is used
Document: IG-DART v1.2
- Section: '4.1.1'
+ Section: "4.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND351
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
@@ -61,17 +59,18 @@ Check:
- name: --RPENDY
operator: exists
- name: --RPENDY
- operator: non_empty
- # when one of the above is populated, RPHASE may not be empty
+ operator:
+ non_empty
+ # when one of the above is populated, RPHASE may not be empty
- name: RPHASE
operator: empty
Core:
Id: CORE-000946
Status: Published
- Version: '1'
-Description: Raise an error when one of the timing variables is populated and
- RPHASE is not populated
+ Version: "1"
+Description: Raise an error when one of the timing variables is populated and RPHASE is not
+ populated
Executability: Fully Executable
Outcome:
Message: RPHASE must be populated when one of the timing variables is populated
diff --git a/Published/CORE-000947/rule.yml b/Published/CORE-000947/rule.yml
index 055c674d6..5415e4503 100644
--- a/Published/CORE-000947/rule.yml
+++ b/Published/CORE-000947/rule.yml
@@ -5,101 +5,102 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'New variables (other than those that are from the same general
- observation class) must not be added, and existing variables
- must not be renamed or modified for novel usage.'
+ - Cited Guidance:
+ "New variables (other than those that are from the same general observation class)
+ must not be added, and existing variables must not be renamed or modified for novel usage."
Document: IG v3.0
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND270
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'New variables (other than those from the same general
- observation class) must not be added, and existing variables
- must not be renamed or modified for novel usage.'
+ - Cited Guidance:
+ "New variables (other than those from the same general observation class) must
+ not be added, and existing variables must not be renamed or modified for novel usage."
Document: IG v3.1
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND270.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'New variables (other than those from the same general
- observation class) must not be added, and existing variables
- must not be renamed or modified for novel usage.'
+ - Cited Guidance:
+ "New variables (other than those from the same general observation class) must
+ not be added, and existing variables must not be renamed or modified for novel usage."
Document: IG v3.1.1
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND270.1
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'New variables (other than those from the same general
- observation class) must not be added, and existing variables
- must not be renamed or modified for novel usage.'
+ - Cited Guidance:
+ "New variables (other than those from the same general observation class) must
+ not be added, and existing variables must not be renamed or modified for novel usage."
Document: IG v3.1.1
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND270.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'New variables (other than those from the same general
- observation class) must not be added, and existing variables
- must not be renamed or modified for novel usage.'
+ - Cited Guidance:
+ "New variables (other than those from the same general observation class) must
+ not be added, and existing variables must not be renamed or modified for novel usage."
Document: IG v3.1
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND270.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'New variables (other than those from the same general
- observation class) must not be added, and existing variables
- must not be renamed or modified for novel usage.'
+ - Cited Guidance:
+ "New variables (other than those from the same general observation class) must
+ not be added, and existing variables must not be renamed or modified for novel usage."
Document: IG v3.1.1
- Section: '2.3'
+ Section: "2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND270.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
# TODO in future?: add to rule implementation of rules CG0013, TIG0298
# Difference is that the current SEND rule is limited to Interventions, Findings, Events
# Whereas CG0013, TIG0298 is for all classes
- - name: 'variable_name'
- operator: 'is_not_contained_by'
+ - name: "variable_name"
+ operator: "is_not_contained_by"
value: $allowed_variables
Core:
- Status: Published
- Version: '1'
Id: CORE-000947
-Description: 'Report a violation when the variable is not found in the
- underlying SDTM model for the same observation class'
+ Status: Published
+ Version: "1"
+Description:
+ "Report a violation when the variable is not found in the underlying SDTM model for the same
+ observation class"
# Set to "partially executable" as the second part "and use is consistent with SDTM v1.5 definition"
# cannot be implemented as machine-executable
Executability: Partially Executable
@@ -107,8 +108,7 @@ Operations:
- id: $allowed_variables
operator: get_model_column_order
Outcome:
- Message: 'The variable is not found in the underlying SDTM model for the same
- observation class'
+ Message: "The variable is not found in the underlying SDTM model for the same observation class"
# Rule Type: Variable Metadata Check against Library Metadata
Rule Type: Variable Metadata Check
Scope:
diff --git a/Published/CORE-000948/rule.yml b/Published/CORE-000948/rule.yml
index d615c0b33..b3e254527 100644
--- a/Published/CORE-000948/rule.yml
+++ b/Published/CORE-000948/rule.yml
@@ -4,27 +4,29 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Each combination of arm and epoch must occur no more than once
- within a study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Each combination of arm and epoch must occur no more than once within a study
+ design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00069'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00069"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Each combination of arm and epoch must occur no more than once
- within a study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Each combination of arm and epoch must occur no more than once within a study
+ design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00069'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00069"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
$.study.versions.studyDesigns@$sd.
$filter($sd.studyCells,function($v,$i,$a)
@@ -52,15 +54,13 @@ Check: |-
}
)
Core:
- Id: 'CORE-000948'
+ Id: "CORE-000948"
Status: Published
- Version: '1'
-Description: 'Each combination of arm and epoch must occur no more than once
- within a study design.'
+ Version: "1"
+Description: "Each combination of arm and epoch must occur no more than once within a study design."
Executability: Fully Executable
Outcome:
- Message: 'The combination of arm and epoch occurs more than once within the
- study design.'
+ Message: "The combination of arm and epoch occurs more than once within the study design."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -72,5 +72,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyCell'
+ - "StudyCell"
Sensitivity: Record
diff --git a/Published/CORE-000949/rule.yml b/Published/CORE-000949/rule.yml
index 4cbcad824..a16e7a1b7 100644
--- a/Published/CORE-000949/rule.yml
+++ b/Published/CORE-000949/rule.yml
@@ -4,44 +4,41 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Class relationships must conform with the USDM schema based on
- the API specification.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Class relationships must conform with the USDM schema based on the API specification."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00081'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00081"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Class relationships must conform with the USDM schema based on
- the API specification.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Class relationships must conform with the USDM schema based on the API specification."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00081'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00081"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: validator
operator: equal_to
- value: 'const'
+ value: "const"
- name: error_attribute
operator: equal_to
- value: 'instanceType'
+ value: "instanceType"
Core:
- Id: 'CORE-000949'
+ Id: "CORE-000949"
Status: Published
- Version: '1'
-Description: 'Class relationships must conform with the USDM schema based on the
- API specification.'
+ Version: "1"
+Description: "Class relationships must conform with the USDM schema based on the API specification."
Executability: Fully Executable
Outcome:
- Message: 'The class relationship does not conform with the USDM schema.'
+ Message: "The class relationship does not conform with the USDM schema."
Output Variables:
- error_attribute
- message
@@ -49,5 +46,5 @@ Rule Type: JSON Schema Check
Scope:
Entities:
Include:
- - 'ALL'
+ - "ALL"
Sensitivity: Record
diff --git a/Published/CORE-000950/rule.yml b/Published/CORE-000950/rule.yml
index 6d5e52c47..8250abbd8 100644
--- a/Published/CORE-000950/rule.yml
+++ b/Published/CORE-000950/rule.yml
@@ -4,29 +4,29 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled activity/decision instance must only reference an
- epoch that is defined within the same study design as the
- scheduled activity/decision instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A scheduled activity/decision instance must only reference an epoch that is defined
+ within the same study design as the scheduled activity/decision instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00105'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00105"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled activity/decision instance must only reference an
- epoch that is defined within the same study design as the
- scheduled activity/decision instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A scheduled activity/decision instance must only reference an epoch that is defined
+ within the same study design as the scheduled activity/decision instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00105'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00105"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(
$lkp:=$merge($.**.studyDesigns.epochs.{id:%.id});
@@ -47,16 +47,17 @@ Check: |-
]
)
Core:
- Id: 'CORE-000950'
+ Id: "CORE-000950"
Status: Published
- Version: '1'
-Description: 'A scheduled activity/decision instance must only reference an
- epoch that is defined within the same study design as the scheduled
- activity/decision instance.'
+ Version: "1"
+Description:
+ "A scheduled activity/decision instance must only reference an epoch that is defined within
+ the same study design as the scheduled activity/decision instance."
Executability: Fully Executable
Outcome:
- Message: 'The scheduled activity/decision instance references an epoch that is
- not defined within the same study design.'
+ Message:
+ "The scheduled activity/decision instance references an epoch that is not defined within the
+ same study design."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -67,6 +68,6 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'ScheduledActivityInstance'
- - 'ScheduledDecisionInstance'
+ - "ScheduledActivityInstance"
+ - "ScheduledDecisionInstance"
Sensitivity: Record
diff --git a/Published/CORE-000951/rule.yml b/Published/CORE-000951/rule.yml
index a8a952d3f..fe5747acc 100644
--- a/Published/CORE-000951/rule.yml
+++ b/Published/CORE-000951/rule.yml
@@ -4,21 +4,21 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study definition document version''s status must be specified
- using the status Value Set Terminology (C188723) DDF
- codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study definition document version's status must be specified using the status
+ Value Set Terminology (C188723) DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00169'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00169"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: status
operator: equal_to
value: true
@@ -26,7 +26,7 @@ Check:
all:
- name: status.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: status.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -68,11 +68,12 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000951'
+ Id: "CORE-000951"
Status: Published
- Version: '1'
-Description: 'A study definition document version''s status must be specified
- using the status Value Set Terminology (C188723) DDF codelist.'
+ Version: "1"
+Description:
+ "A study definition document version's status must be specified using the status Value Set
+ Terminology (C188723) DDF codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -117,13 +118,12 @@ Operations:
term_value: status.decode
version: status.codeSystemVersion
Outcome:
- Message: 'The study definition document version''s status is not specified using
- the status Value Set Terminology (C188723) DDF codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, the code or decode (either as preferred term or as submission value)
- is found in the codelist (case insensitive) but the corresponding decode or
- code does not match the codelist value (case sensitive), and/or neither code
- nor decode is found in the codelist.'
+ Message:
+ 'The study definition document version''s status is not specified using the status Value Set
+ Terminology (C188723) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is
+ not a valid terminology package date, the code or decode (either as preferred term or as submission
+ value) is found in the codelist (case insensitive) but the corresponding decode or code does not match
+ the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -144,5 +144,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyDefinitionDocumentVersion'
+ - "StudyDefinitionDocumentVersion"
Sensitivity: Record
diff --git a/Published/CORE-000953/rule.yml b/Published/CORE-000953/rule.yml
index 81c622030..8592ec4b2 100644
--- a/Published/CORE-000953/rule.yml
+++ b/Published/CORE-000953/rule.yml
@@ -7,82 +7,86 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies.
Document: Model v2.0
Item: IDVAR
Section: Comments
- - Cited Guidance: Name of the identifying variable in the
- general-observation-class dataset that identifies the related
- record(s).
+ - Cited Guidance:
+ Name of the identifying variable in the general-observation-class dataset
+ that identifies the related record(s).
Document: Model v2.0
Item: IDVAR
Section: Supplemental Qualifiers
- - Cited Guidance: Name of the identifying variable in the
- general-observation-class dataset that identifies the related
- record(s).
+ - Cited Guidance:
+ Name of the identifying variable in the general-observation-class dataset
+ that identifies the related record(s).
Document: Model v2.0
Item: IDVAR
Section: Related Records
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0370
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies.
Document: Model v1.4
Section: 2.2.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0370
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies.
Document: Model v1.7
Section: 2.2.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0370
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: Identifying variable in the parent dataset that identifies the
- record(s) to which the comment applies.
+ - Cited Guidance:
+ Identifying variable in the parent dataset that identifies the record(s) to
+ which the comment applies.
Document: SDTM v2.1
Item: IDVAR
Section: 3.2.2 Comments
- - Cited Guidance: Name of the identifying variable in the
- general-observation-class dataset that identifies the related
- record(s).
+ - Cited Guidance:
+ Name of the identifying variable in the general-observation-class dataset
+ that identifies the related record(s).
Document: SDTM v2.1
Item: IDVAR
Section: 6.2 Supplemental Qualifiers Datasets
- - Cited Guidance: Name of the identifying variable in the
- general-observation-class dataset that identifies the related
- record(s).
+ - Cited Guidance:
+ Name of the identifying variable in the general-observation-class dataset
+ that identifies the related record(s).
Document: SDTM v2.1
Item: IDVAR
Section: Section 6.1 Related Records Dataset
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0534
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: RDOMAIN
@@ -95,9 +99,9 @@ Check:
Core:
Id: CORE-000953
Status: Published
- Version: '1'
-Description: Part C - Raise and error when IDVAR in CO is not populated with a
- valid variable from the dataset referenced in RDOMAIN.
+ Version: "1"
+Description: Part C - Raise and error when IDVAR in CO is not populated with a valid variable from
+ the dataset referenced in RDOMAIN.
Executability: Fully Executable
Match Datasets:
- Child: true
@@ -113,8 +117,8 @@ Operations:
operator: distinct
value_is_reference: true
Outcome:
- Message: Value for IDVAR in CO does not represent a variable present in the
- dataset referenced in RDOMAIN.
+ Message: Value for IDVAR in CO does not represent a variable present in the dataset referenced in
+ RDOMAIN.
Output Variables:
- IDVAR
Rule Type: Record Data
diff --git a/Published/CORE-000954/rule.yml b/Published/CORE-000954/rule.yml
index d5ec78d72..8a4a6d965 100644
--- a/Published/CORE-000954/rule.yml
+++ b/Published/CORE-000954/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An activity with children must not refer to a timeline,
- procedure, biomedical concept, biomedical concept category or
- biomedical concept surrogate.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An activity with children must not refer to a timeline, procedure, biomedical
+ concept, biomedical concept category or biomedical concept surrogate."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00160'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00160"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**.studyDesigns)@$sd.
$sd.activities@$p.
@@ -42,17 +42,17 @@ Check: |-
]
[check=true]
Core:
- Id: 'CORE-000954'
+ Id: "CORE-000954"
Status: Published
- Version: '1'
-Description: 'An activity with children must not refer to a timeline, procedure,
- biomedical concept, biomedical concept category or biomedical concept
- surrogate.'
+ Version: "1"
+Description:
+ "An activity with children must not refer to a timeline, procedure, biomedical concept, biomedical
+ concept category or biomedical concept surrogate."
Executability: Fully Executable
Outcome:
- Message: 'The activity has children but also refers to a timeline, procedure,
- biomedical concept, biomedical concept category, or biomedical concept
- surrogate as well.'
+ Message:
+ "The activity has children but also refers to a timeline, procedure, biomedical concept, biomedical
+ concept category, or biomedical concept surrogate as well."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -67,5 +67,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Activity'
+ - "Activity"
Sensitivity: Record
diff --git a/Published/CORE-000955/rule.yml b/Published/CORE-000955/rule.yml
index 72e4b69ca..58e01e0d5 100644
--- a/Published/CORE-000955/rule.yml
+++ b/Published/CORE-000955/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Every identifier must be unique within the scope of an
- identified organization.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Every identifier must be unique within the scope of an identified organization."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00173'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00173"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions@$sv.
(
@@ -35,15 +34,13 @@ Check: |-
}
).*
Core:
- Id: 'CORE-000955'
+ Id: "CORE-000955"
Status: Published
- Version: '1'
-Description: 'Every identifier must be unique within the scope of an identified
- organization.'
+ Version: "1"
+Description: "Every identifier must be unique within the scope of an identified organization."
Executability: Fully Executable
Outcome:
- Message: 'The identifier text is not unique within the scope of the identified
- organization.'
+ Message: "The identifier text is not unique within the scope of the identified organization."
Output Variables:
- text
- scopeId
@@ -53,8 +50,8 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyIdentifier'
- - 'ReferenceIdentifier'
- - 'AdministrableProductIdentifier'
- - 'MedicalDeviceIdentifier'
+ - "StudyIdentifier"
+ - "ReferenceIdentifier"
+ - "AdministrableProductIdentifier"
+ - "MedicalDeviceIdentifier"
Sensitivity: Record
diff --git a/Published/CORE-000956/rule.yml b/Published/CORE-000956/rule.yml
index 99e5cfad2..5e2450a54 100644
--- a/Published/CORE-000956/rule.yml
+++ b/Published/CORE-000956/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An identified organization is not expected to have more than 1
- identifier for the study.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An identified organization is not expected to have more than 1 identifier for
+ the study."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00174'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00174"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions@$sv.
(
@@ -35,14 +36,13 @@ Check: |-
}
).*
Core:
- Id: 'CORE-000956'
+ Id: "CORE-000956"
Status: Published
- Version: '1'
-Description: 'An identified organization is not expected to have more than 1
- identifier for the study.'
+ Version: "1"
+Description: "An identified organization is not expected to have more than 1 identifier for the study."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'More than 1 study identifier is specified for the same organization.'
+ Message: "More than 1 study identifier is specified for the same organization."
Output Variables:
- text
- scopeId
@@ -51,5 +51,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyIdentifier'
+ - "StudyIdentifier"
Sensitivity: Record
diff --git a/Published/CORE-000957/rule.yml b/Published/CORE-000957/rule.yml
index 473042377..c25fb4cf6 100644
--- a/Published/CORE-000957/rule.yml
+++ b/Published/CORE-000957/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An administrable product property type must be specified
- according to the extensible administrable product property
- type (C215479) DDF codelist (e.g. an entry with a code or
- decode used from the codelist should be consistent with the
- full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An administrable product property type must be specified according to the extensible
+ administrable product property type (C215479) DDF codelist (e.g. an entry with a code or decode
+ used from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00180'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00180"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type
operator: exists
- name: type
@@ -30,7 +29,7 @@ Check:
all:
- name: type.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: type.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000957'
+ Id: "CORE-000957"
Status: Published
- Version: '1'
-Description: "An administrable product property type must be specified according
- to the extensible administrable product property type (C215479) DDF codelist
- (e.g. an entry with a code or decode used from the codelist should be
- consistent with the full entry in the codelist)."
+ Version: "1"
+Description:
+ "An administrable product property type must be specified according to the extensible administrable
+ product property type (C215479) DDF codelist (e.g. an entry with a code or decode used from the codelist
+ should be consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +122,12 @@ Operations:
term_value: type.decode
version: type.codeSystemVersion
Outcome:
- Message: 'The administrable product property type is not specified according to
- the extensible administrable product property type (C215479) DDF codelist -
- codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
- terminology package date, and/or the code or decode (either as preferred
- term or as submission value) is found in the codelist (case insensitive) but
- the corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The administrable product property type is not specified according to the extensible administrable
+ product property type (C215479) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, and/or the code or decode (either as preferred term or as
+ submission value) is found in the codelist (case insensitive) but the corresponding decode or code
+ does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'AdministrableProductProperty'
+ - "AdministrableProductProperty"
Sensitivity: Record
diff --git a/Published/CORE-000958/rule.yml b/Published/CORE-000958/rule.yml
index 26bb5f77c..bc0934f9c 100644
--- a/Published/CORE-000958/rule.yml
+++ b/Published/CORE-000958/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A reference identifier type must be specified according to the
- extensible reference identifier type (C215478) DDF
- codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A reference identifier type must be specified according to the extensible reference
+ identifier type (C215478) DDF codelist (e.g. an entry with a code or decode used from the codelist
+ should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00183'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00183"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type
operator: exists
- name: type
@@ -30,7 +29,7 @@ Check:
all:
- name: type.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: type.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000958'
+ Id: "CORE-000958"
Status: Published
- Version: '1'
-Description: "A reference identifier type must be specified according to the
- extensible reference identifier type (C215478) DDF codelist (e.g. an entry
- with a code or decode used from the codelist should be consistent with the
- full entry in the codelist)."
+ Version: "1"
+Description:
+ "A reference identifier type must be specified according to the extensible reference identifier
+ type (C215478) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent
+ with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +122,12 @@ Operations:
term_value: type.decode
version: type.codeSystemVersion
Outcome:
- Message: 'The reference identifier type is not specified according to the
- extensible reference identifier type (C215478) DDF codelist - codeSystem is
- not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
- package date, and/or the code or decode (either as preferred term or as
- submission value) is found in the codelist (case insensitive) but the
- corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The reference identifier type is not specified according to the extensible reference identifier
+ type (C215478) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a
+ valid terminology package date, and/or the code or decode (either as preferred term or as submission
+ value) is found in the codelist (case insensitive) but the corresponding decode or code does not match
+ the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ReferenceIdentifier'
+ - "ReferenceIdentifier"
Sensitivity: Record
diff --git a/Published/CORE-000959/rule.yml b/Published/CORE-000959/rule.yml
index b2177d26b..52e7e33be 100644
--- a/Published/CORE-000959/rule.yml
+++ b/Published/CORE-000959/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study amendment impact type must be specified according to
- the extensible study amendment impact type (C215481) DDF
- codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study amendment impact type must be specified according to the extensible study
+ amendment impact type (C215481) DDF codelist (e.g. an entry with a code or decode used from
+ the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00199'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00199"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type
operator: exists
- name: type
@@ -30,7 +29,7 @@ Check:
all:
- name: type.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: type.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000959'
+ Id: "CORE-000959"
Status: Published
- Version: '1'
-Description: "A study amendment impact type must be specified according to the
- extensible study amendment impact type (C215481) DDF codelist (e.g. an entry
- with a code or decode used from the codelist should be consistent with the
- full entry in the codelist)."
+ Version: "1"
+Description:
+ "A study amendment impact type must be specified according to the extensible study amendment
+ impact type (C215481) DDF codelist (e.g. an entry with a code or decode used from the codelist should
+ be consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,12 +122,12 @@ Operations:
term_value: type.decode
version: type.codeSystemVersion
Outcome:
- Message: 'The study impact type is not specified according to the extensible
- study amendment impact type (C215481) DDF codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, and/or the code or decode (either as preferred term or as submission
- value) is found in the codelist (case insensitive) but the corresponding
- decode or code does not match the codelist value (case sensitive).'
+ Message:
+ 'The study impact type is not specified according to the extensible study amendment impact
+ type (C215481) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a
+ valid terminology package date, and/or the code or decode (either as preferred term or as submission
+ value) is found in the codelist (case insensitive) but the corresponding decode or code does not match
+ the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -149,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyAmendmentImpact'
+ - "StudyAmendmentImpact"
Sensitivity: Record
diff --git a/Published/CORE-000960/rule.yml b/Published/CORE-000960/rule.yml
index 2b9bf9113..b30b55821 100644
--- a/Published/CORE-000960/rule.yml
+++ b/Published/CORE-000960/rule.yml
@@ -4,26 +4,26 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Narrative content text is expected to be HTML formatted.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Narrative content text is expected to be HTML formatted."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00085'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00085"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: $xhtml_errors
operator: non_empty
Core:
- Id: 'CORE-000960'
+ Id: "CORE-000960"
Status: Published
- Version: '1'
-Description: 'Narrative content text is expected to be HTML formatted.'
+ Version: "1"
+Description: "Narrative content text is expected to be HTML formatted."
Executability: Partially Executable - Possible Overreporting
Operations:
- id: $xhtml_errors
@@ -31,7 +31,7 @@ Operations:
namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0
operator: get_xhtml_errors
Outcome:
- Message: 'The narrative content text contains non-conformant XHTML.'
+ Message: "The narrative content text contains non-conformant XHTML."
Output Variables:
- parent_entity
- parent_id
@@ -42,5 +42,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'NarrativeContent'
+ - "NarrativeContent"
Sensitivity: Record
diff --git a/Published/CORE-000961/rule.yml b/Published/CORE-000961/rule.yml
index c5a27087f..6dc9e7c10 100644
--- a/Published/CORE-000961/rule.yml
+++ b/Published/CORE-000961/rule.yml
@@ -4,31 +4,31 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Encounter ordering using previous and next attributes is
- expected to be consistent with the order of corresponding
- scheduled activity instances according to their specified
- default conditions.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Encounter ordering using previous and next attributes is expected to be consistent
+ with the order of corresponding scheduled activity instances according to their specified default
+ conditions."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00087'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00087"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Encounter ordering using previous and next attributes is
- expected to be consistent with the order of corresponding
- scheduled activity instances according to their specified
- default conditions.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Encounter ordering using previous and next attributes is expected to be consistent
+ with the order of corresponding scheduled activity instances according to their specified default
+ conditions."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00087'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00087"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.study.versions)@$sv.
($sv.studyDesigns)@$sd.
@@ -53,18 +53,18 @@ Check: |-
}[`Encounter order by previous/next` != `Encounter order by timeline refs`]
)
Core:
- Id: 'CORE-000961'
+ Id: "CORE-000961"
Status: Published
- Version: '1'
-Description: 'Encounter ordering using previous and next attributes is expected
- to be consistent with the order of corresponding scheduled activity instances
- according to their specified default conditions.'
+ Version: "1"
+Description:
+ "Encounter ordering using previous and next attributes is expected to be consistent with
+ the order of corresponding scheduled activity instances according to their specified default conditions."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The order of the encounters in the study design (as defined by the
- next attribute) does not match the order of encounters as referenced from
- scheduled activity instances in the main timeline that are ordered by
- default condition.'
+ Message:
+ "The order of the encounters in the study design (as defined by the next attribute) does not
+ match the order of encounters as referenced from scheduled activity instances in the main timeline
+ that are ordered by default condition."
Output Variables:
- name
- ScheduleTimeline.id
@@ -76,7 +76,7 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyDesign'
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "StudyDesign"
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000962/rule.yml b/Published/CORE-000962/rule.yml
index 6f8ed654c..1770200c2 100644
--- a/Published/CORE-000962/rule.yml
+++ b/Published/CORE-000962/rule.yml
@@ -4,29 +4,29 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, if a planned completion number is
- defined, it must be specified either in the study population
- or in all cohorts.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study design, if a planned completion number is defined, it must be
+ specified either in the study population or in all cohorts."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00132'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00132"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, if a planned completion number is
- defined, it must be specified either in the study population
- or in all cohorts.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study design, if a planned completion number is defined, it must be
+ specified either in the study population or in all cohorts."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00132'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00132"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**.studyDesigns)@$sd.
$sd.population@$p.
@@ -67,16 +67,17 @@ Check: |-
]
[check=true]
Core:
- Id: 'CORE-000962'
+ Id: "CORE-000962"
Status: Published
- Version: '1'
-Description: 'Within a study design, if a planned completion number is defined,
- it must be specified either in the study population or in all cohorts.'
+ Version: "1"
+Description:
+ "Within a study design, if a planned completion number is defined, it must be specified either
+ in the study population or in all cohorts."
Executability: Fully Executable
Outcome:
- Message: 'A planned completion number has been specified for both the study
- population and one or more cohorts, or it has been specified for only a
- subset of the cohorts.'
+ Message:
+ "A planned completion number has been specified for both the study population and one or more
+ cohorts, or it has been specified for only a subset of the cohorts."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -90,5 +91,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyDesignPopulation'
+ - "StudyDesignPopulation"
Sensitivity: Record
diff --git a/Published/CORE-000963/rule.yml b/Published/CORE-000963/rule.yml
index a34c66444..c5d5b7ccd 100644
--- a/Published/CORE-000963/rule.yml
+++ b/Published/CORE-000963/rule.yml
@@ -4,29 +4,29 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, if a planned enrollment number is
- defined, it must be specified either in the study population
- or in all cohorts.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study design, if a planned enrollment number is defined, it must be
+ specified either in the study population or in all cohorts."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00133'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00133"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, if a planned enrollment number is
- defined, it must be specified either in the study population
- or in all cohorts.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study design, if a planned enrollment number is defined, it must be
+ specified either in the study population or in all cohorts."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00133'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00133"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**.studyDesigns)@$sd.
$sd.population@$p.
@@ -67,16 +67,17 @@ Check: |-
]
[check=true]
Core:
- Id: 'CORE-000963'
+ Id: "CORE-000963"
Status: Published
- Version: '1'
-Description: 'Within a study design, if a planned enrollment number is defined,
- it must be specified either in the study population or in all cohorts.'
+ Version: "1"
+Description:
+ "Within a study design, if a planned enrollment number is defined, it must be specified either
+ in the study population or in all cohorts."
Executability: Fully Executable
Outcome:
- Message: 'A planned enrollment number has been specified for both the study
- population and the cohorts, or it has been specified for only a subset of
- the cohorts.'
+ Message:
+ "A planned enrollment number has been specified for both the study population and the cohorts,
+ or it has been specified for only a subset of the cohorts."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -90,5 +91,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyDesignPopulation'
+ - "StudyDesignPopulation"
Sensitivity: Record
diff --git a/Published/CORE-000964/rule.yml b/Published/CORE-000964/rule.yml
index 25a2dd6e6..b3b8739fb 100644
--- a/Published/CORE-000964/rule.yml
+++ b/Published/CORE-000964/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a section number is to be displayed then a number must be
- specified.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "If a section number is to be displayed then a number must be specified."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00164'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00164"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**.documentedBy)@$db.
$db.versions@$sv.
@@ -42,14 +41,13 @@ Check: |-
]
[check=true]
Core:
- Id: 'CORE-000964'
+ Id: "CORE-000964"
Status: Published
- Version: '1'
-Description: 'If a section number is to be displayed then a number must be specified.'
+ Version: "1"
+Description: "If a section number is to be displayed then a number must be specified."
Executability: Fully Executable
Outcome:
- Message: 'A section number is indicated to be displayed
- (displaySectionNumber=true) but not specified.'
+ Message: "A section number is indicated to be displayed (displaySectionNumber=true) but not specified."
Output Variables:
- StudyDefinitionDocument.id
- StudyDefinitionDocument.name
@@ -62,5 +60,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'NarrativeContent'
+ - "NarrativeContent"
Sensitivity: Record
diff --git a/Published/CORE-000965/rule.yml b/Published/CORE-000965/rule.yml
index f840cee75..6098c47e1 100644
--- a/Published/CORE-000965/rule.yml
+++ b/Published/CORE-000965/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a section title is to be displayed then a title must be
- specified.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "If a section title is to be displayed then a title must be specified."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00165'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00165"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**.documentedBy)@$db.
$db.versions@$sv.
@@ -42,14 +41,13 @@ Check: |-
]
[check=true]
Core:
- Id: 'CORE-000965'
+ Id: "CORE-000965"
Status: Published
- Version: '1'
-Description: 'If a section title is to be displayed then a title must be specified.'
+ Version: "1"
+Description: "If a section title is to be displayed then a title must be specified."
Executability: Fully Executable
Outcome:
- Message: 'A section title is indicated to be displayed
- (displaySectionTitle=true) but not specified.'
+ Message: "A section title is indicated to be displayed (displaySectionTitle=true) but not specified."
Output Variables:
- StudyDefinitionDocument.id
- StudyDefinitionDocument.name
@@ -62,5 +60,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'NarrativeContent'
+ - "NarrativeContent"
Sensitivity: Record
diff --git a/Published/CORE-000966/rule.yml b/Published/CORE-000966/rule.yml
index 3782eeb49..18ef38e71 100644
--- a/Published/CORE-000966/rule.yml
+++ b/Published/CORE-000966/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If an administration''s dose is specified then a corresponding
- route is expected and vice versa.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If an administration's dose is specified then a corresponding route is expected
+ and vice versa."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00177'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00177"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions.studyInterventions)@$si.
$si.administrations@$sa.
@@ -44,14 +45,15 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-000966'
+ Id: "CORE-000966"
Status: Published
- Version: '1'
-Description: 'If an administration''s dose is specified then a corresponding
- route is expected and vice versa.'
+ Version: "1"
+Description:
+ "If an administration's dose is specified then a corresponding route is expected and vice
+ versa."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The administration dose has been specified without a route or vice versa.'
+ Message: "The administration dose has been specified without a route or vice versa."
Output Variables:
- StudyIntervention.id
- StudyIntervention.name
@@ -64,5 +66,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Administration'
+ - "Administration"
Sensitivity: Record
diff --git a/Published/CORE-000967/rule.yml b/Published/CORE-000967/rule.yml
index 22e7337ae..1052f8e2e 100644
--- a/Published/CORE-000967/rule.yml
+++ b/Published/CORE-000967/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a dose is specified then a corresponding frequency must also
- be specified.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "If a dose is specified then a corresponding frequency must also be specified."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00178'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00178"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions.studyInterventions)@$si.
$si.administrations@$sa.
@@ -45,15 +44,15 @@ Check: |-
"frequency": ($sa.frequency ? ($sa.frequency.standardCode.decode & " (" & $sa.frequency.standardCode.code & ")")),
"check": ($exists($sa.dose.id) and $exists($sa.frequency.id)=false)
}
- )][check=true]
+ )][check=true]
Core:
- Id: 'CORE-000967'
+ Id: "CORE-000967"
Status: Published
- Version: '1'
-Description: 'If a dose is specified then a corresponding frequency must also be specified.'
+ Version: "1"
+Description: "If a dose is specified then a corresponding frequency must also be specified."
Executability: Fully Executable
Outcome:
- Message: 'The administration dose has been specified without a frequency.'
+ Message: "The administration dose has been specified without a frequency."
Output Variables:
- StudyIntervention.id
- StudyIntervention.name
@@ -66,5 +65,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Administration'
+ - "Administration"
Sensitivity: Record
diff --git a/Published/CORE-000968/rule.yml b/Published/CORE-000968/rule.yml
index c21186297..a8a29f552 100644
--- a/Published/CORE-000968/rule.yml
+++ b/Published/CORE-000968/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study definition document version, if a date of a
- specific type exists with a global geographic scope then no
- other dates are expected with the same type.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study definition document version, if a date of a specific type exists
+ with a global geographic scope then no other dates are expected with the same type."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00182'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00182"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study@$s.
$s.documentedBy@$sdd.
@@ -38,17 +38,17 @@ Check: |-
}
).* ~> $distinct
Core:
- Id: 'CORE-000968'
+ Id: "CORE-000968"
Status: Published
- Version: '1'
-Description: 'Within a study definition document version, if a date of a
- specific type exists with a global geographic scope then no other dates are
- expected with the same type.'
+ Version: "1"
+Description:
+ "Within a study definition document version, if a date of a specific type exists with a global
+ geographic scope then no other dates are expected with the same type."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: "There is more than one date of this type for the study definition
- document version, but at least one of the dates has a global geographic
- scope."
+ Message:
+ "There is more than one date of this type for the study definition document version, but at
+ least one of the dates has a global geographic scope."
Output Variables:
- StudyDefinitionDocument.id
- StudyDefinitionDocument.name
@@ -61,5 +61,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'GovernanceDate'
+ - "GovernanceDate"
Sensitivity: Record
diff --git a/Published/CORE-000969/rule.yml b/Published/CORE-000969/rule.yml
index c88a4bb4b..4c00a4db0 100644
--- a/Published/CORE-000969/rule.yml
+++ b/Published/CORE-000969/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a dose is specified, then a corresponding administrable
- product must also be specified either directly or embedded in
- the medical device and vice versa.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If a dose is specified, then a corresponding administrable product must also
+ be specified either directly or embedded in the medical device and vice versa."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00185'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00185"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions)@$sv.
$sv.studyInterventions@$si.
@@ -53,17 +53,17 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-000969'
+ Id: "CORE-000969"
Status: Published
- Version: '1'
-Description: 'If a dose is specified, then a corresponding administrable product
- must also be specified either directly or embedded in the medical device and
- vice versa.'
+ Version: "1"
+Description:
+ "If a dose is specified, then a corresponding administrable product must also be specified
+ either directly or embedded in the medical device and vice versa."
Executability: Fully Executable
Outcome:
- Message: 'The administration dose has been specified without an administrable
- product (either as a direct administrable product or as an embedded product
- via the related medical device) or vice versa.'
+ Message:
+ "The administration dose has been specified without an administrable product (either as a direct
+ administrable product or as an embedded product via the related medical device) or vice versa."
Output Variables:
- StudyIntervention.id
- StudyIntervention.name
@@ -79,5 +79,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Administration'
+ - "Administration"
Sensitivity: Record
diff --git a/Published/CORE-000970/rule.yml b/Published/CORE-000970/rule.yml
index f2d77d7ef..f10013f10 100644
--- a/Published/CORE-000970/rule.yml
+++ b/Published/CORE-000970/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Every study role must apply to either a study version or at
- least one study design, but not both.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Every study role must apply to either a study version or at least one study design,
+ but not both."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00189'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00189"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions@$sv.
($sv.roles
@@ -37,17 +38,18 @@ Check: |-
"StudyVersion.studyDesigns.id": $sv.studyDesigns.id
}
Core:
- Id: 'CORE-000970'
+ Id: "CORE-000970"
Status: Published
- Version: '1'
-Description: 'Every study role must apply to either a study version or at least
- one study design, but not both.'
+ Version: "1"
+Description:
+ "Every study role must apply to either a study version or at least one study design, but
+ not both."
Executability: Fully Executable
Outcome:
- Message: 'The study role does not only apply to the study version or at least
- one study design - it does not apply to anything, it applies to both the
- study version and at least one study design, or it applies to something that
- is not a study version or a study design.'
+ Message:
+ "The study role does not only apply to the study version or at least one study design - it
+ does not apply to anything, it applies to both the study version and at least one study design, or
+ it applies to something that is not a study version or a study design."
Output Variables:
- name
- code
@@ -58,5 +60,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyRole'
+ - "StudyRole"
Sensitivity: Record
diff --git a/Published/CORE-000971/rule.yml b/Published/CORE-000971/rule.yml
index b8303089b..85e78a7b1 100644
--- a/Published/CORE-000971/rule.yml
+++ b/Published/CORE-000971/rule.yml
@@ -4,14 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'At least one attribute must be specified for an address.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "At least one attribute must be specified for an address."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00194'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00194"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions.organizations@$o.
$o.legalAddress[$not(text or lines or city or district or state or postalCode or country)].
@@ -33,13 +33,13 @@ Check: |-
}
)
Core:
- Id: 'CORE-000971'
+ Id: "CORE-000971"
Status: Published
- Version: '1'
-Description: 'At least one attribute must be specified for an address.'
+ Version: "1"
+Description: "At least one attribute must be specified for an address."
Executability: Fully Executable
Outcome:
- Message: 'All attributes of the address are blank.'
+ Message: "All attributes of the address are blank."
Output Variables:
- Organization.id
- Organization.name
diff --git a/Published/CORE-000972/rule.yml b/Published/CORE-000972/rule.yml
index b79a397df..670a08e81 100644
--- a/Published/CORE-000972/rule.yml
+++ b/Published/CORE-000972/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An organization type must be specified according to the
- extensible organization type (C188724) DDF codelist (e.g. an
- entry with a code or decode used from the codelist should be
- consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An organization type must be specified according to the extensible organization
+ type (C188724) DDF codelist (e.g. an entry with a code or decode used from the codelist should
+ be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00200'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00200"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type
operator: exists
- name: type
@@ -29,7 +29,7 @@ Check:
all:
- name: type.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: type.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -39,7 +39,7 @@ Check:
value: true
- name: $codelist_extensible_override
operator: equal_to
- value: 'Y'
+ value: "Y"
- any:
- all:
- name: $code_for_decode_pref_term
@@ -75,13 +75,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000972'
+ Id: "CORE-000972"
Status: Published
- Version: '1'
-Description: "An organization type must be specified according to the extensible
- organization type (C188724) DDF codelist (e.g. an entry with a code or decode
- used from the codelist should be consistent with the full entry in the
- codelist)."
+ Version: "1"
+Description:
+ "An organization type must be specified according to the extensible organization type (C188724)
+ DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the
+ full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -96,25 +96,26 @@ Operations:
ct_package_type: DDF
id: $codelist_extensible
operator: codelist_extensible
- version: type.codeSystemVersion
- # DDF codelist extensibility was not defined in earlier CT packages and
- # defaults to false, so assigning an override:
+ version:
+ type.codeSystemVersion
+ # DDF codelist extensibility was not defined in earlier CT packages and
+ # defaults to false, so assigning an override:
- id: $codelist_extensible_override
map:
- output: "Y"
- type.codeSystemVersion: '2022-09-30'
+ type.codeSystemVersion: "2022-09-30"
- output: "Y"
- type.codeSystemVersion: '2022-12-16'
+ type.codeSystemVersion: "2022-12-16"
- output: "Y"
- type.codeSystemVersion: '2023-03-31'
+ type.codeSystemVersion: "2023-03-31"
- output: "Y"
- type.codeSystemVersion: '2023-06-30'
+ type.codeSystemVersion: "2023-06-30"
- output: "Y"
- type.codeSystemVersion: '2023-09-29'
+ type.codeSystemVersion: "2023-09-29"
- output: "Y"
- type.codeSystemVersion: '2023-12-15'
+ type.codeSystemVersion: "2023-12-15"
- output: "Y"
- type.codeSystemVersion: '2024-03-29'
+ type.codeSystemVersion: "2024-03-29"
operator: map
- codelist_code: $codelist_code
ct_package_type: DDF
@@ -145,12 +146,12 @@ Operations:
term_value: type.decode
version: type.codeSystemVersion
Outcome:
- Message: 'The organization type is not specified according to the extensible
- organization type (C188724) DDF codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, and/or the code or decode (either as preferred term or as submission
- value) is found in the codelist (case insensitive) but the corresponding
- decode or code does not match the codelist value (case sensitive).'
+ Message:
+ 'The organization type is not specified according to the extensible organization type (C188724)
+ DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
+ package date, and/or the code or decode (either as preferred term or as submission value) is found
+ in the codelist (case insensitive) but the corresponding decode or code does not match the codelist
+ value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -172,5 +173,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Organization'
+ - "Organization"
Sensitivity: Record
diff --git a/Published/CORE-000973/rule.yml b/Published/CORE-000973/rule.yml
index 9f45c8a3d..123a29b86 100644
--- a/Published/CORE-000973/rule.yml
+++ b/Published/CORE-000973/rule.yml
@@ -4,14 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'There must be exactly one study role with a code of sponsor.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "There must be exactly one study role with a code of sponsor."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00201'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00201"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions@$sv.
(
@@ -26,21 +26,20 @@ Check: |-
}
)[`# Sponsor Roles` != 1]
Core:
- Id: 'CORE-000973'
+ Id: "CORE-000973"
Status: Published
- Version: '1'
-Description: 'There must be exactly one study role with a code of sponsor.'
+ Version: "1"
+Description: "There must be exactly one study role with a code of sponsor."
Executability: Fully Executable
Outcome:
- Message: 'There is not exactly one study role with a code of sponsor (where
- code.code is C70793).'
+ Message: "There is not exactly one study role with a code of sponsor (where code.code is C70793)."
Output Variables:
- versionIdentifier
- - '# Sponsor Roles'
- - 'Sponsor Roles'
+ - "# Sponsor Roles"
+ - "Sponsor Roles"
Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyVersion'
+ - "StudyVersion"
Sensitivity: Record
diff --git a/Published/CORE-000974/rule.yml b/Published/CORE-000974/rule.yml
index 7a87e5434..69e200ca8 100644
--- a/Published/CORE-000974/rule.yml
+++ b/Published/CORE-000974/rule.yml
@@ -4,14 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The sponsor study role must be applicable to a study version.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "The sponsor study role must be applicable to a study version."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00203'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00203"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions@$sv.
($sv.roles[code.code = "C70793" and $not($sv.id in appliesToIds)])@$r.
@@ -26,15 +26,15 @@ Check: |-
"StudyVersion.id": $sv.id
}
Core:
- Id: 'CORE-000974'
+ Id: "CORE-000974"
Status: Published
- Version: '1'
-Description: 'The sponsor study role must be applicable to a study version.'
+ Version: "1"
+Description: "The sponsor study role must be applicable to a study version."
Executability: Fully Executable
Outcome:
- Message: "The study role is a sponsor role (code.code is C70793) but it is not
- applicable to the study version (appliesToIds does not contain the id of the
- study version)."
+ Message:
+ "The study role is a sponsor role (code.code is C70793) but it is not applicable to the study
+ version (appliesToIds does not contain the id of the study version)."
Output Variables:
- name
- code.code
@@ -45,5 +45,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyRole'
+ - "StudyRole"
Sensitivity: Record
diff --git a/Published/CORE-000975/rule.yml b/Published/CORE-000975/rule.yml
index ee62a3a97..484a37a8a 100644
--- a/Published/CORE-000975/rule.yml
+++ b/Published/CORE-000975/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A medical device identifier type must be specified according to
- the extensible medical device identifier type (C215484) DDF
- codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A medical device identifier type must be specified according to the extensible
+ medical device identifier type (C215484) DDF codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00207'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00207"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: type
operator: exists
- name: type
@@ -30,7 +29,7 @@ Check:
all:
- name: type.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: type.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000975'
+ Id: "CORE-000975"
Status: Published
- Version: '1'
-Description: "A medical device identifier type must be specified according to
- the extensible medical device identifier type (C215484) DDF codelist (e.g. an
- entry with a code or decode used from the codelist should be consistent with
- the full entry in the codelist)."
+ Version: "1"
+Description:
+ "A medical device identifier type must be specified according to the extensible medical device
+ identifier type (C215484) DDF codelist (e.g. an entry with a code or decode used from the codelist should
+ be consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +122,12 @@ Operations:
term_value: type.decode
version: type.codeSystemVersion
Outcome:
- Message: 'The medical device identifier type is not specified according to the
- extensible medical device identifier type (C215484) DDF codelist -
- codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
- terminology package date, and/or the code or decode (either as preferred
- term or as submission value) is found in the codelist (case insensitive) but
- the corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The medical device identifier type is not specified according to the extensible medical device
+ identifier type (C215484) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, and/or the code or decode (either as preferred term or as
+ submission value) is found in the codelist (case insensitive) but the corresponding decode or code
+ does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'MedicalDeviceIdentifier'
+ - "MedicalDeviceIdentifier"
Sensitivity: Record
diff --git a/Published/CORE-000976/rule.yml b/Published/CORE-000976/rule.yml
index 13cebf0b4..bb8e5c911 100644
--- a/Published/CORE-000976/rule.yml
+++ b/Published/CORE-000976/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An administrable product sourcing must be specified using the
- extensible administrable product sourcing (C215483) DDF
- codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An administrable product sourcing must be specified using the extensible administrable
+ product sourcing (C215483) DDF codelist (e.g. an entry with a code or decode used from the codelist
+ should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00208'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00208"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: sourcing
operator: exists
- name: sourcing
@@ -30,7 +29,7 @@ Check:
all:
- name: sourcing.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: sourcing.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000976'
+ Id: "CORE-000976"
Status: Published
- Version: '1'
-Description: "An administrable product sourcing must be specified using the
- extensible administrable product sourcing (C215483) DDF codelist (e.g. an
- entry with a code or decode used from the codelist should be consistent with
- the full entry in the codelist)."
+ Version: "1"
+Description:
+ "An administrable product sourcing must be specified using the extensible administrable product
+ sourcing (C215483) DDF codelist (e.g. an entry with a code or decode used from the codelist should be
+ consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +122,12 @@ Operations:
term_value: sourcing.decode
version: sourcing.codeSystemVersion
Outcome:
- Message: 'The administrable product sourcing is not specified according to the
- extensible administrable product sourcing (C215483) DDF codelist -
- codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
- terminology package date, and/or the code or decode (either as preferred
- term or as submission value) is found in the codelist (case insensitive) but
- the corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The administrable product sourcing is not specified according to the extensible administrable
+ product sourcing (C215483) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, and/or the code or decode (either as preferred term or as
+ submission value) is found in the codelist (case insensitive) but the corresponding decode or code
+ does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'AdministrableProduct'
+ - "AdministrableProduct"
Sensitivity: Record
diff --git a/Published/CORE-000977/rule.yml b/Published/CORE-000977/rule.yml
index ecae528b8..500524906 100644
--- a/Published/CORE-000977/rule.yml
+++ b/Published/CORE-000977/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A medical device sourcing must be specified using the
- extensible medical device sourcing (C215482) DDF codelist
- (e.g. an entry with a code or decode used from the codelist
+ - Cited Guidance:
+ "A medical device sourcing must be specified using the extensible medical device
+ sourcing (C215482) DDF codelist (e.g. an entry with a code or decode used from the codelist
should be consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00209'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00209"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: sourcing
operator: exists
- name: sourcing
@@ -29,7 +29,7 @@ Check:
all:
- name: sourcing.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: sourcing.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -71,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000977'
+ Id: "CORE-000977"
Status: Published
- Version: '1'
-Description: "A medical device sourcing must be specified using the extensible
- medical device sourcing (C215482) DDF codelist (e.g. an entry with a code or
- decode used from the codelist should be consistent with the full entry in the
- codelist)."
+ Version: "1"
+Description:
+ "A medical device sourcing must be specified using the extensible medical device sourcing
+ (C215482) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent
+ with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -122,13 +122,12 @@ Operations:
term_value: sourcing.decode
version: sourcing.codeSystemVersion
Outcome:
- Message: 'The medical device sourcing is not specified according to the
- extensible medical device sourcing (C215482) DDF codelist - codeSystem is
- not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
- package date, and/or the code or decode (either as preferred term or as
- submission value) is found in the codelist (case insensitive) but the
- corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The medical device sourcing is not specified according to the extensible medical device sourcing
+ (C215482) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
+ terminology package date, and/or the code or decode (either as preferred term or as submission value)
+ is found in the codelist (case insensitive) but the corresponding decode or code does not match the
+ codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -149,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'MedicalDevice'
+ - "MedicalDevice"
Sensitivity: Record
diff --git a/Published/CORE-000978/rule.yml b/Published/CORE-000978/rule.yml
index 034918930..477373055 100644
--- a/Published/CORE-000978/rule.yml
+++ b/Published/CORE-000978/rule.yml
@@ -4,21 +4,21 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An administrable product''s product designation must be
- specified using the product designation (C207418) DDF
- codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An administrable product's product designation must be specified using the product
+ designation (C207418) DDF codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00210'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00210"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: productDesignation
operator: equal_to
value: true
@@ -26,7 +26,7 @@ Check:
all:
- name: productDesignation.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: productDesignation.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -68,11 +68,12 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-000978'
+ Id: "CORE-000978"
Status: Published
- Version: '1'
-Description: 'An administrable product''s product designation must be specified
- using the product designation (C207418) DDF codelist.'
+ Version: "1"
+Description:
+ "An administrable product's product designation must be specified using the product designation
+ (C207418) DDF codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -117,13 +118,12 @@ Operations:
term_value: productDesignation.decode
version: productDesignation.codeSystemVersion
Outcome:
- Message: 'The administrable product''s product designation is not specified
- using the product designation (C207418) DDF codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, the code or decode (either as preferred term or as submission value)
- is found in the codelist (case insensitive) but the corresponding decode or
- code does not match the codelist value (case sensitive), and/or neither code
- nor decode is found in the codelist.'
+ Message:
+ 'The administrable product''s product designation is not specified using the product designation
+ (C207418) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
+ terminology package date, the code or decode (either as preferred term or as submission value) is
+ found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist
+ value (case sensitive), and/or neither code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -144,5 +144,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'AdministrableProduct'
+ - "AdministrableProduct"
Sensitivity: Record
diff --git a/Published/CORE-000979/rule.yml b/Published/CORE-000979/rule.yml
index 8a7aec16f..9609d17f5 100644
--- a/Published/CORE-000979/rule.yml
+++ b/Published/CORE-000979/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An interventional study design's intent types must be specified
- according to the extensible Trial Intent Type Response
- (C66736) SDTM codelist (e.g. an entry with a code or decode
- used from the codelist should be consistent with the full
- entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An interventional study design's intent types must be specified according to
+ the extensible Trial Intent Type Response (C66736) SDTM codelist (e.g. an entry with a code
+ or decode used from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00214'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00214"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: intentTypes
operator: exists
- name: intentTypes
@@ -28,13 +27,13 @@ Check:
value: true
- name: parent_rel.Code
operator: equal_to
- value: 'intentTypes'
+ value: "intentTypes"
value_is_literal: true
- not:
all:
- name: codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -76,13 +75,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000979'
+ Id: "CORE-000979"
Status: Published
- Version: '1'
-Description: "An interventional study design's intent types must be specified
- according to the extensible Trial Intent Type Response (C66736) SDTM codelist
- (e.g. an entry with a code or decode used from the codelist should be
- consistent with the full entry in the codelist)."
+ Version: "1"
+Description:
+ "An interventional study design's intent types must be specified according to the extensible
+ Trial Intent Type Response (C66736) SDTM codelist (e.g. an entry with a code or decode used from the
+ codelist should be consistent with the full entry in the codelist)."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -96,7 +95,7 @@ Operations:
- id: $codelist_code
map:
- output: C66736
- parent_rel.Code: 'intentTypes'
+ parent_rel.Code: "intentTypes"
operator: map
- ct_package_types:
- SDTM
@@ -136,13 +135,12 @@ Operations:
term_value: decode
version: codeSystemVersion
Outcome:
- Message: 'The interventional study design''s intent type is not specified
- according to the extensible Trial Intent Type Response (C66736) SDTM
- codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is
- not a valid terminology package date, and/or the code or decode (either as
- preferred term or as submission value) is found in the codelist (case
- insensitive) but the corresponding decode or code does not match the
- codelist value (case sensitive).'
+ Message:
+ 'The interventional study design''s intent type is not specified according to the extensible
+ Trial Intent Type Response (C66736) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, and/or the code or decode (either as preferred term or as
+ submission value) is found in the codelist (case insensitive) but the corresponding decode or code
+ does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -163,5 +161,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
+ - "InterventionalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000980/rule.yml b/Published/CORE-000980/rule.yml
index 3401cd8f9..5266f8291 100644
--- a/Published/CORE-000980/rule.yml
+++ b/Published/CORE-000980/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, if more characteristics are defined,
- they must be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within a study design, if more characteristics are defined, they must be distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00219'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00219"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions.studyDesigns.
(
@@ -31,17 +30,15 @@ Check: |-
}
}
)
- )
+ )
Core:
- Id: 'CORE-000980'
+ Id: "CORE-000980"
Status: Published
- Version: '1'
-Description: 'Within a study design, if more characteristics are defined, they
- must be distinct.'
+ Version: "1"
+Description: "Within a study design, if more characteristics are defined, they must be distinct."
Executability: Fully Executable
Outcome:
- Message: 'The same characteristics code is used more than once within the study
- design.'
+ Message: "The same characteristics code is used more than once within the study design."
Output Variables:
- name
- characteristics
@@ -49,6 +46,6 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000981/rule.yml b/Published/CORE-000981/rule.yml
index 2cf6cd7dc..db04d3cd6 100644
--- a/Published/CORE-000981/rule.yml
+++ b/Published/CORE-000981/rule.yml
@@ -4,14 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A unit must not be specified for a planned enrollment number.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A unit must not be specified for a planned enrollment number."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00234'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00234"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**.studyDesigns)@$sd.
$sd.population@$p.
@@ -59,13 +59,13 @@ Check: |-
]
[check = true]
Core:
- Id: 'CORE-000981'
+ Id: "CORE-000981"
Status: Published
- Version: '1'
-Description: 'A unit must not be specified for a planned enrollment number.'
+ Version: "1"
+Description: "A unit must not be specified for a planned enrollment number."
Executability: Fully Executable
Outcome:
- Message: 'A unit has been specified for a planned enrollment number'
+ Message: "A unit has been specified for a planned enrollment number"
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -79,5 +79,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyDesignPopulation'
+ - "StudyDesignPopulation"
Sensitivity: Record
diff --git a/Published/CORE-000982/rule.yml b/Published/CORE-000982/rule.yml
index bdf2554dd..930e17c0e 100644
--- a/Published/CORE-000982/rule.yml
+++ b/Published/CORE-000982/rule.yml
@@ -4,14 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A unit must not be specified for a planned completion number.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A unit must not be specified for a planned completion number."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00235'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00235"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**.studyDesigns)@$sd.
$sd.population@$p.
@@ -59,13 +59,13 @@ Check: |-
]
[check = true]
Core:
- Id: 'CORE-000982'
+ Id: "CORE-000982"
Status: Published
- Version: '1'
-Description: 'A unit must not be specified for a planned completion number.'
+ Version: "1"
+Description: "A unit must not be specified for a planned completion number."
Executability: Fully Executable
Outcome:
- Message: 'A unit has been specified for a planned completion number'
+ Message: "A unit has been specified for a planned completion number"
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -79,5 +79,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyDesignPopulation'
+ - "StudyDesignPopulation"
Sensitivity: Record
diff --git a/Published/CORE-000983/rule.yml b/Published/CORE-000983/rule.yml
index e5dbbb4c4..b025b9b41 100644
--- a/Published/CORE-000983/rule.yml
+++ b/Published/CORE-000983/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A procedure must only reference a study intervention that is
- referenced by the same study design as the activity within
- which the procedure is defined.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A procedure must only reference a study intervention that is referenced by the
+ same study design as the activity within which the procedure is defined."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00240'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00240"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions)@$sv.
$sv.studyDesigns@$sd.
@@ -35,16 +35,17 @@ Check: |-
"StudyIntervention.name": $sv.studyInterventions[id=$sp.studyInterventionId].name
}]
Core:
- Id: 'CORE-000983'
+ Id: "CORE-000983"
Status: Published
- Version: '1'
-Description: 'A procedure must only reference a study intervention that is
- referenced by the same study design as the activity within which the procedure
- is defined.'
+ Version: "1"
+Description:
+ "A procedure must only reference a study intervention that is referenced by the same study
+ design as the activity within which the procedure is defined."
Executability: Fully Executable
Outcome:
- Message: 'The reference to the intervention is not targetting an intervention
- that has been referenced by the study design as a study intervention.'
+ Message:
+ "The reference to the intervention is not targetting an intervention that has been referenced
+ by the study design as a study intervention."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -58,5 +59,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Procedure'
+ - "Procedure"
Sensitivity: Record
diff --git a/Published/CORE-000984/rule.yml b/Published/CORE-000984/rule.yml
index 19783abc4..6ea990cf7 100644
--- a/Published/CORE-000984/rule.yml
+++ b/Published/CORE-000984/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Each study enrollment must apply to either a geographic scope,
- a study site, or a study cohort.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Each study enrollment must apply to either a geographic scope, a study site,
+ or a study cohort."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00195'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00195"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions@$sv.
$sv.amendments@$a.
@@ -59,16 +60,18 @@ Check: |-
}
)[check=true]
Core:
- Id: 'CORE-000984'
+ Id: "CORE-000984"
Status: Published
- Version: '1'
-Description: 'Each study enrollment must apply to either a geographic scope, a
- study site, or a study cohort.'
+ Version: "1"
+Description:
+ "Each study enrollment must apply to either a geographic scope, a study site, or a study
+ cohort."
Executability: Fully Executable
Outcome:
- Message: 'The study enrollment does not apply to either a geographic scope, a
- study site, or a study cohort - it does not apply to one and only one of
- these, or the value for forStudySiteId or forStudyCohortId is invalid.'
+ Message:
+ "The study enrollment does not apply to either a geographic scope, a study site, or a study
+ cohort - it does not apply to one and only one of these, or the value for forStudySiteId or forStudyCohortId
+ is invalid."
Output Variables:
- StudyAmendment.id
- StudyAmendment.name
diff --git a/Published/CORE-000985/rule.yml b/Published/CORE-000985/rule.yml
index db956421f..969868dc6 100644
--- a/Published/CORE-000985/rule.yml
+++ b/Published/CORE-000985/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'There must be a one-to-one relationship between referenced
- section number and title within any study definition document
- affected by a study amendment.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "There must be a one-to-one relationship between referenced section number and
+ title within any study definition document affected by a study amendment."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00196'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00196"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study@$s.
$s.versions@$sv.
@@ -54,17 +54,17 @@ Check: |-
}
)
Core:
- Id: 'CORE-000985'
+ Id: "CORE-000985"
Status: Published
- Version: '1'
-Description: 'There must be a one-to-one relationship between referenced section
- number and title within any study definition document affected by a study
- amendment.'
+ Version: "1"
+Description:
+ "There must be a one-to-one relationship between referenced section number and title within
+ any study definition document affected by a study amendment."
Executability: Fully Executable
Outcome:
- Message: 'There is not a one-to-one relationship between the referenced section
- number and title within the study definition document affected by the study
- amendment.'
+ Message:
+ "There is not a one-to-one relationship between the referenced section number and title within
+ the study definition document affected by the study amendment."
Output Variables:
- StudyAmendment.id
- StudyAmendment.name
diff --git a/Published/CORE-000986/rule.yml b/Published/CORE-000986/rule.yml
index 15725acdd..b887b507c 100644
--- a/Published/CORE-000986/rule.yml
+++ b/Published/CORE-000986/rule.yml
@@ -4,17 +4,17 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An administrable product must not be referenced as both the
- administrable product for an administration and the embedded
- product of a medical device that is referenced by the same
- administration.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An administrable product must not be referenced as both the administrable product
+ for an administration and the embedded product of a medical device that is referenced by the
+ same administration."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00205'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00205"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions)@$sv.
$sv.studyInterventions@$si.
@@ -35,17 +35,17 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-000986'
+ Id: "CORE-000986"
Status: Published
- Version: '1'
-Description: 'An administrable product must not be referenced as both the
- administrable product for an administration and the embedded product of a
- medical device that is referenced by the same administration.'
+ Version: "1"
+Description:
+ "An administrable product must not be referenced as both the administrable product for an
+ administration and the embedded product of a medical device that is referenced by the same administration."
Executability: Fully Executable
Outcome:
- Message: 'The administrable product is referenced both as the administrable
- product for an administration and as the embedded product of a medical
- device that is referenced by the same administration.'
+ Message:
+ "The administrable product is referenced both as the administrable product for an administration
+ and as the embedded product of a medical device that is referenced by the same administration."
Output Variables:
- StudyIntervention.id
- StudyIntervention.name
@@ -58,5 +58,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Administration'
+ - "Administration"
Sensitivity: Record
diff --git a/Published/CORE-000987/rule.yml b/Published/CORE-000987/rule.yml
index b73120bb7..86d193ccc 100644
--- a/Published/CORE-000987/rule.yml
+++ b/Published/CORE-000987/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An interventional study design's sub types must be specified
- according to the extensible Trial Type Response (C66739) SDTM
- codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An interventional study design's sub types must be specified according to the
+ extensible Trial Type Response (C66739) SDTM codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00215'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00215"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: subTypes
operator: exists
- name: subTypes
@@ -28,13 +27,13 @@ Check:
value: true
- name: parent_rel.Code
operator: equal_to
- value: 'subTypes'
+ value: "subTypes"
value_is_literal: true
- not:
all:
- name: codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -77,13 +76,13 @@ Check:
value: $value_for_code
Core:
- Id: 'CORE-000987'
+ Id: "CORE-000987"
Status: Published
- Version: '1'
-Description: "An interventional study design's sub types must be specified
- according to the extensible Trial Type Response (C66739) SDTM codelist (e.g.
- an entry with a code or decode used from the codelist should be consistent
- with the full entry in the codelist)."
+ Version: "1"
+Description:
+ "An interventional study design's sub types must be specified according to the extensible
+ Trial Type Response (C66739) SDTM codelist (e.g. an entry with a code or decode used from the codelist
+ should be consistent with the full entry in the codelist)."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -97,7 +96,7 @@ Operations:
- id: $codelist_code
map:
- output: C66739
- parent_rel.Code: 'subTypes'
+ parent_rel.Code: "subTypes"
operator: map
- ct_package_types:
- SDTM
@@ -137,13 +136,12 @@ Operations:
term_value: decode
version: codeSystemVersion
Outcome:
- Message: 'The interventional study design''s sub type is not specified according
- to the extensible Trial Type Response (C66739) SDTM codelist - codeSystem is
- not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
- package date, and/or the code or decode (either as preferred term or as
- submission value) is found in the codelist (case insensitive) but the
- corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The interventional study design''s sub type is not specified according to the extensible Trial
+ Type Response (C66739) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, and/or the code or decode (either as preferred term or as
+ submission value) is found in the codelist (case insensitive) but the corresponding decode or code
+ does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -164,5 +162,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
+ - "InterventionalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000988/rule.yml b/Published/CORE-000988/rule.yml
index f41410334..1fd8a22ef 100644
--- a/Published/CORE-000988/rule.yml
+++ b/Published/CORE-000988/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study design's intervention model must be specified according
- to the extensible Intervention Model Response (C99076) SDTM
- codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study design's intervention model must be specified according to the extensible
+ Intervention Model Response (C99076) SDTM codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00216'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00216"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: model
operator: exists
- name: model
@@ -30,7 +29,7 @@ Check:
all:
- name: model.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: model.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000988'
+ Id: "CORE-000988"
Status: Published
- Version: '1'
-Description: "A study design's intervention model must be specified according to
- the extensible Intervention Model Response (C99076) SDTM codelist (e.g. an
- entry with a code or decode used from the codelist should be consistent with
- the full entry in the codelist)."
+ Version: "1"
+Description:
+ "A study design's intervention model must be specified according to the extensible Intervention
+ Model Response (C99076) SDTM codelist (e.g. an entry with a code or decode used from the codelist should
+ be consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +122,12 @@ Operations:
term_value: model.decode
version: model.codeSystemVersion
Outcome:
- Message: 'The study design''s intervention model is not specified according to
- the extensible Intervention Model Response (C99076) SDTM codelist -
- codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
- terminology package date, and/or the code or decode (either as preferred
- term or as submission value) is found in the codelist (case insensitive) but
- the corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The study design''s intervention model is not specified according to the extensible Intervention
+ Model Response (C99076) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, and/or the code or decode (either as preferred term or as
+ submission value) is found in the codelist (case insensitive) but the corresponding decode or code
+ does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
+ - "InterventionalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000989/rule.yml b/Published/CORE-000989/rule.yml
index efd5b8dd0..001a72e83 100644
--- a/Published/CORE-000989/rule.yml
+++ b/Published/CORE-000989/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study design's blinding schema must be specified according to
- the extensible Trial Blinding Schema Response (C66735) SDTM
- codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study design's blinding schema must be specified according to the extensible
+ Trial Blinding Schema Response (C66735) SDTM codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00217'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00217"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: blindingSchema.standardCode
operator: exists
- name: blindingSchema.standardCode
@@ -30,7 +29,7 @@ Check:
all:
- name: blindingSchema.standardCode.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: blindingSchema.standardCode.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000989'
+ Id: "CORE-000989"
Status: Published
- Version: '1'
-Description: "A study design's blinding schema must be specified according to
- the extensible Trial Blinding Schema Response (C66735) SDTM codelist (e.g. an
- entry with a code or decode used from the codelist should be consistent with
- the full entry in the codelist)."
+ Version: "1"
+Description:
+ "A study design's blinding schema must be specified according to the extensible Trial Blinding
+ Schema Response (C66735) SDTM codelist (e.g. an entry with a code or decode used from the codelist should
+ be consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +122,12 @@ Operations:
term_value: blindingSchema.standardCode.decode
version: blindingSchema.standardCode.codeSystemVersion
Outcome:
- Message: 'The study design''s blinding schema is not specified according to the
- extensible Trial Blinding Schema Response (C66735) SDTM codelist -
- codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
- terminology package date, and/or the code or decode (either as preferred
- term or as submission value) is found in the codelist (case insensitive) but
- the corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The study design''s blinding schema is not specified according to the extensible Trial Blinding
+ Schema Response (C66735) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, and/or the code or decode (either as preferred term or as
+ submission value) is found in the codelist (case insensitive) but the corresponding decode or code
+ does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
+ - "InterventionalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000990/rule.yml b/Published/CORE-000990/rule.yml
index 2b9c733a9..e76c689f6 100644
--- a/Published/CORE-000990/rule.yml
+++ b/Published/CORE-000990/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study design's characteristics must be specified according to
- the extensible study design characteristics (C207416) DDF
- codelist (e.g. an entry with a code or decode used from the
- codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study design's characteristics must be specified according to the extensible
+ study design characteristics (C207416) DDF codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00218'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00218"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: characteristics
operator: exists
- name: characteristics
@@ -28,13 +27,13 @@ Check:
value: true
- name: parent_rel.Code
operator: equal_to
- value: 'characteristics'
+ value: "characteristics"
value_is_literal: true
- not:
all:
- name: codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -76,13 +75,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000990'
+ Id: "CORE-000990"
Status: Published
- Version: '1'
-Description: "A study design's characteristics must be specified according to
- the extensible study design characteristics (C207416) DDF codelist (e.g. an
- entry with a code or decode used from the codelist should be consistent with
- the full entry in the codelist)."
+ Version: "1"
+Description:
+ "A study design's characteristics must be specified according to the extensible study design
+ characteristics (C207416) DDF codelist (e.g. an entry with a code or decode used from the codelist should
+ be consistent with the full entry in the codelist)."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -96,7 +95,7 @@ Operations:
- id: $codelist_code
map:
- output: C207416
- parent_rel.Code: 'characteristics'
+ parent_rel.Code: "characteristics"
operator: map
- ct_package_types:
- DDF
@@ -136,13 +135,12 @@ Operations:
term_value: decode
version: codeSystemVersion
Outcome:
- Message: 'The study design''s characteristic is not specified according to the
- extensible study design characteristics (C207416) DDF codelist - codeSystem
- is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
- package date, and/or the code or decode (either as preferred term or as
- submission value) is found in the codelist (case insensitive) but the
- corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The study design''s characteristic is not specified according to the extensible study design
+ characteristics (C207416) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, and/or the code or decode (either as preferred term or as
+ submission value) is found in the codelist (case insensitive) but the corresponding decode or code
+ does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -163,6 +161,6 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000991/rule.yml b/Published/CORE-000991/rule.yml
index d86e5922f..3dfa0022b 100644
--- a/Published/CORE-000991/rule.yml
+++ b/Published/CORE-000991/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study design's observational model must be specified
- according to the extensible Observational Study Model
- (C127259) SDTM codelist (e.g. an entry with a code or decode
- used from the codelist should be consistent with the full
- entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study design's observational model must be specified according to the extensible
+ Observational Study Model (C127259) SDTM codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00223'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00223"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: model
operator: exists
- name: model
@@ -30,7 +29,7 @@ Check:
all:
- name: model.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: model.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000991'
+ Id: "CORE-000991"
Status: Published
- Version: '1'
-Description: "A study design's observational model must be specified according
- to the extensible Observational Study Model (C127259) SDTM codelist (e.g. an
- entry with a code or decode used from the codelist should be consistent with
- the full entry in the codelist)."
+ Version: "1"
+Description:
+ "A study design's observational model must be specified according to the extensible Observational
+ Study Model (C127259) SDTM codelist (e.g. an entry with a code or decode used from the codelist should
+ be consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +122,12 @@ Operations:
term_value: model.decode
version: model.codeSystemVersion
Outcome:
- Message: 'The study design''s observational model is not specified according to
- the extensible Observational Study Model (C127259) SDTM codelist -
- codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
- terminology package date, and/or the code or decode (either as preferred
- term or as submission value) is found in the codelist (case insensitive) but
- the corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The study design''s observational model is not specified according to the extensible Observational
+ Study Model (C127259) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, and/or the code or decode (either as preferred term or as
+ submission value) is found in the codelist (case insensitive) but the corresponding decode or code
+ does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ObservationalStudyDesign'
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000992/rule.yml b/Published/CORE-000992/rule.yml
index 47ca97248..daa9ea6a6 100644
--- a/Published/CORE-000992/rule.yml
+++ b/Published/CORE-000992/rule.yml
@@ -4,23 +4,23 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An observational study design's time perspective must be
- specified according to the extensible Observational Study Time
- Perspective (C127261) SDTM codelist (e.g. an entry with a code
- or decode used from the codelist should be consistent with the
- full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An observational study design's time perspective must be specified according
+ to the extensible Observational Study Time Perspective (C127261) SDTM codelist (e.g. an entry
+ with a code or decode used from the codelist should be consistent with the full entry in the
+ codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00224'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00224"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: timePerspective
operator: exists
- name: timePerspective
@@ -30,7 +30,7 @@ Check:
all:
- name: timePerspective.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: timePerspective.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +72,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-000992'
+ Id: "CORE-000992"
Status: Published
- Version: '1'
-Description: "An observational study design's time perspective must be specified
- according to the extensible Observational Study Time Perspective (C127261)
- SDTM codelist (e.g. an entry with a code or decode used from the codelist
- should be consistent with the full entry in the codelist)."
+ Version: "1"
+Description:
+ "An observational study design's time perspective must be specified according to the extensible
+ Observational Study Time Perspective (C127261) SDTM codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +123,12 @@ Operations:
term_value: timePerspective.decode
version: timePerspective.codeSystemVersion
Outcome:
- Message: 'The observational study design''s time perspective is not specified
- according to the extensible Observational Study Time Perspective (C127261)
- SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
- is not a valid terminology package date, and/or the code or decode (either
- as preferred term or as submission value) is found in the codelist (case
- insensitive) but the corresponding decode or code does not match the
- codelist value (case sensitive).'
+ Message:
+ 'The observational study design''s time perspective is not specified according to the extensible
+ Observational Study Time Perspective (C127261) SDTM codelist - codeSystem is not "http://www.cdisc.org",
+ codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred
+ term or as submission value) is found in the codelist (case insensitive) but the corresponding decode
+ or code does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +149,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ObservationalStudyDesign'
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000993/rule.yml b/Published/CORE-000993/rule.yml
index 8b4184e1d..bd8c2e717 100644
--- a/Published/CORE-000993/rule.yml
+++ b/Published/CORE-000993/rule.yml
@@ -1,108 +1,101 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4607'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB4607"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4607'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB4607"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4607'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB4607"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4607'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB4607"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4607'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB4607"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4607'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB4607"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt)
- dataset.'
- Document: 'FDA'
- Section: 'FDAB046'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset."
+ Document: "FDA"
+ Section: "FDAB046"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB4607'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB4607"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: '$txparmcd'
- operator: 'does_not_contain'
- value: 'PLANMSUB'
+ - name: "$txparmcd"
+ operator: "does_not_contain"
+ value: "PLANMSUB"
Core:
Id: CORE-000993
Status: Published
- Version: '1'
-Description: For each Trial Set (SETCD) in the TX dataset exactly one Planned
- Number of Male Subjects (PLANMSUB) record should be included.
+ Version: "1"
+Description: For each Trial Set (SETCD) in the TX dataset exactly one Planned Number of Male
+ Subjects (PLANMSUB) record should be included.
Executability: Fully Executable
Grouping_Variables:
- SETCD
diff --git a/Published/CORE-000994/rule.yml b/Published/CORE-000994/rule.yml
index c234b6426..4393070d4 100644
--- a/Published/CORE-000994/rule.yml
+++ b/Published/CORE-000994/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'At least the text or the quantity must be specified for a
- duration.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "At least the text or the quantity must be specified for a duration."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00033'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00033"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**[instanceType="Duration"])@$d.
$d.[{
@@ -24,13 +23,13 @@ Check: |-
"check": $not(text or quantity)
}][check=true]
Core:
- Id: 'CORE-000994'
+ Id: "CORE-000994"
Status: Published
- Version: '1'
-Description: 'At least the text or the quantity must be specified for a duration.'
+ Version: "1"
+Description: "At least the text or the quantity must be specified for a duration."
Executability: Fully Executable
Outcome:
- Message: 'The quantity and text are both missing for the specified duration.'
+ Message: "The quantity and text are both missing for the specified duration."
Output Variables:
- text
- quantity
@@ -38,5 +37,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Duration'
+ - "Duration"
Sensitivity: Record
diff --git a/Published/CORE-000995/rule.yml b/Published/CORE-000995/rule.yml
index 377e4b4f8..9bbe1b15a 100644
--- a/Published/CORE-000995/rule.yml
+++ b/Published/CORE-000995/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If the duration will vary, a quantity is not expected for the
- duration and vice versa.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If the duration will vary, a quantity is not expected for the duration and vice
+ versa."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00039'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00039"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**[instanceType="Duration"])@$d.
$d.[(
@@ -39,15 +40,13 @@ Check: |-
"check": (durationWillVary and quantity) or (durationWillVary=false and ($not(quantity) or $exists(quantity)=false))
})][check=true]
Core:
- Id: 'CORE-000995'
+ Id: "CORE-000995"
Status: Published
- Version: '1'
-Description: 'If the duration will vary, a quantity is not expected for the
- duration and vice versa.'
+ Version: "1"
+Description: "If the duration will vary, a quantity is not expected for the duration and vice versa."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The duration quantity is specified while the duration is indicated to
- vary or vice versa.'
+ Message: "The duration quantity is specified while the duration is indicated to vary or vice versa."
Output Variables:
- quantity(value/range)
- durationWillVary
@@ -55,5 +54,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Duration'
+ - "Duration"
Sensitivity: Record
diff --git a/Published/CORE-000996/rule.yml b/Published/CORE-000996/rule.yml
index 121a8aff2..3e2a80707 100644
--- a/Published/CORE-000996/rule.yml
+++ b/Published/CORE-000996/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A planned sex must either include a single entry of male or
- female or both female and male as entries.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A planned sex must either include a single entry of male or female or both female
+ and male as entries."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00188'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00188"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**[plannedSex])@$p.
$p.[{
@@ -24,15 +25,17 @@ Check: |-
"check": ($count(plannedSex.id) != $count($distinct(plannedSex.code))) or false in $map(plannedSex.code,function($v){$v in ["C16576","C20197"]})
}][check=true]
Core:
- Id: 'CORE-000996'
+ Id: "CORE-000996"
Status: Published
- Version: '1'
-Description: 'A planned sex must either include a single entry of male or female
- or both female and male as entries.'
+ Version: "1"
+Description:
+ "A planned sex must either include a single entry of male or female or both female and male
+ as entries."
Executability: Fully Executable
Outcome:
- Message: 'The planned sex includes more than a single entry of male and/or
- female either by duplications or unexpected codes.'
+ Message:
+ "The planned sex includes more than a single entry of male and/or female either by duplications
+ or unexpected codes."
Output Variables:
- name
- plannedSex
@@ -40,6 +43,6 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyCohort'
- - 'StudyDesignPopulation'
+ - "StudyCohort"
+ - "StudyDesignPopulation"
Sensitivity: Record
diff --git a/Published/CORE-000997/rule.yml b/Published/CORE-000997/rule.yml
index d410f65ef..a42b878a6 100644
--- a/Published/CORE-000997/rule.yml
+++ b/Published/CORE-000997/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study role must not reference both assigned persons and
- organizations.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A study role must not reference both assigned persons and organizations."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00190'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00190"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions@$sv.
($sv.roles[assignedPersons and organizationIds])@$r.
@@ -26,14 +25,13 @@ Check: |-
"organizationIds": "["&$join($r.organizationIds.($oid:=$;$oid&": "&($o:=$sv.organizations[id=$oid];$o?$o.name:"Invalid organizationId")),"; ")&"]"
}
Core:
- Id: 'CORE-000997'
+ Id: "CORE-000997"
Status: Published
- Version: '1'
-Description: 'A study role must not reference both assigned persons and organizations.'
+ Version: "1"
+Description: "A study role must not reference both assigned persons and organizations."
Executability: Fully Executable
Outcome:
- Message: 'The study role references both at least one assigned person and at
- least one organization.'
+ Message: "The study role references both at least one assigned person and at least one organization."
Output Variables:
- name
- code
@@ -43,5 +41,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyRole'
+ - "StudyRole"
Sensitivity: Record
diff --git a/Published/CORE-000998/rule.yml b/Published/CORE-000998/rule.yml
index 0cb4a3dbd..8d397b244 100644
--- a/Published/CORE-000998/rule.yml
+++ b/Published/CORE-000998/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study definition document version must not be referenced more
- than once by the same study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study definition document version must not be referenced more than once by
+ the same study design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00197'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00197"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions.studyDesigns.
{
@@ -24,15 +25,17 @@ Check: |-
$filter(documentVersionIds,function($v,$i,$a){$count($a[$=$v])>1}) ~> $sort
}[`Duplicate documentVersionIds`]
Core:
- Id: 'CORE-000998'
+ Id: "CORE-000998"
Status: Published
- Version: '1'
-Description: 'A study definition document version must not be referenced more
- than once by the same study design.'
+ Version: "1"
+Description:
+ "A study definition document version must not be referenced more than once by the same study
+ design."
Executability: Fully Executable
Outcome:
- Message: "The study design references the same study definition document version
- more than once (there are duplicate id values in documentVersionIds)."
+ Message:
+ "The study design references the same study definition document version more than once (there
+ are duplicate id values in documentVersionIds)."
Output Variables:
- name
- "Duplicate documentVersionIds"
@@ -40,6 +43,6 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-000999/rule.yml b/Published/CORE-000999/rule.yml
index c5446e54b..a3cc04d8a 100644
--- a/Published/CORE-000999/rule.yml
+++ b/Published/CORE-000999/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Each study definition document version is expected to be
- referenced by either a study version or a study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Each study definition document version is expected to be referenced by either
+ a study version or a study design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00198'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00198"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study@$s.
$s.documentedBy@$sdd.
@@ -26,15 +27,17 @@ Check: |-
"version": version
}
Core:
- Id: 'CORE-000999'
+ Id: "CORE-000999"
Status: Published
- Version: '1'
-Description: 'Each study definition document version is expected to be
- referenced by either a study version or a study design.'
+ Version: "1"
+Description:
+ "Each study definition document version is expected to be referenced by either a study version
+ or a study design."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: "The study definition document version is not referenced by either a
- study version or a study design."
+ Message:
+ "The study definition document version is not referenced by either a study version or a study
+ design."
Output Variables:
- StudyDefinitionDocument.id
- StudyDefinitionDocument.name
@@ -43,5 +46,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyDefinitionDocumentVersion'
+ - "StudyDefinitionDocumentVersion"
Sensitivity: Record
diff --git a/Published/CORE-001000/rule.yml b/Published/CORE-001000/rule.yml
index 074e20016..2f6effd26 100644
--- a/Published/CORE-001000/rule.yml
+++ b/Published/CORE-001000/rule.yml
@@ -4,14 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The sponsor study role must point to exactly one organization.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "The sponsor study role must point to exactly one organization."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00202'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00202"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions@$sv.
($sv.roles[code.code = "C70793"])@$r.
@@ -27,23 +27,24 @@ Check: |-
"# Valid Organizations": $count($sv.organizations[id in $r.organizationIds])
}
Core:
- Id: 'CORE-001000'
+ Id: "CORE-001000"
Status: Published
- Version: '1'
-Description: 'The sponsor study role must point to exactly one organization.'
+ Version: "1"
+Description: "The sponsor study role must point to exactly one organization."
Executability: Fully Executable
Outcome:
- Message: 'The study role is a sponsor role (code.code is C70793) but it does not
- point to exactly one organization - it does not have exactly one value for
- organizationIds that is a valid id value for an organization.'
+ Message:
+ "The study role is a sponsor role (code.code is C70793) but it does not point to exactly one
+ organization - it does not have exactly one value for organizationIds that is a valid id value for
+ an organization."
Output Variables:
- name
- code
- organizationIds
- - '# Valid Organizations'
+ - "# Valid Organizations"
Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyRole'
+ - "StudyRole"
Sensitivity: Record
diff --git a/Published/CORE-001001/rule.yml b/Published/CORE-001001/rule.yml
index 7a6a36740..4bb94b49a 100644
--- a/Published/CORE-001001/rule.yml
+++ b/Published/CORE-001001/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Sourcing must not be defined for an administrable product which
- is only referenced as an embedded product for a medical
- device.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Sourcing must not be defined for an administrable product which is only referenced
+ as an embedded product for a medical device."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00206'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00206"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions)@$sv.
$sv.administrableProducts@$ap.
@@ -32,15 +32,17 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001001'
+ Id: "CORE-001001"
Status: Published
- Version: '1'
-Description: 'Sourcing must not be defined for an administrable product which is
- only referenced as an embedded product for a medical device.'
+ Version: "1"
+Description:
+ "Sourcing must not be defined for an administrable product which is only referenced as an
+ embedded product for a medical device."
Executability: Fully Executable
Outcome:
- Message: 'The sourcing is defined while the administrable product is only
- referenced to as an embedded product for a medical device.'
+ Message:
+ "The sourcing is defined while the administrable product is only referenced to as an embedded
+ product for a medical device."
Output Variables:
- name
- sourcing
@@ -51,5 +53,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'AdministrableProduct'
+ - "AdministrableProduct"
Sensitivity: Record
diff --git a/Published/CORE-001002/rule.yml b/Published/CORE-001002/rule.yml
index 182cd0724..911fff6dd 100644
--- a/Published/CORE-001002/rule.yml
+++ b/Published/CORE-001002/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, if more sub types are defined, they must
- be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within a study design, if more sub types are defined, they must be distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00220'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00220"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions.studyDesigns.
(
@@ -31,15 +30,15 @@ Check: |-
}
}
)
- )
+ )
Core:
- Id: 'CORE-001002'
+ Id: "CORE-001002"
Status: Published
- Version: '1'
-Description: 'Within a study design, if more sub types are defined, they must be distinct.'
+ Version: "1"
+Description: "Within a study design, if more sub types are defined, they must be distinct."
Executability: Fully Executable
Outcome:
- Message: 'The same sub types code is used more than once within the study design.'
+ Message: "The same sub types code is used more than once within the study design."
Output Variables:
- name
- subTypes
@@ -47,6 +46,6 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001003/rule.yml b/Published/CORE-001003/rule.yml
index e4a519656..45d8f0a13 100644
--- a/Published/CORE-001003/rule.yml
+++ b/Published/CORE-001003/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, if more therapeutic areas are defined,
- they must be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within a study design, if more therapeutic areas are defined, they must be distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00221'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00221"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions.studyDesigns@$sd.(
$sd.therapeuticAreas.
@@ -42,16 +41,15 @@ Check: |-
)
)
Core:
- Id: 'CORE-001003'
+ Id: "CORE-001003"
Status: Published
- Version: '1'
-Description: 'Within a study design, if more therapeutic areas are defined, they
- must be distinct.'
+ Version: "1"
+Description: "Within a study design, if more therapeutic areas are defined, they must be distinct."
Executability: Fully Executable
Outcome:
- Message: 'The therapeutic areas of the study design are not unique - the same
- code is used more than once within the same codeSystem and
- codeSystemVersion.'
+ Message:
+ "The therapeutic areas of the study design are not unique - the same code is used more than
+ once within the same codeSystem and codeSystemVersion."
Output Variables:
- name
- therapeuticAreas.codeSystem
@@ -61,6 +59,6 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001004/rule.yml b/Published/CORE-001004/rule.yml
index f93873368..0909ca30c 100644
--- a/Published/CORE-001004/rule.yml
+++ b/Published/CORE-001004/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An observational study (including patient registries) must be
- specified using the ObservationalStudyDesign class.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An observational study (including patient registries) must be specified using
+ the ObservationalStudyDesign class."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00228'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00228"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions)@$sv.
$sv.studyDesigns@$sd.
@@ -26,15 +27,17 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001004'
+ Id: "CORE-001004"
Status: Published
- Version: '1'
-Description: 'An observational study (including patient registries) must be
- specified using the ObservationalStudyDesign class.'
+ Version: "1"
+Description:
+ "An observational study (including patient registries) must be specified using the ObservationalStudyDesign
+ class."
Executability: Fully Executable
Outcome:
- Message: 'The study type is observational (including patient registries) but is
- not specified using the ObservationalStudyDesign class.'
+ Message:
+ "The study type is observational (including patient registries) but is not specified using
+ the ObservationalStudyDesign class."
Output Variables:
- name
- studyType
@@ -42,6 +45,6 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001005/rule.yml b/Published/CORE-001005/rule.yml
index 2255e2ab6..abd4e2c1f 100644
--- a/Published/CORE-001005/rule.yml
+++ b/Published/CORE-001005/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a study phase is specified for an observational study
- (including patient registries) it is expected to have a study
- phase value indicating "Not Applicable".'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ 'If a study phase is specified for an observational study (including patient registries)
+ it is expected to have a study phase value indicating "Not Applicable".'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00232'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00232"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions)@$sv.
$sv.studyDesigns@$sd.
@@ -29,17 +29,17 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001005'
+ Id: "CORE-001005"
Status: Published
- Version: '1'
-Description: 'If a study phase is specified for an observational study
- (including patient registries) it is expected to have a study phase value
- indicating "Not Applicable".'
+ Version: "1"
+Description:
+ 'If a study phase is specified for an observational study (including patient registries)
+ it is expected to have a study phase value indicating "Not Applicable".'
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The study type is observational (including patient registries) as
- coded by either "C16084" or "C129000" but the study phase is indicating a
- phase which is not "Not Applicable".'
+ Message:
+ 'The study type is observational (including patient registries) as coded by either "C16084"
+ or "C129000" but the study phase is indicating a phase which is not "Not Applicable".'
Output Variables:
- name
- studyType
@@ -48,5 +48,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'ObservationalStudyDesign'
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001006/rule.yml b/Published/CORE-001006/rule.yml
index 5c8f8cdbe..c2016d379 100644
--- a/Published/CORE-001006/rule.yml
+++ b/Published/CORE-001006/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a synonym is specified then it is not expected to be equal
- to the label of the biomedical concept (case insensitive).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If a synonym is specified then it is not expected to be equal to the label of
+ the biomedical concept (case insensitive)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00236'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00236"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions.biomedicalConcepts)@$bc.
$bc.
@@ -27,14 +28,15 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001006'
+ Id: "CORE-001006"
Status: Published
- Version: '1'
-Description: 'If a synonym is specified then it is not expected to be equal to
- the label of the biomedical concept (case insensitive).'
+ Version: "1"
+Description:
+ "If a synonym is specified then it is not expected to be equal to the label of the biomedical
+ concept (case insensitive)."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The synonym is equal to the label (case insensitive).'
+ Message: "The synonym is equal to the label (case insensitive)."
Output Variables:
- name
- label/synonym
@@ -43,5 +45,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'BiomedicalConcept'
+ - "BiomedicalConcept"
Sensitivity: Record
diff --git a/Published/CORE-001007/rule.yml b/Published/CORE-001007/rule.yml
index 722d836b6..fec8e82fd 100644
--- a/Published/CORE-001007/rule.yml
+++ b/Published/CORE-001007/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a strength numerator quantity is specified, it must have a
- unit.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "If a strength numerator quantity is specified, it must have a unit."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00238'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00238"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions)@$sv.
$sv.administrableProducts@$ap.
@@ -35,13 +34,13 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001007'
+ Id: "CORE-001007"
Status: Published
- Version: '1'
-Description: 'If a strength numerator quantity is specified, it must have a unit.'
+ Version: "1"
+Description: "If a strength numerator quantity is specified, it must have a unit."
Executability: Fully Executable
Outcome:
- Message: 'The strength numerator quantity is specified but it has no unit.'
+ Message: "The strength numerator quantity is specified but it has no unit."
Output Variables:
- AdministrableProduct.id
- AdministrableProduct.name
@@ -54,5 +53,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Strength'
+ - "Strength"
Sensitivity: Record
diff --git a/Published/CORE-001008/rule.yml b/Published/CORE-001008/rule.yml
index a3b1cd112..f01d2982f 100644
--- a/Published/CORE-001008/rule.yml
+++ b/Published/CORE-001008/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a strength numerator range is specified, both the minValue
- and maxValue must have a unit.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If a strength numerator range is specified, both the minValue and maxValue must
+ have a unit."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00239'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00239"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions)@$sv.
$sv.administrableProducts@$ap.
@@ -36,15 +37,15 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001008'
+ Id: "CORE-001008"
Status: Published
- Version: '1'
-Description: 'If a strength numerator range is specified, both the minValue and
- maxValue must have a unit.'
+ Version: "1"
+Description: "If a strength numerator range is specified, both the minValue and maxValue must have a unit."
Executability: Fully Executable
Outcome:
- Message: 'The strength numerator range is specified but the minValue and/or
- maxValue does not have a unit.'
+ Message:
+ "The strength numerator range is specified but the minValue and/or maxValue does not have a
+ unit."
Output Variables:
- AdministrableProduct.id
- AdministrableProduct.name
@@ -58,5 +59,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Strength'
+ - "Strength"
Sensitivity: Record
diff --git a/Published/CORE-001009/rule.yml b/Published/CORE-001009/rule.yml
index 7406bad2f..be8c126e1 100644
--- a/Published/CORE-001009/rule.yml
+++ b/Published/CORE-001009/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If the unit is the same (or missing) for both the minimum and
- maximum value, then the minimum value must be less than the
- maximum value.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If the unit is the same (or missing) for both the minimum and maximum value,
+ then the minimum value must be less than the maximum value."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00241'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00241"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.**[instanceType="Range"])@$rg.
$rg.
@@ -30,15 +30,17 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001009'
+ Id: "CORE-001009"
Status: Published
- Version: '1'
-Description: 'If the unit is the same (or missing) for both the minimum and
- maximum value, then the minimum value must be less than the maximum value.'
+ Version: "1"
+Description:
+ "If the unit is the same (or missing) for both the minimum and maximum value, then the minimum
+ value must be less than the maximum value."
Executability: Fully Executable
Outcome:
- Message: 'The maximum value is less or equal to the minimum value while the unit
- is the same (or missing) for both the minimum and maximum value.'
+ Message:
+ "The maximum value is less or equal to the minimum value while the unit is the same (or missing)
+ for both the minimum and maximum value."
Output Variables:
- minValue
- maxValue
@@ -46,5 +48,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Range'
+ - "Range"
Sensitivity: Record
diff --git a/Published/CORE-001010/rule.yml b/Published/CORE-001010/rule.yml
index 10491e720..cc9f5a849 100644
--- a/Published/CORE-001010/rule.yml
+++ b/Published/CORE-001010/rule.yml
@@ -4,14 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A reference substance must not have a reference substance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A reference substance must not have a reference substance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00253'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00253"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions.administrableProducts)@$ap.
$ap.ingredients@$in.
@@ -34,15 +34,15 @@ Check: |-
}
][check=true]
Core:
- Id: 'CORE-001010'
+ Id: "CORE-001010"
Status: Published
- Version: '1'
-Description: 'A reference substance must not have a reference substance.'
+ Version: "1"
+Description: "A reference substance must not have a reference substance."
Executability: Fully Executable
Outcome:
- Message: 'A reference substance is specified for the substance, but the
- substance is a reference substance for another substance (the parent
- substance).'
+ Message:
+ "A reference substance is specified for the substance, but the substance is a reference substance
+ for another substance (the parent substance)."
Output Variables:
- AdministrableProduct.id
- AdministrableProduct.name
@@ -56,5 +56,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Substance'
+ - "Substance"
Sensitivity: Record
diff --git a/Published/CORE-001011/rule.yml b/Published/CORE-001011/rule.yml
index adc31153e..5492e4a27 100644
--- a/Published/CORE-001011/rule.yml
+++ b/Published/CORE-001011/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A primary study amendment reason is not expected to be ''not
- applicable''.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A primary study amendment reason is not expected to be 'not applicable'."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00255'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00255"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions.amendments)@$am.
$am.primaryReason@$pr.
@@ -29,13 +28,13 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001011'
+ Id: "CORE-001011"
Status: Published
- Version: '1'
-Description: 'A primary study amendment reason is not expected to be ''not applicable''.'
+ Version: "1"
+Description: "A primary study amendment reason is not expected to be 'not applicable'."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The primary study amendment reason is ''not applicable'' (code=C48660).'
+ Message: "The primary study amendment reason is 'not applicable' (code=C48660)."
Output Variables:
- StudyAmendment.id
- StudyAmendment.name
@@ -44,5 +43,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyAmendmentReason'
+ - "StudyAmendmentReason"
Sensitivity: Record
diff --git a/Published/CORE-001012/rule.yml b/Published/CORE-001012/rule.yml
index 78721fae0..74f1e71b7 100644
--- a/Published/CORE-001012/rule.yml
+++ b/Published/CORE-001012/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'For each range, a unit must be specified either for both the
- minimum and the maximum value, or for neither of them.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "For each range, a unit must be specified either for both the minimum and the
+ maximum value, or for neither of them."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00242'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00242"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.**[instanceType="Range"])@$rg.
$rg.
@@ -27,15 +28,15 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001012'
+ Id: "CORE-001012"
Status: Published
- Version: '1'
-Description: 'For each range, a unit must be specified either for both the
- minimum and the maximum value, or for neither of them.'
+ Version: "1"
+Description:
+ "For each range, a unit must be specified either for both the minimum and the maximum value,
+ or for neither of them."
Executability: Fully Executable
Outcome:
- Message: 'The unit is specified either for the minimum or the maximum value but
- not for both.'
+ Message: "The unit is specified either for the minimum or the maximum value but not for both."
Output Variables:
- minValue
- maxValue
@@ -43,5 +44,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Range'
+ - "Range"
Sensitivity: Record
diff --git a/Published/CORE-001013/rule.yml b/Published/CORE-001013/rule.yml
index 5bf462fa8..81f886d1e 100644
--- a/Published/CORE-001013/rule.yml
+++ b/Published/CORE-001013/rule.yml
@@ -4,25 +4,25 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The names of all instances of the same class must be unique.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "The names of all instances of the same class must be unique."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00010'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00010"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The names of all instances of the same class must be unique.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "The names of all instances of the same class must be unique."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00010'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00010"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
**.*[id and instanceType and name].$
{
@@ -39,13 +39,13 @@ Check: |-
}})
~> $reduce($append)
Core:
- Id: 'CORE-001013'
+ Id: "CORE-001013"
Status: Published
- Version: '1'
-Description: 'The names of all instances of the same class must be unique.'
+ Version: "1"
+Description: "The names of all instances of the same class must be unique."
Executability: Fully Executable
Outcome:
- Message: 'The same name has been used for more than one instance of the class.'
+ Message: "The same name has been used for more than one instance of the class."
Output Variables:
- name
Rule Type: JSONata
diff --git a/Published/CORE-001014/rule.yml b/Published/CORE-001014/rule.yml
index 966577f48..3be8bfeb2 100644
--- a/Published/CORE-001014/rule.yml
+++ b/Published/CORE-001014/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'At least the text or the family name must be specified for a
- person name.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "At least the text or the family name must be specified for a person name."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00030'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00030"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.**[instanceType="PersonName"])@$pn.
$pn.
@@ -26,13 +25,13 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001014'
+ Id: "CORE-001014"
Status: Published
- Version: '1'
-Description: 'At least the text or the family name must be specified for a person name.'
+ Version: "1"
+Description: "At least the text or the family name must be specified for a person name."
Executability: Fully Executable
Outcome:
- Message: 'Both the text and familyName are missing.'
+ Message: "Both the text and familyName are missing."
Output Variables:
- familyName
- text
@@ -40,5 +39,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'PersonName'
+ - "PersonName"
Sensitivity: Record
diff --git a/Published/CORE-001015/rule.yml b/Published/CORE-001015/rule.yml
index a2be6c01f..1c0f5a0aa 100644
--- a/Published/CORE-001015/rule.yml
+++ b/Published/CORE-001015/rule.yml
@@ -4,25 +4,25 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study version, all id values must be unique.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within a study version, all id values must be unique."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00083'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00083"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study version, all id values must be unique.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within a study version, all id values must be unique."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00083'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00083"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(
**.*[id and instanceType].
@@ -39,13 +39,13 @@ Check: |-
~> $sift(function($v){$count($v) > 1})
).*
Core:
- Id: 'CORE-001015'
+ Id: "CORE-001015"
Status: Published
- Version: '1'
-Description: 'Within a study version, all id values must be unique.'
+ Version: "1"
+Description: "Within a study version, all id values must be unique."
Executability: Fully Executable
Outcome:
- Message: 'The id value is not unique.'
+ Message: "The id value is not unique."
Output Variables:
- name
Rule Type: JSONata
diff --git a/Published/CORE-001016/rule.yml b/Published/CORE-001016/rule.yml
index 1fc68c1e5..32eeafa59 100644
--- a/Published/CORE-001016/rule.yml
+++ b/Published/CORE-001016/rule.yml
@@ -4,14 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A planned duration is expected for the main timeline.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A planned duration is expected for the main timeline."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00153'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00153"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions.studyDesigns)@$sd.
$sd.scheduleTimelines@$st.
@@ -26,13 +26,13 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001016'
+ Id: "CORE-001016"
Status: Published
- Version: '1'
-Description: 'A planned duration is expected for the main timeline.'
+ Version: "1"
+Description: "A planned duration is expected for the main timeline."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The planned duration is not specified for the main timeline.'
+ Message: "The planned duration is not specified for the main timeline."
Output Variables:
- name
- mainTimeline
@@ -40,5 +40,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'ScheduleTimeline'
+ - "ScheduleTimeline"
Sensitivity: Record
diff --git a/Published/CORE-001017/rule.yml b/Published/CORE-001017/rule.yml
index e4a09fb95..d8cde3894 100644
--- a/Published/CORE-001017/rule.yml
+++ b/Published/CORE-001017/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study design must not be characterized as both
- "Single-Centre" and "Multicentre".'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: 'A study design must not be characterized as both "Single-Centre" and "Multicentre".'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00154'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00154"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions.studyDesigns["C217004" in characteristics.code and "C217005" in characteristics.code].
{
@@ -23,15 +22,13 @@ Check: |-
"characteristics": "["&$join(characteristics[code in ["C217004","C217005"]].$.(id&": "&decode&" ("&code&")"),"; ")&"]"
}
Core:
- Id: 'CORE-001017'
+ Id: "CORE-001017"
Status: Published
- Version: '1'
-Description: 'A study design must not be characterized as both "Single-Centre"
- and "Multicentre".'
+ Version: "1"
+Description: 'A study design must not be characterized as both "Single-Centre" and "Multicentre".'
Executability: Fully Executable
Outcome:
- Message: 'The study design is characterized as both "Single-Centre" and
- "Multicentre".'
+ Message: 'The study design is characterized as both "Single-Centre" and "Multicentre".'
Output Variables:
- name
- characteristics
@@ -39,6 +36,6 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001018/rule.yml b/Published/CORE-001018/rule.yml
index 2bb34ec65..5ffd0f8eb 100644
--- a/Published/CORE-001018/rule.yml
+++ b/Published/CORE-001018/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Each defined eligibility criterion must be used by at least one
- study population or cohort within the same study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Each defined eligibility criterion must be used by at least one study population
+ or cohort within the same study design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00158'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00158"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**.studyDesigns)@$s.
$s.eligibilityCriteria@$ec
@@ -30,15 +31,17 @@ Check: |-
"identifier": $ec.identifier
}
Core:
- Id: 'CORE-001018'
+ Id: "CORE-001018"
Status: Published
- Version: '1'
-Description: 'Each defined eligibility criterion must be used by at least one
- study population or cohort within the same study design.'
+ Version: "1"
+Description:
+ "Each defined eligibility criterion must be used by at least one study population or cohort
+ within the same study design."
Executability: Fully Executable
Outcome:
- Message: "The eligibility criterion is not referenced by the study design's
- population or any of its cohorts."
+ Message:
+ "The eligibility criterion is not referenced by the study design's population or any of its
+ cohorts."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -49,5 +52,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'EligibilityCriterion'
+ - "EligibilityCriterion"
Sensitivity: Record
diff --git a/Published/CORE-001019/rule.yml b/Published/CORE-001019/rule.yml
index bbb246be9..bff0d234d 100644
--- a/Published/CORE-001019/rule.yml
+++ b/Published/CORE-001019/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An eligibility criterion must not be referenced by both a study
- design population and any of the cohorts of the same study
- design population.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An eligibility criterion must not be referenced by both a study design population
+ and any of the cohorts of the same study design population."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00159'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00159"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**.studyDesigns)@$s.
$s.eligibilityCriteria@$ec
@@ -33,15 +33,17 @@ Check: |-
"Used in": $s.**[$ec.id in $.criterionIds].(id&(name?"["&name&"]"))
}
Core:
- Id: 'CORE-001019'
+ Id: "CORE-001019"
Status: Published
- Version: '1'
-Description: 'An eligibility criterion must not be referenced by both a study
- design population and any of the cohorts of the same study design population.'
+ Version: "1"
+Description:
+ "An eligibility criterion must not be referenced by both a study design population and any
+ of the cohorts of the same study design population."
Executability: Fully Executable
Outcome:
- Message: "The eligibility criterion is referenced by both the study design's
- population and at least one of its cohorts."
+ Message:
+ "The eligibility criterion is referenced by both the study design's population and at least
+ one of its cohorts."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -53,5 +55,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'EligibilityCriterion'
+ - "EligibilityCriterion"
Sensitivity: Record
diff --git a/Published/CORE-001020/rule.yml b/Published/CORE-001020/rule.yml
index 48389bc9f..a11b5ab17 100644
--- a/Published/CORE-001020/rule.yml
+++ b/Published/CORE-001020/rule.yml
@@ -4,14 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a strength denominator is specified, it must have a unit.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "If a strength denominator is specified, it must have a unit."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00186'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00186"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions.administrableProducts)@$ap.
$ap.ingredients@$in.
@@ -33,13 +33,13 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001020'
+ Id: "CORE-001020"
Status: Published
- Version: '1'
-Description: 'If a strength denominator is specified, it must have a unit.'
+ Version: "1"
+Description: "If a strength denominator is specified, it must have a unit."
Executability: Fully Executable
Outcome:
- Message: 'The unit for the strength denominator is missing.'
+ Message: "The unit for the strength denominator is missing."
Output Variables:
- Ingredient.id
- Substance.id
@@ -51,5 +51,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Strength'
+ - "Strength"
Sensitivity: Record
diff --git a/Published/CORE-001021/rule.yml b/Published/CORE-001021/rule.yml
index f2e3465f7..98fa25220 100644
--- a/Published/CORE-001021/rule.yml
+++ b/Published/CORE-001021/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A product organization role is expected to apply to at least
- one medical device or administrable product.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A product organization role is expected to apply to at least one medical device
+ or administrable product."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00211'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00211"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions)@$sv.
$sv.productOrganizationRoles@$pr.
@@ -28,15 +29,17 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001021'
+ Id: "CORE-001021"
Status: Published
- Version: '1'
-Description: 'A product organization role is expected to apply to at least one
- medical device or administrable product.'
+ Version: "1"
+Description:
+ "A product organization role is expected to apply to at least one medical device or administrable
+ product."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The product organization role does not apply to at least one medical
- device or administrable product.'
+ Message:
+ "The product organization role does not apply to at least one medical device or administrable
+ product."
Output Variables:
- name
- appliesToIds
@@ -44,5 +47,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'ProductOrganizationRole'
+ - "ProductOrganizationRole"
Sensitivity: Record
diff --git a/Published/CORE-001022/rule.yml b/Published/CORE-001022/rule.yml
index 19f045dff..191c2b263 100644
--- a/Published/CORE-001022/rule.yml
+++ b/Published/CORE-001022/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If ''appliesTo'' is specified for a product organization role,
- then the product organization role must only apply to medical
- devices or administrable products.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If 'appliesTo' is specified for a product organization role, then the product
+ organization role must only apply to medical devices or administrable products."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00212'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00212"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions)@$sv.
$sv.productOrganizationRoles@$pr.
@@ -32,16 +32,17 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001022'
+ Id: "CORE-001022"
Status: Published
- Version: '1'
-Description: 'If ''appliesTo'' is specified for a product organization role,
- then the product organization role must only apply to medical devices or
- administrable products.'
+ Version: "1"
+Description:
+ "If 'appliesTo' is specified for a product organization role, then the product organization
+ role must only apply to medical devices or administrable products."
Executability: Fully Executable
Outcome:
- Message: 'At least one of the ''appliesTo'' specifications does not apply to
- medical devices or administrable products.'
+ Message:
+ "At least one of the 'appliesTo' specifications does not apply to medical devices or administrable
+ products."
Output Variables:
- name
- appliesToIds
@@ -50,5 +51,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'ProductOrganizationRole'
+ - "ProductOrganizationRole"
Sensitivity: Record
diff --git a/Published/CORE-001023/rule.yml b/Published/CORE-001023/rule.yml
index d80132aa6..c0aae7336 100644
--- a/Published/CORE-001023/rule.yml
+++ b/Published/CORE-001023/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, if more intent types are defined, they
- must be distinct.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within a study design, if more intent types are defined, they must be distinct."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00222'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00222"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions.studyDesigns.
(
@@ -31,16 +30,15 @@ Check: |-
}
}
)
- )
+ )
Core:
- Id: 'CORE-001023'
+ Id: "CORE-001023"
Status: Published
- Version: '1'
-Description: 'Within a study design, if more intent types are defined, they must
- be distinct.'
+ Version: "1"
+Description: "Within a study design, if more intent types are defined, they must be distinct."
Executability: Fully Executable
Outcome:
- Message: 'The same intent types code is used more than once within the study design.'
+ Message: "The same intent types code is used more than once within the study design."
Output Variables:
- name
- intentTypes
@@ -48,5 +46,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
+ - "InterventionalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001024/rule.yml b/Published/CORE-001024/rule.yml
index 3dc2bd381..d9bd05f86 100644
--- a/Published/CORE-001024/rule.yml
+++ b/Published/CORE-001024/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An interventional study must be specified using the
- InterventionalStudyDesign class.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An interventional study must be specified using the InterventionalStudyDesign
+ class."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00227'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00227"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions)@$sv.
$sv.studyDesigns@$sd.
@@ -26,15 +27,15 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001024'
+ Id: "CORE-001024"
Status: Published
- Version: '1'
-Description: 'An interventional study must be specified using the
- InterventionalStudyDesign class.'
+ Version: "1"
+Description: "An interventional study must be specified using the InterventionalStudyDesign class."
Executability: Fully Executable
Outcome:
- Message: 'The study type is interventional but is not specified using the
- InterventionalStudyDesign class.'
+ Message:
+ "The study type is interventional but is not specified using the InterventionalStudyDesign
+ class."
Output Variables:
- name
- studyType
@@ -42,6 +43,6 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001025/rule.yml b/Published/CORE-001025/rule.yml
index 4185ddd2d..1b093521c 100644
--- a/Published/CORE-001025/rule.yml
+++ b/Published/CORE-001025/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a biospecimen retention indicates that a type of biospecimen
- is retained, then there must be an indication of whether the
- type of biospecimen includes DNA.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If a biospecimen retention indicates that a type of biospecimen is retained,
+ then there must be an indication of whether the type of biospecimen includes DNA."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00231'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00231"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions)@$sv.
$sv.studyDesigns@$sd.
@@ -29,16 +29,17 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001025'
+ Id: "CORE-001025"
Status: Published
- Version: '1'
-Description: 'If a biospecimen retention indicates that a type of biospecimen is
- retained, then there must be an indication of whether the type of biospecimen
- includes DNA.'
+ Version: "1"
+Description:
+ "If a biospecimen retention indicates that a type of biospecimen is retained, then there
+ must be an indication of whether the type of biospecimen includes DNA."
Executability: Fully Executable
Outcome:
- Message: 'The biospecimen retention is indicated as retained (isRetained=true)
- but information whether it includes DNA (includesDNA attribute) is missing.'
+ Message:
+ "The biospecimen retention is indicated as retained (isRetained=true) but information whether
+ it includes DNA (includesDNA attribute) is missing."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -48,5 +49,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'BiospecimenRetention'
+ - "BiospecimenRetention"
Sensitivity: Record
diff --git a/Published/CORE-001026/rule.yml b/Published/CORE-001026/rule.yml
index 01f03af46..64e1cb394 100644
--- a/Published/CORE-001026/rule.yml
+++ b/Published/CORE-001026/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: Each StudyArm is expected to have one StudyCell for each
- StudyEpoch.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: Each StudyArm is expected to have one StudyCell for each StudyEpoch.'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00243'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00243"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions.studyDesigns@$sd.
$sd.arms@$sa.{
@@ -30,13 +29,13 @@ Check: |-
}
}.*[`Missing Epoch Refs`!="[]"]
Core:
- Id: 'CORE-001026'
+ Id: "CORE-001026"
Status: Published
- Version: '1'
-Description: 'Each StudyArm is expected to have one StudyCell for each StudyEpoch.'
+ Version: "1"
+Description: "Each StudyArm is expected to have one StudyCell for each StudyEpoch."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The StudyArm does not have one StudyCell for each StudyEpoch.'
+ Message: "The StudyArm does not have one StudyCell for each StudyEpoch."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -48,5 +47,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyArm'
+ - "StudyArm"
Sensitivity: Record
diff --git a/Published/CORE-001027/rule.yml b/Published/CORE-001027/rule.yml
index f68297409..d4efb605c 100644
--- a/Published/CORE-001027/rule.yml
+++ b/Published/CORE-001027/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An eligibility criterion item must not be used more than once
- within a study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An eligibility criterion item must not be used more than once within a study
+ design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00248'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00248"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions.studyDesigns@$sd.
(
@@ -32,15 +33,13 @@ Check: |-
}{group:$count(details)>1?details}
).*
Core:
- Id: 'CORE-001027'
+ Id: "CORE-001027"
Status: Published
- Version: '1'
-Description: 'An eligibility criterion item must not be used more than once
- within a study design.'
+ Version: "1"
+Description: "An eligibility criterion item must not be used more than once within a study design."
Executability: Fully Executable
Outcome:
- Message: "The eligibility criterion item is used more than once within the study
- design."
+ Message: "The eligibility criterion item is used more than once within the study design."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -50,5 +49,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'EligibilityCriterion'
+ - "EligibilityCriterion"
Sensitivity: Record
diff --git a/Published/CORE-001028/rule.yml b/Published/CORE-001028/rule.yml
index 7e0a76fe0..b1f748840 100644
--- a/Published/CORE-001028/rule.yml
+++ b/Published/CORE-001028/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An eligibility criterion item is expected to be used in at
- least one study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "An eligibility criterion item is expected to be used in at least one study design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00249'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00249"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions@$sv.
$sv.eligibilityCriterionItems
@@ -28,11 +27,10 @@ Check: |-
"name": name
}
Core:
- Id: 'CORE-001028'
+ Id: "CORE-001028"
Status: Published
- Version: '1'
-Description: 'An eligibility criterion item is expected to be used in at least
- one study design.'
+ Version: "1"
+Description: "An eligibility criterion item is expected to be used in at least one study design."
Executability: Partially Executable - Possible Overreporting
Outcome:
Message: "The eligibility criterion item is not used in at least one study design."
@@ -44,5 +42,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'EligibilityCriterionItem'
+ - "EligibilityCriterionItem"
Sensitivity: Record
diff --git a/Published/CORE-001029/rule.yml b/Published/CORE-001029/rule.yml
index 1c78bf144..28819175d 100644
--- a/Published/CORE-001029/rule.yml
+++ b/Published/CORE-001029/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study cohort must only reference indications that are defined
- within the same study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study cohort must only reference indications that are defined within the same
+ study design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00251'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00251"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**.studyDesigns)@$sd.
$sd.population@$sp.
@@ -30,15 +31,15 @@ Check: |-
"Invalid indicationIds": indicationIds[$not($ in $sd.indications.id)]
}
Core:
- Id: 'CORE-001029'
+ Id: "CORE-001029"
Status: Published
- Version: '1'
-Description: 'A study cohort must only reference indications that are defined
- within the same study design.'
+ Version: "1"
+Description: "A study cohort must only reference indications that are defined within the same study design."
Executability: Fully Executable
Outcome:
- Message: 'The reference to the indication is not targetting an indication that
- has been defined within the same study design.'
+ Message:
+ "The reference to the indication is not targetting an indication that has been defined within
+ the same study design."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -51,5 +52,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyCohort'
+ - "StudyCohort"
Sensitivity: Record
diff --git a/Published/CORE-001030/rule.yml b/Published/CORE-001030/rule.yml
index 353aeb830..1ee323bce 100644
--- a/Published/CORE-001030/rule.yml
+++ b/Published/CORE-001030/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study element must only reference study interventions that
- are referenced by the same study design as the study element.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study element must only reference study interventions that are referenced by
+ the same study design as the study element."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00252'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00252"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**.versions)@$sv.
$sv.studyDesigns@$sd.
@@ -29,15 +30,17 @@ Check: |-
"Invalid StudyIntervention.name": "["&$join(studyInterventionIds[$not ($ in $sd.studyInterventionIds)].($oid:=$;$oid&": "&($o:=$sv.studyInterventions[id=$oid];$o?$o.name:"Not defined")),"; ")&"]"
}
Core:
- Id: 'CORE-001030'
+ Id: "CORE-001030"
Status: Published
- Version: '1'
-Description: 'A study element must only reference study interventions that are
- referenced by the same study design as the study element.'
+ Version: "1"
+Description:
+ "A study element must only reference study interventions that are referenced by the same
+ study design as the study element."
Executability: Fully Executable
Outcome:
- Message: 'The reference to the intervention is not targetting an intervention
- that has been referenced by the study design as a study intervention.'
+ Message:
+ "The reference to the intervention is not targetting an intervention that has been referenced
+ by the study design as a study intervention."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -49,5 +52,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyElement'
+ - "StudyElement"
Sensitivity: Record
diff --git a/Published/CORE-001031/rule.yml b/Published/CORE-001031/rule.yml
index 8356897f1..1f91b29ca 100644
--- a/Published/CORE-001031/rule.yml
+++ b/Published/CORE-001031/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The same reason is not expected to be given as a primary and
- secondary reason.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "The same reason is not expected to be given as a primary and secondary reason."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00256'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00256"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(study.versions.amendments)@$am.
$am.secondaryReasons@$sr.
@@ -30,14 +29,13 @@ Check: |-
}
)][check=true]
Core:
- Id: 'CORE-001031'
+ Id: "CORE-001031"
Status: Published
- Version: '1'
-Description: 'The same reason is not expected to be given as a primary and
- secondary reason.'
+ Version: "1"
+Description: "The same reason is not expected to be given as a primary and secondary reason."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The secondary reason code is equal to the primary reason code.'
+ Message: "The secondary reason code is equal to the primary reason code."
Output Variables:
- StudyAmendment.id
- StudyAmendment.name
@@ -47,5 +45,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyAmendmentReason'
+ - "StudyAmendmentReason"
Sensitivity: Record
diff --git a/Published/CORE-001032/rule.yml b/Published/CORE-001032/rule.yml
index cf2488549..cc19ded30 100644
--- a/Published/CORE-001032/rule.yml
+++ b/Published/CORE-001032/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study design must not be characterized as both "Single
- Country" and "Multiple Countries".'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ 'A study design must not be characterized as both "Single Country" and "Multiple
+ Countries".'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00257'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00257"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions.studyDesigns["C217006" in characteristics.code and "C217007" in characteristics.code].
{
@@ -23,15 +24,13 @@ Check: |-
"characteristics": "["&$join(characteristics[code in ["C217006","C217007"]].$.(id&": "&decode&" ("&code&")"),"; ")&"]"
}
Core:
- Id: 'CORE-001032'
+ Id: "CORE-001032"
Status: Published
- Version: '1'
-Description: 'A study design must not be characterized as both "Single Country"
- and "Multiple Countries".'
+ Version: "1"
+Description: 'A study design must not be characterized as both "Single Country" and "Multiple Countries".'
Executability: Fully Executable
Outcome:
- Message: 'The study design is characterized as both "Single Country" and
- "Multiple Countries".'
+ Message: 'The study design is characterized as both "Single Country" and "Multiple Countries".'
Output Variables:
- name
- characteristics
@@ -39,6 +38,6 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001033/rule.yml b/Published/CORE-001033/rule.yml
index 008441ce3..5c7934886 100644
--- a/Published/CORE-001033/rule.yml
+++ b/Published/CORE-001033/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study design is not expected to have more than one of the
- following characteristics: "Randomized", "Stratification",
- "Stratified Randomisation".'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ 'A study design is not expected to have more than one of the following characteristics:
+ "Randomized", "Stratification", "Stratified Randomisation".'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00258'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00258"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions.studyDesigns[$count(characteristics[code in ["C46079","C25689","C147145"]])>1].
{
@@ -24,16 +24,17 @@ Check: |-
"characteristics": "["&$join(characteristics[code in ["C46079","C25689","C147145"]].$.(id&": "&decode&" ("&code&")"),"; ")&"]"
}
Core:
- Id: 'CORE-001033'
+ Id: "CORE-001033"
Status: Published
- Version: '1'
-Description: 'A study design is not expected to have more than one of the
- following characteristics: "Randomized", "Stratification", "Stratified
- Randomisation".'
+ Version: "1"
+Description:
+ 'A study design is not expected to have more than one of the following characteristics: "Randomized",
+ "Stratification", "Stratified Randomisation".'
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The study design has more than one of the following characteristics:
- "Randomized", "Stratification", "Stratified Randomisation".'
+ Message:
+ 'The study design has more than one of the following characteristics: "Randomized", "Stratification",
+ "Stratified Randomisation".'
Output Variables:
- name
- characteristics
@@ -41,6 +42,6 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001034/rule.yml b/Published/CORE-001034/rule.yml
index f1ae6b30b..f45f5342d 100644
--- a/Published/CORE-001034/rule.yml
+++ b/Published/CORE-001034/rule.yml
@@ -7,51 +7,53 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The instance number of a test that is repeated within a given
- timeframe for the same test. The level of granularity can vary
- (e.g., within a time point or within a visit).
+ - Cited Guidance:
+ The instance number of a test that is repeated within a given timeframe for
+ the same test. The level of granularity can vary (e.g., within a time point or within a
+ visit).
Document: Model v2.0
Item: --REPNUM
Section: Findings
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0562
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The instance number of a test that is repeated within a given
- timeframe for the same test. The level of granularity can vary
- (e.g., within a time point or within a visit). For example,
- multiple measurements of blood pressure or multiple analyses
- of a sample.
+ - Cited Guidance:
+ The instance number of a test that is repeated within a given timeframe for
+ the same test. The level of granularity can vary (e.g., within a time point or within a
+ visit). For example, multiple measurements of blood pressure or multiple analyses of a
+ sample.
Document: Model v1.7
Item: --REPNUM
Section: Table 2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0562
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: The instance number of a test that is repeated within a given
- timeframe for the same test. The level of granularity can vary
- (e.g., within a time point or within a visit).
+ - Cited Guidance:
+ The instance number of a test that is repeated within a given timeframe for
+ the same test. The level of granularity can vary (e.g., within a time point or within a
+ visit).
Document: SDTM v2.1
Item: --REPNUM
Section: 3.1.3 The Findings Observation Class
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0648
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: --REPNUM
@@ -72,11 +74,10 @@ Check:
Core:
Id: CORE-001034
Status: Published
- Version: '1'
-Description: Raise an error when REPNUM is in the dataset and there are multiple
- records for a subject for a test within the timeframe identified by the timing
- variables on the record, and --REPNUM is null or not unique per subject per
- test per timing variables.
+ Version: "1"
+Description: Raise an error when REPNUM is in the dataset and there are multiple records for a
+ subject for a test within the timeframe identified by the timing variables on the record, and
+ --REPNUM is null or not unique per subject per test per timing variables.
Executability: Fully Executable
Operations:
- id: $TIMING_VARIABLES
diff --git a/Published/CORE-001035/rule.yml b/Published/CORE-001035/rule.yml
index a714a5a3e..9ca681e19 100644
--- a/Published/CORE-001035/rule.yml
+++ b/Published/CORE-001035/rule.yml
@@ -4,36 +4,35 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled decision instance must refer to a default
- condition.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "A scheduled decision instance must refer to a default condition."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00038'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00038"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'ScheduledDecisionInstance'
+ value: "ScheduledDecisionInstance"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: defaultConditionId
operator: not_exists
- name: defaultConditionId
operator: empty
Core:
- Id: 'CORE-001035'
+ Id: "CORE-001035"
Status: Published
- Version: '1'
-Description: 'A scheduled decision instance must refer to a default condition.'
+ Version: "1"
+Description: "A scheduled decision instance must refer to a default condition."
Executability: Fully Executable
Outcome:
- Message: 'The scheduled decision instance does not refer to a default condition.'
+ Message: "The scheduled decision instance does not refer to a default condition."
Output Variables:
- parent_entity
- parent_id
@@ -45,5 +44,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ScheduledDecisionInstance'
+ - "ScheduledDecisionInstance"
Sensitivity: Record
diff --git a/Published/CORE-001036/rule.yml b/Published/CORE-001036/rule.yml
index 90653dcdd..b4195d81c 100644
--- a/Published/CORE-001036/rule.yml
+++ b/Published/CORE-001036/rule.yml
@@ -4,27 +4,25 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "Within a study design, there must be at least one endpoint with
- level primary."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within a study design, there must be at least one endpoint with level primary."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00041'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00041"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: "Within a study design, there must be at least one endpoint with
- level primary."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Within a study design, there must be at least one endpoint with level primary."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00041'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00041"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
$.study.versions.studyDesigns.
{
@@ -35,23 +33,21 @@ Check: |-
"# Primary endpoints": $count(objectives.endpoints[level.code="C94496"])
}[`# Primary endpoints` = 0][]
Core:
- Id: 'CORE-001036'
+ Id: "CORE-001036"
Status: Published
- Version: '1'
-Description: "Within a study design, there must be at least one endpoint with
- level primary."
+ Version: "1"
+Description: "Within a study design, there must be at least one endpoint with level primary."
Executability: Fully Executable
Outcome:
- Message: "There is not at least one endpoint with a level of primary within the
- study design."
+ Message: "There is not at least one endpoint with a level of primary within the study design."
Output Variables:
- name
- - '# Primary endpoints'
+ - "# Primary endpoints"
Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyDesign'
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "StudyDesign"
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001037/rule.yml b/Published/CORE-001037/rule.yml
index 1be7d7cd1..e8633be1d 100644
--- a/Published/CORE-001037/rule.yml
+++ b/Published/CORE-001037/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Any parameter name referenced in a tag in the text should be
- specified in the data dictionary parameter maps.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Any parameter name referenced in a tag in the text should be specified in the
+ data dictionary parameter maps."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00089'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00089"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check: |-
**.study.versions@$sv.
($sv.studyDesigns)@$sd.($sd.**[$type(text)="string" and $contains(text,/usdm:tag/)])@$st.
@@ -45,17 +46,18 @@ Check: |-
}
)
Core:
- Id: 'CORE-001037'
+ Id: "CORE-001037"
Status: Published
- Version: '1'
-Description: 'Any parameter name referenced in a tag in the text should be
- specified in the data dictionary parameter maps.'
+ Version: "1"
+Description:
+ "Any parameter name referenced in a tag in the text should be specified in the data dictionary
+ parameter maps."
Executability: Fully Executable
Outcome:
- Message: "The parameter name referenced in the text is not specified in the data
- dictionary parameter map - the dictionaryId is missing or invalid, or the
- parameter name does not match a tag in any of the dictionary's parameter
- maps."
+ Message:
+ "The parameter name referenced in the text is not specified in the data dictionary parameter
+ map - the dictionaryId is missing or invalid, or the parameter name does not match a tag in any of
+ the dictionary's parameter maps."
Output Variables:
- name
- Parameter reference
@@ -67,9 +69,9 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'EligibilityCriterion'
- - 'Characteristic'
- - 'Condition'
- - 'Objective'
- - 'Endpoint'
+ - "EligibilityCriterion"
+ - "Characteristic"
+ - "Condition"
+ - "Objective"
+ - "Endpoint"
Sensitivity: Record
diff --git a/Published/CORE-001038/rule.yml b/Published/CORE-001038/rule.yml
index 6027002f5..aff3ff1f4 100644
--- a/Published/CORE-001038/rule.yml
+++ b/Published/CORE-001038/rule.yml
@@ -4,31 +4,31 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'When a condition applies to a procedure, activity, biomedical
- concept, biomedical concept category, or biomedical concept
- surrogate then an instance must be available in the
- corresponding class with the specified id.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "When a condition applies to a procedure, activity, biomedical concept, biomedical
+ concept category, or biomedical concept surrogate then an instance must be available in the
+ corresponding class with the specified id."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00091'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00091"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'When a condition applies to a procedure, activity, biomedical
- concept, biomedical concept category, or biomedical concept
- surrogate then an instance must be available in the
- corresponding class with the specified id.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "When a condition applies to a procedure, activity, biomedical concept, biomedical
+ concept category, or biomedical concept surrogate then an instance must be available in the
+ corresponding class with the specified id."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00091'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00091"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(
$idityp:=$.study.versions.**[id]{id:instanceType};
@@ -54,26 +54,27 @@ Check: |-
]
)
Core:
- Id: 'CORE-001038'
+ Id: "CORE-001038"
Status: Published
- Version: '1'
-Description: 'When a condition applies to a procedure, activity, biomedical
- concept, biomedical concept category, or biomedical concept surrogate then an
- instance must be available in the corresponding class with the specified id.'
+ Version: "1"
+Description:
+ "When a condition applies to a procedure, activity, biomedical concept, biomedical concept
+ category, or biomedical concept surrogate then an instance must be available in the corresponding class
+ with the specified id."
Executability: Fully Executable
Outcome:
- Message: 'The id value specified to indicate what the condition applies to does
- not reference a procedure, activity, biomedical concept, biomedical concept
- category, or biomedical concept surrogate - either the specified id is not
- an id for anything (it is invalid), or the instance identified by the id is
- not one of the expected classes.'
+ Message:
+ "The id value specified to indicate what the condition applies to does not reference a procedure,
+ activity, biomedical concept, biomedical concept category, or biomedical concept surrogate - either
+ the specified id is not an id for anything (it is invalid), or the instance identified by the id is
+ not one of the expected classes."
Output Variables:
- name
- - 'appliesTo id'
- - 'appliesTo instanceType'
+ - "appliesTo id"
+ - "appliesTo instanceType"
Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Condition'
+ - "Condition"
Sensitivity: Record
diff --git a/Published/CORE-001039/rule.yml b/Published/CORE-001039/rule.yml
index 128b59252..5b8ab954c 100644
--- a/Published/CORE-001039/rule.yml
+++ b/Published/CORE-001039/rule.yml
@@ -4,29 +4,29 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled activity instance must only reference an encounter
- that is defined within the same study design as the scheduled
- activity instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A scheduled activity instance must only reference an encounter that is defined
+ within the same study design as the scheduled activity instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00106'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00106"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A scheduled activity instance must only reference an encounter
- that is defined within the same study design as the scheduled
- activity instance.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A scheduled activity instance must only reference an encounter that is defined
+ within the same study design as the scheduled activity instance."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00106'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00106"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(
$lkp:=$merge($.**.studyDesigns.encounters.{id:%.id});
@@ -51,16 +51,17 @@ Check: |-
]
)
Core:
- Id: 'CORE-001039'
+ Id: "CORE-001039"
Status: Published
- Version: '1'
-Description: 'A scheduled activity instance must only reference an encounter
- that is defined within the same study design as the scheduled activity
- instance.'
+ Version: "1"
+Description:
+ "A scheduled activity instance must only reference an encounter that is defined within the
+ same study design as the scheduled activity instance."
Executability: Fully Executable
Outcome:
- Message: 'The scheduled activity instance references an encounter that is not
- defined within the same study design.'
+ Message:
+ "The scheduled activity instance references an encounter that is not defined within the same
+ study design."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -71,5 +72,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'ScheduledActivityInstance'
+ - "ScheduledActivityInstance"
Sensitivity: Record
diff --git a/Published/CORE-001040/rule.yml b/Published/CORE-001040/rule.yml
index 47b2a89c9..e44b3fb58 100644
--- a/Published/CORE-001040/rule.yml
+++ b/Published/CORE-001040/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study element must only reference study interventions that
- are defined within the same study design as the study
- element.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study element must only reference study interventions that are defined within
+ the same study design as the study element."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00109'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00109"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check: |-
(
$lkp:=$merge($.**.studyDesigns.studyInterventions.{id:%.id});
@@ -36,15 +36,17 @@ Check: |-
]
)
Core:
- Id: 'CORE-001040'
+ Id: "CORE-001040"
Status: Published
- Version: '1'
-Description: 'A study element must only reference study interventions that are
- defined within the same study design as the study element.'
+ Version: "1"
+Description:
+ "A study element must only reference study interventions that are defined within the same
+ study design as the study element."
Executability: Fully Executable
Outcome:
- Message: 'The study element references a study intervention that is not defined
- within the same study design.'
+ Message:
+ "The study element references a study intervention that is not defined within the same study
+ design."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -55,5 +57,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyElement'
+ - "StudyElement"
Sensitivity: Record
diff --git a/Published/CORE-001041/rule.yml b/Published/CORE-001041/rule.yml
index 5cc17919d..89d60a6ea 100644
--- a/Published/CORE-001041/rule.yml
+++ b/Published/CORE-001041/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: Within a document version, the specified displayed section
- numbers for narrative content must be unique.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ Within a document version, the specified displayed section numbers for
+ narrative content must be unique.'
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00245'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00245"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
$.study.documentedBy@$sdd.
$sdd.versions@$sddv.
@@ -36,15 +37,15 @@ Check: |-
} {group: $count(details)>1?details}
).*
Core:
- Id: 'CORE-001041'
+ Id: "CORE-001041"
Status: Published
- Version: '1'
-Description: 'Within a document version, the specified displayed section numbers
- for narrative content must be unique.'
+ Version: "1"
+Description:
+ "Within a document version, the specified displayed section numbers for narrative content
+ must be unique."
Executability: Fully Executable
Outcome:
- Message: 'The displayed section number is not unique within the study definition
- document version.'
+ Message: "The displayed section number is not unique within the study definition document version."
Output Variables:
- StudyDefinitionDocument.id
- StudyDefinitionDocument.name
@@ -57,5 +58,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'NarrativeContent'
+ - "NarrativeContent"
Sensitivity: Record
diff --git a/Published/CORE-001042/rule.yml b/Published/CORE-001042/rule.yml
index 24b3a08b1..244325109 100644
--- a/Published/CORE-001042/rule.yml
+++ b/Published/CORE-001042/rule.yml
@@ -4,17 +4,17 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a geographic scope type is global then no code is expected
- to specify the specific area within scope while if it is not
- global then a code is expected to specify the specific area
- within scope.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If a geographic scope type is global then no code is expected to specify the
+ specific area within scope while if it is not global then a code is expected to specify the
+ specific area within scope."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00261'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00261"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
**[instanceType="GeographicScope" and (type.code="C68846")=($exists(code) and code)].
{
@@ -27,18 +27,18 @@ Check: |-
"code.standardCode.decode": code.standardCode.decode
}
Core:
- Id: 'CORE-001042'
+ Id: "CORE-001042"
Status: Published
- Version: '1'
-Description: 'If a geographic scope type is global then no code is expected to
- specify the specific area within scope while if it is not global then a code
- is expected to specify the specific area within scope.'
+ Version: "1"
+Description:
+ "If a geographic scope type is global then no code is expected to specify the specific area
+ within scope while if it is not global then a code is expected to specify the specific area within scope."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The geographic scope is global (type.code = C68846) and a code has
- been specified for the specific area or the geographic scope is not global
- (type.code is not C68846) and no code has been specified for the specific
- area.'
+ Message:
+ "The geographic scope is global (type.code = C68846) and a code has been specified for the
+ specific area or the geographic scope is not global (type.code is not C68846) and no code has been
+ specified for the specific area."
Output Variables:
- type.code
- type.decode
@@ -48,5 +48,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'GeographicScope'
+ - "GeographicScope"
Sensitivity: Record
diff --git a/Published/CORE-001044/rule.yml b/Published/CORE-001044/rule.yml
index 4ee6d6801..2a8e027e6 100644
--- a/Published/CORE-001044/rule.yml
+++ b/Published/CORE-001044/rule.yml
@@ -5,101 +5,101 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to
- test compound rather than challenge agents or other
- interventions.'
+ - Cited Guidance:
+ "When possible, RFSTDTC should be the first day of exposure to test compound rather
+ than challenge agents or other interventions."
Document: FDA
Section: FDAB064
Origin: FDA Business Rules
Rule Identifier:
Id: FB6401
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to
- test compound rather than challenge agents or other
- interventions.'
+ - Cited Guidance:
+ "When possible, RFSTDTC should be the first day of exposure to test compound rather
+ than challenge agents or other interventions."
Document: FDA
Section: FDAB064
Origin: FDA Business Rules
Rule Identifier:
Id: FB6401
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to
- test compound rather than challenge agents or other
- interventions.'
+ - Cited Guidance:
+ "When possible, RFSTDTC should be the first day of exposure to test compound rather
+ than challenge agents or other interventions."
Document: FDA
Section: FDAB064
Origin: FDA Business Rules
Rule Identifier:
Id: FB6401
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to
- test compound rather than challenge agents or other
- interventions.'
+ - Cited Guidance:
+ "When possible, RFSTDTC should be the first day of exposure to test compound rather
+ than challenge agents or other interventions."
Document: FDA
Section: FDAB064
Origin: FDA Business Rules
Rule Identifier:
Id: FB6401
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to
- test compound rather than challenge agents or other
- interventions.'
+ - Cited Guidance:
+ "When possible, RFSTDTC should be the first day of exposure to test compound rather
+ than challenge agents or other interventions."
Document: FDA
Section: FDAB064
Origin: FDA Business Rules
Rule Identifier:
Id: FB6401
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to
- test compound rather than challenge agents or other
- interventions.'
+ - Cited Guidance:
+ "When possible, RFSTDTC should be the first day of exposure to test compound rather
+ than challenge agents or other interventions."
Document: FDA
Section: FDAB064
Origin: FDA Business Rules
Rule Identifier:
Id: FB6401
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to
- test compound rather than challenge agents or other
- interventions.'
+ - Cited Guidance:
+ "When possible, RFSTDTC should be the first day of exposure to test compound rather
+ than challenge agents or other interventions."
Document: FDA
Section: FDAB064
Origin: FDA Business Rules
Rule Identifier:
Id: FB6401
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: "RFSTDTC"
@@ -108,9 +108,9 @@ Check:
Core:
Id: CORE-001044
Status: Published
- Version: '1'
-Description: Subject Reference Start Date/Time (RFSTDTC) should be equal to the
- first Start Date/Time of Treatment (EXSDTC).
+ Version: "1"
+Description: Subject Reference Start Date/Time (RFSTDTC) should be equal to the first Start
+ Date/Time of Treatment (EXSDTC).
Executability: Fully Executable
Operations:
- domain: "EX"
diff --git a/Published/CORE-001045/rule.yml b/Published/CORE-001045/rule.yml
index 47aa49f2e..3a5c98795 100644
--- a/Published/CORE-001045/rule.yml
+++ b/Published/CORE-001045/rule.yml
@@ -4,29 +4,29 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study arm must only reference study populations or cohorts
- that are defined within the same study design as the study
- arm.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study arm must only reference study populations or cohorts that are defined
+ within the same study design as the study arm."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00050'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00050"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study arm must only reference study populations or cohorts
- that are defined within the same study design as the study
- arm.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study arm must only reference study populations or cohorts that are defined
+ within the same study design as the study arm."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00050'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00050"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.**.studyDesigns)@$s.
[
@@ -44,16 +44,17 @@ Check: |-
}
]
Core:
- Id: 'CORE-001045'
+ Id: "CORE-001045"
Status: Published
- Version: '1'
-Description: 'A study arm must only reference study populations or cohorts that
- are defined within the same study design as the study arm.'
+ Version: "1"
+Description:
+ "A study arm must only reference study populations or cohorts that are defined within the
+ same study design as the study arm."
Executability: Fully Executable
Outcome:
- Message: 'The study arm references a populationId that does not match the id of
- any study population or study cohort defined within the same study design as
- the study arm.'
+ Message:
+ "The study arm references a populationId that does not match the id of any study population
+ or study cohort defined within the same study design as the study arm."
Output Variables:
- StudyDesign.id
- StudyDesign.name
diff --git a/Published/CORE-001046/rule.yml b/Published/CORE-001046/rule.yml
index eebfeca21..d8de9c52d 100644
--- a/Published/CORE-001046/rule.yml
+++ b/Published/CORE-001046/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If the intervention model indicates a single group design then
- only one intervention is expected. In all other cases more
- interventions are expected.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If the intervention model indicates a single group design then only one intervention
+ is expected. In all other cases more interventions are expected."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00074'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00074"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check: |-
($.study.versions.studyDesigns)@$sd.
{
@@ -30,28 +30,28 @@ Check: |-
(`interventionModel.code` != "C82640" and `# Study Interventions` <= 1)
]
Core:
- Id: 'CORE-001046'
+ Id: "CORE-001046"
Status: Published
- Version: '1'
-Description: 'If the intervention model indicates a single group design then
- only one intervention is expected. In all other cases more interventions are
- expected.'
+ Version: "1"
+Description:
+ "If the intervention model indicates a single group design then only one intervention is
+ expected. In all other cases more interventions are expected."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The number of study interventions defined for the study design is not
- consistent with intervention model specified for the study design - either
- the model indicates a single group and there is not only one study
- intervention, or the model does not indicate a single group and there are
- not multiple study interventions.'
+ Message:
+ "The number of study interventions defined for the study design is not consistent with intervention
+ model specified for the study design - either the model indicates a single group and there is not
+ only one study intervention, or the model does not indicate a single group and there are not multiple
+ study interventions."
Output Variables:
- id
- name
- interventionModel.code
- interventionModel.decode
- - '# Study Interventions'
+ - "# Study Interventions"
Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyDesign'
+ - "StudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001047/rule.yml b/Published/CORE-001047/rule.yml
index 9f11a6f3f..db1076b96 100644
--- a/Published/CORE-001047/rule.yml
+++ b/Published/CORE-001047/rule.yml
@@ -4,29 +4,29 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a biomedical concept is referenced from an activity then it
- is not expected to be referenced as well by a biomedical
- concept category that is referenced from the same activity.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If a biomedical concept is referenced from an activity then it is not expected
+ to be referenced as well by a biomedical concept category that is referenced from the same activity."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00076'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00076"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If a biomedical concept is referenced from an activity then it
- is not expected to be referenced as well by a biomedical
- concept category that is referenced from the same activity.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If a biomedical concept is referenced from an activity then it is not expected
+ to be referenced as well by a biomedical concept category that is referenced from the same activity."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00076'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00076"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.study.versions)@$sv.
[
@@ -74,17 +74,17 @@ Check: |-
)
]
Core:
- Id: 'CORE-001047'
+ Id: "CORE-001047"
Status: Published
- Version: '1'
-Description: 'If a biomedical concept is referenced from an activity then it is
- not expected to be referenced as well by a biomedical concept category that is
- referenced from the same activity.'
+ Version: "1"
+Description:
+ "If a biomedical concept is referenced from an activity then it is not expected to be referenced
+ as well by a biomedical concept category that is referenced from the same activity."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The activity references both a biomedical concept category and a
- biomedical concept, but the biomedical concept is a member of the referenced
- category or one of its subcategories.'
+ Message:
+ "The activity references both a biomedical concept category and a biomedical concept, but the
+ biomedical concept is a member of the referenced category or one of its subcategories."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -95,5 +95,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Activity'
+ - "Activity"
Sensitivity: Record
diff --git a/Published/CORE-001048/rule.yml b/Published/CORE-001048/rule.yml
index 4115456c1..5ec978e68 100644
--- a/Published/CORE-001048/rule.yml
+++ b/Published/CORE-001048/rule.yml
@@ -4,31 +4,31 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Epoch ordering using previous and next attributes is expected
- to be consistent with the order of corresponding scheduled
- activity instances according to their specified default
- conditions.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Epoch ordering using previous and next attributes is expected to be consistent
+ with the order of corresponding scheduled activity instances according to their specified default
+ conditions."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00088'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00088"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Epoch ordering using previous and next attributes is expected
- to be consistent with the order of corresponding scheduled
- activity instances according to their specified default
- conditions.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Epoch ordering using previous and next attributes is expected to be consistent
+ with the order of corresponding scheduled activity instances according to their specified default
+ conditions."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00088'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00088"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.study.versions)@$sv.
($sv.studyDesigns)@$sd.
@@ -53,18 +53,18 @@ Check: |-
}[`Epoch order by previous/next` != `Epoch order by timeline refs`]
)
Core:
- Id: 'CORE-001048'
+ Id: "CORE-001048"
Status: Published
- Version: '1'
-Description: 'Epoch ordering using previous and next attributes is expected to
- be consistent with the order of corresponding scheduled activity instances
- according to their specified default conditions.'
+ Version: "1"
+Description:
+ "Epoch ordering using previous and next attributes is expected to be consistent with the
+ order of corresponding scheduled activity instances according to their specified default conditions."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The order of the epochs in the study design (as defined by the next
- attribute) does not match the order of epochs as referenced from scheduled
- activity instances in the main timeline that are ordered by default
- condition.'
+ Message:
+ "The order of the epochs in the study design (as defined by the next attribute) does not match
+ the order of epochs as referenced from scheduled activity instances in the main timeline that are
+ ordered by default condition."
Output Variables:
- name
- ScheduleTimeline.id
@@ -76,7 +76,7 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyDesign'
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "StudyDesign"
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001049/rule.yml b/Published/CORE-001049/rule.yml
index 4b2ca5a9e..abfd336f5 100644
--- a/Published/CORE-001049/rule.yml
+++ b/Published/CORE-001049/rule.yml
@@ -4,27 +4,25 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Referenced items in a parameter map must be available elsewhere
- in the data model.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Referenced items in a parameter map must be available elsewhere in the data model."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00124'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00124"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Referenced items in a parameter map must be available elsewhere
- in the data model.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Referenced items in a parameter map must be available elsewhere in the data model."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00124'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00124"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(
$lkp:=**[id and instanceType].$each(function($v,$k){{$join([instanceType,id,$k],"|"):$v}})~>$merge;
@@ -85,15 +83,13 @@ Check: |-
)
)
Core:
- Id: 'CORE-001049'
+ Id: "CORE-001049"
Status: Published
- Version: '1'
-Description: 'Referenced items in a parameter map must be available elsewhere in
- the data model.'
+ Version: "1"
+Description: "Referenced items in a parameter map must be available elsewhere in the data model."
Executability: Fully Executable
Outcome:
- Message: 'The item referenced in the parameter map is not available elsewhere in
- the model.'
+ Message: "The item referenced in the parameter map is not available elsewhere in the model."
Output Variables:
- SyntaxTemplateDictionary.id
- SyntaxTemplateDictionary.name
@@ -103,5 +99,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'ParameterMap'
+ - "ParameterMap"
Sensitivity: Record
diff --git a/Published/CORE-001050/rule.yml b/Published/CORE-001050/rule.yml
index d3af883f5..313fd1e69 100644
--- a/Published/CORE-001050/rule.yml
+++ b/Published/CORE-001050/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Referenced items in the narrative content must be available
- elsewhere in the data model.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Referenced items in the narrative content must be available elsewhere in the
+ data model."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00131'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00131"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
Check: |-
(
$lkp:=**[id and instanceType].$each(function($v,$k){{$join([instanceType,id,$k],"|"):$v}})~>$merge;
@@ -66,15 +67,13 @@ Check: |-
)
)
Core:
- Id: 'CORE-001050'
+ Id: "CORE-001050"
Status: Published
- Version: '1'
-Description: 'Referenced items in the narrative content must be available
- elsewhere in the data model.'
+ Version: "1"
+Description: "Referenced items in the narrative content must be available elsewhere in the data model."
Executability: Fully Executable
Outcome:
- Message: 'The item referenced in the narrative content text is not available
- elsewhere in the model.'
+ Message: "The item referenced in the narrative content text is not available elsewhere in the model."
Output Variables:
- StudyProtocolDocument.id
- StudyProtocolDocument.name
@@ -83,10 +82,10 @@ Outcome:
- name
- sectionNumber
- sectionTitle
- - 'Invalid Reference'
+ - "Invalid Reference"
Rule Type: JSONata
Scope:
Entities:
Include:
- - 'NarrativeContent'
+ - "NarrativeContent"
Sensitivity: Record
diff --git a/Published/CORE-001051/rule.yml b/Published/CORE-001051/rule.yml
index 5a1bdd131..384a66852 100644
--- a/Published/CORE-001051/rule.yml
+++ b/Published/CORE-001051/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Narrative content is expected to point to a child and/or to a
- content item text.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Narrative content is expected to point to a child and/or to a content item text."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00163'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00163"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
$.study.documentedBy@$sdd.
$sdd.versions@$sddv.
@@ -34,15 +33,13 @@ Check: |-
"sectionTitle": $c.sectionTitle
}
Core:
- Id: 'CORE-001051'
+ Id: "CORE-001051"
Status: Published
- Version: '1'
-Description: 'Narrative content is expected to point to a child and/or to a
- content item text.'
+ Version: "1"
+Description: "Narrative content is expected to point to a child and/or to a content item text."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: "The narrative content does not contain either a child or a narrative
- content item."
+ Message: "The narrative content does not contain either a child or a narrative content item."
Output Variables:
- StudyDefinitionDocument.id
- StudyDefinitionDocument.name
@@ -55,5 +52,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'NarrativeContent'
+ - "NarrativeContent"
Sensitivity: Record
diff --git a/Published/CORE-001052/rule.yml b/Published/CORE-001052/rule.yml
index b4619f3db..e8d538dc4 100644
--- a/Published/CORE-001052/rule.yml
+++ b/Published/CORE-001052/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study definition document version must not be referenced more
- than once by the same study version.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study definition document version must not be referenced more than once by
+ the same study version."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00167'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00167"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions.
{
@@ -24,16 +25,17 @@ Check: |-
$filter(documentVersionIds,function($v,$i,$a){$count($a[$=$v])>1}) ~> $sort
}[`Duplicate documentVersionIds`]
Core:
- Id: 'CORE-001052'
+ Id: "CORE-001052"
Status: Published
- Version: '1'
-Description: 'A study definition document version must not be referenced more
- than once by the same study version.'
+ Version: "1"
+Description:
+ "A study definition document version must not be referenced more than once by the same study
+ version."
Executability: Fully Executable
Outcome:
- Message: "The study version references the same study definition document
- version more than once (there are duplicate id values in
- documentVersionIds)."
+ Message:
+ "The study version references the same study definition document version more than once (there
+ are duplicate id values in documentVersionIds)."
Output Variables:
- versionIdentifier
- "Duplicate documentVersionIds"
@@ -41,5 +43,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyVersion'
+ - "StudyVersion"
Sensitivity: Record
diff --git a/Published/CORE-001053/rule.yml b/Published/CORE-001053/rule.yml
index c8d6e53c9..5de0eb9fb 100644
--- a/Published/CORE-001053/rule.yml
+++ b/Published/CORE-001053/rule.yml
@@ -4,14 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'All abbreviations defined for a study version must be unique.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "All abbreviations defined for a study version must be unique."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00170'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00170"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions@$sv.
(
@@ -30,10 +30,10 @@ Check: |-
"expandedText": expandedText
}
Core:
- Id: 'CORE-001053'
+ Id: "CORE-001053"
Status: Published
- Version: '1'
-Description: 'All abbreviations defined for a study version must be unique.'
+ Version: "1"
+Description: "All abbreviations defined for a study version must be unique."
Executability: Fully Executable
Outcome:
Message: "The abbreviation's abbreviated text is not unique within the study version."
@@ -46,5 +46,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Abbreviation'
+ - "Abbreviation"
Sensitivity: Record
diff --git a/Published/CORE-001054/rule.yml b/Published/CORE-001054/rule.yml
index cf8d5987c..f469113f2 100644
--- a/Published/CORE-001054/rule.yml
+++ b/Published/CORE-001054/rule.yml
@@ -4,16 +4,17 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'There must be exactly one sponsor study identifier (i.e., a
- study identifier whose scope is an organization that is
- identified as the organization for the sponsor study role).'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "There must be exactly one sponsor study identifier (i.e., a study identifier
+ whose scope is an organization that is identified as the organization for the sponsor study
+ role)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00172'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00172"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
[$.study.versions@$sv.
(
@@ -33,22 +34,22 @@ Check: |-
}
)][`# Sponsor Identifiers` != 1]
Core:
- Id: 'CORE-001054'
+ Id: "CORE-001054"
Status: Published
- Version: '1'
-Description: 'There must be exactly one sponsor study identifier (i.e., a study
- identifier whose scope is an organization that is identified as the
- organization for the sponsor study role).'
+ Version: "1"
+Description:
+ "There must be exactly one sponsor study identifier (i.e., a study identifier whose scope
+ is an organization that is identified as the organization for the sponsor study role)."
Executability: Fully Executable
Outcome:
- Message: 'The study version does not have exactly one sponsor study identifier.'
+ Message: "The study version does not have exactly one sponsor study identifier."
Output Variables:
- versionIdentifier
- - '# Sponsor Identifiers'
- - 'Sponsor Identifiers'
+ - "# Sponsor Identifiers"
+ - "Sponsor Identifiers"
Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyVersion'
+ - "StudyVersion"
Sensitivity: Record
diff --git a/Published/CORE-001055/rule.yml b/Published/CORE-001055/rule.yml
index 6f0678381..702ed86bc 100644
--- a/Published/CORE-001055/rule.yml
+++ b/Published/CORE-001055/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Narrative content must only reference narrative content that is
- specified within the same study definition document version.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Narrative content must only reference narrative content that is specified within
+ the same study definition document version."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00204'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00204"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
$.study.documentedBy@$sdd.
$sdd.versions@$sddv.
@@ -52,16 +53,17 @@ Check: |-
"Invalid childIds": $c.childIds[$not($ in $sddv.contents.id)] ~> $join("; ")
}
Core:
- Id: 'CORE-001055'
+ Id: "CORE-001055"
Status: Published
- Version: '1'
-Description: 'Narrative content must only reference narrative content that is
- specified within the same study definition document version.'
+ Version: "1"
+Description:
+ "Narrative content must only reference narrative content that is specified within the same
+ study definition document version."
Executability: Fully Executable
Outcome:
- Message: 'The narrative content references a previous, next or child id value
- that does not match the id of any narrative content defined within the same
- study definition document version.'
+ Message:
+ "The narrative content references a previous, next or child id value that does not match the
+ id of any narrative content defined within the same study definition document version."
Output Variables:
- StudyDefinitionDocument.id
- StudyDefinitionDocument.name
@@ -76,5 +78,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'NarrativeContent'
+ - "NarrativeContent"
Sensitivity: Record
diff --git a/Published/CORE-001056/rule.yml b/Published/CORE-001056/rule.yml
index af2053d71..79727fbc0 100644
--- a/Published/CORE-001056/rule.yml
+++ b/Published/CORE-001056/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An observational study design's sampling method must be
- specified according to the extensible Observational Study
- Sampling Method (C127260) SDTM codelist (e.g. an entry with a
- code or decode used from the codelist should be consistent
- with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An observational study design's sampling method must be specified according to
+ the extensible Observational Study Sampling Method (C127260) SDTM codelist (e.g. an entry with
+ a code or decode used from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00225'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00225"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: samplingMethod
operator: exists
- name: samplingMethod
@@ -30,7 +29,7 @@ Check:
all:
- name: samplingMethod.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: samplingMethod.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -72,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-001056'
+ Id: "CORE-001056"
Status: Published
- Version: '1'
-Description: "An observational study design's sampling method must be specified
- according to the extensible Observational Study Sampling Method (C127260) SDTM
- codelist (e.g. an entry with a code or decode used from the codelist should be
- consistent with the full entry in the codelist)."
+ Version: "1"
+Description:
+ "An observational study design's sampling method must be specified according to the extensible
+ Observational Study Sampling Method (C127260) SDTM codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -123,13 +122,12 @@ Operations:
term_value: samplingMethod.decode
version: samplingMethod.codeSystemVersion
Outcome:
- Message: 'The observational study design''s sampling method is not specified
- according to the extensible Observational Study Sampling Method (C127260)
- SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
- is not a valid terminology package date, and/or the code or decode (either
- as preferred term or as submission value) is found in the codelist (case
- insensitive) but the corresponding decode or code does not match the
- codelist value (case sensitive).'
+ Message:
+ 'The observational study design''s sampling method is not specified according to the extensible
+ Observational Study Sampling Method (C127260) SDTM codelist - codeSystem is not "http://www.cdisc.org",
+ codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred
+ term or as submission value) is found in the codelist (case insensitive) but the corresponding decode
+ or code does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -150,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ObservationalStudyDesign'
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001057/rule.yml b/Published/CORE-001057/rule.yml
index 6e0e2f0b2..3e035da80 100644
--- a/Published/CORE-001057/rule.yml
+++ b/Published/CORE-001057/rule.yml
@@ -4,23 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "An observational study design's sub types must be specified
- according to the extensible observational study design subtype
- (C215486) DDF codelist (e.g. an entry with a code or decode
- used from the codelist should be consistent with the full
- entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An observational study design's sub types must be specified according to the
+ extensible observational study design subtype (C215486) DDF codelist (e.g. an entry with a code
+ or decode used from the codelist should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00226'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00226"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: subTypes
operator: exists
- name: subTypes
@@ -28,13 +27,13 @@ Check:
value: true
- name: parent_rel.Code
operator: equal_to
- value: 'subTypes'
+ value: "subTypes"
value_is_literal: true
- not:
all:
- name: codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -76,13 +75,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-001057'
+ Id: "CORE-001057"
Status: Published
- Version: '1'
-Description: "An observational study design's sub types must be specified
- according to the extensible observational study design subtype (C215486) DDF
- codelist (e.g. an entry with a code or decode used from the codelist should be
- consistent with the full entry in the codelist)."
+ Version: "1"
+Description:
+ "An observational study design's sub types must be specified according to the extensible
+ observational study design subtype (C215486) DDF codelist (e.g. an entry with a code or decode used
+ from the codelist should be consistent with the full entry in the codelist)."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -96,7 +95,7 @@ Operations:
- id: $codelist_code
map:
- output: C215486
- parent_rel.Code: 'subTypes'
+ parent_rel.Code: "subTypes"
operator: map
- ct_package_types:
- DDF
@@ -136,13 +135,12 @@ Operations:
term_value: decode
version: codeSystemVersion
Outcome:
- Message: 'The observational study design''s sub type is not specified according
- to the extensible observational study design subtype (C215486) DDF codelist
- - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
- terminology package date, and/or the code or decode (either as preferred
- term or as submission value) is found in the codelist (case insensitive) but
- the corresponding decode or code does not match the codelist value (case
- sensitive).'
+ Message:
+ 'The observational study design''s sub type is not specified according to the extensible observational
+ study design subtype (C215486) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion
+ is not a valid terminology package date, and/or the code or decode (either as preferred term or as
+ submission value) is found in the codelist (case insensitive) but the corresponding decode or code
+ does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -163,5 +161,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'ObservationalStudyDesign'
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001058/rule.yml b/Published/CORE-001058/rule.yml
index 16e8430f6..99fa4b66d 100644
--- a/Published/CORE-001058/rule.yml
+++ b/Published/CORE-001058/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study design's study phase must be specified according to the
- extensible Trial Phase Response (C66737) SDTM codelist (e.g.
- an entry with a code or decode used from the codelist should
- be consistent with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study design's study phase must be specified according to the extensible Trial
+ Phase Response (C66737) SDTM codelist (e.g. an entry with a code or decode used from the codelist
+ should be consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00229'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00229"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: studyPhase.standardCode
operator: exists
- name: studyPhase.standardCode
@@ -29,7 +29,7 @@ Check:
all:
- name: studyPhase.standardCode.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: studyPhase.standardCode.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -71,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-001058'
+ Id: "CORE-001058"
Status: Published
- Version: '1'
-Description: "A study design's study phase must be specified according to the
- extensible Trial Phase Response (C66737) SDTM codelist (e.g. an entry with a
- code or decode used from the codelist should be consistent with the full entry
- in the codelist)."
+ Version: "1"
+Description:
+ "A study design's study phase must be specified according to the extensible Trial Phase Response
+ (C66737) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent
+ with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -122,12 +122,12 @@ Operations:
term_value: studyPhase.standardCode.decode
version: studyPhase.standardCode.codeSystemVersion
Outcome:
- Message: 'The study design''s study phase is not specified according to the
- extensible Trial Phase Response (C66737) SDTM codelist - codeSystem is not
- "http://www.cdisc.org", codeSystemVersion is not a valid terminology package
- date, and/or the code or decode (either as preferred term or as submission
- value) is found in the codelist (case insensitive) but the corresponding
- decode or code does not match the codelist value (case sensitive).'
+ Message:
+ 'The study design''s study phase is not specified according to the extensible Trial Phase Response
+ (C66737) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid
+ terminology package date, and/or the code or decode (either as preferred term or as submission value)
+ is found in the codelist (case insensitive) but the corresponding decode or code does not match the
+ codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -148,6 +148,6 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001059/rule.yml b/Published/CORE-001059/rule.yml
index b72226938..8a0bd8f50 100644
--- a/Published/CORE-001059/rule.yml
+++ b/Published/CORE-001059/rule.yml
@@ -4,20 +4,21 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A study design''s study type must be specified using the Study
- Type Response (C99077) SDTM codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study design's study type must be specified using the Study Type Response (C99077)
+ SDTM codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00230'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00230"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: studyType
operator: equal_to
value: true
@@ -25,7 +26,7 @@ Check:
all:
- name: studyType.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: studyType.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -67,11 +68,12 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-001059'
+ Id: "CORE-001059"
Status: Published
- Version: '1'
-Description: 'A study design''s study type must be specified using the Study
- Type Response (C99077) SDTM codelist.'
+ Version: "1"
+Description:
+ "A study design's study type must be specified using the Study Type Response (C99077) SDTM
+ codelist."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -116,13 +118,12 @@ Operations:
term_value: studyType.decode
version: studyType.codeSystemVersion
Outcome:
- Message: 'The study design''s study type is not specified using the Study Type
- Response (C99077) SDTM codelist - codeSystem is not "http://www.cdisc.org",
- codeSystemVersion is not a valid terminology package date, the code or
- decode (either as preferred term or as submission value) is found in the
- codelist (case insensitive) but the corresponding decode or code does not
- match the codelist value (case sensitive), and/or neither code nor decode is
- found in the codelist.'
+ Message:
+ 'The study design''s study type is not specified using the Study Type Response (C99077) SDTM
+ codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
+ package date, the code or decode (either as preferred term or as submission value) is found in the
+ codelist (case insensitive) but the corresponding decode or code does not match the codelist value
+ (case sensitive), and/or neither code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -143,6 +144,6 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
- - 'ObservationalStudyDesign'
+ - "InterventionalStudyDesign"
+ - "ObservationalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001060/rule.yml b/Published/CORE-001060/rule.yml
index c3070d472..7851ccbb8 100644
--- a/Published/CORE-001060/rule.yml
+++ b/Published/CORE-001060/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A unit must be coded according to the extensible unit (C71620)
- SDTM codelist (e.g. an entry with a code or decode used from
- the codelist should be consistent with the full entry in the
- codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A unit must be coded according to the extensible unit (C71620) SDTM codelist
+ (e.g. an entry with a code or decode used from the codelist should be consistent with the full
+ entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00233'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00233"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: unit.standardCode
operator: exists
- name: unit.standardCode
@@ -29,7 +29,7 @@ Check:
all:
- name: unit.standardCode.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: unit.standardCode.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -71,12 +71,12 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-001060'
+ Id: "CORE-001060"
Status: Published
- Version: '1'
-Description: "A unit must be coded according to the extensible unit (C71620)
- SDTM codelist (e.g. an entry with a code or decode used from the codelist
- should be consistent with the full entry in the codelist)."
+ Version: "1"
+Description:
+ "A unit must be coded according to the extensible unit (C71620) SDTM codelist (e.g. an entry
+ with a code or decode used from the codelist should be consistent with the full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -121,12 +121,11 @@ Operations:
term_value: unit.standardCode.decode
version: unit.standardCode.codeSystemVersion
Outcome:
- Message: 'The unit is not coded according to the extensible unit (C71620) SDTM
- codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is
- not a valid terminology package date, and/or the code or decode (either as
- preferred term or as submission value) is found in the codelist (case
- insensitive) but the corresponding decode or code does not match the
- codelist value (case sensitive).'
+ Message:
+ 'The unit is not coded according to the extensible unit (C71620) SDTM codelist - codeSystem
+ is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the
+ code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive)
+ but the corresponding decode or code does not match the codelist value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -147,5 +146,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Quantity'
+ - "Quantity"
Sensitivity: Record
diff --git a/Published/CORE-001061/rule.yml b/Published/CORE-001061/rule.yml
index c8de16a13..529fe8479 100644
--- a/Published/CORE-001061/rule.yml
+++ b/Published/CORE-001061/rule.yml
@@ -4,20 +4,21 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The unit of a planned age is expected to be specified using
- terms from the Age Unit (C66781) SDTM codelist.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "The unit of a planned age is expected to be specified using terms from the Age
+ Unit (C66781) SDTM codelist."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00237'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00237"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: plannedAge
operator: equal_to
value: true
@@ -29,7 +30,7 @@ Check:
all:
- name: unit.standardCode.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: unit.standardCode.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -71,11 +72,12 @@ Check:
- name: $value_for_code
operator: empty
Core:
- Id: 'CORE-001061'
+ Id: "CORE-001061"
Status: Published
- Version: '1'
-Description: 'The unit of a planned age is expected to be specified using terms
- from the Age Unit (C66781) SDTM codelist.'
+ Version: "1"
+Description:
+ "The unit of a planned age is expected to be specified using terms from the Age Unit (C66781)
+ SDTM codelist."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -89,9 +91,9 @@ Operations:
- id: $codelist_code
map:
- output: C66781
- parent_rel.Quantity: 'minValue'
+ parent_rel.Quantity: "minValue"
- output: C66781
- parent_rel.Quantity: 'maxValue'
+ parent_rel.Quantity: "maxValue"
operator: map
- ct_package_types:
- SDTM
@@ -132,19 +134,18 @@ Operations:
version: unit.standardCode.codeSystemVersion
- id: $variable_with_issue
map:
- - output: 'plannedAge.minValue'
- parent_rel.Quantity: 'minValue'
- - output: 'plannedAge.maxValue'
- parent_rel.Quantity: 'maxValue'
+ - output: "plannedAge.minValue"
+ parent_rel.Quantity: "minValue"
+ - output: "plannedAge.maxValue"
+ parent_rel.Quantity: "maxValue"
operator: map
Outcome:
- Message: 'The unit of the planned age is not specified using the Age Unit
- (C66781) SDTM codelist - codeSystem is not "http://www.cdisc.org",
- codeSystemVersion is not a valid terminology package date, the code or
- decode (either as preferred term or as submission value) is found in the
- codelist (case insensitive) but the corresponding decode or code does not
- match the codelist value (case sensitive), and/or neither code nor decode is
- found in the codelist.'
+ Message:
+ 'The unit of the planned age is not specified using the Age Unit (C66781) SDTM codelist - codeSystem
+ is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code
+ or decode (either as preferred term or as submission value) is found in the codelist (case insensitive)
+ but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither
+ code nor decode is found in the codelist.'
Output Variables:
- parent_entity
- parent_id
@@ -166,6 +167,6 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyDesignPopulation'
- - 'StudyCohort'
+ - "StudyDesignPopulation"
+ - "StudyCohort"
Sensitivity: Record
diff --git a/Published/CORE-001062/rule.yml b/Published/CORE-001062/rule.yml
index 721da905b..49fda0849 100644
--- a/Published/CORE-001062/rule.yml
+++ b/Published/CORE-001062/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An activity must only reference child activities that are
- specified within the same study design.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An activity must only reference child activities that are specified within the
+ same study design."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00254'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00254"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
$.**.studyDesigns@$s.
[
@@ -28,15 +29,17 @@ Check: |-
}
]
Core:
- Id: 'CORE-001062'
+ Id: "CORE-001062"
Status: Published
- Version: '1'
-Description: 'An activity must only reference child activities that are
- specified within the same study design.'
+ Version: "1"
+Description:
+ "An activity must only reference child activities that are specified within the same study
+ design."
Executability: Fully Executable
Outcome:
- Message: 'The activity references a childId that does not match the id of any
- activity defined within the same study design as the activity.'
+ Message:
+ "The activity references a childId that does not match the id of any activity defined within
+ the same study design as the activity."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -46,5 +49,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Activity'
+ - "Activity"
Sensitivity: Record
diff --git a/Published/CORE-001063/rule.yml b/Published/CORE-001063/rule.yml
index 9f180a2fc..03078d0e8 100644
--- a/Published/CORE-001063/rule.yml
+++ b/Published/CORE-001063/rule.yml
@@ -4,22 +4,22 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: "A study role code must be specified according to the extensible
- study role code (C215480) DDF codelist (e.g. an entry with a
- code or decode used from the codelist should be consistent
- with the full entry in the codelist)."
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A study role code must be specified according to the extensible study role code
+ (C215480) DDF codelist (e.g. an entry with a code or decode used from the codelist should be
+ consistent with the full entry in the codelist)."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00259'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00259"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: code
operator: exists
- name: code
@@ -29,7 +29,7 @@ Check:
all:
- name: code.codeSystem
operator: equal_to
- value: 'http://www.cdisc.org'
+ value: "http://www.cdisc.org"
- name: code.codeSystemVersion
operator: is_contained_by
value: $valid_versions
@@ -71,13 +71,13 @@ Check:
operator: equal_to
value: $value_for_code
Core:
- Id: 'CORE-001063'
+ Id: "CORE-001063"
Status: Published
- Version: '1'
-Description: "A study role code must be specified according to the extensible
- study role code (C215480) DDF codelist (e.g. an entry with a code or decode
- used from the codelist should be consistent with the full entry in the
- codelist)."
+ Version: "1"
+Description:
+ "A study role code must be specified according to the extensible study role code (C215480)
+ DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the
+ full entry in the codelist)."
Executability: Fully Executable
Operations:
- id: $codelist_code
@@ -122,12 +122,12 @@ Operations:
term_value: code.decode
version: code.codeSystemVersion
Outcome:
- Message: 'The study role code is not specified using to the extensible study
- role code (C215480) DDF codelist - codeSystem is not "http://www.cdisc.org",
- codeSystemVersion is not a valid terminology package date, and/or the code
- or decode (either as preferred term or as submission value) is found in the
- codelist (case insensitive) but the corresponding decode or code does not
- match the codelist value (case sensitive).'
+ Message:
+ 'The study role code is not specified using to the extensible study role code (C215480) DDF
+ codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology
+ package date, and/or the code or decode (either as preferred term or as submission value) is found
+ in the codelist (case insensitive) but the corresponding decode or code does not match the codelist
+ value (case sensitive).'
Output Variables:
- parent_entity
- parent_id
@@ -148,5 +148,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyRole'
+ - "StudyRole"
Sensitivity: Record
diff --git a/Published/CORE-001065/rule.yml b/Published/CORE-001065/rule.yml
index 70582fb33..baf28fb1a 100644
--- a/Published/CORE-001065/rule.yml
+++ b/Published/CORE-001065/rule.yml
@@ -4,29 +4,29 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, if study type is Interventional then at
- least one intervention is expected to be referenced from a
- procedure.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study design, if study type is Interventional then at least one intervention
+ is expected to be referenced from a procedure."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00101'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "DDF00101"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Within a study design, if study type is Interventional then at
- least one intervention is expected to be referenced from a
- procedure.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Within a study design, if study type is Interventional then at least one intervention
+ is expected to be referenced from a procedure."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00101'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00101"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.study.versions[$not("studyType" in $keys($)) or studyType.code = "C98388"])@$sv.
($sv.studyDesigns[$not("studyType" in $keys($)) or studyType.code = "C98388"])@$sd.
@@ -46,24 +46,26 @@ Check: |-
)
}[`# Referenced Study Interventions` < 1][]
Core:
- Id: 'CORE-001065'
+ Id: "CORE-001065"
Status: Published
- Version: '1'
-Description: 'Within a study design, if study type is Interventional then at
- least one intervention is expected to be referenced from a procedure.'
+ Version: "1"
+Description:
+ "Within a study design, if study type is Interventional then at least one intervention is
+ expected to be referenced from a procedure."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The study type is Interventional (code=C98388) but a study
- intervention is not referenced from any procedure.'
+ Message:
+ "The study type is Interventional (code=C98388) but a study intervention is not referenced
+ from any procedure."
Output Variables:
- name
- studyType.code
- studyType.decode
- - '# Referenced Study Interventions'
+ - "# Referenced Study Interventions"
Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyDesign'
- - 'InterventionalStudyDesign'
+ - "StudyDesign"
+ - "InterventionalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001066/rule.yml b/Published/CORE-001066/rule.yml
index 5957cd81c..6a896d930 100644
--- a/Published/CORE-001066/rule.yml
+++ b/Published/CORE-001066/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The ordering of activities (using the previous and next
- attributes) must include the parents (e.g. activities
- referring to children) preceding their children.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "The ordering of activities (using the previous and next attributes) must include
+ the parents (e.g. activities referring to children) preceding their children."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00161'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00161"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions.studyDesigns@$sd.
$sd.activities@$a.
@@ -52,20 +52,19 @@ Check: |-
}
)[`Issue(s)`]
Core:
- Id: 'CORE-001066'
+ Id: "CORE-001066"
Status: Published
- Version: '1'
-Description: 'The ordering of activities (using the previous and next
- attributes) must include the parents (e.g. activities referring to children)
- preceding their children.'
+ Version: "1"
+Description:
+ "The ordering of activities (using the previous and next attributes) must include the parents
+ (e.g. activities referring to children) preceding their children."
Executability: Fully Executable
Outcome:
- Message: "The previous/next ordering of the activity with respect to child
- activities is incorrect - the activity has children but its nextId is not
- one if its childIds, the activity is a child but its previousId is not its
- parent or another descendant of its parent, and/or the activity's previousId
- refers to an activity with children but the activity is not one of those
- children."
+ Message:
+ "The previous/next ordering of the activity with respect to child activities is incorrect -
+ the activity has children but its nextId is not one if its childIds, the activity is a child but its
+ previousId is not its parent or another descendant of its parent, and/or the activity's previousId
+ refers to an activity with children but the activity is not one of those children."
Output Variables:
- StudyDesign.id
- StudyDesign.name
@@ -81,5 +80,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Activity'
+ - "Activity"
Sensitivity: Record
diff --git a/Published/CORE-001067/rule.yml b/Published/CORE-001067/rule.yml
index efd2b315e..9ef2219f1 100644
--- a/Published/CORE-001067/rule.yml
+++ b/Published/CORE-001067/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'The expanded text for all abbreviations defined for a study
- version are expected to be unique.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "The expanded text for all abbreviations defined for a study version are expected
+ to be unique."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00171'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00171"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
study.versions@$sv.
(
@@ -31,15 +32,13 @@ Check: |-
"expandedText": expandedText
}
Core:
- Id: 'CORE-001067'
+ Id: "CORE-001067"
Status: Published
- Version: '1'
-Description: 'The expanded text for all abbreviations defined for a study
- version are expected to be unique.'
+ Version: "1"
+Description: "The expanded text for all abbreviations defined for a study version are expected to be unique."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: "The abbreviation's expanded text is not unique within the study
- version (case insensitive)."
+ Message: "The abbreviation's expanded text is not unique within the study version (case insensitive)."
Output Variables:
- StudyVersion.id
- StudyVersion.versionIdentifier
@@ -49,5 +48,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'Abbreviation'
+ - "Abbreviation"
Sensitivity: Record
diff --git a/Published/CORE-001068/rule.yml b/Published/CORE-001068/rule.yml
index be0e5bd36..a40ab078a 100644
--- a/Published/CORE-001068/rule.yml
+++ b/Published/CORE-001068/rule.yml
@@ -4,24 +4,24 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Date values associated to a study definition document version
- must be unique regarding the combination of type and
- geographic scopes of the date.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Date values associated to a study definition document version must be unique
+ regarding the combination of type and geographic scopes of the date."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00181'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00181"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: instanceType
operator: equal_to
- value: 'StudyDefinitionDocumentVersion'
+ value: "StudyDefinitionDocumentVersion"
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- all:
- name: code.standardCode.code
@@ -41,12 +41,12 @@ Check:
- type.code
- type.code.GeographicScope
Core:
- Id: 'CORE-001068'
+ Id: "CORE-001068"
Status: Published
- Version: '1'
-Description: 'Date values associated to a study definition document version must
- be unique regarding the combination of type and geographic scopes of the
- date.'
+ Version: "1"
+Description:
+ "Date values associated to a study definition document version must be unique regarding the
+ combination of type and geographic scopes of the date."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -60,8 +60,9 @@ Match Datasets:
- rel_type
Name: GeographicScope
Outcome:
- Message: 'The study definition document version has more than one governance
- date with the same type and geographic scope.'
+ Message:
+ "The study definition document version has more than one governance date with the same type
+ and geographic scope."
Output Variables:
- parent_entity
- parent_id
@@ -81,5 +82,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'StudyDefinitionDocumentVersion'
+ - "StudyDefinitionDocumentVersion"
Sensitivity: Record
diff --git a/Published/CORE-001069/rule.yml b/Published/CORE-001069/rule.yml
index 6121d4ee4..d9b2a9ad5 100644
--- a/Published/CORE-001069/rule.yml
+++ b/Published/CORE-001069/rule.yml
@@ -4,26 +4,26 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Narrative content item text is expected to be HTML formatted.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Narrative content item text is expected to be HTML formatted."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00187'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00187"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- name: $xhtml_errors
operator: non_empty
Core:
- Id: 'CORE-001069'
+ Id: "CORE-001069"
Status: Published
- Version: '1'
-Description: 'Narrative content item text is expected to be HTML formatted.'
+ Version: "1"
+Description: "Narrative content item text is expected to be HTML formatted."
Executability: Partially Executable - Possible Overreporting
Operations:
- id: $xhtml_errors
@@ -31,7 +31,7 @@ Operations:
namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0
operator: get_xhtml_errors
Outcome:
- Message: 'The narrative content item text contains non-conformant XHTML.'
+ Message: "The narrative content item text contains non-conformant XHTML."
Output Variables:
- parent_entity
- parent_id
@@ -42,5 +42,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'NarrativeContentItem'
+ - "NarrativeContentItem"
Sensitivity: Record
diff --git a/Published/CORE-001070/rule.yml b/Published/CORE-001070/rule.yml
index 6d7b11e2d..8fec97792 100644
--- a/Published/CORE-001070/rule.yml
+++ b/Published/CORE-001070/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A masking is not expected to be defined for any study role in a
- study design with an open label blinding schema.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A masking is not expected to be defined for any study role in a study design
+ with an open label blinding schema."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00191'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00191"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
$.study.versions@$sv.
[
@@ -39,15 +40,17 @@ Check: |-
}
]
Core:
- Id: 'CORE-001070'
+ Id: "CORE-001070"
Status: Published
- Version: '1'
-Description: 'A masking is not expected to be defined for any study role in a
- study design with an open label blinding schema.'
+ Version: "1"
+Description:
+ "A masking is not expected to be defined for any study role in a study design with an open
+ label blinding schema."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'A masking is defined for the study role, but the role applies to a
- study design with an open label blinding schema.'
+ Message:
+ "A masking is defined for the study role, but the role applies to a study design with an open
+ label blinding schema."
Output Variables:
- name
- code
@@ -60,5 +63,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'StudyRole'
+ - "StudyRole"
Sensitivity: Record
diff --git a/Published/CORE-001071/rule.yml b/Published/CORE-001071/rule.yml
index f7b61ffb6..8fd76f156 100644
--- a/Published/CORE-001071/rule.yml
+++ b/Published/CORE-001071/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A masking is expected to be defined for at least two study
- roles in a study design with a double blind blinding schema.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A masking is expected to be defined for at least two study roles in a study design
+ with a double blind blinding schema."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00192'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00192"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.study.versions)@$sv.
($sv.studyDesigns)@$sd
@@ -47,15 +48,17 @@ Check: |-
)
][`# Masked Roles` < 2]
Core:
- Id: 'CORE-001071'
+ Id: "CORE-001071"
Status: Published
- Version: '1'
-Description: 'A masking is expected to be defined for at least two study roles
- in a study design with a double blind blinding schema.'
+ Version: "1"
+Description:
+ "A masking is expected to be defined for at least two study roles in a study design with
+ a double blind blinding schema."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The study design has a double blind blinding schema (code=C15228) but
- there are not at least two applicable study roles that are masked.'
+ Message:
+ "The study design has a double blind blinding schema (code=C15228) but there are not at least
+ two applicable study roles that are masked."
Output Variables:
- name
- blindingSchema.code
@@ -66,5 +69,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
+ - "InterventionalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001072/rule.yml b/Published/CORE-001072/rule.yml
index 1e7d1e466..23f6f1aad 100644
--- a/Published/CORE-001072/rule.yml
+++ b/Published/CORE-001072/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'A masking is expected to be defined for at least one study role
- in a study design with a blinding schema that is not open
- label or double blind.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "A masking is expected to be defined for at least one study role in a study design
+ with a blinding schema that is not open label or double blind."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00193'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00193"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.study.versions)@$sv.
($sv.studyDesigns)@$sd
@@ -49,16 +49,17 @@ Check: |-
)
][`# Masked Roles` < 1]
Core:
- Id: 'CORE-001072'
+ Id: "CORE-001072"
Status: Published
- Version: '1'
-Description: 'A masking is expected to be defined for at least one study role in
- a study design with a blinding schema that is not open label or double blind.'
+ Version: "1"
+Description:
+ "A masking is expected to be defined for at least one study role in a study design with a
+ blinding schema that is not open label or double blind."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The study design has a blinding schema that is not open label or
- double blind (code is not C49659 or C15228) but there is no applicable study
- role that is masked.'
+ Message:
+ "The study design has a blinding schema that is not open label or double blind (code is not
+ C49659 or C15228) but there is no applicable study role that is masked."
Output Variables:
- name
- blindingSchema.code
@@ -69,5 +70,5 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
+ - "InterventionalStudyDesign"
Sensitivity: Record
diff --git a/Published/CORE-001073/rule.yml b/Published/CORE-001073/rule.yml
index 9a6bc9c79..277a48ce1 100644
--- a/Published/CORE-001073/rule.yml
+++ b/Published/CORE-001073/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Referenced items in the narrative content item texts must be
- available elsewhere in the data model.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Referenced items in the narrative content item texts must be available elsewhere
+ in the data model."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00244'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00244"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(
$lkp:=**[id and instanceType].$each(function($v,$k){{$join([instanceType,id,$k],"|"):$v}})~>$merge;
@@ -58,21 +59,21 @@ Check: |-
)
)
Core:
- Id: 'CORE-001073'
+ Id: "CORE-001073"
Status: Published
- Version: '1'
-Description: 'Referenced items in the narrative content item texts must be
- available elsewhere in the data model.'
+ Version: "1"
+Description:
+ "Referenced items in the narrative content item texts must be available elsewhere in the
+ data model."
Executability: Fully Executable
Outcome:
- Message: 'The item referenced in the narrative content item text is not
- available elsewhere in the model.'
+ Message: "The item referenced in the narrative content item text is not available elsewhere in the model."
Output Variables:
- name
- - 'Invalid Reference'
+ - "Invalid Reference"
Rule Type: JSONata
Scope:
Entities:
Include:
- - 'NarrativeContentItem'
+ - "NarrativeContentItem"
Sensitivity: Record
diff --git a/Published/CORE-001074/rule.yml b/Published/CORE-001074/rule.yml
index cc4ebf105..823b523b7 100644
--- a/Published/CORE-001074/rule.yml
+++ b/Published/CORE-001074/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Any parameter name referenced in a tag in the text should be
- specified in the data dictionary parameter maps.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Any parameter name referenced in a tag in the text should be specified in the
+ data dictionary parameter maps."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00246'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00246"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
**.study.versions@$sv.
($sv.**[$type(text)="string" and $contains(text,/usdm:tag/)])@$st.
@@ -45,17 +46,18 @@ Check: |-
}
)
Core:
- Id: 'CORE-001074'
+ Id: "CORE-001074"
Status: Published
- Version: '1'
-Description: 'Any parameter name referenced in a tag in the text should be
- specified in the data dictionary parameter maps.'
+ Version: "1"
+Description:
+ "Any parameter name referenced in a tag in the text should be specified in the data dictionary
+ parameter maps."
Executability: Fully Executable
Outcome:
- Message: "The parameter name referenced in the text is not specified in the data
- dictionary parameter map - the dictionaryId is missing or invalid, or the
- parameter name does not match a tag in any of the dictionary's parameter
- maps."
+ Message:
+ "The parameter name referenced in the text is not specified in the data dictionary parameter
+ map - the dictionaryId is missing or invalid, or the parameter name does not match a tag in any of
+ the dictionary's parameter maps."
Output Variables:
- name
- Parameter reference
@@ -67,10 +69,10 @@ Rule Type: JSONata
Scope:
Entities:
Include:
- - 'EligibilityCriterionItem'
- - 'Characteristic'
- - 'Condition'
- - 'Objective'
- - 'Endpoint'
- - 'IntercurrentEvent'
+ - "EligibilityCriterionItem"
+ - "Characteristic"
+ - "Condition"
+ - "Objective"
+ - "Endpoint"
+ - "IntercurrentEvent"
Sensitivity: Record
diff --git a/Published/CORE-001075/rule.yml b/Published/CORE-001075/rule.yml
index d60042e50..6d1716114 100644
--- a/Published/CORE-001075/rule.yml
+++ b/Published/CORE-001075/rule.yml
@@ -4,15 +4,14 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Id values are expected not to have spaces in their string
- values.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: "Id values are expected not to have spaces in their string values."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00260'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00260"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(**[$contains($string(id)," ")])@$i.
{
@@ -22,18 +21,18 @@ Check: |-
"name": $i.name
}
Core:
- Id: 'CORE-001075'
+ Id: "CORE-001075"
Status: Published
- Version: '1'
-Description: 'Id values are expected not to have spaces in their string values.'
+ Version: "1"
+Description: "Id values are expected not to have spaces in their string values."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The id value contains a space.'
+ Message: "The id value contains a space."
Output Variables:
- name
Rule Type: JSONata
Scope:
Entities:
Include:
- - 'ALL'
+ - "ALL"
Sensitivity: Record
diff --git a/Published/CORE-001076/rule.yml b/Published/CORE-001076/rule.yml
index 2980932d9..713801a0d 100644
--- a/Published/CORE-001076/rule.yml
+++ b/Published/CORE-001076/rule.yml
@@ -4,21 +4,21 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'An activity is expected to refer to at least one procedure,
- biomedical concept, biomedical concept category, biomedical
- concept surrogate, child activity, or timeline.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "An activity is expected to refer to at least one procedure, biomedical concept,
+ biomedical concept category, biomedical concept surrogate, child activity, or timeline."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00263'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00263"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- name: rel_type
operator: equal_to
- value: 'definition'
+ value: "definition"
- any:
- name: definedProcedures
operator: not_exists
@@ -65,17 +65,17 @@ Check:
- name: timelineId
operator: empty
Core:
- Id: 'CORE-001076'
+ Id: "CORE-001076"
Status: Published
- Version: '1'
-Description: 'An activity is expected to refer to at least one procedure,
- biomedical concept, biomedical concept category, biomedical concept surrogate,
- child activity, or timeline.'
+ Version: "1"
+Description:
+ "An activity is expected to refer to at least one procedure, biomedical concept, biomedical
+ concept category, biomedical concept surrogate, child activity, or timeline."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The activity does not refer to any procedure, biomedical concept,
- biomedical concept category, biomedical concept surrogate, child activity,
- or timeline.'
+ Message:
+ "The activity does not refer to any procedure, biomedical concept, biomedical concept category,
+ biomedical concept surrogate, child activity, or timeline."
Output Variables:
- parent_entity
- parent_id
@@ -92,5 +92,5 @@ Rule Type: Record Data
Scope:
Entities:
Include:
- - 'Activity'
+ - "Activity"
Sensitivity: Record
diff --git a/Published/CORE-001077/rule.yml b/Published/CORE-001077/rule.yml
index c727db8df..bf6663f76 100644
--- a/Published/CORE-001077/rule.yml
+++ b/Published/CORE-001077/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'If an interventional model indicates a cross-over, parallel or
- factorial design then more than 1 intervention is expected.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "If an interventional model indicates a cross-over, parallel or factorial design
+ then more than 1 intervention is expected."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00213'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00213"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
($.study.versions)@$sv.
($sv.studyDesigns[studyType.code = "C98388"])@$sd.
@@ -31,28 +32,29 @@ Check: |-
(`model.code` in ["C82637","C82639","C82638"] and `# Referenced Study Interventions` <= 1)
]
Core:
- Id: 'CORE-001077'
+ Id: "CORE-001077"
Status: Published
- Version: '1'
-Description: 'If an interventional model indicates a cross-over, parallel or
- factorial design then more than 1 intervention is expected.'
+ Version: "1"
+Description:
+ "If an interventional model indicates a cross-over, parallel or factorial design then more
+ than 1 intervention is expected."
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'The number of study interventions referenced for the interventional
- study design is not consistent with intervention model specified for the
- study design - the model indicates a cross-over, parallel or factorial
- design (model.code is C82637, C82639, or C82638) and there are not
- references to multiple study interventions.'
+ Message:
+ "The number of study interventions referenced for the interventional study design is not consistent
+ with intervention model specified for the study design - the model indicates a cross-over, parallel
+ or factorial design (model.code is C82637, C82639, or C82638) and there are not references to multiple
+ study interventions."
Output Variables:
- name
- studyType.code
- studyType.decode
- model.code
- model.decode
- - '# Referenced Study Interventions'
+ - "# Referenced Study Interventions"
Rule Type: JSONata
Scope:
Entities:
Include:
- - 'InterventionalStudyDesign'
+ - "InterventionalStudyDesign"
Sensitivity: Record
diff --git a/Unpublished/ADAMIG/AD0005/rule.yml b/Unpublished/ADAMIG/AD0005/rule.yml
index 106fd8f4b..30f21b7ca 100644
--- a/Unpublished/ADAMIG/AD0005/rule.yml
+++ b/Unpublished/ADAMIG/AD0005/rule.yml
@@ -9,7 +9,7 @@ Authorities:
no (not included in the population), Y = yes (included). Null
values are not allowed.
Document: ADaM IG v1.3
- Item: '4'
+ Item: "4"
Section: 3.1.4
- Cited Guidance: >-
' For character flags with variable names that end in FL and
@@ -23,13 +23,13 @@ Authorities:
1/null schemes apply to numeric flags with variable names that
end in FN and which are not population indicators. '
Document: ADaM IG v1.3
- Item: '9'
+ Item: "9"
Section: 3.1.4
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '5'
- Version: '5.0'
- Version: '1.3'
+ Id: "5"
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
@@ -38,7 +38,7 @@ Authorities:
no (not included in the population), Y = yes (included). Null
values are not allowed.
Document: ADaM IG v1.2
- Item: '4'
+ Item: "4"
Section: 3.1.4
- Cited Guidance: >-
' For character flags with variable names that end in FL and
@@ -52,13 +52,13 @@ Authorities:
1/null schemes apply to numeric flags with variable names that
end in FN and which are not population indicators. '
Document: ADaM IG v1.2
- Item: '9'
+ Item: "9"
Section: 3.1.4
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '5'
- Version: '5.0'
- Version: '1.2'
+ Id: "5"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
@@ -68,7 +68,7 @@ Authorities:
no (not included in the population), Y = yes (included). Null
values are not allowed.
Document: ADaM IG v1.1
- Item: '4'
+ Item: "4"
Section: 3.1.4
- Cited Guidance: >-
' For character flags with variable names that end in FL and
@@ -82,13 +82,13 @@ Authorities:
1/null schemes apply to numeric flags with variable names that
end in FN and which are not population indicators. '
Document: ADaM IG v1.1
- Item: '9'
+ Item: "9"
Section: 3.1.4
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '5'
- Version: '5.0'
- Version: '1.1'
+ Id: "5"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
@@ -98,7 +98,7 @@ Authorities:
no (not included in the population), Y = yes (included). Null
values are not allowed.
Document: ADaM IG v1.0
- Item: '4'
+ Item: "4"
Section: 3.1.4
- Cited Guidance: >-
' For character flags with variable names that end in FL and
@@ -112,13 +112,13 @@ Authorities:
1/null schemes apply to numeric flags with variable names that
end in FN and which are not population indicators. '
Document: ADaM IG v1.0
- Item: '9'
+ Item: "9"
Section: 3.1.4
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '5'
- Version: '5.0'
- Version: '1.0'
+ Id: "5"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
#- name: variable_name
@@ -129,13 +129,13 @@ Check:
value:
- Y
- N
- - ''
- #- name: CRIT1FL #*FL like --FL
+ - ""
+ #- name: CRIT1FL #*FL like --FL
# operator: non_empty
Core:
Id: CDISC.ADaMIG.AD0005
Status: Draft
- Version: '1'
+ Version: "1"
Description: A variable with a suffix of FL must have a value Y, N or null
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0006/rule.yml b/Unpublished/ADAMIG/AD0006/rule.yml
index b5b2a6eae..048205224 100644
--- a/Unpublished/ADAMIG/AD0006/rule.yml
+++ b/Unpublished/ADAMIG/AD0006/rule.yml
@@ -7,9 +7,9 @@ Authorities:
- Cited Guidance: >-
For subject-level numeric population flag variables':'' 0 = no
(not included), 1 = yes (included). Null values are not
- allowed.
+ allowed.
Document: ADaM IG v1.3
- Item: '5'
+ Item: "5"
Section: 3.1.4
- Cited Guidance: >-
For character flags with variable names that end in FL and
@@ -23,13 +23,13 @@ Authorities:
1/null schemes apply to numeric flags with variable names that
end in FN and which are not population indicators.
Document: ADaM IG v1.3
- Item: '9'
+ Item: "9"
Section: 3.1.4
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '6'
- Version: '5.0'
- Version: '1.3'
+ Id: "6"
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
@@ -39,7 +39,7 @@ Authorities:
(not included), 1 = yes (included). Null values are not
allowed.
Document: ADaM IG v1.2
- Item: '5'
+ Item: "5"
Section: 3.1.4
- Cited Guidance: >-
For character flags with variable names that end in FL and
@@ -53,13 +53,13 @@ Authorities:
1/null schemes apply to numeric flags with variable names that
end in FN and which are not population indicators.
Document: ADaM IG v1.2
- Item: '9'
+ Item: "9"
Section: 3.1.4
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '6'
- Version: '5.0'
- Version: '1.2'
+ Id: "6"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
@@ -68,7 +68,7 @@ Authorities:
(not included), 1 = yes (included). Null values are not
allowed.
Document: ADaM IG v1.1
- Item: '5'
+ Item: "5"
Section: 3.1.4
- Cited Guidance: >-
For character flags with variable names that end in FL and
@@ -79,13 +79,13 @@ Authorities:
flags with variable names that end in FN and that are not
population indicators.
Document: ADaM IG v1.1
- Item: '9'
+ Item: "9"
Section: 3.1.4
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '6'
- Version: '5.0'
- Version: '1.1'
+ Id: "6"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
@@ -95,7 +95,7 @@ Authorities:
allowed.
Document: ADaM IG v1.0
Item: 5 (General Flag Variable Conventions)
- Section: '3'
+ Section: "3"
- Cited Guidance: >-
For character flags with variable names that end in FL and
that are not population flags, a scheme of Y/N/null, or Y/null
@@ -106,12 +106,12 @@ Authorities:
population indicators.
Document: ADaM IG v1.0
Item: 9 (General Flag Variable Conventions)
- Section: '3'
+ Section: "3"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '6'
- Version: '5.0'
- Version: '1.0'
+ Id: "6"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: -- 'FN'
@@ -126,7 +126,7 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0006
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
'A variable with a suffix of FN must have a value that is not 0, 1 or null'
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0007/rule.yml b/Unpublished/ADAMIG/AD0007/rule.yml
index 9a75d5c77..38f2c0818 100644
--- a/Unpublished/ADAMIG/AD0007/rule.yml
+++ b/Unpublished/ADAMIG/AD0007/rule.yml
@@ -7,9 +7,9 @@ Authorities:
- Cited Guidance: >-
For subject-level numeric population flag variables':'' 0 = no
(not included), 1 = yes (included). Null values are not
- allowed.
+ allowed.
Document: ADaM IG v1.3
- Item: '5'
+ Item: "5"
Section: 3.1.4
- Cited Guidance: >-
For character flags with variable names that end in FL and
@@ -23,13 +23,13 @@ Authorities:
1/null schemes apply to numeric flags with variable names that
end in FN and which are not population indicators.
Document: ADaM IG v1.3
- Item: '9'
+ Item: "9"
Section: 3.1.4
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '7'
- Version: '5.0'
- Version: '1.3'
+ Id: "7"
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
@@ -39,7 +39,7 @@ Authorities:
(not included), 1 = yes (included). Null values are not
allowed.
Document: ADaM IG v1.2
- Item: '5'
+ Item: "5"
Section: 3.1.4
- Cited Guidance: >-
For character flags with variable names that end in FL and
@@ -53,13 +53,13 @@ Authorities:
1/null schemes apply to numeric flags with variable names that
end in FN and which are not population indicators.
Document: ADaM IG v1.2
- Item: '9'
+ Item: "9"
Section: 3.1.4
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '7'
- Version: '5.0'
- Version: '1.2'
+ Id: "7"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
@@ -68,7 +68,7 @@ Authorities:
(not included), 1 = yes (included). Null values are not
allowed.
Document: ADaM IG v1.1
- Item: '5'
+ Item: "5"
Section: 3.1.4
- Cited Guidance: >-
For character flags with variable names that end in FL and
@@ -79,13 +79,13 @@ Authorities:
flags with variable names that end in FN and that are not
population indicators.
Document: ADaM IG v1.1
- Item: '9'
+ Item: "9"
Section: 3.1.4
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '7'
- Version: '5.0'
- Version: '1.1'
+ Id: "7"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
@@ -95,7 +95,7 @@ Authorities:
allowed.
Document: ADaM IG v1.0
Item: 5 (General Flag Variable Conventions)
- Section: '3'
+ Section: "3"
- Cited Guidance: >-
For character flags with variable names that end in FL and
that are not population flags, a scheme of Y/N/null, or Y/null
@@ -106,12 +106,12 @@ Authorities:
population indicators.
Document: ADaM IG v1.0
Item: 9 (General Flag Variable Conventions)
- Section: '3'
+ Section: "3"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '7'
- Version: '5.0'
- Version: '1.0'
+ Id: "7"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: -- 'FN'
@@ -126,7 +126,7 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0007
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
'A variable with a suffix of FN must have a value that is not 0, 1 or null'
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0010/rule.yml b/Unpublished/ADAMIG/AD0010/rule.yml
index 7cf104079..1243397e5 100644
--- a/Unpublished/ADAMIG/AD0010/rule.yml
+++ b/Unpublished/ADAMIG/AD0010/rule.yml
@@ -7,10 +7,10 @@ Authorities:
- Cited Guidance: >-
For subject-level character population flag variables: N = no
(not included in the population), Y = yes (included). Null
- values are not allowed.
+ values are not allowed.
Document: ADaM IG v1.0
- Item: '4'
- Section: '3.1.4'
+ Item: "4"
+ Section: "3.1.4"
- Cited Guidance: >-
For character flags with variable names that end in FL and
that are not population flags, a scheme of Y/N/null, or Y/null
@@ -21,25 +21,25 @@ Authorities:
be analyzed differently. Y/null can be used when the need is
to analyze just the Y values. Corresponding 1/0/null and
1/null schemes apply to numeric flags with variable names that
- end in FN and which are not population indicators.
+ end in FN and which are not population indicators.
Document: ADaM IG v1.0
- Item: '9'
- Section: '3.1.4'
+ Item: "9"
+ Section: "3.1.4"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '10'
- Version: '5.0'
- Version: '1.3'
+ Id: "10"
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: >-
For subject-level character population flag variables: N = no
(not included in the population), Y = yes (included). Null
- values are not allowed.
+ values are not allowed.
Document: ADaM IG v1.0
- Item: '4'
- Section: '3.1.4'
+ Item: "4"
+ Section: "3.1.4"
- Cited Guidance: >-
For character flags with variable names that end in FL and
that are not population flags, a scheme of Y/N/null, or Y/null
@@ -50,25 +50,25 @@ Authorities:
be analyzed differently. Y/null can be used when the need is
to analyze just the Y values. Corresponding 1/0/null and
1/null schemes apply to numeric flags with variable names that
- end in FN and which are not population indicators.
+ end in FN and which are not population indicators.
Document: ADaM IG v1.0
- Item: '9'
- Section: '3.1.4'
+ Item: "9"
+ Section: "3.1.4"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '10'
- Version: '5.0'
- Version: '1.2'
+ Id: "10"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: >-
For subject-level character population flag variables: N = no
(not included in the population), Y = yes (included). Null
- values are not allowed.
+ values are not allowed.
Document: ADaM IG v1.0
- Item: '4'
- Section: '3.1.4'
+ Item: "4"
+ Section: "3.1.4"
- Cited Guidance: >-
For character flags with variable names that end in FL and
that are not population flags, a scheme of Y/N/null, or Y/null
@@ -76,68 +76,68 @@ Authorities:
3.3.8.1, some common character flags use the scheme Y/null.
Corresponding 1/0/null and 1/null schemes apply to numeric
flags with variable names that end in FN and that are not
- population indicators.
+ population indicators.
Document: ADaM IG v1.0
- Item: '9'
- Section: '3.1.4'
+ Item: "9"
+ Section: "3.1.4"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '10'
- Version: '5.0'
- Version: '1.1'
+ Id: "10"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: >-
For subject-level character population flag variables:N = no
(not included in the population), Y = yes (included). Null
- values are not allowed.
+ values are not allowed.
Document: ADaM IG v1.0
- Item: '4 (General Flag Variable Conventions):'
- Section: '3'
+ Item: "4 (General Flag Variable Conventions):"
+ Section: "3"
- Cited Guidance: >-
For subject-level character For character flags that are not
population flags, a scheme of Y/N/null, or Y/null may be
specified. As indicated in Table 3.2.6.1, some common
character flags use the scheme Y/null. Corresponding 1/0/null
and 1/null schemes apply to numeric flags that are not
- population indicators.
+ population indicators.
Document: ADaM IG v1.0
- Item: '9 (General Flag Variable Conventions):'
- Section: '3'
+ Item: "9 (General Flag Variable Conventions):"
+ Section: "3"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '10'
- Version: '5.0'
- Version: '1.0'
+ Id: "10"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: variable_name
operator: ends_with
- value: 'FL'
+ value: "FL"
- name: vatiable_value
operator: equal_to
- value: 'Y'
+ value: "Y"
- any:
- all:
- name: Root(variable_name)
operator: ends_with
- value: 'FN'
+ value: "FN"
- name: root(variable_value)
operator: not_equal_to
- value: '1'
- #
+ value: "1"
+ #
Core:
Id: CDSIC.ADaMIG.AD0010
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
'A variable with a suffix of FL is equal to Y and a variable with the same
root and a suffix of FN is not equal to 1'
Executability: Fully Executable
Outcome:
- Message: A variable with a suffix of FL is equal to Y and a variable with the
- same root and a suffix of FN is not equal to 1
+ Message: A variable with a suffix of FL is equal to Y and a variable with the same root and a
+ suffix of FN is not equal to 1
Output Variables:
- variable_name
diff --git a/Unpublished/ADAMIG/AD0013/rule.yml b/Unpublished/ADAMIG/AD0013/rule.yml
index 010449467..4dc1de43b 100644
--- a/Unpublished/ADAMIG/AD0013/rule.yml
+++ b/Unpublished/ADAMIG/AD0013/rule.yml
@@ -4,164 +4,156 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: In developing naming conventions, sponsors should consider the
- requirements noted in the eCTD guidance document as well as
- the need to conform to the SAS Transport format requirements
- (e.g., the total length of the name cannot exceed 8
- characters).
+ - Cited Guidance:
+ In developing naming conventions, sponsors should consider the requirements
+ noted in the eCTD guidance document as well as the need to conform to the SAS Transport
+ format requirements (e.g., the total length of the name cannot exceed 8 characters).
Document: Model v2.1
- Item: ''
+ Item: ""
Section: 4.1.2
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
- and Oracle constraints, all ADaM variable names must be no
- more than 8 characters in length, start with a letter (not
- underscore), and be composed only of letters (A-Z), underscore
- (_), and numerals (0-9). All ADaM variable labels must be no
- more than 40 characters in length. All ADaM character
- variables must be no more than 200 characters in length.
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format and Oracle
+ constraints, all ADaM variable names must be no more than 8 characters in length, start
+ with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and
+ numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All
+ ADaM character variables must be no more than 200 characters in length.
Document: ADaM IG v1.3
- Item: '1'
+ Item: "1"
Section: 3.1.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: '13'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "13"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '13'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "13"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: In developing naming conventions, sponsors should consider the
- requirements noted in the eCTD guidance document as well as
- the need to conform to the SAS Transport format requirements
- (e.g., the total length of the name cannot exceed 8
- characters).
+ - Cited Guidance:
+ In developing naming conventions, sponsors should consider the requirements
+ noted in the eCTD guidance document as well as the need to conform to the SAS Transport
+ format requirements (e.g., the total length of the name cannot exceed 8 characters).
Document: Model v2.1
- Item: ''
+ Item: ""
Section: 4.1.2
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
- and Oracle constraints, all ADaM variable names must be no
- more than 8 characters in length, start with a letter (not
- underscore), and be composed only of letters (A-Z), underscore
- (_), and numerals (0-9). All ADaM variable labels must be no
- more than 40 characters in length. All ADaM character
- variables must be no more than 200 characters in length.
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format and Oracle
+ constraints, all ADaM variable names must be no more than 8 characters in length, start
+ with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and
+ numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All
+ ADaM character variables must be no more than 200 characters in length.
Document: ADaM IG v1.2
- Item: '1'
+ Item: "1"
Section: Section 3.1.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: '13'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "13"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '13'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "13"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: In developing naming conventions, sponsors should consider the
- requirements noted in the eCTD guidance document as well as
- the need to conform to the SAS Transport format requirements
- (e.g., the total length of the name cannot exceed 8
- characters).
+ - Cited Guidance:
+ In developing naming conventions, sponsors should consider the requirements
+ noted in the eCTD guidance document as well as the need to conform to the SAS Transport
+ format requirements (e.g., the total length of the name cannot exceed 8 characters).
Document: Model v2.1
- Item: ''
+ Item: ""
Section: 4.1.2
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
- and Oracle constraints, all ADaM variable names must be no
- more than 8 characters in length, start with a letter (not
- underscore), and be composed only of letters (A-Z), underscore
- (_), and numerals (0-9). All ADaM variable labels must be no
- more than 40 characters in length. All ADaM character
- variables must be no more than 200 characters in length.
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format and Oracle
+ constraints, all ADaM variable names must be no more than 8 characters in length, start
+ with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and
+ numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All
+ ADaM character variables must be no more than 200 characters in length.
Document: ADaM IG v1.1
- Item: '1'
+ Item: "1"
Section: Section 3.1.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: '13'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "13"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '13'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "13"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: In developing naming conventions, sponsors should consider the
- requirements noted in the eCTD guidance document as well as
- the need to conform to the SAS Transport format requirements
- (e.g., the total length of the name cannot exceed 8
- characters).
+ - Cited Guidance:
+ In developing naming conventions, sponsors should consider the requirements
+ noted in the eCTD guidance document as well as the need to conform to the SAS Transport
+ format requirements (e.g., the total length of the name cannot exceed 8 characters).
Document: Model v2.1
- Item: ''
+ Item: ""
Section: 4.1.2
- - Cited Guidance: To ensure compliance with SAS Transport file and Oracle
- constraints, all ADaM variable names must be no more than 8
- characters in length, start with a letter (not underscore),
- and be comprised only of letters (A-Z), underscore (_), and
- numerals (0-9). All ADaM variable labels must be no more than
- 40 characters in length. All ADaM character variables must be
- no more than 200 characters in length.
+ - Cited Guidance:
+ To ensure compliance with SAS Transport file and Oracle constraints, all
+ ADaM variable names must be no more than 8 characters in length, start with a letter (not
+ underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9).
+ All ADaM variable labels must be no more than 40 characters in length. All ADaM character
+ variables must be no more than 200 characters in length.
Document: ADaM IG v1.0
Item: 5 (General Variable Naming Conventions)
- Section: '3'
+ Section: "3"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '13'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "13"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '13'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "13"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
@@ -172,8 +164,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0013
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: Variable name must be less than 8 charatcters
diff --git a/Unpublished/ADAMIG/AD0014/rule.yml b/Unpublished/ADAMIG/AD0014/rule.yml
index 55a70875c..7014b5140 100644
--- a/Unpublished/ADAMIG/AD0014/rule.yml
+++ b/Unpublished/ADAMIG/AD0014/rule.yml
@@ -1,263 +1,252 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'Model v2.1'
+ - Name: "Model v2.1"
References:
- Citations:
- - Cited Guidance: <- In developing naming conventions, sponsors should consider
- the requirements noted in the eCTD guidance document as well
- as the need to conform to the SAS Transport format
- requirements (e.g., the total length of the name cannot exceed
- 8 characters).
+ - Cited Guidance: <- In developing naming conventions, sponsors should consider the
+ requirements noted in the eCTD guidance document as well as the need to conform to the SAS
+ Transport format requirements (e.g., the total length of the name cannot exceed 8
+ characters).
Document: Model v2.1
- Item: ''
+ Item: ""
Section: 4.1.2
Criteria:
Logical Expression:
- Condition: ''
- Rule: '14'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "14"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '14'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "14"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
- and Oracle constraints, all ADaM variable names must be no
- more than 8 characters in length, start with a letter (not
- underscore), and be comprised only of letters (A-Z),
- underscore (_), and numerals (0-9). All ADaM variable labels
- must be no more than 40 characters in length. All ADaM
- character variables must be no more than 200 characters in
- length.
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format and Oracle
+ constraints, all ADaM variable names must be no more than 8 characters in length, start
+ with a letter (not underscore), and be comprised only of letters (A-Z), underscore (_),
+ and numerals (0-9). All ADaM variable labels must be no more than 40 characters in length.
+ All ADaM character variables must be no more than 200 characters in length.
Document: ADaMIG v1.3
- Item: '1'
- Section: '3.1.1'
+ Item: "1"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '14'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "14"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '14'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "14"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Organization: CDISC
Standards:
- - Name: 'Model v2.1'
+ - Name: "Model v2.1"
References:
- Citations:
- - Cited Guidance: <- In developing naming conventions, sponsors should consider
- the requirements noted in the eCTD guidance document as well
- as the need to conform to the SAS Transport format
- requirements (e.g., the total length of the name cannot exceed
- 8 characters).
+ - Cited Guidance: <- In developing naming conventions, sponsors should consider the
+ requirements noted in the eCTD guidance document as well as the need to conform to the SAS
+ Transport format requirements (e.g., the total length of the name cannot exceed 8
+ characters).
Document: Model v2.1
- Item: ''
+ Item: ""
Section: 4.1.2
Criteria:
Logical Expression:
- Condition: ''
- Rule: '14'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "14"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '14'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "14"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
- and Oracle constraints, all ADaM variable names must be no
- more than 8 characters in length, start with a letter (not
- underscore), and be comprised only of letters (A-Z),
- underscore (_), and numerals (0-9). All ADaM variable labels
- must be no more than 40 characters in length. All ADaM
- character variables must be no more than 200 characters in
- length.
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format and Oracle
+ constraints, all ADaM variable names must be no more than 8 characters in length, start
+ with a letter (not underscore), and be comprised only of letters (A-Z), underscore (_),
+ and numerals (0-9). All ADaM variable labels must be no more than 40 characters in length.
+ All ADaM character variables must be no more than 200 characters in length.
Document: ADaMIG v1.2
- Item: '1'
- Section: '3.1.1'
+ Item: "1"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '14'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "14"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '14'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "14"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Organization: CDISC
Standards:
- - Name: 'Model v2.1'
+ - Name: "Model v2.1"
References:
- Citations:
- - Cited Guidance: <- In developing naming conventions, sponsors should consider
- the requirements noted in the eCTD guidance document as well
- as the need to conform to the SAS Transport format
- requirements (e.g., the total length of the name cannot exceed
- 8 characters).
+ - Cited Guidance: <- In developing naming conventions, sponsors should consider the
+ requirements noted in the eCTD guidance document as well as the need to conform to the SAS
+ Transport format requirements (e.g., the total length of the name cannot exceed 8
+ characters).
Document: Model v2.1
- Item: ''
+ Item: ""
Section: 4.1.2
Criteria:
Logical Expression:
- Condition: ''
- Rule: '14'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "14"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '14'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "14"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
- and Oracle constraints, all ADaM variable names must be no
- more than 8 characters in length, start with a letter (not
- underscore), and be comprised only of letters (A-Z),
- underscore (_), and numerals (0-9). All ADaM variable labels
- must be no more than 40 characters in length. All ADaM
- character variables must be no more than 200 characters in
- length.
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format and Oracle
+ constraints, all ADaM variable names must be no more than 8 characters in length, start
+ with a letter (not underscore), and be comprised only of letters (A-Z), underscore (_),
+ and numerals (0-9). All ADaM variable labels must be no more than 40 characters in length.
+ All ADaM character variables must be no more than 200 characters in length.
Document: ADaMIG v1.1
- Item: '1'
- Section: '3.1.1'
+ Item: "1"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '14'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "14"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '14'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "14"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Organization: CDISC
Standards:
- - Name: 'Model v2.1'
+ - Name: "Model v2.1"
References:
- Citations:
- - Cited Guidance: <- In developing naming conventions, sponsors should consider
- the requirements noted in the eCTD guidance document as well
- as the need to conform to the SAS Transport format
- requirements (e.g., the total length of the name cannot exceed
- 8 characters).
+ - Cited Guidance: <- In developing naming conventions, sponsors should consider the
+ requirements noted in the eCTD guidance document as well as the need to conform to the SAS
+ Transport format requirements (e.g., the total length of the name cannot exceed 8
+ characters).
Document: Model v2.1
- Item: ''
+ Item: ""
Section: 4.1.2
Criteria:
Logical Expression:
- Condition: ''
- Rule: '14'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "14"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '14'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "14"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: To ensure compliance with SAS Transport file and Oracle
- constraints, all ADaM variable names must be no more than 8
- characters in length, start with a letter (not underscore),
- and be comprised only of letters (A-Z), underscore (_), and
- numerals (0-9). All ADaM variable labels must be no more than
- 40 characters in length. All ADaM character variables must be
- no more than 200 characters in length.8 characters).
+ - Cited Guidance:
+ To ensure compliance with SAS Transport file and Oracle constraints, all
+ ADaM variable names must be no more than 8 characters in length, start with a letter (not
+ underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9).
+ All ADaM variable labels must be no more than 40 characters in length. All ADaM character
+ variables must be no more than 200 characters in length.8 characters).
Document: ADaMIG v1.0
- Item: '5 (General Variable Naming Conventions)'
- Section: '3'
+ Item: "5 (General Variable Naming Conventions)"
+ Section: "3"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '14'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "14"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '14'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "14"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: variable_name
operator: not_prefix_matches_regex
prefix: 0
- value: '[A-Z]'
+ value: "[A-Z]"
Core:
Id: CDISC.ADaMIG.AD0014
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: A variable name does not start with a letter (A-Z)
diff --git a/Unpublished/ADAMIG/AD0016/rule.yml b/Unpublished/ADAMIG/AD0016/rule.yml
index a8de4537a..d52e831cf 100644
--- a/Unpublished/ADAMIG/AD0016/rule.yml
+++ b/Unpublished/ADAMIG/AD0016/rule.yml
@@ -4,164 +4,156 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: In developing naming conventions, sponsors should consider the
- requirements noted in the eCTD guidance document as well as
- the need to conform to the SAS Transport format requirements
- (e.g., the total length of the name cannot exceed 8
- characters).
+ - Cited Guidance:
+ In developing naming conventions, sponsors should consider the requirements
+ noted in the eCTD guidance document as well as the need to conform to the SAS Transport
+ format requirements (e.g., the total length of the name cannot exceed 8 characters).
Document: Model v2.1
- Item: ''
+ Item: ""
Section: 4.1.2
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
- and Oracle constraints, all ADaM variable names must be no
- more than 8 characters in length, start with a letter (not
- underscore), and be composed only of letters (A-Z), underscore
- (_), and numerals (0-9). All ADaM variable labels must be no
- more than 40 characters in length. All ADaM character
- variables must be no more than 200 characters in length.
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format and Oracle
+ constraints, all ADaM variable names must be no more than 8 characters in length, start
+ with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and
+ numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All
+ ADaM character variables must be no more than 200 characters in length.
Document: ADaM IG v1.3
- Item: '1'
+ Item: "1"
Section: 3.1.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: '16'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "16"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '16'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "16"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: In developing naming conventions, sponsors should consider the
- requirements noted in the eCTD guidance document as well as
- the need to conform to the SAS Transport format requirements
- (e.g., the total length of the name cannot exceed 8
- characters).
+ - Cited Guidance:
+ In developing naming conventions, sponsors should consider the requirements
+ noted in the eCTD guidance document as well as the need to conform to the SAS Transport
+ format requirements (e.g., the total length of the name cannot exceed 8 characters).
Document: Model v2.1
- Item: ''
+ Item: ""
Section: 4.1.2
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
- and Oracle constraints, all ADaM variable names must be no
- more than 8 characters in length, start with a letter (not
- underscore), and be composed only of letters (A-Z), underscore
- (_), and numerals (0-9). All ADaM variable labels must be no
- more than 40 characters in length. All ADaM character
- variables must be no more than 200 characters in length.
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format and Oracle
+ constraints, all ADaM variable names must be no more than 8 characters in length, start
+ with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and
+ numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All
+ ADaM character variables must be no more than 200 characters in length.
Document: ADaM IG v1.2
- Item: '1'
+ Item: "1"
Section: Section 3.1.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: '16'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "16"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '16'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "16"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: In developing naming conventions, sponsors should consider the
- requirements noted in the eCTD guidance document as well as
- the need to conform to the SAS Transport format requirements
- (e.g., the total length of the name cannot exceed 8
- characters).
+ - Cited Guidance:
+ In developing naming conventions, sponsors should consider the requirements
+ noted in the eCTD guidance document as well as the need to conform to the SAS Transport
+ format requirements (e.g., the total length of the name cannot exceed 8 characters).
Document: Model v2.1
- Item: ''
+ Item: ""
Section: 4.1.2
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
- and Oracle constraints, all ADaM variable names must be no
- more than 8 characters in length, start with a letter (not
- underscore), and be composed only of letters (A-Z), underscore
- (_), and numerals (0-9). All ADaM variable labels must be no
- more than 40 characters in length. All ADaM character
- variables must be no more than 200 characters in length.
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format and Oracle
+ constraints, all ADaM variable names must be no more than 8 characters in length, start
+ with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and
+ numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All
+ ADaM character variables must be no more than 200 characters in length.
Document: ADaM IG v1.1
- Item: '1'
+ Item: "1"
Section: Section 3.1.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: '16'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "16"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '16'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "16"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: In developing naming conventions, sponsors should consider the
- requirements noted in the eCTD guidance document as well as
- the need to conform to the SAS Transport format requirements
- (e.g., the total length of the name cannot exceed 8
- characters).
+ - Cited Guidance:
+ In developing naming conventions, sponsors should consider the requirements
+ noted in the eCTD guidance document as well as the need to conform to the SAS Transport
+ format requirements (e.g., the total length of the name cannot exceed 8 characters).
Document: Model v2.1
- Item: ''
+ Item: ""
Section: 4.1.2
- - Cited Guidance: To ensure compliance with SAS Transport file and Oracle
- constraints, all ADaM variable names must be no more than 8
- characters in length, start with a letter (not underscore),
- and be comprised only of letters (A-Z), underscore (_), and
- numerals (0-9). All ADaM variable labels must be no more than
- 40 characters in length. All ADaM character variables must be
- no more than 200 characters in length.
+ - Cited Guidance:
+ To ensure compliance with SAS Transport file and Oracle constraints, all
+ ADaM variable names must be no more than 8 characters in length, start with a letter (not
+ underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9).
+ All ADaM variable labels must be no more than 40 characters in length. All ADaM character
+ variables must be no more than 200 characters in length.
Document: ADaM IG v1.0
Item: 5 (General Variable Naming Conventions)
- Section: '3'
+ Section: "3"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '16'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "16"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '16'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "16"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
@@ -171,8 +163,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0016
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: Label must be less than 40 charatcters
diff --git a/Unpublished/ADAMIG/AD0017/rule.yml b/Unpublished/ADAMIG/AD0017/rule.yml
index ea0e5fe14..aec12f34a 100644
--- a/Unpublished/ADAMIG/AD0017/rule.yml
+++ b/Unpublished/ADAMIG/AD0017/rule.yml
@@ -4,126 +4,117 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: In developing naming conventions, sponsors should consider the
- requirements noted in the eCTD guidance document as well as
- the need to conform to the SAS Transport format requirements
- (e.g., the total length of the name cannot exceed 8
- characters).
+ - Cited Guidance:
+ In developing naming conventions, sponsors should consider the requirements
+ noted in the eCTD guidance document as well as the need to conform to the SAS Transport
+ format requirements (e.g., the total length of the name cannot exceed 8 characters).
Document: Model v2.1
- Item: '1'
+ Item: "1"
Section: 4.1.2
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
- and Oracle constraints, all ADaM variable names must be no
- more than 8 characters in length, start with a letter (not
- underscore), and be composed only of letters (A-Z), underscore
- (_), and numerals (0-9). All ADaM variable labels must be no
- more than 40 characters in length. All ADaM character
- variables must be no more than 200 characters in length.
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format and Oracle
+ constraints, all ADaM variable names must be no more than 8 characters in length, start
+ with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and
+ numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All
+ ADaM character variables must be no more than 200 characters in length.
Document: ADaM IG v1.3
- Item: '1'
+ Item: "1"
Section: 3.1.1
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '17'
- Version: '1'
- Version: '5.0'
- Version: '1.3'
+ Id: "17"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: In developing naming conventions, sponsors should consider the
- requirements noted in the eCTD guidance document as well as
- the need to conform to the SAS Transport format requirements
- (e.g., the total length of the name cannot exceed 8
- characters).
+ - Cited Guidance:
+ In developing naming conventions, sponsors should consider the requirements
+ noted in the eCTD guidance document as well as the need to conform to the SAS Transport
+ format requirements (e.g., the total length of the name cannot exceed 8 characters).
Document: Model v2.1
- Item: '1'
+ Item: "1"
Section: 4.1.2
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
- and Oracle constraints, all ADaM variable names must be no
- more than 8 characters in length, start with a letter (not
- underscore), and be composed only of letters (A-Z), underscore
- (_), and numerals (0-9). All ADaM variable labels must be no
- more than 40 characters in length. All ADaM character
- variables must be no more than 200 characters in length.''
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format and Oracle
+ constraints, all ADaM variable names must be no more than 8 characters in length, start
+ with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and
+ numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All
+ ADaM character variables must be no more than 200 characters in length.''
Document: ADaM IG v1.2
- Item: '1'
+ Item: "1"
Section: 3.1.1
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '17'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "17"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: In developing naming conventions, sponsors should consider the
- requirements noted in the eCTD guidance document as well as
- the need to conform to the SAS Transport format requirements
- (e.g., the total length of the name cannot exceed 8
- characters).
+ - Cited Guidance:
+ In developing naming conventions, sponsors should consider the requirements
+ noted in the eCTD guidance document as well as the need to conform to the SAS Transport
+ format requirements (e.g., the total length of the name cannot exceed 8 characters).
Document: Model v2.1
- Item: '1'
+ Item: "1"
Section: 4.1.2
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
- and Oracle constraints, all ADaM variable names must be no
- more than 8 characters in length, start with a letter (not
- underscore), and be composed only of letters (A-Z), underscore
- (_), and numerals (0-9). All ADaM variable labels must be no
- more than 40 characters in length. All ADaM character
- variables must be no more than 200 characters in length.
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format and Oracle
+ constraints, all ADaM variable names must be no more than 8 characters in length, start
+ with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and
+ numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All
+ ADaM character variables must be no more than 200 characters in length.
Document: ADaM IG v1.1
- Item: '1'
+ Item: "1"
Section: 3.1.1
- - Cited Guidance: In developing naming conventions, sponsors should consider the
- requirements noted in the eCTD guidance document as well as
- the need to conform to the SAS Transport format requirements
- (e.g., the total length of the name cannot exceed 8
- characters).
+ - Cited Guidance:
+ In developing naming conventions, sponsors should consider the requirements
+ noted in the eCTD guidance document as well as the need to conform to the SAS Transport
+ format requirements (e.g., the total length of the name cannot exceed 8 characters).
Document: Model v2.1
- Item: '1'
+ Item: "1"
Section: 4.1.2
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '17'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "17"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: In developing naming conventions, sponsors should consider the
- requirements noted in the eCTD guidance document as well as
- the need to conform to the SAS Transport format requirements
- (e.g., the total length of the name cannot exceed 8
- characters).
+ - Cited Guidance:
+ In developing naming conventions, sponsors should consider the requirements
+ noted in the eCTD guidance document as well as the need to conform to the SAS Transport
+ format requirements (e.g., the total length of the name cannot exceed 8 characters).
Document: Model v2.1
- Item: '1'
+ Item: "1"
Section: 4.1.2
- - Cited Guidance: To ensure compliance with SAS Transport file and Oracle
- constraints, all ADaM variable names must be no more than 8
- characters in length, start with a letter (not underscore),
- and be comprised only of letters (A-Z), underscore (_), and
- numerals (0-9). All ADaM variable labels must be no more than
- 40 characters in length. All ADaM character variables must be
- no more than 200 characters in length
+ - Cited Guidance:
+ To ensure compliance with SAS Transport file and Oracle constraints, all
+ ADaM variable names must be no more than 8 characters in length, start with a letter (not
+ underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9).
+ All ADaM variable labels must be no more than 40 characters in length. All ADaM character
+ variables must be no more than 200 characters in length
Document: ADaM IG v1.0
Item: 5 (General Variable Naming Conventions)':'
- Section: '3'
+ Section: "3"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '17'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "17"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- - name: variable_data_type # ariable_value to work with other rule types than value metadata check against the define-xml #895
+ - name: variable_data_type # ariable_value to work with other rule types than value metadata check against the define-xml #895
operator: equal_to
value: char
- name: variable_value
@@ -132,7 +123,7 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0017
Status: Draft
- Version: '1'
+ Version: "1"
Description: Variable Value must not be greather than 200 characters long
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/ADAMIG/AD0019/rule.yml b/Unpublished/ADAMIG/AD0019/rule.yml
index 7f391489e..56ea16041 100644
--- a/Unpublished/ADAMIG/AD0019/rule.yml
+++ b/Unpublished/ADAMIG/AD0019/rule.yml
@@ -2,65 +2,65 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '19'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.3
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
Population Indicator(s) have a Codelist / Controlled Term value
of "Y, N".
+ Document: ADaM IG v1.3
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "19"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '19'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.2
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
Population Indicator(s) have a Codelist / Controlled Term value
of "Y, N".
+ Document: ADaM IG v1.2
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "19"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '19'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.1
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
Population Indicator(s) have a Codelist / Controlled Term value
of "Y, N".
+ Document: ADaM IG v1.1
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "19"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '19'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.0
- Section: '3.1'
- Item: Table 3.1.1
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
Population Indicator(s) have a Codelist / Controlled Term value
of "Y, N".
+ Document: ADaM IG v1.0
+ Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "19"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: COMPLFL
@@ -73,7 +73,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0019
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
Raise an error when COMPLFL is present and has a value that is not Y or N
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0020/rule.yml b/Unpublished/ADAMIG/AD0020/rule.yml
index b55b41df5..e3054806b 100644
--- a/Unpublished/ADAMIG/AD0020/rule.yml
+++ b/Unpublished/ADAMIG/AD0020/rule.yml
@@ -2,65 +2,65 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '20'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.3
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.3
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "20"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '20'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.2
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.2
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "20"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '20'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.1
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.1
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "20"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '20'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.0
- Section: '3.1'
- Item: Table 3.1.1
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.0
+ Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "20"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: FASFL
@@ -73,7 +73,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0020
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
Raise an error when FASFL is present and has a value that is not Y or N
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0021/rule.yml b/Unpublished/ADAMIG/AD0021/rule.yml
index 2a28ff35f..585c76566 100644
--- a/Unpublished/ADAMIG/AD0021/rule.yml
+++ b/Unpublished/ADAMIG/AD0021/rule.yml
@@ -2,65 +2,65 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '21'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.3
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.3
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "21"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '21'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.2
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.2
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "21"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '21'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.1
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.1
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "21"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '21'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.0
- Section: '3.1'
- Item: Table 3.1.1
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.0
+ Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "21"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: ITTFL
@@ -73,7 +73,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0021
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
Raise an error when ITTFL is present and has a value that is not Y or N
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0022/rule.yml b/Unpublished/ADAMIG/AD0022/rule.yml
index fa816dd42..4a84003a4 100644
--- a/Unpublished/ADAMIG/AD0022/rule.yml
+++ b/Unpublished/ADAMIG/AD0022/rule.yml
@@ -2,65 +2,65 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '22'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.3
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.3
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "22"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '22'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.2
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.2
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "22"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '22'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.1
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.1
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "22"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '22'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.0
- Section: '3.1'
- Item: Table 3.1.1
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.0
+ Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "22"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: PPROTFL
@@ -73,7 +73,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0022
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
Raise an error when PPROTFL is present and has a value that is not Y or N
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0023/rule.yml b/Unpublished/ADAMIG/AD0023/rule.yml
index eb23ea21e..11580d524 100644
--- a/Unpublished/ADAMIG/AD0023/rule.yml
+++ b/Unpublished/ADAMIG/AD0023/rule.yml
@@ -2,65 +2,65 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '23'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.3
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.3
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "23"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '23'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.2
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.2
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "23"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '23'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.1
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.1
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "23"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '23'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.0
- Section: '3.1'
- Item: Table 3.1.1
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.0
+ Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "23"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: SAFFL
@@ -73,7 +73,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0023
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
Raise an error when SAFFL is present and has a value that is not Y or N
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0024/rule.yml b/Unpublished/ADAMIG/AD0024/rule.yml
index 1142a9405..2d401eb5c 100644
--- a/Unpublished/ADAMIG/AD0024/rule.yml
+++ b/Unpublished/ADAMIG/AD0024/rule.yml
@@ -2,65 +2,65 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '24'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.3
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.3
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "24"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '24'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.2
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.2
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "24"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '24'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.1
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.1
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "24"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '24'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.0
- Section: '3.1'
- Item: Table 3.1.1
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.0
+ Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "24"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: RANDFL
@@ -73,7 +73,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0024
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
Raise an error when RANDFL is present and has a value that is not Y or N
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0025/rule.yml b/Unpublished/ADAMIG/AD0025/rule.yml
index 1fa687b7f..6c95bd226 100644
--- a/Unpublished/ADAMIG/AD0025/rule.yml
+++ b/Unpublished/ADAMIG/AD0025/rule.yml
@@ -2,65 +2,65 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '25'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.3
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.3
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "25"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '25'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.2
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.2
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "25"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '25'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.1
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.1
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "25"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '25'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.0
- Section: '3.1'
- Item: Table 3.1.1
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s)
have a Codelist / Controlled Term value of "Y, N".
+ Document: ADaM IG v1.0
+ Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "25"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: ENRLFL
@@ -73,7 +73,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0025
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
Raise an error when ENRLFL is present and has a value that is not Y or N
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0026/rule.yml b/Unpublished/ADAMIG/AD0026/rule.yml
index d36f1dd88..fe1a260b8 100644
--- a/Unpublished/ADAMIG/AD0026/rule.yml
+++ b/Unpublished/ADAMIG/AD0026/rule.yml
@@ -2,69 +2,69 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '26'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.3
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.3
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "26"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '26'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.2
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.2
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "26"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '26'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.1
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.1
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "26"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '26'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.0
- Section: '3.1'
- Item: Table 3.1.1
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN) can also
be included.
+ Document: ADaM IG v1.0
+ Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "26"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: COMPLFN
@@ -77,7 +77,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0026
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
Raise an error when COMPLFN is present and has a value that is not 1 or 0
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0027/rule.yml b/Unpublished/ADAMIG/AD0027/rule.yml
index 526d7c286..0ed3a31c4 100644
--- a/Unpublished/ADAMIG/AD0027/rule.yml
+++ b/Unpublished/ADAMIG/AD0027/rule.yml
@@ -2,69 +2,69 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '27'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.3
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.3
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "27"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '27'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.2
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.2
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "27"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '27'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.1
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.1
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "27"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '27'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.0
- Section: '3.1'
- Item: Table 3.1.1
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN) can also
be included.
+ Document: ADaM IG v1.0
+ Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "27"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: FASFN
@@ -77,7 +77,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0027
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
Raise an error when FASFN is present and has a value that is not 1 or 0
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0028/rule.yml b/Unpublished/ADAMIG/AD0028/rule.yml
index 12e00411a..cf50eecb5 100644
--- a/Unpublished/ADAMIG/AD0028/rule.yml
+++ b/Unpublished/ADAMIG/AD0028/rule.yml
@@ -2,69 +2,69 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '28'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.3
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.3
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "28"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '28'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.2
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.2
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "28"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '28'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.1
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.1
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "28"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '28'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.0
- Section: '3.1'
- Item: Table 3.1.1
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN) can also
be included.
+ Document: ADaM IG v1.0
+ Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "28"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: ITTFN
@@ -77,7 +77,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0028
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
Raise an error when ITTFN is present and has a value that is not 1 or 0
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0029/rule.yml b/Unpublished/ADAMIG/AD0029/rule.yml
index 488eee9ee..3b8e3a7ff 100644
--- a/Unpublished/ADAMIG/AD0029/rule.yml
+++ b/Unpublished/ADAMIG/AD0029/rule.yml
@@ -2,69 +2,69 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '29'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.3
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.3
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "29"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '29'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.2
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.2
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "29"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '29'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.1
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.1
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "29"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '29'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.0
- Section: '3.1'
- Item: Table 3.1.1
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN) can also
be included.
+ Document: ADaM IG v1.0
+ Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "29"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: PPROTFN
@@ -77,7 +77,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0029
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
Raise an error when PPROTFN is present and has a value that is not 1 or 0
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0030/rule.yml b/Unpublished/ADAMIG/AD0030/rule.yml
index ca63695cb..adc78b77d 100644
--- a/Unpublished/ADAMIG/AD0030/rule.yml
+++ b/Unpublished/ADAMIG/AD0030/rule.yml
@@ -2,69 +2,69 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '30'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.3
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.3
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "30"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '30'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.2
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.2
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "30"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '30'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.1
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.1
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "30"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '30'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.0
- Section: '3.1'
- Item: Table 3.1.1
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN) can also
be included.
+ Document: ADaM IG v1.0
+ Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "30"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: SAFFN
@@ -77,7 +77,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0030
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
Raise an error when SAFFN is present and has a value that is not 1 or 0
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0031/rule.yml b/Unpublished/ADAMIG/AD0031/rule.yml
index e734df469..1aaeb7c90 100644
--- a/Unpublished/ADAMIG/AD0031/rule.yml
+++ b/Unpublished/ADAMIG/AD0031/rule.yml
@@ -2,69 +2,69 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '31'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.3
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.3
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "31"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '31'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.2
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.2
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "31"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '31'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.1
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.1
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "31"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '31'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.0
- Section: '3.1'
- Item: Table 3.1.1
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN) can also
be included.
+ Document: ADaM IG v1.0
+ Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "31"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: RANDFN
@@ -77,7 +77,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0031
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
Raise an error when RANDFN is present and has a value that is not 1 or 0
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0032/rule.yml b/Unpublished/ADAMIG/AD0032/rule.yml
index 9d4404dd8..43f6447e3 100644
--- a/Unpublished/ADAMIG/AD0032/rule.yml
+++ b/Unpublished/ADAMIG/AD0032/rule.yml
@@ -2,69 +2,69 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '32'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.3
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.3
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "32"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '32'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.2
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.2
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "32"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '32'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.1
- Section: '3.2'
- Item: Table 3.2.3
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN, where 0=No
and 1=Yes) of the population flag can also be included.
+ Document: ADaM IG v1.1
+ Item: Table 3.2.3
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "32"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '32'
- Version: '1'
- Version: '4.0'
- Citations:
- - Document: ADaM IG v1.0
- Section: '3.1'
- Item: Table 3.1.1
- Cited Guidance: >-
+ - Citations:
+ - Cited Guidance: >-
The values of subject-level population flags cannot be blank. If
a flag is used, the corresponding numeric version (*FN) can also
be included.
+ Document: ADaM IG v1.0
+ Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "32"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: ENRLFN
@@ -77,7 +77,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0032
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
Raise an error when ENRLFN is present and has a value that is not 1 or 0
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0039/rule.yml b/Unpublished/ADAMIG/AD0039/rule.yml
index a06dbf705..6ea2e6ae5 100644
--- a/Unpublished/ADAMIG/AD0039/rule.yml
+++ b/Unpublished/ADAMIG/AD0039/rule.yml
@@ -2,20 +2,10 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADAMIG
- Version: '1.3'
References:
- # Origin for ADaM/ADaMIG should be defined in yaml validation schema
- - Origin: ADaM and ADaMIG Conformance Rules
- Rule Identifier:
- Id: AD0039
- Version: '1'
- # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema
- Version: '4.0'
- Citations:
- - Document: IG v1.3
- Section: 3.1.3
- Item: '1'
- Cited Guidance: >-
+ # Origin for ADaM/ADaMIG should be defined in yaml validation schema
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.3, Section 3.1.3, Item 1: As described in Table 3.1.5.1,
variables whose names end in DTF are date imputation flags. *DTF
variables represent the
@@ -28,25 +18,36 @@ Authorities:
*TMF may be needed to describe the level of imputation in *DTM if
imputation was done. Note that the list of examples in
Table 3.1.3.1 is not exhaustive.
+ Document: IG v1.3
+ Item: "1"
+ Section: 3.1.3
+ Origin: ADaM and ADaMIG Conformance Rules
+ Rule Identifier:
+ Id: AD0039
+ Version:
+ "1"
+ # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema
+ Version: "4.0"
+ Version: "1.3"
Check:
all:
-# - name: "variable_name"
-# operator: matches_regex
-# value: ^[A-Z][A-Z0-9]{0,4}DTF$
-# - name: "variable_name"
-# operator: non_empty
+ # - name: "variable_name"
+ # operator: matches_regex
+ # value: ^[A-Z][A-Z0-9]{0,4}DTF$
+ # - name: "variable_name"
+ # operator: non_empty
- name: ADTF
operator: does_not_use_valid_codelist_terms
value: DATEFL
Core:
# Need to make yaml validation accept ADAMIG
- # Will we need to prepend ADaM rules with "AD0..."?
+ # Will we need to prepend ADaM rules with "AD0..."?
# (column "Check Number" in ADaM_Conformance_Rules_v4.0 is 1-3 digits only, some with a ",1" (e.g. "37,01") )
Id: CDISC.ADAMIG.AD0039
Status: Draft
- Version: '1'
-Description: Raise an error when a variable ends with DTF and values are not according
- to the DATEFL controlled terminology codelist
+ Version: "1"
+Description: Raise an error when a variable ends with DTF and values are not according to the DATEFL
+ controlled terminology codelist
Outcome:
Message: The values of ADTF are not following the DATEFL codelist
Output Variables:
diff --git a/Unpublished/ADAMIG/AD0041/rule.yml b/Unpublished/ADAMIG/AD0041/rule.yml
index 8422bd2e3..0e81acde4 100644
--- a/Unpublished/ADAMIG/AD0041/rule.yml
+++ b/Unpublished/ADAMIG/AD0041/rule.yml
@@ -7,20 +7,20 @@ Authorities:
- Cited Guidance: >-
Numeric date, time, and datetime variables should be
formatted, so as to be human-readable with no loss of
- precision.
+ precision.
Document: IG v1.3
- Item: '1'
+ Item: "1"
Section: 3.1.2
- Cited Guidance: >-
- Variables whose names end in DT are numeric dates.
+ Variables whose names end in DT are numeric dates.
Document: IG v1.3
- Item: '2'
+ Item: "2"
Section: 3.1.2
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '41'
- Version: '5.0'
- Version: '1.3'
+ Id: "41"
+ Version: "5.0"
+ Version: "1.3"
Check:
#1. check variable type is numeric 2. has suffix DT 3. has date format (look up list?)
all:
@@ -30,17 +30,17 @@ Check:
operator: ends_with
value: DT
- name: variable_name #3
- operator: does_not_use_valid_format_terms #need to be able to extract metadata from xpt and read format from unit test data: add row call format under each column
+ operator: does_not_use_valid_format_terms #need to be able to extract metadata from xpt and read format from unit test data: add row call format under each column
Core:
Id: CDISC.ADAMIG.AD0041
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when a variable ends with DT and does not have a date format #list of all valid date format available?
Outcome:
Message: Value of --DT do not have a date format #human readable as per guidance then could define a list of acceptable formats?
#Output Variables:
- # - --DT
+ # - --DT
#wildcard bing used
Rule Type: Record Data
Scope:
diff --git a/Unpublished/ADAMIG/AD0046/rule.yml b/Unpublished/ADAMIG/AD0046/rule.yml
index b64337131..d04db26a9 100644
--- a/Unpublished/ADAMIG/AD0046/rule.yml
+++ b/Unpublished/ADAMIG/AD0046/rule.yml
@@ -10,13 +10,13 @@ Authorities:
create a relative day variable that includes day 0, then its
name must not end in DY.
Document: ADAM IG v1.3
- Item: '8'
+ Item: "8"
Section: 3.1.2
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '46'
- Version: '5.0'
- Version: '1.3'
+ Id: "46"
+ Version: "5.0"
+ Version: "1.3"
- Name: ADAMIG
References:
- Citations:
@@ -26,13 +26,13 @@ Authorities:
is a need to create a relative day variable that includes day
0, then its name must not end in DY.
Document: ADAM IG v1.2
- Item: '8'
+ Item: "8"
Section: 3.1.2
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '46'
- Version: '5.0'
- Version: '1.2'
+ Id: "46"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADAMIG
References:
@@ -43,13 +43,13 @@ Authorities:
create a relative day variable that includes day 0, then its
name must not end in DY.
Document: ADAM IG v1.1
- Item: '8'
+ Item: "8"
Section: 3.1.2
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '46'
- Version: '5.0'
- Version: '1.1'
+ Id: "46"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADAMIG
References:
@@ -63,19 +63,19 @@ Authorities:
anchor date then the anchor date used must be stored in an
ADaM dataset.
Document: ADAM IG v1.0
- Item: '8 (General Timing Variable Conventions)'
- Section: '3'
+ Item: "8 (General Timing Variable Conventions)"
+ Section: "3"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '46'
- Version: '5.0'
- Version: '1.0'
+ Id: "46"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: variable_name
operator: ends_with
- value: 'DY'
+ value: "DY"
# - name: variable_name
# operator: equal_to
# value: 0
@@ -83,7 +83,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0046
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when a variable ends with DY and has value equl to 0
Outcome:
Message: Value of 0 is not permitted with variable ending with suffix DY
diff --git a/Unpublished/ADAMIG/AD0047/rule.yml b/Unpublished/ADAMIG/AD0047/rule.yml
index 285f3baab..f9ccce22a 100644
--- a/Unpublished/ADAMIG/AD0047/rule.yml
+++ b/Unpublished/ADAMIG/AD0047/rule.yml
@@ -2,57 +2,57 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- - Origin: ADaM Conformance Rules
- Version: '4.0'
- Rule Identifier:
- Id: '47'
- Version: '1'
- Citations:
+ - Citations:
- Cited Guidance: SITEID has Core=Req.
Document: ADaM IG v1.3
- Section: '3.2'
Item: Table 3.2.1
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "47"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
- Version: '1.2'
References:
- - Origin: ADaM Conformance Rules
- Version: '4.0'
- Rule Identifier:
- Id: '47'
- Version: '1'
- Citations:
+ - Citations:
- Cited Guidance: SITEID has Core=Req.
Document: ADaM IG v1.2
- Section: '3.2'
Item: Table 3.2.1
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "47"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
- Version: '1.1'
References:
- - Origin: ADaM Conformance Rules
- Version: '4.0'
- Rule Identifier:
- Id: '47'
- Version: '1'
- Citations:
+ - Citations:
- Cited Guidance: SITEID has Core=Req.
Document: ADaM IG v1.1
- Section: '3.2'
Item: Table 3.2.1
+ Section: "3.2"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "47"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
- Version: '1.0'
References:
- - Origin: ADaM Conformance Rules
- Version: '4.0'
- Rule Identifier:
- Id: '47'
- Version: '1'
- Citations:
+ - Citations:
- Cited Guidance: SITEID has Core=Req.
Document: ADaM IG v1.0
- Section: '3.1'
Item: Table 3.1.1
+ Section: "3.1"
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "47"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: SITEID
@@ -60,7 +60,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0047
Status: Draft
- Version: '1'
+ Version: "1"
Description: Variable SITEID should be present in dataset ADSL
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/ADAMIG/AD0049/rule.yml b/Unpublished/ADAMIG/AD0049/rule.yml
index 170b965eb..51d9a5c12 100644
--- a/Unpublished/ADAMIG/AD0049/rule.yml
+++ b/Unpublished/ADAMIG/AD0049/rule.yml
@@ -7,72 +7,72 @@ Authorities:
- Cited Guidance: AGE has Core=Req
Document: ADaMIG
Item: Table 3.1.1
- Section: '3.1'
+ Section: "3.1"
Criteria:
- Plain Language Expression: ''
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '49'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "49"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: AGE has Core=Req
Document: ADaMIG
Item: Table 3.2.2
- Section: '3.2'
+ Section: "3.2"
Criteria:
- Plain Language Expression: ''
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '49'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "49"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: AGE has Core=Req
Document: ADaMIG
Item: Table 3.2.2
- Section: '3.2'
+ Section: "3.2"
Criteria:
- Plain Language Expression: ''
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '49'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "49"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: AGE has Core=Req
Document: ADaMIG
Item: Table 3.2.2
- Section: '3.2'
+ Section: "3.2"
Criteria:
- Plain Language Expression: ''
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '49'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "49"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
- name: AGE
@@ -80,7 +80,7 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0049
Status: Draft
- Version: '1'
+ Version: "1"
Description: Variable AGE must be present in dataset ADSL
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/ADAMIG/AD0050/rule.yml b/Unpublished/ADAMIG/AD0050/rule.yml
index eb2772a6a..fa390f57b 100644
--- a/Unpublished/ADAMIG/AD0050/rule.yml
+++ b/Unpublished/ADAMIG/AD0050/rule.yml
@@ -6,85 +6,85 @@ Authorities:
- Citations:
- Cited Guidance: AGEU has Core=Req
Document: ADaMIG
- Item: 'Table 3.1.1'
- Section: '3.1'
+ Item: "Table 3.1.1"
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '50'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "50"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: AGEU has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.2'
- Section: '3.2'
+ Item: "Table 3.2.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '50'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "50"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: AGEU has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.2'
- Section: '3.2'
+ Item: "Table 3.2.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '50'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "50"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: AGEU has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.2'
- Section: '3.2'
+ Item: "Table 3.2.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '50'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "50"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -93,8 +93,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD050
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: AGEU is not present in ADSL
diff --git a/Unpublished/ADAMIG/AD0051/rule.yml b/Unpublished/ADAMIG/AD0051/rule.yml
index e23da604d..390bc1568 100644
--- a/Unpublished/ADAMIG/AD0051/rule.yml
+++ b/Unpublished/ADAMIG/AD0051/rule.yml
@@ -6,85 +6,85 @@ Authorities:
- Citations:
- Cited Guidance: SEX has Core=Req
Document: ADaMIG
- Item: 'Table 3.1.1'
- Section: '3.1'
+ Item: "Table 3.1.1"
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '51'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "51"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: SEX has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.2'
- Section: '3.2'
+ Item: "Table 3.2.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '51'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "51"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: SEX has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.2'
- Section: '3.2'
+ Item: "Table 3.2.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '51'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "51"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: SEX has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.2'
- Section: '3.2'
+ Item: "Table 3.2.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '51'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "51"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -93,8 +93,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD051
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SEX is not present in ADSL
diff --git a/Unpublished/ADAMIG/AD0052/rule.yml b/Unpublished/ADAMIG/AD0052/rule.yml
index 466fbe8a8..91d1db3e2 100644
--- a/Unpublished/ADAMIG/AD0052/rule.yml
+++ b/Unpublished/ADAMIG/AD0052/rule.yml
@@ -6,85 +6,85 @@ Authorities:
- Citations:
- Cited Guidance: RACE has Core=Req
Document: ADaMIG
- Item: 'Table 3.1.1'
- Section: '3.1'
+ Item: "Table 3.1.1"
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '52'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "52"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: RACE has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.2'
- Section: '3.2'
+ Item: "Table 3.2.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '52'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "52"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: RACE has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.2'
- Section: '3.2'
+ Item: "Table 3.2.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '52'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "52"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: RACE has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.2'
- Section: '3.2'
+ Item: "Table 3.2.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '52'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "52"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -93,8 +93,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD052
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: RACE is not present in ADSL
diff --git a/Unpublished/ADAMIG/AD0053/rule.yml b/Unpublished/ADAMIG/AD0053/rule.yml
index 6837b74bf..a5f16aca7 100644
--- a/Unpublished/ADAMIG/AD0053/rule.yml
+++ b/Unpublished/ADAMIG/AD0053/rule.yml
@@ -2,26 +2,27 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
References:
- # Origin for ADaM/ADaMIG should be defined in yaml validation schema
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: '53'
- Version: '1'
- # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema
- Version: '4.0'
- Citations:
- - Document: IG v1.3
- Section: 3.1.1
- Item: '3'
- Cited Guidance: >-
+ # Origin for ADaM/ADaMIG should be defined in yaml validation schema
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.3, Section 3.1.1, Item 3: Any variable in an ADaM dataset
whose name is the same as an SDTM variable must be a copy of the
SDTM variable,
and its label, meaning, and values must not be modified. ADaM adheres
to a principle of harmonization known as "same name, same meaning,
same values."
+ Document: IG v1.3
+ Item: "3"
+ Section: 3.1.1
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: "53"
+ Version:
+ "1"
+ # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema
+ Version: "4.0"
+ Version: "1.3"
Check:
all:
- name: USUBJID
@@ -29,18 +30,18 @@ Check:
value: $dm_usubjid
Core:
# Need to make yaml validation accept ADAMIG
- # Will we need to prepend ADaM rules with "AD0..."?
+ # Will we need to prepend ADaM rules with "AD0..."?
# (column "Check Number" in ADaM_Conformance_Rules_v4.0 is 1-3 digits only, some with a ",1" (e.g. "37,01") )
Id: CDISC.ADAMIG.AD0053
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when the values of USUBJID are not present in SDTM.DM
Executability: Fully Executable
Operations:
- - operator: distinct
- domain: DM
- name: USUBJID
+ - domain: DM
id: $dm_usubjid
+ name: USUBJID
+ operator: distinct
Outcome:
Message: The values of USUBJID are not present in SDTM.DM
Output Variables:
diff --git a/Unpublished/ADAMIG/AD0070/rule.yml b/Unpublished/ADAMIG/AD0070/rule.yml
index 86357b543..c7863136c 100644
--- a/Unpublished/ADAMIG/AD0070/rule.yml
+++ b/Unpublished/ADAMIG/AD0070/rule.yml
@@ -8,13 +8,13 @@ Authorities:
the secondary variable of the variable pair cannot be present
in the dataset unless the primary variable is also present
Document: ADaM IG v1.3
- Item: '7'
+ Item: "7"
Section: 3.1.1
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '70'
- Version: '5.0'
- Version: '1.3'
+ Id: "70"
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
@@ -22,13 +22,13 @@ Authorities:
the secondary variable of the variable pair cannot be present
in the dataset unless the primary variable is also present
Document: ADaM IG v1.3
- Item: '7'
+ Item: "7"
Section: 3.1.1
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '70'
- Version: '5.0'
- Version: '1.2'
+ Id: "70"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
@@ -36,52 +36,52 @@ Authorities:
the secondary variable of the variable pair cannot be present
in the dataset unless the primary variable is also present
Document: ADaM IG v1.3
- Item: '7'
+ Item: "7"
Section: 3.1.1
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '70'
- Version: '5.0'
- Version: '1.1'
+ Id: "70"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: >-
One-to-one map to TRxxAGy
Document: ADaM IG v1.0
- Item: ''
+ Item: ""
Section: 3.1, Table 3.1.1
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '70'
- Version: '5.0'
- Version: '1.0'
+ Id: "70"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- - name: variable_name #in dataset
+ - name: variable_name #in dataset
operator: starts_with
value: TR
- - name: variable_name #in dataset
+ - name: variable_name #in dataset
operator: contains
value: AG
- - name: variable_name #in dataset
+ - name: variable_name #in dataset
operator: ends_with
- value: N
- #- name: Root_variable_name #substrings up to 'N' and checks fro presence, if returns false then fails
- # operator: not_exists
+ value:
+ N
+ #- name: Root_variable_name #substrings up to 'N' and checks fro presence, if returns false then fails
+ # operator: not_exists
Core:
Id: CDSIC.ADaMIG.AD0070
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
'A variable with a prefix of TR, containing AG with a suffix of N is present
and a variable with the same root without a suffix of N is not present'
Executability: Fully Executable
Outcome:
- Message: A variable with a prefix of TR, containing AG with a suffix of N is
- present and a variable with the same root without a suffix of N is not
- present
+ Message: A variable with a prefix of TR, containing AG with a suffix of N is present and a
+ variable with the same root without a suffix of N is not present
Output Variables:
- variable_name
- TTR01AG1N
diff --git a/Unpublished/ADAMIG/AD0111/rule.yml b/Unpublished/ADAMIG/AD0111/rule.yml
index 7c5802cc9..a371346a5 100644
--- a/Unpublished/ADAMIG/AD0111/rule.yml
+++ b/Unpublished/ADAMIG/AD0111/rule.yml
@@ -1,121 +1,121 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU
- must also be included in the dataset, and the anchor time
- variable must be identified in the metadata for ARELTM'
- Document: 'ADaMIG'
- Item: 'Table 3.2.3.1'
- Section: '3.2.3'
+ - Cited Guidance:
+ "When ARELTM is present, the anchor time variable and ARELTMU must also be included
+ in the dataset, and the anchor time variable must be identified in the metadata for ARELTM"
+ Document: "ADaMIG"
+ Item: "Table 3.2.3.1"
+ Section: "3.2.3"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
- Type: 'Failure'
- Origin: 'ADaM Conformance Rules'
- Release Notes: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
+ Type: "Failure"
+ Origin: "ADaM Conformance Rules"
+ Release Notes: ""
Rule Identifier:
- Id: '111'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
- - Name: 'ADaMIG'
+ Id: "111"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU
- must also be included in the dataset, and the anchor time
- variable must be identified in the metadata for ARELTM'
- Document: 'ADaMIG'
- Item: 'Table 3.3.3.1'
- Section: '3.3.3'
+ - Cited Guidance:
+ "When ARELTM is present, the anchor time variable and ARELTMU must also be included
+ in the dataset, and the anchor time variable must be identified in the metadata for ARELTM"
+ Document: "ADaMIG"
+ Item: "Table 3.3.3.1"
+ Section: "3.3.3"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
- Type: 'Failure'
- Origin: 'ADaM Conformance Rules'
- Release Notes: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
+ Type: "Failure"
+ Origin: "ADaM Conformance Rules"
+ Release Notes: ""
Rule Identifier:
- Id: '111'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
- - Name: 'ADaMIG'
+ Id: "111"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU
- must also be included in the dataset, and the anchor time
- variable must be identified in the metadata for ARELTM'
- Document: 'ADaMIG'
- Item: 'Table 3.3.3.1'
- Section: '3.3.3'
+ - Cited Guidance:
+ "When ARELTM is present, the anchor time variable and ARELTMU must also be included
+ in the dataset, and the anchor time variable must be identified in the metadata for ARELTM"
+ Document: "ADaMIG"
+ Item: "Table 3.3.3.1"
+ Section: "3.3.3"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
- Type: 'Failure'
- Origin: 'ADaM Conformance Rules'
- Release Notes: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
+ Type: "Failure"
+ Origin: "ADaM Conformance Rules"
+ Release Notes: ""
Rule Identifier:
- Id: '111'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
- - Name: 'ADaMIG'
+ Id: "111"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU
- must also be included in the dataset, and the anchor time
- variable must be identified in the metadata for ARELTM'
- Document: 'ADaMIG'
- Item: 'Table 3.3.3.1'
- Section: '3.3.3'
+ - Cited Guidance:
+ "When ARELTM is present, the anchor time variable and ARELTMU must also be included
+ in the dataset, and the anchor time variable must be identified in the metadata for ARELTM"
+ Document: "ADaMIG"
+ Item: "Table 3.3.3.1"
+ Section: "3.3.3"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
- Type: 'Failure'
- Origin: 'ADaM Conformance Rules'
- Release Notes: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
+ Type: "Failure"
+ Origin: "ADaM Conformance Rules"
+ Release Notes: ""
Rule Identifier:
- Id: '111'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
- - Name: 'ADaMIG'
+ Id: "111"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: 'The MDBDS supports analysis needs by adding SPDEVID as a
- required key variable and USUBJID as a conditionally required
- variable. See the BDS class for further details.'
- Document: 'ADaMIG-MD'
- Item: 'Table 3.3.3.1'
- Section: '3.1'
+ - Cited Guidance:
+ "The MDBDS supports analysis needs by adding SPDEVID as a required key variable
+ and USUBJID as a conditionally required variable. See the BDS class for further details."
+ Document: "ADaMIG-MD"
+ Item: "Table 3.3.3.1"
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
- Type: 'Failure'
- Origin: 'ADaM Conformance Rules'
- Release Notes: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
+ Type: "Failure"
+ Origin: "ADaM Conformance Rules"
+ Release Notes: ""
Rule Identifier:
- Id: '111'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "111"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -126,11 +126,11 @@ Check:
Core:
Id: CDISC.ADAMIG.111
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'When ARELTM is present, ARELTMU must also be present'
+ Message: "When ARELTM is present, ARELTMU must also be present"
Output Variables:
- USUBJID
- SUBJID
@@ -144,5 +144,5 @@ Scope:
- MEDICAL DEVICE BASIC DATA STRUCTURE
Datasets:
Include:
- - 'ALL'
+ - "ALL"
Sensitivity: Dataset
diff --git a/Unpublished/ADAMIG/AD0112/rule.yml b/Unpublished/ADAMIG/AD0112/rule.yml
index 4b429f4c8..64b62ed47 100644
--- a/Unpublished/ADAMIG/AD0112/rule.yml
+++ b/Unpublished/ADAMIG/AD0112/rule.yml
@@ -7,86 +7,86 @@ Authorities:
- Cited Guidance: >-
When ARELTM is present, the anchor time variable and ARELTMU
must also be included in the dataset, and the anchor time
- variable must be identified in the metadata for ARELTM.
+ variable must be identified in the metadata for ARELTM.
Document: ADaM IG v1.3
- Item: ''
- Section: '3.3.3, Table 3.3.3.1'
+ Item: ""
+ Section: "3.3.3, Table 3.3.3.1"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '112'
- Version: '5.0'
- - Name: 'ADaMIG-MD' # schema error : onlt accepts ADaMIG at present
+ Id: "112"
+ Version: "5.0"
+ - Name: "ADaMIG-MD" # schema error : onlt accepts ADaMIG at present
References:
- Citations:
- Cited Guidance: >-
v1.0, Section 3.1: The MDBDS supports analysis needs by adding
SPDEVID as a required key variable and USUBJID as a
conditionally required variable. See the BDS class for further
- details..
+ details..
Document: ADaM MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '112'
- Version: '5.0'
- Version: '1.0' #or '1.3' against rule set 1.3 in excel sheet?
+ Id: "112"
+ Version: "5.0"
+ Version: "1.0" #or '1.3' against rule set 1.3 in excel sheet?
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: >-
When ARELTM is present, the anchor time variable and ARELTMU
must also be included in the dataset, and the anchor time
- variable must be identified in the metadata for ARELTM.
+ variable must be identified in the metadata for ARELTM.
Document: ADaM IG v1.2
- Item: ''
- Section: '3.3.3, Table 3.3.3.1'
+ Item: ""
+ Section: "3.3.3, Table 3.3.3.1"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '112'
- Version: '5.0'
- Version: '1.2'
+ Id: "112"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: >-
When ARELTM is present, the anchor time variable and ARELTMU
must also be included in the dataset, and the anchor time
- variable must be identified in the metadata for ARELTM.
+ variable must be identified in the metadata for ARELTM.
Document: ADaM IG v1.1
- Item: ''
- Section: '3.3.3, Table 3.3.3.1'
+ Item: ""
+ Section: "3.3.3, Table 3.3.3.1"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '112'
- Version: '5.0'
- Version: '1.1'
+ Id: "112"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: >-
When ARELTM is present, the anchor time variable and ARELTMU
must also be included in the dataset, and the anchor time
- variable must be identified in the metadata for ARELTM.
+ variable must be identified in the metadata for ARELTM.
Document: ADaM IG v1.0
- Item: ''
- Section: '3.2.3, Table 3.2.3.1'
+ Item: ""
+ Section: "3.2.3, Table 3.2.3.1"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '112'
- Version: '5.0'
- Version: '1.0'
+ Id: "112"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: ARELTM
operator: non_empty
- value: ''
+ value: ""
- name: ARELTMU
operator: empty
Core:
Id: CDSIC.ADaMIG.AD0112
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
'ARELTM is populated and ARELTMU is not populated'
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0113/rule.yml b/Unpublished/ADAMIG/AD0113/rule.yml
index 5ff955004..7cde57486 100644
--- a/Unpublished/ADAMIG/AD0113/rule.yml
+++ b/Unpublished/ADAMIG/AD0113/rule.yml
@@ -6,15 +6,15 @@ Authorities:
- Citations:
- Cited Guidance: >-
The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU
- is required if ARELTM is present.
+ is required if ARELTM is present.
Document: ADaM IG v1.3
- Item: ''
- Section: '3.3.3, Table 3.3.3.1'
+ Item: ""
+ Section: "3.3.3, Table 3.3.3.1"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '113'
- Version: '5.0'
- - Name: 'ADaMIG-MD' # schema error : onlt accepts ADaMIG at present
+ Id: "113"
+ Version: "5.0"
+ - Name: "ADaMIG-MD" # schema error : onlt accepts ADaMIG at present
References:
- Citations:
- Cited Guidance: >-
@@ -22,28 +22,28 @@ Authorities:
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaM v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '113'
- Version: '2.0' #? where to set rule id version
- Version: '5.0'
- Version: '1.0' #or '1.3' against overall Conformance rule set 1.3 in excel sheet?
+ Id: "113"
+ Version: "2.0" #? where to set rule id version
+ Version: "5.0"
+ Version: "1.0" #or '1.3' against overall Conformance rule set 1.3 in excel sheet?
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: >-
The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU
- is required if ARELTM is present.
+ is required if ARELTM is present.
Document: ADaM IG v1.2
- Item: ''
- Section: '3.3.3, Table 3.3.3.1'
+ Item: ""
+ Section: "3.3.3, Table 3.3.3.1"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '113'
- Version: '5.0'
- Version: '1.2'
+ Id: "113"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
@@ -51,28 +51,28 @@ Authorities:
The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU
is required if ARELTM is present.
Document: ADaM IG v1.1
- Item: ''
- Section: '3.3.3, Table 3.3.3.1'
+ Item: ""
+ Section: "3.3.3, Table 3.3.3.1"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '113'
- Version: '5.0'
- Version: '1.1'
+ Id: "113"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: >-
The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU
- is required if ARELTM is present.
+ is required if ARELTM is present.
Document: ADaM IG v1.0
- Item: ''
- Section: '3.2.3, Table 3.2.3.1'
+ Item: ""
+ Section: "3.2.3, Table 3.2.3.1"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '113'
- Version: '5.0'
- Version: '1.0'
+ Id: "113"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: ARELTMU
@@ -82,7 +82,7 @@ Check:
Core:
Id: CDSIC.ADaMIG.AD0113
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
'ARELTMU is present and ARELTM is not present'
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/AD0252/rule.yml b/Unpublished/ADAMIG/AD0252/rule.yml
index 4145100b0..69cc13e5b 100644
--- a/Unpublished/ADAMIG/AD0252/rule.yml
+++ b/Unpublished/ADAMIG/AD0252/rule.yml
@@ -1,40 +1,40 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: ''
- Document: ''
- Item: ''
- Section: ''
+ - Cited Guidance: ""
+ Document: ""
+ Item: ""
+ Section: ""
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
- Type: ''
- Origin: ''
- Release Notes: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
+ Type: ""
+ Origin: ""
+ Release Notes: ""
Rule Identifier:
- Id: '252'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "252"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
- - name: ''
- operator: ''
- value: ''
+ - name: ""
+ operator: ""
+ value: ""
Core:
Id: CDISC.ADAMIG.252
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Dataset Metadata Check
Scope:
Classes:
diff --git a/Unpublished/ADAMIG/AD0869/rule.yml b/Unpublished/ADAMIG/AD0869/rule.yml
index 11c10d8fa..01e3f2006 100644
--- a/Unpublished/ADAMIG/AD0869/rule.yml
+++ b/Unpublished/ADAMIG/AD0869/rule.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
- primary variable must also be included.
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the primary
+ variable must also be included.
Document: ADaM v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '869'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "869"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0869
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: RACEN is present, but RACE is not present
diff --git a/Unpublished/ADAMIG/AD0870/rule.yml b/Unpublished/ADAMIG/AD0870/rule.yml
index ae85852c6..61497408c 100644
--- a/Unpublished/ADAMIG/AD0870/rule.yml
+++ b/Unpublished/ADAMIG/AD0870/rule.yml
@@ -1,29 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Numeric version of SEX. Can be extended to other values
- beyond 1 and 2. Example values can be as follows ':' 1=Male,
- 2=Male
+ - Cited Guidance:
+ <- Numeric version of SEX. Can be extended to other values beyond 1 and 2.
+ Example values can be as follows ':' 1=Male, 2=Male
Document: ADPPKIG v1.0
- Item: 'Table 3.3'
- Section: '3.3'
+ Item: "Table 3.3"
+ Section: "3.3"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '870'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "870"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -34,11 +34,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0870
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'SEX is populated, but SEXN is not populated'
+ Message: "SEX is populated, but SEXN is not populated"
Output Variables:
- SEX
- SEXN
diff --git a/Unpublished/ADAMIG/AD0871/rule.yml b/Unpublished/ADAMIG/AD0871/rule.yml
index 29f595a0e..fe12e5b41 100644
--- a/Unpublished/ADAMIG/AD0871/rule.yml
+++ b/Unpublished/ADAMIG/AD0871/rule.yml
@@ -1,29 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Numeric version of SEX. Can be extended to other values
- beyond 1 and 2. Example values can be as follows':' 1=Male,
- 2=Female
+ - Cited Guidance:
+ <- Numeric version of SEX. Can be extended to other values beyond 1 and 2.
+ Example values can be as follows':' 1=Male, 2=Female
Document: ADPPKIG v1.0
- Item: 'Table 3.3'
- Section: '3.3'
+ Item: "Table 3.3"
+ Section: "3.3"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '871'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "871"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -34,11 +34,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0871
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'SEXN is populated, but SEX is not populated'
+ Message: "SEXN is populated, but SEX is not populated"
Output Variables:
- SEX
- SEXN
diff --git a/Unpublished/ADAMIG/AD0878/rule.yml b/Unpublished/ADAMIG/AD0878/rule.yml
index d6a8e4549..a9cecd928 100644
--- a/Unpublished/ADAMIG/AD0878/rule.yml
+++ b/Unpublished/ADAMIG/AD0878/rule.yml
@@ -6,22 +6,22 @@ Authorities:
- Citations:
- Cited Guidance: <- Numeric version of COUNTRY
Document: ADPPKIG v1.0
- Item: 'Table 3.3'
- Section: '3.2'
+ Item: "Table 3.3"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '878'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "878"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,8 +35,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0878
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: COUNTRY is not unique for a given value of COUNTRYN
diff --git a/Unpublished/ADAMIG/AD0879/rule.yml b/Unpublished/ADAMIG/AD0879/rule.yml
index 2b4682b87..ee324337e 100644
--- a/Unpublished/ADAMIG/AD0879/rule.yml
+++ b/Unpublished/ADAMIG/AD0879/rule.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
- primary variable must also be included.
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the primary
+ variable must also be included.
Document: ADaM v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '879'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "879"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0879
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: COUNTRYN is present, but COUNTRY is not present
diff --git a/Unpublished/ADAMIG/AD0880/rule.yml b/Unpublished/ADAMIG/AD0880/rule.yml
index 76b71f429..a12fd5ac2 100644
--- a/Unpublished/ADAMIG/AD0880/rule.yml
+++ b/Unpublished/ADAMIG/AD0880/rule.yml
@@ -1,27 +1,27 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- Cited Guidance: <- Numeric version of COUNTRY
Document: ADPPKIG v1.0
- Item: 'Table 3.3'
- Section: '3.2'
+ Item: "Table 3.3"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '880'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "880"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -32,11 +32,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0880
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'COUNTRY is populated, but COUNTRYL is not populated'
+ Message: "COUNTRY is populated, but COUNTRYL is not populated"
Output Variables:
- COUNTRY
- COUNTRYL
diff --git a/Unpublished/ADAMIG/AD0881/rule.yml b/Unpublished/ADAMIG/AD0881/rule.yml
index 9799916f5..0d3aec68a 100644
--- a/Unpublished/ADAMIG/AD0881/rule.yml
+++ b/Unpublished/ADAMIG/AD0881/rule.yml
@@ -1,27 +1,27 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- Cited Guidance: <- Numeric version of COUNTRY
Document: ADPPKIG v1.0
- Item: 'Table 3.3'
- Section: '3.2'
+ Item: "Table 3.3"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '881'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "881"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -32,11 +32,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0881
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'COUNTRYL is populated, but COUNTRY is not populated'
+ Message: "COUNTRYL is populated, but COUNTRY is not populated"
Output Variables:
- COUNTRY
- COUNTRYL
diff --git a/Unpublished/ADAMIG/AD0882/rule.yml b/Unpublished/ADAMIG/AD0882/rule.yml
index 414d661a8..93582e15b 100644
--- a/Unpublished/ADAMIG/AD0882/rule.yml
+++ b/Unpublished/ADAMIG/AD0882/rule.yml
@@ -6,22 +6,22 @@ Authorities:
- Citations:
- Cited Guidance: <- Numeric version of COUNTRY.
Document: ADPPKIG v1.0
- Item: 'Table 3.3'
- Section: '3.2'
+ Item: "Table 3.3"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '882'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "882"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,8 +35,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0882
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: COUNTRYL is not unique for a given value of COUNTRY
diff --git a/Unpublished/ADAMIG/AD0883/rule.yml b/Unpublished/ADAMIG/AD0883/rule.yml
index 8d8c0011c..1dfd0c182 100644
--- a/Unpublished/ADAMIG/AD0883/rule.yml
+++ b/Unpublished/ADAMIG/AD0883/rule.yml
@@ -6,22 +6,22 @@ Authorities:
- Citations:
- Cited Guidance: <- Numeric version of COUNTRY
Document: ADPPKIG v1.0
- Item: 'Table 3.3'
- Section: '3.2'
+ Item: "Table 3.3"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '883'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "883"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,8 +35,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0883
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: COUNTRY is not unique for a given value of COUNTRYL
diff --git a/Unpublished/ADAMIG/AD0884/rule.yml b/Unpublished/ADAMIG/AD0884/rule.yml
index aee475f78..b124cee9e 100644
--- a/Unpublished/ADAMIG/AD0884/rule.yml
+++ b/Unpublished/ADAMIG/AD0884/rule.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
- primary variable must also be included.
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the primary
+ variable must also be included.
Document: ADaM v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '884'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "884"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0884
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: COUNTRYL is present, but COUNTRY is not present
diff --git a/Unpublished/ADAMIG/AD0885/rule.yml b/Unpublished/ADAMIG/AD0885/rule.yml
index ab168a972..9e44a57e4 100644
--- a/Unpublished/ADAMIG/AD0885/rule.yml
+++ b/Unpublished/ADAMIG/AD0885/rule.yml
@@ -1,27 +1,27 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- Cited Guidance: <-Core Value is required.
Document: ADaM v1.3
- Item: 'TABLE 3.2'
- Section: '3.2'
+ Item: "TABLE 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '885'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "885"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -30,8 +30,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0885
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: USUBJIDN is not present
diff --git a/Unpublished/ADAMIG/AD0886/rule.yml b/Unpublished/ADAMIG/AD0886/rule.yml
index bf0785885..1b86c00e1 100644
--- a/Unpublished/ADAMIG/AD0886/rule.yml
+++ b/Unpublished/ADAMIG/AD0886/rule.yml
@@ -1,27 +1,27 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- Cited Guidance: <-Core Value is required.
Document: ADaM v1.3
- Item: 'TABLE 3.2'
- Section: '3.2'
+ Item: "TABLE 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '886'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "886"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -30,8 +30,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0886
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: AFRLT is not present
diff --git a/Unpublished/ADAMIG/AD0887/rule.yml b/Unpublished/ADAMIG/AD0887/rule.yml
index a6b6da5b9..918063c92 100644
--- a/Unpublished/ADAMIG/AD0887/rule.yml
+++ b/Unpublished/ADAMIG/AD0887/rule.yml
@@ -1,27 +1,27 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- Cited Guidance: <-Core Value is required.
Document: ADaM v1.3
- Item: 'TABLE 3.2'
- Section: '3.2'
+ Item: "TABLE 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '887'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "887"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -30,8 +30,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0887
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: EVID is not present
diff --git a/Unpublished/ADAMIG/AD0888/rule.yml b/Unpublished/ADAMIG/AD0888/rule.yml
index e6e283231..17629395a 100644
--- a/Unpublished/ADAMIG/AD0888/rule.yml
+++ b/Unpublished/ADAMIG/AD0888/rule.yml
@@ -1,27 +1,27 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- Cited Guidance: <-Core Value is required.
Document: ADaM v1.3
- Item: 'TABLE 3.2'
- Section: '3.2'
+ Item: "TABLE 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '888'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "888"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -30,8 +30,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0888
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: DV is not present
diff --git a/Unpublished/ADAMIG/AD0889/rule.yml b/Unpublished/ADAMIG/AD0889/rule.yml
index 71a9a3e2c..c66310d26 100644
--- a/Unpublished/ADAMIG/AD0889/rule.yml
+++ b/Unpublished/ADAMIG/AD0889/rule.yml
@@ -1,27 +1,27 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- Cited Guidance: <-Core Value is required.
Document: ADaM v1.3
- Item: 'TABLE 3.2'
- Section: '3.2'
+ Item: "TABLE 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '889'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "889"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -30,8 +30,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0889
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: MDV is not present
diff --git a/Unpublished/ADAMIG/AD0890/rule.yml b/Unpublished/ADAMIG/AD0890/rule.yml
index 21c0ea71d..7602707fe 100644
--- a/Unpublished/ADAMIG/AD0890/rule.yml
+++ b/Unpublished/ADAMIG/AD0890/rule.yml
@@ -1,27 +1,27 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- Cited Guidance: <-Core Value is required.
Document: ADaM v1.3
- Item: 'TABLE 3.2'
- Section: '3.2'
+ Item: "TABLE 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '890'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "890"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -30,8 +30,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0890
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: AMT is not present
diff --git a/Unpublished/ADAMIG/AD0891/rule.yml b/Unpublished/ADAMIG/AD0891/rule.yml
index a8faac519..cde22d7d1 100644
--- a/Unpublished/ADAMIG/AD0891/rule.yml
+++ b/Unpublished/ADAMIG/AD0891/rule.yml
@@ -4,95 +4,99 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between COHORT and
- COHORTN. When COHORT and COHORTN are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between COHORT and COHORTN. When
+ COHORT and COHORTN are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '891'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "891"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between COHORT and
- COHORTN. When COHORT and COHORTN are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between COHORT and COHORTN. When
+ COHORT and COHORTN are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '891'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "891"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between COHORT and
- COHORTN. When COHORT and COHORTN are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between COHORT and COHORTN. When
+ COHORT and COHORTN are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '891'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "891"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between COHORT and
- COHORTN. When COHORT and COHORTN are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between COHORT and COHORTN. When
+ COHORT and COHORTN are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '891'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "891"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
@@ -106,8 +110,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0891
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: COHORTN is not unique for a given value of COHORT
diff --git a/Unpublished/ADAMIG/AD0892/rule.yml b/Unpublished/ADAMIG/AD0892/rule.yml
index 47fdc01ab..c567813d1 100644
--- a/Unpublished/ADAMIG/AD0892/rule.yml
+++ b/Unpublished/ADAMIG/AD0892/rule.yml
@@ -4,95 +4,99 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between COHORT and
- COHORTN. When COHORT and COHORTN are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between COHORT and COHORTN. When
+ COHORT and COHORTN are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '892'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "892"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between COHORT and
- COHORTN. When COHORT and COHORTN are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between COHORT and COHORTN. When
+ COHORT and COHORTN are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '892'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "892"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between COHORT and
- COHORTN. When COHORT and COHORTN are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between COHORT and COHORTN. When
+ COHORT and COHORTN are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '892'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "892"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between COHORT and
- COHORTN. When COHORT and COHORTN are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between COHORT and COHORTN. When
+ COHORT and COHORTN are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '892'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "892"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
@@ -106,8 +110,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0892
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: COHORT is not unique for a given value of COHORTN
diff --git a/Unpublished/ADAMIG/AD0893/rule.yml b/Unpublished/ADAMIG/AD0893/rule.yml
index 5ddbef93a..ebe04c728 100644
--- a/Unpublished/ADAMIG/AD0893/rule.yml
+++ b/Unpublished/ADAMIG/AD0893/rule.yml
@@ -4,95 +4,99 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and
- ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When
+ ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '893'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "893"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and
- ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When
+ ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '893'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "893"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and
- ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When
+ ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '893'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "893"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and
- ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When
+ ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '893'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "893"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
@@ -106,8 +110,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0893
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ACYCLEC is not unique for a given value of ACYCLE
diff --git a/Unpublished/ADAMIG/AD0894/rule.yml b/Unpublished/ADAMIG/AD0894/rule.yml
index dc06a50d6..660a7d53a 100644
--- a/Unpublished/ADAMIG/AD0894/rule.yml
+++ b/Unpublished/ADAMIG/AD0894/rule.yml
@@ -4,95 +4,99 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and
- ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When
+ ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '894'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "894"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and
- ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When
+ ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '894'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "894"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and
- ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When
+ ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '894'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "894"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and
- ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given
- record, either both must be populated or both must be null.
+ - Cited Guidance:
+ <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When
+ ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or
+ both must be null.
Document: ADNCAIG v1.0
- Item: 'Table 4.2.1'
- Section: '4.2'
+ Item: "Table 4.2.1"
+ Section: "4.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '894'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "894"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
@@ -106,8 +110,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0894
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ACYCLE is not unique for a given value of ACYCLEC
diff --git a/Unpublished/ADAMIG/AD0895/rule.yml b/Unpublished/ADAMIG/AD0895/rule.yml
index c0f1af303..bac9d18d3 100644
--- a/Unpublished/ADAMIG/AD0895/rule.yml
+++ b/Unpublished/ADAMIG/AD0895/rule.yml
@@ -10,10 +10,10 @@ Authorities:
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '895'
- Version: '1'
- Version: '5.0'
- Version: '1.3'
+ Id: "895"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
@@ -23,10 +23,10 @@ Authorities:
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '895'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "895"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
@@ -36,10 +36,10 @@ Authorities:
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '895'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "895"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
@@ -49,26 +49,25 @@ Authorities:
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '895'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "895"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: ANL02FL
operator: exists
- name: variable_label
operator: does_not_contain
- value: '02'
+ value: "02"
Core:
Id:
Status: Draft
- Version: '1'
+ Version: "1"
Description: For analysis flag ANLzzFL, the label should contain the number zz.
Executability: Fully Executable
Outcome:
- Message: trigger an error when zz in variable label is not equal to zz in
- ANLzzFL variable name.
+ Message: trigger an error when zz in variable label is not equal to zz in ANLzzFL variable name.
Rule Type: Variable Metadata Check
Scope:
Classes:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml
index f1d89b10d..2325ed420 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml
@@ -2,21 +2,22 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADAMIG
- Version: '1.3'
References:
- # Origin for ADaM/ADaMIG should be defined in yaml validation schema
- - Origin: ADaM Conformance Rules
- Rule Identifier:
- Id: AD0061
- Version: '1'
- # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema
- Version: '4.0'
- Citations:
- - Document: IG v1.3
- Section: 3.2
- Cited Guidance: >-
+ # Origin for ADaM/ADaMIG should be defined in yaml validation schema
+ - Citations:
+ - Cited Guidance: >-
ADaM IG v1.3, Section 3.2, Table 3.2.6: TRTSDT and/or TRTSDTM are
required if there is an investigational product.
+ Document: IG v1.3
+ Section: 3.2
+ Origin: ADaM Conformance Rules
+ Rule Identifier:
+ Id: AD0061
+ Version:
+ "1"
+ # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema
+ Version: "4.0"
+ Version: "1.3"
Check:
all:
- name: $TRTSDT_EXISTS
@@ -29,20 +30,19 @@ Check:
operator: exists
Core:
# Need to make yaml validation accept ADAMIG
- # Will we need to prepend ADaM rules with "AD0..."?
+ # Will we need to prepend ADaM rules with "AD0..."?
# (column "Check Number" in ADaM_Conformance_Rules_v4.0 is 1-3 digits only, some with a ",1" (e.g. "37,01") )
Id: CDISC.ADAMIG.AD0061
Status: Draft
- Version: '1'
-Description: Raise an error when TRTSDT and/or TRTSDTM are not present, though data
- exist in SDTM.EX
+ Version: "1"
+Description: Raise an error when TRTSDT and/or TRTSDTM are not present, though data exist in SDTM.EX
Operations:
- - id: $TRTSDT_EXISTS
- domain: ADSL
+ - domain: ADSL
+ id: $TRTSDT_EXISTS
name: TRTSDT
operator: variable_exists
- - id: $TRTSDTM_EXISTS
- domain: ADSL
+ - domain: ADSL
+ id: $TRTSDTM_EXISTS
name: TRTSDTM
operator: variable_exists
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0088/CDISC.ADAMIG.AD0088.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0088/CDISC.ADAMIG.AD0088.yml
index 30a2c3073..e7d892745 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0088/CDISC.ADAMIG.AD0088.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0088/CDISC.ADAMIG.AD0088.yml
@@ -2,71 +2,71 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '88'
- Version: '1'
- Version: '4.0'
+ Id: "88"
+ Version: "1"
+ Version: "4.0"
Citations:
- Document: ADaM IG v1.3
- Section: '3.2'
+ Section: "3.2"
Item: Table 3.2.1
Cited Guidance: STUDYID has Core=Req.
- Document: ADaM IG v1.3
- Section: '3.3'
+ Section: "3.3"
Item: Table 3.3.1.1
Cited Guidance: STUDYID has Core=Req.
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '88'
- Version: '1'
- Version: '4.0'
+ Id: "88"
+ Version: "1"
+ Version: "4.0"
Citations:
- Document: ADaM IG v1.2
- Section: '3.2'
+ Section: "3.2"
Item: Table 3.2.1
Cited Guidance: STUDYID has Core=Req.
- Document: ADaM IG v1.2
- Section: '3.3'
+ Section: "3.3"
Item: Table 3.3.1.1
Cited Guidance: STUDYID has Core=Req.
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '88'
- Version: '1'
- Version: '4.0'
+ Id: "88"
+ Version: "1"
+ Version: "4.0"
Citations:
- Document: ADaM IG v1.1
- Section: '3.2'
+ Section: "3.2"
Item: Table 3.2.1
Cited Guidance: STUDYID has Core=Req.
- Document: ADaM IG v1.1
- Section: '3.3'
+ Section: "3.3"
Item: Table 3.3.1.1
Cited Guidance: STUDYID has Core=Req.
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '88'
- Version: '1'
- Version: '4.0'
+ Id: "88"
+ Version: "1"
+ Version: "4.0"
Citations:
- Document: ADaM IG v1.0
- Section: '3.1'
+ Section: "3.1"
Item: Table 3.1.1
Cited Guidance: STUDYID has Core=Req.
- Document: ADaM IG v1.0
- Section: '3.2'
+ Section: "3.2"
Item: Table 3.2.1.1
Cited Guidance: STUDYID has Core=Req.
Check:
@@ -76,7 +76,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0088
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when STUDYID is not present
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0089/CDISC.ADAMIG.AD0089.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0089/CDISC.ADAMIG.AD0089.yml
index b9f136f45..399468229 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0089/CDISC.ADAMIG.AD0089.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0089/CDISC.ADAMIG.AD0089.yml
@@ -2,71 +2,71 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '89'
- Version: '1'
- Version: '4.0'
+ Id: "89"
+ Version: "1"
+ Version: "4.0"
Citations:
- Document: ADaM IG v1.3
- Section: '3.2'
+ Section: "3.2"
Item: Table 3.2.1
Cited Guidance: USUBJID has Core=Req.
- Document: ADaM IG v1.3
- Section: '3.3'
+ Section: "3.3"
Item: Table 3.3.1.1
Cited Guidance: USUBJID has Core=Req.
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '89'
- Version: '1'
- Version: '4.0'
+ Id: "89"
+ Version: "1"
+ Version: "4.0"
Citations:
- Document: ADaM IG v1.2
- Section: '3.2'
+ Section: "3.2"
Item: Table 3.2.1
Cited Guidance: USUBJID has Core=Req.
- Document: ADaM IG v1.2
- Section: '3.3'
+ Section: "3.3"
Item: Table 3.3.1.1
Cited Guidance: USUBJID has Core=Req.
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '89'
- Version: '1'
- Version: '4.0'
+ Id: "89"
+ Version: "1"
+ Version: "4.0"
Citations:
- Document: ADaM IG v1.1
- Section: '3.2'
+ Section: "3.2"
Item: Table 3.2.1
Cited Guidance: USUBJID has Core=Req.
- Document: ADaM IG v1.1
- Section: '3.3'
+ Section: "3.3"
Item: Table 3.3.1.1
Cited Guidance: USUBJID has Core=Req.
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '89'
- Version: '1'
- Version: '4.0'
+ Id: "89"
+ Version: "1"
+ Version: "4.0"
Citations:
- Document: ADaM IG v1.0
- Section: '3.1'
+ Section: "3.1"
Item: Table 3.1.1
Cited Guidance: USUBJID has Core=Req.
- Document: ADaM IG v1.0
- Section: '3.2'
+ Section: "3.2"
Item: Table 3.2.1.1
Cited Guidance: USUBJID has Core=Req.
Check:
@@ -76,7 +76,7 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0089
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when USUBJID is not present
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0261/CDISC.ADAMIG.AD0261.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0261/CDISC.ADAMIG.AD0261.yml
index 1790a2c36..15cf0d25c 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0261/CDISC.ADAMIG.AD0261.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0261/CDISC.ADAMIG.AD0261.yml
@@ -4,79 +4,87 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: --DECOD has Core=Cond and the CDISC Notes state "Required for
+ - Cited Guidance:
+ --DECOD has Core=Cond and the CDISC Notes state "Required for
Adverse Event data".
Document: OCCDS IG v1.0
Item: Table 3.2.3.1
Section: 3.2.3
- - Cited Guidance: --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC
+ - Cited Guidance:
+ --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC
Notes state "Required for Adverse Event data".
Document: OCCDS IG v1.1
Item: Table 3.2.3.1
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '261'
- Version: '1'
- Version: '4.0'
- Version: '1.3'
+ Id: "261"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: --DECOD has Core=Cond and the CDISC Notes state "Required for
+ - Cited Guidance:
+ --DECOD has Core=Cond and the CDISC Notes state "Required for
Adverse Event data".
Document: OCCDS IG v1.0
Item: Table 3.2.3.1
Section: 3.2.3
- - Cited Guidance: --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC
+ - Cited Guidance:
+ --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC
Notes state "Required for Adverse Event data".
Document: OCCDS IG v1.1
Item: Table 3.2.3.1
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '261'
- Version: '1'
- Version: '4.0'
- Version: '1.2'
+ Id: "261"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: --DECOD has Core=Cond and the CDISC Notes state "Required for
+ - Cited Guidance:
+ --DECOD has Core=Cond and the CDISC Notes state "Required for
Adverse Event data".
Document: OCCDS IG v1.0
Item: Table 3.2.3.1
Section: 3.2.3
- - Cited Guidance: --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC
+ - Cited Guidance:
+ --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC
Notes state "Required for Adverse Event data".
Document: OCCDS IG v1.1
Item: Table 3.2.3.1
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '261'
- Version: '1'
- Version: '4.0'
- Version: '1.1'
+ Id: "261"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: --DECOD has Core=Cond and the CDISC Notes state "Required for
+ - Cited Guidance:
+ --DECOD has Core=Cond and the CDISC Notes state "Required for
Adverse Event data".
Document: OCCDS IG v1.0
Item: Table 3.2.3.1
Section: 3.2.3
- - Cited Guidance: --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC
+ - Cited Guidance:
+ --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC
Notes state "Required for Adverse Event data".
Document: OCCDS IG v1.1
Item: Table 3.2.3.1
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '261'
- Version: '1'
- Version: '4.0'
- Version: '1.0'
+ Id: "261"
+ Version: "1"
+ Version: "4.0"
+ Version: "1.0"
Check:
all:
- name: AEDECOD
@@ -84,12 +92,12 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0261
Status: Draft
- Version: '1'
+ Version: "1"
Description: Variable AEDECOD should be present in analysis dataset for Adverse
Event analysis
Executability: Fully Executable
Outcome:
- Message: Variable AEDECOD is not present in ADVERSE EVENT dataset #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AEDECOD is not present in ADVERSE EVENT dataset #Can we output actual dataset name in message, eg ADAE3M?
#Output Variables:
# - AEDECOD
Rule Type: Record Data
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0262/CDISC.ADAMIG.AD0262.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0262/CDISC.ADAMIG.AD0262.yml
index e5ae396be..5ecfda056 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0262/CDISC.ADAMIG.AD0262.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0262/CDISC.ADAMIG.AD0262.yml
@@ -2,77 +2,85 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '262'
- Version: '1'
+ Id: "262"
+ Version: "1"
Citations:
- - Cited Guidance: --BODSYS has Core=Cond and the CDISC Notes state "Required
+ - Cited Guidance:
+ --BODSYS has Core=Cond and the CDISC Notes state "Required
for Adverse Event data".
Document: OCCDS IG v1.0
Section: 3.2.3
Item: Table 3.2.3.1
- - Cited Guidance: --BODSYS has Core=Req for SubClass=ADVERSE EVENT and
+ - Cited Guidance:
+ --BODSYS has Core=Req for SubClass=ADVERSE EVENT and
the CDISC Notes state "Required for Adverse Event data".
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '262'
- Version: '1'
+ Id: "262"
+ Version: "1"
Citations:
- - Cited Guidance: --BODSYS has Core=Cond and the CDISC Notes state "Required
+ - Cited Guidance:
+ --BODSYS has Core=Cond and the CDISC Notes state "Required
for Adverse Event data".
Document: OCCDS IG v1.0
Section: 3.2.3
Item: Table 3.2.3.1
- - Cited Guidance: --BODSYS has Core=Req for SubClass=ADVERSE EVENT and
+ - Cited Guidance:
+ --BODSYS has Core=Req for SubClass=ADVERSE EVENT and
the CDISC Notes state "Required for Adverse Event data".
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '262'
- Version: '1'
+ Id: "262"
+ Version: "1"
Citations:
- - Cited Guidance: --BODSYS has Core=Cond and the CDISC Notes state "Required
+ - Cited Guidance:
+ --BODSYS has Core=Cond and the CDISC Notes state "Required
for Adverse Event data".
Document: OCCDS IG v1.0
Section: 3.2.3
Item: Table 3.2.3.1
- - Cited Guidance: --BODSYS has Core=Req for SubClass=ADVERSE EVENT and
+ - Cited Guidance:
+ --BODSYS has Core=Req for SubClass=ADVERSE EVENT and
the CDISC Notes state "Required for Adverse Event data".
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '262'
- Version: '1'
+ Id: "262"
+ Version: "1"
Citations:
- - Cited Guidance: --BODSYS has Core=Cond and the CDISC Notes state "Required
+ - Cited Guidance:
+ --BODSYS has Core=Cond and the CDISC Notes state "Required
for Adverse Event data".
Document: OCCDS IG v1.0
Section: 3.2.3
Item: Table 3.2.3.1
- - Cited Guidance: --BODSYS has Core=Req for SubClass=ADVERSE EVENT and
+ - Cited Guidance:
+ --BODSYS has Core=Req for SubClass=ADVERSE EVENT and
the CDISC Notes state "Required for Adverse Event data".
Document: OCCDS IG v1.1
Section: 3.2.3
@@ -84,12 +92,13 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0262
Status: Draft
- Version: '1'
-Description: Variable AEBODSYS should be present in analysis dataset for Adverse Event
+ Version: "1"
+Description:
+ Variable AEBODSYS should be present in analysis dataset for Adverse Event
analysis
Executability: Fully Executable
Outcome:
- Message: Variable AEBODSYS is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AEBODSYS is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0278/CDISC.ADAMIG.AD0278.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0278/CDISC.ADAMIG.AD0278.yml
index 1d25683de..a5f6a6dad 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0278/CDISC.ADAMIG.AD0278.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0278/CDISC.ADAMIG.AD0278.yml
@@ -2,13 +2,13 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '278'
- Version: '1'
+ Id: "278"
+ Version: "1"
Citations:
- Cited Guidance: AESER has Core=Req.
Document: OCCDS IG v1.0
@@ -19,13 +19,13 @@ Authorities:
Section: 3.2.8
Item: Table 3.2.8.1
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '278'
- Version: '1'
+ Id: "278"
+ Version: "1"
Citations:
- Cited Guidance: AESER has Core=Req.
Document: OCCDS IG v1.0
@@ -36,13 +36,13 @@ Authorities:
Section: 3.2.8
Item: Table 3.2.8.1
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '278'
- Version: '1'
+ Id: "278"
+ Version: "1"
Citations:
- Cited Guidance: AESER has Core=Req.
Document: OCCDS IG v1.0
@@ -53,13 +53,13 @@ Authorities:
Section: 3.2.8
Item: Table 3.2.8.1
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '278'
- Version: '1'
+ Id: "278"
+ Version: "1"
Citations:
- Cited Guidance: AESER has Core=Req.
Document: OCCDS IG v1.0
@@ -76,12 +76,13 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0278
Status: Draft
- Version: '1'
-Description: Variable AESER should be present in analysis dataset for Adverse Event
+ Version: "1"
+Description:
+ Variable AESER should be present in analysis dataset for Adverse Event
analysis
Executability: Fully Executable
Outcome:
- Message: Variable AESER is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AESER is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0620/CDISC.ADAMIG.AD0620.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0620/CDISC.ADAMIG.AD0620.yml
index c50c9aa76..55d4398ae 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0620/CDISC.ADAMIG.AD0620.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0620/CDISC.ADAMIG.AD0620.yml
@@ -10,10 +10,10 @@ Authorities:
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '620'
- Version: '1'
- Version: '5.0'
- Version: '1.3'
+ Id: "620"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
@@ -23,10 +23,10 @@ Authorities:
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '620'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "620"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
@@ -36,10 +36,10 @@ Authorities:
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '620'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "620"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
@@ -49,10 +49,10 @@ Authorities:
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '620'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "620"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: AETERM
@@ -60,12 +60,12 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0620
Status: Draft
- Version: '1'
+ Version: "1"
Description: Variable AETERM should be present in analysis dataset for Adverse
Event analysis
Executability: Fully Executable
Outcome:
- Message: Variable AETERM is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AETERM is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0621/CDISC.ADAMIG.AD0621.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0621/CDISC.ADAMIG.AD0621.yml
index 5df66f6c8..9d6f8cd93 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0621/CDISC.ADAMIG.AD0621.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0621/CDISC.ADAMIG.AD0621.yml
@@ -2,52 +2,52 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '621'
- Version: '1'
+ Id: "621"
+ Version: "1"
Citations:
- Cited Guidance: TRTEMFL has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.5
Item: Table 3.2.5.3
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '621'
- Version: '1'
+ Id: "621"
+ Version: "1"
Citations:
- Cited Guidance: TRTEMFL has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.5
Item: Table 3.2.5.3
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '621'
- Version: '1'
+ Id: "621"
+ Version: "1"
Citations:
- Cited Guidance: TRTEMFL has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.5
Item: Table 3.2.5.3
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '621'
- Version: '1'
+ Id: "621"
+ Version: "1"
Citations:
- Cited Guidance: TRTEMFL has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
@@ -60,12 +60,13 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0621
Status: Draft
- Version: '1'
-Description: Variable TRTEMFL should be present in analysis dataset for Adverse Event
+ Version: "1"
+Description:
+ Variable TRTEMFL should be present in analysis dataset for Adverse Event
analysis
Executability: Fully Executable
Outcome:
- Message: Variable TRTEMFL is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable TRTEMFL is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0623/CDISC.ADAMIG.AD0623.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0623/CDISC.ADAMIG.AD0623.yml
index 5f09e0e50..83d2aada9 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0623/CDISC.ADAMIG.AD0623.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0623/CDISC.ADAMIG.AD0623.yml
@@ -2,52 +2,52 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '623'
- Version: '1'
+ Id: "623"
+ Version: "1"
Citations:
- Cited Guidance: --SEQ has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.2
Item: Table 3.2.2.2
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '623'
- Version: '1'
+ Id: "623"
+ Version: "1"
Citations:
- Cited Guidance: --SEQ has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.2
Item: Table 3.2.2.2
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '623'
- Version: '1'
+ Id: "623"
+ Version: "1"
Citations:
- Cited Guidance: --SEQ has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.2
Item: Table 3.2.2.2
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '623'
- Version: '1'
+ Id: "623"
+ Version: "1"
Citations:
- Cited Guidance: --SEQ has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
@@ -60,12 +60,13 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0623
Status: Draft
- Version: '1'
-Description: Variable AESEQ should be present in analysis dataset for Adverse Event
+ Version: "1"
+Description:
+ Variable AESEQ should be present in analysis dataset for Adverse Event
analysis
Executability: Fully Executable
Outcome:
- Message: Variable AESEQ is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AESEQ is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0624/CDISC.ADAMIG.AD0624.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0624/CDISC.ADAMIG.AD0624.yml
index bd129b649..e0b93ca11 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0624/CDISC.ADAMIG.AD0624.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0624/CDISC.ADAMIG.AD0624.yml
@@ -2,52 +2,52 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '624'
- Version: '1'
+ Id: "624"
+ Version: "1"
Citations:
- Cited Guidance: --LLT has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '624'
- Version: '1'
+ Id: "624"
+ Version: "1"
Citations:
- Cited Guidance: --LLT has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '624'
- Version: '1'
+ Id: "624"
+ Version: "1"
Citations:
- Cited Guidance: --LLT has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '624'
- Version: '1'
+ Id: "624"
+ Version: "1"
Citations:
- Cited Guidance: --LLT has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
@@ -60,12 +60,13 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0624
Status: Draft
- Version: '1'
-Description: Variable AELLT should be present in analysis dataset for Adverse Event
+ Version: "1"
+Description:
+ Variable AELLT should be present in analysis dataset for Adverse Event
analysis
Executability: Fully Executable
Outcome:
- Message: Variable AELLT is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AELLT is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0625/CDISC.ADAMIG.AD0625.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0625/CDISC.ADAMIG.AD0625.yml
index af98f8055..214e7ef8f 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0625/CDISC.ADAMIG.AD0625.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0625/CDISC.ADAMIG.AD0625.yml
@@ -2,52 +2,52 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '625'
- Version: '1'
+ Id: "625"
+ Version: "1"
Citations:
- Cited Guidance: --BDSYCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '625'
- Version: '1'
+ Id: "625"
+ Version: "1"
Citations:
- Cited Guidance: --BDSYCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '625'
- Version: '1'
+ Id: "625"
+ Version: "1"
Citations:
- Cited Guidance: --BDSYCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '625'
- Version: '1'
+ Id: "625"
+ Version: "1"
Citations:
- Cited Guidance: --BDSYCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
@@ -60,12 +60,13 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0625
Status: Draft
- Version: '1'
-Description: Variable AEBDSYCD should be present in analysis dataset for Adverse Event
+ Version: "1"
+Description:
+ Variable AEBDSYCD should be present in analysis dataset for Adverse Event
analysis
Executability: Fully Executable
Outcome:
- Message: Variable AEBDSYCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AEBDSYCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0626/CDISC.ADAMIG.AD0626.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0626/CDISC.ADAMIG.AD0626.yml
index 30aa1a976..f78ef2d1c 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0626/CDISC.ADAMIG.AD0626.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0626/CDISC.ADAMIG.AD0626.yml
@@ -2,52 +2,52 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '626'
- Version: '1'
+ Id: "626"
+ Version: "1"
Citations:
- Cited Guidance: --LLTCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '626'
- Version: '1'
+ Id: "626"
+ Version: "1"
Citations:
- Cited Guidance: --LLTCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '626'
- Version: '1'
+ Id: "626"
+ Version: "1"
Citations:
- Cited Guidance: --LLTCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '626'
- Version: '1'
+ Id: "626"
+ Version: "1"
Citations:
- Cited Guidance: --LLTCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
@@ -60,12 +60,13 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0626
Status: Draft
- Version: '1'
-Description: Variable AELLTCD should be present in analysis dataset for Adverse Event
+ Version: "1"
+Description:
+ Variable AELLTCD should be present in analysis dataset for Adverse Event
analysis
Executability: Fully Executable
Outcome:
- Message: Variable AELLTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AELLTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0627/CDISC.ADAMIG.AD0627.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0627/CDISC.ADAMIG.AD0627.yml
index ee9dad601..5833cfd68 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0627/CDISC.ADAMIG.AD0627.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0627/CDISC.ADAMIG.AD0627.yml
@@ -2,52 +2,52 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '627'
- Version: '1'
+ Id: "627"
+ Version: "1"
Citations:
- Cited Guidance: --HLT has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '627'
- Version: '1'
+ Id: "627"
+ Version: "1"
Citations:
- Cited Guidance: --HLT has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '627'
- Version: '1'
+ Id: "627"
+ Version: "1"
Citations:
- Cited Guidance: --HLT has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '627'
- Version: '1'
+ Id: "627"
+ Version: "1"
Citations:
- Cited Guidance: --HLT has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
@@ -60,12 +60,13 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0627
Status: Draft
- Version: '1'
-Description: Variable AEHLT should be present in analysis dataset for Adverse Event
+ Version: "1"
+Description:
+ Variable AEHLT should be present in analysis dataset for Adverse Event
analysis
Executability: Fully Executable
Outcome:
- Message: Variable AEHLT is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AEHLT is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0628/CDISC.ADAMIG.AD0628.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0628/CDISC.ADAMIG.AD0628.yml
index d444c0e3b..fb49c3349 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0628/CDISC.ADAMIG.AD0628.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0628/CDISC.ADAMIG.AD0628.yml
@@ -2,52 +2,52 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '628'
- Version: '1'
+ Id: "628"
+ Version: "1"
Citations:
- Cited Guidance: --HLTCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '628'
- Version: '1'
+ Id: "628"
+ Version: "1"
Citations:
- Cited Guidance: --HLTCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '628'
- Version: '1'
+ Id: "628"
+ Version: "1"
Citations:
- Cited Guidance: --HLTCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '628'
- Version: '1'
+ Id: "628"
+ Version: "1"
Citations:
- Cited Guidance: --HLTCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
@@ -60,12 +60,13 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0628
Status: Draft
- Version: '1'
-Description: Variable AEHLTCD should be present in analysis dataset for Adverse Event
+ Version: "1"
+Description:
+ Variable AEHLTCD should be present in analysis dataset for Adverse Event
analysis
Executability: Fully Executable
Outcome:
- Message: Variable AEHLTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AEHLTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0629/CDISC.ADAMIG.AD0629.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0629/CDISC.ADAMIG.AD0629.yml
index 11f7fe69b..96b7aac36 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0629/CDISC.ADAMIG.AD0629.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0629/CDISC.ADAMIG.AD0629.yml
@@ -2,52 +2,52 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '629'
- Version: '1'
+ Id: "629"
+ Version: "1"
Citations:
- Cited Guidance: --HLGT has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '629'
- Version: '1'
+ Id: "629"
+ Version: "1"
Citations:
- Cited Guidance: --HLGT has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '629'
- Version: '1'
+ Id: "629"
+ Version: "1"
Citations:
- Cited Guidance: --HLGT has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '629'
- Version: '1'
+ Id: "629"
+ Version: "1"
Citations:
- Cited Guidance: --HLGT has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
@@ -60,12 +60,13 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0629
Status: Draft
- Version: '1'
-Description: Variable AEHLGT should be present in analysis dataset for Adverse Event
+ Version: "1"
+Description:
+ Variable AEHLGT should be present in analysis dataset for Adverse Event
analysis
Executability: Fully Executable
Outcome:
- Message: Variable AEHLGT is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AEHLGT is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0630/CDISC.ADAMIG.AD0630.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0630/CDISC.ADAMIG.AD0630.yml
index a29256b47..724c41e43 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0630/CDISC.ADAMIG.AD0630.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0630/CDISC.ADAMIG.AD0630.yml
@@ -10,10 +10,10 @@ Authorities:
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '630'
- Version: '1'
- Version: '5.0'
- Version: '1.3'
+ Id: "630"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
@@ -23,10 +23,10 @@ Authorities:
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '630'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "630"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
@@ -36,10 +36,10 @@ Authorities:
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '630'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "630"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
@@ -49,10 +49,10 @@ Authorities:
Section: 3.2.3
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '630'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "630"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: AEHLGTCD
@@ -60,12 +60,12 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0630
Status: Draft
- Version: '1'
+ Version: "1"
Description: Variable AEHLGTCD should be present in analysis dataset for Adverse
Event analysis
Executability: Fully Executable
Outcome:
- Message: Variable AEHLGTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AEHLGTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0631/CDISC.ADAMIG.AD0631.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0631/CDISC.ADAMIG.AD0631.yml
index b8854773d..46659f8e9 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0631/CDISC.ADAMIG.AD0631.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0631/CDISC.ADAMIG.AD0631.yml
@@ -2,52 +2,52 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '631'
- Version: '1'
+ Id: "631"
+ Version: "1"
Citations:
- Cited Guidance: --PTCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '631'
- Version: '1'
+ Id: "631"
+ Version: "1"
Citations:
- Cited Guidance: --PTCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '631'
- Version: '1'
+ Id: "631"
+ Version: "1"
Citations:
- Cited Guidance: --PTCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '631'
- Version: '1'
+ Id: "631"
+ Version: "1"
Citations:
- Cited Guidance: --PTCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
@@ -60,12 +60,13 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0631
Status: Draft
- Version: '1'
-Description: Variable AEPTCD should be present in analysis dataset for Adverse Event
+ Version: "1"
+Description:
+ Variable AEPTCD should be present in analysis dataset for Adverse Event
analysis
Executability: Fully Executable
Outcome:
- Message: Variable AEPTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AEPTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0632/CDISC.ADAMIG.AD0632.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0632/CDISC.ADAMIG.AD0632.yml
index 91494d96a..f9d13e09f 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0632/CDISC.ADAMIG.AD0632.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0632/CDISC.ADAMIG.AD0632.yml
@@ -2,52 +2,52 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '632'
- Version: '1'
+ Id: "632"
+ Version: "1"
Citations:
- Cited Guidance: --SOC has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '632'
- Version: '1'
+ Id: "632"
+ Version: "1"
Citations:
- Cited Guidance: --SOC has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '632'
- Version: '1'
+ Id: "632"
+ Version: "1"
Citations:
- Cited Guidance: --SOC has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '632'
- Version: '1'
+ Id: "632"
+ Version: "1"
Citations:
- Cited Guidance: --SOC has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
@@ -60,12 +60,13 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0632
Status: Draft
- Version: '1'
-Description: Variable AESOC should be present in analysis dataset for Adverse Event
+ Version: "1"
+Description:
+ Variable AESOC should be present in analysis dataset for Adverse Event
analysis
Executability: Fully Executable
Outcome:
- Message: Variable AESOC is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AESOC is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0633/CDISC.ADAMIG.AD0633.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0633/CDISC.ADAMIG.AD0633.yml
index b3ebdbb02..78a576d61 100644
--- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0633/CDISC.ADAMIG.AD0633.yml
+++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0633/CDISC.ADAMIG.AD0633.yml
@@ -2,52 +2,52 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '633'
- Version: '1'
+ Id: "633"
+ Version: "1"
Citations:
- Cited Guidance: --SOCCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '633'
- Version: '1'
+ Id: "633"
+ Version: "1"
Citations:
- Cited Guidance: --SOCCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '633'
- Version: '1'
+ Id: "633"
+ Version: "1"
Citations:
- Cited Guidance: --SOCCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
Section: 3.2.3
Item: Table 3.2.3.1
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '633'
- Version: '1'
+ Id: "633"
+ Version: "1"
Citations:
- Cited Guidance: --SOCCD has Core=Req for SubClass=ADVERSE EVENT.
Document: OCCDS IG v1.1
@@ -60,12 +60,13 @@ Check:
Core:
Id: CDISC.ADAMIG.AD0633
Status: Draft
- Version: '1'
-Description: Variable AESOCCD should be present in analysis dataset for Adverse Event
+ Version: "1"
+Description:
+ Variable AESOCCD should be present in analysis dataset for Adverse Event
analysis
Executability: Fully Executable
Outcome:
- Message: Variable AESOCCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
+ Message: Variable AESOCCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M?
Rule Type: Record Data
Scope:
Data Structures:
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0054/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0054/rule.yml
index d91555033..0e01ec2f0 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0054/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0054/rule.yml
@@ -6,104 +6,112 @@ Authorities:
- Citations:
- Cited Guidance: The ADSL dataset contains one record per subject.
Document: ADaM IG v1.3
- Item: ''
- Section: '1.3'
- - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of
- clinical trial design.'
+ Item: ""
+ Section: "1.3"
+ - Cited Guidance:
+ "ADSL contains one record per subject, regardless of the type of clinical trial
+ design."
Document: ADaMIG v1.3
- Item: ''
- Section: '2.3.1'
- - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of
- the type of clinical trial design.'
+ Item: ""
+ Section: "2.3.1"
+ - Cited Guidance:
+ "The structure of ADSL is one record per subject, regardless of the type of clinical
+ trial design."
Document: ADaM IG v1.3
- Item: ''
- Section: '3.2'
+ Item: ""
+ Section: "3.2"
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '54'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "54"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: The ADSL dataset contains one record per subject.
Document: ADaM IG v1.2
- Item: ''
- Section: '1.3'
- - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of
- clinical trial design.'
+ Item: ""
+ Section: "1.3"
+ - Cited Guidance:
+ "ADSL contains one record per subject, regardless of the type of clinical trial
+ design."
Document: ADaM IG v1.2
- Item: ''
- Section: '2.3.1'
- - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of
- the type of clinical trial design.'
+ Item: ""
+ Section: "2.3.1"
+ - Cited Guidance:
+ "The structure of ADSL is one record per subject, regardless of the type of clinical
+ trial design."
Document: ADaM IG v1.2
- Item: ''
- Section: '3.2'
+ Item: ""
+ Section: "3.2"
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '54'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "54"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: The ADSL dataset contains one record per subject.
Document: ADaM IG v1.1
- Item: ''
- Section: '1.3'
- - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of
- clinical trial design.'
+ Item: ""
+ Section: "1.3"
+ - Cited Guidance:
+ "ADSL contains one record per subject, regardless of the type of clinical trial
+ design."
Document: ADaM IG v1.1
- Item: ''
- Section: '2.3.1'
- - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of
- the type of clinical trial design.'
+ Item: ""
+ Section: "2.3.1"
+ - Cited Guidance:
+ "The structure of ADSL is one record per subject, regardless of the type of clinical
+ trial design."
Document: ADaM IG v1.1
- Item: ''
- Section: '3.2'
+ Item: ""
+ Section: "3.2"
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '54'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "54"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: The ADSL dataset contains one record per subject.
Document: ADaM IG v1.0
- Item: ''
- Section: '1.3'
- - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of
- clinical trial design.'
+ Item: ""
+ Section: "1.3"
+ - Cited Guidance:
+ "ADSL contains one record per subject, regardless of the type of clinical trial
+ design."
Document: ADaM IG v1.0
- Item: ''
- Section: '2.3.1'
- - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of
- the type of clinical trial design.'
+ Item: ""
+ Section: "2.3.1"
+ - Cited Guidance:
+ "The structure of ADSL is one record per subject, regardless of the type of clinical
+ trial design."
Document: ADaM IG v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '54'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "54"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
@@ -114,11 +122,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0054
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'Duplicate USUBJIDs: Only one record permitted per USUBJID'
+ Message: "Duplicate USUBJIDs: Only one record permitted per USUBJID"
Output Variables:
- USUBJID
- STUDYID
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0060/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0060/rule.yml
index 24681db27..2650b4761 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0060/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0060/rule.yml
@@ -7,13 +7,13 @@ Authorities:
- Cited Guidance: >-
Variables whose names end in DTM are numeric datetimes
Document: ADaM IG v1.3
- Item: '3'
+ Item: "3"
Section: 3.1.2
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '60'
- Version: '5.0'
- Version: '1.3'
+ Id: "60"
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
@@ -21,39 +21,39 @@ Authorities:
- Cited Guidance: >-
Variables whose names end in DTM are numeric datetimes
Document: ADaM IG v1.3
- Item: '3'
+ Item: "3"
Section: 3.1.2
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '60'
- Version: '5.0'
- Version: '1.2'
+ Id: "60"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: >-
Variables whose names end in DTM are numeric datetimes
Document: ADaM IG v1.3
- Item: '3'
+ Item: "3"
Section: 3.1.2
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '60'
- Version: '5.0'
- Version: '1.1'
+ Id: "60"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: >-
Variables whose names end in DTM are numeric datetimes
Document: ADaM IG v1.3
- Item: '3 (General Timing Variable Conventions)'
- Section: '3'
+ Item: "3 (General Timing Variable Conventions)"
+ Section: "3"
Origin: ADaM Conformance Rules
Rule Identifier:
- Id: '60'
- Version: '5.0'
- Version: '1.0'
+ Id: "60"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: -- DTM
@@ -62,7 +62,7 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0060
Status: Draft
- Version: '1'
+ Version: "1"
Description: >-
'A variable with a suffix of DTM must be numeric'
Executability: Fully Executable
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0143/CDISC.ADaMIG.AD0143.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0143/CDISC.ADaMIG.AD0143.yml
index 99007e2e2..4fc7034a4 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0143/CDISC.ADaMIG.AD0143.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0143/CDISC.ADaMIG.AD0143.yml
@@ -4,34 +4,36 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '143'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "143"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '143'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "143"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format
and Oracle constraints, all ADaM variable names must be no
more than 8 characters in length, start with a letter (not
underscore), and be comprised only of letters (A-Z),
@@ -40,38 +42,40 @@ Authorities:
character variables must be no more than 200 characters in
length.
Document: ADaMIG v1.2
- Item: '1'
+ Item: "1"
Section: 3.1.1
- - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file
+ - Cited Guidance:
+ Values of PARAMCD should follow the SAS Version 5 transport file
format and Oracle constraints as noted under General Variable
Conventions in Section 3.1.1.
Document: ADaM IG v1.2
- Item: '1'
+ Item: "1"
Section: 3.4.1, Table 3.3.4.1.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: '143'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "143"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '143'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "143"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format
and Oracle constraints, all ADaM variable names must be no
more than 8 characters in length, start with a letter (not
underscore), and be comprised only of letters (A-Z),
@@ -80,38 +84,40 @@ Authorities:
character variables must be no more than 200 characters in
length.
Document: ADaMIG v1.2
- Item: '1'
+ Item: "1"
Section: 3.1.1
- - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file
+ - Cited Guidance:
+ Values of PARAMCD should follow the SAS Version 5 transport file
format and Oracle constraints as noted under General Variable
Conventions in Section 3.1.1.
Document: ADaM IG v1.2
- Item: '1'
+ Item: "1"
Section: 3.4.1, Table 3.3.4.1.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: '143'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "143"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '143'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "143"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format
and Oracle constraints, all ADaM variable names must be no
more than 8 characters in length, start with a letter (not
underscore), and be comprised only of letters (A-Z),
@@ -120,38 +126,40 @@ Authorities:
character variables must be no more than 200 characters in
length.
Document: ADaMIG v1.1
- Item: '1'
+ Item: "1"
Section: 3.1.1
- - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file
+ - Cited Guidance:
+ Values of PARAMCD should follow the SAS Version 5 transport file
format and Oracle constraints as noted under General Variable
Conventions in Section 3.1.1.
Document: ADaM IG v1.1
- Item: '1'
+ Item: "1"
Section: 3.3.4, Table 3.3.4.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: '143'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "143"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '143'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "143"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: Values of PARAMCD should follow SAS 5 variable naming
+ - Cited Guidance:
+ Values of PARAMCD should follow SAS 5 variable naming
conventions (8 characters or less; starts with a letter;
contains only letters and digits).
Document: ADaMIG v1.0
@@ -159,21 +167,21 @@ Authorities:
Section: 3.2.4
Criteria:
Logical Expression:
- Condition: ''
- Rule: '143'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "143"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '143'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "143"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
@@ -184,8 +192,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0143
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: Variable name has more than 8 characters
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0144/CDISC.ADaMIG.AD0144.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0144/CDISC.ADaMIG.AD0144.yml
index 817cac66f..9d6118aa1 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0144/CDISC.ADaMIG.AD0144.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0144/CDISC.ADaMIG.AD0144.yml
@@ -1,36 +1,38 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG-MD'
+ - Name: "ADaMIG-MD"
References:
- Citations:
- - Cited Guidance: <-The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ <-The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '144'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "144"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '144'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "144"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format
and Oracle constraints, all ADaM variable names must be no
more than 8 characters in length, start with a letter (not
underscore), and be comprised only of letters (A-Z),
@@ -39,55 +41,57 @@ Authorities:
character variables must be no more than 200 characters in
length.
Document: ADaMIG v1.1
- Item: '1'
- Section: '3.1.1'
+ Item: "1"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '144'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "144"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '144'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "144"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file
+ - Cited Guidance:
+ Values of PARAMCD should follow the SAS Version 5 transport file
format and Oracle constraints as noted under General Variable
Conventions in Section 3.1.1.
Document: ADaMIG v1.1
- Item: ''
- Section: '3.3.4, Table 3.3.4.1'
+ Item: ""
+ Section: "3.3.4, Table 3.3.4.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '144'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "144"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '144'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "144"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format
and Oracle constraints, all ADaM variable names must be no
more than 8 characters in length, start with a letter (not
underscore), and be comprised only of letters (A-Z),
@@ -96,55 +100,57 @@ Authorities:
character variables must be no more than 200 characters in
length.
Document: ADaMIG v1.1
- Item: '1'
- Section: '3.1.1'
+ Item: "1"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '144'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "144"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '144'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "144"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file
+ - Cited Guidance:
+ Values of PARAMCD should follow the SAS Version 5 transport file
format and Oracle constraints as noted under General Variable
Conventions in Section 3.1.1.
Document: ADaMIG v1.1
- Item: ''
- Section: '3.3.4, Table 3.3.4.1'
+ Item: ""
+ Section: "3.3.4, Table 3.3.4.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '144'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "144"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '144'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "144"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format
and Oracle constraints, all ADaM variable names must be no
more than 8 characters in length, start with a letter (not
underscore), and be comprised only of letters (A-Z),
@@ -153,77 +159,79 @@ Authorities:
character variables must be no more than 200 characters in
length.
Document: ADaMIG v1.1
- Item: '1'
- Section: '3.1.1'
+ Item: "1"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '144'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "144"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '144'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "144"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file
+ - Cited Guidance:
+ Values of PARAMCD should follow the SAS Version 5 transport file
format and Oracle constraints as noted under General Variable
Conventions in Section 3.1.1.
Document: ADaMIG v1.1
- Item: ''
- Section: '3.3.4, Table 3.3.4.1'
+ Item: ""
+ Section: "3.3.4, Table 3.3.4.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '144'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "144"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '144'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "144"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: Values of PARAMCD should follow SAS 5 variable naming
+ - Cited Guidance:
+ Values of PARAMCD should follow SAS 5 variable naming
conventions (8 characters or less; starts with a letter;
contains only letters and digits).
Document: ADaMIG v1.0
- Item: ''
- Section: '3.2.4, table 3.2.4.1'
+ Item: ""
+ Section: "3.2.4, table 3.2.4.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '144'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "144"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '144'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "144"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
@@ -234,8 +242,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0144
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: PARAMCD starts with a character other than a letter
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0145/CDISC.ADaMIG.AD0145.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0145/CDISC.ADaMIG.AD0145.yml
index 602795926..9b1b1d611 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0145/CDISC.ADaMIG.AD0145.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0145/CDISC.ADaMIG.AD0145.yml
@@ -4,34 +4,36 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: '145'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "145"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '145'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "145"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format
and Oracle constraints, all ADaM variable names must be no
more than 8 characters in length, start with a letter (not
underscore), and be comprised only of letters (A-Z),
@@ -40,38 +42,40 @@ Authorities:
character variables must be no more than 200 characters in
length. characters).
Document: ADaMIG v1.3
- Item: '1'
+ Item: "1"
Section: 3.1.1
- - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file
+ - Cited Guidance:
+ Values of PARAMCD should follow the SAS Version 5 transport file
format and Oracle constraints as noted under General Variable
Conventions in Section 3.1.1.
Document: ADaM IG v1.3
- Item: '1'
+ Item: "1"
Section: 3.3.4.1, Table 3.3.4.1.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: '145'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "145"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '145'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "145"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format
and Oracle constraints, all ADaM variable names must be no
more than 8 characters in length, start with a letter (not
underscore), and be comprised only of letters (A-Z),
@@ -80,38 +84,40 @@ Authorities:
character variables must be no more than 200 characters in
length. characters).
Document: ADaMIG v1.2
- Item: '1'
+ Item: "1"
Section: 3.1.1
- - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file
+ - Cited Guidance:
+ Values of PARAMCD should follow the SAS Version 5 transport file
format and Oracle constraints as noted under General Variable
Conventions in Section 3.1.1.
Document: ADaM IG v1.2
- Item: '1'
+ Item: "1"
Section: 3.3.4.1, Table 3.3.4.1.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: '145'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "145"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '145'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "145"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: To ensure compliance with SAS Version 5 transport file format
+ - Cited Guidance:
+ To ensure compliance with SAS Version 5 transport file format
and Oracle constraints, all ADaM variable names must be no
more than 8 characters in length, start with a letter (not
underscore), and be comprised only of letters (A-Z),
@@ -120,38 +126,40 @@ Authorities:
character variables must be no more than 200 characters in
length. characters).
Document: ADaMIG v1.1
- Item: '1'
+ Item: "1"
Section: 3.1.1
- - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file
+ - Cited Guidance:
+ Values of PARAMCD should follow the SAS Version 5 transport file
format and Oracle constraints as noted under General Variable
Conventions in Section 3.1.1.
Document: ADaM IG v1.1
- Item: '1'
+ Item: "1"
Section: 3.3.4, Table 3.3.4.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: '145'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "145"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '145'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "145"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Organization: CDISC
Standards:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: Values of PARAMCD should follow SAS 5 variable naming
+ - Cited Guidance:
+ Values of PARAMCD should follow SAS 5 variable naming
conventions (8 characters or less; starts with a letter;
contains only letters and digits).
Document: ADaMIG v1.0
@@ -159,21 +167,21 @@ Authorities:
Section: 3.2.4
Criteria:
Logical Expression:
- Condition: ''
- Rule: '145'
- Plain Language Expression: ''
+ Condition: ""
+ Rule: "145"
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '145'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "145"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
@@ -184,8 +192,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0145
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: PARAMCD has characters that are not letters, digits, and underscores
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0159/CDISC.ADaMIG.AD0159.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0159/CDISC.ADaMIG.AD0159.yml
index 8ba403b98..45e19f504 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0159/CDISC.ADaMIG.AD0159.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0159/CDISC.ADaMIG.AD0159.yml
@@ -10,18 +10,18 @@ Authorities:
Section: 3.2.5
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: 'AWTARGET is not populated'
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: "AWTARGET is not populated"
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '159'
- Version: ''
- Validator Rule Message: 'AWTDIFF is populated and AWTARGET is not populated'
- Version: '5.0'
- Version: '1.0'
+ Id: "159"
+ Version: ""
+ Validator Rule Message: "AWTDIFF is populated and AWTARGET is not populated"
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
@@ -32,18 +32,18 @@ Authorities:
Section: 3.2.5
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: 'AWTARGET is not populated'
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: "AWTARGET is not populated"
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '159'
- Version: ''
- Validator Rule Message: 'AWTDIFF is populated and AWTARGET is not populated'
- Version: '5.0'
- Version: '1.1'
+ Id: "159"
+ Version: ""
+ Validator Rule Message: "AWTDIFF is populated and AWTARGET is not populated"
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
@@ -54,18 +54,18 @@ Authorities:
Section: 3.2.5
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: 'AWTARGET is not populated'
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: "AWTARGET is not populated"
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '159'
- Version: ''
- Validator Rule Message: 'AWTDIFF is populated and AWTARGET is not populated'
- Version: '5.0'
- Version: '1.2'
+ Id: "159"
+ Version: ""
+ Validator Rule Message: "AWTDIFF is populated and AWTARGET is not populated"
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
@@ -76,42 +76,43 @@ Authorities:
Section: 3.2.5
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: 'AWTARGET is not populated'
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: "AWTARGET is not populated"
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '159'
- Version: '2'
- Validator Rule Message: 'AWTDIFF is populated and AWTARGET is not populated'
- Version: '5.0'
- Version: '1.3'
+ Id: "159"
+ Version: "2"
+ Validator Rule Message: "AWTDIFF is populated and AWTARGET is not populated"
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.Absolute
difference between ADY or ARELTM and AWTARGET.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: 'AWTARGET is not populated'
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: "AWTARGET is not populated"
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '159'
- Version: '2'
- Validator Rule Message: 'AWTDIFF is populated and AWTARGET is not populated'
- Version: '5.0'
- Version: '1.0'
+ Id: "159"
+ Version: "2"
+ Validator Rule Message: "AWTDIFF is populated and AWTARGET is not populated"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
@@ -123,8 +124,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0159
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: AWTARGET must be populated when AWTDIFF is populated
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0160/CDISC.ADaMIG.AD0160.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0160/CDISC.ADaMIG.AD0160.yml
index 796c10114..d2516e792 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0160/CDISC.ADaMIG.AD0160.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0160/CDISC.ADaMIG.AD0160.yml
@@ -15,13 +15,13 @@ Authorities:
Plain Language Expression: When AWU is present, AWLO and AWH must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '160'
- Version: ''
+ Id: "160"
+ Version: ""
Validator Rule Message: AWU is present but AWLO and AWHI are not present
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
@@ -37,15 +37,15 @@ Authorities:
Type: Failure
Origin: ADaM Conformance Rules
Related Rules:
- - Id: '896'
+ - Id: "896"
Relationship: Related
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '160'
- Version: '1.0'
+ Id: "160"
+ Version: "1.0"
Validator Rule Message: AWU is present but AWLO and AWHI are not present
- Version: '5.0'
- Version: '1.1'
+ Version: "5.0"
+ Version: "1.1"
#check logic that both need to absent for tule to fire?
@@ -67,8 +67,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0160
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: AWU is present but AWLO and AWHI are not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0163/CDISC.ADaMIG.AD0163.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0163/CDISC.ADaMIG.AD0163.yml
index c26585865..ce69b35f6 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0163/CDISC.ADaMIG.AD0163.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0163/CDISC.ADaMIG.AD0163.yml
@@ -15,13 +15,13 @@ Authorities:
Plain Language Expression: When BTOXGR is present, ATOXGR must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '163'
- Version: ''
+ Id: "163"
+ Version: ""
Validator Rule Message: BTOXGR is present but ATOXGR is not present
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
@@ -36,13 +36,13 @@ Authorities:
Plain Language Expression: When BTOXGR is present, ATOXGR must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '163'
- Version: ''
+ Id: "163"
+ Version: ""
Validator Rule Message: BTOXGR is present but ATOXGR is not present
- Version: '5.0'
- Version: '1.1'
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
@@ -58,19 +58,19 @@ Authorities:
Plain Language Expression: When BTOXGR is present, ATOXGR must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '163'
- Version: ''
+ Id: "163"
+ Version: ""
Validator Rule Message: BTOXGR is present but ATOXGR is not present
- Version: '5.0'
- Version: '1.2'
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: ATOXGR of the baseline record identified by ABLFL.
Document: ADaMIG
- Item: ''
+ Item: ""
Section: 3.3.7, Table 3.3.7.1
Criteria:
Logical Expression:
@@ -79,22 +79,23 @@ Authorities:
Plain Language Expression: When BTOXGR is present, ATOXGR must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '163'
- Version: '2'
+ Id: "163"
+ Version: "2"
Validator Rule Message: BTOXGR is present but ATOXGR is not present
- Version: '5.0'
- Version: '1.3'
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details."
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
Condition: BTOXGR is present and ATOXGR is not present
@@ -102,13 +103,13 @@ Authorities:
Plain Language Expression: When BTOXGR is present, ATOXGR must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '163'
- Version: '2'
+ Id: "163"
+ Version: "2"
Validator Rule Message: BTOXGR is present but ATOXGR is not present
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
@@ -120,8 +121,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0163
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: BTOXGR is present but ATOXGR is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0164/CDISC.ADaMIG.AD0164.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0164/CDISC.ADaMIG.AD0164.yml
index d1fe6949d..49174d2b2 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0164/CDISC.ADaMIG.AD0164.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0164/CDISC.ADaMIG.AD0164.yml
@@ -4,12 +4,13 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details."
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
Condition: BTOXGR is present and ABLFL is not present
@@ -17,13 +18,13 @@ Authorities:
Plain Language Expression: When BTOXGR is present, ABLFL must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '164'
- Version: '2'
+ Id: "164"
+ Version: "2"
Validator Rule Message: BTOXGR is present but ABLFL is not present
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
@@ -38,13 +39,13 @@ Authorities:
Plain Language Expression: When BTOXGR is present, ABLFL must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '164'
- Version: ''
+ Id: "164"
+ Version: ""
Validator Rule Message: BTOXGR is present but ABLFL is not present
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
@@ -60,13 +61,13 @@ Authorities:
Plain Language Expression: When BTOXGR is present, ABLFL must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '164'
- Version: ''
+ Id: "164"
+ Version: ""
Validator Rule Message: BTOXGR is present but ABLFL is not present
- Version: '5.0'
- Version: '1.1'
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
@@ -82,13 +83,13 @@ Authorities:
Plain Language Expression: When BTOXGR is present, ABLFL must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '164'
- Version: ''
+ Id: "164"
+ Version: ""
Validator Rule Message: BTOXGR is present but ABLFL is not present
- Version: '5.0'
- Version: '1.2'
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
@@ -104,13 +105,13 @@ Authorities:
Plain Language Expression: When BTOXGR is present, ABLFL must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '164'
- Version: ''
+ Id: "164"
+ Version: ""
Validator Rule Message: BTOXGR is present but ABLFL is not present
- Version: '5.0'
- Version: '1.3'
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -122,8 +123,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0164
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: BTOXGR is present but ABLFL is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0166/CDISC.ADaMIG.AD0166.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0166/CDISC.ADaMIG.AD0166.yml
index 7e31f9a16..7f05cec89 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0166/CDISC.ADaMIG.AD0166.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0166/CDISC.ADaMIG.AD0166.yml
@@ -4,12 +4,13 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details."
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
Condition: BNRIND is present and ANRIND is not present
@@ -17,13 +18,13 @@ Authorities:
Plain Language Expression: When BNRIND is present, ANRIND must also
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '166'
- Version: '2'
+ Id: "166"
+ Version: "2"
Validator Rule Message: BTOXGR is present but ABLFL is not present
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
@@ -38,13 +39,13 @@ Authorities:
Plain Language Expression: When BNRIND is present, ANRIND must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '166'
- Version: ''
+ Id: "166"
+ Version: ""
Validator Rule Message: BNRIND is present but ANRIND is not present
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
@@ -60,13 +61,13 @@ Authorities:
Plain Language Expression: When BNRIND is present, ANRIND must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '166'
- Version: ''
+ Id: "166"
+ Version: ""
Validator Rule Message: BNRIND is present but ANRIND is not present
- Version: '5.0'
- Version: '1.1'
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
@@ -82,13 +83,13 @@ Authorities:
Plain Language Expression: When BNRIND is present, ANRIND must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '166'
- Version: ''
+ Id: "166"
+ Version: ""
Validator Rule Message: BNRIND is present but ANRIND is not present
- Version: '5.0'
- Version: '1.2'
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
@@ -104,13 +105,13 @@ Authorities:
Plain Language Expression: When BNRIND is present, ANRIND must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '166'
- Version: '2'
+ Id: "166"
+ Version: "2"
Validator Rule Message: BNRIND is present but ANRIND is not present
- Version: '5.0'
- Version: '1.3'
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -122,8 +123,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0166
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: BNRIND is present but ANRIND is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0167/CDISC.ADaMIG.AD0167.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0167/CDISC.ADaMIG.AD0167.yml
index d754f9319..df83cb0bf 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0167/CDISC.ADaMIG.AD0167.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0167/CDISC.ADaMIG.AD0167.yml
@@ -4,12 +4,13 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details."
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
Condition: BNRIND is present and ABLFL is not present
@@ -17,13 +18,13 @@ Authorities:
Plain Language Expression: When BNRIND is present, ABLFL must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '167'
- Version: '2'
+ Id: "167"
+ Version: "2"
Validator Rule Message: BNRIND is present but ABLFL is not present
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
@@ -38,13 +39,13 @@ Authorities:
Plain Language Expression: When BNRIND is present, ABLFL must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '167'
- Version: '1'
+ Id: "167"
+ Version: "1"
Validator Rule Message: BNRIND is present but ABLFL is not present
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
@@ -60,13 +61,13 @@ Authorities:
Plain Language Expression: When BNRIND is present, ABLFL must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '167'
- Version: '1'
+ Id: "167"
+ Version: "1"
Validator Rule Message: BNRIND is present but ABLFL is not present
- Version: '5.0'
- Version: '1.1'
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
@@ -82,13 +83,13 @@ Authorities:
Plain Language Expression: When BNRIND is present, ABLFL must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '167'
- Version: '1'
+ Id: "167"
+ Version: "1"
Validator Rule Message: BNRIND is present but ABLFL is not present
- Version: '5.0'
- Version: '1.2'
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
@@ -104,13 +105,13 @@ Authorities:
Plain Language Expression: When BNRIND is present, ABLFL must also be present
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '167'
- Version: '2'
+ Id: "167"
+ Version: "2"
Validator Rule Message: BNRIND is present but ABLFL is not present
- Version: '5.0'
- Version: '1.3'
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -122,8 +123,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0167
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: BNRIND is present but ABLFL is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0169/CDISC.ADaMIG.AD0169.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0169/CDISC.ADaMIG.AD0169.yml
index c5afadb06..8ab073d8c 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0169/CDISC.ADaMIG.AD0169.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0169/CDISC.ADaMIG.AD0169.yml
@@ -4,12 +4,13 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details."
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
Condition: Event indicator value is a positive integer greater or equal to zero
@@ -17,16 +18,17 @@ Authorities:
Plain Language Expression: CNSR value must be whole numbers greater then/equal to zero
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '169'
- Version: '2'
+ Id: "169"
+ Version: "2"
Validator Rule Message: CNSR value is not an integer >= 0
- Version: '5.0'
+ Version: "5.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: It is strongly recommended to use 0 as an event indicator and
+ - Cited Guidance:
+ It is strongly recommended to use 0 as an event indicator and
positive integers as censoring indicators
Document: ADaMIG
Item: Table 3.2.5.3
@@ -38,17 +40,18 @@ Authorities:
Plain Language Expression: CNSR value must be whole numbers greater then/equal to zero
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '169'
- Version: '1'
+ Id: "169"
+ Version: "1"
Validator Rule Message: CNSR value is not an integer >= 0
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: It is strongly recommended to use 0 as an event indicator and
+ - Cited Guidance:
+ It is strongly recommended to use 0 as an event indicator and
positive integers as censoring indicators
Document: ADaMIG
Item: Table 3.3.6.1
@@ -60,17 +63,18 @@ Authorities:
Plain Language Expression: CNSR value must be whole numbers greater then/equal to zero
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '169'
- Version: '1'
+ Id: "169"
+ Version: "1"
Validator Rule Message: CNSR value is not an integer >= 0
- Version: '5.0'
- Version: '1.1'
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: It is strongly recommended to use 0 as an event indicator and
+ - Cited Guidance:
+ It is strongly recommended to use 0 as an event indicator and
positive integers as censoring indicators
Document: ADaMIG
Item: Table 3.3.6.1
@@ -82,17 +86,18 @@ Authorities:
Plain Language Expression: CNSR value must be whole numbers greater then/equal to zero
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '169'
- Version: '1'
+ Id: "169"
+ Version: "1"
Validator Rule Message: CNSR value is not an integer >= 0
- Version: '5.0'
- Version: '1.2'
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: It is strongly recommended to use 0 as an event indicator and
+ - Cited Guidance:
+ It is strongly recommended to use 0 as an event indicator and
positive integers as censoring indicators
Document: ADaMIG
Item: Table 3.3.6.1
@@ -104,13 +109,13 @@ Authorities:
Plain Language Expression: CNSR value must be whole numbers greater then/equal to zero
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '169'
- Version: '2'
+ Id: "169"
+ Version: "2"
Validator Rule Message: CNSR value is not an integer >= 0
- Version: '5.0'
- Version: '1.3'
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -121,8 +126,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0169
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: CNSR value is not an integer >= 0
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0176/CDISC.ADaMIG.AD0176.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0176/CDISC.ADaMIG.AD0176.yml
index 42150bbd7..d88757a0f 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0176/CDISC.ADaMIG.AD0176.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0176/CDISC.ADaMIG.AD0176.yml
@@ -4,7 +4,7 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: 'Codelist/Controlled Terms: Y {Y, NULL}'
+ - Cited Guidance: "Codelist/Controlled Terms: Y {Y, NULL}"
Document: ADaMIG
Item: Table 3.2.6.1
Section: 3.2.6
@@ -15,17 +15,17 @@ Authorities:
Plain Language Expression: ABLFL is equal to Y or missing
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '176'
- Version: ''
+ Id: "176"
+ Version: ""
Validator Rule Message: ABLFL must equal to Y or missing
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: 'Codelist/Controlled Terms: Y {Y, NULL}'
+ - Cited Guidance: "Codelist/Controlled Terms: Y {Y, NULL}"
Document: ADaMIG
Item: Table 3.3.8.1
Section: 3.3.8
@@ -36,13 +36,13 @@ Authorities:
Plain Language Expression: ABLFL is equal to Y or missing
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '176'
- Version: ''
+ Id: "176"
+ Version: ""
Validator Rule Message: ABLFL must equal to Y or missing
- Version: '5.0'
- Version: '1.1'
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
- name: ABLFL
@@ -53,8 +53,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0176
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ABLFL is not equal to Y or missing
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0178/CDISC.ADaMIG.AD0178.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0178/CDISC.ADaMIG.AD0178.yml
index 29c266df1..7b2a5a0b6 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0178/CDISC.ADaMIG.AD0178.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0178/CDISC.ADaMIG.AD0178.yml
@@ -4,28 +4,28 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: 'Codelist/Controlled Terms: Y {Y, NULL}'
+ - Cited Guidance: "Codelist/Controlled Terms: Y {Y, NULL}"
Document: ADaMIG
Item: Table 3.2.6.1
Section: 3.2.6
Criteria:
Logical Expression:
- Condition: ''
+ Condition: ""
Rule: ANLzzzL is equal to Y or null
Plain Language Expression: ANLzzFL is equal to Y or missing
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '178'
- Version: ''
+ Id: "178"
+ Version: ""
Validator Rule Message: ANLzzFL must equal to Y or missing
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: 'Codelist/Controlled Terms: Y {Y, NULL}'
+ - Cited Guidance: "Codelist/Controlled Terms: Y {Y, NULL}"
Document: ADaMIG
Item: Table 3.3.8.1
Section: 3.3.8
@@ -36,22 +36,22 @@ Authorities:
Plain Language Expression: ANLzzFL is equal to Y or missing
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '178'
- Version: ''
+ Id: "178"
+ Version: ""
Validator Rule Message: ANLzzFL must equal to Y or missing
- Version: '5.0'
- Version: '1.1'
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
- name: variable_name
operator: matches_regex
- value: 'AN/[0-9]/[0-9]/FL'
- - name: &variable_name #how to refer to return variable from first check?
+ value: "AN/[0-9]/[0-9]/FL"
+ - name: &variable_name #how to refer to return variable from first check?
operator: is_not_contained_by
value:
- - 'Y'
+ - "Y"
#or
# all:
@@ -63,12 +63,11 @@ Check:
# value:
# - 'Y'
-
Core:
Id: CDISC.ADaMIG.AD0178
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ANLzzFL is not equal to Y or missing
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0194/CDISC.ADaMIG.AD0194.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0194/CDISC.ADaMIG.AD0194.yml
index 9c9cd31e6..7bfa0c490 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0194/CDISC.ADaMIG.AD0194.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0194/CDISC.ADaMIG.AD0194.yml
@@ -4,25 +4,26 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '194'
- Version: '2'
+ Id: "194"
+ Version: "2"
Validator Rule Message: PARAM must be present
- Version: '5.0'
+ Version: "5.0"
- Name: ADaMIG
References:
- Citations:
@@ -32,18 +33,18 @@ Authorities:
Section: 3.2.4
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '194'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "194"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
@@ -53,62 +54,64 @@ Authorities:
Section: 3.3.4
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '194'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "194"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: PARAM has Core=Req and PARAM must be present and populated on
+ - Cited Guidance:
+ PARAM has Core=Req and PARAM must be present and populated on
every record in a BDS dataset.
Document: ADaMIG
Item: Table 3.3.4.1.1
Section: 3.3.4.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '194'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "194"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: PARAM has Core=Req and PARAM must be present and populated on
+ - Cited Guidance:
+ PARAM has Core=Req and PARAM must be present and populated on
every record in a BDS dataset.
Document: ADaMIG
Item: Table 3.3.4.1.1
Section: 3.3.4.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '194'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "194"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
- name: PARAM
@@ -116,8 +119,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0194
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: PARAM is not present in dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0195/CDISC.ADaMIG.AD0195.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0195/CDISC.ADaMIG.AD0195.yml
index e1513e920..8a31d6916 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0195/CDISC.ADaMIG.AD0195.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0195/CDISC.ADaMIG.AD0195.yml
@@ -4,25 +4,26 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '195'
- Version: '2'
+ Id: "195"
+ Version: "2"
Validator Rule Message: PARAMCD must be present
- Version: '5.0'
+ Version: "5.0"
- Name: ADaMIG
References:
- Citations:
@@ -32,18 +33,18 @@ Authorities:
Section: 3.2.4.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '195'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "195"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
@@ -53,62 +54,64 @@ Authorities:
Section: 3.3.4
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '195'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "195"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: PARAMCD has Core=Req and PARAMCD must be present and populated
+ - Cited Guidance:
+ PARAMCD has Core=Req and PARAMCD must be present and populated
on every record in a BDS dataset.
Document: ADaMIG
Item: Table 3.3.4.1.1
Section: 3.3.4.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '195'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "195"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: PARAMCD has Core=Req and PARAMCD must be present and populated
+ - Cited Guidance:
+ PARAMCD has Core=Req and PARAMCD must be present and populated
on every record in a BDS dataset.
Document: ADaMIG
Item: Table 3.3.4.1.1
Section: 3.3.4.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '195'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "195"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
- name: PARAMCD
@@ -116,8 +119,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0195
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: PARAMCD is not present in dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0196/CDISC.ADaMIG.AD0196.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0196/CDISC.ADaMIG.AD0196.yml
index 01fbd6476..cf23727b3 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0196/CDISC.ADaMIG.AD0196.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0196/CDISC.ADaMIG.AD0196.yml
@@ -4,55 +4,58 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '196'
- Version: '2'
+ Id: "196"
+ Version: "2"
Validator Rule Message: PARAM must be present
- Version: '5.0'
+ Version: "5.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: -< 'The ADaM document introduces the ADaM Basic Data Structure.
+ - Cited Guidance:
+ -< 'The ADaM document introduces the ADaM Basic Data Structure.
A BDS dataset contains one or more records per subject, per
analysis parameter, per analysis timepoint. Analysis timepoint
is conditionally required, depending on the analysis. In
situations where there is no analysis timepoint, the structure
is one or more records per subject per analysis parameter.'
Document: ADaMIG
- Item: ''
- Section: '3.2'
+ Item: ""
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '196'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "196"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: -< 'The ADaM model document introduces the ADaM Basic Data
+ - Cited Guidance:
+ -< 'The ADaM model document introduces the ADaM Basic Data
Structure. A BDS dataset contains one or more records per
subject, per analysis parameter, per analysis timepoint.
Analysis timepoint is conditionally required, depending on the
@@ -60,66 +63,68 @@ Authorities:
the structure is one or more records per subject per analysis
parameter''
Document: ADaMIG
- Item: ''
- Section: '3.3'
+ Item: ""
+ Section: "3.3"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '196'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "196"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: -< 'PARAM has Core=Req and PARAM must be present and populated
+ - Cited Guidance:
+ -< 'PARAM has Core=Req and PARAM must be present and populated
on every record in a BDS dataset.'
Document: ADaMIG
Item: Table 3.3.4.1.1
Section: 3.3.4.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '196'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "196"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: -< 'PARAM has Core=Req and PARAM must be present and populated
+ - Cited Guidance:
+ -< 'PARAM has Core=Req and PARAM must be present and populated
on every record in a BDS dataset.'
Document: ADaMIG
Item: Table 3.3.4.1.1
Section: 3.3.4.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '196'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "196"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
- name: PARAM
@@ -127,8 +132,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0196
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: PARAM must be populated for all records in dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0197/CDISC.ADaMIG.AD0197.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0197/CDISC.ADaMIG.AD0197.yml
index ce40afced..0e52289ee 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0197/CDISC.ADaMIG.AD0197.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0197/CDISC.ADaMIG.AD0197.yml
@@ -4,29 +4,31 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '197'
- Version: '2'
+ Id: "197"
+ Version: "2"
Validator Rule Message: PARAMCD must be populated
- Version: '5.0'
+ Version: "5.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: -< 'The ADaM model document introduces the ADaM Basic Data
+ - Cited Guidance:
+ -< 'The ADaM model document introduces the ADaM Basic Data
Structure. A BDS dataset contains one or more records per
subject, per analysis parameter, per analysis timepoint.
Analysis timepoint is conditionally required, depending on the
@@ -34,26 +36,27 @@ Authorities:
the structure is one or more records per subject per analysis
parameter.'
Document: ADaMIG
- Item: ''
- Section: '3.3'
+ Item: ""
+ Section: "3.3"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '197'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "197"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: -< 'The ADaM model document introduces the ADaM Basic Data
+ - Cited Guidance:
+ -< 'The ADaM model document introduces the ADaM Basic Data
Structure. A BDS dataset contains one or more records per
subject, per analysis parameter, per analysis timepoint.
Analysis timepoint is conditionally required, depending on the
@@ -61,66 +64,68 @@ Authorities:
the structure is one or more records per subject per analysis
parameter.'
Document: ADaMIG
- Item: ''
- Section: '3.3'
+ Item: ""
+ Section: "3.3"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '197'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "197"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: -< 'PARAMCD has Core=Req and PARAMCD must be present and
+ - Cited Guidance:
+ -< 'PARAMCD has Core=Req and PARAMCD must be present and
populated on every record in a BDS dataset.'
Document: ADaMIG
Item: Table 3.3.4.1.1
Section: 3.3.4.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '197'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "197"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: -< 'PARAMCD has Core=Req and PARAMCD must be present and
+ - Cited Guidance:
+ -< 'PARAMCD has Core=Req and PARAMCD must be present and
populated on every record in a BDS dataset.'
Document: ADaMIG
Item: Table 3.3.4.1.1
Section: 3.3.4.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '197'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "197"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
- name: PARAMCD
@@ -128,8 +133,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0197
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: PARAMCD must be populted for ecery record in the dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0198/CDISC.ADaMIG.AD0198.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0198/CDISC.ADaMIG.AD0198.yml
index f512903b9..48203da1b 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0198/CDISC.ADaMIG.AD0198.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0198/CDISC.ADaMIG.AD0198.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '198'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "198"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
@@ -33,18 +34,18 @@ Authorities:
Section: 3.2.4
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '198'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "198"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
@@ -54,65 +55,67 @@ Authorities:
Section: 3.3.4
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '198'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "198"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: AVALC is required if AVAL is not present, since either AVAL or
+ - Cited Guidance:
+ AVALC is required if AVAL is not present, since either AVAL or
AVALC must be present in the dataset.
Document: ADaMIG
Item: Table 3.3.4.1.1
Section: 3.3.4.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
#Related Rules:
# - Id: ''
# Relationship: Predecessor | Related | Successor
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '198'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "198"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: AVALC is required if AVAL is not present, since either AVAL or
+ - Cited Guidance:
+ AVALC is required if AVAL is not present, since either AVAL or
AVALC must be present in the dataset.
Document: ADaMIG
Item: Table 3.3.4.1.1
Section: 3.3.4.1
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '198'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "198"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
- name: AVALC
@@ -122,8 +125,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0198
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: AVAL or AVALC must be present in dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0204/CDISC.ADaMIG.AD0204.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0204/CDISC.ADaMIG.AD0204.yml
index 9fe69064c..c11e72e25 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0204/CDISC.ADaMIG.AD0204.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0204/CDISC.ADaMIG.AD0204.yml
@@ -4,91 +4,95 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: If the variable is not a copy of DM.AGE, then an additional
+ - Cited Guidance:
+ If the variable is not a copy of DM.AGE, then an additional
differently named variable must be added.
Document: ADaMIG
Item: Table 3.1.1
- Section: '3.1'
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '204'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "204"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: When the value of ADSL.USUBJID is equal to the value of
+ - Cited Guidance:
+ When the value of ADSL.USUBJID is equal to the value of
DM.USUBJID, ADSL.AGE must equal to DM.AGE
Document: ADaMIG
- Item: 'Table 3.2.2: DM.AGE'
- Section: '3.2'
+ Item: "Table 3.2.2: DM.AGE"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '204'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "204"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: When the value of ADSL.USUBJID is equal to the value of
+ - Cited Guidance:
+ When the value of ADSL.USUBJID is equal to the value of
DM.USUBJID, ADSL.AGE must equal to DM.AGE
Document: ADaMIG
- Item: 'Table 3.2.2: DM.AGE'
- Section: '3.2'
+ Item: "Table 3.2.2: DM.AGE"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '204'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "204"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: When the value of ADSL.USUBJID is equal to the value of
+ - Cited Guidance:
+ When the value of ADSL.USUBJID is equal to the value of
DM.USUBJID, ADSL.AGE must equal to DM.AGE
Document: ADaMIG
- Item: 'Table 3.2.2: DM.AGE'
- Section: '3.2'
+ Item: "Table 3.2.2: DM.AGE"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '204'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "204"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
# - name: USUBJID
@@ -100,8 +104,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0204
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Match Datasets:
- Keys:
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0211/CDISC.ADaMIG.AD0211.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0211/CDISC.ADaMIG.AD0211.yml
index 70f02599c..c5898552c 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0211/CDISC.ADaMIG.AD0211.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0211/CDISC.ADaMIG.AD0211.yml
@@ -4,52 +4,52 @@ Authorities:
- Organization: CDISC
Standards:
- Name: ADaMIG
- Version: '1.3'
+ Version: "1.3"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '211'
- Version: '1.0'
+ Id: "211"
+ Version: "1.0"
Citations:
- Cited Guidance: Codelist/Controlled Terms 1 {1,NULL}
Document: ADaM IG v1.3
Section: 3.3.8
Item: Table 3.3.8.1
- Name: ADaMIG
- Version: '1.2'
+ Version: "1.2"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '211'
- Version: '1.0'
+ Id: "211"
+ Version: "1.0"
Citations:
- Cited Guidance: Codelist/Controlled Terms 1 {1,NULL}
Document: ADaM IG v1.2
Section: 3.3.8
Item: Table 3.3.8.1
- Name: ADaMIG
- Version: '1.1'
+ Version: "1.1"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '211'
- Version: '1.0'
+ Id: "211"
+ Version: "1.0"
Citations:
- Cited Guidance: Codelist/Controlled Terms 1 {1,NULL}
Document: ADaM IG v1.1
Section: 3.3.8
Item: Table 3.3.8.1
- Name: ADaMIG
- Version: '1.0'
+ Version: "1.0"
References:
- Origin: ADaM Conformance Rules
- Version: '4.0'
+ Version: "4.0"
Rule Identifier:
- Id: '211'
- Version: '1.0'
+ Id: "211"
+ Version: "1.0"
Citations:
- Cited Guidance: Codelist/Controlled Terms 1 {1,NULL}
Document: ADaM IG v1.0
@@ -65,7 +65,7 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0211
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when ABLFN is not equal to 1 or null
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0252b/CDISC.ADaMIG.AD0252b.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0252b/CDISC.ADaMIG.AD0252b.yml
index 2c5aa6e1c..e9541e8e2 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0252b/CDISC.ADaMIG.AD0252b.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0252b/CDISC.ADaMIG.AD0252b.yml
@@ -4,209 +4,218 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the OCCDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '252'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "252"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.1
- Item: '1'
- Section: '1.1.2.1'
+ Item: "1"
+ Section: "1.1.2.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '252'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "252"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.0
- Item: ''
- Section: '1.1'
+ Item: ""
+ Section: "1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '252'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "252"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Version: '1.3'
+ Version: "1.3"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.1
- Item: '1'
- Section: '1.1.2.1'
+ Item: "1"
+ Section: "1.1.2.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '252'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "252"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.0
- Item: ''
- Section: '1.1'
+ Item: ""
+ Section: "1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '252'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "252"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.1
- Item: '1'
- Section: '1.1.2.1'
+ Item: "1"
+ Section: "1.1.2.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '252'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "252"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.0
- Item: ''
- Section: '1.1'
+ Item: ""
+ Section: "1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '252'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "252"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Version: '1.1'
+ Version: "1.1"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.1
- Item: '1'
- Section: '1.1.2.1'
+ Item: "1"
+ Section: "1.1.2.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '252'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "252"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.0
- Item: ''
- Section: '1.1'
+ Item: ""
+ Section: "1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '252'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "252"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
@@ -217,8 +226,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0252b
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: AVAL or AVALC must not be present in dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254/CDISC.ADaMIG.AD0254.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254/CDISC.ADaMIG.AD0254.yml
index a50e46537..b44046ae4 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254/CDISC.ADaMIG.AD0254.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254/CDISC.ADaMIG.AD0254.yml
@@ -4,193 +4,194 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the OCCDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "254"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-There is no PARAM nor AVAL
Document: OCCDS v1.1
- Item: ''
- Section: '3.2'
+ Item: ""
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "254"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- Cited Guidance: <- There is no PARAM nor AVAL
Document: OCCDS v1.0
- Item: ''
- Section: '3.2'
+ Item: ""
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "254"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-There is no PARAM nor AVAL
Document: OCCDS v1.1
- Item: ''
- Section: '3.2'
+ Item: ""
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "254"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- Cited Guidance: <-There is no PARAM nor AVAL
Document: OCCDS v1.0
- Item: ''
- Section: '3.2'
+ Item: ""
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "254"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-TThere is no PARAM nor AVAL
Document: OCCDS v1.1
- Item: ''
- Section: '3.2'
+ Item: ""
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "254"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- Cited Guidance: <-There is no PARAM nor AVAL
Document: OCCDS v1.0
- Item: ''
- Section: '3.2'
+ Item: ""
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "254"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Version: '1.1'
+ Version: "1.1"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-There is no PARAM nor AVAL
Document: OCCDS v1.1
- Item: ''
- Section: '3.2'
+ Item: ""
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "254"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-There is no PARAM nor AVAL
Document: OCCDS v1.0
- Item: ''
- Section: '3.2'
+ Item: ""
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "254"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
@@ -200,8 +201,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0254
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: PARAM must not be present in Occurence dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254b/CDISC.ADaMIG.AD0254b.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254b/CDISC.ADaMIG.AD0254b.yml
index 4ea1af004..aa09549d4 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254b/CDISC.ADaMIG.AD0254b.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254b/CDISC.ADaMIG.AD0254b.yml
@@ -4,209 +4,218 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the OCCDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "254"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.1
- Item: '1'
- Section: '1.1.2.1'
+ Item: "1"
+ Section: "1.1.2.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "254"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.0
- Item: ''
- Section: '1.1'
+ Item: ""
+ Section: "1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "254"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Version: '1.3'
+ Version: "1.3"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.1
- Item: '1'
- Section: '1.1.2.1'
+ Item: "1"
+ Section: "1.1.2.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "254"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.0
- Item: ''
- Section: '1.1'
+ Item: ""
+ Section: "1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "254"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.1
- Item: '1'
- Section: '1.1.2.1'
+ Item: "1"
+ Section: "1.1.2.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "254"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.0
- Item: ''
- Section: '1.1'
+ Item: ""
+ Section: "1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "254"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Version: '1.1'
+ Version: "1.1"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.1
- Item: '1'
- Section: '1.1.2.1'
+ Item: "1"
+ Section: "1.1.2.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "254"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in
+ - Cited Guidance:
+ <-There is no need for AVAL or AVALC. Occurrences are counted in
analysis, and there are typically one or more records for each
occurrence assessment.
Document: OCCDS v1.0
- Item: ''
- Section: '1.1'
+ Item: ""
+ Section: "1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '254'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "254"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
@@ -217,8 +226,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0254b
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: AVAL or AVALC must not be present in dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0268/CDISC.ADaMIG.AD0268.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0268/CDISC.ADaMIG.AD0268.yml
index deb91b1c6..fc32ad68f 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0268/CDISC.ADaMIG.AD0268.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0268/CDISC.ADaMIG.AD0268.yml
@@ -4,203 +4,212 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and allowing USUBJID to be a
conditionally required variable. See the OCCDS class for
further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '268'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "268"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN
+ - Cited Guidance:
+ <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN
is included"
Document: OCCDS v1.1
- Item: 'Table 3.2.4.1'
- Section: '3.2.4'
+ Item: "Table 3.2.4.1"
+ Section: "3.2.4"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '268'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "268"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether
+ - Cited Guidance:
+ <- CDISC Notes for ADURU state':'' "Conditional on whether
ADURN is included and units are not included in the label of
ADURN".
Document: OCCDS v1.0
- Item: 'Table 3.2.4.1'
- Section: '3.2.4'
+ Item: "Table 3.2.4.1"
+ Section: "3.2.4"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '268'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "268"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN
+ - Cited Guidance:
+ <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN
is included"
Document: OCCDS v1.1
- Item: 'Table 3.2.4.1'
- Section: '3.2.4'
+ Item: "Table 3.2.4.1"
+ Section: "3.2.4"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '268'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "268"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether
+ - Cited Guidance:
+ <- CDISC Notes for ADURU state':'' "Conditional on whether
ADURN is included and units are not included in the label of
ADURN".
Document: OCCDS v1.0
- Item: 'Table 3.2.4.1'
- Section: '3.2.4'
+ Item: "Table 3.2.4.1"
+ Section: "3.2.4"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '268'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "268"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN
+ - Cited Guidance:
+ <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN
is included"
Document: OCCDS v1.1
- Item: 'Table 3.2.4.1'
- Section: '3.2.4'
+ Item: "Table 3.2.4.1"
+ Section: "3.2.4"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '268'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "268"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether
+ - Cited Guidance:
+ <- CDISC Notes for ADURU state':'' "Conditional on whether
ADURN is included and units are not included in the label of
ADURN".
Document: OCCDS v1.0
- Item: 'Table 3.2.4.1'
- Section: '3.2.4'
+ Item: "Table 3.2.4.1"
+ Section: "3.2.4"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '268'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "268"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN
+ - Cited Guidance:
+ <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN
is included"
Document: OCCDS v1.1
- Item: 'Table 3.2.4.1'
- Section: '3.2.4'
+ Item: "Table 3.2.4.1"
+ Section: "3.2.4"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '268'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "268"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether
+ - Cited Guidance:
+ <- CDISC Notes for ADURU state':'' "Conditional on whether
ADURN is included and units are not included in the label of
ADURN".
Document: OCCDS v1.0
- Item: 'Table 3.2.4.1'
- Section: '3.2.4'
+ Item: "Table 3.2.4.1"
+ Section: "3.2.4"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '268'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "268"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
@@ -212,8 +221,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0268
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ADURN must be populated when ADURN is not missing
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0269/CDISC.ADaMIG.AD0269.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0269/CDISC.ADaMIG.AD0269.yml
index c9e9e2f2b..e5f5ef3d2 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0269/CDISC.ADaMIG.AD0269.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0269/CDISC.ADaMIG.AD0269.yml
@@ -4,201 +4,202 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and allowing USUBJID as a conditionally
required variable. See the OCCDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '269'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "269"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.3'
- Section: '3.2.5'
+ Item: "Table 3.2.5.3"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '269'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "269"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- Cited Guidance: <- Code List / Controlled Terms have allowable values of':' "Y"
Document: OCCDS v1.0
- Item: 'Table 3.2.5.3'
- Section: '3.2.5'
+ Item: "Table 3.2.5.3"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '269'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "269"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.3'
- Section: '3.2.5'
+ Item: "Table 3.2.5.3"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '269'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "269"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.0
- Item: 'Table 3.2.5.3'
- Section: '3.2.5'
+ Item: "Table 3.2.5.3"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '269'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "269"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.3'
- Section: '3.2.5'
+ Item: "Table 3.2.5.3"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '269'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "269"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.3'
- Section: '3.2.5'
+ Item: "Table 3.2.5.3"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '269'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "269"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Version: '1.1'
+ Version: "1.1"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.3'
- Section: '3.2.5'
+ Item: "Table 3.2.5.3"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '269'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "269"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.3'
- Section: '3.2.5'
+ Item: "Table 3.2.5.3"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '269'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "269"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: TRTEMFL
operator: is_not_contained_by
value:
- - 'Y'
- - ''
+ - "Y"
+ - ""
# - name: TRTEMFL
# operator: non_empty
# - name: TRTEMFL
@@ -207,8 +208,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0269
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: TRTEMFL is not equal to Y or null
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0270/CDISC.ADaMIG.AD0270.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0270/CDISC.ADaMIG.AD0270.yml
index 2ac532db0..e38a3f166 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0270/CDISC.ADaMIG.AD0270.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0270/CDISC.ADaMIG.AD0270.yml
@@ -4,201 +4,202 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and allowing USUBJID as a conditionally
required variable. See the OCCDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '270'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "270"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '270'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "270"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- Cited Guidance: <- Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.0
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '270'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "270"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '270'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "270"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.0
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '270'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "270"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '270'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "270"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '270'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "270"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Version: '1.1'
+ Version: "1.1"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '270'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "270"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '270'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "270"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: PREFL
operator: is_not_contained_by
value:
- - 'Y'
- - ''
+ - "Y"
+ - ""
# - name: TRTEMFL
# operator: non_empty
# - name: TRTEMFL
@@ -207,8 +208,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0270
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: PREFL is not equal to Y or null
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0271/CDISC.ADaMIG.AD0271.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0271/CDISC.ADaMIG.AD0271.yml
index 43f9e3b47..8c3a45c3e 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0271/CDISC.ADaMIG.AD0271.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0271/CDISC.ADaMIG.AD0271.yml
@@ -4,201 +4,202 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and allowing USUBJID as a conditionally
required variable. See the OCCDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '271'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "271"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '271'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "271"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- Cited Guidance: <- Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.0
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '271'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "271"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '271'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "271"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.0
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '271'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "271"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '271'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "271"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '271'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "271"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Version: '1.1'
+ Version: "1.1"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '271'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "271"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y"
Document: OCCDS v1.1
- Item: 'Table 3.2.5.5'
- Section: '3.2.5'
+ Item: "Table 3.2.5.5"
+ Section: "3.2.5"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '271'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "271"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: FUPFL
operator: is_not_contained_by
value:
- - 'Y'
- - ''
+ - "Y"
+ - ""
# - name: FUPFL
# operator: non_empty
# - name: FUPFL
@@ -207,8 +208,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0271
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: FUPFL not equal to Y or null
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0279/CDISC.ADaMIG.AD0279.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0279/CDISC.ADaMIG.AD0279.yml
index 9fbe78790..b714d009b 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0279/CDISC.ADaMIG.AD0279.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0279/CDISC.ADaMIG.AD0279.yml
@@ -1,11 +1,11 @@
Authorities:
- Organization: CDISC
Standards:
-
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: -< In a pair of corresponding variables (e.g., TRTP and TRTPN),
+ - Cited Guidance:
+ -< In a pair of corresponding variables (e.g., TRTP and TRTPN),
the primary or most commonly used variable does not have the
suffix or extension (i.e., N for Numeric or C for Character).
The relevant suffix is used only on the name of the secondary
@@ -19,93 +19,97 @@ Authorities:
one-to-one relationship between the values of the two
variables, as described in Item 5 above.
Document: ADaMIG-MD v1.0
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '279'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "279"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and allowing USUBJID as a conditionally
required variable. See the OCCDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '279'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "279"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code
+ - Cited Guidance:
+ <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code
List / Controlled Terms have allowable values of ';' "1, 2,
3".
Document: OCCDS v1.1
- Item: 'Table 3.2.8.1'
- Section: '3.2.8'
+ Item: "Table 3.2.8.1"
+ Section: "3.2.8"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '279'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "279"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code
+ - Cited Guidance:
+ <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code
List / Controlled Terms have allowable values of ';' "1, 2,
3".
Document: OCCDS v1.0
- Item: 'Table 3.2.8.1'
- Section: '3.2.8'
+ Item: "Table 3.2.8.1"
+ Section: "3.2.8"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '279'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "279"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: -< In a pair of corresponding variables (e.g., TRTP and TRTPN),
+ - Cited Guidance:
+ -< In a pair of corresponding variables (e.g., TRTP and TRTPN),
the primary or most commonly used variable does not have the
suffix or extension (i.e., N for Numeric or C for Character).
The relevant suffix is used only on the name of the secondary
@@ -119,70 +123,73 @@ Authorities:
one-to-one relationship between the values of the two
variables, as described in Item 5 above.
Document: ADaMIG-MD v1.0
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '279'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "279"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code
+ - Cited Guidance:
+ <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code
List / Controlled Terms have allowable values of ';' "1, 2,
3".
Document: OCCDS v1.1
- Item: 'Table 3.2.8.1'
- Section: '3.2.8'
+ Item: "Table 3.2.8.1"
+ Section: "3.2.8"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '279'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "279"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code
+ - Cited Guidance:
+ <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code
List / Controlled Terms have allowable values of ';' "1, 2,
3".
Document: OCCDS v1.0
- Item: 'Table 3.2.8.1'
- Section: '3.2.8'
+ Item: "Table 3.2.8.1"
+ Section: "3.2.8"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '279'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "279"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: -< In a pair of corresponding variables (e.g., TRTP and TRTPN),
+ - Cited Guidance:
+ -< In a pair of corresponding variables (e.g., TRTP and TRTPN),
the primary or most commonly used variable does not have the
suffix or extension (e.g., N for Numeric or C for Character).
The relevant suffix is used only on the name of the
@@ -197,70 +204,73 @@ Authorities:
the values of the two variables, as described in ADaMIG v1.1,
Section 3.1.1, Item 5.
Document: ADaMIG-MD v1.0
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '279'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "279"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code
+ - Cited Guidance:
+ <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code
List / Controlled Terms have allowable values of ';' "1, 2,
3".
Document: OCCDS v1.1
- Item: 'Table 3.2.8.1'
- Section: '3.2.8'
+ Item: "Table 3.2.8.1"
+ Section: "3.2.8"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '279'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "279"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code
+ - Cited Guidance:
+ <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code
List / Controlled Terms have allowable values of ';' "1, 2,
3".
Document: OCCDS v1.0
- Item: 'Table 3.2.8.1'
- Section: '3.2.8'
+ Item: "Table 3.2.8.1"
+ Section: "3.2.8"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '279'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "279"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: -< In general, if SDTM character variables are converted to
+ - Cited Guidance:
+ -< In general, if SDTM character variables are converted to
numeric variables in ADaM datasets, then they should be named
as they are in the SDTM with an "N" suffix added. For example,
the numeric version of the DM SEX variable is SEXN in an ADaM
@@ -272,61 +282,61 @@ Authorities:
character variables. Note also that this convention does not
apply to date/time variables.
Document: ADaMIG-MD v1.0
- Item: '9 (General Variable Naming Conventions)'
- Section: '3.1.1'
+ Item: "9 (General Variable Naming Conventions)"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '279'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "279"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: OCCDS
References:
- Citations:
- Cited Guidance: <-CDISC Notes for AESEVN state':' "Code AE.AESEV to numeric".
Document: OCCDS v1.1
- Item: 'Table 3.2.8.1'
- Section: '3.2.8'
+ Item: "Table 3.2.8.1"
+ Section: "3.2.8"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '279'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "279"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- Cited Guidance: <-CDISC Notes for AESEVN state':' "Code AE.AESEV to numeric".
Document: OCCDS v1.0
- Item: 'Table 3.2.8.1'
- Section: '3.2.8'
+ Item: "Table 3.2.8.1"
+ Section: "3.2.8"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '279'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "279"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
@@ -348,8 +358,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0279
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: AESEVN not equal to Y or null
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0363/CDISC.ADaMIG.AD0363.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0363/CDISC.ADaMIG.AD0363.yml
index 06892e45f..93262ab8e 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0363/CDISC.ADaMIG.AD0363.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0363/CDISC.ADaMIG.AD0363.yml
@@ -4,29 +4,31 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: Code List / Controlled Terms for ONTRTFL have allowable values
+ - Cited Guidance:
+ Code List / Controlled Terms for ONTRTFL have allowable values
of':' "Y"
Document: ADaMIG
Item: Table 3.2.6.1
Section: 3.2.6
Criteria:
Logical Expression:
- Condition: ''
+ Condition: ""
Rule: ONTRTFL have allowable values of "Y"
Plain Language Expression: ONTRTFL is equal to Y
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '363'
- Version: ''
+ Id: "363"
+ Version: ""
Validator Rule Message: ONTRTFL can only have values of "Y"
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: Code List / Controlled Terms for ONTRTFL have allowable values
+ - Cited Guidance:
+ Code List / Controlled Terms for ONTRTFL have allowable values
of':' "Y"
Document: ADaMIG
Item: Table 3.3.8.1
@@ -38,13 +40,13 @@ Authorities:
Plain Language Expression: ONTRTFL is equal to Y or missing
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '363'
- Version: ''
+ Id: "363"
+ Version: ""
Validator Rule Message: ONTRTFL must equal to Y or missing
- Version: '5.0'
- Version: '1.1'
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
- name: ONTRTFL
@@ -52,13 +54,13 @@ Check:
- name: ONTRTFL
operator: is_not_contained_by
value:
- - 'Y'
+ - "Y"
Core:
Id: CDISC.ADaMIG.AD0363
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ONTRTFL is not equal to Y or missing
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0364/CDISC.ADaMIG.AD0364.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0364/CDISC.ADaMIG.AD0364.yml
index dae206fea..fab819904 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0364/CDISC.ADaMIG.AD0364.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0364/CDISC.ADaMIG.AD0364.yml
@@ -4,152 +4,159 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and allowing USUBJID as a conditionally
required variable. See the OCCDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '364'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "364"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <- CDISC Notes for DOSEU state":"" "Conditional on whether
+ - Cited Guidance:
+ <- CDISC Notes for DOSEU state":"" "Conditional on whether
DOSEON and/or DOSCUMA are included."
Document: OCCDS v1.1
- Item: 'Table 3.2.7.1'
- Section: '3.2.7'
+ Item: "Table 3.2.7.1"
+ Section: "3.2.7"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '364'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "364"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <-CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON
+ - Cited Guidance:
+ <-CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON
and/or DOSCUMA are included."
Document: OCCDS v1.0
- Item: 'Table 3.2.7.1'
- Section: '3.2.7'
+ Item: "Table 3.2.7.1"
+ Section: "3.2.7"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '364'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "364"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Version: '1.3'
+ Version: "1.3"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <- CDISC Notes for DOSEU state":"" "Conditional on whether
+ - Cited Guidance:
+ <- CDISC Notes for DOSEU state":"" "Conditional on whether
DOSEON and/or DOSCUMA are included."
Document: OCCDS v1.1
- Item: 'Table 3.2.7.1'
- Section: '3.2.7'
+ Item: "Table 3.2.7.1"
+ Section: "3.2.7"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '364'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "364"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <-CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON
+ - Cited Guidance:
+ <-CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON
and/or DOSCUMA are included."
Document: OCCDS v1.0
- Item: 'Table 3.2.7.1'
- Section: '3.2.7'
+ Item: "Table 3.2.7.1"
+ Section: "3.2.7"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '364'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "364"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Version: '1.2'
+ Version: "1.2"
- Name: OCCDS
References:
- Citations:
- - Cited Guidance: <- CDISC Notes for DOSEU state":"" "Conditional on whether
+ - Cited Guidance:
+ <- CDISC Notes for DOSEU state":"" "Conditional on whether
DOSEON and/or DOSCUMA are included."
Document: OCCDS v1.1
- Item: 'Table 3.2.7.1'
- Section: '3.2.7'
+ Item: "Table 3.2.7.1"
+ Section: "3.2.7"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '364'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "364"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
- Citations:
- - Cited Guidance: <-CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON
+ - Cited Guidance:
+ <-CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON
and/or DOSCUMA are included."
Document: OCCDS v1.0
- Item: 'Table 3.2.7.1'
- Section: '3.2.7'
+ Item: "Table 3.2.7.1"
+ Section: "3.2.7"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '364'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "364"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
- name: DOSEU
@@ -162,8 +169,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0364
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: DOSEU is not present but DOSEON or DOSCUMA are present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0373/CDISC.ADaMIG.AD0373.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0373/CDISC.ADaMIG.AD0373.yml
index 07aacb88a..c06d7410e 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0373/CDISC.ADaMIG.AD0373.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0373/CDISC.ADaMIG.AD0373.yml
@@ -4,95 +4,99 @@ Authorities:
- Name: ADTTE
References:
- Citations:
- - Cited Guidance: CNSR is a required variable for a time-to-event analysis
+ - Cited Guidance:
+ CNSR is a required variable for a time-to-event analysis
dataset, though it is a conditionally required variable with
respect to the ADaM BDS.
Document: ADTTE
Item: Table 4.2
- Section: '4'
+ Section: "4"
Criteria:
Logical Expression:
- Condition: ''
+ Condition: ""
Rule: CNSR is a required variable for a time-to-event analysis dataset
- Plain Language Expression: ''
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '373'
- Version: ''
+ Id: "373"
+ Version: ""
Validator Rule Message: CNSR is a required variable for a time-to-event analysis dataset
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
- Name: ADTTE
References:
- Citations:
- - Cited Guidance: CNSR is a required variable for a time-to-event analysis
+ - Cited Guidance:
+ CNSR is a required variable for a time-to-event analysis
dataset, though it is a conditionally required variable with
respect to the ADaM BDS.
Document: ADTTE
Item: Table 4.2
- Section: '4'
+ Section: "4"
Criteria:
Logical Expression:
- Condition: ''
+ Condition: ""
Rule: CNSR is a required variable for a time-to-event analysis dataset
- Plain Language Expression: ''
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '373'
- Version: ''
+ Id: "373"
+ Version: ""
Validator Rule Message: CNSR is a required variable for a time-to-event analysis dataset
- Version: '5.0'
- Version: '1.1'
+ Version: "5.0"
+ Version: "1.1"
- Name: ADTTE
References:
- Citations:
- - Cited Guidance: CNSR is a required variable for a time-to-event analysis
+ - Cited Guidance:
+ CNSR is a required variable for a time-to-event analysis
dataset, though it is a conditionally required variable with
respect to the ADaM BDS.
Document: ADTTE
Item: Table 4.2
- Section: '4'
+ Section: "4"
Criteria:
Logical Expression:
- Condition: ''
+ Condition: ""
Rule: CNSR is a required variable for a time-to-event analysis dataset
- Plain Language Expression: ''
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '373'
- Version: ''
+ Id: "373"
+ Version: ""
Validator Rule Message: CNSR is a required variable for a time-to-event analysis dataset
- Version: '5.0'
- Version: '1.2'
+ Version: "5.0"
+ Version: "1.2"
- Name: ADTTE
References:
- Citations:
- - Cited Guidance: CNSR is a required variable for a time-to-event analysis
+ - Cited Guidance:
+ CNSR is a required variable for a time-to-event analysis
dataset, though it is a conditionally required variable with
respect to the ADaM BDS.
Document: ADTTE
Item: Table 4.2
- Section: '4'
+ Section: "4"
Criteria:
Logical Expression:
- Condition: ''
+ Condition: ""
Rule: CNSR is a required variable for a time-to-event analysis dataset
- Plain Language Expression: ''
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '373'
- Version: ''
+ Id: "373"
+ Version: ""
Validator Rule Message: CNSR is a required variable for a time-to-event analysis dataset
- Version: '5.0'
- Version: '1.3'
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -102,8 +106,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0373
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: CNSR is required for TTE analysis
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0522b/CDISC.ADaMIG.AD0522b.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0522b/CDISC.ADaMIG.AD0522b.yml
index bd6396dab..9c94dc696 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0522b/CDISC.ADaMIG.AD0522b.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0522b/CDISC.ADaMIG.AD0522b.yml
@@ -4,94 +4,98 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '522'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "522"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '522'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "522"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.2
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '522'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "522"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.1
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '522'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "522"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
@@ -102,8 +106,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0522b
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: BTOXGRN present but BTOXGR is not present in dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0523b/CDISC.ADaMIG.AD0523b.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0523b/CDISC.ADaMIG.AD0523b.yml
index 2088a5c19..028565389 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0523b/CDISC.ADaMIG.AD0523b.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0523b/CDISC.ADaMIG.AD0523b.yml
@@ -4,94 +4,98 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '523'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "523"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '523'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "523"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.2
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '523'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "523"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.1
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '523'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "523"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
@@ -102,8 +106,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0523b
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ATOXGRLN present but ATOXGRL not be present in dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0524/CDISC.ADaMIG.AD0524.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0524/CDISC.ADaMIG.AD0524.yml
index 2bd8e8730..d051fbc55 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0524/CDISC.ADaMIG.AD0524.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0524/CDISC.ADaMIG.AD0524.yml
@@ -4,94 +4,98 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '524'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "524"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '524'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "524"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.2
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '524'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "524"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.1
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '524'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "524"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
@@ -102,8 +106,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0524
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ATOXGRHN present but ATOXGRH not be present in dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0525/CDISC.ADaMIG.AD0525.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0525/CDISC.ADaMIG.AD0525.yml
index 496114256..0f9254642 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0525/CDISC.ADaMIG.AD0525.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0525/CDISC.ADaMIG.AD0525.yml
@@ -4,94 +4,98 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '525'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "525"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '525'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "525"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.2
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '525'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "525"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.1
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '525'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "525"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
@@ -102,8 +106,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0525
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ABLFN present but ABLFL not be present in dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0529/CDISC.ADaMIG.AD0529.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0529/CDISC.ADaMIG.AD0529.yml
index 80f3b00c3..640b3fcf5 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0529/CDISC.ADaMIG.AD0529.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0529/CDISC.ADaMIG.AD0529.yml
@@ -4,94 +4,98 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '529'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "529"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '529'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "529"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.2
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '529'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "529"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.1
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '529'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "529"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
@@ -102,8 +106,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0529
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: AESEVN present but AESEV not be present in dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0530/CDISC.ADaMIG.AD0530.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0530/CDISC.ADaMIG.AD0530.yml
index 3b6ba8694..3fe3f6d96 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0530/CDISC.ADaMIG.AD0530.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0530/CDISC.ADaMIG.AD0530.yml
@@ -4,94 +4,98 @@ Authorities:
- Name: ADaMIG-MD
References:
- Citations:
- - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a
+ - Cited Guidance:
+ The MDBDS supports analysis needs by adding SPDEVID as a
required key variable and USUBJID as a conditionally required
variable. See the BDS class for further details.
Document: ADaMIG-MD v1.0
- Item: ''
- Section: '3.1'
+ Item: ""
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '530'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
+ Id: "530"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '530'
- Version: '2'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "530"
+ Version: "2"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.2
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '530'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "530"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- When a secondary variable is included in the dataset, then
+ - Cited Guidance:
+ <- When a secondary variable is included in the dataset, then
the primary variable must also be included.
Document: ADaMIG v1.1
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '530'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "530"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
@@ -102,8 +106,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0530
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ASEVN present but ASEV not be present in dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD055/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD055/rule.yml
index fcc34c085..48766d85e 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD055/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD055/rule.yml
@@ -6,85 +6,85 @@ Authorities:
- Citations:
- Cited Guidance: SUBJID has Core=Req
Document: ADaMIG
- Item: 'Table 3.1.1'
- Section: '3.1'
+ Item: "Table 3.1.1"
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '55'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "55"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: SUBJID has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.1'
- Section: '3.2'
+ Item: "Table 3.2.1"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '55'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "55"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: SUBJID has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.1'
- Section: '3.2'
+ Item: "Table 3.2.1"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '55'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "55"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: SUBJID has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.1'
- Section: '3.2'
+ Item: "Table 3.2.1"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '55'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "55"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -93,8 +93,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD055
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SUBJID is not present in ADSL
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0619/CDISC.ADaMIG.AD0619.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0619/CDISC.ADaMIG.AD0619.yml
index 6bc8871d1..9d06d4e1b 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0619/CDISC.ADaMIG.AD0619.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0619/CDISC.ADaMIG.AD0619.yml
@@ -4,29 +4,31 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: Code List / Controlled Terms for LVOTFL have allowable values
+ - Cited Guidance:
+ Code List / Controlled Terms for LVOTFL have allowable values
of':' "Y"
Document: ADaMIG
Item: Table 3.2.6.1
Section: 3.2.6
Criteria:
Logical Expression:
- Condition: ''
+ Condition: ""
Rule: LVOTFL have allowable values of "Y"
Plain Language Expression: LVOTFL is equal to Y
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '619'
- Version: ''
+ Id: "619"
+ Version: ""
Validator Rule Message: LVOTFL can only have values of "Y"
- Version: '5.0'
- Version: '1.0'
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: Code List / Controlled Terms for LVOTFL have allowable values
+ - Cited Guidance:
+ Code List / Controlled Terms for LVOTFL have allowable values
of':' "Y"
Document: ADaMIG
Item: Table 3.3.8.1
@@ -38,13 +40,13 @@ Authorities:
Plain Language Expression: LVOTFL is equal to Y or missing
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '619'
- Version: ''
+ Id: "619"
+ Version: ""
Validator Rule Message: LVOTFL must equal to Y or missing
- Version: '5.0'
- Version: '1.1'
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
- name: LVOTFL
@@ -52,13 +54,13 @@ Check:
- name: LVOTFL
operator: is_not_contained_by
value:
- - 'Y'
+ - "Y"
Core:
Id: CDISC.ADaMIG.AD0619
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: LVOTFL is not equal to Y or missing
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD064/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD064/rule.yml
index e489d25f6..d2491cb82 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD064/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD064/rule.yml
@@ -6,88 +6,91 @@ Authorities:
- Citations:
- Cited Guidance: One-to-one map to TRTxxA
Document: ADaMIG
- Item: 'Table 3.1.1'
- Section: '3.1'
+ Item: "Table 3.1.1"
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '64'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "64"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: the secondary variable of the variable pair cannot be present in
- the dataset unless the primary variable is also present
+ - Cited Guidance:
+ the secondary variable of the variable pair cannot be present in the dataset
+ unless the primary variable is also present
Document: ADaMIG
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '64'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "64"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: When a secondary variable is included in the dataset, then the
- primary variable must also be included
+ - Cited Guidance:
+ When a secondary variable is included in the dataset, then the primary
+ variable must also be included
Document: ADaMIG
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '64'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "64"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: When a secondary variable is included in the dataset, then the
- primary variable must also be included
+ - Cited Guidance:
+ When a secondary variable is included in the dataset, then the primary
+ variable must also be included
Document: ADaMIG
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '64'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "64"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -100,18 +103,19 @@ Check:
Core:
Id: CDISC.ADaMIG.AD064
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Operations:
- find: ^TRT([0-9]{2})AN*$
id: $generated_variable_name
name: variable_name
operator: regex_find_replace
- replace: TRT\1A
- # generates TRTxxA
- # TRT11AN -> TRT11A
- # ABCDE -> TRTA or null?
+ replace:
+ TRT\1A
+ # generates TRTxxA
+ # TRT11AN -> TRT11A
+ # ABCDE -> TRTA or null?
Outcome:
Message: TRTxxAN is present and TRTxxA is not present in ADSL
Output Variables:
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD071/CDISC.ADaMIG.AD071.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD071/CDISC.ADaMIG.AD071.yml
index 7f5eae74a..008187fa9 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD071/CDISC.ADaMIG.AD071.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD071/CDISC.ADaMIG.AD071.yml
@@ -6,85 +6,85 @@ Authorities:
- Citations:
- Cited Guidance: ARM has Core=Req
Document: ADaMIG
- Item: 'Table 3.1.1'
- Section: '3.1'
+ Item: "Table 3.1.1"
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '71'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "71"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: ARM has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.4'
- Section: '3.2'
+ Item: "Table 3.2.4"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '71'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "71"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: ARM has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.4'
- Section: '3.2'
+ Item: "Table 3.2.4"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '71'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "71"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: ARM has Core=Req
Document: ADaMIG
- Item: 'Table 3.2.4'
- Section: '3.2'
+ Item: "Table 3.2.4"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '71'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "71"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -93,8 +93,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD071
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ARM is not present in ADSL
@@ -108,5 +108,5 @@ Scope:
- SUBJECT LEVEL ANALYSIS DATASET
Datasets:
Include:
- - 'ALL'
+ - "ALL"
Sensitivity: Dataset
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD072/CDISC.ADaMIG.AD072.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD072/CDISC.ADaMIG.AD072.yml
index d9ce6784e..3adf75585 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD072/CDISC.ADaMIG.AD072.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD072/CDISC.ADaMIG.AD072.yml
@@ -6,88 +6,91 @@ Authorities:
- Citations:
- Cited Guidance: At least TRT01P is required.
Document: ADaMIG
- Item: 'Table 3.1.1'
- Section: '3.1'
+ Item: "Table 3.1.1"
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '72'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "72"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: the secondary variable of the variable pair cannot be present in
+ - Cited Guidance:
+ the secondary variable of the variable pair cannot be present in
the dataset unless the primary variable is also present
Document: ADaMIG
- Item: 'Table 3.2.4'
- Section: '3.2'
+ Item: "Table 3.2.4"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '72'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "72"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: the secondary variable of the variable pair cannot be present in
+ - Cited Guidance:
+ the secondary variable of the variable pair cannot be present in
the dataset unless the primary variable is also present
Document: ADaMIG
- Item: 'Table 3.2.4'
- Section: '3.2'
+ Item: "Table 3.2.4"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '72'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "72"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: the secondary variable of the variable pair cannot be present in
+ - Cited Guidance:
+ the secondary variable of the variable pair cannot be present in
the dataset unless the primary variable is also present
Document: ADaMIG
- Item: 'Table 3.2.4'
- Section: '3.2'
+ Item: "Table 3.2.4"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '72'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "72"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -96,8 +99,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD072
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: TRT01P is not present in ADSL
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD080/CDISC.ADaMIG.AD080.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD080/CDISC.ADaMIG.AD080.yml
index cea70a2c5..987a763c4 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD080/CDISC.ADaMIG.AD080.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD080/CDISC.ADaMIG.AD080.yml
@@ -6,85 +6,85 @@ Authorities:
- Citations:
- Cited Guidance: CDISC Notes for TRTxxP state':'' At least TRT01P is required
Document: ADaMIG
- Item: 'Table 3.1.1'
- Section: '3.1'
+ Item: "Table 3.1.1"
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '80'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.0'
+ Id: "80"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.0"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: CDISC Notes for TRTxxP state':'' At least TRT01P is required
Document: ADaMIG
- Item: 'Table 3.1.1'
- Section: '3.1'
+ Item: "Table 3.1.1"
+ Section: "3.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '80'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: "80"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: CDISC Notes for TRTxxP state':'' At least TRT01P is required
Document: ADaMIG
- Item: 'Table 3.1.1'
- Section: '3.2'
+ Item: "Table 3.1.1"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '80'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.2'
+ Id: "80"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.2"
- Name: ADaMIG
References:
- Citations:
- Cited Guidance: CDISC Notes for TRTxxP state':'' At least TRT01P is required
Document: ADaMIG
- Item: 'Table 3.1.1'
- Section: '3.2'
+ Item: "Table 3.1.1"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '80'
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "80"
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
#follwoing is temporary coding to run the data, until oeprator to catched paired TRTxxA/TRTxxAP created.
Check:
any:
@@ -140,8 +140,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD080
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
#Operations:
# - find: ^TRT([0-9]{2})AN*$
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0800/CDISC.ADaMIG.AD0800.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0800/CDISC.ADaMIG.AD0800.yml
index 04fba21b7..925a33e1f 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0800/CDISC.ADaMIG.AD0800.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0800/CDISC.ADaMIG.AD0800.yml
@@ -1,29 +1,30 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of STUDYID. The numeric
+ - Cited Guidance:
+ <- Unique numerical representation of STUDYID. The numeric
versions of the primary/character variables can be assigned
from its corresponding character pair variable.
Document: ADPPKIG v1.0
- Item: ''
- Section: '3.2, Table 3.2'
+ Item: ""
+ Section: "3.2, Table 3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '800'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "800"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -34,8 +35,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0800
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: STUDYID is populated, but STUDYIDN is not populated
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0802/CDISC.ADaMIG.AD0802.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0802/CDISC.ADaMIG.AD0802.yml
index 3ea4bea06..d1de76c30 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0802/CDISC.ADaMIG.AD0802.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0802/CDISC.ADaMIG.AD0802.yml
@@ -1,29 +1,30 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of STUDYID. The numeric
+ - Cited Guidance:
+ <- Unique numerical representation of STUDYID. The numeric
versions of the primary/character variables can be assigned
from its corresponding character pair variable.
Document: ADPPKIG v1.0
- Item: ''
+ Item: ""
Section: Table 3.2'
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '802'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "802"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0802
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: STUDYIDN is not unique for a given value of STUDYID
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0804/CDISC.ADaMIG.AD0804.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0804/CDISC.ADaMIG.AD0804.yml
index d9d10ba56..f2e6c0652 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0804/CDISC.ADaMIG.AD0804.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0804/CDISC.ADaMIG.AD0804.yml
@@ -4,25 +4,26 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the
primary variable must also be included.
Document: ADPPKIG v1.0
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '804'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "804"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0804
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: STUDYIDN is present, but STUDYID is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0805/CDISC.ADaMIG.AD0805.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0805/CDISC.ADaMIG.AD0805.yml
index 8d12e4b73..e4be60724 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0805/CDISC.ADaMIG.AD0805.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0805/CDISC.ADaMIG.AD0805.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- 'Unique character representation of SUBJTYP. For
+ - Cited Guidance:
+ <- 'Unique character representation of SUBJTYP. For
first-in-human studies, the value can be “Healthy volunteers'
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '805'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "805"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0805
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SUBJTYP is populated, but SUBJTYPC is not populated
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0806/CDISC.ADaMIG.AD0806.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0806/CDISC.ADaMIG.AD0806.yml
index 35c7dd958..f76863a7a 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0806/CDISC.ADaMIG.AD0806.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0806/CDISC.ADaMIG.AD0806.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- 'Unique character representation of SUBJTYP. For
+ - Cited Guidance:
+ <- 'Unique character representation of SUBJTYP. For
first-in-human studies, the value can be “Healthy volunteers"'
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '806'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "806"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0806
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SUBJTYP is populated, but SUBJTYPC is not populated
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0807/CDISC.ADaMIG.AD0807.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0807/CDISC.ADaMIG.AD0807.yml
index 69fb90a46..34a27913e 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0807/CDISC.ADaMIG.AD0807.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0807/CDISC.ADaMIG.AD0807.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Unique character representation of SUBJTYP. For
+ - Cited Guidance:
+ <- Unique character representation of SUBJTYP. For
first-in-human studies, the value can be “Healthy volunteers.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '807'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "807"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -36,8 +37,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0807
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SUBJTYPC is not unique for a given value of SUBJTYP
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0809/CDISC.ADaMIG.AD0809.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0809/CDISC.ADaMIG.AD0809.yml
index bb41d3d5e..54954f685 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0809/CDISC.ADaMIG.AD0809.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0809/CDISC.ADaMIG.AD0809.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the
primary variable must also be included.
Document: ADaMIG v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '809'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "809"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0809
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SUBJTYPC is present, but SUBJTYP is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0811/CDISC.ADaMIG.AD0811.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0811/CDISC.ADaMIG.AD0811.yml
index c451b970c..4edd63d22 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0811/CDISC.ADaMIG.AD0811.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0811/CDISC.ADaMIG.AD0811.yml
@@ -1,27 +1,27 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- Cited Guidance: Unique numerical representation of USUBJID.
Document: ADPPKIG v1.0,
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '811'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "811"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -32,8 +32,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0811
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: USUBJIDN is populated but USUBJID is missing
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0812/CDISC.ADaMIG.AD0812.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0812/CDISC.ADaMIG.AD0812.yml
index ae8afd2db..5e19299e2 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0812/CDISC.ADaMIG.AD0812.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0812/CDISC.ADaMIG.AD0812.yml
@@ -6,22 +6,22 @@ Authorities:
- Citations:
- Cited Guidance: <-Unique numerical representation of USUBJID
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '812'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "812"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,8 +35,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0812
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: USUBJIDN is not unique for a given value of USUBJID
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0813/CDISC.ADaMIG.AD0813.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0813/CDISC.ADaMIG.AD0813.yml
index ed0d49070..282cff698 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0813/CDISC.ADaMIG.AD0813.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0813/CDISC.ADaMIG.AD0813.yml
@@ -6,22 +6,22 @@ Authorities:
- Citations:
- Cited Guidance: <-Unique numerical representation of USUBJID
Document: ADPPKIG v1.0
- Item: ''
+ Item: ""
Section: Table 3.2'
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '813'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "813"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,8 +35,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0813
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: USUBJID is not unique for a given value of USUBJIDN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0814/CDISC.ADaMIG.AD0814.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0814/CDISC.ADaMIG.AD0814.yml
index d75c100a9..518cb9d72 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0814/CDISC.ADaMIG.AD0814.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0814/CDISC.ADaMIG.AD0814.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the
primary variable must also be included.
Document: ADaMIG v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '814'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "814"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0814
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: USUBJIDN is present, but USUBJID is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0815/CDISC.ADaMIG.AD0815.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0815/CDISC.ADaMIG.AD0815.yml
index 46008d561..028c931ec 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0815/CDISC.ADaMIG.AD0815.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0815/CDISC.ADaMIG.AD0815.yml
@@ -1,29 +1,30 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: Unique numerical representation of SUBJID. The numeric versions
+ - Cited Guidance:
+ Unique numerical representation of SUBJID. The numeric versions
of the primary/character variables can be assigned from its
corresponding character pair variable.
Document: ADPPKIG v1.0,
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '815'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "815"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -34,8 +35,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0815
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SUBJID is populated but SUBJIDN is missing
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0816/CDISC.ADaMIG.AD0816.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0816/CDISC.ADaMIG.AD0816.yml
index 1a38acb45..599bd5967 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0816/CDISC.ADaMIG.AD0816.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0816/CDISC.ADaMIG.AD0816.yml
@@ -1,29 +1,30 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: Unique numerical representation of SUBJID. The numeric versions
+ - Cited Guidance:
+ Unique numerical representation of SUBJID. The numeric versions
of the primary/character variables can be assigned from its
corresponding character pair variable.
Document: ADPPKIG v1.0,
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '816'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "816"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -34,8 +35,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0816
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SUBJIDN is populated but SUBJID is missing
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0817/CDISC.ADaMIG.AD0817.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0817/CDISC.ADaMIG.AD0817.yml
index b63d28c31..89ca8d935 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0817/CDISC.ADaMIG.AD0817.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0817/CDISC.ADaMIG.AD0817.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of SUBJID. The numeric
+ - Cited Guidance:
+ <- Unique numerical representation of SUBJID. The numeric
versions of the primary/character variables can be assigned
from its corresponding character pair variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '817'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "817"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0817
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SUBJIDN is not unique for a given value of SUBJID
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0818/CDISC.ADaMIG.AD0818.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0818/CDISC.ADaMIG.AD0818.yml
index 986b1a259..3084814ef 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0818/CDISC.ADaMIG.AD0818.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0818/CDISC.ADaMIG.AD0818.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of SUBJID. The numeric
+ - Cited Guidance:
+ <- Unique numerical representation of SUBJID. The numeric
versions of the primary/character variables can be assigned
from its corresponding character pair variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '818'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "818"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0818
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SUBJID is not unique for a given value of SUBJIDN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0819/CDISC.ADaMIG.AD0819.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0819/CDISC.ADaMIG.AD0819.yml
index d9d111ec8..515659f75 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0819/CDISC.ADaMIG.AD0819.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0819/CDISC.ADaMIG.AD0819.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the
primary variable must also be included.
Document: ADaMIG v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '819'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "819"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0819
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SUBJIDN is present, but SUBJID is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0820/CDISC.ADaMIG.AD0820.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0820/CDISC.ADaMIG.AD0820.yml
index 74c082c59..2a6bf9f54 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0820/CDISC.ADaMIG.AD0820.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0820/CDISC.ADaMIG.AD0820.yml
@@ -1,29 +1,30 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: Unique numerical representation of SITEID. The numeric versions
+ - Cited Guidance:
+ Unique numerical representation of SITEID. The numeric versions
of the primary/character variables can be assigned from its
corresponding character pair variable.
Document: ADPPKIG v1.0,
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '820'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "820"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -34,8 +35,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0820
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SITEID is populated but SITEIDN is not populated
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0821/CDISC.ADaMIG.AD0821.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0821/CDISC.ADaMIG.AD0821.yml
index 2c80f9138..1b3ae1e61 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0821/CDISC.ADaMIG.AD0821.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0821/CDISC.ADaMIG.AD0821.yml
@@ -1,29 +1,30 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: Unique numerical representation of SITEID. The numeric versions
+ - Cited Guidance:
+ Unique numerical representation of SITEID. The numeric versions
of the primary/character variables can be assigned from its
corresponding character pair variable.
Document: ADPPKIG v1.0,
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '821'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "821"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -34,8 +35,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0821
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SITEIDN is populated but SITEID is not populated
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0822/CDISC.ADaMIG.AD0822.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0822/CDISC.ADaMIG.AD0822.yml
index b40afea2f..7aa7e69f3 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0822/CDISC.ADaMIG.AD0822.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0822/CDISC.ADaMIG.AD0822.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of SITEID. The numeric
+ - Cited Guidance:
+ <- Unique numerical representation of SITEID. The numeric
versions of the primary/character variables can be assigned
from its corresponding character pair variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '822'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "822"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0822
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SITEIDN is not unique for a given value of SITEID
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0823/CDISC.ADaMIG.AD0823.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0823/CDISC.ADaMIG.AD0823.yml
index 726cebf5d..57167f4c5 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0823/CDISC.ADaMIG.AD0823.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0823/CDISC.ADaMIG.AD0823.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of SITEID. The numeric
+ - Cited Guidance:
+ <- Unique numerical representation of SITEID. The numeric
versions of the primary/character variables can be assigned
from its corresponding character pair variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '823'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "823"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0823
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SITEIDN is not unique for a given value of SITEID
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0824/CDISC.ADaMIG.AD0824.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0824/CDISC.ADaMIG.AD0824.yml
index e0ae8af00..07a4066aa 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0824/CDISC.ADaMIG.AD0824.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0824/CDISC.ADaMIG.AD0824.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the
primary variable must also be included.
Document: ADaMIG v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '824'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "824"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0824
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SITEIDN is present, but SITEID is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0825/CDISC.ADaMIG.AD0825.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0825/CDISC.ADaMIG.AD0825.yml
index 16633e410..4c8dce371 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0825/CDISC.ADaMIG.AD0825.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0825/CDISC.ADaMIG.AD0825.yml
@@ -1,31 +1,32 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-Captures primary reason for identifying the record for data
+ - Cited Guidance:
+ <-Captures primary reason for identifying the record for data
issues, e.g., dose time imputation flags, etc. A sequential
number starting with 1 and increments with each unique reason.
Examples of reasons for identification of Data Issue can be
found in Section 3.4.
Document: ADaMPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '825'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "825"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -36,11 +37,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0825
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'FLGREASC is populated, but FLGREAS is not populated'
+ Message: "FLGREASC is populated, but FLGREAS is not populated"
Output Variables:
- FLGREASC
- FLGREAS
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0826/CDISC.ADaMIG.AD0826.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0826/CDISC.ADaMIG.AD0826.yml
index a331babd0..4b85dd624 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0826/CDISC.ADaMIG.AD0826.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0826/CDISC.ADaMIG.AD0826.yml
@@ -1,31 +1,32 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-Captures primary reason for identifying the record for data
+ - Cited Guidance:
+ <-Captures primary reason for identifying the record for data
issues, e.g., dose time imputation flags, etc. A sequential
number starting with 1 and increments with each unique reason.
Examples of reasons for identification of Data Issue can be
found in Section 3.4.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '826'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "826"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -36,11 +37,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0826
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'FLGREAS is populated, but FLGREASC is not populated'
+ Message: "FLGREAS is populated, but FLGREASC is not populated"
Output Variables:
- FLGREASC
- FLGREAS
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0827/CDISC.ADaMIG.AD0827.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0827/CDISC.ADaMIG.AD0827.yml
index dea7541cb..d20134c30 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0827/CDISC.ADaMIG.AD0827.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0827/CDISC.ADaMIG.AD0827.yml
@@ -4,28 +4,29 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Captures primary reason for identifying the record for data
+ - Cited Guidance:
+ <- Captures primary reason for identifying the record for data
issues, e.g., dose time imputation flags, etc. A sequential
number starting with 1 and increments with each unique reason.
Examples of reasons for identification of Data Issue can be
found in Section 3.4.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '827'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "827"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -39,8 +40,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0827
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: FLGREASC is not unique for a given value of FLGREASC
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0828/CDISC.ADaMIG.AD0828.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0828/CDISC.ADaMIG.AD0828.yml
index 7d81495b0..97dbf3dbc 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0828/CDISC.ADaMIG.AD0828.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0828/CDISC.ADaMIG.AD0828.yml
@@ -4,28 +4,29 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Captures primary reason for identifying the record for data
+ - Cited Guidance:
+ <- Captures primary reason for identifying the record for data
issues, e.g., dose time imputation flags, etc. A sequential
number starting with 1 and increments with each unique reason.
Examples of reasons for identification of Data Issue can be
found in Section 3.4.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '828'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "828"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -39,8 +40,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0828
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: FLGREAS is not unique for a given value of FLGREAS
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0829/CDISC.ADaMIG.AD0829.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0829/CDISC.ADaMIG.AD0829.yml
index 6599274f6..0f19b35d5 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0829/CDISC.ADaMIG.AD0829.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0829/CDISC.ADaMIG.AD0829.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the
primary variable must also be included.
Document: ADaMIG v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '829'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "829"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0829
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: FLGREAS is present, but FLGREAS is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0830/CDISC.ADaMIG.AD0830.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0830/CDISC.ADaMIG.AD0830.yml
index 777aaefb1..98addd435 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0830/CDISC.ADaMIG.AD0830.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0830/CDISC.ADaMIG.AD0830.yml
@@ -1,30 +1,31 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of DVID. Convention is
+ - Cited Guidance:
+ <- Unique numerical representation of DVID. Convention is
normally 0=dose, 1=for the first observation of interest, etc.
The numeric versions of the primary/character variables can be
assigned from its corresponding character pair variable.
Document: ADaMPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '830'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "830"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,11 +36,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0830
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'DVID is populated, but DVIDN is not populated'
+ Message: "DVID is populated, but DVIDN is not populated"
Output Variables:
- DDVID
- DVIDN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0831/CDISC.ADaMIG.AD0831.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0831/CDISC.ADaMIG.AD0831.yml
index 297a8d7a2..88a556c1c 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0831/CDISC.ADaMIG.AD0831.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0831/CDISC.ADaMIG.AD0831.yml
@@ -1,30 +1,31 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of DVID. Convention is
+ - Cited Guidance:
+ <- Unique numerical representation of DVID. Convention is
normally 0=dose, 1=for the first observation of interest, etc.
The numeric versions of the primary/character variables can be
assigned from its corresponding character pair variable.
Document: ADaMPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '831'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "831"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,11 +36,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0831
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'DVIDN is populated, but DVID is not populated'
+ Message: "DVIDN is populated, but DVID is not populated"
Output Variables:
- DDVID
- DVIDN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0832/CDISC.ADaMIG.AD0832.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0832/CDISC.ADaMIG.AD0832.yml
index 35e3e4616..f046c5e7b 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0832/CDISC.ADaMIG.AD0832.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0832/CDISC.ADaMIG.AD0832.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of SITEID. The numeric
+ - Cited Guidance:
+ <- Unique numerical representation of SITEID. The numeric
versions of the primary/character variables can be assigned
from its corresponding character pair variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '832'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "832"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0832
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: DVIDN is not unique for a given value of DVID
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0833/CDISC.ADaMIG.AD0833.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0833/CDISC.ADaMIG.AD0833.yml
index 215a34933..8e62a5540 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0833/CDISC.ADaMIG.AD0833.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0833/CDISC.ADaMIG.AD0833.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of SITEID. The numeric
+ - Cited Guidance:
+ <- Unique numerical representation of SITEID. The numeric
versions of the primary/character variables can be assigned
from its corresponding character pair variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '833'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "833"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0833
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: DVID is not unique for a given value of DVIDN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0834/CDISC.ADaMIG.AD0834.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0834/CDISC.ADaMIG.AD0834.yml
index 18847bdf3..a9d163ca8 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0834/CDISC.ADaMIG.AD0834.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0834/CDISC.ADaMIG.AD0834.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the
primary variable must also be included.
Document: ADaM v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '834'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "834"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0834
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: DIVDN is present, but DIVD is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0835/CDISC.ADaMIG.AD0835.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0835/CDISC.ADaMIG.AD0835.yml
index ac11bc7a9..0c58b3105 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0835/CDISC.ADaMIG.AD0835.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0835/CDISC.ADaMIG.AD0835.yml
@@ -1,30 +1,31 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of DVID. Convention is
+ - Cited Guidance:
+ <- Unique numerical representation of DVID. Convention is
normally 0=dose, 1=for the first observation of interest, etc.
The numeric versions of the primary/character variables can be
assigned from its corresponding character pair variable.
Document: ADaMPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '835'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "835"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,11 +36,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0835
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'BLQF is populated, but BLQFN is not populated'
+ Message: "BLQF is populated, but BLQFN is not populated"
Output Variables:
- BLQF
- BLQFN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0836/CDISC.ADaMIG.AD0836.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0836/CDISC.ADaMIG.AD0836.yml
index c303c1627..60b88718e 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0836/CDISC.ADaMIG.AD0836.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0836/CDISC.ADaMIG.AD0836.yml
@@ -1,30 +1,31 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of DVID. Convention is
+ - Cited Guidance:
+ <- Unique numerical representation of DVID. Convention is
normally 0=dose, 1=for the first observation of interest, etc.
The numeric versions of the primary/character variables can be
assigned from its corresponding character pair variable.
Document: ADaMPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '836'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "836"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,11 +36,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0836
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'BLQF is populated, but BLQFN is not populated'
+ Message: "BLQF is populated, but BLQFN is not populated"
Output Variables:
- BLQF
- BLQFN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0837/CDISC.ADaMIG.AD0837.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0837/CDISC.ADaMIG.AD0837.yml
index a5a92dfde..295906305 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0837/CDISC.ADaMIG.AD0837.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0837/CDISC.ADaMIG.AD0837.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of SITEID. The numeric
+ - Cited Guidance:
+ <- Unique numerical representation of SITEID. The numeric
versions of the primary/character variables can be assigned
from its corresponding character pair variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '837'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "837"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0837
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: BLQFN is not unique for a given value of BLQF
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0838/CDISC.ADaMIG.AD0838.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0838/CDISC.ADaMIG.AD0838.yml
index a8c9e5c52..89b1c7550 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0838/CDISC.ADaMIG.AD0838.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0838/CDISC.ADaMIG.AD0838.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of SITEID. The numeric
+ - Cited Guidance:
+ <- Unique numerical representation of SITEID. The numeric
versions of the primary/character variables can be assigned
from its corresponding character pair variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '838'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "838"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0838
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: BLQF is not unique for a given value of BLQFN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0839/CDISC.ADaMIG.AD0839.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0839/CDISC.ADaMIG.AD0839.yml
index e9ab929cc..b47effe8b 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0839/CDISC.ADaMIG.AD0839.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0839/CDISC.ADaMIG.AD0839.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the
primary variable must also be included.
Document: ADaM v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '839'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "839"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0839
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: BLQFLN is present, but BLQFL is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0840/CDISC.ADaMIG.AD0840.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0840/CDISC.ADaMIG.AD0840.yml
index bc1caaa04..ccb4eafee 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0840/CDISC.ADaMIG.AD0840.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0840/CDISC.ADaMIG.AD0840.yml
@@ -1,30 +1,31 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of DVID. Convention is
+ - Cited Guidance:
+ <- Unique numerical representation of DVID. Convention is
normally 0=dose, 1=for the first observation of interest, etc.
The numeric versions of the primary/character variables can be
assigned from its corresponding character pair variable.
Document: ADaMPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '840'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "840"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,11 +36,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0840
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'ALQFL is populated, but ALQFLN is not populated'
+ Message: "ALQFL is populated, but ALQFLN is not populated"
Output Variables:
- ALQFL
- ALQFLN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0841/CDISC.ADaMIG.AD0841.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0841/CDISC.ADaMIG.AD0841.yml
index f1a00454d..b54edca80 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0841/CDISC.ADaMIG.AD0841.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0841/CDISC.ADaMIG.AD0841.yml
@@ -1,30 +1,31 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of DVID. Convention is
+ - Cited Guidance:
+ <- Unique numerical representation of DVID. Convention is
normally 0=dose, 1=for the first observation of interest, etc.
The numeric versions of the primary/character variables can be
assigned from its corresponding character pair variable.
Document: ADaMPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '841'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "841"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,11 +36,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0841
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'ALQFLN is populated, but ALQFL is not populated'
+ Message: "ALQFLN is populated, but ALQFL is not populated"
Output Variables:
- ALQFL
- ALQFLN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0842/CDISC.ADaMIG.AD0842.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0842/CDISC.ADaMIG.AD0842.yml
index e9950f33c..7411921ad 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0842/CDISC.ADaMIG.AD0842.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0842/CDISC.ADaMIG.AD0842.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of SITEID. The numeric
+ - Cited Guidance:
+ <- Unique numerical representation of SITEID. The numeric
versions of the primary/character variables can be assigned
from its corresponding character pair variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '842'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "842"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0842
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ALQFLN is not unique for a given value of ALQFL
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0843/CDISC.ADaMIG.AD0843.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0843/CDISC.ADaMIG.AD0843.yml
index 7ed51e72a..5f101045c 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0843/CDISC.ADaMIG.AD0843.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0843/CDISC.ADaMIG.AD0843.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of SITEID. The numeric
+ - Cited Guidance:
+ <- Unique numerical representation of SITEID. The numeric
versions of the primary/character variables can be assigned
from its corresponding character pair variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '843'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "843"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0843
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ALQF is not unique for a given value of ALQFN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0844/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0844/rule.yml
index 441b9d200..dc919a148 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0844/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0844/rule.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
- primary variable must also be included.
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the primary
+ variable must also be included.
Document: ADaM v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '844'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "844"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0844
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ALQFLN is present, but ALQFL is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0845/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0845/rule.yml
index 1dc809fe7..92e63498f 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0845/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0845/rule.yml
@@ -1,30 +1,31 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of DVID. Convention is
- normally 0=dose, 1=for the first observation of interest, etc.
- The numeric versions of the primary/character variables can be
- assigned from its corresponding character pair variable.
+ - Cited Guidance:
+ <- Unique numerical representation of DVID. Convention is normally 0=dose,
+ 1=for the first observation of interest, etc. The numeric versions of the
+ primary/character variables can be assigned from its corresponding character pair
+ variable.
Document: ADaMPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '845'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "845"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,11 +36,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0845
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'FORM is populated, but FORMN is not populated'
+ Message: "FORM is populated, but FORMN is not populated"
Output Variables:
- FORM
- FORMN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0846/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0846/rule.yml
index 80b3c816f..bd63f9acc 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0846/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0846/rule.yml
@@ -1,30 +1,31 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of DVID. Convention is
- normally 0=dose, 1=for the first observation of interest, etc.
- The numeric versions of the primary/character variables can be
- assigned from its corresponding character pair variable.
+ - Cited Guidance:
+ <- Unique numerical representation of DVID. Convention is normally 0=dose,
+ 1=for the first observation of interest, etc. The numeric versions of the
+ primary/character variables can be assigned from its corresponding character pair
+ variable.
Document: ADaMPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '846'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "846"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,11 +36,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0846
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'FORMN is populated, but FORM is not populated'
+ Message: "FORMN is populated, but FORM is not populated"
Output Variables:
- FORM
- FORMN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0847/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0847/rule.yml
index 3289111d4..8017676c9 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0847/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0847/rule.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of SITEID. The numeric
- versions of the primary/character variables can be assigned
- from its corresponding character pair variable.
+ - Cited Guidance:
+ <- Unique numerical representation of SITEID. The numeric versions of the
+ primary/character variables can be assigned from its corresponding character pair
+ variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '847'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "847"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0847
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: FORMN is not unique for a given value of FORM
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0848/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0848/rule.yml
index ab4e78749..049fedb6f 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0848/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0848/rule.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Unique numerical representation of SITEID. The numeric
- versions of the primary/character variables can be assigned
- from its corresponding character pair variable.
+ - Cited Guidance:
+ <- Unique numerical representation of SITEID. The numeric versions of the
+ primary/character variables can be assigned from its corresponding character pair
+ variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '848'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "848"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0848
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: FORM is not unique for a given value of FORMN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0849/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0849/rule.yml
index 1e659c33c..4ee8df846 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0849/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0849/rule.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
- primary variable must also be included.
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the primary
+ variable must also be included.
Document: ADaM v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '849'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "849"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0849
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: FORMN is present, but FORM is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0850/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0850/rule.yml
index c6aad5850..9790a9543 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0850/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0850/rule.yml
@@ -1,29 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: Derived from ROUTE as one-on-one unique match. The character
- versions of the primary/character variables can be assigned
- from its corresponding numeric pair variable.
+ - Cited Guidance:
+ Derived from ROUTE as one-on-one unique match. The character versions of the
+ primary/character variables can be assigned from its corresponding numeric pair variable.
Document: ADaMPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '850'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "850"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -34,11 +34,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0850
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'ROUTE is populated, but ROUTEN is not populated'
+ Message: "ROUTE is populated, but ROUTEN is not populated"
Output Variables:
- ROUTE
- ROUTEN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0851/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0851/rule.yml
index 75902a799..bc4a2fe0f 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0851/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0851/rule.yml
@@ -1,29 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: Derived from ROUTE as one-on-one unique match. The character
- versions of the primary/character variables can be assigned
- from its corresponding numeric pair variable.
+ - Cited Guidance:
+ Derived from ROUTE as one-on-one unique match. The character versions of the
+ primary/character variables can be assigned from its corresponding numeric pair variable.
Document: ADaMPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '851'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "851"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -34,11 +34,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0851
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'ROUTEN is populated, but ROUTE is not populated'
+ Message: "ROUTEN is populated, but ROUTE is not populated"
Output Variables:
- ROUTE
- ROUTEN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0852/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0852/rule.yml
index 9044aa883..4025468b7 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0852/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0852/rule.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Derived from ROUTE as one-on-one unique match. The numeric
- versions of the primary/character variables can be assigned
- from its corresponding character pair variable.
+ - Cited Guidance:
+ <- Derived from ROUTE as one-on-one unique match. The numeric versions of
+ the primary/character variables can be assigned from its corresponding character pair
+ variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '852'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "852"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0852
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ROUTEN is not unique for a given value of ROUTE
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0853/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0853/rule.yml
index 315c15314..ed5c08569 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0853/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0853/rule.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Derived from ROUTE as one-on-one unique match. The numeric
- versions of the primary/character variables can be assigned
- from its corresponding character pair variable.
+ - Cited Guidance:
+ <- Derived from ROUTE as one-on-one unique match. The numeric versions of
+ the primary/character variables can be assigned from its corresponding character pair
+ variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '853'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "853"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0853
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ROUTE is not unique for a given value of ROUTEN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0854/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0854/rule.yml
index 7b093c799..a35d5ecb7 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0854/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0854/rule.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
- primary variable must also be included.
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the primary
+ variable must also be included.
Document: ADaM v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '854'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "854"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0854
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ROUTEC is present, but ROUTE is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0855/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0855/rule.yml
index 1eb4a62fa..1812c9ee2 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0855/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0855/rule.yml
@@ -1,29 +1,30 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The
- character versions of the primary/character variables can be
- assigned from its corresponding numeric pair variable.
+ - Cited Guidance:
+ <- Derived from ACYCLE as one-on-one unique match. The character versions
+ of the primary/character variables can be assigned from its corresponding numeric pair
+ variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '855'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "855"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -34,11 +35,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0855
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'ACYCLE is populated, but ACYCLEC is not populated'
+ Message: "ACYCLE is populated, but ACYCLEC is not populated"
Output Variables:
- ACYCLE
- ACYCLEC
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0856/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0856/rule.yml
index 3cf07b4a8..70c680831 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0856/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0856/rule.yml
@@ -1,29 +1,30 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The
- character versions of the primary/character variables can be
- assigned from its corresponding numeric pair variable.
+ - Cited Guidance:
+ <- Derived from ACYCLE as one-on-one unique match. The character versions
+ of the primary/character variables can be assigned from its corresponding numeric pair
+ variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '856'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "856"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -34,11 +35,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0856
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'ACYCLEC is populated, but ACYCLE is not populated'
+ Message: "ACYCLEC is populated, but ACYCLE is not populated"
Output Variables:
- ACYCLE
- ACYCLEC
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0857/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0857/rule.yml
index 9d1d58429..1be74b8c6 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0857/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0857/rule.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The
- character versions of the primary/character variables can be
- assigned from its corresponding numeric pair variable.
+ - Cited Guidance:
+ <- Derived from ACYCLE as one-on-one unique match. The character versions
+ of the primary/character variables can be assigned from its corresponding numeric pair
+ variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '857'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "857"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0857
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ACYCLEC is not unique for a given value of ACYCLE
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0858/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0858/rule.yml
index 7690f0b98..856a3f9d8 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0858/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0858/rule.yml
@@ -4,26 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The
- character versions of the primary/character variables can be
- assigned from its corresponding numeric pair variable..
+ - Cited Guidance:
+ <- Derived from ACYCLE as one-on-one unique match. The character versions
+ of the primary/character variables can be assigned from its corresponding numeric pair
+ variable..
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '858'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "858"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0858
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ACYCLE is not unique for a given value of ACYCLEC
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0859/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0859/rule.yml
index 0df771b91..2342b2079 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0859/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0859/rule.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
- primary variable must also be included.
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the primary
+ variable must also be included.
Document: ADaM v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '859'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "859"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0859
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: ACYCLEC is present, but ACYCLE is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml
index d067dc165..27e649d36 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml
@@ -1,30 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Character representation of the COHORT variable. There must
- be a one-to-one mapping to COHORT. The character versions of
- the primary/character variables can be assigned from its
- corresponding numeric pair variable.
+ - Cited Guidance: <- Character representation of the COHORT variable. There must be a
+ one-to-one mapping to COHORT. The character versions of the primary/character variables
+ can be assigned from its corresponding numeric pair variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '860'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "860"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,11 +34,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0860
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'COHORT is populated, but COHORTC is not populated'
+ Message: "COHORT is populated, but COHORTC is not populated"
Output Variables:
- COHORT
- COHORTC
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml
index 065272ba6..74316f698 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml
@@ -1,30 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Character representation of the COHORT variable. There must
- be a one-to-one mapping to COHORT. The character versions of
- the primary/character variables can be assigned from its
- corresponding numeric pair variable.
+ - Cited Guidance: <- Character representation of the COHORT variable. There must be a
+ one-to-one mapping to COHORT. The character versions of the primary/character variables
+ can be assigned from its corresponding numeric pair variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '861'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "861"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,11 +34,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0861
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'COHORTC is populated, but COHORT is not populated'
+ Message: "COHORTC is populated, but COHORT is not populated"
Output Variables:
- COHORT
- COHORTC
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml
index 1e228c98a..a9d794fec 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml
@@ -4,27 +4,26 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Character representation of the COHORT variable. There must
- be a one-to-one mapping to COHORT. The character versions of
- the primary/character variables can be assigned from its
- corresponding numeric pair variable.
+ - Cited Guidance: <- Character representation of the COHORT variable. There must be a
+ one-to-one mapping to COHORT. The character versions of the primary/character variables
+ can be assigned from its corresponding numeric pair variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '862'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "862"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -38,8 +37,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0862
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: COHORTC is not unique for a given value of COHORT
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml
index a78b06cbc..aabcd3ebb 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml
@@ -4,27 +4,26 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Character representation of the COHORT variable. There must
- be a one-to-one mapping to COHORT. The character versions of
- the primary/character variables can be assigned from its
- corresponding numeric pair variable.
+ - Cited Guidance: <- Character representation of the COHORT variable. There must be a
+ one-to-one mapping to COHORT. The character versions of the primary/character variables
+ can be assigned from its corresponding numeric pair variable.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '863'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "863"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -38,8 +37,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0863
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: COHORT is not unique for a given value of COHORTC
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0864/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0864/rule.yml
index d619d7314..7618ac2cf 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0864/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0864/rule.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
- primary variable must also be included.
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the primary
+ variable must also be included.
Document: ADaM v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '864'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "864"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0864
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: COHORTC is present, but COHORT is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml
index a75787302..d2c4e4280 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml
@@ -1,31 +1,30 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the
- specification. 1=American Indian OR Alaska Native, 2=Asian,
- 3=Black/African American, 4=Native Hawaiian OR Other Pacific
- Islander, 5=White. If races need to be categorized
- differently, then use variables ARACE and ARACEN.
+ - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification.
+ 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian
+ OR Other Pacific Islander, 5=White. If races need to be categorized differently, then use
+ variables ARACE and ARACEN.
Document: ADPPKIG v1.0
- Item: 'Table 3.3'
- Section: '3.2'
+ Item: "Table 3.3"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '865'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "865"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -36,11 +35,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0865
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'RACE is populated, but RACEN is not populated'
+ Message: "RACE is populated, but RACEN is not populated"
Output Variables:
- RACE
- RACEN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml
index 455bfe573..83e5b2349 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml
@@ -1,31 +1,30 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the
- specification. 1=American Indian OR Alaska Native, 2=Asian,
- 3=Black/African American, 4=Native Hawaiian OR Other Pacific
- Islander, 5=White. If races need to be categorized
- differently, then use variables ARACE and ARACEN.
+ - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification.
+ 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian
+ OR Other Pacific Islander, 5=White. If races need to be categorized differently, then use
+ variables ARACE and ARACEN.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '866'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "866"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -36,11 +35,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0866
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'RACEN is populated, but RACE is not populated'
+ Message: "RACEN is populated, but RACE is not populated"
Output Variables:
- RACE
- RACEN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml
index 2472acc8d..bf0c28e19 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml
@@ -4,28 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the
- specification. 1=American Indian OR Alaska Native, 2=Asian,
- 3=Black/African American, 4=Native Hawaiian OR Other Pacific
- Islander, 5=White. If RACEs need to be categorized
- differently, then use variables ARACE and ARACEN.
+ - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification.
+ 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian
+ OR Other Pacific Islander, 5=White. If RACEs need to be categorized differently, then use
+ variables ARACE and ARACEN.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '867'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "867"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -39,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0867
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: RACEN is not unique for a given value of RACE
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml
index 03486b5ae..399e9eae7 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml
@@ -4,28 +4,27 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the
- specification. 1=American Indian OR Alaska Native, 2=Asian,
- 3=Black/African American, 4=Native Hawaiian OR Other Pacific
- Islander, 5=White. If RACEs need to be categorized
- differently, then use variables ARACE and ARACEN.
+ - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification.
+ 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian
+ OR Other Pacific Islander, 5=White. If RACEs need to be categorized differently, then use
+ variables ARACE and ARACEN.
Document: ADPPKIG v1.0
- Item: 'Table 3.2'
- Section: '3.2'
+ Item: "Table 3.2"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '868'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "868"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -39,8 +38,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0868
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: RACE is not unique for a given value of RACEN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0872/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0872/rule.yml
index f1bb29487..ef673112f 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0872/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0872/rule.yml
@@ -4,26 +4,26 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Numeric version of SEX. Can be extended to other values
- beyond 1 and 2. Example values can be as follows':' 1=Male,
- 2=Female
+ - Cited Guidance:
+ <- Numeric version of SEX. Can be extended to other values beyond 1 and 2.
+ Example values can be as follows':' 1=Male, 2=Female
Document: ADPPKIG v1.0
- Item: 'Table 3.3'
- Section: '3.3'
+ Item: "Table 3.3"
+ Section: "3.3"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '872'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "872"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +37,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0872
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SEXN is not unique for a given value of SEX
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0873/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0873/rule.yml
index ea81235dd..7c76e4de9 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0873/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0873/rule.yml
@@ -4,26 +4,26 @@ Authorities:
- Name: ADaMIG
References:
- Citations:
- - Cited Guidance: <- Numeric version of SEX. Can be extended to other values
- beyond 1 and 2. Example values can be as follows':' 1=Male,
- 2=Female
+ - Cited Guidance:
+ <- Numeric version of SEX. Can be extended to other values beyond 1 and 2.
+ Example values can be as follows':' 1=Male, 2=Female
Document: ADPPKIG v1.0
- Item: 'Table 3.3'
- Section: '3.3'
+ Item: "Table 3.3"
+ Section: "3.3"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '873'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "873"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -37,8 +37,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0873
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SEX is not unique for a given value of SEXN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0874/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0874/rule.yml
index d38a64479..5e58e12f4 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0874/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0874/rule.yml
@@ -1,28 +1,29 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- - Cited Guidance: <-When a secondary variable is included in the dataset, then the
- primary variable must also be included.
+ - Cited Guidance:
+ <-When a secondary variable is included in the dataset, then the primary
+ variable must also be included.
Document: ADaM v1.3
- Item: '6'
- Section: '3.1.1'
+ Item: "6"
+ Section: "3.1.1"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '874'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "874"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -33,8 +34,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0874
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: SEXN is present, but SEX is not present
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0875/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0875/rule.yml
index 2b510f23b..51571f580 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0875/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0875/rule.yml
@@ -1,27 +1,27 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- Cited Guidance: <- Numeric version of COUNTRY
Document: ADPPKIG v1.0
- Item: 'Table 3.3'
- Section: '3.2'
+ Item: "Table 3.3"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '875'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "875"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -32,11 +32,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0875
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'COUNTRY is populated, but COUNTRYN is not populated'
+ Message: "COUNTRY is populated, but COUNTRYN is not populated"
Output Variables:
- COUNTRY
- COUNTRYN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0876/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0876/rule.yml
index 52f020f0a..f8064ea2c 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0876/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0876/rule.yml
@@ -1,27 +1,27 @@
Authorities:
- Organization: CDISC
Standards:
- - Name: 'ADaMIG'
+ - Name: "ADaMIG"
References:
- Citations:
- Cited Guidance: <- Numeric version of COUNTRY
Document: ADPPKIG v1.0
- Item: 'Table 3.3'
- Section: '3.2'
+ Item: "Table 3.3"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '876'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "876"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -32,11 +32,11 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0876
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'COUNTRYN is populated, but COUNTRY is not populated'
+ Message: "COUNTRYN is populated, but COUNTRY is not populated"
Output Variables:
- COUNTRY
- COUNTRYN
diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0877/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0877/rule.yml
index 9b7999145..fbb7dc9cc 100644
--- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0877/rule.yml
+++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0877/rule.yml
@@ -6,22 +6,22 @@ Authorities:
- Citations:
- Cited Guidance: <- Numeric version of COUNTRY.
Document: ADPPKIG v1.0
- Item: 'Table 3.3'
- Section: '3.2'
+ Item: "Table 3.3"
+ Section: "3.2"
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Failure
Origin: ADaM Conformance Rules
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: '877'
- Version: '1'
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.3'
+ Id: "877"
+ Version: "1"
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.3"
Check:
all:
@@ -35,8 +35,8 @@ Check:
Core:
Id: CDISC.ADaMIG.AD0877
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: COUNTRYN is not unique for a given value of COUNTRY
diff --git a/Unpublished/FDA Business Rules/CORE-000734/rule.yml b/Unpublished/FDA Business Rules/CORE-000734/rule.yml
index b80a627be..ba3a15faa 100644
--- a/Unpublished/FDA Business Rules/CORE-000734/rule.yml
+++ b/Unpublished/FDA Business Rules/CORE-000734/rule.yml
@@ -1,78 +1,76 @@
# Variable: TSPARMCD, TSVAL
# TSPARMCD = 'FDATCHSP'
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: '"All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG). Page 13: In
- addition to the study parameters indicated in the appendix
- section, if the study data submitted follows a Therapeutic
- Area User Guide (TAUG) or an FDA Technical Specification,30
- use the values for TSPARM/TSPARMCD and TSVAL from the table
+ - Cited Guidance:
+ '"All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG). Page 13: In addition to the study parameters indicated in
+ the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG)
+ or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table
below in the TS domain."'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1104'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB1104"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: '"All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG). Page 13: In
- addition to the study parameters indicated in the appendix
- section, if the study data submitted follows a Therapeutic
- Area User Guide (TAUG) or an FDA Technical Specification,30
- use the values for TSPARM/TSPARMCD and TSVAL from the table
+ - Cited Guidance:
+ '"All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG). Page 13: In addition to the study parameters indicated in
+ the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG)
+ or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table
below in the TS domain."'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1104'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB1104"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: '"All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG). Page 13: In
- addition to the study parameters indicated in the appendix
- section, if the study data submitted follows a Therapeutic
- Area User Guide (TAUG) or an FDA Technical Specification,30
- use the values for TSPARM/TSPARMCD and TSVAL from the table
+ - Cited Guidance:
+ '"All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG). Page 13: In addition to the study parameters indicated in
+ the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG)
+ or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table
below in the TS domain."'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1104'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB1104"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: TSPARMCD
- operator: 'not_equal_to'
- value: 'FDATCHSP'
+ operator: "not_equal_to"
+ value: "FDATCHSP"
Core:
Id: CORE-000734
Status: Draft
- Version: '1'
-Description: 'TSVAL (Standard Name) matches corresponding name as listed on the
- study data standards resources website for technical specification documents.'
+ Version: "1"
+Description:
+ "TSVAL (Standard Name) matches corresponding name as listed on the study data standards resources
+ website for technical specification documents."
Executability: Fully Executable
Outcome:
- Message: 'TSVAL (Standard Name) does not match corresponding name as listed in
- on the study data standards resources website for technical specification
- documents.'
+ Message:
+ "TSVAL (Standard Name) does not match corresponding name as listed in on the study data standards
+ resources website for technical specification documents."
Output Variables:
- TSPARMCD
- TSVAL
diff --git a/Unpublished/FDA Business Rules/CORE-000737/rule.yml b/Unpublished/FDA Business Rules/CORE-000737/rule.yml
index a4659e0d3..a575a30c4 100644
--- a/Unpublished/FDA Business Rules/CORE-000737/rule.yml
+++ b/Unpublished/FDA Business Rules/CORE-000737/rule.yml
@@ -1,102 +1,107 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG).'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG)."
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1102'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB1102"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG).'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG)."
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1102'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB1102"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG).'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG)."
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1102'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB1102"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: TSPARMCD
operator: not_contains_all
value:
- - 'ACTSUB'
- - 'ADAPT'
- - 'ADDON'
- - 'AGEMAX'
- - 'AGEMIN'
- - 'COMPTRT'
- - 'DCUTDESC'
- - 'DCUTDTC'
- - 'EXTTIND'
- - 'FCNTRY'
- - 'HLTSUBJI'
- - 'LENGTH'
- - 'NARMS'
- - 'NCOHORT'
- - 'OBJPRIM'
- - 'OBJSEC'
- - 'ONGOSIND'
- - 'OUTMSPRI'
- - 'PDPSTIND'
- - 'PDSTIND'
- - 'PIPIND'
- - 'PLANSUB'
- - 'RDIND'
- - 'REGID'
- - 'SENDTC'
- - 'SEXPOP'
- - 'SPONSOR'
- - 'SDTMVER'
- - 'SDTIGVER'
- - 'STOPRULE'
- - 'SSTDTC'
- - 'STYPE'
- - 'TBLIND'
- - 'TCNTRL'
- - 'THERAREA'
- - 'TITLE'
- - 'TPHASE'
- - 'TTYPE'
- - 'INDIC'
- - 'RANDQT'
- - name: 'TSVAL'
+ - "ACTSUB"
+ - "ADAPT"
+ - "ADDON"
+ - "AGEMAX"
+ - "AGEMIN"
+ - "COMPTRT"
+ - "DCUTDESC"
+ - "DCUTDTC"
+ - "EXTTIND"
+ - "FCNTRY"
+ - "HLTSUBJI"
+ - "LENGTH"
+ - "NARMS"
+ - "NCOHORT"
+ - "OBJPRIM"
+ - "OBJSEC"
+ - "ONGOSIND"
+ - "OUTMSPRI"
+ - "PDPSTIND"
+ - "PDSTIND"
+ - "PIPIND"
+ - "PLANSUB"
+ - "RDIND"
+ - "REGID"
+ - "SENDTC"
+ - "SEXPOP"
+ - "SPONSOR"
+ - "SDTMVER"
+ - "SDTIGVER"
+ - "STOPRULE"
+ - "SSTDTC"
+ - "STYPE"
+ - "TBLIND"
+ - "TCNTRL"
+ - "THERAREA"
+ - "TITLE"
+ - "TPHASE"
+ - "TTYPE"
+ - "INDIC"
+ - "RANDQT"
+ - name: "TSVAL"
operator: non_empty
Core:
Id: CORE-000737
Status: Draft
- Version: '1'
-Description: 'The set of parameters without conditions listed in the TCG,
- Appendix B, is not included in the list of TSPARAMCD with TSVAL populated.'
+ Version: "1"
+Description:
+ "The set of parameters without conditions listed in the TCG, Appendix B, is not included
+ in the list of TSPARAMCD with TSVAL populated."
Executability: Fully Executable
Outcome:
- Message: 'The set of parameters without conditions listed in the TCG, Appendix
- B, is not included in the list of TSPARAMCD with TSVAL populated.'
+ Message:
+ "The set of parameters without conditions listed in the TCG, Appendix B, is not included in
+ the list of TSPARAMCD with TSVAL populated."
Output Variables:
- TSVAL
- TSPARMCD
diff --git a/Unpublished/FDA Business Rules/CORE-000738/rule.yml b/Unpublished/FDA Business Rules/CORE-000738/rule.yml
index ea23ee53d..6bd4f1b19 100644
--- a/Unpublished/FDA Business Rules/CORE-000738/rule.yml
+++ b/Unpublished/FDA Business Rules/CORE-000738/rule.yml
@@ -1,42 +1,42 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1106'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB1106"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1106'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB1106"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1106'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB1106"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
any:
- name: $crmdur_count
@@ -44,19 +44,19 @@ Check:
value: 1
- all:
- name: $crmdur_count
- operator: 'greater_than_or_equal_to'
+ operator: "greater_than_or_equal_to"
value: 1
- name: TSPARMCD
operator: equal_to
- value: 'CRMDUR'
+ value: "CRMDUR"
- name: TSVAL
operator: empty
Core:
Id: CORE-000738
Status: Draft
- Version: '1'
-Description: 'No occurrence of TSPARMCD=’CRMDUR’ is included in TS or TSVAL is null.'
+ Version: "1"
+Description: "No occurrence of TSPARMCD=’CRMDUR’ is included in TS or TSVAL is null."
Executability: Partially Executable
Operations:
- domain: TS
@@ -66,7 +66,7 @@ Operations:
name: TSPARMCD
operator: record_count
Outcome:
- Message: 'No occurrence of TSPARMCD=’CRMDUR’ is included in TS or TSVAL is null.'
+ Message: "No occurrence of TSPARMCD=’CRMDUR’ is included in TS or TSVAL is null."
Output Variables:
- TSPARMCD
- TSVAL
diff --git a/Unpublished/FDA Business Rules/CORE-000748/rule.yml b/Unpublished/FDA Business Rules/CORE-000748/rule.yml
index 26f9b04bf..f3b90fa54 100644
--- a/Unpublished/FDA Business Rules/CORE-000748/rule.yml
+++ b/Unpublished/FDA Business Rules/CORE-000748/rule.yml
@@ -13,9 +13,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB2504
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -25,9 +25,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB2504
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: ARMNRS
@@ -42,9 +42,8 @@ Check:
Core:
Id: CORE-000748
Status: Draft
- Version: '1'
-Description: If a subject is assigned to an arm code, the subject should have a
- record in EX.
+ Version: "1"
+Description: If a subject is assigned to an arm code, the subject should have a record in EX.
Executability: Partially Executable
Operations:
- domain: EX
diff --git a/Unpublished/FDA Business Rules/FB0804/rule.yml b/Unpublished/FDA Business Rules/FB0804/rule.yml
index 5fe2815d3..8f991b842 100644
--- a/Unpublished/FDA Business Rules/FB0804/rule.yml
+++ b/Unpublished/FDA Business Rules/FB0804/rule.yml
@@ -1,97 +1,104 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All treatment exposure date/time should be between first and
- last study treatment date/time.'
- Document: 'FDA'
- Section: 'FDAB008'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "All treatment exposure date/time should be between first and last study treatment
+ date/time."
+ Document: "FDA"
+ Section: "FDAB008"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB0804'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB0804"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All treatment exposure date/time should be between first and
- last study treatment date/time.'
- Document: 'FDA'
- Section: 'FDAB008'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "All treatment exposure date/time should be between first and last study treatment
+ date/time."
+ Document: "FDA"
+ Section: "FDAB008"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB0804'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB0804"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'All treatment exposure date/time should be between first and
- last study treatment date/time.'
- Document: 'FDA'
- Section: 'FDAB008'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "All treatment exposure date/time should be between first and last study treatment
+ date/time."
+ Document: "FDA"
+ Section: "FDAB008"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB0804'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB0804"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'All treatment exposure date/time should be between first and
- last study treatment date/time.'
- Document: 'FDA'
- Section: 'FDAB008'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "All treatment exposure date/time should be between first and last study treatment
+ date/time."
+ Document: "FDA"
+ Section: "FDAB008"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB0804'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB0804"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'All treatment exposure date/time should be between first and
- last study treatment date/time.'
- Document: 'FDA'
- Section: 'FDAB008'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "All treatment exposure date/time should be between first and last study treatment
+ date/time."
+ Document: "FDA"
+ Section: "FDAB008"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB0804'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB0804"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'All treatment exposure date/time should be between first and
- last study treatment date/time.'
- Document: 'FDA'
- Section: 'FDAB008'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "All treatment exposure date/time should be between first and last study treatment
+ date/time."
+ Document: "FDA"
+ Section: "FDAB008"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB0804'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB0804"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'All treatment exposure date/time should be between first and
- last study treatment date/time.'
- Document: 'FDA'
- Section: 'FDAB008'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "All treatment exposure date/time should be between first and last study treatment
+ date/time."
+ Document: "FDA"
+ Section: "FDAB008"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB0804'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB0804"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# rule failure criteria: TSPARMCD.EXPSTDTC => EXENDTC or EXENDTC => TSPARMCD.EXPENDTC
Check:
any:
@@ -105,12 +112,13 @@ Check:
# EXENDTC => TSPARMCD.EXPENDTC
- name: --ENDTC
operator: date_greater_than_or_equal_to
- value: $ts_expendtc_value
- #value: '2001-01-01'
+ value:
+ $ts_expendtc_value
+ #value: '2001-01-01'
Core:
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Operations:
- domain: TS
@@ -127,8 +135,9 @@ Operations:
name: TSVAL
operator: distinct
Outcome:
- Message: 'Treatment exposure end date/time (EXENDTC) falls outside the date/time
- experimental start (EXPSTDTC) and end date (EXPENDTC) in the TS dataset.'
+ Message:
+ "Treatment exposure end date/time (EXENDTC) falls outside the date/time experimental start
+ (EXPSTDTC) and end date (EXPENDTC) in the TS dataset."
Output Variables:
- EXENDTC
- $ts_expstdtc_value
diff --git a/Unpublished/FDA Business Rules/FB1113/rule.yml b/Unpublished/FDA Business Rules/FB1113/rule.yml
index d657e7b24..949944d14 100644
--- a/Unpublished/FDA Business Rules/FB1113/rule.yml
+++ b/Unpublished/FDA Business Rules/FB1113/rule.yml
@@ -1,83 +1,82 @@
# Variable: TSPARMCD
-# Condition:
+# Condition:
# Success Criteria: The count of occurrences of TSPARAMCD = not in the set (‘FCNTRY’, ‘OBJPRIM’, ‘OBJSEC’, ‘OUTMSPRI’, ‘OUTMSSEC’, 'RANDQT', ‘REGID’, ‘TITLE’, ‘TTYPE’) included in the list of TSPARAMCD with TSVAL populated is eq 1.
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1113'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB1113"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1113'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB1113"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1113'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB1113"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
any:
- all:
- name: TSPARMCD
- operator: 'equal_to'
- value: 'ADDON'
+ operator: "equal_to"
+ value: "ADDON"
value_is_literal: true
- name: TSVAL
- operator: 'equal_to'
- value: 'Y'
+ operator: "equal_to"
+ value: "Y"
value_is_literal: true
- name: $tsparmcd
operator: does_not_contain
- value: 'CURTRT'
+ value: "CURTRT"
value_is_literal: true
- all:
- name: TSPARMCD
- operator: 'equal_to'
- value: 'ADDON'
+ operator: "equal_to"
+ value: "ADDON"
value_is_literal: true
- name: TSVAL
- operator: 'equal_to'
- value: 'Y'
+ operator: "equal_to"
+ value: "Y"
value_is_literal: true
- name: TSPARMCD
- operator: 'equal_to'
- value: 'CURTRT'
+ operator: "equal_to"
+ value: "CURTRT"
value_is_literal: true
- name: TSVAL
operator: empty
Core:
Id:
Status: Draft
- Version: '1'
-Description: The count of occurrences of TSPARAMCD = not in the set
- ('FCNTRY', 'OBJPRIM', 'OBJSEC', 'OUTMSPRI', .'OUTMSSEC', 'RANDQT', 'REGID',
- 'TITLE', 'TTYPE') included in the list of TSPARAMCD with TSVAL populated is eq
- 1.
+ Version: "1"
+Description: The count of occurrences of TSPARAMCD = not in the set ('FCNTRY', 'OBJPRIM',
+ 'OBJSEC', 'OUTMSPRI', .'OUTMSSEC', 'RANDQT', 'REGID', 'TITLE', 'TTYPE') included in the list of
+ TSPARAMCD with TSVAL populated is eq 1.
Executability: Fully Executable
Operations:
- domain: TS
@@ -85,11 +84,10 @@ Operations:
name: TSPARMCD
operator: distinct
Outcome:
- Message: No occurrence of TSPARAMCD='CURTRT' is included in TS or TSVAL is
- null.The count of occurrences of TSPARAMCD = not in the set
- ('FCNTRY', 'OBJPRIM', 'OBJSEC', 'OUTMSPRI', .'OUTMSSEC', 'RANDQT', 'REGID',
- 'TITLE', 'TTYPE') included in the list of TSPARAMCD with TSVAL populated is
- gt 1.
+ Message: No occurrence of TSPARAMCD='CURTRT' is included in TS or TSVAL is null.The count of
+ occurrences of TSPARAMCD = not in the set ('FCNTRY', 'OBJPRIM', 'OBJSEC', 'OUTMSPRI',
+ .'OUTMSSEC', 'RANDQT', 'REGID', 'TITLE', 'TTYPE') included in the list of TSPARAMCD with TSVAL
+ populated is gt 1.
Output Variables:
- TSPARMCD
- TSVAL
diff --git a/Unpublished/FDA Business Rules/FB1901/rule.yml b/Unpublished/FDA Business Rules/FB1901/rule.yml
index fbcf2d665..042ee8009 100644
--- a/Unpublished/FDA Business Rules/FB1901/rule.yml
+++ b/Unpublished/FDA Business Rules/FB1901/rule.yml
@@ -4,133 +4,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum
- length of the actual data within the dataset.
+ - Cited Guidance:
+ SUPPQUAL variable length should be no longer than the maximum length of the
+ actual data within the dataset.
Document: FDA
Section: FDAB019
Origin: FDA Business Rules
Rule Identifier:
Id: FB1901
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum
- length of the actual data within the dataset.
+ - Cited Guidance:
+ SUPPQUAL variable length should be no longer than the maximum length of the
+ actual data within the dataset.
Document: FDA
Section: FDAB019
Origin: FDA Business Rules
Rule Identifier:
Id: FB1901
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum
- length of the actual data within the dataset.
+ - Cited Guidance:
+ SUPPQUAL variable length should be no longer than the maximum length of the
+ actual data within the dataset.
Document: FDA
Section: FDAB019
Origin: FDA Business Rules
Rule Identifier:
Id: FB1901
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum
- length of the actual data within the dataset.
+ - Cited Guidance:
+ SUPPQUAL variable length should be no longer than the maximum length of the
+ actual data within the dataset.
Document: FDA
Section: FDAB019
Origin: FDA Business Rules
Rule Identifier:
Id: FB1901
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum
- length of the actual data within the dataset.
+ - Cited Guidance:
+ SUPPQUAL variable length should be no longer than the maximum length of the
+ actual data within the dataset.
Document: FDA
Section: FDAB019
Origin: FDA Business Rules
Rule Identifier:
Id: FB1901
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum
- length of the actual data within the dataset.
+ - Cited Guidance:
+ SUPPQUAL variable length should be no longer than the maximum length of the
+ actual data within the dataset.
Document: FDA
Section: FDAB019
Origin: FDA Business Rules
Rule Identifier:
Id: FB1901
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum
- length of the actual data within the dataset.
+ - Cited Guidance:
+ SUPPQUAL variable length should be no longer than the maximum length of the
+ actual data within the dataset.
Document: FDA
Section: FDAB019
Origin: FDA Business Rules
Rule Identifier:
Id: FB1901
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum
- length of the actual data within the dataset.
+ - Cited Guidance:
+ SUPPQUAL variable length should be no longer than the maximum length of the
+ actual data within the dataset.
Document: FDA
Section: FDAB019
Origin: FDA Business Rules
Rule Identifier:
Id: FB1901
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum
- length of the actual data within the dataset.
+ - Cited Guidance:
+ SUPPQUAL variable length should be no longer than the maximum length of the
+ actual data within the dataset.
Document: FDA
Section: FDAB019
Origin: FDA Business Rules
Rule Identifier:
Id: FB1901
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum
- length of the actual data within the dataset.
+ - Cited Guidance:
+ SUPPQUAL variable length should be no longer than the maximum length of the
+ actual data within the dataset.
Document: FDA
Section: FDAB019
Origin: FDA Business Rules
Rule Identifier:
Id: FB1901
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: SUPPQUAL
@@ -147,10 +157,9 @@ Check:
- all_variables
Core:
Status: Draft
- Version: '1'
-Description: All variables in each of the SUPPQUAL and RELREC datasets have a
- length that is not longer than the length of the longest value for that
- variable.
+ Version: "1"
+Description: All variables in each of the SUPPQUAL and RELREC datasets have a length that is not
+ longer than the length of the longest value for that variable.
Executability: Partially Executable
Outcome:
Message: The length of the variable is longer than the data within the variable
diff --git a/Unpublished/FDA Business Rules/FB6501/rule.yml b/Unpublished/FDA Business Rules/FB6501/rule.yml
index ce2f6e917..001e44392 100644
--- a/Unpublished/FDA Business Rules/FB6501/rule.yml
+++ b/Unpublished/FDA Business Rules/FB6501/rule.yml
@@ -1,97 +1,90 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6501'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6501'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6501'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6501'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6501'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6501'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6501'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6501: When DS domain is present in the define.xml, but no DS dataset is present in the submission
# then the define.xml must contain ItemGroupDef for DS with attribute def:HasNoData marked as "Yes"
Check:
@@ -105,11 +98,11 @@ Check:
value: false
- name: filename
operator: empty
-#
+#
Core:
Status: Draft
- Version: '1'
-Description: 'DS dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "DS dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing DS dataset.
diff --git a/Unpublished/FDA Business Rules/FB6502/rule.yml b/Unpublished/FDA Business Rules/FB6502/rule.yml
index 4a0d3b1dc..ee50a2a63 100644
--- a/Unpublished/FDA Business Rules/FB6502/rule.yml
+++ b/Unpublished/FDA Business Rules/FB6502/rule.yml
@@ -1,97 +1,90 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6502'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6502"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6502'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6502"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6502'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6502"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6502'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6502"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6502'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6502"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6502'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6502"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6502'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6502"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6502: When CL domain is present in the define.xml, but no CL dataset is present in the submission
# then the define.xml must contain ItemGroupDef for CL with attribute def:HasNoData marked as "Yes"
Check:
@@ -105,11 +98,11 @@ Check:
value: false
- name: filename
operator: empty
-#
+#
Core:
Status: Draft
- Version: '1'
-Description: 'CL dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "CL dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing CL dataset.
diff --git a/Unpublished/FDA Business Rules/FB6503/rule.yml b/Unpublished/FDA Business Rules/FB6503/rule.yml
index 024755f5c..736bef370 100644
--- a/Unpublished/FDA Business Rules/FB6503/rule.yml
+++ b/Unpublished/FDA Business Rules/FB6503/rule.yml
@@ -1,97 +1,90 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6503'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6503"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6503'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6503"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6503'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6503"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6503'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6503"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6503'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6503"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6503'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6503"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6503'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6503"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6503: When EG domain is present in the define.xml, but no EG dataset is present in the submission
# then the define.xml must contain ItemGroupDef for EG with attribute def:HasNoData marked as "Yes"
Check:
@@ -105,11 +98,11 @@ Check:
value: false
- name: filename
operator: empty
-#
+#
Core:
Status: Draft
- Version: '1'
-Description: 'EG dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "EG dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing EG dataset.
diff --git a/Unpublished/FDA Business Rules/FB6504/rule.yml b/Unpublished/FDA Business Rules/FB6504/rule.yml
index b788622fe..f8b6f2607 100644
--- a/Unpublished/FDA Business Rules/FB6504/rule.yml
+++ b/Unpublished/FDA Business Rules/FB6504/rule.yml
@@ -1,97 +1,90 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6504'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6504"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6504'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6504"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6504'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6504"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6504'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6504"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6504'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6504"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6504'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6504"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6504'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6504"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6504: When EX domain is present in the define.xml, but no EX dataset is present in the submission
# then the define.xml must contain ItemGroupDef for EX with attribute def:HasNoData marked as "Yes"
Check:
@@ -105,11 +98,11 @@ Check:
value: false
- name: filename
operator: empty
-#
+#
Core:
Status: Draft
- Version: '1'
-Description: 'EX dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "EX dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing EX dataset.
diff --git a/Unpublished/FDA Business Rules/FB6505/rule.yml b/Unpublished/FDA Business Rules/FB6505/rule.yml
index 39daca75a..cfe5fc490 100644
--- a/Unpublished/FDA Business Rules/FB6505/rule.yml
+++ b/Unpublished/FDA Business Rules/FB6505/rule.yml
@@ -1,97 +1,90 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6505'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6505"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6505'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6505"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6505'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6505"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6505'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6505"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6505'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6505"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6505'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6505"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6505'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6505"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6505: When LB domain is present in the define.xml, but no LB dataset is present in the submission
# then the define.xml must contain ItemGroupDef for LB with attribute def:HasNoData marked as "Yes"
Check:
@@ -105,11 +98,11 @@ Check:
value: false
- name: filename
operator: empty
-#
+#
Core:
Status: Draft
- Version: '1'
-Description: 'LB dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "LB dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing LB dataset.
diff --git a/Unpublished/FDA Business Rules/FB6506/rule.yml b/Unpublished/FDA Business Rules/FB6506/rule.yml
index 23db7ad64..8f8d3cb3a 100644
--- a/Unpublished/FDA Business Rules/FB6506/rule.yml
+++ b/Unpublished/FDA Business Rules/FB6506/rule.yml
@@ -1,97 +1,90 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6506'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6506"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6506'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6506"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6506'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6506"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6506'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6506"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6506'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6506"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6506'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6506"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6506'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6506"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6506: When MA domain is present in the define.xml, but no MA dataset is present in the submission
# then the define.xml must contain ItemGroupDef for MA with attribute def:HasNoData marked as "Yes"
Check:
@@ -105,11 +98,11 @@ Check:
value: false
- name: filename
operator: empty
-#
+#
Core:
Status: Draft
- Version: '1'
-Description: 'MA dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "MA dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing MA dataset.
diff --git a/Unpublished/FDA Business Rules/FB6507/rule.yml b/Unpublished/FDA Business Rules/FB6507/rule.yml
index 9635c99aa..871842585 100644
--- a/Unpublished/FDA Business Rules/FB6507/rule.yml
+++ b/Unpublished/FDA Business Rules/FB6507/rule.yml
@@ -1,97 +1,90 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6507'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6507"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6507'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6507"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6507'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6507"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6507'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6507"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6507'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6507"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6507'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6507"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6507'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6507"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6507: When MI domain is present in the define.xml, but no MI dataset is present in the submission
# then the define.xml must contain ItemGroupDef for MI with attribute def:HasNoData marked as "Yes"
Check:
@@ -105,11 +98,11 @@ Check:
value: false
- name: filename
operator: empty
-#
+#
Core:
Status: Draft
- Version: '1'
-Description: 'MI dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "MI dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing MI dataset.
diff --git a/Unpublished/FDA Business Rules/FB6508/rule.yml b/Unpublished/FDA Business Rules/FB6508/rule.yml
index cc81827b3..81ce13a28 100644
--- a/Unpublished/FDA Business Rules/FB6508/rule.yml
+++ b/Unpublished/FDA Business Rules/FB6508/rule.yml
@@ -1,97 +1,90 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6508'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6508"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6508'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6508"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6508'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6508"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6508'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6508"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6508'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6508"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6508'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6508"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6508'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6508"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6507: When PC domain is present in the define.xml, but no PC dataset is present in the submission
# then the define.xml must contain ItemGroupDef for PC with attribute def:HasNoData marked as "Yes"
Check:
@@ -105,11 +98,11 @@ Check:
value: false
- name: filename
operator: empty
-#
+#
Core:
Status: Draft
- Version: '1'
-Description: 'PC dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "PC dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing PC dataset.
diff --git a/Unpublished/FDA Business Rules/FB6509/rule.yml b/Unpublished/FDA Business Rules/FB6509/rule.yml
index 2ed1de5c8..935daeed4 100644
--- a/Unpublished/FDA Business Rules/FB6509/rule.yml
+++ b/Unpublished/FDA Business Rules/FB6509/rule.yml
@@ -1,97 +1,90 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6509'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6509"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6509'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6509"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6509'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6509"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6509'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6509"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6509'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6509"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6509'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6509"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6509'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6509"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6507: When PP domain is present in the define.xml, but no PP dataset is present in the submission
# then the define.xml must contain ItemGroupDef for PP with attribute def:HasNoData marked as "Yes"
Check:
@@ -105,11 +98,11 @@ Check:
value: false
- name: filename
operator: empty
-#
+#
Core:
Status: Draft
- Version: '1'
-Description: 'PP dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "PP dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing PP dataset.
diff --git a/Unpublished/FDA Business Rules/FB6510/rule.yml b/Unpublished/FDA Business Rules/FB6510/rule.yml
index 243d65488..33396bd35 100644
--- a/Unpublished/FDA Business Rules/FB6510/rule.yml
+++ b/Unpublished/FDA Business Rules/FB6510/rule.yml
@@ -1,99 +1,92 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6510'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6510"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6510'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6510"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6510'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6510"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6510'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6510"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6510'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6510"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6510'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6510"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6510'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6510"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6510: When VS domain is present in the define.xml, but no VS dataset is present in the submission
-# then the define.xml must contain ItemGroupDef for VS with attribute def:HasNoData marked as "Yes"
+# then the define.xml must contain ItemGroupDef for VS with attribute def:HasNoData marked as "Yes"
Check:
all:
# Also SEE FB0405
@@ -105,11 +98,11 @@ Check:
value: false
- name: filename
operator: empty
-#
+#
Core:
Status: Draft
- Version: '1'
-Description: 'VS dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "VS dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing VS dataset.
diff --git a/Unpublished/FDA Business Rules/FB6601/rule.yml b/Unpublished/FDA Business Rules/FB6601/rule.yml
index e2b8cb9ff..e4be22802 100644
--- a/Unpublished/FDA Business Rules/FB6601/rule.yml
+++ b/Unpublished/FDA Business Rules/FB6601/rule.yml
@@ -1,93 +1,93 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
# Not applicable to SEND 3.0
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ In SEND 3.1 data elements that would be mapped to RE and CV should be
+ submitted if collected and included in the study report.'
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6601'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6601"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6601'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6601"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6601'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6601"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6601'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6601"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ In SEND 3.1 data elements that would be mapped to RE and CV should be
+ submitted if collected and included in the study report.'
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6601'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6601"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6601'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6601"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6601: When CV domain is present in the define.xml, but no CV dataset is present in the submission
-# then the define.xml must contain ItemGroupDef for CV with attribute def:HasNoData marked as "Yes"
+# then the define.xml must contain ItemGroupDef for CV with attribute def:HasNoData marked as "Yes"
Check:
all:
# Also SEE FB0405
@@ -99,11 +99,11 @@ Check:
value: false
- name: filename
operator: empty
-#
+#
Core:
Status: Draft
- Version: '1'
-Description: 'CV dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "CV dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing CV dataset.
diff --git a/Unpublished/FDA Business Rules/FB6602/rule.yml b/Unpublished/FDA Business Rules/FB6602/rule.yml
index 1f76c25b2..ac5fba790 100644
--- a/Unpublished/FDA Business Rules/FB6602/rule.yml
+++ b/Unpublished/FDA Business Rules/FB6602/rule.yml
@@ -1,93 +1,93 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
# Not applicable to SEND 3.0
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6602'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6602"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6602'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6602"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6602'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6602"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6602'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6602"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report..'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report.."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6602'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6602"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6602'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6602"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6602: When RE domain is present in the define.xml, but no RE dataset is present in the submission
-# then the define.xml must contain ItemGroupDef for RE with attribute def:HasNoData marked as "Yes"
+# then the define.xml must contain ItemGroupDef for RE with attribute def:HasNoData marked as "Yes"
Check:
all:
# Also SEE FB0405
@@ -99,11 +99,11 @@ Check:
value: false
- name: filename
operator: empty
-#
+#
Core:
Status: Draft
- Version: '1'
-Description: 'RE dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "RE dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing RE dataset.
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml
index 379ce50ac..0d848c3f5 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml
@@ -2,13 +2,13 @@ Authorities:
- Organization: FDA
Standards:
- Name: SDTMIG
- Version: '3.2 '
References:
- Origin: FDA Business Rules
Rule Identifier:
Id: FDAB017
- Version: '1'
- Version: '1.5'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2 "
Check:
all:
- name: SSSTRESC
@@ -22,20 +22,20 @@ Check:
Core:
Id: FDA.SDTMIG.CT2001
Status: Draft
- Version: '1'
-Description: Variable must be populated with terms from its CDISC controlled terminology
- codelist. New terms cannot be added into non-extensible codelists.
+ Version: "1"
+Description: Variable must be populated with terms from its CDISC controlled terminology codelist.
+ New terms cannot be added into non-extensible codelists.
Operations:
- - operator: distinct
- domain: DS
- name: DSDECOD
- id: $ds_dsdecod
+ - domain: DS
group:
- USUBJID
+ id: $ds_dsdecod
+ name: DSDECOD
+ operator: distinct
Outcome:
Message: Variable value not found in non-extensible codelist.
Output Variables:
- -
+ -
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0101/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0101/rule.yml
index c6ed2d757..7fea770ad 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0101/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0101/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0101
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0101
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -34,9 +34,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB0101
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
# Because the data we're checking involves a pivoted join, there are multiple rows per
@@ -50,7 +50,7 @@ Check:
Core:
Id: FDA.SDTMIG.FB0101
Status: Draft
- Version: '1'
+ Version: "1"
Description: Treatment-emergent flag should be present in SUPPAE for each Adverse Event.
Executability: Fully Executable
Match Datasets:
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0405/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0405/rule.yml
index bb9db48f6..a55d05db4 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0405/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0405/rule.yml
@@ -1,42 +1,45 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should
- be submitted if collected.'
- Document: 'FDA'
- Section: 'FDAB004'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted if
+ collected."
+ Document: "FDA"
+ Section: "FDAB004"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB0405'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB0405"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should
- be submitted if collected.'
- Document: 'FDA'
- Section: 'FDAB004'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted if
+ collected."
+ Document: "FDA"
+ Section: "FDAB004"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB0405'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB0405"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should
- be submitted if collected.'
- Document: 'FDA'
- Section: 'FDAB004'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted if
+ collected."
+ Document: "FDA"
+ Section: "FDAB004"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB0405'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB0405"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: define_dataset_name
@@ -50,7 +53,7 @@ Check:
Core:
Id: FDA.SDTMIG.FB0405
Status: Draft
- Version: '1'
+ Version: "1"
Description: LB dataset should be present in the submission when related data is collected.
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0411/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0411/rule.yml
index 687540f9d..33c77a0ab 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0411/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0411/rule.yml
@@ -4,42 +4,45 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be
- submitted if collected.
+ - Cited Guidance:
+ AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted
+ if collected.
Document: FDA
Section: FDAB004
Origin: FDA Business Rules
Rule Identifier:
Id: FB0411
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be
- submitted if collected.
+ - Cited Guidance:
+ AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted
+ if collected.
Document: FDA
Section: FDAB004
Origin: FDA Business Rules
Rule Identifier:
Id: FB0411
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be
- submitted if collected.
+ - Cited Guidance:
+ AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted
+ if collected.
Document: FDA
Section: FDAB004
Origin: FDA Business Rules
Rule Identifier:
Id: FB0411
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: PC
@@ -49,11 +52,11 @@ Check:
value:
- Domain: PC
- Attribute: def:HasNoData
- - Value: 'Yes'
+ - Value: "Yes"
Core:
Id: FDA.SDTMIG.FB0411
Status: Draft
- Version: '1'
+ Version: "1"
Description: PC dataset is present in the submission
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml
index 461f951e1..53e2dc10b 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml
@@ -4,126 +4,136 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB080
Origin: FDA Business Rules
Rule Identifier:
Id: FB0801
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0801
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0801
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- # Not applicable to SENDIG-3.0
+ Version: "1"
+ Version: "1.5"
+ Version:
+ "3.4"
+ # Not applicable to SENDIG-3.0
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0801
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0801
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0801
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0801
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0801
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0801
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
any:
# This part of the rule is solely about --STDTC, NOT about --ENDTC
# Remark that date_less_than and date_greater_than compare the shortest common part of the two dates.
- # For example, when 2025-11-03 is compared with 2025-11-02T15:26,
+ # For example, when 2025-11-03 is compared with 2025-11-02T15:26,
# the comparison done is between 2025-11-03 and 2025-11-02.
# Similarly, when the comparison is done between 2025-11-03T07 and 2025-11-03T07:45
# then the comparison done is between 2025-11-03T07 and 2025-11-03T07
@@ -136,10 +146,9 @@ Check:
Core:
Id: FDA.SDTMIG.FB0801
Status: Draft
- Version: '1'
-Description: Treatment exposure start date/time (--STDTC) should fall on or
- between first (RFXSTDTC) and last (RFXENDTC) study treatment date/time in the
- DM dataset.
+ Version: "1"
+Description: Treatment exposure start date/time (--STDTC) should fall on or between first (RFXSTDTC)
+ and last (RFXENDTC) study treatment date/time in the DM dataset.
Executability: Fully Executable
Match Datasets:
- Keys:
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml
index f2ae9cff9..2335763ca 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml
@@ -4,126 +4,136 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB080
Origin: FDA Business Rules
Rule Identifier:
Id: FB0802
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0802
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0802
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- # Not applicable to SENDIG-3.0
+ Version: "1"
+ Version: "1.5"
+ Version:
+ "3.4"
+ # Not applicable to SENDIG-3.0
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0802
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0802
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0802
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0802
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0802
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0802
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
any:
# This part of the rule is solely about --ENDTC, NOT about --STDTC
# Remark that date_less_than and date_greater_than compare the shortest common part of the two dates.
- # For example, when 2025-11-03 is compared with 2025-11-02T15:26,
+ # For example, when 2025-11-03 is compared with 2025-11-02T15:26,
# the comparison done is between 2025-11-03 and 2025-11-02.
# Similarly, when the comparison is done between 2025-11-03T07 and 2025-11-03T07:45
# then the comparison done is between 2025-11-03T07 and 2025-11-03T07
@@ -136,10 +146,9 @@ Check:
Core:
Id: FDA.SDTMIG.FB0802
Status: Draft
- Version: '1'
-Description: Treatment exposure end date/time (--ENDTC) should fall on or
- between first (RFXSTDTC) and last (RFXENDTC) study treatment date/time in the
- DM dataset.
+ Version: "1"
+Description: Treatment exposure end date/time (--ENDTC) should fall on or between first (RFXSTDTC)
+ and last (RFXENDTC) study treatment date/time in the DM dataset.
Executability: Fully Executable
Match Datasets:
- Keys:
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml
index d06a928c3..1d613228e 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml
@@ -1,98 +1,105 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
# Alsot applicable to SENDIG-3.0
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0803
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0803
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0803
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0803
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0803
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0803
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: All treatment exposure date/time should be between first and
- last study treatment date/time.
+ - Cited Guidance:
+ All treatment exposure date/time should be between first and last study
+ treatment date/time.
Document: FDA
Section: FDAB008
Origin: FDA Business Rules
Rule Identifier:
Id: FB0803
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# rule failure criteria: TSPARMCD.EXPSTDTC => EXSTDTC OR EXSTDTC => TSPARMCD.EXPENDTC
Check:
all:
@@ -102,10 +109,9 @@ Check:
Core:
Id: FDA.SDTMIG.FB0803
Status: Draft
- Version: '1'
-Description: Treatment exposure start date/time (EXSTDTC) should fall on or
- between the date/time experimental start (EXPSTDTC) and end date (EXPENDTC) in
- the TS dataset.
+ Version: "1"
+Description: Treatment exposure start date/time (EXSTDTC) should fall on or between the date/time
+ experimental start (EXPSTDTC) and end date (EXPENDTC) in the TS dataset.
Executability: Fully Executable
Operations:
- domain: TS
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml
index 56146bc4b..760425b9f 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml
@@ -1,45 +1,48 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG).'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG)."
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1101'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB1101"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG).'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG)."
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1101'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB1101"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG).'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG)."
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1101'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB1101"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
any:
- name: TA
@@ -53,13 +56,12 @@ Check:
Core:
Id: FDA.SDTMIG.FB1101
Status: Draft
- Version: '1'
-Description: All trial design datasets as listed in the corresponding IG should
- be present in the submission.
+ Version: "1"
+Description: All trial design datasets as listed in the corresponding IG should be present in the
+ submission.
Executability: Fully Executable
Outcome:
- Message: Not all trial design datasets as listed in the corresponding IG have
- been submitted.
+ Message: Not all trial design datasets as listed in the corresponding IG have been submitted.
Rule Type: Domain Presence Check
Scope:
Classes:
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1103/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1103/rule.yml
index 7d830fc20..5a0a5dcf9 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1103/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1103/rule.yml
@@ -5,72 +5,70 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG) Page 13: In
- addition to the study parameters indicated in the appendix
- section, if the study data submitted follows a Therapeutic
- Area User Guide (TAUG) or an FDA Technical Specification,30
- use the values for TSPARM/TSPARMCD and TSVAL from the table
- below in the TS domain.'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG) Page 13: In addition to the study parameters indicated in
+ the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG)
+ or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table
+ below in the TS domain."
Document: FDA
Section: FDAB011
Origin: FDA Business Rules
Rule Identifier:
Id: FB1103
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG) Page 13: In
- addition to the study parameters indicated in the appendix
- section, if the study data submitted follows a Therapeutic
- Area User Guide (TAUG) or an FDA Technical Specification,30
- use the values for TSPARM/TSPARMCD and TSVAL from the table
- below in the TS domain.'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG) Page 13: In addition to the study parameters indicated in
+ the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG)
+ or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table
+ below in the TS domain."
Document: FDA
Section: FDAB011
Origin: FDA Business Rules
Rule Identifier:
Id: FB1103
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG) Page 13: In
- addition to the study parameters indicated in the appendix
- section, if the study data submitted follows a Therapeutic
- Area User Guide (TAUG) or an FDA Technical Specification,30
- use the values for TSPARM/TSPARMCD and TSVAL from the table
- below in the TS domain.'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG) Page 13: In addition to the study parameters indicated in
+ the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG)
+ or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table
+ below in the TS domain."
Document: FDA
Section: FDAB011
Origin: FDA Business Rules
Rule Identifier:
Id: FB1103
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: TSPARMCD
operator: equal_to
- value: 'CTAUG'
+ value: "CTAUG"
- name: TSVAL
operator: is_not_contained_by
value: $terms
Core:
Id: FDA.SDTMIG.FB1103
Status: Draft
- Version: '1'
-Description: 'Raise an issue when TSVAL (Standard Name) does not match
- corresponding name as listed in section 5.2 of the TCG for TAUGs and is in the
- CTAUGRS codelist (C160925), as published in the CDISC Library.'
+ Version: "1"
+Description:
+ "Raise an issue when TSVAL (Standard Name) does not match corresponding name as listed in
+ section 5.2 of the TCG for TAUGs and is in the CTAUGRS codelist (C160925), as published in the CDISC
+ Library."
Executability: Fully Executable
# 2025-09-29: still throws an error when tested on an Excel file
# See Github ticket 1338: https://github.com/cdisc-org/cdisc-rules-engine/issues/1338
@@ -82,9 +80,9 @@ Operations:
operator: codelist_terms
returntype: value
Outcome:
- Message: 'TSVAL (Standard Name) does not match corresponding name as listed in
- section 5.2 of the TCG for TAUGs and is in the CTAUGRS codelist (C160925),
- as published in the CDISC Library.'
+ Message:
+ "TSVAL (Standard Name) does not match corresponding name as listed in section 5.2 of the TCG
+ for TAUGs and is in the CTAUGRS codelist (C160925), as published in the CDISC Library."
Output Variables:
- TSPARMCD
- TSVAL
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1107/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1107/rule.yml
index e14039d4f..b1efc55a0 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1107/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1107/rule.yml
@@ -2,72 +2,71 @@
# Condition: TSPARAMCD=’ADDON’ and TSVAL=’Y’
# Success Criteria: At least one occurrence of TSPARAMCD=’CURTRT’ is included in TS with TSVAL populated.
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1107'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB1107"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1107'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB1107"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1107'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB1107"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- all:
- name: TSPARMCD
- operator: 'equal_to'
- value: 'ADDON'
+ operator: "equal_to"
+ value: "ADDON"
value_is_literal: true
- name: TSVAL
- operator: 'equal_to'
- value: 'Y'
+ operator: "equal_to"
+ value: "Y"
value_is_literal: true
- any:
- name: $tsparmcd
operator: does_not_contain
- value: 'CURTRT'
+ value: "CURTRT"
value_is_literal: true
- name: TSPARMCD
- operator: 'equal_to'
- value: 'CURTRT'
+ operator: "equal_to"
+ value: "CURTRT"
value_is_literal: true
- name: TSVAL
operator: empty
Core:
Id: FDA.SDTMIG.FB1107
Status: Draft
- Version: '1'
-Description: At least one occurrence of TSPARAMCD='CURTRT' is included in TS
- with TSVAL populated.
+ Version: "1"
+Description: At least one occurrence of TSPARAMCD='CURTRT' is included in TS with TSVAL populated.
Executability: Fully Executable
Operations:
- domain: TS
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1108/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1108/rule.yml
index c1266188a..65367365d 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1108/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1108/rule.yml
@@ -1,57 +1,55 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1108'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB1108"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1108'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB1108"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1108'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB1108"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- - name: 'TSPARMCD'
+ - name: "TSPARMCD"
operator: equal_to
value: DCUTDESC
Core:
Id: FDA.SDTMIG.FB1108
Status: Draft
- Version: '1'
-Description: 'TSPARAMCD=DCUTDESC and TSPARAMCD=DCUTDTC do not share the same
- TSGRPID and TSVAL values.'
+ Version: "1"
+Description: "TSPARAMCD=DCUTDESC and TSPARAMCD=DCUTDTC do not share the same TSGRPID and TSVAL values."
Executability: Fully Executable
Outcome:
- Message: 'TSPARAMCD=DCUTDESC and TSPARAMCD=DCUTDTC do not share the same TSGRPID
- and TSVAL values.'
+ Message: "TSPARAMCD=DCUTDESC and TSPARAMCD=DCUTDTC do not share the same TSGRPID and TSVAL values."
Output Variables:
- TSPARMCD
- TSVAL
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1109/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1109/rule.yml
index 59513fdf9..d66079819 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1109/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1109/rule.yml
@@ -1,42 +1,42 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1109'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB1109"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1109'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB1109"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1109'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB1109"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: TSPARMCD
@@ -84,72 +84,72 @@ Check:
Core:
Id: FDA.SDTMIG.FB1109
Status: Draft
- Version: '1'
-Description: 'The set (EGBLIND, EGCTMON, EGLEADPR, EGLEADSM, EGRDMETH, EGREPLBL,
- EGREPLTR, EGTWVALG) is included in the list of TSPARAMCD with TSVAL
- populated.'
+ Version: "1"
+Description:
+ "The set (EGBLIND, EGCTMON, EGLEADPR, EGLEADSM, EGRDMETH, EGREPLBL, EGREPLTR, EGTWVALG) is
+ included in the list of TSPARAMCD with TSVAL populated."
Executability: Fully Executable
Operations:
- domain: TS
filter:
TSPARMCD: EGBLIND
- TSVAL: ''
+ TSVAL: ""
id: $blind_count
name: TSPARMCD
operator: record_count
- domain: TS
filter:
TSPARMCD: EGCTMON
- TSVAL: ''
+ TSVAL: ""
id: $ctmon_count
name: TSPARMCD
operator: record_count
- domain: TS
filter:
TSPARMCD: EGLEADPR
- TSVAL: ''
+ TSVAL: ""
id: $leadpr_count
name: TSPARMCD
operator: record_count
- domain: TS
filter:
TSPARMCD: EGLEADSM
- TSVAL: ''
+ TSVAL: ""
id: $leadsm_count
name: TSPARMCD
operator: record_count
- domain: TS
filter:
TSPARMCD: EGRDMETH
- TSVAL: ''
+ TSVAL: ""
id: $rdmeth_count
name: TSPARMCD
operator: record_count
- domain: TS
filter:
TSPARMCD: EGREPLBL
- TSVAL: ''
+ TSVAL: ""
id: $replbl_count
name: TSPARMCD
operator: record_count
- domain: TS
filter:
TSPARMCD: EGREPLTR
- TSVAL: ''
+ TSVAL: ""
id: $repltr_count
name: TSPARMCD
operator: record_count
- domain: TS
filter:
TSPARMCD: EGTWVALG
- TSVAL: ''
+ TSVAL: ""
id: $twvalg_count
name: TSPARMCD
operator: record_count
Outcome:
- Message: 'The set (EGBLIND, EGCTMON, EGLEADPR, EGLEADSM, EGRDMETH, EGREPLBL,
- EGREPLTR, EGTWVALG) is included in the list of TSPARAMCD with TSVAL
- populated.'
+ Message:
+ "The set (EGBLIND, EGCTMON, EGLEADPR, EGLEADSM, EGRDMETH, EGREPLBL, EGREPLTR, EGTWVALG) is
+ included in the list of TSPARAMCD with TSVAL populated."
Output Variables:
- TSVAL
- $blind_count
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1112/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1112/rule.yml
index a0ed4fba8..98cabcaa3 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1112/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1112/rule.yml
@@ -1,42 +1,42 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1112'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB1112"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1112'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB1112"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'TCG, Appendix B'
- Document: 'FDA'
- Section: 'FDAB011'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "TCG, Appendix B"
+ Document: "FDA"
+ Section: "FDAB011"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB1112'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Id: "FB1112"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: $PCLASS_COUNT
@@ -54,9 +54,10 @@ Check:
Core:
Id: FDA.SDTMIG.FB1112
Status: Draft
- Version: '1'
-Description: 'The count of occurrences of TSPARAMCD = PCLASS is in the list of
- TSPARAMCD with TSVAL populated is gt 1.'
+ Version: "1"
+Description:
+ "The count of occurrences of TSPARAMCD = PCLASS is in the list of TSPARAMCD with TSVAL populated
+ is gt 1."
Executability: Partially Executable
Operations:
- filter:
@@ -68,8 +69,9 @@ Operations:
id: $INTTYPE_EXISTS
operator: record_count
Outcome:
- Message: 'The count of occurrences of TSPARAMCD = PCLASS is in the list of
- TSPARAMCD with TSVAL populated is gt 1.'
+ Message:
+ "The count of occurrences of TSPARAMCD = PCLASS is in the list of TSPARAMCD with TSVAL populated
+ is gt 1."
Output Variables:
- TSPARMCD
- TSVAL
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml
index 0b4ca2548..18d66bce0 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml
@@ -4,133 +4,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A variable's length across a study should be no longer than the
- maximum length of the actual data (except for SUPPQUAL).
+ - Cited Guidance:
+ A variable's length across a study should be no longer than the maximum
+ length of the actual data (except for SUPPQUAL).
Document: FDA
Section: FDAB018
Origin: FDA Business Rules
Rule Identifier:
Id: FB1801
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A variable's length across a study should be no longer than the
- maximum length of the actual data (except for SUPPQUAL).
+ - Cited Guidance:
+ A variable's length across a study should be no longer than the maximum
+ length of the actual data (except for SUPPQUAL).
Document: FDA
Section: FDAB018
Origin: FDA Business Rules
Rule Identifier:
Id: FB1801
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A variable's length across a study should be no longer than the
- maximum length of the actual data (except for SUPPQUAL).
+ - Cited Guidance:
+ A variable's length across a study should be no longer than the maximum
+ length of the actual data (except for SUPPQUAL).
Document: FDA
Section: FDAB018
Origin: FDA Business Rules
Rule Identifier:
Id: FB1801
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A variable's length across a study should be no longer than the
- maximum length of the actual data (except for SUPPQUAL).
+ - Cited Guidance:
+ A variable's length across a study should be no longer than the maximum
+ length of the actual data (except for SUPPQUAL).
Document: FDA
Section: FDAB018
Origin: FDA Business Rules
Rule Identifier:
Id: FB1801
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A variable's length across a study should be no longer than the
- maximum length of the actual data (except for SUPPQUAL).
+ - Cited Guidance:
+ A variable's length across a study should be no longer than the maximum
+ length of the actual data (except for SUPPQUAL).
Document: FDA
Section: FDAB018
Origin: FDA Business Rules
Rule Identifier:
Id: FB1801
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A variable's length across a study should be no longer than the
- maximum length of the actual data (except for SUPPQUAL).
+ - Cited Guidance:
+ A variable's length across a study should be no longer than the maximum
+ length of the actual data (except for SUPPQUAL).
Document: FDA
Section: FDAB018
Origin: FDA Business Rules
Rule Identifier:
Id: FB1801
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: A variable's length across a study should be no longer than the
- maximum length of the actual data (except for SUPPQUAL).
+ - Cited Guidance:
+ A variable's length across a study should be no longer than the maximum
+ length of the actual data (except for SUPPQUAL).
Document: FDA
Section: FDAB018
Origin: FDA Business Rules
Rule Identifier:
Id: FB1801
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A variable's length across a study should be no longer than the
- maximum length of the actual data (except for SUPPQUAL).
+ - Cited Guidance:
+ A variable's length across a study should be no longer than the maximum
+ length of the actual data (except for SUPPQUAL).
Document: FDA
Section: FDAB018
Origin: FDA Business Rules
Rule Identifier:
Id: FB1801
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A variable's length across a study should be no longer than the
- maximum length of the actual data (except for SUPPQUAL).
+ - Cited Guidance:
+ A variable's length across a study should be no longer than the maximum
+ length of the actual data (except for SUPPQUAL).
Document: FDA
Section: FDAB018
Origin: FDA Business Rules
Rule Identifier:
Id: FB1801
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: A variable's length across a study should be no longer than the
- maximum length of the actual data (except for SUPPQUAL).
+ - Cited Guidance:
+ A variable's length across a study should be no longer than the maximum
+ length of the actual data (except for SUPPQUAL).
Document: FDA
Section: FDAB018
Origin: FDA Business Rules
Rule Identifier:
Id: FB1801
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: variable_size
@@ -139,10 +149,9 @@ Check:
Core:
Id: FDA.SDTMIG.FB1801
Status: Draft
- Version: '1'
-Description: The length of each variable cannot be different between datasets
- and should not be longer than the maximum length of the data contained by the
- variable
+ Version: "1"
+Description: The length of each variable cannot be different between datasets and should not be
+ longer than the maximum length of the data contained by the variable
Executability: Partially Executable
# Operations:
#- id: $size
@@ -154,7 +163,7 @@ Outcome:
- variable_size
- variable_value_length
- variable_name
- # - $size
+ # - $size
Rule Type: Variable Metadata Check
Scope:
Classes:
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml
index e23f08d5a..d088a0046 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml
@@ -7,16 +7,15 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For interventional studies all treated subjects should have
- exposure data.
+ - Cited Guidance: For interventional studies all treated subjects should have exposure data.
Document: FDA
Section: FDAB023
Origin: FDA Business Rules
Rule Identifier:
Id: FB2303
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
Check:
all:
- name: ACTARMCD
@@ -39,9 +38,9 @@ Check:
Core:
Id: FDA.SDTMIG.FB2303
Status: Draft
- Version: '1'
-Description: All subjects in the Exposure domain who are participating in a
- study that includes an interventional product must be assigned to a treatment.
+ Version: "1"
+Description: All subjects in the Exposure domain who are participating in a study that includes an
+ interventional product must be assigned to a treatment.
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -53,8 +52,8 @@ Operations:
name: USUBJID
operator: distinct
Outcome:
- Message: A subject has a record in EX but is not assigned to a treatment while
- participating in an interventional study
+ Message: A subject has a record in EX but is not assigned to a treatment while participating in an
+ interventional study
Output Variables:
- ACTARMCD
- TSPARMCD
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2503/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2503/rule.yml
index af2d97043..2b4fb1c5b 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2503/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2503/rule.yml
@@ -13,9 +13,9 @@ Authorities:
Origin: FDA Business Rules
Rule Identifier:
Id: FB2503
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
Check:
all:
- name: ARMCD
@@ -33,7 +33,7 @@ Check:
Core:
Id: FDA.SDTMIG.FB2503
Status: Draft
- Version: '1'
+ Version: "1"
Description: If a subject is assigned to an arm, the subject should have a record in EX.
Executability: Partially Executable
Operations:
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml
index 0c70770cc..d6990e24a 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml
@@ -7,143 +7,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3211
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3211
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3211
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3211
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3211
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3211
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3211
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3211
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3211
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if
- collected, and study day of observation (--DY) should be
- submitted.
+ - Cited Guidance:
+ Start date/time of observation (--DTC) should be submitted, if collected,
+ and study day of observation (--DY) should be submitted.
Document: FDA
Section: FDAB032
Origin: FDA Business Rules
Rule Identifier:
Id: FB3211
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: --STDTC
@@ -156,9 +156,9 @@ Check:
Core:
Id: FDA.SDTMIG.FB3211
Status: Draft
- Version: '1'
-Description: Start Date/Time of Observation (--STDTC) is prior or equal to
- Date/Time of Collection (--DTC)
+ Version: "1"
+Description: Start Date/Time of Observation (--STDTC) is prior or equal to Date/Time of Collection
+ (--DTC)
Executability: Fully Executable
Outcome:
Message: --STDTC falls after --DTC.
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3402/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3402/rule.yml
index f277246db..9fd74ae4b 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3402/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3402/rule.yml
@@ -1,148 +1,139 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3402'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB3402"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3402'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB3402"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3402'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB3402"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3402'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB3402"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3402'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB3402"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3402'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3402"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3402'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3402"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3402'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB3402"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3402'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB3402"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3402'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB3402"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
# TODO: check/adapt for value with different granularity
all:
- name: EXSTDTC
operator: date_greater_than
- value: '$max_dsstdtc'
+ value: "$max_dsstdtc"
Core:
Id: FDA.SDTMIG.FB3402
Status: Draft
- Version: '1'
-Description: 'Start Date/Time of Treatment (EXSTDTC) should be prior or equal to
- the Start Date/Time of the latest Disposition Event (DSSTDTC).'
+ Version: "1"
+Description:
+ "Start Date/Time of Treatment (EXSTDTC) should be prior or equal to the Start Date/Time of
+ the latest Disposition Event (DSSTDTC)."
Executability: Fully Executable
Operations:
- domain: DS
@@ -152,7 +143,7 @@ Operations:
name: DSSTDTC
operator: max_date
Outcome:
- Message: 'EXSTDTC falls after the last DSSTDTC.'
+ Message: "EXSTDTC falls after the last DSSTDTC."
Output Variables:
- EXSTDTC
- $max_dsstdtc
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3403/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3403/rule.yml
index 5de444556..70b7ebacf 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3403/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3403/rule.yml
@@ -1,148 +1,139 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3403'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB3403"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3403'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB3403"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3403'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB3403"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3403'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB3403"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3403'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB3403"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3403'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3403"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3403'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3403"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3403'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB3403"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3403'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB3403"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'Study start and end date/time should include month, day, and
- year.'
- Document: 'FDA'
- Section: 'FDAB034'
+ - Cited Guidance: "Study start and end date/time should include month, day, and year."
+ Document: "FDA"
+ Section: "FDAB034"
Origin: FDA Business Rules
Rule Identifier:
- Id: 'FB3403'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB3403"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
# TODO: check/adapt for value with different granularity
all:
- name: EXENDTC
operator: date_greater_than
- value: '$max_dsstdtc'
+ value: "$max_dsstdtc"
Core:
Id: FDA.SDTMIG.FB3403
Status: Draft
- Version: '1'
-Description: 'End Date/Time of Treatment (EXENDTC) should be prior or equal to
- the Start Date/Time of the latest Disposition Event (DSSTDTC).'
+ Version: "1"
+Description:
+ "End Date/Time of Treatment (EXENDTC) should be prior or equal to the Start Date/Time of
+ the latest Disposition Event (DSSTDTC)."
Executability: Fully Executable
Operations:
- domain: DS
@@ -152,7 +143,7 @@ Operations:
name: DSSTDTC
operator: max_date
Outcome:
- Message: 'EXENDTC falls after the last DSSTDTC.'
+ Message: "EXENDTC falls after the last DSSTDTC."
Output Variables:
- EXENDTC
- $max_dsstdtc
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml
index c34f745fb..32ff92c72 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml
@@ -7,42 +7,39 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3405
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3405
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Study start and end date/time should include month, day, and
- year.
+ - Cited Guidance: Study start and end date/time should include month, day, and year.
Document: FDA
Section: FDAB034
Origin: FDA Business Rules
Rule Identifier:
Id: FB3405
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
Check:
all:
- name: --STDTC
@@ -55,9 +52,9 @@ Check:
Core:
Id: FDA.SDTMIG.FB3405
Status: Draft
- Version: '1'
-Description: Start Date/Time (--STDTC) should be prior or equal to the Date/Time
- of End of Participation (RFPENDTC)
+ Version: "1"
+Description: Start Date/Time (--STDTC) should be prior or equal to the Date/Time of End of
+ Participation (RFPENDTC)
Executability: Fully Executable
Match Datasets:
- Keys:
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3801/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3801/rule.yml
index 0d35a3a34..9bad1c13d 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3801/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3801/rule.yml
@@ -1,136 +1,146 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Timing information of interventions, findings and events should
- be submitted, if collected.'
- Document: 'FDA'
- Section: 'FDAB038'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Timing information of interventions, findings and events should be submitted,
+ if collected."
+ Document: "FDA"
+ Section: "FDAB038"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3801'
- Version: '1'
- Version: '1.5'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "FB3801"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Timing information of interventions, findings and events should
- be submitted, if collected.'
- Document: 'FDA'
- Section: 'FDAB038'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Timing information of interventions, findings and events should be submitted,
+ if collected."
+ Document: "FDA"
+ Section: "FDAB038"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3801'
- Version: '1'
- Version: '1.5'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "FB3801"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Timing information of interventions, findings and events should
- be submitted, if collected.'
- Document: 'FDA'
- Section: 'FDAB038'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Timing information of interventions, findings and events should be submitted,
+ if collected."
+ Document: "FDA"
+ Section: "FDAB038"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3801'
- Version: '1'
- Version: '1.5'
- Version: '3.4'
- - Name: 'SENDIG'
+ Id: "FB3801"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Timing information of interventions, findings and events should
- be submitted, if collected.'
- Document: 'FDA'
- Section: 'FDAB038'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Timing information of interventions, findings and events should be submitted,
+ if collected."
+ Document: "FDA"
+ Section: "FDAB038"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3801'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB3801"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Timing information of interventions, findings and events should
- be submitted, if collected.'
- Document: 'FDA'
- Section: 'FDAB038'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Timing information of interventions, findings and events should be submitted,
+ if collected."
+ Document: "FDA"
+ Section: "FDAB038"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3801'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB3801"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Timing information of interventions, findings and events should
- be submitted, if collected.'
- Document: 'FDA'
- Section: 'FDAB038'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Timing information of interventions, findings and events should be submitted,
+ if collected."
+ Document: "FDA"
+ Section: "FDAB038"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3801'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB3801"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'Timing information of interventions, findings and events should
- be submitted, if collected.'
- Document: 'FDA'
- Section: 'FDAB038'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Timing information of interventions, findings and events should be submitted,
+ if collected."
+ Document: "FDA"
+ Section: "FDAB038"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3801'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB3801"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Timing information of interventions, findings and events should
- be submitted, if collected.'
- Document: 'FDA'
- Section: 'FDAB038'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Timing information of interventions, findings and events should be submitted,
+ if collected."
+ Document: "FDA"
+ Section: "FDAB038"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3801'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB3801"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Timing information of interventions, findings and events should
- be submitted, if collected.'
- Document: 'FDA'
- Section: 'FDAB038'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Timing information of interventions, findings and events should be submitted,
+ if collected."
+ Document: "FDA"
+ Section: "FDAB038"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3801'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB3801"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'Timing information of interventions, findings and events should
- be submitted, if collected.'
- Document: 'FDA'
- Section: 'FDAB038'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "Timing information of interventions, findings and events should be submitted,
+ if collected."
+ Document: "FDA"
+ Section: "FDAB038"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB3801'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB3801"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: define_variable_is_collected
@@ -142,8 +152,8 @@ Check:
Core:
Id: FDA.SDTMIG.FB3801
Status: Draft
- Version: '1'
-Description: 'Timing information should be submitted when collected.'''
+ Version: "1"
+Description: "Timing information should be submitted when collected.'"
Executability: Partially Executable
Operations:
- id: $dataset_variables
@@ -153,7 +163,7 @@ Operations:
key_value: Timing
operator: get_model_filtered_variables
Outcome:
- Message: 'Timing information is collected but not submitted.'
+ Message: "Timing information is collected but not submitted."
Output Variables:
- $dataset_variables
- $timing_variables
diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB7101/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB7101/rule.yml
index 71a350564..04990ab49 100644
--- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB7101/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB7101/rule.yml
@@ -4,133 +4,143 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A specimen material type should be named consistently across
- pharmacokinetic datasets within a submission.
+ - Cited Guidance:
+ A specimen material type should be named consistently across pharmacokinetic
+ datasets within a submission.
Document: FDA
Section: FDAB071
Origin: FDA Business Rules
Rule Identifier:
Id: FB7101
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A specimen material type should be named consistently across
- pharmacokinetic datasets within a submission.
+ - Cited Guidance:
+ A specimen material type should be named consistently across pharmacokinetic
+ datasets within a submission.
Document: FDA
Section: FDAB071
Origin: FDA Business Rules
Rule Identifier:
Id: FB7101
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A specimen material type should be named consistently across
- pharmacokinetic datasets within a submission.
+ - Cited Guidance:
+ A specimen material type should be named consistently across pharmacokinetic
+ datasets within a submission.
Document: FDA
Section: FDAB071
Origin: FDA Business Rules
Rule Identifier:
Id: FB7101
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A specimen material type should be named consistently across
- pharmacokinetic datasets within a submission.
+ - Cited Guidance:
+ A specimen material type should be named consistently across pharmacokinetic
+ datasets within a submission.
Document: FDA
Section: FDAB071
Origin: FDA Business Rules
Rule Identifier:
Id: FB7101
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A specimen material type should be named consistently across
- pharmacokinetic datasets within a submission.
+ - Cited Guidance:
+ A specimen material type should be named consistently across pharmacokinetic
+ datasets within a submission.
Document: FDA
Section: FDAB071
Origin: FDA Business Rules
Rule Identifier:
Id: FB7101
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A specimen material type should be named consistently across
- pharmacokinetic datasets within a submission.
+ - Cited Guidance:
+ A specimen material type should be named consistently across pharmacokinetic
+ datasets within a submission.
Document: FDA
Section: FDAB071
Origin: FDA Business Rules
Rule Identifier:
Id: FB7101
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: A specimen material type should be named consistently across
- pharmacokinetic datasets within a submission.
+ - Cited Guidance:
+ A specimen material type should be named consistently across pharmacokinetic
+ datasets within a submission.
Document: FDA
Section: FDAB071
Origin: FDA Business Rules
Rule Identifier:
Id: FB7101
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A specimen material type should be named consistently across
- pharmacokinetic datasets within a submission.
+ - Cited Guidance:
+ A specimen material type should be named consistently across pharmacokinetic
+ datasets within a submission.
Document: FDA
Section: FDAB071
Origin: FDA Business Rules
Rule Identifier:
Id: FB7101
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A specimen material type should be named consistently across
- pharmacokinetic datasets within a submission.
+ - Cited Guidance:
+ A specimen material type should be named consistently across pharmacokinetic
+ datasets within a submission.
Document: FDA
Section: FDAB071
Origin: FDA Business Rules
Rule Identifier:
Id: FB7101
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: A specimen material type should be named consistently across
- pharmacokinetic datasets within a submission.
+ - Cited Guidance:
+ A specimen material type should be named consistently across pharmacokinetic
+ datasets within a submission.
Document: FDA
Section: FDAB071
Origin: FDA Business Rules
Rule Identifier:
Id: FB7101
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: PPCAT
@@ -144,9 +154,10 @@ Check:
Core:
Id: FDA.SDTMIG.FB7101
Status: Draft
- Version: '1'
-Description: 'For the same drug or metabolite (PCTEST), specimen type (PCSPEC)
- should be consistent across pharmacokinetic datasets within a submission.'
+ Version: "1"
+Description:
+ "For the same drug or metabolite (PCTEST), specimen type (PCSPEC) should be consistent across
+ pharmacokinetic datasets within a submission."
Executability: Partially Executable
Match Datasets:
- Name: RELREC
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB1115/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB1115/rule.yml
index 975e9e26a..abd1d19e0 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB1115/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB1115/rule.yml
@@ -5,45 +5,45 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'The set of parameters without conditions listed in the TCG,
- Appendix C, is not included in the list of TSPARAMCD with
- TSVAL populated.'
+ - Cited Guidance:
+ "The set of parameters without conditions listed in the TCG, Appendix C, is not
+ included in the list of TSPARAMCD with TSVAL populated."
Document: FDA
Section: FDAB011
Origin: FDA Business Rules
Rule Identifier:
Id: FB1115
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'The set of parameters without conditions listed in the TCG,
- Appendix C, is not included in the list of TSPARAMCD with
- TSVAL populated.'
+ - Cited Guidance:
+ "The set of parameters without conditions listed in the TCG, Appendix C, is not
+ included in the list of TSPARAMCD with TSVAL populated."
Document: FDA
Section: FDAB011
Origin: FDA Business Rules
Rule Identifier:
Id: FB1115
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'The set of parameters without conditions listed in the TCG,
- Appendix C, is not included in the list of TSPARAMCD with
- TSVAL populated.'
+ - Cited Guidance:
+ "The set of parameters without conditions listed in the TCG, Appendix C, is not
+ included in the list of TSPARAMCD with TSVAL populated."
Document: FDA
Section: FDAB011
Origin: FDA Business Rules
Rule Identifier:
Id: FB1115
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
# List of parameters for which there must be a record, i.e. TSPARMCD:
# 'AGEU','DOSDUR','DOSENDTC','DOSSTDTC','EXPENDTC','EXPSTDTC','GLPFL','GLPTYP','PCLASS','PPTCNAM','PPTEGID','PPTEGSYM','PPTMDA','ROUTE','SDESIGN','SEXPOP','SNDCTVER','SNDIGVER','SPECIES','SPLANSUB','SPLRNAM','SPREFID','SSPONSOR','SSTYP','STCAT','STDIR','STITLE','STRAIN','STRPSTAT','STSTDTC','TFCNTRY','TRMSAC','TRT','TRTCAS','TRTUNII','TRTV','TSTFLOC','TSTFNAM'
# Starting from the code for FB1102 (which is for SDTM, but here the list is for SEND)
@@ -53,57 +53,57 @@ Check:
operator: not_contains_all
value:
- AGEU
- #- 'DOSDUR'
- #- 'DOSENDTC'
- #- 'DOSSTDTC'
- #- 'EXPENDTC'
- #- 'EXPSTDTC'
- #- 'GLPFL'
- #- 'GLPTYP'
- #- 'PCLASS'
- #- 'PPTCNAM'
- #- 'PPTEGID'
- #- 'PPTEGSYM'
- #- 'PPTEGSYM'
- #- 'PPTMDA'
- #- 'ROUTE'
- #- 'SDESIGN'
- #- 'SEXPOP'
- #- 'SNDCTVER'
- #- 'SPECIES'
- #- 'SPLANSUB'
- #- 'SPLRNAM'
- #- 'SPREFID'
- #- 'SSPONSOR'
- #- 'SSTYP'
- #- 'STCAT'
- #- 'STDIR'
- #- 'STITLE'
- #- 'STRAIN'
- #- 'STRPSTAT'
- #- 'STSTDTC'
- #- 'TFCNTRY'
- #- 'TRMSAC'
- #- 'TRT'
- #- 'TRTCAS'
- #- 'TRTUNII'
- #- 'TRTV'
- #- 'TSTFLOC'
- #- 'TSTFNAM'
+ #- 'DOSDUR'
+ #- 'DOSENDTC'
+ #- 'DOSSTDTC'
+ #- 'EXPENDTC'
+ #- 'EXPSTDTC'
+ #- 'GLPFL'
+ #- 'GLPTYP'
+ #- 'PCLASS'
+ #- 'PPTCNAM'
+ #- 'PPTEGID'
+ #- 'PPTEGSYM'
+ #- 'PPTEGSYM'
+ #- 'PPTMDA'
+ #- 'ROUTE'
+ #- 'SDESIGN'
+ #- 'SEXPOP'
+ #- 'SNDCTVER'
+ #- 'SPECIES'
+ #- 'SPLANSUB'
+ #- 'SPLRNAM'
+ #- 'SPREFID'
+ #- 'SSPONSOR'
+ #- 'SSTYP'
+ #- 'STCAT'
+ #- 'STDIR'
+ #- 'STITLE'
+ #- 'STRAIN'
+ #- 'STRPSTAT'
+ #- 'STSTDTC'
+ #- 'TFCNTRY'
+ #- 'TRMSAC'
+ #- 'TRT'
+ #- 'TRTCAS'
+ #- 'TRTUNII'
+ #- 'TRTV'
+ #- 'TSTFLOC'
+ #- 'TSTFNAM'
- - name: 'TSVAL'
+ - name: "TSVAL"
operator: non_empty
Core:
Id: FDA.SENDIG.FB1115
Status: Draft
- Version: '1'
-Description: 'Check whether all values in the list are populated for TSPARMCD
- and TSVAL is populated'
+ Version: "1"
+Description: "Check whether all values in the list are populated for TSPARMCD and TSVAL is populated"
Executability: Fully Executable
Outcome:
- Message: 'The set of parameters without conditions listed in the TCG, Appendix
- C, is not included in the list of TSPARAMCD with TSVAL populated.'
+ Message:
+ "The set of parameters without conditions listed in the TCG, Appendix C, is not included in
+ the list of TSPARAMCD with TSVAL populated."
Output Variables:
- TSVAL
- TSPARMCD
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml
index 9f887b87d..0376f779e 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml
@@ -5,31 +5,31 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Required timing variables for identification of the day on
- which group summaries (group means and incidences) are
- calculated should be populated for nonclinical data.'
+ - Cited Guidance:
+ "Required timing variables for identification of the day on which group summaries
+ (group means and incidences) are calculated should be populated for nonclinical data."
Document: FDA
Section: FDAB047
Origin: FDA Business Rules
Rule Identifier:
Id: FB4702
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Required timing variables for identification of the day on
- which group summaries (group means and incidences) are
- calculated should be populated for nonclinical data.'
+ - Cited Guidance:
+ "Required timing variables for identification of the day on which group summaries
+ (group means and incidences) are calculated should be populated for nonclinical data."
Document: FDA
Section: FDAB042
Origin: FDA Business Rules
Rule Identifier:
Id: FB4702
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
Check:
all:
# Rule = At least one of VISITDY or --NOMDY is populated as these are required timing variables
@@ -49,24 +49,25 @@ Check:
- name: --USCHFL
operator: empty
- any:
- # --VISITDY column is absent or --VISITDY is
+ # --VISITDY column is absent or --VISITDY is
# P.S. VISITDY = PLANNED Study Day of Collection
- name: VISITDY
operator: not_exists
- name: VISITDY
- operator: 'empty'
- # TEST CONDITION. Remark that --MOMDY is "expected"
+ operator:
+ "empty"
+ # TEST CONDITION. Remark that --MOMDY is "expected"
- name: --NOMDY
- operator: 'empty'
+ operator: "empty"
Core:
Id: FDA.SENDIG.FB4702
Status: Draft
- Version: '1'
-# Description: 'Either VISITDY or --NOMDY must be populated when # --ORRES is
+ Version: "1"
+# Description: 'Either VISITDY or --NOMDY must be populated when # --ORRES is
# populated and --USCHFL is not populated'
-Description: VISITDY or --NOMDY should be populated for scheduled records as
- these are required timing variables for identification of the day on which
- group summaries (Group Means and Incidences) are calculated.
+Description: VISITDY or --NOMDY should be populated for scheduled records as these are required
+ timing variables for identification of the day on which group summaries (Group Means and
+ Incidences) are calculated.
Executability: Fully Executable
Outcome:
#Message: 'Either VISITDY or --NOMDY must be populated when --ORRES is populated
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB5132/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB5132/rule.yml
index 631b86388..4b996d040 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB5132/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB5132/rule.yml
@@ -5,106 +5,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5132
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5132
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5132
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5132
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5132
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5132
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Variables intended only for human studies should not be
- included in nonclinical data.'
+ - Cited Guidance:
+ "Variables intended only for human studies should not be included in nonclinical
+ data."
Document: FDA
Section: FDAB051
Origin: FDA Business Rules
Rule Identifier:
Id: FB5132
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- - name: 'TSVALCD'
+ - name: "TSVALCD"
operator: exists
Core:
Id: FDA.SENDIG.FB5132
Status: Draft
- Version: '1'
-Description: 'TSVALCD (Parameter Value Code) must not be in SEND dataset'
+ Version: "1"
+Description: "TSVALCD (Parameter Value Code) must not be in SEND dataset"
Executability: Fully Executable
Outcome:
- Message: 'TSVALCD must not be present in SEND dataset'
+ Message: "TSVALCD must not be present in SEND dataset"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6403/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6403/rule.yml
index fefbb1ecc..b9b5c318a 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6403/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6403/rule.yml
@@ -5,101 +5,101 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to
- test compound rather than challenge agents or other
- interventions.'
+ - Cited Guidance:
+ "When possible, RFSTDTC should be the first day of exposure to test compound rather
+ than challenge agents or other interventions."
Document: FDA
Section: FDAB064
Origin: FDA Business Rules
Rule Identifier:
Id: FB6403
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to
- test compound rather than challenge agents or other
- interventions.'
+ - Cited Guidance:
+ "When possible, RFSTDTC should be the first day of exposure to test compound rather
+ than challenge agents or other interventions."
Document: FDA
Section: FDAB064
Origin: FDA Business Rules
Rule Identifier:
Id: FB6403
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to
- test compound rather than challenge agents or other
- interventions.'
+ - Cited Guidance:
+ "When possible, RFSTDTC should be the first day of exposure to test compound rather
+ than challenge agents or other interventions."
Document: FDA
Section: FDAB064
Origin: FDA Business Rules
Rule Identifier:
Id: FB6403
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to
- test compound rather than challenge agents or other
- interventions.'
+ - Cited Guidance:
+ "When possible, RFSTDTC should be the first day of exposure to test compound rather
+ than challenge agents or other interventions."
Document: FDA
Section: FDAB064
Origin: FDA Business Rules
Rule Identifier:
Id: FB6403
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to
- test compound rather than challenge agents or other
- interventions.'
+ - Cited Guidance:
+ "When possible, RFSTDTC should be the first day of exposure to test compound rather
+ than challenge agents or other interventions."
Document: FDA
Section: FDAB064
Origin: FDA Business Rules
Rule Identifier:
Id: FB6403
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to
- test compound rather than challenge agents or other
- interventions.'
+ - Cited Guidance:
+ "When possible, RFSTDTC should be the first day of exposure to test compound rather
+ than challenge agents or other interventions."
Document: FDA
Section: FDAB064
Origin: FDA Business Rules
Rule Identifier:
Id: FB6403
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to
- test compound rather than challenge agents or other
- interventions.'
+ - Cited Guidance:
+ "When possible, RFSTDTC should be the first day of exposure to test compound rather
+ than challenge agents or other interventions."
Document: FDA
Section: FDAB064
Origin: FDA Business Rules
Rule Identifier:
Id: FB6403
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- all:
@@ -119,9 +119,10 @@ Check:
Core:
Id: FDA.SENDIG.FB6403
Status: Draft
- Version: '1'
-Description: 'RFSTDTC should be the first treatment exposure date/time from EX
- and not equal to start dates from PR/CM/AG'
+ Version: "1"
+Description:
+ "RFSTDTC should be the first treatment exposure date/time from EX and not equal to start
+ dates from PR/CM/AG"
Executability: Fully Executable
Operations:
- domain: "EX"
@@ -149,8 +150,9 @@ Operations:
name: "AGSTDTC"
operator: "min_date"
Outcome:
- Message: 'RFSTDTC is not the first treatment exposure date/time from EX and
- equal to one of the start dates from PR/CM/AG'
+ Message:
+ "RFSTDTC is not the first treatment exposure date/time from EX and equal to one of the start
+ dates from PR/CM/AG"
Output Variables:
- RFSTDTC
- $ex_exstdtc
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6501/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6501/rule.yml
index a7171a48b..5a44374cc 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6501/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6501/rule.yml
@@ -1,99 +1,92 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6501'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6501'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6501'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6501"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6501'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6501'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6501'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6501'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6501"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6501: When DS domain is present in the define.xml, but no DS dataset is present in the submission
-# then the define.xml must contain ItemGroupDef for DS with attribute def:HasNoData marked as "Yes"
+# then the define.xml must contain ItemGroupDef for DS with attribute def:HasNoData marked as "Yes"
Check:
all:
- name: DS
@@ -104,8 +97,8 @@ Check:
Core:
Id: FDA.SENDIG.FB6501
Status: Draft
- Version: '1'
-Description: 'DS dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "DS dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing DS dataset.
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6502/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6502/rule.yml
index 231f74321..6bb229b33 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6502/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6502/rule.yml
@@ -1,99 +1,92 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6502'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6502"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6502'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6502"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6502'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6502"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6502'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6502"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6502'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6502"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6502'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6502"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6502'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6502"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6502: When CL domain is present in the define.xml, but no CL dataset is present in the submission
-# then the define.xml must contain ItemGroupDef for CL with attribute def:HasNoData marked as "Yes"
+# then the define.xml must contain ItemGroupDef for CL with attribute def:HasNoData marked as "Yes"
Check:
all:
- name: CL
@@ -104,9 +97,8 @@ Check:
Core:
Id: FDA.SENDIG.FB6502
Status: Draft
- Version: '1'
-Description: 'CL dataset should be present in the submission when related data
- is collected.'
+ Version: "1"
+Description: "CL dataset should be present in the submission when related data is collected."
Executability: Fully Executable
Outcome:
Message: Missing CL dataset.
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6503/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6503/rule.yml
index 8ba8435c3..c0a2551a3 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6503/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6503/rule.yml
@@ -1,99 +1,92 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6503'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6503"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6503'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6503"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6503'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6503"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6503'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6503"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6503'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6503"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6503'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6503"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6503'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6503"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6503: When EG domain is present in the define.xml, but no EG dataset is present in the submission
-# then the define.xml must contain ItemGroupDef for EG with attribute def:HasNoData marked as "Yes"
+# then the define.xml must contain ItemGroupDef for EG with attribute def:HasNoData marked as "Yes"
Check:
all:
- name: EG
@@ -104,8 +97,8 @@ Check:
Core:
Id: FDA.SENDIG.FB6503
Status: Draft
- Version: '1'
-Description: 'EG dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "EG dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing EG dataset.
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6504/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6504/rule.yml
index 256eebbc3..e156809f9 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6504/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6504/rule.yml
@@ -1,99 +1,92 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6504'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6504"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6504'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6504"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6504'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6504"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6504'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6504"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6504'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6504"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6504'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6504"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6504'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6504"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6504: When EX domain is present in the define.xml, but no EX dataset is present in the submission
-# then the define.xml must contain ItemGroupDef for EX with attribute def:HasNoData marked as "Yes"
+# then the define.xml must contain ItemGroupDef for EX with attribute def:HasNoData marked as "Yes"
Check:
all:
- name: EX
@@ -104,8 +97,8 @@ Check:
Core:
Id: FDA.SENDIG.FB6504
Status: Draft
- Version: '1'
-Description: 'EX dataset is present in the submission when related data is collected'
+ Version: "1"
+Description: "EX dataset is present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing EX dataset.
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6505/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6505/rule.yml
index b86b30c13..ae908b6cc 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6505/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6505/rule.yml
@@ -1,99 +1,92 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6505'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6505"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6505'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6505"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6505'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6505"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6505'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6505"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6505'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6505"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6505'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6505"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6505'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6505"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6505: When LB domain is present in the define.xml, but no LB dataset is present in the submission
-# then the define.xml must contain ItemGroupDef for LB with attribute def:HasNoData marked as "Yes"
+# then the define.xml must contain ItemGroupDef for LB with attribute def:HasNoData marked as "Yes"
Check:
all:
- name: LB
@@ -104,8 +97,8 @@ Check:
Core:
Id: FDA.SENDIG.FB6505
Status: Draft
- Version: '1'
-Description: 'LB dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "LB dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing LB dataset.
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6506/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6506/rule.yml
index eeea6365c..690e50f20 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6506/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6506/rule.yml
@@ -1,99 +1,92 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6506'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6506"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6506'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6506"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6506'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6506"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6506'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6506"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6506'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6506"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6506'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6506"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6506'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6506"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6506: When MA domain is present in the define.xml, but no MA dataset is present in the submission
-# then the define.xml must contain ItemGroupDef for MA with attribute def:HasNoData marked as "Yes"
+# then the define.xml must contain ItemGroupDef for MA with attribute def:HasNoData marked as "Yes"
Check:
all:
- name: MA
@@ -104,8 +97,8 @@ Check:
Core:
Id: FDA.SENDIG.FB6506
Status: Draft
- Version: '1'
-Description: 'MA dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "MA dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing MA dataset.
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6507/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6507/rule.yml
index 36fb23cef..80a26fe18 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6507/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6507/rule.yml
@@ -1,99 +1,92 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6507'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6507"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6507'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6507"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6507'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6507"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6507'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6507"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6507'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6507"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6507'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6507"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6507'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6507"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6507: When MI domain is present in the define.xml, but no MI dataset is present in the submission
-# then the define.xml must contain ItemGroupDef for MI with attribute def:HasNoData marked as "Yes"
+# then the define.xml must contain ItemGroupDef for MI with attribute def:HasNoData marked as "Yes"
Check:
all:
- name: MI
@@ -104,8 +97,8 @@ Check:
Core:
Id: FDA.SENDIG.FB6507
Status: Draft
- Version: '1'
-Description: 'MI dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "MI dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing MI dataset.
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6508/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6508/rule.yml
index 9af4acfea..d7c850467 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6508/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6508/rule.yml
@@ -1,99 +1,92 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6508'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6508"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6508'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6508"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6508'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6508"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6508'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6508"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6508'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6508"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6508'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6508"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6508'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6508"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule 6508: When PC domain is present in the define.xml, but no PC dataset is present in the submission
-# then the define.xml must contain ItemGroupDef for PC with attribute def:HasNoData marked as "Yes"
+# then the define.xml must contain ItemGroupDef for PC with attribute def:HasNoData marked as "Yes"
Check:
all:
- name: PC
@@ -104,8 +97,8 @@ Check:
Core:
Id: FDA.SENDIG.FB6508
Status: Draft
- Version: '1'
-Description: 'PC dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "PC dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing PC dataset.
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6509/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6509/rule.yml
index 9d60efde9..deb0445dd 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6509/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6509/rule.yml
@@ -1,99 +1,92 @@
Authorities:
- - Organization: 'FDA'
+ - Organization: "FDA"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6509'
- Version: '1'
- Version: '1.5'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "FB6509"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6509'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6509"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6509'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6509"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6509'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6509"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6509'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6509"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6509'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6509"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted
- if collected.'
- Document: 'FDA'
- Section: 'FDAB056'
- Origin: 'FDA Business Rules'
+ - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected."
+ Document: "FDA"
+ Section: "FDAB056"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6509'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6509"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB6509: When PP domain is present in the define.xml, but no PP dataset is present in the submission
-# then the define.xml must contain ItemGroupDef for PP with attribute def:HasNoData marked as "Yes"
+# then the define.xml must contain ItemGroupDef for PP with attribute def:HasNoData marked as "Yes"
Check:
all:
- name: PP
@@ -104,8 +97,8 @@ Check:
Core:
Id: FDA.SENDIG.FB6509
Status: Draft
- Version: '1'
-Description: 'PC dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "PC dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing PP dataset.
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6601/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6601/rule.yml
index f0f017a0f..0694bf37d 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6601/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6601/rule.yml
@@ -1,93 +1,94 @@
Authorities:
- - Organization: 'FDA'
- # FB6601 is not applicable to SENDIG-3.0
+ - Organization:
+ "FDA"
+ # FB6601 is not applicable to SENDIG-3.0
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6601'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6601"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6601'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6601"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6601'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6601"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6601'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6601"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6601'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6601"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6601'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6601"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB5610: When CV domain is present in the define.xml, but no CV dataset is present in the submission
-# then the define.xml must contain ItemGroupDef for CV with attribute def:HasNoData marked as "Yes"
+# then the define.xml must contain ItemGroupDef for CV with attribute def:HasNoData marked as "Yes"
Check:
all:
- name: CV
@@ -98,8 +99,8 @@ Check:
Core:
Id: FDA.SENDIG.FB6601
Status: Draft
- Version: '1'
-Description: 'CV dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "CV dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing CV dataset.
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6602/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6602/rule.yml
index cd5a98304..d98326766 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6602/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6602/rule.yml
@@ -1,96 +1,96 @@
Authorities:
- - Organization: 'FDA'
- # FB6602 is not applicable to SENDIG-3.0
+ - Organization:
+ "FDA"
+ # FB6602 is not applicable to SENDIG-3.0
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6602'
- Version: '1'
- Version: '1.5'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "FB6602"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6602'
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "FB6602"
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6602'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "FB6602"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6602'
- Version: '1'
- Version: '1.5'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "FB6602"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6602'
- Version: '1'
- Version: '1.5'
- Version: '1.2'
- - Name: 'SENDIG-AR'
+ Id: "FB6602"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
+ - Name: "SENDIG-AR"
References:
- Citations:
- - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV
- should be submitted if collected and included in the study
- report.'
- Document: 'FDA'
- Section: 'FDAB066'
- Origin: 'FDA Business Rules'
+ - Cited Guidance:
+ "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted
+ if collected and included in the study report."
+ Document: "FDA"
+ Section: "FDAB066"
+ Origin: "FDA Business Rules"
Rule Identifier:
- Id: 'FB6602'
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Id: "FB6602"
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# Rule FB5610: When RE domain is present in the define.xml, but no RE dataset is present in the submission
-# then the define.xml must contain ItemGroupDef for RE with attribute def:HasNoData marked as "Yes"
+# then the define.xml must contain ItemGroupDef for RE with attribute def:HasNoData marked as "Yes"
Check:
all:
-
- name: RE
operator: not_exists
- name: define_dataset_has_no_data
@@ -99,8 +99,8 @@ Check:
Core:
Id: FDA.SENDIG.FB6602
Status: Draft
- Version: '1'
-Description: 'RE dataset should be present in the submission when related data is collected'
+ Version: "1"
+Description: "RE dataset should be present in the submission when related data is collected"
Executability: Fully Executable
Outcome:
Message: Missing RE dataset.
diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml
index 79555c59e..e53d5bbca 100644
--- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml
@@ -4,31 +4,33 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'For carcinogenicity studies, MIRESCAT should be populated
- unless MISTRESC has a value of UNREMARKABLE (for SENDIGv3.1)
- or NORMAL (for SENDIGv3.0) or MISTAT has a value of NOT DONE.'
+ - Cited Guidance:
+ "For carcinogenicity studies, MIRESCAT should be populated unless MISTRESC has
+ a value of UNREMARKABLE (for SENDIGv3.1) or NORMAL (for SENDIGv3.0) or MISTAT has a value of
+ NOT DONE."
Document: FDA
Section: FDAB082
Origin: FDA Business Rules
Rule Identifier:
Id: FB8202
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'For carcinogenicity studies, MIRESCAT should be populated
- unless MISTRESC has a value of UNREMARKABLE (for SENDIGv3.1)
- or NORMAL (for SENDIGv3.0) or MISTAT has a value of NOT DONE.'
+ - Cited Guidance:
+ "For carcinogenicity studies, MIRESCAT should be populated unless MISTRESC has
+ a value of UNREMARKABLE (for SENDIGv3.1) or NORMAL (for SENDIGv3.0) or MISTAT has a value of
+ NOT DONE."
Document: FDA
Section: FDAB082
Origin: FDA Business Rules
Rule Identifier:
Id: FB8202
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
Check:
all:
# TODO: still causes an error as this is a check on the dataset level
@@ -42,19 +44,18 @@ Check:
- all:
- name: MISTRESC
operator: not_equal_to
- value: 'UNREMARKABLE'
+ value: "UNREMARKABLE"
- name: MISTAT
operator: not_equal_to
- value: 'NOT DONE'
+ value: "NOT DONE"
- name: MIRESCAT
operator: empty
Core:
Id: FDA.SENDIG.FB8202
Status: Draft
- Version: '1'
-Description: For carcinogenicity studies, MIRESCAT value should be populated
- when MISTRESC does not have a value of UNREMARKABLE or MISTAT has a value of
- NOT DONE.
+ Version: "1"
+Description: For carcinogenicity studies, MIRESCAT value should be populated when MISTRESC does not
+ have a value of UNREMARKABLE or MISTAT has a value of NOT DONE.
Executability: Fully Executable
Outcome:
Message: MIRESCAT value is missing.
diff --git a/Unpublished/FDA Business Rules/FDA.TRC1734a/rule.yml b/Unpublished/FDA Business Rules/FDA.TRC1734a/rule.yml
index de3527c1b..102e91f3d 100644
--- a/Unpublished/FDA Business Rules/FDA.TRC1734a/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.TRC1734a/rule.yml
@@ -4,153 +4,153 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734a
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734a
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734a
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734a
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734a
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734a
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734a
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734a
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734a
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734a
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: TS
@@ -158,7 +158,7 @@ Check:
Core:
Id: FDA.TRC1734a
Status: Draft
- Version: '1'
+ Version: "1"
Description: TS dataset is present in the submission.
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/FDA Business Rules/FDA.TRC1734b/rule.yml b/Unpublished/FDA Business Rules/FDA.TRC1734b/rule.yml
index 3c2051d6a..8e7217fb0 100644
--- a/Unpublished/FDA Business Rules/FDA.TRC1734b/rule.yml
+++ b/Unpublished/FDA Business Rules/FDA.TRC1734b/rule.yml
@@ -7,153 +7,153 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734b
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734b
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734b
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734b
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734b
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734b
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734b
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734b
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734b
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: A dataset named ts.xpt with information on study start date must
- be present for each study in Module 4, sections 4.2.3.1,
- 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2,
- 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
+ - Cited Guidance:
+ A dataset named ts.xpt with information on study start date must be present
+ for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections
+ 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2
Document: FDA
Section: TRC1734
Origin: FDA Business Rules
Rule Identifier:
Id: TRC1734b
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
Check:
all:
- name: TS
@@ -165,9 +165,8 @@ Check:
Core:
Id: FDA.TRC1734b
Status: Draft
- Version: '1'
-Description: FDA desired parameter Study Start Date (SSTDTC) should be present
- in the TS domain.
+ Version: "1"
+Description: FDA desired parameter Study Start Date (SSTDTC) should be present in the TS domain.
Executability: Fully Executable
Operations:
- domain: TS
diff --git a/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml b/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml
index a43f9e4c1..fd20a6a8d 100644
--- a/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml
+++ b/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml
@@ -7,93 +7,99 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG).'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG)."
Document: FDA
Section: FDAB011
Origin: FDA Business Rules
Rule Identifier:
Id: FB1119
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG).'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG)."
Document: FDA
Section: FDAB011
Origin: FDA Business Rules
Rule Identifier:
Id: FB1119
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG).'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG)."
Document: FDA
Section: FDAB011
Origin: FDA Business Rules
Rule Identifier:
Id: FB1119
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG).'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG)."
Document: FDA
Section: FDAB011
Origin: FDA Business Rules
Rule Identifier:
Id: FB1119
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG).'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG)."
Document: FDA
Section: FDAB011
Origin: FDA Business Rules
Rule Identifier:
Id: FB1119
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'All trial design data should be submitted as specified in the
- FDA Study Data Technical Conformance Guide (TCG).'
+ - Cited Guidance:
+ "All trial design data should be submitted as specified in the FDA Study Data
+ Technical Conformance Guide (TCG)."
Document: FDA
Section: FDAB011
Origin: FDA Business Rules
Rule Identifier:
Id: FB1119
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'TSPARAMCD=RECSAC is included in TS with TSVAL populated.'
+ - Cited Guidance: "TSPARAMCD=RECSAC is included in TS with TSVAL populated."
Document: FDA
Section: FDAB011
Origin: FDA Business Rules
Rule Identifier:
Id: FB1119
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
# FDAB1119 is just one of the many parts of FDAB011. This is currently just a temporary solution, Core:
# as the better solution is to have all the SEND-required PARMCD-s in the CDISC Library and iterate over them
Check:
@@ -103,10 +109,11 @@ Check:
- all:
- name: TSPARMCD
operator: does_not_contain
- value: RECSAC
- # TSVAL empty for TSPARMCD=RECSAC
- # REMARK: test at the record level
- # OR: should we use a "filter" here?
+ value:
+ RECSAC
+ # TSVAL empty for TSPARMCD=RECSAC
+ # REMARK: test at the record level
+ # OR: should we use a "filter" here?
- all:
- name: TSPARMCD
operator: equal_to
@@ -117,9 +124,8 @@ Check:
Core:
Id: FFDA.SENDIG.FB1119
Status: Draft
- Version: '1'
-Description: 'Raise an error when TSPARMCD=RECSAC is not in the TS dataset, or
- when its TSVAL is not populated'
+ Version: "1"
+Description: "Raise an error when TSPARMCD=RECSAC is not in the TS dataset, or when its TSVAL is not populated"
Executability: Fully Executable
Outcome:
Message: TSPARMCD=RECSAC is missing or it's TSVAL value is empty
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0002/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0002/rule.yml
index 92009499d..fc7fea2f8 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0002/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0002/rule.yml
@@ -13,36 +13,37 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0002
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Collected duration of an event, intervention, or finding
- represented in ISO 8601 character format. Used only if
- collected on the CRF and not derived.
+ - Cited Guidance:
+ Collected duration of an event, intervention, or finding represented in ISO
+ 8601 character format. Used only if collected on the CRF and not derived.
Document: Model v1.4
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0002
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Collected duration of an event, intervention, or finding. Used
- only if collected on the CRF and not derived. Format=ISO8601
+ - Cited Guidance:
+ Collected duration of an event, intervention, or finding. Used only if
+ collected on the CRF and not derived. Format=ISO8601
Document: Model v1.7
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0002
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: define_variable_is_collected
@@ -57,15 +58,15 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0002
Status: Draft
- Version: '1'
-Description: Raise a message when --DUR exists in a dataset, confirm collected
- and not derived.
+ Version: "1"
+Description: Raise a message when --DUR exists in a dataset, confirm collected and not derived.
Executability: Fully Executable
Operations:
- id: $dur_is_null
name: --DUR
- operator: variable_is_null
- # Return true if at least one record is non null
+ operator:
+ variable_is_null
+ # Return true if at least one record is non null
Outcome:
Message: --DUR exists in a dataset, confirm collected and not derived.
Output Variables:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml
index c2bc9a8a7..7f21adcfe 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml
@@ -7,43 +7,45 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The sponsor does not have the discretion to exclude permissible
- variables when they contain data.
+ - Cited Guidance:
+ The sponsor does not have the discretion to exclude permissible variables
+ when they contain data.
Document: IG v3.2
Section: 4.1.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0015
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The sponsor does not have the discretion to exclude permissible
- variables when they contain data.
+ - Cited Guidance:
+ The sponsor does not have the discretion to exclude permissible variables
+ when they contain data.
Document: IG v3.3
Section: 4.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0015
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If a study includes a data item that would be represented in a
- Permissible variable, then that variable must be included in
- the SDTM dataset, even if null.
+ - Cited Guidance:
+ If a study includes a data item that would be represented in a Permissible
+ variable, then that variable must be included in the SDTM dataset, even if null.
Document: IG v3.4
Section: 4.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0015
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all:
- name: define_variable_name
@@ -58,16 +60,16 @@ Check:
operator: not_exists
- name: variable_is_empty
operator: equal_to
- value: 'Yes'
+ value: "Yes"
Core:
Id: CDISC.SDTMIG.CG0015
Status: Draft
- Version: '1'
-Description: Raise an error when a variable is permissible, data is collected
- but variable has no data.
+ Version: "1"
+Description: Raise an error when a variable is permissible, data is collected but variable has no
+ data.
Executability: Fully Executable
Outcome:
- Message: 'Variable is permissible, data is collected but data is missing.'
+ Message: "Variable is permissible, data is collected but data is missing."
Output Variables:
- library_variable_name
- library_variable_core
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml
index 574e2d1b0..fcd7c7301 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: Each record is unique per sponsor defined key variables as documented in the define.xml
Authorities:
- Organization: CDISC
@@ -7,84 +7,82 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Note that the key variables shown in this table are examples
- only. A sponsor's actual key structure may be different.
+ - Cited Guidance: Note that the key variables shown in this table are examples only. A
+ sponsor's actual key structure may be different.
Document: IG v3.4
Section: Table 3.2.1
- - Cited Guidance: Since the purpose of this column is to aid reviewers in
- understanding the structure of a dataset, sponsors should list
- all of the natural keys (see definition below) for the
- dataset. These keys should define uniqueness for records
- within a dataset, and may define a record sort order. The
- identified keys for each dataset should be consistent with the
- description of the dataset structure as described in the
- Define-XML document.
+ - Cited Guidance:
+ Since the purpose of this column is to aid reviewers in understanding the
+ structure of a dataset, sponsors should list all of the natural keys (see definition
+ below) for the dataset. These keys should define uniqueness for records within a dataset,
+ and may define a record sort order. The identified keys for each dataset should be
+ consistent with the description of the dataset structure as described in the Define-XML
+ document.
Document: IG v3.4
Section: 3.2.1.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0019
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Table 3.2.1[Note that the key variables shown in this table are
- examples only. A sponsor's actual key structure may be
- different.]|3.2.1.1[Since the purpose of this column is to aid
- reviewers in understanding the structure of a dataset,
- sponsors should list all of the natural keys (see definition
- below) for the dataset. These keys should define uniqueness
- for records within a dataset, and may define a record sort
+ - Cited Guidance:
+ Table 3.2.1[Note that the key variables shown in this table are examples
+ only. A sponsor's actual key structure may be different.]|3.2.1.1[Since the purpose of
+ this column is to aid reviewers in understanding the structure of a dataset, sponsors
+ should list all of the natural keys (see definition below) for the dataset. These keys
+ should define uniqueness for records within a dataset, and may define a record sort
order.]
Document: IG v3.2
Section: Table 3.2.1|3.2.1.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0019
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Table 3.2.1[Note that the key variables shown in this table are
- examples only. A sponsor's actual key structure may be
- different.]||3.2.1.1[Since the purpose of this column is to
- aid reviewers in understanding the structure of a dataset,
- sponsors should list all of the natural keys (see definition
- below) for the dataset. These keys should define uniqueness
- for records within a dataset, and may define a record sort
+ - Cited Guidance:
+ Table 3.2.1[Note that the key variables shown in this table are examples
+ only. A sponsor's actual key structure may be different.]||3.2.1.1[Since the purpose of
+ this column is to aid reviewers in understanding the structure of a dataset, sponsors
+ should list all of the natural keys (see definition below) for the dataset. These keys
+ should define uniqueness for records within a dataset, and may define a record sort
order.]
Document: IG v3.3
Section: Table 3.2.1|3.2.1.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0019
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: define_dataset_key_sequence
- operator: is_not_unique_set
- # the operator can be changed to the opposite to make sure we get output
- #operator: is_unique_set
+ operator:
+ is_not_unique_set
+ # the operator can be changed to the opposite to make sure we get output
+ #operator: is_unique_set
Core:
Id: CDISC.SDTMIG.CG0019
Status: Draft
- Version: '1'
-Description: Trigger error if records are not unique as per sponsor defined key
- variables as documented in the define.xml
+ Version: "1"
+Description: Trigger error if records are not unique as per sponsor defined key variables as
+ documented in the define.xml
Executability: Fully Executable
Match Datasets:
- Keys:
- USUBJID
Name: SUPP--
Outcome:
- Message: Records are not unique as per sponsor defined key variables as
- documented in the define.xml
+ Message: Records are not unique as per sponsor defined key variables as documented in the
+ define.xml
Output Variables:
- define_dataset_key_sequence
- define_dataset_variable_order
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml
index 36d5160ab..9d0d0155d 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml
@@ -7,77 +7,70 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: CMDECOD is the standardized medication/therapy term derived by
- the sponsor from the coding dictionary. It is expected that
- the reported term (CMTRT) or the modified term (CMMODIFY) will
- be coded using a standard dictionary
+ - Cited Guidance:
+ CMDECOD is the standardized medication/therapy term derived by the sponsor
+ from the coding dictionary. It is expected that the reported term (CMTRT) or the modified
+ term (CMMODIFY) will be coded using a standard dictionary
Document: IG v3.4
Item: Assumption 2c
Section: 6.1.2
- - Cited Guidance: Standardized or dictionary-derived text description of CMTRT or
- CMMODIFY. Equivalent to the generic medication name in WHO
- Drug. The sponsor is expected to provide the dictionary name
- and version used to map the terms utilizing the define.xml
- external codelist attributes. If an intervention term does not
- have a decode value in the dictionary then CMDECOD will be
- left blank.
+ - Cited Guidance:
+ Standardized or dictionary-derived text description of CMTRT or CMMODIFY.
+ Equivalent to the generic medication name in WHO Drug. The sponsor is expected to provide
+ the dictionary name and version used to map the terms utilizing the define.xml external
+ codelist attributes. If an intervention term does not have a decode value in the
+ dictionary then CMDECOD will be left blank.
Document: IG v3.3
Item: Specification
Section: 6.1.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0096
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.2[6.1][Assumption 2c][CMDECOD is the standardized
- medication/therapy term derived by the sponsor from the coding
- dictionary. It is expected that the reported term (CMTRT) or
- the modified term (CMMODIFY) will be coded using a standard
- dictionary.]|IG v3.2[6.1][Specification][Standardized or
- dictionary-derived text description of CMTRT or CMMODIFY.
- Equivalent to the generic medication name in WHO Drug. The
- sponsor is expected to provide the dictionary name and version
- used to map the terms utilizing the define.xml external
- codelist attributes. If an intervention term does not have a
- decode value in the dictionary then CMDECOD will be left
- blank.]
+ - Cited Guidance:
+ IG v3.2[6.1][Assumption 2c][CMDECOD is the standardized medication/therapy
+ term derived by the sponsor from the coding dictionary. It is expected that the reported
+ term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard
+ dictionary.]|IG v3.2[6.1][Specification][Standardized or dictionary-derived text
+ description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug.
+ The sponsor is expected to provide the dictionary name and version used to map the terms
+ utilizing the define.xml external codelist attributes. If an intervention term does not
+ have a decode value in the dictionary then CMDECOD will be left blank.]
Document: IG v3.2
Item: IG v3.2[6.1][Assumption 2c]|IG v3.2[6.1][Specification]
Section: IG v3.2[6.1]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0096
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[6.1.2][Assumption 2c][CMDECOD is the standardized
- medication/therapy term derived by the sponsor from the coding
- dictionary. It is expected that the reported term (CMTRT) or
- the modified term (CMMODIFY) will be coded using a standard
- dictionary.]|IG v3.3[6.1.2][Specification][Standardized or
- dictionary-derived text description of CMTRT or CMMODIFY.
- Equivalent to the generic medication name in WHO Drug. The
- sponsor is expected to provide the dictionary name and version
- used to map the terms utilizing the define.xml external
- codelist attributes. If an intervention term does not have a
- decode value in the dictionary then CMDECOD will be left
- blank.]
+ - Cited Guidance:
+ IG v3.3[6.1.2][Assumption 2c][CMDECOD is the standardized medication/therapy
+ term derived by the sponsor from the coding dictionary. It is expected that the reported
+ term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard
+ dictionary.]|IG v3.3[6.1.2][Specification][Standardized or dictionary-derived text
+ description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug.
+ The sponsor is expected to provide the dictionary name and version used to map the terms
+ utilizing the define.xml external codelist attributes. If an intervention term does not
+ have a decode value in the dictionary then CMDECOD will be left blank.]
Document: IG v3.3
Item: IG v3.3[6.1.2][Assumption 2c]|IG v3.3[6.1.2][Specification]
Section: IG v3.3[6.1.2]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0096
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: CMTRT
@@ -87,7 +80,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0096
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when CMTRT is populated, CMDECOD is empty
Executability: Fully Executable
Outcome:
@@ -100,8 +93,8 @@ Scope:
Classes:
Include:
- ALL
- #- INTERVENTIONS
- #- STUDY REFERENCE
+ #- INTERVENTIONS
+ #- STUDY REFERENCE
Domains:
Include:
- CM
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml
index 71339e17d..a94c13722 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml
@@ -7,77 +7,70 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: CMDECOD is the standardized medication/therapy term derived by
- the sponsor from the coding dictionary. It is expected that
- the reported term (CMTRT) or the modified term (CMMODIFY) will
- be coded using a standard dictionary
+ - Cited Guidance:
+ CMDECOD is the standardized medication/therapy term derived by the sponsor
+ from the coding dictionary. It is expected that the reported term (CMTRT) or the modified
+ term (CMMODIFY) will be coded using a standard dictionary
Document: IG v3.4
Item: Assumption 2c
Section: 6.1.2
- - Cited Guidance: Standardized or dictionary-derived text description of CMTRT or
- CMMODIFY. Equivalent to the generic medication name in WHO
- Drug. The sponsor is expected to provide the dictionary name
- and version used to map the terms utilizing the define.xml
- external codelist attributes. If an intervention term does not
- have a decode value in the dictionary then CMDECOD will be
- left blank.
+ - Cited Guidance:
+ Standardized or dictionary-derived text description of CMTRT or CMMODIFY.
+ Equivalent to the generic medication name in WHO Drug. The sponsor is expected to provide
+ the dictionary name and version used to map the terms utilizing the define.xml external
+ codelist attributes. If an intervention term does not have a decode value in the
+ dictionary then CMDECOD will be left blank.
Document: IG v3.3
Item: Specification
Section: 6.1.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0096b
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.2[6.1][Assumption 2c][CMDECOD is the standardized
- medication/therapy term derived by the sponsor from the coding
- dictionary. It is expected that the reported term (CMTRT) or
- the modified term (CMMODIFY) will be coded using a standard
- dictionary.]|IG v3.2[6.1][Specification][Standardized or
- dictionary-derived text description of CMTRT or CMMODIFY.
- Equivalent to the generic medication name in WHO Drug. The
- sponsor is expected to provide the dictionary name and version
- used to map the terms utilizing the define.xml external
- codelist attributes. If an intervention term does not have a
- decode value in the dictionary then CMDECOD will be left
- blank.]
+ - Cited Guidance:
+ IG v3.2[6.1][Assumption 2c][CMDECOD is the standardized medication/therapy
+ term derived by the sponsor from the coding dictionary. It is expected that the reported
+ term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard
+ dictionary.]|IG v3.2[6.1][Specification][Standardized or dictionary-derived text
+ description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug.
+ The sponsor is expected to provide the dictionary name and version used to map the terms
+ utilizing the define.xml external codelist attributes. If an intervention term does not
+ have a decode value in the dictionary then CMDECOD will be left blank.]
Document: IG v3.2
Item: IG v3.2[6.1][Assumption 2c]|IG v3.2[6.1][Specification]
Section: IG v3.2[6.1]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0096b
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: IG v3.3[6.1.2][Assumption 2c][CMDECOD is the standardized
- medication/therapy term derived by the sponsor from the coding
- dictionary. It is expected that the reported term (CMTRT) or
- the modified term (CMMODIFY) will be coded using a standard
- dictionary.]|IG v3.3[6.1.2][Specification][Standardized or
- dictionary-derived text description of CMTRT or CMMODIFY.
- Equivalent to the generic medication name in WHO Drug. The
- sponsor is expected to provide the dictionary name and version
- used to map the terms utilizing the define.xml external
- codelist attributes. If an intervention term does not have a
- decode value in the dictionary then CMDECOD will be left
- blank.]
+ - Cited Guidance:
+ IG v3.3[6.1.2][Assumption 2c][CMDECOD is the standardized medication/therapy
+ term derived by the sponsor from the coding dictionary. It is expected that the reported
+ term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard
+ dictionary.]|IG v3.3[6.1.2][Specification][Standardized or dictionary-derived text
+ description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug.
+ The sponsor is expected to provide the dictionary name and version used to map the terms
+ utilizing the define.xml external codelist attributes. If an intervention term does not
+ have a decode value in the dictionary then CMDECOD will be left blank.]
Document: IG v3.3
Item: IG v3.3[6.1.2][Assumption 2c]|IG v3.3[6.1.2][Specification]
Section: IG v3.3[6.1.2]
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0096b
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: CMTRT
@@ -89,12 +82,12 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0096b
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when CMTRT is populated, CMDECOD is empty
Executability: Fully Executable
Operations:
- - domain: WHODD #Custiom lookup
- id: $DNames #$whodrug_refs_valid
+ - domain: WHODD #Custiom lookup
+ id: $DNames #$whodrug_refs_valid
name: DrugName
operator: distinct #valid_whodrug_references
@@ -108,8 +101,8 @@ Scope:
Classes:
Include:
- ALL
- #- INTERVENTIONS
- #- STUDY REFERENCE
+ #- INTERVENTIONS
+ #- STUDY REFERENCE
Domains:
Include:
- CM
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml
index b82083307..f4bc3f4a6 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml
@@ -1,5 +1,5 @@
# Variable: CMTRT
-# Condition:
+# Condition:
# Rule: CMTRT = collected on CRF
Authorities:
- Organization: CDISC
@@ -7,54 +7,52 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Verbatim medication name that is either pre-printed or collected
- on a CRF.
+ - Cited Guidance: Verbatim medication name that is either pre-printed or collected on a CRF.
Document: IG v3.4
Item: Specification
Section: 6.1.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0097
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Verbatim medication name that is either pre-printed or collected
- on a CRF.
+ - Cited Guidance: Verbatim medication name that is either pre-printed or collected on a CRF.
Document: IG v3.2
Item: Specification
- Section: '6.1'
+ Section: "6.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0097
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Verbatim medication name that is either pre-printed or collected
- on a CRF.
+ - Cited Guidance: Verbatim medication name that is either pre-printed or collected on a CRF.
Document: IG v3.3
Item: Specification
Section: 6.1.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0097
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: variable_name
operator: equal_to
- value: CMTRT
- # skipping cases when CMTRT is not provided (though this should never be the case)
- #- name: CMTRT
- # operator: non_empty
- # Generate an issue when CMTRT is not declared as "collected" in the define.xml
+ value:
+ CMTRT
+ # skipping cases when CMTRT is not provided (though this should never be the case)
+ #- name: CMTRT
+ # operator: non_empty
+ # Generate an issue when CMTRT is not declared as "collected" in the define.xml
- name: define_variable_is_collected
operator: equal_to
value: false
@@ -62,7 +60,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0097
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error if CMTRT was not collected on CRF
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0103/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0103/rule.yml
index 38cd14f10..35bcda3fe 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0103/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0103/rule.yml
@@ -1,51 +1,54 @@
# Variable: EXDOSU
-# Condition:
+# Condition:
# Rule: EXDOSU = protocol-specified unit
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0103
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing
- protocol-specified values.
+ - Citations:
+ - Cited Guidance:
+ Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified
+ values.
Document: IG v3.4
Item: Specification
Section: 6.1.3.1
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0103
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing
- protocol-specified values.
- Document: IG v3.2
- Item: Specification
- Section: '6.1'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified
+ values.
+ Document: IG v3.2
+ Item: Specification
+ Section: "6.1"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0103
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing
- protocol-specified values.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified
+ values.
Document: IG v3.3
Item: Specification
Section: 6.1.3.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0103
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: EXDOSU
@@ -57,7 +60,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0103
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error if EXDOSU not expressed in protocol-specified units
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0104/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0104/rule.yml
index 7211cad60..cb3fd4298 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0104/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0104/rule.yml
@@ -1,51 +1,54 @@
# Variable: EXTRT
-# Condition:
+# Condition:
# Rule: EXTRT = protocol-specified treatment
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0104
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Name of the protocol-specified study treatment given
- during the dosing period for the observation.
+ - Citations:
+ - Cited Guidance:
+ Name of the protocol-specified study treatment given during the dosing
+ period for the observation.
Document: IG v3.4
Item: Specification
Section: 6.1.3.1
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0104
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Name of the protocol-specified study treatment given
- during the dosing period for the observation.
- Document: IG v3.2
- Item: Specification
- Section: '6.1'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ Name of the protocol-specified study treatment given during the dosing
+ period for the observation.
+ Document: IG v3.2
+ Item: Specification
+ Section: "6.1"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0104
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Name of the protocol-specified study treatment given
- during the dosing period for the observation.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Name of the protocol-specified study treatment given during the dosing
+ period for the observation.
Document: IG v3.3
Item: Specification
Section: 6.1.3.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0104
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: EXTRT
@@ -57,7 +60,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0104
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error if EXTRT is not the protocol-specified treatment
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml
index e9cd9c452..0566783d1 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml
@@ -7,39 +7,37 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '[Associated Persons datasets are given a prefix of AP-- to
- identify the data as AP data to and distinguish them from
- study subject data.][Associated Persons domain codes in the
- DOMAIN column of every record are also given a prefix of AP--
- to identify the domains as AP domains and to distinguish them
- from study subject domains. AP domain codes are therefore four
- characters long.]'
+ - Cited Guidance:
+ "[Associated Persons datasets are given a prefix of AP-- to identify the data
+ as AP data to and distinguish them from study subject data.][Associated Persons domain codes
+ in the DOMAIN column of every record are also given a prefix of AP-- to identify the domains
+ as AP domains and to distinguish them from study subject domains. AP domain codes are therefore
+ four characters long.]"
Document: AP Guide v1.0
- Section: '2'
+ Section: "2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0155
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '[Associated Persons datasets are given a prefix of AP-- to
- identify the data as AP data to and distinguish them from
- study subject data.][Associated Persons domain codes in the
- DOMAIN column of every record are also given a prefix of AP--
- to identify the domains as AP domains and to distinguish them
- from study subject domains. AP domain codes are therefore four
- characters long.]'
+ - Cited Guidance:
+ "[Associated Persons datasets are given a prefix of AP-- to identify the data
+ as AP data to and distinguish them from study subject data.][Associated Persons domain codes
+ in the DOMAIN column of every record are also given a prefix of AP-- to identify the domains
+ as AP domains and to distinguish them from study subject domains. AP domain codes are therefore
+ four characters long.]"
Document: AP Guide v1.0
- Section: '2'
+ Section: "2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0155
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: DOMAIN
@@ -51,9 +49,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0155
Status: Draft
- Version: '1'
-Description: Raise an error when DOMAIN value begins with AP and length of
- domain variable is not 4 or DOMAIN value doesn't end with a valid SDTM domain.
+ Version: "1"
+Description: Raise an error when DOMAIN value begins with AP and length of domain variable is not 4
+ or DOMAIN value doesn't end with a valid SDTM domain.
Executability: Partially Executable - Possible Overreporting
Outcome:
Message: AP DOMAIN value should start with 'AP' and length should be equal to 4.
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0156/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0156/rule.yml
index fb97ba216..5f6af0ad5 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0156/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0156/rule.yml
@@ -5,63 +5,63 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.2'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0156
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Identifier for a single associated person, a group
- of associated persons, or a pool of associated persons. If APID
- identifies a pool, POOLDEF records must exist for each associated
- person.
+ - Citations:
+ - Cited Guidance:
+ Identifier for a single associated person, a group of associated persons, or
+ a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for
+ each associated person.
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0156
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Identifier for a single associated person, a group
- of associated persons, or a pool of associated persons. If APID
- identifies a pool, POOLDEF records must exist for each associated
- person.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Identifier for a single associated person, a group of associated persons, or
+ a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for
+ each associated person.
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
- - Name: SDTMIG
- Version: '3.4'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0156
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Identifier for a single associated person, a group
- of associated persons, or a pool of associated persons. If APID
- identifies a pool, POOLDEF records must exist for each associated
- person.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Identifier for a single associated person, a group of associated persons, or
+ a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for
+ each associated person.
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0156
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0156
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0157/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0157/rule.yml
index 41f5277b8..bfc0f5602 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0157/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0157/rule.yml
@@ -5,47 +5,48 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0157
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Relationship described is to a study subject.RSUBJID
- is not in DM.USUBJID.
+ - Citations:
+ - Cited Guidance: Relationship described is to a study subject.RSUBJID is not in DM.USUBJID.
Document: APGuidev1.0
Item: RSUBJID
Section: 2.1.1
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0157
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: RSUBJID will be populated with the USUBJID of the
- related subject or the POOLID of the related pool.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ RSUBJID will be populated with the USUBJID of the related subject or the
+ POOLID of the related pool.
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0157
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: RSUBJID will be populated with the USUBJID of the
- related subject or the POOLID of the related pool.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ RSUBJID will be populated with the USUBJID of the related subject or the
+ POOLID of the related pool.
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0157
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: RSUBJID
@@ -54,7 +55,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0157
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when RSUBJID in not in DM.USUBJID
Executability: Fully Executable
Operations:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml
index 5c133671c..2e1d3be20 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml
@@ -5,47 +5,50 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0158
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: RSUBJID will be populated with the USUBJID of the
- related subject or the POOLID of the related pool.
+ - Citations:
+ - Cited Guidance:
+ RSUBJID will be populated with the USUBJID of the related subject or the
+ POOLID of the related pool.
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0158
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: RSUBJID will be populated with the USUBJID of the
- related subject or the POOLID of the related pool.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ RSUBJID will be populated with the USUBJID of the related subject or the
+ POOLID of the related pool.
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0158
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: RSUBJID will be populated with the USUBJID of the
- related subject or the POOLID of the related pool.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ RSUBJID will be populated with the USUBJID of the related subject or the
+ POOLID of the related pool.
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0158
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -56,9 +59,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0158
Status: Draft
- Version: '1'
-Description: Trigger error if relationship described is to a pool and RSUBJID is not
- in POOLDEF.POOLID
+ Version: "1"
+Description: Trigger error if relationship described is to a pool and RSUBJID is not in
+ POOLDEF.POOLID
Executability: Fully Executable
Outcome:
Message: RSUBJID is not in POOLDEF.POOLID
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml
index 2f2a4493a..2e5efd456 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml
@@ -5,47 +5,50 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0159
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: RSUBJID will be populated with the USUBJID of the
- related subject or the POOLID of the related pool.
+ - Citations:
+ - Cited Guidance:
+ RSUBJID will be populated with the USUBJID of the related subject or the
+ POOLID of the related pool.
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0159
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: RSUBJID will be populated with the USUBJID of the
- related subject or the POOLID of the related pool.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ RSUBJID will be populated with the USUBJID of the related subject or the
+ POOLID of the related pool.
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0159
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: RSUBJID will be populated with the USUBJID of the
- related subject or the POOLID of the related pool.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ RSUBJID will be populated with the USUBJID of the related subject or the
+ POOLID of the related pool.
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0159
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -55,13 +58,13 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0159
Status: Draft
- Version: '1'
-Description: Trigger error if relationship described is to a study (but not to individual
- study subject) and RSUBJID is not null
+ Version: "1"
+Description: Trigger error if relationship described is to a study (but not to individual study
+ subject) and RSUBJID is not null
Executability: Fully Executable
Outcome:
- Message: Relationship described is to a study (but not to individua study subject)
- and RSUBJID is not null
+ Message: Relationship described is to a study (but not to individua study subject) and RSUBJID is
+ not null
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml
index 3f2eda3b8..2e7c1ce13 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml
@@ -5,62 +5,62 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0160
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If RSUBJID is populated, describes the relationship
- of the associated person(s) identified in APID to the subject or
- pool identified in RSUBJID. If RDEVID is populated, describes the
- relationship of the associated person(s) identified in APID to the
- device identified in RDEVID. If RSUBJID and RDEVID are null, SREL
- describes the relationship of the associated person(s) identified
- in APID to the study identified in STUDYID.
+ - Citations:
+ - Cited Guidance:
+ If RSUBJID is populated, describes the relationship of the associated
+ person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is
+ populated, describes the relationship of the associated person(s) identified in APID to
+ the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the
+ relationship of the associated person(s) identified in APID to the study identified in
+ STUDYID.
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0160
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If RSUBJID is populated, describes the relationship
- of the associated person(s) identified in APID to the subject or
- pool identified in RSUBJID. If RDEVID is populated, describes the
- relationship of the associated person(s) identified in APID to the
- device identified in RDEVID. If RSUBJID and RDEVID are null, SREL
- describes the relationship of the associated person(s) identified
- in APID to the study identified in STUDYID
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If RSUBJID is populated, describes the relationship of the associated
+ person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is
+ populated, describes the relationship of the associated person(s) identified in APID to
+ the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the
+ relationship of the associated person(s) identified in APID to the study identified in
+ STUDYID
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0160
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If RSUBJID is populated, describes the relationship
- of the associated person(s) identified in APID to the subject or
- pool identified in RSUBJID. If RDEVID is populated, describes the
- relationship of the associated person(s) identified in APID to the
- device identified in RDEVID. If RSUBJID and RDEVID are null, SREL
- describes the relationship of the associated person(s) identified
- in APID to the study identified in STUDYID
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If RSUBJID is populated, describes the relationship of the associated
+ person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is
+ populated, describes the relationship of the associated person(s) identified in APID to
+ the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the
+ relationship of the associated person(s) identified in APID to the study identified in
+ STUDYID
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0160
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: RSUBJID
@@ -70,13 +70,13 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0160
Status: Draft
- Version: '1'
-Description: Trigger error when RSUBJID ^= null and SREL does not describe the relationship
- of associated person to study subject or pool
+ Version: "1"
+Description: Trigger error when RSUBJID ^= null and SREL does not describe the relationship of
+ associated person to study subject or pool
Executability: Fully Executable
Outcome:
- Message: SREL does not describe the relationship of associated person to study subject
- or pool when RSUBJID is not null
+ Message: SREL does not describe the relationship of associated person to study subject or pool
+ when RSUBJID is not null
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml
index 7709aa969..85cf08818 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml
@@ -5,62 +5,62 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0161
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If RSUBJID is populated, describes the relationship
- of the associated person(s) identified in APID to the subject or
- pool identified in RSUBJID. If RDEVID is populated, describes the
- relationship of the associated person(s) identified in APID to the
- device identified in RDEVID. If RSUBJID and RDEVID are null, SREL
- describes the relationship of the associated person(s) identified
- in APID to the study identified in STUDYID.
+ - Citations:
+ - Cited Guidance:
+ If RSUBJID is populated, describes the relationship of the associated
+ person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is
+ populated, describes the relationship of the associated person(s) identified in APID to
+ the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the
+ relationship of the associated person(s) identified in APID to the study identified in
+ STUDYID.
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0161
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If RSUBJID is populated, describes the relationship
- of the associated person(s) identified in APID to the subject or
- pool identified in RSUBJID. If RDEVID is populated, describes the
- relationship of the associated person(s) identified in APID to the
- device identified in RDEVID. If RSUBJID and RDEVID are null, SREL
- describes the relationship of the associated person(s) identified
- in APID to the study identified in STUDYID
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If RSUBJID is populated, describes the relationship of the associated
+ person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is
+ populated, describes the relationship of the associated person(s) identified in APID to
+ the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the
+ relationship of the associated person(s) identified in APID to the study identified in
+ STUDYID
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0161
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If RSUBJID is populated, describes the relationship
- of the associated person(s) identified in APID to the subject or
- pool identified in RSUBJID. If RDEVID is populated, describes the
- relationship of the associated person(s) identified in APID to the
- device identified in RDEVID. If RSUBJID and RDEVID are null, SREL
- describes the relationship of the associated person(s) identified
- in APID to the study identified in STUDYID
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If RSUBJID is populated, describes the relationship of the associated
+ person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is
+ populated, describes the relationship of the associated person(s) identified in APID to
+ the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the
+ relationship of the associated person(s) identified in APID to the study identified in
+ STUDYID
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0161
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: RDEVID
@@ -70,13 +70,13 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0161
Status: Draft
- Version: '1'
-Description: Trigger error when RDEVID ^= null and SREL does not describe relationship
- of associated person to device identified in RDEVID
+ Version: "1"
+Description: Trigger error when RDEVID ^= null and SREL does not describe relationship of associated
+ person to device identified in RDEVID
Executability: Fully Executable
Outcome:
- Message: SREL does not describe relationship of associated person to device identified
- in RDEVID when RDEVID ^= null
+ Message: SREL does not describe relationship of associated person to device identified in RDEVID
+ when RDEVID ^= null
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml
index 9bdee06e6..4875d0c4f 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml
@@ -7,13 +7,12 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If RSUBJID is populated, describes the relationship of the
- associated person(s) identified in APID to the subject or pool
- identified in RSUBJID. If RDEVID is populated, describes the
- relationship of the associated person(s) identified in APID to
- the device identified in RDEVID. If RSUBJID and RDEVID are
- null, SREL describes the relationship of the associated
- person(s) identified in APID to the study identified in
+ - Cited Guidance:
+ If RSUBJID is populated, describes the relationship of the associated
+ person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is
+ populated, describes the relationship of the associated person(s) identified in APID to
+ the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the
+ relationship of the associated person(s) identified in APID to the study identified in
STUDYID.
Document: AP Guide v1.0
Item: Specification
@@ -21,39 +20,37 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0162
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If RSUBJID is populated, describes the relationship of the
- associated person(s) identified in APID to the subject or
- pool identified in RSUBJID. If RDEVID is populated, describes
- the relationship of the associated person(s) identified in
- APID to the device identified in RDEVID. If RSUBJID and
- RDEVID are null, SREL describes the relationship of the
- associated person(s) identified in APID to the study
- identified in STUDYID
+ - Cited Guidance:
+ If RSUBJID is populated, describes the relationship of the associated
+ person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is
+ populated, describes the relationship of the associated person(s) identified in APID to
+ the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the
+ relationship of the associated person(s) identified in APID to the study identified in
+ STUDYID
Document: AP Guide v1.0
Item: Specification
Section: 2.1.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0162
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If RSUBJID is populated, describes the relationship of the
- associated person(s) identified in APID to the subject or pool
- identified in RSUBJID. If RDEVID is populated, describes the
- relationship of the associated person(s) identified in APID to
- the device identified in RDEVID. If RSUBJID and RDEVID are
- null, SREL describes the relationship of the associated
- person(s) identified in APID to the study identified in
+ - Cited Guidance:
+ If RSUBJID is populated, describes the relationship of the associated
+ person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is
+ populated, describes the relationship of the associated person(s) identified in APID to
+ the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the
+ relationship of the associated person(s) identified in APID to the study identified in
STUDYID
Document: AP Guide v1.0
Item: Specification
@@ -61,21 +58,20 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0162
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
Core:
Id: CDISC.SDTMIG.CG0162
Status: Draft
- Version: '1'
-Description: Trigger error when RSUBJID = null and RDEVID = null and SREL does
- not describe the relationship of associated person to study identified in
- STUDYID
+ Version: "1"
+Description: Trigger error when RSUBJID = null and RDEVID = null and SREL does not describe the
+ relationship of associated person to study identified in STUDYID
Executability: Not Executable
Outcome:
- Message: SREL does not describe the relationship of associated person to study
- identified in STUDYID when RSUBJID = null and RDEVID = null
+ Message: SREL does not describe the relationship of associated person to study identified in
+ STUDYID when RSUBJID = null and RDEVID = null
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0167/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0167/rule.yml
index 10f2e4f00..4667284b0 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0167/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0167/rule.yml
@@ -1,66 +1,63 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: Comments are unsolicited, free-text and voluntary
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0167
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The Comments special-purpose domain provides a solution
- for submitting free-text comments related to data in one or more
- SDTM domains (as described in Section 8.5, Relating Comments to
- a Parent Domain) or collected on a separate CRF page dedicated to
- comments. Comments are generally not responses to specific questions;
- instead, comments usually consist of voluntary, free-text or unsolicited
- observations.
+ - Citations:
+ - Cited Guidance:
+ The Comments special-purpose domain provides a solution for submitting
+ free-text comments related to data in one or more SDTM domains (as described in Section
+ 8.5, Relating Comments to a Parent Domain) or collected on a separate CRF page dedicated
+ to comments. Comments are generally not responses to specific questions; instead, comments
+ usually consist of voluntary, free-text or unsolicited observations.
Document: IG v3.4
Item: Assumption 1
- Section: '5.1'
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Section: "5.1"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0167
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: 'The Comments special-purpose domain provides a solution
- for submitting free-text comments related to data in one or more
- SDTM domains (as described in Section 8: 8.5, Relating Comments
- To A Parent Domain) or collected on a separate CRF page dedicated
- to comments. Comments are generally not responses to specific questions;
- instead, comments usually consist of voluntary, free-text or unsolicited
- observations.'
- Document: IG v3.2
- Item: Specification
- Section: '5'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ "The Comments special-purpose domain provides a solution for submitting free-text
+ comments related to data in one or more SDTM domains (as described in Section 8: 8.5, Relating
+ Comments To A Parent Domain) or collected on a separate CRF page dedicated to comments. Comments
+ are generally not responses to specific questions; instead, comments usually consist of voluntary,
+ free-text or unsolicited observations."
+ Document: IG v3.2
+ Item: Specification
+ Section: "5"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0167
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: 'The Comments special-purpose domain provides a solution
- for submitting free-text comments related to data in one or more
- SDTM domains (as described in Section 8: 8.5, Relating Comments
- To A Parent Domain) or collected on a separate CRF page dedicated
- to comments. Comments are generally not responses to specific questions;
- instead, comments usually consist of voluntary, free-text or unsolicited
- observations.'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ "The Comments special-purpose domain provides a solution for submitting free-text
+ comments related to data in one or more SDTM domains (as described in Section 8: 8.5, Relating
+ Comments To A Parent Domain) or collected on a separate CRF page dedicated to comments. Comments
+ are generally not responses to specific questions; instead, comments usually consist of voluntary,
+ free-text or unsolicited observations."
Document: IG v3.3
Item: Specification
- Section: '5.1'
+ Section: "5.1"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0167
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -68,7 +65,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0167
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when comments are not unsolicited, free-text and voluntary
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml
index 028b53e16..4c4cb3807 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml
@@ -5,53 +5,51 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0169
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: 'When the comment text is longer than 200 characters,
- the first 200 characters of the comment will be in COVAL, the next
- 200 in COVAL1, and additional text stored as needed to COVALn. See
- example, Rows 3-4. '
+ - Citations:
+ - Cited Guidance:
+ "When the comment text is longer than 200 characters, the first 200 characters
+ of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed
+ to COVALn. See example, Rows 3-4. "
Document: IG v3.4
Item: Assumption 3
- Section: '5.1'
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Section: "5.1"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0169
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: When the comment text is longer than 200 characters,
- the first 200 characters of the comment will be in COVAL, the next
- 200 in COVAL1, and additional text stored as needed to COVALn. See
- example, Rows 3-4.
- Document: IG v3.2
- Item: Assumption 3
- Section: '5'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance: When the comment text is longer than 200 characters, the first 200
+ characters of the comment will be in COVAL, the next 200 in COVAL1, and additional text
+ stored as needed to COVALn. See example, Rows 3-4.
+ Document: IG v3.2
+ Item: Assumption 3
+ Section: "5"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0169
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: When the comment text is longer than 200 characters,
- the first 200 characters of the comment will be in COVAL, the next
- 200 in COVAL1, and additional text stored as needed to COVALn. See
- example, Rows 3-4.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance: When the comment text is longer than 200 characters, the first 200
+ characters of the comment will be in COVAL, the next 200 in COVAL1, and additional text
+ stored as needed to COVALn. See example, Rows 3-4.
Document: IG v3.3
Item: Assumption 3
- Section: '5.1'
+ Section: "5.1"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0169
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: COVAL1
@@ -61,9 +59,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0169
Status: Draft
- Version: '1'
-Description: Trigger error when there are no comments greater than 200 characters
- and COVALn is present
+ Version: "1"
+Description: Trigger error when there are no comments greater than 200 characters and COVALn is
+ present
Executability: Fully Executable
Outcome:
Message: COVALn is present in dataset when no comments are greater than 200 characters
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml
index c875ae76e..9dc66078f 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml
@@ -7,48 +7,48 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'When collected data fit a Qualifier variable listed in SDTM:
- Sections 3.1.1, 3.1.2, or 3.1.3, and are represented in the
- Findings About domain, then the name of the variable should be
- used as the value of FATESTCD.'
+ - Cited Guidance:
+ "When collected data fit a Qualifier variable listed in SDTM: Sections 3.1.1,
+ 3.1.2, or 3.1.3, and are represented in the Findings About domain, then the name of the variable
+ should be used as the value of FATESTCD."
Document: IG v3.4
Section: 6.4.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0173
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'When collected data fit a Qualifier variable listed in SDTM:
- Sections 2.2.1, 2.2.2, or 2.2.3, and are represented in the
- Findings About domain, then the name of the variable should be
- used as the value of FATESTCD.'
+ - Cited Guidance:
+ "When collected data fit a Qualifier variable listed in SDTM: Sections 2.2.1,
+ 2.2.2, or 2.2.3, and are represented in the Findings About domain, then the name of the variable
+ should be used as the value of FATESTCD."
Document: IG v3.2
Section: 6.4.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0173
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'When collected data fit a Qualifier variable listed in SDTM:
- Sections 2.2.1, 2.2.2, or 2.2.3, and are represented in the
- Findings About domain, then the name of the variable should be
- used as the value of FATESTCD.'
+ - Cited Guidance:
+ "When collected data fit a Qualifier variable listed in SDTM: Sections 2.2.1,
+ 2.2.2, or 2.2.3, and are represented in the Findings About domain, then the name of the variable
+ should be used as the value of FATESTCD."
Document: IG v3.3
Section: 6.4.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0173
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: $label_referenced_variable_role
@@ -60,19 +60,18 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0173
Status: Draft
- Version: '1'
-Description: Trigger error when collected data fits a Qualifier variable listed
- in specified SDTM Sections and are represented in the Findings About domain,
- and the name of the variable is used as FATESTCD
+ Version: "1"
+Description: Trigger error when collected data fits a Qualifier variable listed in specified SDTM
+ Sections and are represented in the Findings About domain, and the name of the variable is used as
+ FATESTCD
Executability: Partially Executable - Possible Underreporting
Operations:
- id: $label_referenced_variable_name
name: FATESTCD
operator: label_referenced_variable_metadata
Outcome:
- Message: Collected data fits a Qualifier variable listed in specified SDTM
- Sections and are represented in the Findings About domain, and the name of
- the variable is used as FATESTCD
+ Message: Collected data fits a Qualifier variable listed in specified SDTM Sections and are
+ represented in the Findings About domain, and the name of the variable is used as FATESTCD
Output Variables:
- $label_referenced_variable_name
Rule Type: Record Data
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml
index 4e5be2aa1..55734ac01 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml
@@ -17,39 +17,37 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0184
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For normal range values that are character in ordinal scale or
- if categorical ranges were supplied (e.g., "-1 to +1",
- "NEGATIVE TO TRACE").
+ - Cited Guidance: For normal range values that are character in ordinal scale or if
+ categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE").
Document: IG v3.2
Item: Specification
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0184
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For normal range values that are character in ordinal scale or
- if categorical ranges were supplied (e.g., "-1 to +1",
- "NEGATIVE TO TRACE").
+ - Cited Guidance: For normal range values that are character in ordinal scale or if
+ categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE").
Document: IG v3.3
Item: Specification
Section: 6.3.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0184
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
# Changed by Marcelina Hungria on 2025-07-22
# Fixed the regex per Description.
@@ -63,7 +61,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0184
Status: Draft
- Version: '1'
+ Version: "1"
Description: When LBORRES is a continuous measurement, LBSTNRC should be null
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0186/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0186/rule.yml
index 9c8040033..5234af168 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0186/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0186/rule.yml
@@ -1,50 +1,47 @@
# Variable: LBORNRLO
-# Condition:
+# Condition:
# Rule: LBORNRLO is expressed using the units in LBORRESU
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0186
- Version: '2'
- Version: '2.0'
- Citations:
- - Cited Guidance: Lower end of reference range for continuous measurement
- in original units.
+ - Citations:
+ - Cited Guidance: Lower end of reference range for continuous measurement in original units.
Document: SDTMIG v3.4
Section: 6.3.5.6
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0186
- Version: '2'
- Version: '2.0'
- Citations:
- - Cited Guidance: Lower end of reference range for continuous measurements
- in original units.
- Document: IG v3.2
- Item: Specification
- Section: '6.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance: Lower end of reference range for continuous measurements in original units.
+ Document: IG v3.2
+ Item: Specification
+ Section: "6.3"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0186
- Version: '2'
- Version: '2.0'
- Citations:
- - Cited Guidance: Lower end of reference range for continuous measurements
- in original units.
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance: Lower end of reference range for continuous measurements in original units.
Document: IG v3.3
Item: Specification
Section: 6.3.6
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0186
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: LBORNRLO
@@ -53,7 +50,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0186
Status: Draft
- Version: '1'
+ Version: "1"
Description: LBORNRLO is expressed using the units in LBORRESU
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0187/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0187/rule.yml
index 2a411cb75..8c106ce09 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0187/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0187/rule.yml
@@ -1,61 +1,58 @@
# Variable: LBORNRHI
-# Condition:
+# Condition:
# Rule: LBORNRHI is expressed using the units in LBORRESU
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.2'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0187
- Version: '2'
- Version: '2.0'
- Citations:
- - Cited Guidance: Upper end of reference range for continuous measurements
- in original units.
+ - Citations:
+ - Cited Guidance: Upper end of reference range for continuous measurements in original units.
Document: IG v3.2
Item: Specification
- Section: '6.3'
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Section: "6.3"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0187
- Version: '2'
- Version: '2.0'
- Citations:
- - Cited Guidance: Upper end of reference range for continuous measurements
- in original units.
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance: Upper end of reference range for continuous measurements in original units.
Document: IG v3.3
Item: Specification
Section: 6.3.6
- - Name: SDTMIG
- Version: '3.4'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0187
- Version: '2'
- Version: '2.0'
- Citations:
- - Cited Guidance: Upper end of reference range for continuous measurement
- in original units.
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance: Upper end of reference range for continuous measurement in original units.
Document: IG v3.4
Item: Specification
Section: 6.3.5.6
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0187
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0187
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml
index 8b30c896f..af9162a76 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml
@@ -1,5 +1,5 @@
# Variable: LBSTNRLO
-# Condition:
+# Condition:
# Rule: LBSTNRLO is expressed using the units in LBSTRESU
Authorities:
- Organization: CDISC
@@ -15,9 +15,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0188
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -25,13 +25,13 @@ Authorities:
LBSTRESC/LBSTRESN in standardized units.
Document: IG v3.2
Item: Specification
- Section: '6.3'
+ Section: "6.3"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0188
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -43,9 +43,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0188
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: LBSTRESU
@@ -59,7 +59,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0188
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error if LBORNRLO is not expressed using the units in LBSTRESU
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0189/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0189/rule.yml
index a9de80441..b870cd59d 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0189/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0189/rule.yml
@@ -1,51 +1,54 @@
# Variable: LBSTNRHI
-# Condition:
+# Condition:
# Rule: LBSTNRHI is expressed using the units in LBSTRESU
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0189
- Version: '2'
- Version: '2.0'
- Citations:
- - Cited Guidance: Upper end of reference range for continuous measurements
- in standardized units.
+ - Citations:
+ - Cited Guidance:
+ Upper end of reference range for continuous measurements in standardized
+ units.
Document: IG v3.4
Item: Specification
Section: 6.3.5.6
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0189
- Version: '2'
- Version: '2.0'
- Citations:
- - Cited Guidance: Upper end of reference range for continuous measurements
- in standardized units.
- Document: IG v3.2
- Item: Specification
- Section: '6.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ Upper end of reference range for continuous measurements in standardized
+ units.
+ Document: IG v3.2
+ Item: Specification
+ Section: "6.3"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0189
- Version: '2'
- Version: '2.0'
- Citations:
- - Cited Guidance: Upper end of reference range for continuous measurements
- in standardized units.
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Upper end of reference range for continuous measurements in standardized
+ units.
Document: IG v3.3
Item: Specification
Section: 6.3.6
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0189
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: LBSTRESU
@@ -59,7 +62,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0189
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error if LBSTNRHI is not expressed using the units in LBSTRESU
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml
index 404a740cf..3a1345f5c 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml
@@ -5,44 +5,44 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0190
- Version: '2'
- Version: '2.0'
- Citations:
+ - Citations:
- Cited Guidance: Reference Range for Char Rslt-Std Units
Document: IG v3.4
Item: Specification
Section: 6.3.5.6
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0190
- Version: '2'
- Version: '2.0'
- Citations:
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: Reference Range for Char Rslt-Std Units
Document: IG v3.2
Item: Specification
- Section: '6.3'
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Section: "6.3"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0190
- Version: '2'
- Version: '2.0'
- Citations:
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: Reference Range for Char Rslt-Std Units
Document: IG v3.3
Item: Specification
Section: 6.3.6
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0190
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: LBSTRESU
@@ -53,9 +53,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0190
Status: Draft
- Version: '1'
-Description: Trigger error if LBSTRESU is not null and LBSTNRC is not expressed using
- the units in LBSTRESU
+ Version: "1"
+Description: Trigger error if LBSTRESU is not null and LBSTNRC is not expressed using the units in
+ LBSTRESU
Executability: Fully Executable
Outcome:
Message: LBSTNRC is not expressed using the units in LBSTRESU when LBSTRESU is populated.
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0192/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0192/rule.yml
index 73bb6ee9d..529334cab 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0192/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0192/rule.yml
@@ -5,29 +5,28 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.2'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0192
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: 3. MBTESTCD value for organisms present in a specimen
- is 'ORGANISM'.
+ - Citations:
+ - Cited Guidance: 3. MBTESTCD value for organisms present in a specimen is 'ORGANISM'.
Document: IG v3.2
Item: Assumption 3
- Section: '6.3'
+ Section: "6.3"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0192
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0192
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0196/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0196/rule.yml
index 69415d911..239d610f9 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0196/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0196/rule.yml
@@ -5,57 +5,58 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.2'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ Text description of any abnormal findings. If the examination was completed
+ and there were no abnormal findings, the value should be NORMAL.
+ Document: IG v3.2
+ Section: "6.3"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0196
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Text description of any abnormal findings. If the
- examination was completed and there were no abnormal findings, the
- value should be NORMAL.
- Document: IG v3.2
- Section: '6.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0196
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Text description of any abnormal findings. If the
- examination was completed and there were no abnormal findings, the
- value should be NORMAL.
+ - Citations:
+ - Cited Guidance:
+ Text description of any abnormal findings. If the examination was completed
+ and there were no abnormal findings, the value should be NORMAL.
Document: IG v3.3
Section: 6.3.12
- - Name: SDTMIG
- Version: '3.4'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0196
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If the examination was completed and there were no
- abnormal findings, the value should be "NORMAL".
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If the examination was completed and there were no abnormal findings, the
+ value should be "NORMAL".
Document: IG v3.4
Item: Specification
Section: 6.3.8
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0196
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0196
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml
index 590dd1781..435f88005 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml
@@ -5,48 +5,48 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0197
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If there are findings for a body system, then either
- the dictionary preferred term (if findings are coded using a dictionary)
- or PEORRES (if findings are not encoded) should appear here.
+ - Citations:
+ - Cited Guidance: If there are findings for a body system, then either the dictionary
+ preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not
+ encoded) should appear here.
Document: IG v3.4
Item: Specification
Section: 6.3.8
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0197
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If there are findings for a body system, then either
- the dictionary preferred term (if findings are coded using a dictionary)
- or PEORRES (if findings are not coded) should appear here.
- Document: IG v3.2
- Section: '6.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance: If there are findings for a body system, then either the dictionary
+ preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not
+ coded) should appear here.
+ Document: IG v3.2
+ Section: "6.3"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0197
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If there are findings for a body system, then either
- the dictionary preferred term (if findings are coded using a dictionary)
- or PEORRES (if findings are not coded) should appear here.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance: If there are findings for a body system, then either the dictionary
+ preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not
+ coded) should appear here.
Document: IG v3.3
Section: 6.3.12
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0197
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: PESTRESC
@@ -61,9 +61,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0197
Status: Draft
- Version: '1'
-Description: Trigger error when PESTRESC ^= null but PESTRESC does not equal PEORRES
- OR a dictionary coded preferred term
+ Version: "1"
+Description: Trigger error when PESTRESC ^= null but PESTRESC does not equal PEORRES OR a dictionary
+ coded preferred term
Executability: Fully Executable
Outcome:
Message: PESTRESC does not equal PEORRES OR a dictionary coded preferred term
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0198/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0198/rule.yml
index 401d9df36..952de7fee 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0198/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0198/rule.yml
@@ -1,54 +1,54 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: Relationships represented in RELREC are collected relationships
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ Relationships represented in RELREC are collected relationships, either by
+ explicit references or check boxes on the CRF, or by design of the CRF, such as vital
+ signs captured during an exercise stress test.
+ Document: IG v3.4
+ Section: "8.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0198
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Relationships represented in RELREC are collected
- relationships, either by explicit references or check boxes on the
- CRF, or by design of the CRF, such as vital signs captured during
- an exercise stress test.
- Document: IG v3.4
- Section: '8.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.2'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ Relationships represented in RELREC are collected relationships, either by
+ explicit references or check boxes on the CRF, or by design of the CRF, such as vital
+ signs captured during an exercise stress test.
+ Document: IG v3.2
+ Section: "8.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0198
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Relationships represented in RELREC are collected
- relationships, either by explicit references or check boxes on the
- CRF, or by design of the CRF, such as vital signs captured during
- an exercise stress test.
- Document: IG v3.2
- Section: '8.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ Relationships represented in RELREC are collected relationships, either by
+ explicit references or check boxes on the CRF, or by design of the CRF, such as vital
+ signs captured during an exercise stress test.
+ Document: IG v3.3
+ Section: "8.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0198
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Relationships represented in RELREC are collected
- relationships, either by explicit references or check boxes on the
- CRF, or by design of the CRF, such as vital signs captured during
- an exercise stress test.
- Document: IG v3.3
- Section: '8.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -58,9 +58,8 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0198
Status: Draft
- Version: '1'
-Description: Trigger error when relationship represented in RELREC is not a collected
- relationship
+ Version: "1"
+Description: Trigger error when relationship represented in RELREC is not a collected relationship
Executability: Fully Executable
Outcome:
Message: Relationship represented in RELREC is not a collected relationship
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml
index 510ed00fe..102ea45e5 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml
@@ -1,63 +1,63 @@
# Variable: --DTC
-# Condition:
+# Condition:
# Rule: --DTC is date/time of specimen collection or observation, not date/time of recording/acquisition
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0236
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: For any domain based on the Findings general observation
- class, such as lab tests which are based on a specimen, the collection
- date is likely to be tied to when the specimen or source of the
- finding was captured, not necessarily when the data was recorded.
- in order to ensure that the critical timing information is always
- represented in the same variable, the --DTC variable is used to
- represent the time of specimen collection.
+ - Citations:
+ - Cited Guidance:
+ For any domain based on the Findings general observation class, such as lab
+ tests which are based on a specimen, the collection date is likely to be tied to when the
+ specimen or source of the finding was captured, not necessarily when the data was
+ recorded. in order to ensure that the critical timing information is always represented in
+ the same variable, the --DTC variable is used to represent the time of specimen
+ collection.
Document: IG v3.4
Section: 4.4.8
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0236
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: For any domain based on the Findings general observation
- class, such as lab tests which are based on a specimen, the collection
- date is likely to be tied to when the specimen or source of the
- finding was captured, not necessarily when the data was recorded.
- in order to ensure that the critical timing information is always
- represented in the same variable, the --DTC variable is used to
- represent the time of specimen collection.
- Document: IG v3.2
- Section: 4.1.4.8
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ For any domain based on the Findings general observation class, such as lab
+ tests which are based on a specimen, the collection date is likely to be tied to when the
+ specimen or source of the finding was captured, not necessarily when the data was
+ recorded. in order to ensure that the critical timing information is always represented in
+ the same variable, the --DTC variable is used to represent the time of specimen
+ collection.
+ Document: IG v3.2
+ Section: 4.1.4.8
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0236
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: For any domain based on the Findings general observation
- class, such as lab tests which are based on a specimen, the collection
- date is likely to be tied to when the specimen or source of the
- finding was captured, not necessarily when the data were recorded.
- In order to ensure that the critical timing information is always
- represented in the same variable, the --DTC variable is used to
- represent the time of specimen collection.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ For any domain based on the Findings general observation class, such as lab
+ tests which are based on a specimen, the collection date is likely to be tied to when the
+ specimen or source of the finding was captured, not necessarily when the data were
+ recorded. In order to ensure that the critical timing information is always represented in
+ the same variable, the --DTC variable is used to represent the time of specimen
+ collection.
Document: IG v3.3
Section: 4.4.8
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0236
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -65,13 +65,13 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0236
Status: Draft
- Version: '1'
-Description: Trigger error when --DTC is date/time of recording/acquisition, not date/time
- of specimen collection or observation
+ Version: "1"
+Description: Trigger error when --DTC is date/time of recording/acquisition, not date/time of
+ specimen collection or observation
Executability: Fully Executable
Outcome:
- Message: --DTC is date/time of recording/acquisition, not date/time of specimen
- collection or observation
+ Message: --DTC is date/time of recording/acquisition, not date/time of specimen collection or
+ observation
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml
index 1343a4af2..ea36c7b03 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml
@@ -5,59 +5,59 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0237
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: For any domain based on the Findings general observation
- class, such as lab tests which are based on a specimen, the collection
- date is likely to be tied to when the specimen or source of the
- finding was captured, not necessarily when the data was recorded.
- in order to ensure that the critical timing information is always
- represented in the same variable, the --DTC variable is used to
- represent the time of specimen collection.
+ - Citations:
+ - Cited Guidance:
+ For any domain based on the Findings general observation class, such as lab
+ tests which are based on a specimen, the collection date is likely to be tied to when the
+ specimen or source of the finding was captured, not necessarily when the data was
+ recorded. in order to ensure that the critical timing information is always represented in
+ the same variable, the --DTC variable is used to represent the time of specimen
+ collection.
Document: IG v3.4
Section: 4.4.8
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0237
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: For any domain based on the Findings general observation
- class, such as lab tests which are based on a specimen, the collection
- date is likely to be tied to when the specimen or source of the
- finding was captured, not necessarily when the data was recorded.
- in order to ensure that the critical timing information is always
- represented in the same variable, the --DTC variable is used to
- represent the time of specimen collection.
- Document: IG v3.2
- Section: 4.1.4.8
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ For any domain based on the Findings general observation class, such as lab
+ tests which are based on a specimen, the collection date is likely to be tied to when the
+ specimen or source of the finding was captured, not necessarily when the data was
+ recorded. in order to ensure that the critical timing information is always represented in
+ the same variable, the --DTC variable is used to represent the time of specimen
+ collection.
+ Document: IG v3.2
+ Section: 4.1.4.8
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0237
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: For any domain based on the Findings general observation
- class, such as lab tests which are based on a specimen, the collection
- date is likely to be tied to when the specimen or source of the
- finding was captured, not necessarily when the data were recorded.
- In order to ensure that the critical timing information is always
- represented in the same variable, the --DTC variable is used to
- represent the time of specimen collection.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ For any domain based on the Findings general observation class, such as lab
+ tests which are based on a specimen, the collection date is likely to be tied to when the
+ specimen or source of the finding was captured, not necessarily when the data were
+ recorded. In order to ensure that the critical timing information is always represented in
+ the same variable, the --DTC variable is used to represent the time of specimen
+ collection.
Document: IG v3.3
Section: 4.4.8
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0237
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: --DTC
@@ -67,13 +67,13 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0237
Status: Draft
- Version: '1'
-Description: Trigger error when --DTC is present and not populated with the date/time
- of recording/data acquisition
+ Version: "1"
+Description: Trigger error when --DTC is present and not populated with the date/time of
+ recording/data acquisition
Executability: Fully Executable
Outcome:
- Message: --DTC is present in dataset and is not populated with the date/time of
- recording/data acquisition
+ Message: --DTC is present in dataset and is not populated with the date/time of recording/data
+ acquisition
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0238/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0238/rule.yml
index c06ab2bca..084620540 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0238/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0238/rule.yml
@@ -4,109 +4,75 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "\"Dates are generally used only as timing variables, ... but
- there may be occasions when it may be preferable\
-
- \ to model a date as a result (--ORRES) in a
- Findings dataset. ... this situation may occasionally occur
- when\
-
- \ a) a group of questions (each of which has
- a date response) is asked and analyzed together; or b) the
- Event(s)\
-
- \ and Intervention(s) in question are not
- medically significant (often the case when included in
- questionnaires).\
-
- \ Consider the following cases - Calculated
- due date, Date of last day on the job, Date of high school
- graduation.\
-
- \ One approach to modeling these data would
- be to place the text of the question in --TEST and the
- response to the\
-
- \ question, a date represented in ISO 8601
- format, in --ORRES and --STRESC as long as these date results
- do not\
-
- \ contain the dates of medically significant
- events or interventions. Again, use extreme caution when
- storing dates\
-
- \ as the results of Findings. Remember, in
- most cases, these dates should be timing variables associated
- with a\
-
- \ record in an Intervention or Events
- dataset.\""
+ - Cited Guidance:
+ "\"Dates are generally used only as timing variables, ... but there may be occasions
+ when it may be preferable \n to model a date as a result (--ORRES) in a Findings dataset. ...
+ this situation may occasionally occur when \n a) a group of questions (each of which has a date
+ response) is asked and analyzed together; or b) the Event(s) \n and Intervention(s) in question
+ are not medically significant (often the case when included in questionnaires). \n Consider
+ the following cases - Calculated due date, Date of last day on the job, Date of high school
+ graduation. \n One approach to modeling these data would be to place the text of the question
+ in --TEST and the response to the \n question, a date represented in ISO 8601 format, in --ORRES
+ and --STRESC as long as these date results do not \n contain the dates of medically significant
+ events or interventions. Again, use extreme caution when storing dates \n as the results of
+ Findings. Remember, in most cases, these dates should be timing variables associated with a\
+ \ \n record in an Intervention or Events dataset.\""
Document: IG v3.4
Section: 4.4.9
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0238
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Dates are generally used only as timing variables, ... but
- there may be occasions when it may be preferable to model a
- date as a result (--ORRES) in a Findings dataset. ... this
- situation may occasionally occur when a) a group of questions
- (each of which has a date response) is asked and analyzed
- together; or b) the Event(s) and Intervention(s) in question
- are not medically significant (often the case when included in
- questionnaires). Consider the following cases: Calculated due
- date; Date of last day on the job; Date of high school
- graduation. One approach to modeling these data would be to
- place the text of the question in --TEST and the response to
- the question, a date represented in ISO 8601 format, in
- --ORRES and --STRESC as long as these date results do not
- contain the dates of medically significant events or
- interventions. Again, use extreme caution when storing dates
- as the results of Findings. Remember, in most cases, these
- dates should be timing variables associated with a record in
- an Intervention or Events dataset.'
+ - Cited Guidance:
+ "Dates are generally used only as timing variables, ... but there may be occasions
+ when it may be preferable to model a date as a result (--ORRES) in a Findings dataset. ... this
+ situation may occasionally occur when a) a group of questions (each of which has a date response)
+ is asked and analyzed together; or b) the Event(s) and Intervention(s) in question are not medically
+ significant (often the case when included in questionnaires). Consider the following cases:
+ Calculated due date; Date of last day on the job; Date of high school graduation. One approach
+ to modeling these data would be to place the text of the question in --TEST and the response
+ to the question, a date represented in ISO 8601 format, in --ORRES and --STRESC as long as these
+ date results do not contain the dates of medically significant events or interventions. Again,
+ use extreme caution when storing dates as the results of Findings. Remember, in most cases,
+ these dates should be timing variables associated with a record in an Intervention or Events
+ dataset."
Document: IG v3.2
Section: 4.1.4.9
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0238
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Dates are generally used only as timing variables, ... but
- there may be occasions when it may be preferable to model a
- date as a result (--ORRES) in a Findings dataset. ... this
- situation may occasionally occur when a) a group of questions
- (each of which has a date response) is asked and analyzed
- together; or b) the Event(s) and Intervention(s) in question
- are not medically significant (often the case when included in
- questionnaires). Consider the following cases: Calculated due
- date, Date of last day on the job, Date of high school
- graduation. One approach to modeling these data would be to
- place the text of the question in --TEST and the response to
- the question, a date represented in ISO 8601 format, in
- --ORRES and --STRESC as long as these date results do not
- contain the dates of medically significant events or
- interventions. Again, use extreme caution when storing dates
- as the results of Findings. Remember, in most cases, these
- dates should be timing variables associated with a record in
- an Intervention or Events dataset.'
+ - Cited Guidance:
+ "Dates are generally used only as timing variables, ... but there may be occasions
+ when it may be preferable to model a date as a result (--ORRES) in a Findings dataset. ... this
+ situation may occasionally occur when a) a group of questions (each of which has a date response)
+ is asked and analyzed together; or b) the Event(s) and Intervention(s) in question are not medically
+ significant (often the case when included in questionnaires). Consider the following cases:
+ Calculated due date, Date of last day on the job, Date of high school graduation. One approach
+ to modeling these data would be to place the text of the question in --TEST and the response
+ to the question, a date represented in ISO 8601 format, in --ORRES and --STRESC as long as these
+ date results do not contain the dates of medically significant events or interventions. Again,
+ use extreme caution when storing dates as the results of Findings. Remember, in most cases,
+ these dates should be timing variables associated with a record in an Intervention or Events
+ dataset."
Document: IG v3.3
Section: 4.4.9
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0238
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
# Variable: --ORRES
# Condition: Date Value
# Rule: --ORRES in ISO 8601 date format
@@ -124,7 +90,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0238
Status: Draft
- Version: '1'
+ Version: "1"
Description: Where -ORRES is a date or time, it must be entered in an ISO 8601 format
Executability: Partially Executable
# this rule is actually not executable
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml
index f72d609c8..5af59ff9b 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml
@@ -5,47 +5,50 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0249
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If an Element does not end with a decision that could
- lead to a shortened path within the Arm, then TATRANS will be blank.
+ - Citations:
+ - Cited Guidance:
+ If an Element does not end with a decision that could lead to a shortened
+ path within the Arm, then TATRANS will be blank.
Document: IG v3.4
Item: Assumption 7
Section: 7.2.1
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0249
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If an Element does not end with a decision that could
- lead to a shortened path within the Arm, then TATRANS will be blank.
- Document: IG v3.2
- Item: Assumption 7
- Section: '7.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ If an Element does not end with a decision that could lead to a shortened
+ path within the Arm, then TATRANS will be blank.
+ Document: IG v3.2
+ Item: Assumption 7
+ Section: "7.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0249
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If an Element does not end with a decision that could
- lead to a shortened path within the Arm, then TATRANS will be blank.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If an Element does not end with a decision that could lead to a shortened
+ path within the Arm, then TATRANS will be blank.
Document: IG v3.3
Item: Assumption 7
Section: 7.2.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0249
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -55,13 +58,13 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0249
Status: Draft
- Version: '1'
-Description: Trigger error when element does not end with a decision that could lead
- to a shortened path within the Arm and TATRANS is not null
+ Version: "1"
+Description: Trigger error when element does not end with a decision that could lead to a shortened
+ path within the Arm and TATRANS is not null
Executability: Fully Executable
Outcome:
- Message: TATRANS is populated when the element does not end with a decision that
- could lead to a shortened path within the Arm
+ Message: TATRANS is populated when the element does not end with a decision that could lead to a
+ shortened path within the Arm
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml
index bac069b87..1c9abba64 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml
@@ -1,52 +1,50 @@
# Variable: EPOCH
-# Condition:
+# Condition:
# Rule: Each value of EPOCH is not associated with more than one conceptual trial period
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0250
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: 'EPOCH may be used as a timing variable in other datasets,
- such as EX and DS, and values of EPOCH must be different for different
- epochs. '
+ - Citations:
+ - Cited Guidance:
+ "EPOCH may be used as a timing variable in other datasets, such as EX and DS,
+ and values of EPOCH must be different for different epochs. "
Document: IG v3.4
Item: Assumption 12
Section: 7.2.1
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0250
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: '... values of EPOCH must be different for different
- epochs.'
- Document: IG v3.2
- Item: Assumption 11
- Section: '7.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance: "... values of EPOCH must be different for different epochs."
+ Document: IG v3.2
+ Item: Assumption 11
+ Section: "7.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0250
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: '... values of EPOCH must be different for different
- epochs.'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance: "... values of EPOCH must be different for different epochs."
Document: IG v3.3
Item: Assumption 12
Section: 7.2.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0250
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -54,9 +52,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0250
Status: Draft
- Version: '1'
-Description: Trigger error when at least one EPOCH is associated with more than one
- conceptual trial period
+ Version: "1"
+Description: Trigger error when at least one EPOCH is associated with more than one conceptual trial
+ period
Executability: Fully Executable
Outcome:
Message: At least one EPOCH is associated with more than one conceptual trial period
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0251/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0251/rule.yml
index 84b8d30b7..2c846e7ba 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0251/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0251/rule.yml
@@ -5,47 +5,50 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0251
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: TABRANCH describes the outcome of a branch decision
- point in the trial design for subjects in the Arm.
+ - Citations:
+ - Cited Guidance:
+ TABRANCH describes the outcome of a branch decision point in the trial
+ design for subjects in the Arm.
Document: IG v3.4
Item: Assumption 3
Section: 7.2.1
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0251
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: TABRANCH describes the outcome of a branch decision
- point in the trial design for subjects in the Arm
- Document: IG v3.2
- Item: Assumption 3
- Section: '7.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ TABRANCH describes the outcome of a branch decision point in the trial
+ design for subjects in the Arm
+ Document: IG v3.2
+ Item: Assumption 3
+ Section: "7.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0251
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: TABRANCH describes the outcome of a branch decision
- point in the trial design for subjects in the Arm
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ TABRANCH describes the outcome of a branch decision point in the trial
+ design for subjects in the Arm
Document: IG v3.3
Item: Assumption 3
Section: 7.2.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0251
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -55,7 +58,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0251
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when trial design branches and TABRANCH is null
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml
index c018b73c7..1ea8ce869 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml
@@ -7,10 +7,10 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If the trial design allows a subject to transition to an Element
- other than the next Element in sequence, then the conditions
- for transitioning to those other Elements, and the alternative
- Element sequences, are specified in this rule (e.g.,
+ - Cited Guidance:
+ If the trial design allows a subject to transition to an Element other than
+ the next Element in sequence, then the conditions for transitioning to those other
+ Elements, and the alternative Element sequences, are specified in this rule (e.g.,
Responders go to washout).
Document: IG v3.4
Item: Specification
@@ -18,33 +18,33 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0252
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If the trial design allows a subject to transition to an Element
- other than the next Element in sequence, then the conditions
- for transitioning to those other Elements, and the alternative
- Element sequences, are specified in this rule (e.g.,
+ - Cited Guidance:
+ If the trial design allows a subject to transition to an Element other than
+ the next Element in sequence, then the conditions for transitioning to those other
+ Elements, and the alternative Element sequences, are specified in this rule (e.g.,
Responders go to washout).
Document: IG v3.2
Item: Specification
- Section: '7.2'
+ Section: "7.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0252
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If the trial design allows a subject to transition to an Element
- other than the next Element in sequence, then the conditions
- for transitioning to those other Elements, and the alternative
- Element sequences, are specified in this rule (e.g.,
+ - Cited Guidance:
+ If the trial design allows a subject to transition to an Element other than
+ the next Element in sequence, then the conditions for transitioning to those other
+ Elements, and the alternative Element sequences, are specified in this rule (e.g.,
Responders go to washout).
Document: IG v3.3
Item: Specification
@@ -52,21 +52,21 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0252
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
Core:
Id: CDISC.SDTMIG.CG0252
Status: Draft
- Version: '1'
-Description: Trigger error when trial Design allows for a Subject to transition
- to an Element other than the next Element in sequence, and TATRANS is null
+ Version: "1"
+Description: Trigger error when trial Design allows for a Subject to transition to an Element other
+ than the next Element in sequence, and TATRANS is null
Executability: Not Executable
Outcome:
- Message: TATRANS is null when trial Design allows for a Subject to transition to
- an Element other than the next Element in sequence
+ Message: TATRANS is null when trial Design allows for a Subject to transition to an Element other
+ than the next Element in sequence
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml
index c27662092..f8e014d05 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml
@@ -7,62 +7,64 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If inclusion/exclusion criteria were amended during the trial,
- then each complete set of criteria must be included in the TI
- domain. TIVERS is used to distinguish between the versions.
+ - Cited Guidance:
+ If inclusion/exclusion criteria were amended during the trial, then each
+ complete set of criteria must be included in the TI domain. TIVERS is used to distinguish
+ between the versions.
Document: IG v3.4
Item: Assumption 1
Section: 7.4.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0253
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If inclusion/exclusion criteria were amended during the trial,
- then each complete set of criteria must be included in the TI
- domain. TIVERS is used to distinguish between the versions.
+ - Cited Guidance:
+ If inclusion/exclusion criteria were amended during the trial, then each
+ complete set of criteria must be included in the TI domain. TIVERS is used to distinguish
+ between the versions.
Document: IG v3.2
Item: Assumption 1
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0253
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If inclusion/exclusion criteria were amended during the trial,
- then each complete set of criteria must be included in the TI
- domain. TIVERS is used to distinguish between the versions.
+ - Cited Guidance:
+ If inclusion/exclusion criteria were amended during the trial, then each
+ complete set of criteria must be included in the TI domain. TIVERS is used to distinguish
+ between the versions.
Document: IG v3.3
Item: Assumption 1
Section: 7.4.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0253
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
-
Core:
Id: CDISC.SDTMIG.CG0253
Status: Draft
- Version: '1'
-Description: Trigger error when TIVERS is null and there is more than one
- version of the IE criteria in study documentation
+ Version: "1"
+Description: Trigger error when TIVERS is null and there is more than one version of the IE criteria
+ in study documentation
Executability: Not Executable
Outcome:
- Message: TIVERS is null when there is more than one version of the IE criteria
- in study documentation
+ Message: TIVERS is null when there is more than one version of the IE criteria in study
+ documentation
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml
index 945747b3b..0613f760b 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml
@@ -5,47 +5,50 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0254
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The number of this version of the Inclusion/Exclusion
- criteria. May be omitted if there is only one version.
+ - Citations:
+ - Cited Guidance:
+ The number of this version of the Inclusion/Exclusion criteria. May be
+ omitted if there is only one version.
Document: IG v3.4
Item: Specification
Section: 7.4.1
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0254
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The number of this version of the Inclusion/Exclusion
- criteria. May be omitted if there is only one version.
- Document: IG v3.2
- Item: Specification
- Section: '7.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ The number of this version of the Inclusion/Exclusion criteria. May be
+ omitted if there is only one version.
+ Document: IG v3.2
+ Item: Specification
+ Section: "7.4"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0254
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The number of this version of the Inclusion/Exclusion
- criteria. May be omitted if there is only one version.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ The number of this version of the Inclusion/Exclusion criteria. May be
+ omitted if there is only one version.
Document: IG v3.3
Item: Specification
Section: 7.4.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0254
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -55,13 +58,12 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0254
Status: Draft
- Version: '1'
-Description: Trigger error when TIVERS is not present in the data and there is more
- than one version of the IE criteria
+ Version: "1"
+Description: Trigger error when TIVERS is not present in the data and there is more than one version
+ of the IE criteria
Executability: Fully Executable
Outcome:
- Message: TIVERS is not present in the data when there is more than one version of
- the IE criteria
+ Message: TIVERS is not present in the data when there is more than one version of the IE criteria
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0267/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0267/rule.yml
index ef442f0bb..257ece748 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0267/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0267/rule.yml
@@ -14,22 +14,22 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0267
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: The version number of the Reference Terminology, if applicable.
Document: IG v3.2
Item: Specification
- Section: '7.4'
+ Section: "7.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0267
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -40,15 +40,15 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0267
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
Core:
Id: CDISC.SDTMIG.CG0267
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when Reference Terminology is versioned and TSVCDVER is null
Executability: Not Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml
index f05e9bbf5..750c80781 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml
@@ -5,47 +5,50 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0295
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If the timing of Visits for a trial does not depend
- on which ARM a subject is in, then ARMCD should be null.
+ - Citations:
+ - Cited Guidance:
+ If the timing of Visits for a trial does not depend on which ARM a subject
+ is in, then ARMCD should be null.
Document: IG v3.4
Item: Specification
Section: 7.3.1
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0295
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If the timing of Visits for a trial does not depend
- on which ARM a subject is in, then ARMCD should be null.
- Document: IG v3.2
- Item: Specification
- Section: '7'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ If the timing of Visits for a trial does not depend on which ARM a subject
+ is in, then ARMCD should be null.
+ Document: IG v3.2
+ Item: Specification
+ Section: "7"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0295
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If the timing of Visits for a trial does not depend
- on which ARM a subject is in, then ARMCD should be null.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If the timing of Visits for a trial does not depend on which ARM a subject
+ is in, then ARMCD should be null.
Document: IG v3.3
Item: Specification
Section: 7.3.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0295
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -55,13 +58,13 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0295
Status: Draft
- Version: '1'
-Description: Trigger error when ARMCD is populated and the timing and number of Visits
- for a trial does not depend on which ARM a subject is in
+ Version: "1"
+Description: Trigger error when ARMCD is populated and the timing and number of Visits for a trial
+ does not depend on which ARM a subject is in
Executability: Fully Executable
Outcome:
- Message: ARMCD is populated and the timing and number of Visits for a trial does
- not depend on which ARM a subject is in
+ Message: ARMCD is populated and the timing and number of Visits for a trial does not depend on
+ which ARM a subject is in
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml
index 3301657c2..ef0fa03d7 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml
@@ -5,47 +5,50 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0296
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If the timing of Visits for a trial does not depend
- on which Arm a subject is in, then Arm should be left blank.
+ - Citations:
+ - Cited Guidance:
+ If the timing of Visits for a trial does not depend on which Arm a subject
+ is in, then Arm should be left blank.
Document: IG v3.4
Item: Specification
Section: 7.3.1
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0296
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If the timing of Visits for a trial does not depend
- on which Arm a subject is in, then Arm should be left blank.
- Document: IG v3.2
- Item: Specification
- Section: '7'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ If the timing of Visits for a trial does not depend on which Arm a subject
+ is in, then Arm should be left blank.
+ Document: IG v3.2
+ Item: Specification
+ Section: "7"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0296
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If the timing of Visits for a trial does not depend
- on which Arm a subject is in, then Arm should be left blank.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If the timing of Visits for a trial does not depend on which Arm a subject
+ is in, then Arm should be left blank.
Document: IG v3.3
Item: Specification
Section: 7.3.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0296
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -55,12 +58,12 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0296
Status: Draft
- Version: '1'
-Description: Trigger error when ARM is populated and the timing and number of Visits
- for a trial does not depend on which ARM a subject is in
+ Version: "1"
+Description: Trigger error when ARM is populated and the timing and number of Visits for a trial
+ does not depend on which ARM a subject is in
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0298/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0298/rule.yml
index dddaef268..b523f0579 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0298/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0298/rule.yml
@@ -1,48 +1,48 @@
# Variable: VISIT
-# Condition:
+# Condition:
# Rule: VISIT is described in protocol
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0298
- Version: '1'
- Version: '2.0'
- Citations:
+ - Citations:
- Cited Guidance: Protocol-defined description of clinical encounter.
Document: IG v3.4
Item: Specification
Section: 7.3.1
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0298
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: Protocol-defined description of clinical encounter.
Document: IG v3.2
Item: Specification
- Section: '7'
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Section: "7"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0298
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: Protocol-defined description of clinical encounter.
Document: IG v3.3
Item: Specification
Section: 7.3.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0298
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -50,7 +50,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0298
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when a visit is not described in the protocol
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0312/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0312/rule.yml
index cf1c6b202..094fe5cf9 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0312/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0312/rule.yml
@@ -7,46 +7,48 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: "'A custom domain may only be created if the data are different
- in nature and do not fit into an existing published domain.'"
+ - Cited Guidance:
+ "'A custom domain may only be created if the data are different in nature and
+ do not fit into an existing published domain.'"
Document: IG v3.4
Item: NA
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0312
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The following standard domains, listed in alphabetical order by
- Domain Code, with their respective domain codes have been
- defined or referenced by the CDISC SDS Team in this document.
- Note that other domain models may be posted separately for
- comment after this publication. See list in 2.5
+ - Cited Guidance:
+ The following standard domains, listed in alphabetical order by Domain Code,
+ with their respective domain codes have been defined or referenced by the CDISC SDS Team
+ in this document. Note that other domain models may be posted separately for comment after
+ this publication. See list in 2.5
Document: IG v3.2
- Section: '2.5'
+ Section: "2.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0312
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A custom domain may only be created if the data are different in
- nature and do not fit into an existing published domain.
+ - Cited Guidance:
+ A custom domain may only be created if the data are different in nature and
+ do not fit into an existing published domain.
Document: IG v3.3
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0312
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
any:
- all:
@@ -176,7 +178,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0312
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when custom domains use the reserved or modelled standard names
Executability: Fully Executable
Operations:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0320/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0320/rule.yml
index 6742cedb3..04e3a3566 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0320/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0320/rule.yml
@@ -7,50 +7,53 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Include the topic variable from the identified general
- observation class (e.g., --TESTCD for Findings) in the SDTM.
+ - Cited Guidance:
+ Include the topic variable from the identified general observation class
+ (e.g., --TESTCD for Findings) in the SDTM.
Document: IG v3.4
Item: Item 3.b.
- Section: '2.6'
- - Cited Guidance: For a Findings domain, the topic variable, --TESTCD, should use
- Controlled Terminology (e.g., "SYSBP" for Systolic Blood
- Pressure)
+ Section: "2.6"
+ - Cited Guidance:
+ For a Findings domain, the topic variable, --TESTCD, should use Controlled
+ Terminology (e.g., "SYSBP" for Systolic Blood Pressure)
Document: IG v3.4
Section: 4.3.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0320
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Include the Topic variable from the identified general
- observation class (e.g., --TESTCD for Findings)
+ - Cited Guidance:
+ Include the Topic variable from the identified general observation class
+ (e.g., --TESTCD for Findings)
Document: IG v3.2
Item: 3.b
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0320
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Include the Topic variable from the identified general
- observation class (e.g., --TESTCD for Findings)
+ - Cited Guidance:
+ Include the Topic variable from the identified general observation class
+ (e.g., --TESTCD for Findings)
Document: IG v3.3
Item: 3.b
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0320
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: define_dataset_is_non_standard
@@ -65,7 +68,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0320
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when variable --TESTCD is missing for custom Findings domains
Executability: Fully Executable
Operations:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml
index d8de0ffda..287f9f750 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml
@@ -5,45 +5,45 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: This section describes the overall process for creating a custom
- domain, which must be based on one of the three SDTM general
- observation classes.
+ - Cited Guidance:
+ This section describes the overall process for creating a custom domain,
+ which must be based on one of the three SDTM general observation classes.
Document: IG v3.4
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0321
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: This section describes the overall process for creating a custom
- domain, which must be based on one of the three SDTM general
- observation classes.
+ - Cited Guidance:
+ This section describes the overall process for creating a custom domain,
+ which must be based on one of the three SDTM general observation classes.
Document: IG v3.2
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0321
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: This section describes the overall process for creating a custom
- domain, which must be based on one of the three SDTM general
- observation classes.
+ - Cited Guidance:
+ This section describes the overall process for creating a custom domain,
+ which must be based on one of the three SDTM general observation classes.
Document: IG v3.3
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0321
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
# Variable: GEN
# Condition: Custom domain present in study
# Rule: Custom domain is based on one of the observation classes
@@ -79,28 +79,29 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0321
Status: Draft
- Version: '1'
-Description: Trigger error when a custom domain is present and is not based on
- one of the observation classes
+ Version: "1"
+Description: Trigger error when a custom domain is present and is not based on one of the
+ observation classes
Executability: Fully Executable
Operations:
- id: $custom_domain
operator: domain_is_custom
- id: $dataset_variables
- operator: get_column_order_from_dataset
- # - id: $model_filtered_variables`
- # key_name: "role"
- # key_value: "Identifier"
- # operation: get_model_filtered_variables`
+ operator:
+ get_column_order_from_dataset
+ # - id: $model_filtered_variables`
+ # key_name: "role"
+ # key_value: "Identifier"
+ # operation: get_model_filtered_variables`
Outcome:
Message: Custom domain is not based on one of the observation classes
Output Variables:
- dataset_name
- $dataset_variables
- $custom_domain
- # - define_dataset_name
- # - define_dataset_is_non_standard
- # - define_dataset_class
+ # - define_dataset_name
+ # - define_dataset_is_non_standard
+ # - define_dataset_class
Rule Type: Dataset Metadata Check
Scope:
Classes:
@@ -110,5 +111,4 @@ Scope:
Include:
- ALL
Sensitivity: Dataset
-
# Document End
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml
index f66b23de5..323fe51b4 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml
@@ -5,50 +5,53 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0322
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: TESTRL should be expressed without referring to Arm.
- If the Element appears in more than one Arm in the Trial Arms dataset,
- then the Element description (ELEMENT) must not refer to any Arms
+ - Citations:
+ - Cited Guidance:
+ TESTRL should be expressed without referring to Arm. If the Element appears
+ in more than one Arm in the Trial Arms dataset, then the Element description (ELEMENT)
+ must not refer to any Arms
Document: IG v3.4
Item: Assumption 8
Section: 7.2.2
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0322
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: TESTRL should be expressed without referring to Arm.
- If the Element appears in more than one Arm in the Trial Arms dataset;
- then the Element description (ELEMENT) must not refer to any Arms.
- Document: IG v3.2
- Item: Assumption 8 for TE
- Section: '7.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ TESTRL should be expressed without referring to Arm. If the Element appears
+ in more than one Arm in the Trial Arms dataset; then the Element description (ELEMENT)
+ must not refer to any Arms.
+ Document: IG v3.2
+ Item: Assumption 8 for TE
+ Section: "7.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0322
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: TESTRL should be expressed without referring to Arm.
- If the Element appears in more than one Arm in the Trial Arms dataset;
- then the Element description (ELEMENT) must not refer to any Arms.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ TESTRL should be expressed without referring to Arm. If the Element appears
+ in more than one Arm in the Trial Arms dataset; then the Element description (ELEMENT)
+ must not refer to any Arms.
Document: IG v3.3
Item: Assumption 8
Section: 7.2.2
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0322
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: ELEMENT
@@ -57,17 +60,16 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0322
Status: Draft
- Version: '1'
-Description: When ELEMENT is associated with more than 1 arm, the ELEMENT value must
- not refer to a specific ARM
+ Version: "1"
+Description: When ELEMENT is associated with more than 1 arm, the ELEMENT value must not refer to a
+ specific ARM
Executability: Fully Executable
Match Datasets:
- - Name: TA
- Keys:
+ - Keys:
- ARM
+ Name: TA
Outcome:
- Message: ELEMENT value refers to a specific ARM when ELEMENT is associated with
- more than 1 arm
+ Message: ELEMENT value refers to a specific ARM when ELEMENT is associated with more than 1 arm
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml
index c43660e64..3dd5dc4f9 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml
@@ -5,53 +5,53 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0323
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: TESTRL should be expressed without referring to Epoch.
- If the Element appears in more than one Epoch in the Trial Arms
- dataset, then the Element description (ELEMENT) must not refer to
- any Epochs.
+ - Citations:
+ - Cited Guidance:
+ TESTRL should be expressed without referring to Epoch. If the Element
+ appears in more than one Epoch in the Trial Arms dataset, then the Element description
+ (ELEMENT) must not refer to any Epochs.
Document: IG v3.4
Item: Assumption 9
Section: 7.2.2
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0323
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: TESTRL should be expressed without referring to Epoch.
- If the Element appears in more than one Epoch in the Trial Arms
- dataset; then the Element description (ELEMENT) must not refer to
- any Epochs.
- Document: IG v3.2
- Item: Assumption 9 for TE
- Section: '7.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ TESTRL should be expressed without referring to Epoch. If the Element
+ appears in more than one Epoch in the Trial Arms dataset; then the Element description
+ (ELEMENT) must not refer to any Epochs.
+ Document: IG v3.2
+ Item: Assumption 9 for TE
+ Section: "7.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0323
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: TESTRL should be expressed without referring to Epoch.
- If the Element appears in more than one Epoch in the Trial Arms
- dataset; then the Element description (ELEMENT) must not refer to
- any Epochs.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ TESTRL should be expressed without referring to Epoch. If the Element
+ appears in more than one Epoch in the Trial Arms dataset; then the Element description
+ (ELEMENT) must not refer to any Epochs.
Document: IG v3.3
Item: Assumption 9
Section: 7.2.2
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0323
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: $ta_element
@@ -63,9 +63,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0323
Status: Draft
- Version: '1'
-Description: When ELEMENT is associated with more than 1 EPOCH, ELEMENT should not
- refer to a specific EPOCH.
+ Version: "1"
+Description: When ELEMENT is associated with more than 1 EPOCH, ELEMENT should not refer to a
+ specific EPOCH.
Executability: Fully Executable
Operations:
- domain: TA
@@ -77,8 +77,7 @@ Operations:
name: EPOCH
operator: distinct
Outcome:
- Message: ELEMENT refers to a specific EPOCH when ELEMENT is associated with more
- than 1 EPOCH
+ Message: ELEMENT refers to a specific EPOCH when ELEMENT is associated with more than 1 EPOCH
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml
index 1f1e2444d..a4fdf3b21 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml
@@ -1,54 +1,54 @@
# Variable: TEENRL
-# Condition:
+# Condition:
# Rule: TEENRL value does not refer to any specific ARM
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0324
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The Trial Arms dataset, not the Trial Elements dataset,
- describes where the subject moves next, so TEENRL must be expressed
- without referring to Arm.
+ - Citations:
+ - Cited Guidance:
+ The Trial Arms dataset, not the Trial Elements dataset, describes where the
+ subject moves next, so TEENRL must be expressed without referring to Arm.
Document: IG v3.4
Item: Assumption 13
Section: 7.2.2
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0324
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The Trial Arms dataset; not the Trial Elements dataset;
- describes where the subject moves next; so TEENRL must be expressed
- without referring to Arm.
- Document: IG v3.2
- Item: Assumption 13 for TE
- Section: '7.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ The Trial Arms dataset; not the Trial Elements dataset; describes where the
+ subject moves next; so TEENRL must be expressed without referring to Arm.
+ Document: IG v3.2
+ Item: Assumption 13 for TE
+ Section: "7.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0324
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The Trial Arms dataset; not the Trial Elements dataset;
- describes where the subject moves next; so TEENRL must be expressed
- without referring to Arm.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ The Trial Arms dataset; not the Trial Elements dataset; describes where the
+ subject moves next; so TEENRL must be expressed without referring to Arm.
Document: IG v3.3
Item: Assumption 13
Section: 7.2.2
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0324
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TEENRL
@@ -57,9 +57,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0324
Status: Draft
- Version: '1'
-Description: TEENRL should not reference a specific ARM. This rule has only been
- partially executed to identify explicit references to ARM.
+ Version: "1"
+Description: TEENRL should not reference a specific ARM. This rule has only been partially executed
+ to identify explicit references to ARM.
Executability: Fully Executable
Operations:
- domain: TA
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml
index 6aba7c733..e280b7c1d 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml
@@ -7,54 +7,53 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple result values (--ORRES) are reported for a test in a
- Findings class dataset, multiple records should be submitted
- for that --TESTCD. When a finding can have multiple results,
- the key structure for the findings dataset must be adequate to
- distinguish between the multiple results. See Section 4.1.9
- Assigning Natural Keys in the Metadata.
+ - Cited Guidance:
+ If multiple result values (--ORRES) are reported for a test in a Findings
+ class dataset, multiple records should be submitted for that --TESTCD. When a finding can
+ have multiple results, the key structure for the findings dataset must be adequate to
+ distinguish between the multiple results. See Section 4.1.9 Assigning Natural Keys in the
+ Metadata.
Document: IG v3.4
Section: 4.2.8.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0347
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Multiple Values for a Findings Result Variable. If multiple
- result values (--ORRES) are reported for a test in a Findings
- class dataset; multiple records should be submitted for that
- --TESTCD. Example: - EGTESTCD=RHYRATE; EGTEST=Rhythm and Rate;
- EGORRES=ATRIAL FIBRILLATION. - EGTESTCD=RHYRATE; EGTEST=Rhythm
- and Rate; EGORRES=ATRIAL FLUTTER'
+ - Cited Guidance:
+ "Multiple Values for a Findings Result Variable. If multiple result values (--ORRES)
+ are reported for a test in a Findings class dataset; multiple records should be submitted for
+ that --TESTCD. Example: - EGTESTCD=RHYRATE; EGTEST=Rhythm and Rate; EGORRES=ATRIAL FIBRILLATION.
+ - EGTESTCD=RHYRATE; EGTEST=Rhythm and Rate; EGORRES=ATRIAL FLUTTER"
Document: IG v3.2
Section: 4.1.2.8.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0347
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If multiple result values (--ORRES) are reported for a test in a
- Findings class dataset; multiple records should be submitted
- for that --TESTCD. When a finding can have multiple results;
- the key structure for the findings dataset must be adequate to
- distinguish between the multiple results. See Section 4.1.9
- Assigning Natural Keys in the Metadata.
+ - Cited Guidance:
+ If multiple result values (--ORRES) are reported for a test in a Findings
+ class dataset; multiple records should be submitted for that --TESTCD. When a finding can
+ have multiple results; the key structure for the findings dataset must be adequate to
+ distinguish between the multiple results. See Section 4.1.9 Assigning Natural Keys in the
+ Metadata.
Document: IG v3.3
Section: 4.2.8.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0347
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: --ORRES
@@ -67,13 +66,13 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0347
Status: Draft
- Version: '1'
-Description: Trigger error when --ORRES is equal to MULTIPLE when it is not a
- valid response in the context of the finding (e.g., Questionnaire CT)
+ Version: "1"
+Description: Trigger error when --ORRES is equal to MULTIPLE when it is not a valid response in the
+ context of the finding (e.g., Questionnaire CT)
Executability: Fully Executable
Outcome:
- Message: --ORRES is equal to MULTIPLE when it is not a valid response in the
- context of the finding (e.g., Questionnaire CT)
+ Message: --ORRES is equal to MULTIPLE when it is not a valid response in the context of the
+ finding (e.g., Questionnaire CT)
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0375/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0375/rule.yml
index 837780414..4610deca8 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0375/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0375/rule.yml
@@ -1,75 +1,72 @@
# Variable: TDANCVAR
-# Condition:
+# Condition:
# Rule: TDANCVAR = date variable name in ADSL
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0375
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: 'A reference to the date variable name that provides
- the start point from which the planned disease assessment schedule
- is measured. This must be referenced from the ADaM ADSL dataset
- e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference
- date variable name.'
+ - Citations:
+ - Cited Guidance:
+ "A reference to the date variable name that provides the start point from which
+ the planned disease assessment schedule is measured. This must be referenced from the ADaM ADSL
+ dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference date variable name."
Document: IG v3.4
Item: Specification
Section: 7.3.2
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0375
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: 'IG v3.2[7.3][A reference to the date variable name
- that provides the start point from which the planned disease assessment
- schedule is measured. This must be referenced from the ADaM ADSL
- dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a
- reference date variable name.]|Model v1.4[3.5.1][A reference to
- the date variable name that provides the start point from which
- the planned disease assessment schedule is measured. This must be
- referenced from the ADaM ADSL dataset e.g. ANCH1DT. Note: TDANCVAR
- is to contain the name of a reference date variable name.]'
- Document: IG v3.2|Model v1.4
- Section: IG v3.2[7.3]|Model v1.4[3.5.1]
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ "IG v3.2[7.3][A reference to the date variable name that provides the start point
+ from which the planned disease assessment schedule is measured. This must be referenced from
+ the ADaM ADSL dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference date
+ variable name.]|Model v1.4[3.5.1][A reference to the date variable name that provides the start
+ point from which the planned disease assessment schedule is measured. This must be referenced
+ from the ADaM ADSL dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference
+ date variable name.]"
+ Document: IG v3.2|Model v1.4
+ Section: IG v3.2[7.3]|Model v1.4[3.5.1]
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0375
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: 'IG v3.3[7.3.2][A reference to the date variable name
- that provides the start point from which the planned disease assessment
- schedule is measured. This must be referenced from the ADaM ADSL
- dataset (e.g., ANCH1DT). Note: TDANCVAR is to contain the name of
- a reference date variable name.]|Model v1.7[3.4.1][A reference to
- the date variable name that provides the start point from which
- the planned disease assessment schedule is measured. This must be
- referenced from the ADaM ADSL dataset (e.g., ANCH1DT). Note: TDANCVAR
- is to contain the name of a reference date variable name.]'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ "IG v3.3[7.3.2][A reference to the date variable name that provides the start
+ point from which the planned disease assessment schedule is measured. This must be referenced
+ from the ADaM ADSL dataset (e.g., ANCH1DT). Note: TDANCVAR is to contain the name of a reference
+ date variable name.]|Model v1.7[3.4.1][A reference to the date variable name that provides the
+ start point from which the planned disease assessment schedule is measured. This must be referenced
+ from the ADaM ADSL dataset (e.g., ANCH1DT). Note: TDANCVAR is to contain the name of a reference
+ date variable name.]"
Document: IG v3.3|Model v1.7
Section: IG v3.3[7.3.2]|Model v1.7[3.4.1]
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0375
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TDANCVAR
operator: is_not_contained_by
- value: '[date variable name in ADSL]'
+ value: "[date variable name in ADSL]"
Core:
Id: CDISC.SDTMIG.CG0375
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when TDANCVAR is not a date variable name in ADSL
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0377/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0377/rule.yml
index 8af1bc7a3..17ce75ffc 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0377/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0377/rule.yml
@@ -1,5 +1,5 @@
# Variable: --LLT
-# Condition:
+# Condition:
# Rule: --LLT = MedDRA lowest level TERM
Authorities:
- Organization: CDISC
@@ -14,9 +14,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0377
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
@@ -26,9 +26,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0377
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -38,9 +38,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0377
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: $is_valid_llt_value
@@ -49,7 +49,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0377
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when --LLT is not a valid MedDRA lowest level TERM.
Executability: Fully Executable
Operations:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml
index f2d06a7fe..04fe86199 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml
@@ -14,39 +14,37 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0379
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Dictionary or sponsor-defined derived text description of the
- topic variable; --TERM; or the modified topic variable
- (--MODIFY); if applicable. Equivalent to the Preferred Term
- (PT in MedDRA).
+ - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic
+ variable; --TERM; or the modified topic variable (--MODIFY); if applicable. Equivalent to
+ the Preferred Term (PT in MedDRA).
Document: Model v1.7
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0379
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Dictionary or sponsor-defined derived text description of the
- topic variable; --TERM; or the modified topic variable
- (--MODIFY); if applicable. Equivalent to the Preferred Term
- (PT in MedDRA).
+ - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic
+ variable; --TERM; or the modified topic variable (--MODIFY); if applicable. Equivalent to
+ the Preferred Term (PT in MedDRA).
Document: Model v1.4
Section: 2.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0379
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: --DECOD
@@ -57,9 +55,8 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0378
Status: Draft
- Version: '1'
-Description: Raise an error when --DECOD is completed but is not a valid MedDRA
- preferred TERM.
+ Version: "1"
+Description: Raise an error when --DECOD is completed but is not a valid MedDRA preferred TERM.
Executability: Fully Executable
Operations:
- case_sensitive: true
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0380/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0380/rule.yml
index 8667d4c30..133bae716 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0380/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0380/rule.yml
@@ -1,47 +1,46 @@
# Variable: --PTCD
-# Condition:
+# Condition:
# Rule: --PTCD = MedDRA preferred TERM code
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0380
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The preferred term code assigned to the event from
- MedDRA.
+ - Citations:
+ - Cited Guidance: The preferred term code assigned to the event from MedDRA.
Document: Model v2.0
Item: --PTCD
Section: Events
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0380
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: MedDRA Preferred Term code.
Document: Model v1.4
Section: 2.2.2
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0380
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: MedDRA Preferred Term code.
Document: Model v1.7
Section: 2.2.2
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0380
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: --PTCD
@@ -51,7 +50,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0380
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when --PTCD is not a valid MedDRA preferred term code
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0381/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0381/rule.yml
index eb93d0709..42c734793 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0381/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0381/rule.yml
@@ -1,47 +1,48 @@
# Variable: --HLT
-# Condition:
+# Condition:
# Rule: --HLT = MedDRA high level TERM
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0381
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The high-level term from the primary hierarchy assigned
- to the event from MedDRA.
+ - Citations:
+ - Cited Guidance:
+ The high-level term from the primary hierarchy assigned to the event from
+ MedDRA.
Document: Model v2.0
Item: --HLT
Section: Events
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0381
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: MedDRA High Level Term from the primary path.
Document: Model v1.4
Section: 2.2.2
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0381
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: MedDRA High Level Term from the primary path.
Document: Model v1.7
Section: 2.2.2
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0381
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: --HLT
@@ -51,7 +52,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0381
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when --HLT is not a valid MedDRA high level TERM
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0382/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0382/rule.yml
index bbd1b414d..76a7e58b1 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0382/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0382/rule.yml
@@ -1,47 +1,48 @@
# Variable: --HLTCD
-# Condition:
+# Condition:
# Rule: --HLTCD = MedDRA high level TERM code
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0382
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The high-level term code from the primary hierarchy
- assigned to the event from MedDRA.
+ - Citations:
+ - Cited Guidance:
+ The high-level term code from the primary hierarchy assigned to the event
+ from MedDRA.
Document: Model v2.0
Item: --HLTCD
Section: Events
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0382
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: MedDRA High Level Term code from the primary path.
Document: Model v1.4
Section: 2.2.2
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0382
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: MedDRA High Level Term code from the primary path.
Document: Model v1.7
Section: 2.2.2
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0382
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: --HLTCD
@@ -51,7 +52,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0382
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when --HLTCD is not a valid MedDRA high level TERM code
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0383/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0383/rule.yml
index 7b6148dcf..2687b14ed 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0383/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0383/rule.yml
@@ -1,47 +1,48 @@
# Variable: --HLGT
-# Condition:
+# Condition:
# Rule: --HLGT = MedDRA high level group TERM
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0383
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The high-level group term from the primary hierarchy
- assigned to the event from MedDRA.
+ - Citations:
+ - Cited Guidance:
+ The high-level group term from the primary hierarchy assigned to the event
+ from MedDRA.
Document: Model v2.0
Item: --HLGT
Section: Events
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0383
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: MedDRA High Level Group Term from the primary path.
Document: Model v1.4
Section: 2.2.2
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0383
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: MedDRA High Level Group Term from the primary path.
Document: Model v1.7
Section: 2.2.2
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0383
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: --HLGT
@@ -51,7 +52,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0383
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when --HLGT is not a valid MedDRA high level group TERM
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0384/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0384/rule.yml
index a17f1c83e..87937e3bd 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0384/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0384/rule.yml
@@ -1,49 +1,48 @@
# Variable: --HLGTCD
-# Condition:
+# Condition:
# Rule: --HLGTCD = MedDRA high level group TERM code
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0384
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The high-level group term code from the primary hierarchy
- assigned to the event from MedDRA.
+ - Citations:
+ - Cited Guidance:
+ The high-level group term code from the primary hierarchy assigned to the
+ event from MedDRA.
Document: Model v2.0
Item: --HLGTCD
Section: Events
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0384
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: MedDRA High Level Group Term code from the primary
- path.
- Document: Model v1.4
- Section: 2.2.2
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance: MedDRA High Level Group Term code from the primary path.
+ Document: Model v1.4
+ Section: 2.2.2
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0384
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: MedDRA High Level Group Term code from the primary
- path.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance: MedDRA High Level Group Term code from the primary path.
Document: Model v1.7
Section: 2.2.2
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0384
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: --HLGTCD
@@ -53,9 +52,8 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0384
Status: Draft
- Version: '1'
-Description: Trigger error when --HLGTCD is not a valid MedDRA high level group TERM
- code
+ Version: "1"
+Description: Trigger error when --HLGTCD is not a valid MedDRA high level group TERM code
Executability: Fully Executable
Outcome:
Message: --HLGTCD is not a valid MedDRA high level group TERM code
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0385/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0385/rule.yml
index 3504c6ead..3f8b72220 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0385/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0385/rule.yml
@@ -1,53 +1,53 @@
# Variable: --BODSYS
-# Condition:
+# Condition:
# Rule: --BODSYS = MedDRA system organ class
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0385
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: A standardized or dictionary derived name for the
- body system or organ class. Body system or system organ class assigned
- for analysis from a standard hierarchy (e.g., MedDRA) associated
- with an event.
+ - Citations:
+ - Cited Guidance:
+ A standardized or dictionary derived name for the body system or organ
+ class. Body system or system organ class assigned for analysis from a standard hierarchy
+ (e.g., MedDRA) associated with an event.
Document: Model v2.0
Item: --BODSYS
Section: Events
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0385
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: 'Body system or system organ class assigned for analysis
- from a standard hierarchy (e.g. MedDRA) associated with an event.
- Example: GASTROINTESTINAL DISORDERS.'
- Document: Model v1.4
- Section: 2.2.2
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ "Body system or system organ class assigned for analysis from a standard hierarchy
+ (e.g. MedDRA) associated with an event. Example: GASTROINTESTINAL DISORDERS."
+ Document: Model v1.4
+ Section: 2.2.2
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0385
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: 'Body system or system organ class assigned for analysis
- from a standard hierarchy (e.g. MedDRA) associated with an event.
- Example: GASTROINTESTINAL DISORDERS.'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ "Body system or system organ class assigned for analysis from a standard hierarchy
+ (e.g. MedDRA) associated with an event. Example: GASTROINTESTINAL DISORDERS."
Document: Model v1.7
Section: 2.2.2
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0385
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: --BODSYS
@@ -57,7 +57,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0385
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when --BODSYS is not a valid MedDRA system organ class
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml
index 1e03135fe..03e60b80b 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml
@@ -1,5 +1,5 @@
# Variable: --BDSYCD
-# Condition:
+# Condition:
# Rule: --BDSYCD = MedDRA system organ class code
Authorities:
- Organization: CDISC
@@ -7,58 +7,59 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A standardized or dictionary derived short sequence of
- characters used to represent the body system or organ class.
- MedDRA System Organ Class code corresponding to --BODSYS
- assigned for analysis.
+ - Cited Guidance:
+ A standardized or dictionary derived short sequence of characters used to
+ represent the body system or organ class. MedDRA System Organ Class code corresponding to
+ --BODSYS assigned for analysis.
Document: Model v2.0
Item: --BDSYCD
Section: Events
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0386
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: MedDRA System Organ Class code corresponding to -BODSYS assigned
- for analysis.
+ - Cited Guidance: MedDRA System Organ Class code corresponding to -BODSYS assigned for
+ analysis.
Document: Model v1.4
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0386
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: MedDRA System Organ Class code corresponding to -BODSYS assigned
- for analysis.
+ - Cited Guidance: MedDRA System Organ Class code corresponding to -BODSYS assigned for
+ analysis.
Document: Model v1.7
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0386
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- metadata: $valid_codes
operator: equal_to
- value: true
- #- name: --BDSYCD
- # operator: is_contained_by
- # value:
- # - MedDRA system organ class code
+ value:
+ true
+ #- name: --BDSYCD
+ # operator: is_contained_by
+ # value:
+ # - MedDRA system organ class code
Core:
Id: CDISC.SDTMIG.CG0386
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when --BDSYCD is not a valid MedDRA system organ class code
Executability: Fully Executable
Operations:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml
index 9a0bec5bc..cfa133326 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml
@@ -1,67 +1,68 @@
# Variable: --LOINC
-# Condition:
+# Condition:
# Rule: --LOINC = valid code in the version of the LOINC dictionary specified in define.xml
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0400
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: A short sequence of characters used to represent laboratory
- and clinical tests within the Logical Observation Identifiers Names
- and Codes (LOINC) database.
+ - Citations:
+ - Cited Guidance:
+ A short sequence of characters used to represent laboratory and clinical
+ tests within the Logical Observation Identifiers Names and Codes (LOINC) database.
Document: Model v2.0
Item: --LOINC
Section: Findings
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0400
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Logical Observation Identifiers Names and Codes (LOINC)
- code for the topic variable such as a lab test.
- Document: Model v1.4
- Section: 2.2.3
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ Logical Observation Identifiers Names and Codes (LOINC) code for the topic
+ variable such as a lab test.
+ Document: Model v1.4
+ Section: 2.2.3
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0400
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Logical Observation Identifiers Names and Codes (LOINC)
- code for the topic variable such as a lab test.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Logical Observation Identifiers Names and Codes (LOINC) code for the topic
+ variable such as a lab test.
Document: Model v1.7
Section: 2.2.3
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0400
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: --LOINC
operator: is_not_contained_by
value:
- - LOINC codes contained in the version of the LOINC dictionary specified in
- define.xml
+ - LOINC codes contained in the version of the LOINC dictionary specified in define.xml
Core:
Id: CDISC.SDTMIG.CG0400
Status: Draft
- Version: '1'
-Description: Trigger error when --LOINC is not a valid code in the version of the
- LOINC dictionary specified in define.xml
+ Version: "1"
+Description: Trigger error when --LOINC is not a valid code in the version of the LOINC dictionary
+ specified in define.xml
Executability: Fully Executable
Outcome:
- Message: --LOINC is not a valid code in the version of the LOINC dictionary specified
- in define.xml
+ Message: --LOINC is not a valid code in the version of the LOINC dictionary specified in
+ define.xml
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0418/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0418/rule.yml
index bfffa97f9..19669ae2e 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0418/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0418/rule.yml
@@ -1,5 +1,5 @@
# Variable: TAETORD
-# Condition:
+# Condition:
# Rule: TAETORD order of elements match order in TA within ARM of the Subject
Authorities:
- Organization: CDISC
@@ -7,43 +7,46 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Number that gives the planned order of the Element within the
- Arm (see Trial Arms; Section 3.2.2 ).
+ - Cited Guidance:
+ Number that gives the planned order of the Element within the Arm (see Trial
+ Arms; Section 3.2.2 ).
Document: Model v1.4
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0418
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Number that gives the planned order of the Element within the
- Arm (see Section 3.1.2; Trial Arms).
+ - Cited Guidance:
+ Number that gives the planned order of the Element within the Arm (see
+ Section 3.1.2; Trial Arms).
Document: Model v1.7
Section: 2.2.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0418
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: An assigned numeric identifier that gives the planned order of
- the element within the trial arm of the study.
+ - Cited Guidance:
+ An assigned numeric identifier that gives the planned order of the element
+ within the trial arm of the study.
Document: Model v2.0
Item: TAETORD
Section: Timing
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0418
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all:
- name: TAETORD
@@ -56,12 +59,11 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0418
Status: Draft
- Version: '1'
-Description: 'Trigger error when the order of TAETORD does not match the order
- of Trial Arms'
+ Version: "1"
+Description: "Trigger error when the order of TAETORD does not match the order of Trial Arms"
Executability: Fully Executable
Outcome:
- Message: 'TAETORD does not match the order of Trial Arms'
+ Message: "TAETORD does not match the order of Trial Arms"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml
index b7f394c25..be9f01778 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml
@@ -7,55 +7,55 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'The unit of measure for the standardized result of the
- measurement, test, or examination. Variable(s) Qualified:
- --STRESC and --STRESN and --STNRLO and --STNRHI and --STREFC
- and --STREFN and --LLOQ and --ULOQ.'
+ - Cited Guidance:
+ "The unit of measure for the standardized result of the measurement, test, or
+ examination. Variable(s) Qualified: --STRESC and --STRESN and --STNRLO and --STNRHI and --STREFC
+ and --STREFN and --LLOQ and --ULOQ."
Document: Model v2.0
Item: --STRESU
Section: Findings
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0425
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '--STRESU: Standardized units used for --STRESC and --STRESN.'
+ - Cited Guidance: "--STRESU: Standardized units used for --STRESC and --STRESN."
Document: Model v1.4
Section: 2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0425
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: '--STRESU:Standardized units used for --STRESC, --STRESN,
- --STREFC, and --STREFN. Example: "mol/L".'
+ - Cited Guidance:
+ '--STRESU:Standardized units used for --STRESC, --STRESN, --STREFC, and --STREFN.
+ Example: "mol/L".'
Document: Model v1.7
Section: 2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0425
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
Core:
Id: CDISC.SDTMIG.CG0425
Status: Draft
- Version: '1'
-Description: Trigger error if --STRESU is null when --STRESC ^= null and units
- are applicable for the result
+ Version: "1"
+Description: Trigger error if --STRESU is null when --STRESC ^= null and units are applicable for
+ the result
Executability: Not Executable
Outcome:
- Message: --STRESU is null when --STRESC ^= null and units are applicable for the
- result
+ Message: --STRESU is null when --STRESC ^= null and units are applicable for the result
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml
index 3ec81f330..0ab552b56 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml
@@ -7,50 +7,50 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When the study does not include the data item for an expected
- variable, however, a null column must still be included in the
- dataset, and a comment must be included in the Define-XML
- document to state that the study does not include the data
+ - Cited Guidance:
+ When the study does not include the data item for an expected variable,
+ however, a null column must still be included in the dataset, and a comment must be
+ included in the Define-XML document to state that the study does not include the data
item.
Document: IG v3.4
Section: 4.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0431
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When no data has been collected for an expected variable;
- however; a null column must still be included in the dataset;
- and a comment must be included in the define.xml to state that
- data was not collected.
+ - Cited Guidance:
+ When no data has been collected for an expected variable; however; a null
+ column must still be included in the dataset; and a comment must be included in the
+ define.xml to state that data was not collected.
Document: IG v3.2
Section: 4.1.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0431
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When the study does not include the data item for an expected
- variable; however; a null column must still be included in the
- dataset; and a comment must be included in the Define-XML
- document to state that the study does not include the data
+ - Cited Guidance:
+ When the study does not include the data item for an expected variable;
+ however; a null column must still be included in the dataset; and a comment must be
+ included in the Define-XML document to state that the study does not include the data
item.
Document: IG v3.3
Section: 4.1.5
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0431
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: variable_name
@@ -65,16 +65,15 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0431
Status: Draft
- Version: '1'
-Description: Raise an error when the variable Core Status = Expected, data is
- collected, but the variable has no data.
+ Version: "1"
+Description: Raise an error when the variable Core Status = Expected, data is collected, but the
+ variable has no data.
Executability: Fully Executable
Operations:
- id: $expected_variables
operator: expected_variables
Outcome:
- Message: Variable is empty, where variable core status is expected and data is
- collected.
+ Message: Variable is empty, where variable core status is expected and data is collected.
Output Variables:
- variable_name
- variable_is_empty
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0436/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0436/rule.yml
index 415c19bd8..e5889daea 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0436/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0436/rule.yml
@@ -1,5 +1,5 @@
# Variable: --SOC
-# Condition:
+# Condition:
# Rule: --SOC = MedDRA primary system organ class
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0436
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -25,9 +25,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0436
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
@@ -38,9 +38,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0436
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all:
- name: --SOC
@@ -50,7 +50,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0436
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when --SOC is not a valid MedDRA primary system organ class
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0437/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0437/rule.yml
index af5c02228..61920f006 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0437/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0437/rule.yml
@@ -1,5 +1,5 @@
# Variable: --SOCCD
-# Condition:
+# Condition:
# Rule: --SOCCD = MedDRA primary system organ class
Authorities:
- Organization: CDISC
@@ -13,9 +13,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0437
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
@@ -25,23 +25,24 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0437
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The system organ class code from the primary hierarchy assigned
- in the MedDRA dictionary.
+ - Cited Guidance:
+ The system organ class code from the primary hierarchy assigned in the
+ MedDRA dictionary.
Document: Model v2.0
Item: --SOCCD
Section: Events
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0437
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all:
- name: --SOCCD
@@ -51,9 +52,8 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0437
Status: Draft
- Version: '1'
-Description: Trigger error when --SOCCD is not a valid MedDRA primary system
- organ class code
+ Version: "1"
+Description: Trigger error when --SOCCD is not a valid MedDRA primary system organ class code
Executability: Fully Executable
Outcome:
Message: --SOCCD is not a valid MedDRA primary system organ class code
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0442/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0442/rule.yml
index faa0c4eb1..281f6d46a 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0442/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0442/rule.yml
@@ -1,5 +1,5 @@
# Variable: --SOCCD
-# Condition:
+# Condition:
# Rule: --SOCCD = MedDRA primary system organ class
Authorities:
- Organization: CDISC
@@ -7,31 +7,31 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
- Table 1. TSVAL may have controlled terminology depending on
- the value of TSPARMCD
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.2
Section: 7.4|Appendix C1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0442
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Further information about the parameters is included below in
- Table 1. TSVAL may have controlled terminology depending on
- the value of TSPARMCD
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.3
Section: 7.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0442
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -40,12 +40,11 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0442
Status: Draft
- Version: '1'
+ Version: "1"
Description: TSVAL is a valid preferred term from FDA Substance Registration System (SRS)
Executability: Fully Executable
Outcome:
- Message: TSVAL is not a valid preferred term from FDA Substance Registration
- System (SRS)
+ Message: TSVAL is not a valid preferred term from FDA Substance Registration System (SRS)
Output Variables:
- --SOCCD
Rule Type: Record Data
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0443/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0443/rule.yml
index e8ab396ec..adb5b3b7f 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0443/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0443/rule.yml
@@ -5,45 +5,45 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.2'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0443
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
Section: 7.4|Appendix C1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0443
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0443
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0443
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0445/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0445/rule.yml
index e33c45eef..b5a64df35 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0445/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0445/rule.yml
@@ -5,45 +5,45 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.2'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0445
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
Section: 7.4|Appendix C1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0445
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0445
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0445
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0446/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0446/rule.yml
index 535299ccd..f27a348f1 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0446/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0446/rule.yml
@@ -5,45 +5,45 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.2'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0446
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
Section: 7.4|Appendix C1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0446
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0446
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0446
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0448/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0448/rule.yml
index cb28838a6..4cc44f67d 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0448/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0448/rule.yml
@@ -5,45 +5,45 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.2'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0448
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
Section: 7.4|Appendix C1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0448
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0448
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0448
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0449/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0449/rule.yml
index 10e5a2e22..a8c9fabf7 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0449/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0449/rule.yml
@@ -5,45 +5,45 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.2'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0449
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
Section: 7.4|Appendix C1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0449
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0449
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0449
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0450/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0450/rule.yml
index 48e9e2480..da142c27c 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0450/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0450/rule.yml
@@ -5,45 +5,45 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.2'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0450
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
Section: 7.4|Appendix C1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0450
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0450
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0450
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0451/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0451/rule.yml
index 1d7a09097..c243e4fef 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0451/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0451/rule.yml
@@ -5,45 +5,45 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.2'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0451
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
Section: 7.4|Appendix C1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0451
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0451
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0451
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0453/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0453/rule.yml
index e879411ba..4001f4743 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0453/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0453/rule.yml
@@ -5,45 +5,45 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.2'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0453
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
Section: 7.4|Appendix C1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0453
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0453
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0453
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0454/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0454/rule.yml
index 6670a6b17..b02994e36 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0454/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0454/rule.yml
@@ -5,45 +5,45 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.2'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0454
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.2
Item: Assumption 3
Section: 7.4|Appendix C1
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0454
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Further information about the parameters is included
- below in Table 1. TSVAL may have controlled terminology depending
- on the value of TSPARMCD
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Further information about the parameters is included below in Table 1. TSVAL
+ may have controlled terminology depending on the value of TSPARMCD
Document: IG v3.3
Item: Assumption 3
- Section: '7.4'
+ Section: "7.4"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0454
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0454
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0460/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0460/rule.yml
index e7ab50f5f..2e382a4c2 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0460/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0460/rule.yml
@@ -1,47 +1,48 @@
# Variable: --HLT
-# Condition:
+# Condition:
# Rule: --HLT on path to MedDRA primary system organ class
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0460
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The high-level term from the primary hierarchy assigned
- to the event from MedDRA.
+ - Citations:
+ - Cited Guidance:
+ The high-level term from the primary hierarchy assigned to the event from
+ MedDRA.
Document: Model v2.0
Item: --HLT
Section: Events
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0460
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: MedDRA High Level Term from the primary path.
Document: Model v1.4
Section: 2.2.2
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0460
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: MedDRA High Level Term from the primary path.
Document: Model v1.7
Section: 2.2.2
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0460
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -51,9 +52,8 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0460
Status: Draft
- Version: '1'
-Description: Trigger error when --HLT is not on the path to MedDRA primary system
- organ class
+ Version: "1"
+Description: Trigger error when --HLT is not on the path to MedDRA primary system organ class
Executability: Fully Executable
Outcome:
Message: --HLT is not on the path to MedDRA primary system organ class
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0461/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0461/rule.yml
index 0dfaf07bf..b4946c40e 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0461/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0461/rule.yml
@@ -1,47 +1,48 @@
# Variable: --HLGT
-# Condition:
+# Condition:
# Rule: --HLGT on path to MedDRA primary system organ class
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0461
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The high-level term code from the primary hierarchy
- assigned to the event from MedDRA.
+ - Citations:
+ - Cited Guidance:
+ The high-level term code from the primary hierarchy assigned to the event
+ from MedDRA.
Document: Model v2.0
Item: --HLTCD
Section: Events
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0461
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: MedDRA High Level Term code from the primary path.
Document: Model v1.4
Section: 2.2.2
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0461
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: MedDRA High Level Term code from the primary path.
Document: Model v1.7
Section: 2.2.2
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0461
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -51,9 +52,8 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0461
Status: Draft
- Version: '1'
-Description: Trigger error when --HLGT is not on the path to MedDRA primary system
- organ class
+ Version: "1"
+Description: Trigger error when --HLGT is not on the path to MedDRA primary system organ class
Executability: Fully Executable
Outcome:
Message: --HLGT is not on the path to MedDRA primary system organ class
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0463/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0463/rule.yml
index b9578d42a..47a5825f1 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0463/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0463/rule.yml
@@ -7,44 +7,47 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Include the Topic variable from the identified general
- observation class (e.g., --TESTCD for Findings) in the SDTM
+ - Cited Guidance:
+ Include the Topic variable from the identified general observation class
+ (e.g., --TESTCD for Findings) in the SDTM
Document: IG v3.4
Item: Assumption 3b
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0463
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Include the Topic variable from the identified general
- observation class (e.g., --TESTCD for Findings)
+ - Cited Guidance:
+ Include the Topic variable from the identified general observation class
+ (e.g., --TESTCD for Findings)
Document: IG v3.2
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0463
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Include the Topic variable from the identified general
- observation class (e.g., --TESTCD for Findings)
+ - Cited Guidance:
+ Include the Topic variable from the identified general observation class
+ (e.g., --TESTCD for Findings)
Document: IG v3.3
Item: 3.b
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0463
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: define_dataset_is_non_standard
@@ -58,7 +61,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0463
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when --TRT is not present in custom interventions dataset
Executability: Fully Executable
Operations:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0464/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0464/rule.yml
index c73750630..95909e355 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0464/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0464/rule.yml
@@ -7,45 +7,48 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Include the Topic variable from the identified general
- observation class (e.g., --TESTCD for Findings) in the SDTM
+ - Cited Guidance:
+ Include the Topic variable from the identified general observation class
+ (e.g., --TESTCD for Findings) in the SDTM
Document: IG v3.4
Item: Assumption 3b
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0464
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Include the Topic variable from the identified general
- observation class (e.g., --TESTCD for Findings)
+ - Cited Guidance:
+ Include the Topic variable from the identified general observation class
+ (e.g., --TESTCD for Findings)
Document: IG v3.2
Item: 3.b
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0464
- Version: '2'
- Version: '2.0'
- Version: '3.2'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Include the topic variable from the identified general
- observation class (e.g., --TESTCD for Findings) in the SDTM.
+ - Cited Guidance:
+ Include the topic variable from the identified general observation class
+ (e.g., --TESTCD for Findings) in the SDTM.
Document: IG v3.3
Item: 3.b
- Section: '2.6'
+ Section: "2.6"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0464
- Version: '2'
- Version: '2.0'
- Version: '3.3'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: define_dataset_is_non_standard
@@ -60,7 +63,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0464
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when --TERM is not present in custom events dataset
Executability: Fully Executable
Operations:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0466/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0466/rule.yml
index 553d3908b..3e681e27d 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0466/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0466/rule.yml
@@ -5,44 +5,46 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0466
- Version: '1'
- Version: '2.0'
- Citations:
+ - Citations:
- Cited Guidance: Units will be those used for --STRESU.
Document: Model v2.0
Item: --LLOQ
Section: Findings
- - Name: SDTMIG
- Version: '3.2'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0466
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Indicates the lower limit of quantitation for an assay.
- Units will be those used for --STRESU.
- Document: Model v1.4
- Section: 2.2.3
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ - Citations:
+ - Cited Guidance:
+ Indicates the lower limit of quantitation for an assay. Units will be those
+ used for --STRESU.
+ Document: Model v1.4
+ Section: 2.2.3
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0466
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Indicates the lower limit of quantitation for an assay.
- Units will be those used for --STRESU.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Indicates the lower limit of quantitation for an assay. Units will be those
+ used for --STRESU.
Document: Model v1.7
Section: 2.2.3
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0466
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: --LLOQ
@@ -52,7 +54,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0466
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when --LLOQ is not expressed using the units in --STRESU
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0523/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0523/rule.yml
index 10d4424ae..49948afde 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0523/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0523/rule.yml
@@ -5,34 +5,35 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0523
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects
- who were not assigned to treatment. The same reason will provide
- the reason that both are null.
+ - Citations:
+ - Cited Guidance:
+ Both ARMCD and ACTARMCD will be null for subjects who were not assigned to
+ treatment. The same reason will provide the reason that both are null.
Document: IG v3.4
Item: Assumption 4
- Section: '5.2'
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Section: "5.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0523
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects
- who were not assigned to treatment
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Both ARMCD and ACTARMCD will be null for subjects who were not assigned to
+ treatment
Document: IG v3.3
Item: Assumption 4
- Section: '5.2'
+ Section: "5.2"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0523
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -42,9 +43,8 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0523
Status: Draft
- Version: '1'
-Description: Trigger error when ARMCD is populated for a subject who was not assigned
- to treatment
+ Version: "1"
+Description: Trigger error when ARMCD is populated for a subject who was not assigned to treatment
Executability: Fully Executable
Outcome:
Message: ARMCD is populated for a subject who was not assigned to treatment
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml
index c5d9230b7..d15ad7341 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml
@@ -5,34 +5,35 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0524
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects
- who were not assigned to treatment. The same reason will provide
- the reason that both are null.
+ - Citations:
+ - Cited Guidance:
+ Both ARMCD and ACTARMCD will be null for subjects who were not assigned to
+ treatment. The same reason will provide the reason that both are null.
Document: IG v3.4
Item: Assumption 4
- Section: '5.2'
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Section: "5.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0524
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects
- who were not assigned to treatment
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Both ARMCD and ACTARMCD will be null for subjects who were not assigned to
+ treatment
Document: IG v3.3
Item: Assumption 4
- Section: '5.2'
+ Section: "5.2"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0524
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -42,9 +43,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0524
Status: Draft
- Version: '1'
-Description: Trigger error when ACTARMCD is populated for a subject who was not assigned
- to treatment
+ Version: "1"
+Description: Trigger error when ACTARMCD is populated for a subject who was not assigned to
+ treatment
Executability: Fully Executable
Outcome:
Message: ACTARMCD is populated for a subject who was not assigned to treatment
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml
index 1eef4e907..26379d8d0 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml
@@ -5,37 +5,37 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0525
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If the race was collected via an "Other, Specify"
- field and the sponsor chooses not to map the value as described
- in the current FDA guidance (see CDISC Notes for RACE in the domain
- specification), then the value of RACE should be “OTHER”.
+ - Citations:
+ - Cited Guidance:
+ If the race was collected via an "Other, Specify" field and the sponsor
+ chooses not to map the value as described in the current FDA guidance (see CDISC Notes for
+ RACE in the domain specification), then the value of RACE should be “OTHER”.
Document: IG v3.4
Item: Assumption 6
- Section: '5.2'
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Section: "5.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0525
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If the race was collected via an "Other; Specify"
- field and the sponsor chooses not to map the value as described
- in the current FDA guidance (see CDISC Notes for RACE in the domain
- specification) then the value of RACE should be 'OTHER'.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If the race was collected via an "Other; Specify" field and the sponsor
+ chooses not to map the value as described in the current FDA guidance (see CDISC Notes for
+ RACE in the domain specification) then the value of RACE should be 'OTHER'.
Document: IG v3.3
Item: Assumption 6
- Section: '5.2'
+ Section: "5.2"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0525
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -46,9 +46,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0525
Status: Draft
- Version: '1'
-Description: Trigger error when Sponsor collects Other, specify and chooses to map
- the value to SUPPDM, and NOT - RACE = 'OTHER' or RACE = 'MULTIPLE'
+ Version: "1"
+Description: Trigger error when Sponsor collects Other, specify and chooses to map the value to
+ SUPPDM, and NOT - RACE = 'OTHER' or RACE = 'MULTIPLE'
Executability: Fully Executable
Outcome:
Message: ???
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0526/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0526/rule.yml
index e983ce48b..74d920647 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0526/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0526/rule.yml
@@ -5,33 +5,35 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0526
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: 'If a subject refuses to provide or does not know
- their race information, the value of RACE could be “UNKNOWN”. '
+ - Citations:
+ - Cited Guidance:
+ "If a subject refuses to provide or does not know their race information, the
+ value of RACE could be “UNKNOWN”. "
Document: IG v3.4
Item: Assumption 6
- Section: '5.2'
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Section: "5.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0526
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If a subject refuses to provide race information;
- the value of RACE could be 'UNKNOWN'.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If a subject refuses to provide race information; the value of RACE could be
+ 'UNKNOWN'.
Document: IG v3.3
Item: Assumption 6
- Section: '5.2'
+ Section: "5.2"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0526
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -42,9 +44,8 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0526
Status: Draft
- Version: '1'
-Description: Trigger error when subject does not specify race and RACE is not equal
- to "UNKNOWN"
+ Version: "1"
+Description: Trigger error when subject does not specify race and RACE is not equal to "UNKNOWN"
Executability: Fully Executable
Outcome:
Message: RACE is not equal to "UNKNOWN" when subject did not specify race
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml
index a8713984d..477cadd69 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml
@@ -5,35 +5,35 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0527
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If multiple races are collected, then the value of
- RACE should be “MULTIPLE” and the additional information will be
- included in the Supplemental Qualifiers dataset.
+ - Citations:
+ - Cited Guidance:
+ If multiple races are collected, then the value of RACE should be “MULTIPLE”
+ and the additional information will be included in the Supplemental Qualifiers dataset.
Document: IG v3.4
Item: Assumption 6
- Section: '5.2'
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Section: "5.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0527
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: If multiple races were collected and one was designated
- as primary; RACE in DM should be the primary race and additional
- races should be reported in SUPPDM
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ If multiple races were collected and one was designated as primary; RACE in
+ DM should be the primary race and additional races should be reported in SUPPDM
Document: IG v3.3
Item: Assumption 6
- Section: '5.2'
+ Section: "5.2"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0527
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -44,13 +44,13 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0527
Status: Draft
- Version: '1'
-Description: Trigger error when RACE does not equal "MULTIPLE" when multiple races
- collected and primary race not specified
+ Version: "1"
+Description: Trigger error when RACE does not equal "MULTIPLE" when multiple races collected and
+ primary race not specified
Executability: Fully Executable
Outcome:
- Message: RACE does not equal "MULTIPLE" when multiple races collected and primary
- race not specified
+ Message: RACE does not equal "MULTIPLE" when multiple races collected and primary race not
+ specified
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml
index 3b39f665b..c5c029564 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml
@@ -5,80 +5,70 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0532
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Specification[Reference Start Date/time for the subject
- in ISO 8601 character format. Usually equivalent to date/time when
- subject was first exposed to study treatment. See Assumption 9 for
- additional detail on when RFSTDTC may be null.]|Assumption 9[As
- described in Section 4.1.4, Order of the Variables, RFSTDTC is used
- to calculate study day variables. RFSTDTC is usually defined as
- the date/time when a subject was first exposed to study drug. This
- definition applies for most interventional studies, when the start
- of treatment is the natural and preferred starting point for study
- day variables and thus the logical value for RFSTDTC. In such studies,
- when data are submitted for subjects who are ineligible for treatment
- (e.g., screen failures with ARMNRS = "SCREEN FAILURE"), subjects
- who were enrolled but not assigned to an arm (e.g., ARMNRS = "NOT
- ASSIGNED"), or subjects who were randomized but not treated (e.g.,
- ARMNRS = "NOT TREATED"), RFSTDTC will be null. For studies with
- designs that include a substantial portion of subjects who are not
- expected to be treated, a different protocol milestone may be chosen
- as the starting point for study day variables. Some examples include
- non-interventional or observational studies, studies with a no-treatment
- arm, or studies where there is a delay between randomization and
- treatment.]
+ - Citations:
+ - Cited Guidance: Specification[Reference Start Date/time for the subject in ISO 8601
+ character format. Usually equivalent to date/time when subject was first exposed to study
+ treatment. See Assumption 9 for additional detail on when RFSTDTC may be null.]|Assumption
+ 9[As described in Section 4.1.4, Order of the Variables, RFSTDTC is used to calculate
+ study day variables. RFSTDTC is usually defined as the date/time when a subject was first
+ exposed to study drug. This definition applies for most interventional studies, when the
+ start of treatment is the natural and preferred starting point for study day variables and
+ thus the logical value for RFSTDTC. In such studies, when data are submitted for subjects
+ who are ineligible for treatment (e.g., screen failures with ARMNRS = "SCREEN FAILURE"),
+ subjects who were enrolled but not assigned to an arm (e.g., ARMNRS = "NOT ASSIGNED"), or
+ subjects who were randomized but not treated (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will
+ be null. For studies with designs that include a substantial portion of subjects who are
+ not expected to be treated, a different protocol milestone may be chosen as the starting
+ point for study day variables. Some examples include non-interventional or observational
+ studies, studies with a no-treatment arm, or studies where there is a delay between
+ randomization and treatment.]
Document: IG v3.3
Item: Specification|Assumption 9
- Section: '5.2'
- - Name: SDTMIG
- Version: '3.4'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Section: "5.2"
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0532
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Specification[Reference Start Date/time for the subject
- in ISO 8601 character format. Usually equivalent to date/time when
- subject was first exposed to study treatment. See Assumption 9 for
- additional detail on when RFSTDTC may be null.| Assumption 9 [RFSTDTC
- is used to calculate study day variables. RFSTDTC is usually defined
- as the date/time when a subject was first exposed to study drug.
- This definition applies for most interventional studies, when the
- start of treatment is the natural and preferred starting point for
- study day variables and thus the logical value for RFSTDTC. In such
- studies, when data are submitted for subjects who are ineligible
- for treatment (e.g., screen failures with ARMNRS = "SCREEN FAILURE"),
- subjects who were enrolled but not assigned to an arm (e.g., ARMNRS
- = "NOT ASSIGNED"), or subjects who were randomized but not treated
- (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will be null. For studies
- with designs that include a substantial portion of subjects who
- are not expected to be treated, a different protocol milestone may
- be chosen as the starting point for study day variables. Some examples
- include non-interventional or observational studies, studies with
- a no-treatment Arm, or studies where there is a delay between randomization
- and treatment.]
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance: Specification[Reference Start Date/time for the subject in ISO 8601
+ character format. Usually equivalent to date/time when subject was first exposed to study
+ treatment. See Assumption 9 for additional detail on when RFSTDTC may be null.| Assumption
+ 9 [RFSTDTC is used to calculate study day variables. RFSTDTC is usually defined as the
+ date/time when a subject was first exposed to study drug. This definition applies for most
+ interventional studies, when the start of treatment is the natural and preferred starting
+ point for study day variables and thus the logical value for RFSTDTC. In such studies,
+ when data are submitted for subjects who are ineligible for treatment (e.g., screen
+ failures with ARMNRS = "SCREEN FAILURE"), subjects who were enrolled but not assigned to
+ an arm (e.g., ARMNRS = "NOT ASSIGNED"), or subjects who were randomized but not treated
+ (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will be null. For studies with designs that
+ include a substantial portion of subjects who are not expected to be treated, a different
+ protocol milestone may be chosen as the starting point for study day variables. Some
+ examples include non-interventional or observational studies, studies with a no-treatment
+ Arm, or studies where there is a delay between randomization and treatment.]
Document: IG v3.4
Item: Specification|Assumption 9
- Section: '5.2'
+ Section: "5.2"
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0532
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0532
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml
index fa47e7b23..962c0f630 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml
@@ -10,37 +10,37 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For types of Disease Milestones that can occur multiple times,
- MIDS will usually be an abbreviated version of MIDSTYPE and
- will always end with a sequence number. Sequence numbers
- should start with one and indicate the chronological order of
- the instances of this type of Disease Milestone.
+ - Cited Guidance:
+ For types of Disease Milestones that can occur multiple times, MIDS will
+ usually be an abbreviated version of MIDSTYPE and will always end with a sequence number.
+ Sequence numbers should start with one and indicate the chronological order of the
+ instances of this type of Disease Milestone.
Document: IG v3.4
Item: Assumption 2.b
- Section: '5.4'
+ Section: "5.4"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0546
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: For types of Disease Milestones that can occur multiple times,
- MIDS will usually be an abbreviated version of MIDSTYPE and
- will always end with a sequence number. Sequence numbers
- should start with one and indicate the chronological order of
- the instances of this type of Disease Milestone.
+ - Cited Guidance:
+ For types of Disease Milestones that can occur multiple times, MIDS will
+ usually be an abbreviated version of MIDSTYPE and will always end with a sequence number.
+ Sequence numbers should start with one and indicate the chronological order of the
+ instances of this type of Disease Milestone.
Document: IG v3.3
Item: Assumption 2.b
- Section: '5.5'
+ Section: "5.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0546
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: TMRPT
@@ -65,9 +65,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0546
Status: Draft
- Version: '1'
-Description: Trigger error when MIDSTYPE=TM.MIDSTYPE and TM.TMRPT=Y and MIDS is
- not suffixed with a sequence number in consistent chronological order
+ Version: "1"
+Description: Trigger error when MIDSTYPE=TM.MIDSTYPE and TM.TMRPT=Y and MIDS is not suffixed with a
+ sequence number in consistent chronological order
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -80,8 +80,8 @@ Operations:
id: $records_per_usubjid_per_midstype
operator: record_count
Outcome:
- Message: MIDS is not suffixed with a sequence number in consistent chronological
- order with SMSTDTC.
+ Message: MIDS is not suffixed with a sequence number in consistent chronological order with
+ SMSTDTC.
Output Variables:
- MIDSTYPE
- $records_per_usubjid_per_midstype
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0548/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0548/rule.yml
index 9a904660f..28b56d4ee 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0548/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0548/rule.yml
@@ -1,35 +1,35 @@
# Variable: --ORREF
-# Condition:
+# Condition:
# Rule: --ORREF in same units as --ORRES
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0548
- Version: '1'
- Version: '2.0'
- Citations:
+ - Citations:
- Cited Guidance: --ORREF uses the same units as --ORRES, if applicable.
Document: Model v2.0
Item: --ORREF
Section: Findings
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0548
- Version: '1'
- Version: '2.0'
- Citations:
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
- Cited Guidance: --ORREF uses the same units as --ORRES, if applicable.
Document: Model v1.7
Item: --ORREF
Section: Table 2.2.3
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0548
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: --ORREF
@@ -37,7 +37,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0548
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when --ORREF is not in the same units as --ORRES
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0551/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0551/rule.yml
index 28c972c8a..d1d6075e0 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0551/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0551/rule.yml
@@ -1,39 +1,39 @@
# Variable: --STREFN
-# Condition:
+# Condition:
# Rule: --STREFN in same units as --STRESN
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0551
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Reference value for continuous or numeric results
- or findings in standard format or in standard units. --STREFN uses
- the same units as --STRESN, if applicable.
+ - Citations:
+ - Cited Guidance:
+ Reference value for continuous or numeric results or findings in standard
+ format or in standard units. --STREFN uses the same units as --STRESN, if applicable.
Document: Model v2.0
Item: --STREFN
Section: Findings
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0551
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Reference value for continuous or numeric results
- or findings in standard format or in standard units. --STREFN uses
- the same units as --STRESN, if applicable.
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ Reference value for continuous or numeric results or findings in standard
+ format or in standard units. --STREFN uses the same units as --STRESN, if applicable.
Document: Model v1.7
Item: --STREFN
Section: Table 2.2.3
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0551
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: --STREFN
@@ -41,7 +41,7 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0551
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when --STREFN is not in the same units as --STRESN
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml
index e11a7f736..1dfdedd39 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml
@@ -3,24 +3,22 @@
# Rule: Terminology is for non-normalized parameter (Codelist "PKUNIT")
# Notes by author, Marcelina Hungria:
# - The rule as written by the Conformance Rules team is fully executable
-# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted.
-# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future
+# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted.
+# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where
- the choice depends on whether the value of the pharmacokinetic
- parameter is normalized. Codelist PKUNIT is used for
- non-normalized parameters. Codelists PKUDMG and PKUDUG are
- used when parameters are normalized by dose amount in
- milligrams or micrograms respectively. Codelists PKUWG and
- PKUWKG are used when parameters are normalized by weight in
- grams or kilograms respectively. Multiple subset codelists
- were created for the unique unit expressions of the same
- concept across codelists, this approach allows study-context
+ - Cited Guidance:
+ There are separate codelists used for PPORRESU/PPSTRESU where the choice
+ depends on whether the value of the pharmacokinetic parameter is normalized. Codelist
+ PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when
+ parameters are normalized by dose amount in milligrams or micrograms respectively.
+ Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or
+ kilograms respectively. Multiple subset codelists were created for the unique unit
+ expressions of the same concept across codelists, this approach allows study-context
appropriate use of unit values for PK analysis subtypes
Document: IG v3.4
Item: Assumption 3
@@ -28,22 +26,20 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0555
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where
- the choice depends on whether the value of the pharmacokinetic
- parameter is normalized. Codelist PKUNIT is used for
- non-normalized parameters. Codelists PKUDMG and PKUDUG are
- used when parameters are normalized by dose amount in
- milligrams or micrograms respectively. Codelists PKUWG and
- PKUWKG are used when parameters are normalized by weight in
- grams or kilograms respectively. Multiple subset codelists
- were created for the unique unit expressions of the same
- concept across codelists, this approach allows study-context
+ - Cited Guidance:
+ There are separate codelists used for PPORRESU/PPSTRESU where the choice
+ depends on whether the value of the pharmacokinetic parameter is normalized. Codelist
+ PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when
+ parameters are normalized by dose amount in milligrams or micrograms respectively.
+ Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or
+ kilograms respectively. Multiple subset codelists were created for the unique unit
+ expressions of the same concept across codelists, this approach allows study-context
appropriate use of unit values for PK analysis subtypes.
Document: IG v3.3
Item: Assumption 3
@@ -51,9 +47,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0555
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: PPTEST
@@ -65,9 +61,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0555
Status: Draft
- Version: '1'
-Description: Trigger error when parameter is non-normalized and value in
- PPORRESU is not for a non-normalized parameter.
+ Version: "1"
+Description: Trigger error when parameter is non-normalized and value in PPORRESU is not for a
+ non-normalized parameter.
Executability: Fully Executable
Operations:
- codelists:
@@ -77,8 +73,7 @@ Operations:
operator: codelist_terms
returntype: value
Outcome:
- Message: Parameter is non-normalized, and the value in PPORRESU is not in
- codelist PKUNIT.
+ Message: Parameter is non-normalized, and the value in PPORRESU is not in codelist PKUNIT.
Output Variables:
- PPTESTCD
- PPTEST
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml
index b72beef95..8637853e1 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml
@@ -3,24 +3,22 @@
# Rule: Terminology is for parameter normalized by dose amount.
# Notes by author, Marcelina Hungria:
# - The rule as written by the Conformance Rules team is fully executable
-# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted.
-# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future
+# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted.
+# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where
- the choice depends on whether the value of the pharmacokinetic
- parameter is normalized. Codelist PKUNIT is used for
- non-normalized parameters. Codelists PKUDMG and PKUDUG are
- used when parameters are normalized by dose amount in
- milligrams or micrograms respectively. Codelists PKUWG and
- PKUWKG are used when parameters are normalized by weight in
- grams or kilograms respectively. Multiple subset codelists
- were created for the unique unit expressions of the same
- concept across codelists, this approach allows study-context
+ - Cited Guidance:
+ There are separate codelists used for PPORRESU/PPSTRESU where the choice
+ depends on whether the value of the pharmacokinetic parameter is normalized. Codelist
+ PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when
+ parameters are normalized by dose amount in milligrams or micrograms respectively.
+ Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or
+ kilograms respectively. Multiple subset codelists were created for the unique unit
+ expressions of the same concept across codelists, this approach allows study-context
appropriate use of unit values for PK analysis subtypes
Document: IG v3.4
Item: Assumption 3
@@ -28,22 +26,20 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0556
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where
- the choice depends on whether the value of the pharmacokinetic
- parameter is normalized. Codelist PKUNIT is used for
- non-normalized parameters. Codelists PKUDMG and PKUDUG are
- used when parameters are normalized by dose amount in
- milligrams or micrograms respectively. Codelists PKUWG and
- PKUWKG are used when parameters are normalized by weight in
- grams or kilograms respectively. Multiple subset codelists
- were created for the unique unit expressions of the same
- concept across codelists, this approach allows study-context
+ - Cited Guidance:
+ There are separate codelists used for PPORRESU/PPSTRESU where the choice
+ depends on whether the value of the pharmacokinetic parameter is normalized. Codelist
+ PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when
+ parameters are normalized by dose amount in milligrams or micrograms respectively.
+ Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or
+ kilograms respectively. Multiple subset codelists were created for the unique unit
+ expressions of the same concept across codelists, this approach allows study-context
appropriate use of unit values for PK analysis subtypes.
Document: IG v3.3
Item: Assumption 3
@@ -51,9 +47,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0556
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: PPTEST
@@ -68,9 +64,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0556
Status: Draft
- Version: '1'
-Description: Trigger error when parameter is normalized by dose and value in
- PPORRESU is not for a parameter normalized by dose.
+ Version: "1"
+Description: Trigger error when parameter is normalized by dose and value in PPORRESU is not for a
+ parameter normalized by dose.
Executability: Fully Executable
Operations:
- codelists:
@@ -86,8 +82,8 @@ Operations:
operator: codelist_terms
returntype: value
Outcome:
- Message: Parameter is normalized by dose, and the value in PPORRESU is not in
- codelist PKUDMG nor in codelist PKUDUG.
+ Message: Parameter is normalized by dose, and the value in PPORRESU is not in codelist PKUDMG nor
+ in codelist PKUDUG.
Output Variables:
- PPTESTCD
- PPTEST
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml
index 67528e778..c46cd8f72 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml
@@ -3,24 +3,22 @@
# Rule: Terminology is for parameter normalized by weight
# Notes by author, Marcelina Hungria:
# - The rule as written by the Conformance Rules team is fully executable
-# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted.
-# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future
+# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted.
+# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where
- the choice depends on whether the value of the pharmacokinetic
- parameter is normalized. Codelist PKUNIT is used for
- non-normalized parameters. Codelists PKUDMG and PKUDUG are
- used when parameters are normalized by dose amount in
- milligrams or micrograms respectively. Codelists PKUWG and
- PKUWKG are used when parameters are normalized by weight in
- grams or kilograms respectively. Multiple subset codelists
- were created for the unique unit expressions of the same
- concept across codelists, this approach allows study-context
+ - Cited Guidance:
+ There are separate codelists used for PPORRESU/PPSTRESU where the choice
+ depends on whether the value of the pharmacokinetic parameter is normalized. Codelist
+ PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when
+ parameters are normalized by dose amount in milligrams or micrograms respectively.
+ Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or
+ kilograms respectively. Multiple subset codelists were created for the unique unit
+ expressions of the same concept across codelists, this approach allows study-context
appropriate use of unit values for PK analysis subtypes
Document: IG v3.4
Item: Assumption 3
@@ -28,22 +26,20 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0557
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where
- the choice depends on whether the value of the pharmacokinetic
- parameter is normalized. Codelist PKUNIT is used for
- non-normalized parameters. Codelists PKUDMG and PKUDUG are
- used when parameters are normalized by dose amount in
- milligrams or micrograms respectively. Codelists PKUWG and
- PKUWKG are used when parameters are normalized by weight in
- grams or kilograms respectively. Multiple subset codelists
- were created for the unique unit expressions of the same
- concept across codelists, this approach allows study-context
+ - Cited Guidance:
+ There are separate codelists used for PPORRESU/PPSTRESU where the choice
+ depends on whether the value of the pharmacokinetic parameter is normalized. Codelist
+ PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when
+ parameters are normalized by dose amount in milligrams or micrograms respectively.
+ Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or
+ kilograms respectively. Multiple subset codelists were created for the unique unit
+ expressions of the same concept across codelists, this approach allows study-context
appropriate use of unit values for PK analysis subtypes.
Document: IG v3.3
Item: Assumption 3
@@ -51,9 +47,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0557
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: PPTEST
@@ -68,9 +64,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0557
Status: Draft
- Version: '1'
-Description: Trigger error when parameter is normalized by weight and value in
- PPORRESU is not for a parameter normalized by weight.
+ Version: "1"
+Description: Trigger error when parameter is normalized by weight and value in PPORRESU is not for a
+ parameter normalized by weight.
Executability: Fully Executable
Operations:
- codelists:
@@ -86,8 +82,8 @@ Operations:
operator: codelist_terms
returntype: value
Outcome:
- Message: Parameter is normalized by weight, and the value in PPORRESU is not in
- codelist PKUWG nor in codelist PKUWKG.
+ Message: Parameter is normalized by weight, and the value in PPORRESU is not in codelist PKUWG nor
+ in codelist PKUWKG.
Output Variables:
- PPTESTCD
- PPTEST
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml
index b2b0bd0a6..2bf5f978f 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml
@@ -3,24 +3,22 @@
# Rule: Terminology is for non-normalized parameter
# Notes by author, Marcelina Hungria:
# - The rule as written by the Conformance Rules team is fully executable
-# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted.
-# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future
+# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted.
+# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where
- the choice depends on whether the value of the pharmacokinetic
- parameter is normalized. Codelist PKUNIT is used for
- non-normalized parameters. Codelists PKUDMG and PKUDUG are
- used when parameters are normalized by dose amount in
- milligrams or micrograms respectively. Codelists PKUWG and
- PKUWKG are used when parameters are normalized by weight in
- grams or kilograms respectively. Multiple subset codelists
- were created for the unique unit expressions of the same
- concept across codelists, this approach allows study-context
+ - Cited Guidance:
+ There are separate codelists used for PPORRESU/PPSTRESU where the choice
+ depends on whether the value of the pharmacokinetic parameter is normalized. Codelist
+ PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when
+ parameters are normalized by dose amount in milligrams or micrograms respectively.
+ Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or
+ kilograms respectively. Multiple subset codelists were created for the unique unit
+ expressions of the same concept across codelists, this approach allows study-context
appropriate use of unit values for PK analysis subtypes
Document: IG v3.4
Item: Assumption 3
@@ -28,22 +26,20 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0558
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where
- the choice depends on whether the value of the pharmacokinetic
- parameter is normalized. Codelist PKUNIT is used for
- non-normalized parameters. Codelists PKUDMG and PKUDUG are
- used when parameters are normalized by dose amount in
- milligrams or micrograms respectively. Codelists PKUWG and
- PKUWKG are used when parameters are normalized by weight in
- grams or kilograms respectively. Multiple subset codelists
- were created for the unique unit expressions of the same
- concept across codelists, this approach allows study-context
+ - Cited Guidance:
+ There are separate codelists used for PPORRESU/PPSTRESU where the choice
+ depends on whether the value of the pharmacokinetic parameter is normalized. Codelist
+ PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when
+ parameters are normalized by dose amount in milligrams or micrograms respectively.
+ Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or
+ kilograms respectively. Multiple subset codelists were created for the unique unit
+ expressions of the same concept across codelists, this approach allows study-context
appropriate use of unit values for PK analysis subtypes.
Document: IG v3.3
Item: Assumption 3
@@ -51,9 +47,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0558
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: PPTEST
@@ -65,9 +61,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0558
Status: Draft
- Version: '1'
-Description: Trigger error when parameter is non-normalized and value in
- PPSTRESU is not for a non-normalized parameter.
+ Version: "1"
+Description: Trigger error when parameter is non-normalized and value in PPSTRESU is not for a
+ non-normalized parameter.
Executability: Fully Executable
Operations:
- codelists:
@@ -77,8 +73,7 @@ Operations:
operator: codelist_terms
returntype: value
Outcome:
- Message: Parameter is non-normalized, and the value in PPSTRESU is not in
- codelist PKUNIT.
+ Message: Parameter is non-normalized, and the value in PPSTRESU is not in codelist PKUNIT.
Output Variables:
- PPTESTCD
- PPTEST
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml
index e1c21b585..db69012b7 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml
@@ -3,24 +3,22 @@
# Rule: Terminology is for non-normalized parameter
# Notes by author, Marcelina Hungria:
# - The rule as written by the Conformance Rules team is fully executable
-# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted.
-# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future
+# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted.
+# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where
- the choice depends on whether the value of the pharmacokinetic
- parameter is normalized. Codelist PKUNIT is used for
- non-normalized parameters. Codelists PKUDMG and PKUDUG are
- used when parameters are normalized by dose amount in
- milligrams or micrograms respectively. Codelists PKUWG and
- PKUWKG are used when parameters are normalized by weight in
- grams or kilograms respectively. Multiple subset codelists
- were created for the unique unit expressions of the same
- concept across codelists, this approach allows study-context
+ - Cited Guidance:
+ There are separate codelists used for PPORRESU/PPSTRESU where the choice
+ depends on whether the value of the pharmacokinetic parameter is normalized. Codelist
+ PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when
+ parameters are normalized by dose amount in milligrams or micrograms respectively.
+ Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or
+ kilograms respectively. Multiple subset codelists were created for the unique unit
+ expressions of the same concept across codelists, this approach allows study-context
appropriate use of unit values for PK analysis subtypes
Document: IG v3.4
Item: Assumption 3
@@ -28,22 +26,20 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0559
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where
- the choice depends on whether the value of the pharmacokinetic
- parameter is normalized. Codelist PKUNIT is used for
- non-normalized parameters. Codelists PKUDMG and PKUDUG are
- used when parameters are normalized by dose amount in
- milligrams or micrograms respectively. Codelists PKUWG and
- PKUWKG are used when parameters are normalized by weight in
- grams or kilograms respectively. Multiple subset codelists
- were created for the unique unit expressions of the same
- concept across codelists, this approach allows study-context
+ - Cited Guidance:
+ There are separate codelists used for PPORRESU/PPSTRESU where the choice
+ depends on whether the value of the pharmacokinetic parameter is normalized. Codelist
+ PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when
+ parameters are normalized by dose amount in milligrams or micrograms respectively.
+ Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or
+ kilograms respectively. Multiple subset codelists were created for the unique unit
+ expressions of the same concept across codelists, this approach allows study-context
appropriate use of unit values for PK analysis subtypes.
Document: IG v3.3
Item: Assumption 3
@@ -51,9 +47,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0559
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: PPTEST
@@ -68,9 +64,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0559
Status: Draft
- Version: '1'
-Description: Trigger error when parameter is normalized by dose and value in
- PPSTRESU is not for a parameter normalized by dose.
+ Version: "1"
+Description: Trigger error when parameter is normalized by dose and value in PPSTRESU is not for a
+ parameter normalized by dose.
Executability: Fully Executable
Operations:
- codelists:
@@ -86,8 +82,8 @@ Operations:
operator: codelist_terms
returntype: value
Outcome:
- Message: Parameter is normalized by dose, and the value in PPSTRESU is not in
- codelist PKUDMG nor in codelist PKUDUG.
+ Message: Parameter is normalized by dose, and the value in PPSTRESU is not in codelist PKUDMG nor
+ in codelist PKUDUG.
Output Variables:
- PPTESTCD
- PPTEST
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml
index 70395fa29..c4802d8a0 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml
@@ -3,24 +3,22 @@
# Rule: Terminology is for parameter normalized by weight
# Notes by author, Marcelina Hungria:
# - The rule as written by the Conformance Rules team is fully executable
-# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted.
-# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future
+# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted.
+# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where
- the choice depends on whether the value of the pharmacokinetic
- parameter is normalized. Codelist PKUNIT is used for
- non-normalized parameters. Codelists PKUDMG and PKUDUG are
- used when parameters are normalized by dose amount in
- milligrams or micrograms respectively. Codelists PKUWG and
- PKUWKG are used when parameters are normalized by weight in
- grams or kilograms respectively. Multiple subset codelists
- were created for the unique unit expressions of the same
- concept across codelists, this approach allows study-context
+ - Cited Guidance:
+ There are separate codelists used for PPORRESU/PPSTRESU where the choice
+ depends on whether the value of the pharmacokinetic parameter is normalized. Codelist
+ PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when
+ parameters are normalized by dose amount in milligrams or micrograms respectively.
+ Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or
+ kilograms respectively. Multiple subset codelists were created for the unique unit
+ expressions of the same concept across codelists, this approach allows study-context
appropriate use of unit values for PK analysis subtypes
Document: IG v3.4
Item: Assumption 3
@@ -28,22 +26,20 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0560
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where
- the choice depends on whether the value of the pharmacokinetic
- parameter is normalized. Codelist PKUNIT is used for
- non-normalized parameters. Codelists PKUDMG and PKUDUG are
- used when parameters are normalized by dose amount in
- milligrams or micrograms respectively. Codelists PKUWG and
- PKUWKG are used when parameters are normalized by weight in
- grams or kilograms respectively. Multiple subset codelists
- were created for the unique unit expressions of the same
- concept across codelists, this approach allows study-context
+ - Cited Guidance:
+ There are separate codelists used for PPORRESU/PPSTRESU where the choice
+ depends on whether the value of the pharmacokinetic parameter is normalized. Codelist
+ PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when
+ parameters are normalized by dose amount in milligrams or micrograms respectively.
+ Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or
+ kilograms respectively. Multiple subset codelists were created for the unique unit
+ expressions of the same concept across codelists, this approach allows study-context
appropriate use of unit values for PK analysis subtypes.
Document: IG v3.3
Item: Assumption 3
@@ -51,9 +47,9 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0560
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: PPTEST
@@ -68,9 +64,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0560
Status: Draft
- Version: '1'
-Description: Trigger error when parameter is normalized by weight and value in
- PPSTRESU is not for a parameter not normalized by weight.
+ Version: "1"
+Description: Trigger error when parameter is normalized by weight and value in PPSTRESU is not for a
+ parameter not normalized by weight.
Executability: Fully Executable
Operations:
- codelists:
@@ -86,8 +82,8 @@ Operations:
operator: codelist_terms
returntype: value
Outcome:
- Message: Parameter is normalized by weight, and the value in PPSTRESU is not in
- codelist PKUWG nor in codelist PKUWKG.
+ Message: Parameter is normalized by weight, and the value in PPSTRESU is not in codelist PKUWG nor
+ in codelist PKUWKG.
Output Variables:
- PPTESTCD
- PPTEST
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml
index cadc9310f..f3f55a6eb 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml
@@ -5,41 +5,40 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0563
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Used to indicate a derived record (e.g., a record
- that represents the average of other records such as a computed
- baseline). Should be "Y" or null.
+ - Citations:
+ - Cited Guidance:
+ Used to indicate a derived record (e.g., a record that represents the
+ average of other records such as a computed baseline). Should be "Y" or null.
Document: SDTMIG v3.4
Section: Section 6.3.9.3
- - Name: SDTMIG
- Version: '3.3'
- References:
- - Origin: SDTM and SDTMIG Conformance Rules
+ Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0563
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: The RS domain is intended for collected data. This
- includes records derived by the investigator or with a data collection
- tool, but not sponsor-derived records. Sponsor-derived records and
- results should be provided in an analysis dataset. For example,
- BEST Response assessment records must be included in the RS domain
- only when provided by an assessor, not the sponsor. a. Totals and
- sub-totals in clinical classification measures are considered collected
- data if recorded by an assessor. If these totals are operationally
- derived through a data collection tool, such as an eCRF or ePRO
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+ - Name: SDTMIG
+ References:
+ - Citations:
+ - Cited Guidance:
+ The RS domain is intended for collected data. This includes records derived
+ by the investigator or with a data collection tool, but not sponsor-derived records.
+ Sponsor-derived records and results should be provided in an analysis dataset. For
+ example, BEST Response assessment records must be included in the RS domain only when
+ provided by an assessor, not the sponsor. a. Totals and sub-totals in clinical
+ classification measures are considered collected data if recorded by an assessor. If these
+ totals are operationally derived through a data collection tool, such as an eCRF or ePRO
device, then RSDRVL should be "Y".
Document: IG v3.3
Item: Assumption 4
Section: 6.3.13.3
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0563
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name:
@@ -50,13 +49,12 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0563
Status: Draft
- Version: '1'
-Description: Raise an error when record is derived in a data collection tool and RSDRVFL
- is not equal to "Y"
+ Version: "1"
+Description: Raise an error when record is derived in a data collection tool and RSDRVFL is not
+ equal to "Y"
Executability: Fully Executable
Outcome:
- Message: Record is derived in a data collection tool and RSDRVFL is not equal to
- "Y"
+ Message: Record is derived in a data collection tool and RSDRVFL is not equal to "Y"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0604/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0604/rule.yml
index 6ba89bd19..4d1c2747d 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0604/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0604/rule.yml
@@ -5,31 +5,31 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0604
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: When findings are collected about an event or intervention,
- and the name of the event or intervention is collected in an "Other,
- specify" CRF field, the value in --OBJ variable depends on whether
- the FA record has a parent record and whether the "Other, specify"
- value was coded.
+ - Citations:
+ - Cited Guidance:
+ When findings are collected about an event or intervention, and the name of
+ the event or intervention is collected in an "Other, specify" CRF field, the value in
+ --OBJ variable depends on whether the FA record has a parent record and whether the
+ "Other, specify" value was coded.
Document: IG v3.4
Section: 4.2.7.4
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0604
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0604
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0605/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0605/rule.yml
index 440dc71dd..194313eaa 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0605/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0605/rule.yml
@@ -5,31 +5,31 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0605
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: When findings are collected about an event or intervention,
- and the name of the event or intervention is collected in an "Other,
- specify" CRF field, the value in --OBJ variable depends on whether
- the FA record has a parent record and whether the "Other, specify"
- value was coded.
+ - Citations:
+ - Cited Guidance:
+ When findings are collected about an event or intervention, and the name of
+ the event or intervention is collected in an "Other, specify" CRF field, the value in
+ --OBJ variable depends on whether the FA record has a parent record and whether the
+ "Other, specify" value was coded.
Document: IG v3.4
Section: 4.2.7.4
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0605
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0605
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml
index 13d523ca2..c9f2799ec 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml
@@ -5,20 +5,21 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0607
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: In cases of tests that target an organism, group of
- organisms, or antigen for identification, MBTEST equals the name
- of the organism/antigen targeted by the identification assay.
+ - Citations:
+ - Cited Guidance:
+ In cases of tests that target an organism, group of organisms, or antigen
+ for identification, MBTEST equals the name of the organism/antigen targeted by the
+ identification assay.
Document: SDTMIG v3.4
Item: Assumption 1
Section: 6.3.5.7.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0607
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all:
- name: MBTEST
@@ -27,13 +28,13 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0607
Status: Draft
- Version: '1'
-Description: Verify MBTEST equals the name of the organism/antigen targeted by the
- identification assay.
+ Version: "1"
+Description: Verify MBTEST equals the name of the organism/antigen targeted by the identification
+ assay.
Executability: Fully Executable
Outcome:
- Message: Test targets an organism, group of organisms, or antigen, but MBTEST is
- not the name of the organism/antigen.
+ Message: Test targets an organism, group of organisms, or antigen, but MBTEST is not the name of
+ the organism/antigen.
Rule Type: Range and limit
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml
index c321be4cb..f7ff8702d 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml
@@ -5,21 +5,21 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0608
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: In cases of tests that target an organism, group of
- organisms, or antigen for identification, MBTEST equals the name
- of the organism/antigen targeted by the identification assay, and MBTSTDTL
- should be “DETECTION”.
+ - Citations:
+ - Cited Guidance:
+ In cases of tests that target an organism, group of organisms, or antigen
+ for identification, MBTEST equals the name of the organism/antigen targeted by the
+ identification assay, and MBTSTDTL should be “DETECTION”.
Document: SDTMIG v3.4
Item: Assumption 1
Section: 6.3.5.7.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0608
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all:
- name: MBTSTDTL
@@ -28,13 +28,12 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0608
Status: Draft
- Version: '1'
-Description: Verify MBTSTDTL is "DETECTION" if the tests targets an organism, group
- of organisms, or antigen.
+ Version: "1"
+Description: Verify MBTSTDTL is "DETECTION" if the tests targets an organism, group of organisms, or
+ antigen.
Executability: Fully Executable
Outcome:
- Message: Test targets an organism, group of organisms, or antigen, but MBTSTDTL
- is not "DETECTION"
+ Message: Test targets an organism, group of organisms, or antigen, but MBTSTDTL is not "DETECTION"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml
index e7e53b0cf..49ee46109 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml
@@ -5,23 +5,22 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0609
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: For non-targeted identification of organisms (i.e.,
- tests that have the ability to identify a range of organisms without
- specifically targeting any), the value for MBTESTCD/MBTEST should
- be "MCORGIDN"/"Microbial Organism Identification", and the result
- should be the name of the organism or group of organisms found
- to be present.
+ - Citations:
+ - Cited Guidance:
+ For non-targeted identification of organisms (i.e., tests that have the
+ ability to identify a range of organisms without specifically targeting any), the value
+ for MBTESTCD/MBTEST should be "MCORGIDN"/"Microbial Organism Identification", and the
+ result should be the name of the organism or group of organisms found to be present.
Document: SDTMIG v3.4
Item: Assumption 1
Section: 6.3.5.7.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0609
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all:
- name: MBTESTCD
@@ -30,9 +29,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0609
Status: Draft
- Version: '1'
-Description: Verify MBTESTCD is "MCORGIDN" if the test is for a non-targeted identification
- of organisms.
+ Version: "1"
+Description: Verify MBTESTCD is "MCORGIDN" if the test is for a non-targeted identification of
+ organisms.
Executability: Fully Executable
Outcome:
Message: Test targets an organism, group of organisms, or antigen, but
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml
index 90671941a..f2e8c3b85 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml
@@ -5,21 +5,21 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0610
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Culture characteristics covers concepts such as growth/no
- growth, colony quantification measures, colony color, colony morphology,
- etc.... MBTESTCD/MBTEST should be the name of the organism or group
- of organisms being characterized.
+ - Citations:
+ - Cited Guidance:
+ Culture characteristics covers concepts such as growth/no growth, colony
+ quantification measures, colony color, colony morphology, etc.... MBTESTCD/MBTEST should
+ be the name of the organism or group of organisms being characterized.
Document: SDTMIG v3.4
Item: Assumption 1
Section: 6.3.5.7.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0610
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all:
- name: MBTEST
@@ -28,13 +28,13 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0610
Status: Draft
- Version: '1'
-Description: If the test is for culture characteristics, verify that MBTEST equals
- the name of the organism/antigen being characterized.
+ Version: "1"
+Description: If the test is for culture characteristics, verify that MBTEST equals the name of the
+ organism/antigen being characterized.
Executability: Fully Executable
Outcome:
- Message: Test is for culture characteristics, but MBTEST is not the name of the organism
- or group of organisms.
+ Message: Test is for culture characteristics, but MBTEST is not the name of the organism or group
+ of organisms.
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0614/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0614/rule.yml
index 8b8ea8a26..ca1e3604e 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0614/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0614/rule.yml
@@ -5,30 +5,31 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0614
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: In cases of tests that target an organism, group of
- organisms, or antigen for identification, MBTEST equals the name
- of the organism/antigen targeted by the identification assay.
+ - Citations:
+ - Cited Guidance:
+ In cases of tests that target an organism, group of organisms, or antigen
+ for identification, MBTEST equals the name of the organism/antigen targeted by the
+ identification assay.
Document: IG v3.4
Item: Assumption 1
Section: 6.3.5.7.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0614
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0614
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0615/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0615/rule.yml
index 935acc3dc..86f5a2e88 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0615/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0615/rule.yml
@@ -5,31 +5,31 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0615
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: In cases of tests that target an organism, group of
- organisms, or antigen for identification, MBTEST equals the name
- of the organism/antigen targeted by the identification assay, and
- MBTSTDTL should be “DETECTION”.
+ - Citations:
+ - Cited Guidance:
+ In cases of tests that target an organism, group of organisms, or antigen
+ for identification, MBTEST equals the name of the organism/antigen targeted by the
+ identification assay, and MBTSTDTL should be “DETECTION”.
Document: IG v3.4
Item: Assumption 1
Section: 6.3.5.7.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0615
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0615
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0616/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0616/rule.yml
index 3612ebb92..c2d0c97ac 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0616/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0616/rule.yml
@@ -5,33 +5,32 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0616
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: For non-targeted identification of organisms (i.e.,
- tests that have the ability to identify a range of organisms without
- specifically targeting any), the value for MBTESTCD/MBTEST should
- be "MCORGIDN"/"Microbial Organism Identification", and the result
- should be the name of the organism or group of organisms found to
- be present.
+ - Citations:
+ - Cited Guidance:
+ For non-targeted identification of organisms (i.e., tests that have the
+ ability to identify a range of organisms without specifically targeting any), the value
+ for MBTESTCD/MBTEST should be "MCORGIDN"/"Microbial Organism Identification", and the
+ result should be the name of the organism or group of organisms found to be present.
Document: IG v3.4
Item: Assumption 1
Section: 6.3.5.7.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0616
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0616
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0617/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0617/rule.yml
index fbf778ff8..613822c74 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0617/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0617/rule.yml
@@ -5,31 +5,31 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.4'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: CG0617
- Version: '1'
- Version: '2.0'
- Citations:
- - Cited Guidance: Culture characteristics covers concepts such as growth/no
- growth, colony quantification measures, colony color, colony morphology,
- etc.... MBTESTCD/MBTEST should be the name of the organism or group
- of organisms being characterized.
+ - Citations:
+ - Cited Guidance:
+ Culture characteristics covers concepts such as growth/no growth, colony
+ quantification measures, colony color, colony morphology, etc.... MBTESTCD/MBTEST should
+ be the name of the organism or group of organisms being characterized.
Document: IG v3.4
Item: Assumption 1
Section: 6.3.5.7.1
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: CG0617
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
all: []
Core:
Id: CDISC.SDTMIG.CG0617
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml
index 91184c95b..4ba06266b 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml
@@ -2,7 +2,7 @@
# Condition: Variable Core Status = Permissible and data is planned to be collected
# Rule: Variable present in dataset
# Logically, this check tests:
-# if a library variable exists in the define,
+# if a library variable exists in the define,
# it should exist in the datasets
Authorities:
- Organization: CDISC
@@ -10,33 +10,33 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If a study includes a data item that would be represented in a
- Permissible variable, then that variable must be included in
- the SDTM dataset, even if null. Indicate no data were
- available for that variable in the Define-XML document."
+ - Cited Guidance:
+ If a study includes a data item that would be represented in a Permissible
+ variable, then that variable must be included in the SDTM dataset, even if null. Indicate
+ no data were available for that variable in the Define-XML document."
Document: IG v3.4
- Section: '2.5'
+ Section: "2.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0651
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If a study includes a data item that would be represented in a
- Permissible variable, then that variable must be included in
- the SDTM dataset, even if null. Indicate no data were
- available for that variable in the Define-XML document.
+ - Cited Guidance:
+ If a study includes a data item that would be represented in a Permissible
+ variable, then that variable must be included in the SDTM dataset, even if null. Indicate
+ no data were available for that variable in the Define-XML document.
Document: IG v3.3
- Section: '2.5'
+ Section: "2.5"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0651
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: define_variable_name
@@ -52,9 +52,9 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0651
Status: Draft
- Version: '1'
-Description: Raise an error when variable Core Status = Permissible and data is
- planned to be collected, but variable is not present
+ Version: "1"
+Description: Raise an error when variable Core Status = Permissible and data is planned to be
+ collected, but variable is not present
Executability: Partially Executable - Possible Underreporting
Operations:
- id: $permissible_variables
@@ -62,8 +62,8 @@ Operations:
- id: $get_column_order_from_dataset
operator: get_column_order_from_dataset
Outcome:
- Message: Variable is missing, where variable core status is permissible and data
- is planned to be collected.
+ Message: Variable is missing, where variable core status is permissible and data is planned to be
+ collected.
Output Variables:
- define_variable_name
- $get_column_order_from_dataset
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml
index 138171e56..650e465a0 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml
@@ -1,27 +1,26 @@
# Variable: DOMAIN
# Condition: AP Core Domain
-# Rule: Value length = 4 characters beginning with 'AP' and ending with 2 character SDTM domain
+# Rule: Value length = 4 characters beginning with 'AP' and ending with 2 character SDTM domain
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Associated Persons datasets are given a prefix of AP-- to
- identify the data as AP data to and distinguish them from
- study subject data. Associated Persons domain codes in the
- DOMAIN column of every record are also given a prefix of AP--
- to identify the domains as AP domains and to distinguish them
- from study subject domains. AP domain codes are therefore four
- characters long.
+ - Cited Guidance:
+ Associated Persons datasets are given a prefix of AP-- to identify the data
+ as AP data to and distinguish them from study subject data. Associated Persons domain
+ codes in the DOMAIN column of every record are also given a prefix of AP-- to identify the
+ domains as AP domains and to distinguish them from study subject domains. AP domain codes
+ are therefore four characters long.
Document: AP Guide v1.0
Section: Section 2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0663
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
any:
# Fire query if domain name does not start with APFA and does not have the format "AP" followed by an alpha character, then an alphanum character
@@ -32,8 +31,9 @@ Check:
value: ^APFA$
- name: DOMAIN
operator: not_matches_regex
- value: ^AP[A-Z][A-Z0-9]$
- # Fire query if domain name starts with APFA and is not followed by an alpha character, then an alphanum character
+ value:
+ ^AP[A-Z][A-Z0-9]$
+ # Fire query if domain name starts with APFA and is not followed by an alpha character, then an alphanum character
- all:
- name: DOMAIN
operator: prefix_matches_regex
@@ -42,30 +42,32 @@ Check:
- name: DOMAIN
operator: not_suffix_matches_regex
suffix: 2
- value: '[A-Z0-9][A-Z0-9]$'
- # Fire query if characters 3/4 refers to invalid SDTM domain
+ value:
+ "[A-Z0-9][A-Z0-9]$"
+ # Fire query if characters 3/4 refers to invalid SDTM domain
- name: DOMAIN
operator: suffix_is_not_contained_by
suffix: 2
- value: $valid_domain_name
- # Fire query if characters 5/6 refers to invalid SDTM domain (for APFA domains)
+ value:
+ $valid_domain_name
+ # Fire query if characters 5/6 refers to invalid SDTM domain (for APFA domains)
- name: DOMAIN
operator: matches_regex
value: ^APFA(AD|AX|AP|SQ|SA)$
Core:
Id: CDISC.SDTMIG.CG0663
Status: Draft
- Version: '1'
-Description: Raise an error when an AP Core Domain does not have a value length
- of 4 characters beginning with 'AP' and ending with 2 character SDTM domain
+ Version: "1"
+Description: Raise an error when an AP Core Domain does not have a value length of 4 characters
+ beginning with 'AP' and ending with 2 character SDTM domain
Executability: Fully Executable
Operations:
- id: $valid_domain_name
name: domain_suffix
operator: extract_metadata
Outcome:
- Message: AP Core Domain does not have a value length of 4 characters beginning
- with 'AP' and ending with 2 character SDTM domain
+ Message: AP Core Domain does not have a value length of 4 characters beginning with 'AP' and
+ ending with 2 character SDTM domain
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0998/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0998/rule.yml
index f9330d567..200526fa2 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0998/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0998/rule.yml
@@ -1,6 +1,6 @@
# Variable: --
-# Condition:
-# Rule:
+# Condition:
+# Rule:
Authorities:
- Organization: CDISC
Standards:
@@ -10,16 +10,16 @@ Authorities:
- Cited Guidance: xxx.
Document: IG v3.4
Item: Item 3.b.
- Section: '2.6'
+ Section: "2.6"
- Cited Guidance: yyyyyyy.
Document: IG v3.4
Section: 4.3.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0998
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
Check:
any:
@@ -33,9 +33,8 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0998
Status: Draft
- Version: '1'
-Description: All TDM dataset(s) for the corresponding IG should be included in
- every submission.
+ Version: "1"
+Description: All TDM dataset(s) for the corresponding IG should be included in every submission.
Executability: Fully Executable
Grouping_Variables:
- $study_domains
diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0999/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0999/rule.yml
index 72df69234..729c9e9c0 100644
--- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0999/rule.yml
+++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0999/rule.yml
@@ -1,6 +1,6 @@
# Variable: --
-# Condition:
-# Rule:
+# Condition:
+# Rule:
Authorities:
- Organization: CDISC
Standards:
@@ -10,16 +10,16 @@ Authorities:
- Cited Guidance: xxx.
Document: IG v3.4
Item: Item 3.b.
- Section: '2.6'
+ Section: "2.6"
- Cited Guidance: yyyyyyy.
Document: IG v3.4
Section: 4.3.6
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0999
- Version: '2'
- Version: '2.0'
- Version: '3.4'
+ Version: "2"
+ Version: "2.0"
+ Version: "3.4"
Check:
all:
@@ -38,9 +38,8 @@ Check:
Core:
Id: CDISC.SDTMIG.CG0999
Status: Draft
- Version: '1'
-Description: Testing rule type Variables Metadata Check against Define XML and
- Library Metadata
+ Version: "1"
+Description: Testing rule type Variables Metadata Check against Define XML and Library Metadata
Executability: Fully Executable
Outcome:
Message: "Issue with codelist definition in the Define-XML document."
diff --git a/Unpublished/SDTMIG/CG0011/rule.yml b/Unpublished/SDTMIG/CG0011/rule.yml
index 51dea3977..3b95d3896 100644
--- a/Unpublished/SDTMIG/CG0011/rule.yml
+++ b/Unpublished/SDTMIG/CG0011/rule.yml
@@ -1,45 +1,48 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specified controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specified controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011'
- Version: '1'
- Version: '2.0'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "CG0011"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specified controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specified controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011'
- Version: '1'
- Version: '2.0'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "CG0011"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specified controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specified controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011'
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Id: "CG0011"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
# REMARK: This rule is strongly related to rule SEND49
all:
@@ -49,31 +52,32 @@ Check:
value:
- STUDYID
- DOMAIN # seems to give false positives when C66734 codelist is referenced for "DOMAIN"
- # check whether variable has assigned CT in the CDISC Library
+ # check whether variable has assigned CT in the CDISC Library
- name: library_variable_ccode
- operator: non_empty
- # if yes, a "CodeListRef" must be available either on the "Variable-ItemDef"
- # or on each of the corresponding ValueList ItemDefs
- #- any:
- # - name: define_variable_ccode
- # operator: empty
- #value: '1234'
- #- name: variable_name
- # operator: equal_to
- # value: library_variable_name
- #- name: library_variable_data_type
- # operator: not_equal_to
- # value: ISO8601
- #- name: variable_order_number
- # operator: not_equal_to
- # value: 1
+ operator:
+ non_empty
+ # if yes, a "CodeListRef" must be available either on the "Variable-ItemDef"
+ # or on each of the corresponding ValueList ItemDefs
+ #- any:
+ # - name: define_variable_ccode
+ # operator: empty
+ #value: '1234'
+ #- name: variable_name
+ # operator: equal_to
+ # value: library_variable_name
+ #- name: library_variable_data_type
+ # operator: not_equal_to
+ # value: ISO8601
+ #- name: variable_order_number
+ # operator: not_equal_to
+ # value: 1
Core:
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'Test message'
+ Message: "Test message"
Output Variables:
- library_variable_ccode
- define_variable_ccode
diff --git a/Unpublished/SDTMIG/CG0011A1/rule.yml b/Unpublished/SDTMIG/CG0011A1/rule.yml
index 2444277d6..ad536cf6c 100644
--- a/Unpublished/SDTMIG/CG0011A1/rule.yml
+++ b/Unpublished/SDTMIG/CG0011A1/rule.yml
@@ -1,68 +1,73 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specified controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specified controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011A1'
- Version: '1'
- Version: '2.0'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "CG0011A1"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specified controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specified controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011A1'
- Version: '1'
- Version: '2.0'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "CG0011A1"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specifieda controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011A1'
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Id: "CG0011A1"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
Check:
# PART A1: --DUR must be in ISO-8601 "duration" format
all:
- name: --DUR
operator: non_empty
- - name: --DUR
- # negative: true means: allow negative durations
+ - name:
+ --DUR
+ # negative: true means: allow negative durations
negative: true
- operator: invalid_duration
- #- name: --DUR
- # operator: not_matches_regex
- # value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$
- #- name: --DUR
- # operator: not_matches_regex
- # value: ^-?P([0-9]+W)$
+ operator:
+ invalid_duration
+ #- name: --DUR
+ # operator: not_matches_regex
+ # value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$
+ #- name: --DUR
+ # operator: not_matches_regex
+ # value: ^-?P([0-9]+W)$
Core:
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'Variable value for --DUR does not comply with ISO-8601-duration format'
+ Message: "Variable value for --DUR does not comply with ISO-8601-duration format"
#Output Variables:
# - library_variable_ccode
# - define_variable_ccode
diff --git a/Unpublished/SDTMIG/CG0011A2/rule.yml b/Unpublished/SDTMIG/CG0011A2/rule.yml
index a5488423e..b1c3968e7 100644
--- a/Unpublished/SDTMIG/CG0011A2/rule.yml
+++ b/Unpublished/SDTMIG/CG0011A2/rule.yml
@@ -1,64 +1,68 @@
# CG0011A = --DUR variables
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specified controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specified controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011A2'
- Version: '1'
- Version: '2.0'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "CG0011A2"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specified controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specified controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011A2'
- Version: '1'
- Version: '2.0'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "CG0011A2"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specifieda controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011A2'
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Id: "CG0011A2"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
# Part A2: check whether --DUR is declared as "durationDatetime"
Check:
all:
- name: --DUR
negative: true
- operator: invalid_duration
- #operator: non_conformant_value_data_type
- #value: 'durationDatetime'
+ operator:
+ invalid_duration
+ #operator: non_conformant_value_data_type
+ #value: 'durationDatetime'
Core:
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Variable Metadata Check against Define XML
# Rule Type: Variable Metadata Check against Library Metadata
-# Alternative:
+# Alternative:
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CG0011B1/rule.yml b/Unpublished/SDTMIG/CG0011B1/rule.yml
index f15a84526..d8c9ede42 100644
--- a/Unpublished/SDTMIG/CG0011B1/rule.yml
+++ b/Unpublished/SDTMIG/CG0011B1/rule.yml
@@ -1,46 +1,49 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specified controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specified controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011B1'
- Version: '1'
- Version: '2.0'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "CG0011B1"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specified controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specified controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011B1'
- Version: '1'
- Version: '2.0'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "CG0011B1"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specifieda controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011B1'
- Version: '1'
- Version: '2.0'
- Version: '3.4'
-# TODO?: when 2 violations in same row, this is reported as 1 violation
+ Id: "CG0011B1"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
+# TODO?: when 2 violations in same row, this is reported as 1 violation
Check:
any:
- all:
@@ -57,8 +60,9 @@ Check:
- name: --ENDTC
operator: non_empty
- name: --ENDTC
- operator: invalid_date
- # DM-specific date/time variables
+ operator:
+ invalid_date
+ # DM-specific date/time variables
- all:
- name: RFSTDTC
operator: non_empty
@@ -108,11 +112,11 @@ Check:
operator: invalid_date
Core:
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: ''
+ Message: ""
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CG0011C2/rule.yml b/Unpublished/SDTMIG/CG0011C2/rule.yml
index 6a15bd167..934ae6895 100644
--- a/Unpublished/SDTMIG/CG0011C2/rule.yml
+++ b/Unpublished/SDTMIG/CG0011C2/rule.yml
@@ -1,45 +1,48 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SDTMIG'
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specified controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specified controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011C2'
- Version: '1'
- Version: '2.0'
- Version: '3.2'
- - Name: 'SDTMIG'
+ Id: "CG0011C2"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specified controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specified controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011C2'
- Version: '1'
- Version: '2.0'
- Version: '3.3'
- - Name: 'SDTMIG'
+ Id: "CG0011C2"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
+ - Name: "SDTMIG"
References:
- Citations:
- - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format
- guidelines for variables, when provided'
- Document: 'SDTMIG'
- Section: '3.2.2'
+ - Cited Guidance:
+ "Following SDTM-specifieda controlled terminology and format guidelines for variables,
+ when provided"
+ Document: "SDTMIG"
+ Section: "3.2.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
- Id: 'CG0011C2'
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Id: "CG0011C2"
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
# CG0011C2: if the variable is under controlled terminology (according CDISC-Library)
# then a CodeList must be referenced in the define.xml
Check:
@@ -71,17 +74,17 @@ Check:
Core:
Status: Draft
- Version: '1'
-Description: 'Variables that are under CT must have an associated codelist
- defined in the define.xml'
+ Version: "1"
+Description: "Variables that are under CT must have an associated codelist defined in the define.xml"
Executability: Fully Executable
Outcome:
- Message: 'The variable is under controlled terminology, but no codelist has been
- defined for it in the define.xml'
+ Message:
+ "The variable is under controlled terminology, but no codelist has been defined for it in the
+ define.xml"
Output Variables:
- library_variable_ccode
# Rule Type: Define Item Metadata Check against Library Metadata
-# Rule Type: Define Item Metadata Check against Library Metadata
+# Rule Type: Define Item Metadata Check against Library Metadata
Rule Type: Variable Metadata Check against Define XML and Library Metadata
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CORE-000205/rule.yml b/Unpublished/SDTMIG/CORE-000205/rule.yml
index bcf2558c4..1f87ed8ea 100644
--- a/Unpublished/SDTMIG/CORE-000205/rule.yml
+++ b/Unpublished/SDTMIG/CORE-000205/rule.yml
@@ -14,39 +14,41 @@ Authorities:
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0399
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Indicates the upper limit of quantitation for an assay. Units
- will be those used for --STRESU.
+ - Cited Guidance:
+ Indicates the upper limit of quantitation for an assay. Units will be those
+ used for --STRESU.
Document: Model v1.4
Section: 2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0399
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Indicates the upper limit of quantitation for an assay. Units
- will be those used for --STRESU.
+ - Cited Guidance:
+ Indicates the upper limit of quantitation for an assay. Units will be those
+ used for --STRESU.
Document: Model v1.7
Section: 2.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0399
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Core:
Id: CORE-000205
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when --ULOQ is not expressed using the units in --STRESU
Executability: Not Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CORE-000343/rule.yml b/Unpublished/SDTMIG/CORE-000343/rule.yml
index 6037e40b9..a2b5c227f 100644
--- a/Unpublished/SDTMIG/CORE-000343/rule.yml
+++ b/Unpublished/SDTMIG/CORE-000343/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: Variable Format = SDTM-specified controlled terminology and format guidelines for variables, when provided
Authorities:
- Organization: CDISC
@@ -7,52 +7,55 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Following SDTM-specified controlled terminology and format
- guidelines for variables, when provided
+ - Cited Guidance:
+ Following SDTM-specified controlled terminology and format guidelines for
+ variables, when provided
Document: IG v3.4
Section: 3.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0011
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Following SDTM-specified controlled terminology and format
- guidelines for variables, when provided
+ - Cited Guidance:
+ Following SDTM-specified controlled terminology and format guidelines for
+ variables, when provided
Document: IG v3.2
Section: 3.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0011
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Following SDTM-specified controlled terminology and format
- guidelines for variables, when provided
+ - Cited Guidance:
+ Following SDTM-specified controlled terminology and format guidelines for
+ variables, when provided
Document: IG v3.3
Section: 3.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0011
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Core:
Id: CORE-000343
Status: Draft
- Version: '1'
-Description: Trigger error when variable format does not match SDTM-specified
- controlled terminology or format guidelines for variables (when provided)
+ Version: "1"
+Description: Trigger error when variable format does not match SDTM-specified controlled terminology
+ or format guidelines for variables (when provided)
Executability: Not Executable
Outcome:
- Message: Variable format does not match SDTM-specified controlled terminology or
- format guidelines for variables (when provided)
+ Message: Variable format does not match SDTM-specified controlled terminology or format guidelines
+ for variables (when provided)
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CORE-000344/rule.yml b/Unpublished/SDTMIG/CORE-000344/rule.yml
index 73311323c..47bae367a 100644
--- a/Unpublished/SDTMIG/CORE-000344/rule.yml
+++ b/Unpublished/SDTMIG/CORE-000344/rule.yml
@@ -7,72 +7,69 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Conformance with the SDTMIG Domain Models is minimally indicated
- by following SDTM-specified controlled terminology and format
- guidelines for variables, when provided
+ - Cited Guidance: Conformance with the SDTMIG Domain Models is minimally indicated by
+ following SDTM-specified controlled terminology and format guidelines for variables, when
+ provided
Document: IG v3.4
Section: 3.2.2
- - Cited Guidance: The SDTM permits one value for each Qualifier variable per
- record. If multiple values exist (e.g., due to a "Check all
- that apply" instruction on a CRF), then the value for the
- Qualifier variable should be "MULTIPLE" and SUPP-- should be
- used to store the individual responses.
+ - Cited Guidance:
+ The SDTM permits one value for each Qualifier variable per record. If
+ multiple values exist (e.g., due to a "Check all that apply" instruction on a CRF), then
+ the value for the Qualifier variable should be "MULTIPLE" and SUPP-- should be used to
+ store the individual responses.
Document: IG v3.4
Section: 4.2.8.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0020
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally
- indicated by following SDTM-specified controlled terminology
- and format guidelines for variables, when
- provided]4.1.2.8.3[The SDTM permits one value for each
- Qualifier variable per record. If multiple values exist (e.g.,
- due to a "Check all that apply" instruction on a CRF), then
- the value for the Qualifier variable should be "MULTIPLE" and
- SUPP-- should be used to store the individual responses.]
+ - Cited Guidance:
+ 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by
+ following SDTM-specified controlled terminology and format guidelines for variables, when
+ provided]4.1.2.8.3[The SDTM permits one value for each Qualifier variable per record. If
+ multiple values exist (e.g., due to a "Check all that apply" instruction on a CRF), then
+ the value for the Qualifier variable should be "MULTIPLE" and SUPP-- should be used to
+ store the individual responses.]
Document: IG v3.2
Section: 3.2.2|4.1.2.8.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0020
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally
- indicated by following SDTM-specified controlled terminology
- and format guidelines for variables, when provided]4.2.8.3[The
- SDTM permits one value for each Qualifier variable per record.
- If multiple values exist (e.g., due to a "Check all that
- apply" instruction on a CRF), then the value for the Qualifier
- variable should be "MULTIPLE" and SUPP-- should be used to
+ - Cited Guidance:
+ 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by
+ following SDTM-specified controlled terminology and format guidelines for variables, when
+ provided]4.2.8.3[The SDTM permits one value for each Qualifier variable per record. If
+ multiple values exist (e.g., due to a "Check all that apply" instruction on a CRF), then
+ the value for the Qualifier variable should be "MULTIPLE" and SUPP-- should be used to
store the individual responses.]
Document: IG v3.3
Section: 3.2.2|4.2.8.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0020
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Core:
Id: CORE-000344
Status: Draft
- Version: '1'
-Description: Trigger error if the value of a variable, which is associated with
- an extensible codelist, is in the associated codelist or equal to 'MULTIPLE'
+ Version: "1"
+Description: Trigger error if the value of a variable, which is associated with an extensible
+ codelist, is in the associated codelist or equal to 'MULTIPLE'
Executability: Not Executable
Outcome:
- Message: Variable is not equal to value within the extensible codelist, nor
- equal to MULTIPLE
+ Message: Variable is not equal to value within the extensible codelist, nor equal to MULTIPLE
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CORE-000345/rule.yml b/Unpublished/SDTMIG/CORE-000345/rule.yml
index fe62b7e49..b5c2d95e6 100644
--- a/Unpublished/SDTMIG/CORE-000345/rule.yml
+++ b/Unpublished/SDTMIG/CORE-000345/rule.yml
@@ -7,66 +7,63 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: Conformance with the SDTMIG Domain Models is minimally indicated
- by following SDTM-specified controlled terminology and format
- guidelines for variables, when provided
+ - Cited Guidance: Conformance with the SDTMIG Domain Models is minimally indicated by
+ following SDTM-specified controlled terminology and format guidelines for variables, when
+ provided
Document: IG v3.4
Section: 3.2.2
- - Cited Guidance: When the CRF includes a list of values for a qualifier field
- that includes "Other" and the "Other" is supplemented with a
- "Specify" free text field
+ - Cited Guidance:
+ When the CRF includes a list of values for a qualifier field that includes
+ "Other" and the "Other" is supplemented with a "Specify" free text field
Document: IG v3.4
Section: 4.2.7.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0021
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally
- indicated by following SDTM-specified controlled terminology
- and format guidelines for variables, when
- provided]|4.1.2.7.1[When the CRF includes a list of values for
- a qualifier field that includes "Other" and the "Other" is
- supplemented with a "Specify" free text field,]
+ - Cited Guidance:
+ 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by
+ following SDTM-specified controlled terminology and format guidelines for variables, when
+ provided]|4.1.2.7.1[When the CRF includes a list of values for a qualifier field that
+ includes "Other" and the "Other" is supplemented with a "Specify" free text field,]
Document: IG v3.2
Section: 3.2.2|4.1.2.7.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0021
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally
- indicated by following SDTM-specified controlled terminology
- and format guidelines for variables, when
- provided]|4.2.7.1[When the CRF includes a list of values for a
- qualifier field that includes "Other" and the "Other" is
- supplemented with a "Specify" free text field,]
+ - Cited Guidance:
+ 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by
+ following SDTM-specified controlled terminology and format guidelines for variables, when
+ provided]|4.2.7.1[When the CRF includes a list of values for a qualifier field that
+ includes "Other" and the "Other" is supplemented with a "Specify" free text field,]
Document: IG v3.3
Section: 3.2.2|4.2.7.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0021
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Core:
Id: CORE-000345
Status: Draft
- Version: '1'
-Description: Trigger error if the value of a variable, which is associated with
- an extensible codelist, is in the associated codelist or equal to 'OTHER'
+ Version: "1"
+Description: Trigger error if the value of a variable, which is associated with an extensible
+ codelist, is in the associated codelist or equal to 'OTHER'
Executability: Not Executable
Outcome:
- Message: Variable is not equal to value within the extensible codelist, nor
- equal to OTHER
+ Message: Variable is not equal to value within the extensible codelist, nor equal to OTHER
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CORE-000346/rule.yml b/Unpublished/SDTMIG/CORE-000346/rule.yml
index 11ffac590..e36307550 100644
--- a/Unpublished/SDTMIG/CORE-000346/rule.yml
+++ b/Unpublished/SDTMIG/CORE-000346/rule.yml
@@ -7,49 +7,52 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A value which represents an alteration to a collected value for
- coding purposes. Synonym Qualifier of --TERM.
+ - Cited Guidance:
+ A value which represents an alteration to a collected value for coding
+ purposes. Synonym Qualifier of --TERM.
Document: Model v2.0
Item: --MODIFY
Section: Events
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0047
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If the value for --TERM is modified for coding purposes, then
- the modified text is placed here.
+ - Cited Guidance:
+ If the value for --TERM is modified for coding purposes, then the modified
+ text is placed here.
Document: Model v1.4
Item: Table 2.2.2
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0047
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If the value for --TERM is modified for coding purposes, then
- the modified text is placed here.
+ - Cited Guidance:
+ If the value for --TERM is modified for coding purposes, then the modified
+ text is placed here.
Document: Model v1.7
Item: Table 2.2.2.1
Section: 2.2.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0047
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Core:
Id: CORE-000346
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when --TERM has been modified for coding and --MODIFY is null
Executability: Not Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CORE-000347/rule.yml b/Unpublished/SDTMIG/CORE-000347/rule.yml
index 07583dd8d..e16a5a405 100644
--- a/Unpublished/SDTMIG/CORE-000347/rule.yml
+++ b/Unpublished/SDTMIG/CORE-000347/rule.yml
@@ -7,54 +7,56 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When DSCAT = "DISPOSITION EVENT" DSTERM contains either
- "COMPLETED" or, if the subject did not complete, specific
- verbatim information about the reason for non-completion
+ - Cited Guidance:
+ When DSCAT = "DISPOSITION EVENT" DSTERM contains either "COMPLETED" or, if
+ the subject did not complete, specific verbatim information about the reason for
+ non-completion
Document: IG v3.4
Item: Assumption 3b
Section: 6.2.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0071
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When DSCAT='DISPOSITION EVENT", DSTERM contains either
- "COMPLETED" or, if the subject did not complete, specific
- verbatim information about the disposition event
+ - Cited Guidance:
+ When DSCAT='DISPOSITION EVENT", DSTERM contains either "COMPLETED" or, if
+ the subject did not complete, specific verbatim information about the disposition event
Document: IG v3.2
Item: Assumption 3a
- Section: '6.2'
+ Section: "6.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0071
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: When DSCAT = "DISPOSITION EVENT" DSTERM contains either
- "COMPLETED" or, if the subject did not complete, specific
- verbatim information about the reason for non-completion
+ - Cited Guidance:
+ When DSCAT = "DISPOSITION EVENT" DSTERM contains either "COMPLETED" or, if
+ the subject did not complete, specific verbatim information about the reason for
+ non-completion
Document: IG v3.3
Item: Assumption 3b
Section: 6.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0071
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: When DSCAT = "DISPOSITION EVENT" DSTERM contains
- either "COMPLETED" or, if the subject did not complete,
- specific verbatim information about the reason for
+ - Cited Guidance:
+ When DSCAT = "DISPOSITION EVENT" DSTERM contains either "COMPLETED" or, if
+ the subject did not complete, specific verbatim information about the reason for
non-completion
Document: TIG v1.0
Item: Assumption 3b
@@ -62,20 +64,20 @@ Authorities:
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0340
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Core:
Id: CORE-000347
Status: Draft
- Version: '1'
-Description: Trigger error when DSCAT = 'DISPOSITION EVENT' and DSTERM does not
- equal 'COMPLETED' or the reason for discontinuation
+ Version: "1"
+Description: Trigger error when DSCAT = 'DISPOSITION EVENT' and DSTERM does not equal 'COMPLETED' or
+ the reason for discontinuation
Executability: Not Executable
Outcome:
- Message: DSTERM does not equal 'COMPLETED' or the reason for discontinuation
- when DSCAT = 'DISPOSITION EVENT'
+ Message: DSTERM does not equal 'COMPLETED' or the reason for discontinuation when DSCAT =
+ 'DISPOSITION EVENT'
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SDTMIG/CORE-000348/rule.yml b/Unpublished/SDTMIG/CORE-000348/rule.yml
index 9512156da..0539746b8 100644
--- a/Unpublished/SDTMIG/CORE-000348/rule.yml
+++ b/Unpublished/SDTMIG/CORE-000348/rule.yml
@@ -1,5 +1,5 @@
# Variable: GEN
-# Condition:
+# Condition:
# Rule: Event is not derived
Authorities:
- Organization: CDISC
@@ -7,54 +7,54 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The DV domain is an Events model for collected protocol
- deviations and not for derived protocol deviations that are
- more likely to be part of analysis.
+ - Cited Guidance:
+ The DV domain is an Events model for collected protocol deviations and not
+ for derived protocol deviations that are more likely to be part of analysis.
Document: IG v3.4
Item: Assumption 1
Section: 6.2.7
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0076
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The DV domain is an Events model for collected protocol
- deviations and not for derived protocol deviations that are
- more likely to be part of analysis
+ - Cited Guidance:
+ The DV domain is an Events model for collected protocol deviations and not
+ for derived protocol deviations that are more likely to be part of analysis
Document: IG v3.2
Item: Assumption 1
- Section: '6.2'
+ Section: "6.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0076
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: The DV domain is an Events model for collected protocol
- deviations and not for derived protocol deviations that are
- more likely to be part of analysis.
+ - Cited Guidance:
+ The DV domain is an Events model for collected protocol deviations and not
+ for derived protocol deviations that are more likely to be part of analysis.
Document: IG v3.3
Item: Assumption 1
Section: 6.2.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0076
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Core:
Id: CORE-000348
Status: Draft
- Version: '1'
-Description: Trigger error if deviation record is a derived variable, not a
- deviation that was collected
+ Version: "1"
+Description: Trigger error if deviation record is a derived variable, not a deviation that was
+ collected
Executability: Not Executable
Outcome:
Message: Deviation event must not be derived deviation
diff --git a/Unpublished/SDTMIG/CORE-000349/rule.yml b/Unpublished/SDTMIG/CORE-000349/rule.yml
index 8b83f57c9..4931d9481 100644
--- a/Unpublished/SDTMIG/CORE-000349/rule.yml
+++ b/Unpublished/SDTMIG/CORE-000349/rule.yml
@@ -1,5 +1,5 @@
# Variable: CMTRT
-# Condition:
+# Condition:
# Rule: CMTRT = collected medication name only
Authorities:
- Organization: CDISC
@@ -7,52 +7,52 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: CMTRT should only include the medication/therapy name and should
- not include dosage, formulation, or other qualifying
- information.
+ - Cited Guidance:
+ CMTRT should only include the medication/therapy name and should not include
+ dosage, formulation, or other qualifying information.
Document: IG v3.4
Item: Assumption 2a
Section: 6.1.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0098
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: CMTRT should only include the medication/therapy name and should
- not include dosage, formulation, or other qualifying
- information.
+ - Cited Guidance:
+ CMTRT should only include the medication/therapy name and should not include
+ dosage, formulation, or other qualifying information.
Document: IG v3.2
Item: Assumption 2a
- Section: '6.1'
+ Section: "6.1"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0098
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: CMTRT should only include the medication/therapy name and should
- not include dosage, formulation, or other qualifying
- information.
+ - Cited Guidance:
+ CMTRT should only include the medication/therapy name and should not include
+ dosage, formulation, or other qualifying information.
Document: IG v3.3
Item: Assumption 2a
Section: 6.1.2
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0098
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Core:
Id: CORE-000349
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error if CMTRT contains more than just the medication name
Executability: Not Executable
Outcome:
diff --git a/Unpublished/SDTMIG/CORE-000350/rule.yml b/Unpublished/SDTMIG/CORE-000350/rule.yml
index 6926731d4..74b7174e6 100644
--- a/Unpublished/SDTMIG/CORE-000350/rule.yml
+++ b/Unpublished/SDTMIG/CORE-000350/rule.yml
@@ -7,49 +7,52 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A value which represents an alteration to a collected value for
- coding purposes. Synonym Qualifier of --TRT.
+ - Cited Guidance:
+ A value which represents an alteration to a collected value for coding
+ purposes. Synonym Qualifier of --TRT.
Document: Model v2.0
Item: --MODIFY
Section: Interventions
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0099
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If the value for --TRT is modified for coding purposes, then the
- modified text is placed here.
+ - Cited Guidance:
+ If the value for --TRT is modified for coding purposes, then the modified
+ text is placed here.
Document: Model v1.4
Section: 2.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0099
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: If the value for --TRT is modified for coding purposes, then the
- modified text is placed here.
+ - Cited Guidance:
+ If the value for --TRT is modified for coding purposes, then the modified
+ text is placed here.
Document: Model v1.7
Section: 2.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0099
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
Core:
Id: CORE-000350
Status: Draft
- Version: '1'
-Description: Trigger error if --TRT represents an alteration to the collected
- value for coding purposes and --MODIFY is null
+ Version: "1"
+Description: Trigger error if --TRT represents an alteration to the collected value for coding
+ purposes and --MODIFY is null
Executability: Not Executable
Outcome:
Message: --MODIFY is null when --TRT represents an alteration to the collected value.
diff --git a/Unpublished/SDTMIG/CORE-000536/rule.yml b/Unpublished/SDTMIG/CORE-000536/rule.yml
index 67dbc123e..5e48d7a85 100644
--- a/Unpublished/SDTMIG/CORE-000536/rule.yml
+++ b/Unpublished/SDTMIG/CORE-000536/rule.yml
@@ -1,5 +1,5 @@
# Variable: ARMCD
-# Condition:
+# Condition:
# Rule: ARMCD is a valid planned arm code
Authorities:
- Organization: CDISC
@@ -7,63 +7,60 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A trial design domain that contains each planned arm in the
- trial.
+ - Cited Guidance: A trial design domain that contains each planned arm in the trial.
Document: IG 3.4
- Item: ''
+ Item: ""
Section: 7.2.1 TA
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0415
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: The trial arms table describes each planned arm in the trial.
Document: IG v3.2
- Section: '7.2'
+ Section: "7.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0415
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: A trial design domain that contains each planned arm in the
- trial.
+ - Cited Guidance: A trial design domain that contains each planned arm in the trial.
Document: IG v3.3
Section: 7.2.1
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0415
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: TIG
References:
- Citations:
- - Cited Guidance: A trial design domain that contains each planned arm in the
- trial.
+ - Cited Guidance: A trial design domain that contains each planned arm in the trial.
Document: TIG 1.0
- Item: ''
+ Item: ""
Section: 2.8.10.27
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0570
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SDTM
- Version: '1.0'
+ Version: "1.0"
Check:
all:
Core:
Id: CORE-000536
Status: Draft
- Version: '1'
+ Version: "1"
Description: Verify that ARMCD in TA domain is valid planned arm code
Executability: Not Executable
Outcome:
diff --git a/Unpublished/SDTMIG/NICRULE.MEDDRA/rule.yml b/Unpublished/SDTMIG/NICRULE.MEDDRA/rule.yml
index d48ff4493..f9b7e4110 100644
--- a/Unpublished/SDTMIG/NICRULE.MEDDRA/rule.yml
+++ b/Unpublished/SDTMIG/NICRULE.MEDDRA/rule.yml
@@ -6,34 +6,34 @@ Authorities:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: NICRULE.MEDDRA
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: NICRULE.MEDDRA
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: NICRULE.MEDDRA
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: $valid_code_term_pairs
operator: not_equal_to
value: true
Core:
- Id: ''
+ Id: ""
Status: Draft
- Version: '1'
+ Version: "1"
Description: MEDDRA CODE TERM PAIRS are wrong for SOCCD
Operations:
- id: $valid_code_term_pairs
diff --git a/Unpublished/SDTMIG/NicTest/rule.yml b/Unpublished/SDTMIG/NicTest/rule.yml
index 13c053fbf..6076fdb18 100644
--- a/Unpublished/SDTMIG/NicTest/rule.yml
+++ b/Unpublished/SDTMIG/NicTest/rule.yml
@@ -2,23 +2,22 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
- Version: '3.3'
References:
- - Origin: SDTM and SDTMIG Conformance Rules
- Rule Identifier:
- Id: Demo
- Version: '1.0'
- Version: '2.0'
- Citations:
- - Cited Guidance: For example, if 0 tablets are taken within a timeframe
- or 0 mL infused at a visit, then ECOCCUR = 'N' is the standard representation
- of the collected doses not taken, not given, or missed. Dose amount
- variables (e.g., ECDOSE, ECDOSTXT) must not be set to zero (0) as
- an alternative method for indicating doses not taken, not given,
- or missed.
+ - Citations:
+ - Cited Guidance:
+ For example, if 0 tablets are taken within a timeframe or 0 mL infused at a
+ visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken,
+ not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to
+ zero (0) as an alternative method for indicating doses not taken, not given, or missed.
Document: SDTMIG v3.3
Item: Assumption 4a
Section: 6.1.3.2
+ Origin: SDTM and SDTMIG Conformance Rules
+ Rule Identifier:
+ Id: Demo
+ Version: "1.0"
+ Version: "2.0"
+ Version: "3.3"
Check:
all:
- name: EXOCCUR
@@ -27,7 +26,7 @@ Check:
Core:
Id: NicTest
Status: Draft
- Version: '1'
+ Version: "1"
Description: Verify the value for ECDOSE is less than 0
Outcome:
Message: ECDOSE is less than or equal to 0
diff --git a/Unpublished/SDTMIG/WHODrug/rule.yml b/Unpublished/SDTMIG/WHODrug/rule.yml
index 0aba16261..259f1d750 100644
--- a/Unpublished/SDTMIG/WHODrug/rule.yml
+++ b/Unpublished/SDTMIG/WHODrug/rule.yml
@@ -6,25 +6,25 @@ Authorities:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: WHODrug
- Version: '1'
- Version: '2.0'
- Version: '3.4'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.4"
- Name: SDTMIG
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: WHODrug
- Version: '1'
- Version: '2.0'
- Version: '3.3'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.3"
- Name: SDTMIG
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: WHODrug
- Version: '1'
- Version: '2.0'
- Version: '3.2'
+ Version: "1"
+ Version: "2.0"
+ Version: "3.2"
Check:
all:
- name: $valid_whodrug_codes
@@ -33,7 +33,7 @@ Check:
Core:
Id: WHODrug
Status: Draft
- Version: '1'
+ Version: "1"
Description: WHODRUG hierarchy is valid in provided whodrug dictionary version
Executability: Fully Executable
Operations:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml
index 7832893ee..fe19d66ee 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml
@@ -4,81 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The sponsor must define what collected date is used to populate
- RFENDTC in the data define file.
+ - Cited Guidance:
+ The sponsor must define what collected date is used to populate RFENDTC in
+ the data define file.
Document: IG v3.0
- Section: '5.1.1'
+ Section: "5.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND101
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The sponsor must define what collected date is used to populate
- RFENDTC in the data define file.
+ - Cited Guidance:
+ The sponsor must define what collected date is used to populate RFENDTC in
+ the data define file.
Document: IG v3.1
- Section: '5.1.1'
+ Section: "5.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND101
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The sponsor must define what collected date is used to populate
- RFENDTC in the data define file.
+ - Cited Guidance:
+ The sponsor must define what collected date is used to populate RFENDTC in
+ the data define file.
Document: IG v3.1.1
- Section: '5.1.1'
+ Section: "5.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND101
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The sponsor must define what collected date is used to populate
- RFENDTC in the data define file.
+ - Cited Guidance:
+ The sponsor must define what collected date is used to populate RFENDTC in
+ the data define file.
Document: IG v3.1.1
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND101
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The sponsor must define what collected date is used to populate
- RFENDTC in the data define file.
+ - Cited Guidance:
+ The sponsor must define what collected date is used to populate RFENDTC in
+ the data define file.
Document: IG v3.1
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND101
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The sponsor must define what collected date is used to populate
- RFENDTC in the data define file.
+ - Cited Guidance:
+ The sponsor must define what collected date is used to populate RFENDTC in
+ the data define file.
Document: IG v3.1.1
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND101
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: variable_name
@@ -88,21 +94,20 @@ Check:
# TODO: change into define_variable_has_method (function requested https://github.com/cdisc-org/cdisc-rules-engine/issues/1047)
- name: define_variable_has_comment
operator: equal_to
- value: false
- #- name: define_variable_origin_type
- # operator: equal_to
- # value: Derived
+ value:
+ false
+ #- name: define_variable_origin_type
+ # operator: equal_to
+ # value: Derived
Core:
Id: CDISC.SENDIG.101
Status: Draft
- Version: '1'
-Description: Raise a message when the define.xml does not explain how DM.RFENDTC
- was populated, using either def:CommentOID (on ItemDef) or MethodOID (on
- ItemRef)
+ Version: "1"
+Description: Raise a message when the define.xml does not explain how DM.RFENDTC was populated,
+ using either def:CommentOID (on ItemDef) or MethodOID (on ItemRef)
Executability: Partially Executable - Possible Underreporting
Outcome:
- Message: No 'method' (through @MethodOID/MethodDef) has been assigned to the
- variable RFENDTC
+ Message: No 'method' (through @MethodOID/MethodDef) has been assigned to the variable RFENDTC
# Rule Type: Value Check against Define XML Variable
Rule Type: Variable Metadata Check against Define XML
Scope:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml
index d4de8277e..7cf879a49 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml
@@ -4,78 +4,78 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If this variable is excluded in the DM domain, the information
- must be present at a higher level (either Trial Sets or Trial
- Summary).
+ - Cited Guidance:
+ If this variable is excluded in the DM domain, the information must be
+ present at a higher level (either Trial Sets or Trial Summary).
Document: IG v3.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND105
- Version: '2'
- Version: '5.0'
- Version: '3.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If this variable is excluded in the DM domain, the information
- must be present at a higher level (either Trial Sets or Trial
- Summary).
+ - Cited Guidance:
+ If this variable is excluded in the DM domain, the information must be
+ present at a higher level (either Trial Sets or Trial Summary).
Document: IG v3.1.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND105
- Version: '2'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If this variable is excluded in the DM domain, the information
- must be present at a higher level (either Trial Sets or Trial
- Summary).
+ - Cited Guidance:
+ If this variable is excluded in the DM domain, the information must be
+ present at a higher level (either Trial Sets or Trial Summary).
Document: IG v3.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND105
- Version: '2'
- Version: '5.0'
- Version: '1.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If this variable is excluded in the DM domain, the information
- must be present at a higher level (either Trial Sets or Trial
- Summary).
+ - Cited Guidance:
+ If this variable is excluded in the DM domain, the information must be
+ present at a higher level (either Trial Sets or Trial Summary).
Document: IG v3.1.2
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND105
- Version: '2'
- Version: '5.0'
- Version: '1.2'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: If this variable is excluded in the DM domain, the information
- must be present at a higher level (either Trial Sets or Trial
- Summary).
+ - Cited Guidance:
+ If this variable is excluded in the DM domain, the information must be
+ present at a higher level (either Trial Sets or Trial Summary).
Document: IG v3.1.2
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND105
- Version: '2'
- Version: '5.0'
- Version: '1.0'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.0"
Check:
# Rule applies for the case that all of DM, TS, and TX are all present
# which applies to >99% of the cases
@@ -83,26 +83,26 @@ Check:
all:
# DM: SPECIES variable does not exists
- name: SPECIES
- operator: not_exists
- # There is no TSPARMCD=SPECIES in TS
- #- name: $distinct_tsparmcd
- # operator: does_not_contain
- # value: SPECIES
- # value_is_literal: true
- #- all:
- # #- name: TX
- # # operator: non_empty
- # - name: $distinct_txparmcd
- # operator: is_not_contained_by
- # value: SPECIES
- # #value_is_literal: true
+ operator:
+ not_exists
+ # There is no TSPARMCD=SPECIES in TS
+ #- name: $distinct_tsparmcd
+ # operator: does_not_contain
+ # value: SPECIES
+ # value_is_literal: true
+ #- all:
+ # #- name: TX
+ # # operator: non_empty
+ # - name: $distinct_txparmcd
+ # operator: is_not_contained_by
+ # value: SPECIES
+ # #value_is_literal: true
Core:
Id: CDISC.SENDIG.105
Status: Draft
- Version: '1'
-Description: Raise an error when the variable SPECIES is not present in DM, and
- there is no record TSPARMCD=SPECIES in TS and there is no record
- TXPARMCD=SPECIES in TX
+ Version: "1"
+Description: Raise an error when the variable SPECIES is not present in DM, and there is no record
+ TSPARMCD=SPECIES in TS and there is no record TXPARMCD=SPECIES in TX
Executability: Fully Executable
#Operations:
# gets the distinct values of TSPARMCD
@@ -120,8 +120,8 @@ Executability: Fully Executable
# name: TXPARMCD
# operator: distinct
Outcome:
- Message: SPECIES in not present in DM and there is no record TSPARMCD=SPECIES in
- TS and there is no record TXPARMCD=SPECIES in TX
+ Message: SPECIES in not present in DM and there is no record TSPARMCD=SPECIES in TS and there is
+ no record TXPARMCD=SPECIES in TX
#Output Variables:
# - $distinct_tsparmcd
# - $distinct_txparmcd
@@ -136,6 +136,6 @@ Scope:
Domains:
Include:
- DM
- # - ALL
- # Sensitivity: Record
+ # - ALL
+ # Sensitivity: Record
Sensitivity: Dataset
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml
index e1d6543ae..6edd4cd61 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml
@@ -4,17 +4,16 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: DM.ARMCD; Should be populated when Arms have been defined in the
- TA domain.
+ - Cited Guidance: DM.ARMCD; Should be populated when Arms have been defined in the TA domain.
Document: IG v3.1
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND107
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
Check:
all:
# TODO: operator "exists" must act on the set of datasets (i.e. the whole submission)
@@ -23,7 +22,7 @@ Check:
# check on value for DM.ARMCD
#- name: ARMCD
# operator: empty
- # 2024-03-15: starting from Wiki under 'operations',
+ # 2024-03-15: starting from Wiki under 'operations',
# Flag an error if MIDS is in the dataset currently being evaluated and the TM domain is not present in the study
# check whether TA dataset is present (in combination with Rule Type: Domain Presence Check)
#- name: TA
@@ -33,10 +32,11 @@ Check:
# value: true
# Just trying an alternative 2024-06-04
- name: ARMCD
- operator: empty
- #- name: $TA_exists
- # operator: equal_to
- # value: true
+ operator:
+ empty
+ #- name: $TA_exists
+ # operator: equal_to
+ # value: true
- name: $TA_present
operator: equal_to
value: true
@@ -44,26 +44,27 @@ Check:
Core:
Id: CDISC.SENDIG.107
Status: Draft
- Version: '1'
-Description: When study does not use multi-stage arm assignments and ARMCD is
- populated, ARMCD must be present in TA.ARMCD. This rule has been executed to
- identify all cases when ARMCD is not present in TA.ARMCD and therefore
- acknowledges that false positives may be recorded when multi-stage arm
- assignments are in use.
+ Version: "1"
+Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must
+ be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not
+ present in TA.ARMCD and therefore acknowledges that false positives may be recorded when
+ multi-stage arm assignments are in use.
Executability: Fully Executable
Operations:
- domain: DM # necessary?
id: $DM_ARMCD_null
name: ARMCD
- operator: variable_is_null
- # Alternative approach 2024-06-04
- # BUT this fails when there is no TA dataset at all
+ operator:
+ variable_is_null
+ # Alternative approach 2024-06-04
+ # BUT this fails when there is no TA dataset at all
- domain: TA
id: $TA_exists
name: ARMCD
- operator: variable_exists
- # 2024-06-04: does this check whether TA is present in the study?
- # NO: it doesn't like that it works as I was thinking
+ operator:
+ variable_exists
+ # 2024-06-04: does this check whether TA is present in the study?
+ # NO: it doesn't like that it works as I was thinking
- id: $TA_present
name: TA
operator: study_domains
@@ -75,9 +76,9 @@ Scope:
Classes:
Include:
- SPECIAL PURPOSE
- # - ALL
+ # - ALL
Domains:
Include:
- DM
- # - TA # ?
+ # - TA # ?
Sensitivity: Record
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.111/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.111/rule.yml
index 3fbc1c34e..047511805 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.111/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.111/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND111
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND111
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -34,9 +34,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND111
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
@@ -46,9 +46,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND111
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
@@ -58,9 +58,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND111
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -70,9 +70,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND111
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: variable_name
@@ -84,7 +84,7 @@ Check:
Core:
Id: CDISC.SENDIG.111
Status: Draft
- Version: '1'
+ Version: "1"
Description: Check 'BRTHDTC ORIGIN = collected in the Define-XML document'
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml
index 65ca53656..509da38d8 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml
@@ -4,114 +4,123 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm
- involving BRTHDTC and RFSTDTC. Sponsors should indicate how
- AGE was populated in the define file comments.
+ - Cited Guidance:
+ Sponsors may choose to derive AGE and AGEU using an algorithm involving
+ BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file
+ comments.
Document: IG v3.0
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND112.1
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm
- involving BRTHDTC and RFSTDTC. Sponsors should indicate how
- AGE was populated in the define file comments.
+ - Cited Guidance:
+ Sponsors may choose to derive AGE and AGEU using an algorithm involving
+ BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file
+ comments.
Document: IG v3.1
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND112.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm
- involving BRTHDTC and RFSTDTC. Sponsors should indicate how
- AGE was populated in the define file comments.
+ - Cited Guidance:
+ Sponsors may choose to derive AGE and AGEU using an algorithm involving
+ BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file
+ comments.
Document: IG v3.1.1
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND112.1
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm
- involving BRTHDTC and RFSTDTC. Sponsors should indicate how
- AGE was populated in the define file comments.
+ - Cited Guidance:
+ Sponsors may choose to derive AGE and AGEU using an algorithm involving
+ BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file
+ comments.
Document: IG v3.1.1
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND112.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm
- involving BRTHDTC and RFSTDTC. Sponsors should indicate how
- AGE was populated in the define file comments.
+ - Cited Guidance:
+ Sponsors may choose to derive AGE and AGEU using an algorithm involving
+ BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file
+ comments.
Document: IG v3.1
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND112.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm
- involving BRTHDTC and RFSTDTC. Sponsors should indicate how
- AGE was populated in the define file comments.
+ - Cited Guidance:
+ Sponsors may choose to derive AGE and AGEU using an algorithm involving
+ BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file
+ comments.
Document: IG v3.1.1
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND112.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: variable_name
operator: equal_to
- value: AGE
- # This may cause to be "overreporting", as there is no function define_variable_is_derived
- # but essentially, AGE should not be "assigned"
+ value:
+ AGE
+ # This may cause to be "overreporting", as there is no function define_variable_is_derived
+ # but essentially, AGE should not be "assigned"
- name: define_variable_is_collected
operator: equal_to
value: false
- name: define_variable_has_comment
operator: equal_to
- value: false
- # Commented out for the moment, as awaiting new function
- #- name: define_variable_has_method
- # operator: equal_to
- # value: false
+ value:
+ false
+ # Commented out for the moment, as awaiting new function
+ #- name: define_variable_has_method
+ # operator: equal_to
+ # value: false
Core:
Id: CDISC.SENDIG.112
Status: Draft
- Version: '1'
-Description: When AGE is described as "derived" in the define.xml, check whether
- either a Method or a Comment is assigned to the variable AGE in the define.xml
+ Version: "1"
+Description: When AGE is described as "derived" in the define.xml, check whether either a Method or
+ a Comment is assigned to the variable AGE in the define.xml
Executability: Partially Executable - Possible Overreporting
Outcome:
- Message: 'When AGE is described as "derived" in the define.xml, either a Comment
- or a Method must be associated to the variable in the define.xml'
+ Message:
+ 'When AGE is described as "derived" in the define.xml, either a Comment or a Method must be
+ associated to the variable in the define.xml'
Rule Type: Value Check against Define XML Variable
Scope:
Classes:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml
index d4fb5b3da..20eed8d57 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml
@@ -4,35 +4,35 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Because there are no time gaps between Elements, the
- SEENDTC value for the last Element is the date of subject disposition.
- # ATTENTION: only applicable to SENDIG-3.0
- # REPLACED by rule 284 as of SENDIG-3-1
+ - Cited Guidance:
+ Because there are no time gaps between Elements, the SEENDTC value for the
+ last Element is the date of subject disposition.
+ # ATTENTION: only applicable to SENDIG-3.0
+ # REPLACED by rule 284 as of SENDIG-3-1
Document: IG v3.0
Item: Specification
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND127
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
Check:
all:
# TODO: operator "exists" must act on the set of datasets (i.e. the whole submission)
- name: SEENDTC
operator: not_equal_to
- value: '2006-06-10'
+ value: "2006-06-10"
Core:
Id: CDISC.SENDIG.127
Status: Draft
- Version: '1'
-Description: Because there are no time gaps between Elements, the SEENDTC value for
- the last Element is the date of subject disposition.
+ Version: "1"
+Description: Because there are no time gaps between Elements, the SEENDTC value for the last Element
+ is the date of subject disposition.
Executability: Fully Executable
Outcome:
- Message: SEENDTC value of last element in SE is not equal to DSSTDTC in DS for the
- subject
+ Message: SEENDTC value of last element in SE is not equal to DSSTDTC in DS for the subject
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml
index 83ef5d2e6..66280d53f 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml
@@ -4,17 +4,18 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The Define-XML document contains an explanation of
- EXDOSE values with respect for intended or actual dose levels.
+ - Cited Guidance:
+ The Define-XML document contains an explanation of EXDOSE values with
+ respect for intended or actual dose levels.
Document: IG v3.1
Item: Assumption 4
Section: 6.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND137
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
Check:
all:
- name: variable_name
@@ -26,14 +27,13 @@ Check:
Core:
Id: CDISC.SENDIG.137
Status: Draft
- Version: '1'
-Description: Raise a message when the define.xml does not contain an explanation of
- EXDOSE values with respect for intended or actual dose levels, using a reference
- to a def:CommentDef
+ Version: "1"
+Description: Raise a message when the define.xml does not contain an explanation of EXDOSE values
+ with respect for intended or actual dose levels, using a reference to a def:CommentDef
Executability: Partially Executable - Possible Underreporting
Outcome:
- Message: The define.xml does not contain an explanation of EXDOSE values with respect
- for intended or actual dose levels
+ Message: The define.xml does not contain an explanation of EXDOSE values with respect for intended
+ or actual dose levels
# Rule Type: Value Check against Define XML Variable
Rule Type: Variable Metadata Check against Define XML
Scope:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml
index f458f5ad9..cd53c5738 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml
@@ -4,71 +4,71 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per subject. The disposition dataset provides a
- record of the final disposition of subjects as they reach
- their final disposition, and this can be recorded at any stage
- throughout the study. At study completion, one record must
- exist for each subject used in the study.
+ - Cited Guidance:
+ One record per subject. The disposition dataset provides a record of the
+ final disposition of subjects as they reach their final disposition, and this can be
+ recorded at any stage throughout the study. At study completion, one record must exist for
+ each subject used in the study.
Document: IG v3.0
Item: Assumption 1.a
Section: 6.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND140
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per subject. The disposition dataset provides a
- record of the final disposition of subjects as they reach
- their final disposition, and this can be recorded at any stage
- throughout the study. At study completion, one record must
- exist for each subject used in the study.
+ - Cited Guidance:
+ One record per subject. The disposition dataset provides a record of the
+ final disposition of subjects as they reach their final disposition, and this can be
+ recorded at any stage throughout the study. At study completion, one record must exist for
+ each subject used in the study.
Document: IG v3.1
Item: Assumption 1.a
Section: 6.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND140
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: One record per subject. The disposition dataset provides a
- record of the final disposition of subjects as they reach
- their final disposition, and this can be recorded at any stage
- throughout the study. At study completion, one record must
- exist for each subject used in the study.
+ - Cited Guidance:
+ One record per subject. The disposition dataset provides a record of the
+ final disposition of subjects as they reach their final disposition, and this can be
+ recorded at any stage throughout the study. At study completion, one record must exist for
+ each subject used in the study.
Document: IG v3.1.1
Item: Assumption 1.a
Section: 6.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND140
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: One record per subject. The disposition dataset provides a
- record of the final disposition of subjects as they reach
- their final disposition, and this can be recorded at any stage
- throughout the study. At study completion, one record must
- exist for each subject used in the study.
+ - Cited Guidance:
+ One record per subject. The disposition dataset provides a record of the
+ final disposition of subjects as they reach their final disposition, and this can be
+ recorded at any stage throughout the study. At study completion, one record must exist for
+ each subject used in the study.
Document: IG v3.1
Item: Assumption 1.a
Section: 6.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND140
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
Check:
# Rule: DS has one record per USUBJID in DM
any:
@@ -85,13 +85,14 @@ Check:
operator: non_empty
- name: USUBJID
operator: is_not_contained_by
- value: $ds_usubjid
- # TODO: how do we express that for each record in DM, there must exactly be one record in DS?
+ value:
+ $ds_usubjid
+ # TODO: how do we express that for each record in DM, there must exactly be one record in DS?
Core:
Id: CDISC.SENDIG.140
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when USUBJID is not present in DM in DM.USUBJID
Executability: Fully Executable
Operations:
@@ -104,8 +105,7 @@ Operations:
name: USUBJID
operator: distinct
Outcome:
- Message: There is no record in DS or there is more than 1 record in DS for a
- record in DM
+ Message: There is no record in DS or there is more than 1 record in DS for a record in DM
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.153/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.153/rule.yml
index 6d00ddf1f..b58706a44 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.153/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.153/rule.yml
@@ -4,87 +4,88 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to
- kg, but the BGSTRESU should remain consistent throughout the
- course of the study.
+ - Cited Guidance:
+ The BGORRESU may change over the course of the study, e.g., g to kg, but the
+ BGSTRESU should remain consistent throughout the course of the study.
Document: IG v3.1
Section: 6.3.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND153
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The BGORRESU for a subject may change over the course of the
- study, for example, g to kg, but the BGSTRESU should remain
- consistent throughout the course of the study.
+ - Cited Guidance:
+ The BGORRESU for a subject may change over the course of the study, for
+ example, g to kg, but the BGSTRESU should remain consistent throughout the course of the
+ study.
Document: IG v3.0
Section: 6.3.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND153
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to
- kg, but the BGSTRESU should remain consistent throughout the
- course of the study.
+ - Cited Guidance:
+ The BGORRESU may change over the course of the study, e.g., g to kg, but the
+ BGSTRESU should remain consistent throughout the course of the study.
Document: IG v3.1.1
Section: 6.3.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND153
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to
- kg, but the BGSTRESU should remain consistent throughout the
- course of the study.
+ - Cited Guidance:
+ The BGORRESU may change over the course of the study, e.g., g to kg, but the
+ BGSTRESU should remain consistent throughout the course of the study.
Document: IG v3.1.1
Section: 6.3.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND153
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to
- kg, but the BGSTRESU should remain consistent throughout the
- course of the study.
+ - Cited Guidance:
+ The BGORRESU may change over the course of the study, e.g., g to kg, but the
+ BGSTRESU should remain consistent throughout the course of the study.
Document: IG v3.1
Section: 6.3.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND153
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to
- kg, but the BGSTRESU should remain consistent throughout the
- course of the study.
+ - Cited Guidance:
+ The BGORRESU may change over the course of the study, e.g., g to kg, but the
+ BGSTRESU should remain consistent throughout the course of the study.
Document: IG v3.1.1
Section: 6.3.2.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND153
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: BGSTRESU
@@ -93,7 +94,7 @@ Check:
Core:
Id: CDISC.SENDIG.153
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when BGSTRESU is not consistent within BGTESTCD
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.161/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.161/rule.yml
index 76966aafb..400c9a4c4 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.161/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.161/rule.yml
@@ -4,59 +4,63 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: CLRESCAT is used for post collection categorization
- of results and should not be a duplication of CLTEST or CLSCAT which
- are considered categories at the time of collection.
+ - Cited Guidance:
+ CLRESCAT is used for post collection categorization of results and should
+ not be a duplication of CLTEST or CLSCAT which are considered categories at the time of
+ collection.
Document: IG v.3.0
Section: 6.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND161
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: CLRESCAT is used for post collection categorization
- of results and should not be a duplication of CLTEST or CLSCAT which
- are considered categories at the time of collection.
+ - Cited Guidance:
+ CLRESCAT is used for post collection categorization of results and should
+ not be a duplication of CLTEST or CLSCAT which are considered categories at the time of
+ collection.
Document: IG v.3.1
Section: 6.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND161
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: CLRESCAT is used for post collection categorization
- of results and should not be a duplication of CLTEST or CLSCAT which
- are considered categories at the time of collection.
+ - Cited Guidance:
+ CLRESCAT is used for post collection categorization of results and should
+ not be a duplication of CLTEST or CLSCAT which are considered categories at the time of
+ collection.
Document: IG v.3.1.1
Section: 6.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND161
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: CLRESCAT is used for post collection categorization
- of results and should not be a duplication of CLTEST or CLSCAT which
- are considered categories at the time of collection.
+ - Cited Guidance:
+ CLRESCAT is used for post collection categorization of results and should
+ not be a duplication of CLTEST or CLSCAT which are considered categories at the time of
+ collection.
Document: IG v.3.1
Section: 6.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND161
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
Check:
any:
- name: CLRESCAT
@@ -68,9 +72,8 @@ Check:
Core:
Id: CDISC.SENDIG.161
Status: Draft
- Version: '1'
-Description: Trigger error when CLRESCAT is equal to CLTEST or when CLRESCAT is equal
- to CLSCAT
+ Version: "1"
+Description: Trigger error when CLRESCAT is equal to CLTEST or when CLRESCAT is equal to CLSCAT
Executability: Fully Executable
Outcome:
Message: CLRESCAT may not be equal to CLTEST and CLRESCAT may not be equal to CLSCAT
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml
index 7e8848899..a63c70466 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND180
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND180
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -34,8 +34,8 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND180
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
@@ -46,9 +46,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND180
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
#- name: MIDTC
@@ -67,28 +67,26 @@ Check:
Core:
Id: CDISC.SENDIG.180
Status: Draft
- Version: '1'
-Description: Raise an error when there is more than one record present for any
- particular Microscopic Finding in the MI Domain, for a specific subject, test
- code, specimen, laterality, directionality, anatomical region and standardized
- resulz
+ Version: "1"
+Description: Raise an error when there is more than one record present for any particular
+ Microscopic Finding in the MI Domain, for a specific subject, test code, specimen, laterality,
+ directionality, anatomical region and standardized resulz
Executability: Fully Executable
Outcome:
- Message: The Microscopic Finding record is not unique for this subject, test
- code, specimen, standardized result and laterality (when present and
- populated), directionality (when present and populated) and anatomical
- region (when present and populated)
+ Message: The Microscopic Finding record is not unique for this subject, test code, specimen,
+ standardized result and laterality (when present and populated), directionality (when present
+ and populated) and anatomical region (when present and populated)
Output Variables:
- USUBJID
- MITESTCD
- MISTRESC
- MISPEC
- # The following variables and values should also appear in the output
- # when the column is present.
- # In case it is not, we get a "skip"
- # - MILAT
- # - MIDIR
- # - MIANTREG
+ # The following variables and values should also appear in the output
+ # when the column is present.
+ # In case it is not, we get a "skip"
+ # - MILAT
+ # - MIDIR
+ # - MIANTREG
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml
index cc9b8dbef..0650a2c40 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml
@@ -6,78 +6,78 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Organ weight measurement ratios should be presented as pure
- ratios ('RATIO') or percentages (unit = %). Ratios and
- percentages should not be mixed.
+ - Cited Guidance:
+ Organ weight measurement ratios should be presented as pure ratios ('RATIO')
+ or percentages (unit = %). Ratios and percentages should not be mixed.
Document: IG v3.1
Item: Assumption 3
Section: 6.3.9.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND190.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Organ weight measurement ratios should be presented as pure
- ratios ('RATIO') or percentages (unit = %). Ratios and
- percentages should not be mixed.
+ - Cited Guidance:
+ Organ weight measurement ratios should be presented as pure ratios ('RATIO')
+ or percentages (unit = %). Ratios and percentages should not be mixed.
Document: IG v3.1.1
Item: Assumption 3
Section: 6.3.9.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND190.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Organ weight measurement ratios should be presented as pure
- ratios ('RATIO') or percentages (unit = %). Ratios and
- percentages should not be mixed.
+ - Cited Guidance:
+ Organ weight measurement ratios should be presented as pure ratios ('RATIO')
+ or percentages (unit = %). Ratios and percentages should not be mixed.
Document: IG v3.1
Item: Assumption 3
Section: 6.3.9.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND190.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Organ weight measurement ratios should be presented as pure
- ratios ('RATIO') or percentages (unit = %). Ratios and
- percentages should not be mixed.
+ - Cited Guidance:
+ Organ weight measurement ratios should be presented as pure ratios ('RATIO')
+ or percentages (unit = %). Ratios and percentages should not be mixed.
Document: IG v3.1.1
Item: Assumption 3
Section: 6.3.9.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND190.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Organ weight measurement ratios should be presented as pure
- ratios ('RATIO') or percentages (unit = %). Ratios and
- percentages should not be mixed.
+ - Cited Guidance:
+ Organ weight measurement ratios should be presented as pure ratios ('RATIO')
+ or percentages (unit = %). Ratios and percentages should not be mixed.
Document: IG v3.1.1
Item: Assumption 3
Section: 6.3.9.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND190.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
# Precondition SEND190.1:
@@ -91,8 +91,9 @@ Check:
value: OWBW
- name: OMTESTCD
operator: equal_to
- value: OWHT
- # Part: Ratios and percentages should not be mixed.
+ value:
+ OWHT
+ # Part: Ratios and percentages should not be mixed.
- all:
- name: OMSTRESU
operator: is_inconsistent_across_dataset
@@ -101,14 +102,13 @@ Check:
Core:
Id: CDISC.SENDIG.190.1B
Status: Draft
- Version: '1'
-Description: "Second part of the rule: trigger error when, for the given test,
- the value of OMSTRESU is inconsistent in the dataset when OMTESTCD is either
- OWBR, OWBW or OWHT"
+ Version: "1"
+Description:
+ "Second part of the rule: trigger error when, for the given test, the value of OMSTRESU is
+ inconsistent in the dataset when OMTESTCD is either OWBR, OWBW or OWHT"
Executability: Fully Executable
Outcome:
- Message: The organ weight standardized measurement unit must be consistent for
- the given OMTESTCD.
+ Message: The organ weight standardized measurement unit must be consistent for the given OMTESTCD.
Output Variables:
- OMTESTCD
- OMSTRESC
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml
index 88999a117..619f34ca7 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml
@@ -6,19 +6,19 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Organ measurement ratios within a single study should either be
- pure ratios with no units specified or percentages with unit
- shown as "%". It is strongly recommended that pure ratios and
- percentages should not be mixed.
+ - Cited Guidance:
+ Organ measurement ratios within a single study should either be pure ratios
+ with no units specified or percentages with unit shown as "%". It is strongly recommended
+ that pure ratios and percentages should not be mixed.
Document: IG v3.0
Item: Assumption 3
Section: 6.3.9.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND190
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
Check:
any:
@@ -29,76 +29,79 @@ Check:
value: OWHT
- name: OMSTRESU
operator: not_equal_to
- value: ''
+ value: ""
- name: OMSTRESU
operator: not_equal_to
- value: '%'
+ value: "%"
- all:
- name: OMTESTCD
operator: equal_to
value: OWBR
- name: OMSTRESU
operator: not_equal_to
- value: ''
+ value: ""
- name: OMSTRESU
operator: not_equal_to
- value: '%'
+ value: "%"
- all:
- name: OMTESTCD
operator: equal_to
value: OWBW
- name: OMSTRESU
operator: not_equal_to
- value: ''
+ value: ""
- name: OMSTRESU
operator: not_equal_to
- value: '%'
- # Part B of the rule: i.e. that within OMTESTCD, OMSTRESU=% and OMSTRESU=null may not be mixed
- # 2026-03-03: we exclude OMSTAT='NOT DONE'
- # "RATIO" is not considered here
- # OMTESTCD=OWBR: Organ to Brain Weight Ratio
- # Raise a violation when the number of OMSTRESU='%'' rcords > 0
- # AND the number of OMSTRESU=null rcords > 0
+ value:
+ "%"
+ # Part B of the rule: i.e. that within OMTESTCD, OMSTRESU=% and OMSTRESU=null may not be mixed
+ # 2026-03-03: we exclude OMSTAT='NOT DONE'
+ # "RATIO" is not considered here
+ # OMTESTCD=OWBR: Organ to Brain Weight Ratio
+ # Raise a violation when the number of OMSTRESU='%'' rcords > 0
+ # AND the number of OMSTRESU=null rcords > 0
- all:
- name: OMTESTCD
operator: equal_to
value: OWBR
- name: OMSTAT # exclude "NOT DONE" records
operator: not_equal_to
- value: 'NOT DONE'
+ value: "NOT DONE"
- name: $owbr_percent
operator: greater_than
value: 0
- name: $owbr_ratio_null_unit
operator: greater_than
- value: 0
- # OMTESTCD=OWBW: Organ to BodyWeight Ratio
- # Raise a violation when the number of OMSTRESU='%'' rcords > 0
- # AND the number of OMSTRESU=null rcords > 0
- # 2026-03-03: we exclude OMSTAT='NOT DONE'
+ value:
+ 0
+ # OMTESTCD=OWBW: Organ to BodyWeight Ratio
+ # Raise a violation when the number of OMSTRESU='%'' rcords > 0
+ # AND the number of OMSTRESU=null rcords > 0
+ # 2026-03-03: we exclude OMSTAT='NOT DONE'
- all:
- name: OMTESTCD
operator: equal_to
value: OWBW
- name: OMSTAT # exclude "NOT DONE" records
operator: not_equal_to
- value: 'NOT DONE'
+ value: "NOT DONE"
- name: $owbw_percent
operator: greater_than
value: 0
- name: $owbw_ratio_null_unit
operator: greater_than
- value: 0
- # OMTESTCD=OWHT: Organ to Heart Weight Ratio
- # Raise a violation when the number of OMSTRESU='%'' rcords > 0
- # AND the number of OMSTRESU='RATIO'' rcords > 0
+ value:
+ 0
+ # OMTESTCD=OWHT: Organ to Heart Weight Ratio
+ # Raise a violation when the number of OMSTRESU='%'' rcords > 0
+ # AND the number of OMSTRESU='RATIO'' rcords > 0
- all:
- name: OMTESTCD
operator: equal_to
value: OWHT
- name: OMSTAT # exclude "NOT DONE" records
operator: not_equal_to
- value: 'NOT DONE'
+ value: "NOT DONE"
- name: $owht_percent
operator: greater_than
value: 0
@@ -108,65 +111,71 @@ Check:
Core:
Id: CDISC.SENDIG.190B
Status: Draft
- Version: '1'
-Description: Trigger error when, for the given test, the value of OMSTRESU is
- inconsistent in the dataset when OMTESTCD is either OWBR, OWBW or OWHT
+ Version: "1"
+Description: Trigger error when, for the given test, the value of OMSTRESU is inconsistent in the
+ dataset when OMTESTCD is either OWBR, OWBW or OWHT
Executability: Fully Executable
Operations:
# OWBR: Organ to Brain Weight Ratio
- filter:
- OMSTRESU: '%'
- OMTESTCD: 'OWBR'
+ OMSTRESU: "%"
+ OMTESTCD: "OWBR"
id: $owbr_percent
name: OMTESTCD # 2026-02-10
operator: record_count
- filter:
- OMSTAT: '' # OMSTAT must be empty
- OMSTRESU: ''
- OMTESTCD: 'OWBR'
- # OMSTRESU: empty # 2026-02-10
+ OMSTAT: "" # OMSTAT must be empty
+ OMSTRESU: ""
+ OMTESTCD:
+ "OWBR"
+ # OMSTRESU: empty # 2026-02-10
id: $owbr_ratio_null_unit
name: OMTESTCD # 2026-02-10
- operator: record_count
- # OWBW: Organ to BodyWeight Ratio
+ operator:
+ record_count
+ # OWBW: Organ to BodyWeight Ratio
- filter:
- OMSTRESU: '%'
- OMTESTCD: 'OWBW'
+ OMSTRESU: "%"
+ OMTESTCD: "OWBW"
id: $owbw_percent
name: OMTESTCD # 2026-02-10
operator: record_count
- filter:
- OMSTAT: '' # OMSTAT must be empty
- OMSTRESU: ''
- OMTESTCD: 'OWBW'
- # OMSTRESU: empty # 2026-02-10
+ OMSTAT: "" # OMSTAT must be empty
+ OMSTRESU: ""
+ OMTESTCD:
+ "OWBW"
+ # OMSTRESU: empty # 2026-02-10
id: $owbw_ratio_null_unit
name: OMTESTCD # 2026-02-10
- operator: record_count
- # OWHT: Organ to Heart Weight Ratio
+ operator:
+ record_count
+ # OWHT: Organ to Heart Weight Ratio
- filter:
- OMSTRESU: '%'
- OMTESTCD: 'OWHT'
+ OMSTRESU: "%"
+ OMTESTCD: "OWHT"
id: $owht_percent
name: OMTESTCD # 2026-02-10
operator: record_count
- filter:
- OMSTAT: '' # OMSTAT must be empty
- OMSTRESU: ''
- OMTESTCD: 'OWHT'
- # OMSTRESU: empty # 2026-02-10
+ OMSTAT: "" # OMSTAT must be empty
+ OMSTRESU: ""
+ OMTESTCD:
+ "OWHT"
+ # OMSTRESU: empty # 2026-02-10
id: $owht_ratio_null_unit
name: OMTESTCD # 2026-02-10
- operator: record_count
- # NOT USED FOR THE MOMENT
- # - domain: OM
- # id: $om_stresu_distinct
- # name: OMSTRESU
- # operator: distinct
+ operator:
+ record_count
+ # NOT USED FOR THE MOMENT
+ # - domain: OM
+ # id: $om_stresu_distinct
+ # name: OMSTRESU
+ # operator: distinct
Outcome:
- Message: The organ weight standardized measurement unit must be consistent for
- the given OMTESTCD'.
+ Message: The organ weight standardized measurement unit must be consistent for the given
+ OMTESTCD'.
Output Variables:
- OMTESTCD
- OMSTRESC
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.203/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.203/rule.yml
index 01a06e988..c352c88a3 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.203/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.203/rule.yml
@@ -1,102 +1,102 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then
- TFDETECT is based off the PM domain variable PMDTC (Start
- Date/Time of Observation). This is calculated as (PMDTC -
- EXSTDTC) + 1.'
- Document: 'SENDIG v3.0'
- Item: 'Assumption 3.b'
- Section: '6.3.14.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based
+ off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC
+ - EXSTDTC) + 1."
+ Document: "SENDIG v3.0"
+ Item: "Assumption 3.b"
+ Section: "6.3.14.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND203'
- Version: '2'
- Version: '5.0'
- Version: '3.0'
- - Name: 'SENDIG'
+ Id: "SEND203"
+ Version: "2"
+ Version: "5.0"
+ Version: "3.0"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then
- TFDETECT is based off the PM domain variable PMDTC (Start
- Date/Time of Observation). This is calculated as (PMDTC -
- EXSTDTC) + 1.'
- Document: 'SENDIG v3.0'
- Item: 'Assumption 4.b'
- Section: '6.3.14.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based
+ off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC
+ - EXSTDTC) + 1."
+ Document: "SENDIG v3.0"
+ Item: "Assumption 4.b"
+ Section: "6.3.14.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND203'
- Version: '2'
- Version: '5.0'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "SEND203"
+ Version: "2"
+ Version: "5.0"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then
- TFDETECT is based off the PM domain variable PMDTC (Start
- Date/Time of Observation). This is calculated as (PMDTC -
- EXSTDTC) + 1.'
- Document: 'SENDIG v3.0'
- Item: 'Assumption 4.b'
- Section: '6.3.14.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based
+ off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC
+ - EXSTDTC) + 1."
+ Document: "SENDIG v3.0"
+ Item: "Assumption 4.b"
+ Section: "6.3.14.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND203'
- Version: '2'
- Version: '5.0'
- Version: '3.1.1'
- - Name: 'SENDIG-DART'
+ Id: "SEND203"
+ Version: "2"
+ Version: "5.0"
+ Version: "3.1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then
- TFDETECT is based off the PM domain variable PMDTC (Start
- Date/Time of Observation). This is calculated as (PMDTC -
- EXSTDTC) + 1.'
- Document: 'SENDIG v3.0'
- Item: 'Assumption 4.b'
- Section: '6.3.14.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based
+ off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC
+ - EXSTDTC) + 1."
+ Document: "SENDIG v3.0"
+ Item: "Assumption 4.b"
+ Section: "6.3.14.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND203'
- Version: '2'
- Version: '5.0'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "SEND203"
+ Version: "2"
+ Version: "5.0"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then
- TFDETECT is based off the PM domain variable PMDTC (Start
- Date/Time of Observation). This is calculated as (PMDTC -
- EXSTDTC) + 1.'
- Document: 'SENDIG v3.0'
- Item: 'Assumption 4.b'
- Section: '6.3.14.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based
+ off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC
+ - EXSTDTC) + 1."
+ Document: "SENDIG v3.0"
+ Item: "Assumption 4.b"
+ Section: "6.3.14.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND203'
- Version: '2'
- Version: '5.0'
- Version: '1.2'
- - Name: 'SENDIG-GENETOX'
+ Id: "SEND203"
+ Version: "2"
+ Version: "5.0"
+ Version: "1.2"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then
- TFDETECT is based off the PM domain variable PMDTC (Start
- Date/Time of Observation). This is calculated as (PMDTC -
- EXSTDTC) + 1.'
- Document: 'SENDIG v3.0'
- Item: 'Assumption 4.b'
- Section: '6.3.14.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based
+ off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC
+ - EXSTDTC) + 1."
+ Document: "SENDIG v3.0"
+ Item: "Assumption 4.b"
+ Section: "6.3.14.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND203'
- Version: '2'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND203"
+ Version: "2"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: PMDTC
@@ -108,15 +108,16 @@ Check:
value: 2 #$val_dy # this is created in the operations statement that follows
# Questions Jozef (Discussion with Christy Kubin):
# I presume we must add that PMSPID = TFSPID
- # Does this assume that all the records with a specific PMSPID all have the same
+ # Does this assume that all the records with a specific PMSPID all have the same
# TFDTC (or at least the data part of it)?
Core:
Id: CDISC.SENDIG.203
Status: Draft
- Version: '1'
-Description: 'Raise an error when TFDETECT is not equal to the date portion of
- PMDTC - date portion of EXSTDTC + 1.'
+ Version: "1"
+Description:
+ "Raise an error when TFDETECT is not equal to the date portion of PMDTC - date portion of
+ EXSTDTC + 1."
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -130,7 +131,7 @@ Operations:
name: --DTC
operator: dy # does dy op take into acct +1?
Outcome:
- Message: 'TFDETECT is not equal to (PMDTC - EXSTDTC) + 1'
+ Message: "TFDETECT is not equal to (PMDTC - EXSTDTC) + 1"
Output Variables:
#- $val_dy
- TFDETECT
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.216/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.216/rule.yml
index 137dc7995..97fa2c24e 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.216/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.216/rule.yml
@@ -4,129 +4,117 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Elements with different start and end rules are different
- Elements and must be represented as unique values in ELEMENT
- and ETCD (i.e., Elements involving the same treatment but
- different durations are different Elements). The same applies
- to nontreatment Elements (e.g., a washout with a fixed
- duration of 14 days is different from a washout that ends
- after 7 days if drug cannot be detected in a blood sample or
- after 14 days if drug can be detected in a blood sample).
- Additional factors beyond treatment, start rule, and either
- end rule or duration do not distinguish separate Elements.
+ - Cited Guidance:
+ Elements with different start and end rules are different Elements and must
+ be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same
+ treatment but different durations are different Elements). The same applies to
+ nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from
+ a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14
+ days if drug can be detected in a blood sample). Additional factors beyond treatment,
+ start rule, and either end rule or duration do not distinguish separate Elements.
Document: IG v3.0
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND216
- Version: '2'
- Version: '5.0'
- Version: '3.0'
+ Version: "2"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Elements with different start and end rules are different
- Elements and must be represented as unique values in ELEMENT
- and ETCD (i.e., Elements involving the same treatment but
- different durations are different Elements). The same applies
- to nontreatment Elements (e.g., a washout with a fixed
- duration of 14 days is different from a washout that ends
- after 7 days if drug cannot be detected in a blood sample or
- after 14 days if drug can be detected in a blood sample).
- Additional factors beyond treatment, start rule, and either
- end rule or duration do not distinguish separate Elements.
+ - Cited Guidance:
+ Elements with different start and end rules are different Elements and must
+ be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same
+ treatment but different durations are different Elements). The same applies to
+ nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from
+ a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14
+ days if drug can be detected in a blood sample). Additional factors beyond treatment,
+ start rule, and either end rule or duration do not distinguish separate Elements.
Document: IG v3.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND216
- Version: '2'
- Version: '5.0'
- Version: '3.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Elements with different start and end rules are different
- Elements and must be represented as unique values in ELEMENT
- and ETCD (i.e., Elements involving the same treatment but
- different durations are different Elements). The same applies
- to nontreatment Elements (e.g., a washout with a fixed
- duration of 14 days is different from a washout that ends
- after 7 days if drug cannot be detected in a blood sample or
- after 14 days if drug can be detected in a blood sample).
- Additional factors beyond treatment, start rule, and either
- end rule or duration do not distinguish separate Elements.
+ - Cited Guidance:
+ Elements with different start and end rules are different Elements and must
+ be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same
+ treatment but different durations are different Elements). The same applies to
+ nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from
+ a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14
+ days if drug can be detected in a blood sample). Additional factors beyond treatment,
+ start rule, and either end rule or duration do not distinguish separate Elements.
Document: IG v3.1.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND216
- Version: '2'
- Version: '5.0'
+ Version: "2"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Elements with different start and end rules are different
- Elements and must be represented as unique values in ELEMENT
- and ETCD (i.e., Elements involving the same treatment but
- different durations are different Elements). The same applies
- to nontreatment Elements (e.g., a washout with a fixed
- duration of 14 days is different from a washout that ends
- after 7 days if drug cannot be detected in a blood sample or
- after 14 days if drug can be detected in a blood sample).
- Additional factors beyond treatment, start rule, and either
- end rule or duration do not distinguish separate Elements.
+ - Cited Guidance:
+ Elements with different start and end rules are different Elements and must
+ be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same
+ treatment but different durations are different Elements). The same applies to
+ nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from
+ a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14
+ days if drug can be detected in a blood sample). Additional factors beyond treatment,
+ start rule, and either end rule or duration do not distinguish separate Elements.
Document: IG v3.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND216
- Version: '2'
- Version: '5.0'
- Version: '1.1'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Elements with different start and end rules are different
- Elements and must be represented as unique values in ELEMENT
- and ETCD (i.e., Elements involving the same treatment but
- different durations are different Elements). The same applies
- to nontreatment Elements (e.g., a washout with a fixed
- duration of 14 days is different from a washout that ends
- after 7 days if drug cannot be detected in a blood sample or
- after 14 days if drug can be detected in a blood sample).
- Additional factors beyond treatment, start rule, and either
- end rule or duration do not distinguish separate Elements.
+ - Cited Guidance:
+ Elements with different start and end rules are different Elements and must
+ be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same
+ treatment but different durations are different Elements). The same applies to
+ nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from
+ a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14
+ days if drug can be detected in a blood sample). Additional factors beyond treatment,
+ start rule, and either end rule or duration do not distinguish separate Elements.
Document: IG v3.1.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND216
- Version: '2'
- Version: '5.0'
- Version: '1.2'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Elements with different start and end rules are different
- Elements and must be represented as unique values in ELEMENT
- and ETCD (i.e., Elements involving the same treatment but
- different durations are different Elements). The same applies
- to nontreatment Elements (e.g., a washout with a fixed
- duration of 14 days is different from a washout that ends
- after 7 days if drug cannot be detected in a blood sample or
- after 14 days if drug can be detected in a blood sample).
- Additional factors beyond treatment, start rule, and either
- end rule or duration do not distinguish separate Elements.
+ - Cited Guidance:
+ Elements with different start and end rules are different Elements and must
+ be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same
+ treatment but different durations are different Elements). The same applies to
+ nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from
+ a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14
+ days if drug can be detected in a blood sample). Additional factors beyond treatment,
+ start rule, and either end rule or duration do not distinguish separate Elements.
Document: IG v3.1.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND216
- Version: '2'
- Version: '5.0'
- Version: '1.0'
+ Version: "2"
+ Version: "5.0"
+ Version: "1.0"
Check:
any:
- all:
@@ -157,13 +145,11 @@ Check:
Core:
Id: CDISC.SENDIG.216
Status: Draft
- Version: '1'
-Description: The combination of ELEMENT, TESTRL, TEENRL, and TEDUR must be
- unique for each ETCD.
+ Version: "1"
+Description: The combination of ELEMENT, TESTRL, TEENRL, and TEDUR must be unique for each ETCD.
Executability: Fully Executable
Outcome:
- Message: The combination of ELEMENT, TESTRL, TEENRL, and TEDUR is not unique for
- each ETCD
+ Message: The combination of ELEMENT, TESTRL, TEENRL, and TEDUR is not unique for each ETCD
Output Variables:
- ELEMENT
- TESTRL
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.217/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.217/rule.yml
index 2e9ef9d3e..b33aff074 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.217/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.217/rule.yml
@@ -1,5 +1,5 @@
# Variable: ALL
-# Condition:
+# Condition:
# Rule: No gaps between elements
Authorities:
- Organization: CDISC
@@ -7,130 +7,122 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: There are no gaps between Elements. The instant one Element
- ends, the next Element begins. A subject spends no time
- "between" Elements; The Elements in each Arm must be
- consecutive in time; it is not correct to leave any gaps in
- time between Elements.
+ - Cited Guidance:
+ There are no gaps between Elements. The instant one Element ends, the next
+ Element begins. A subject spends no time "between" Elements; The Elements in each Arm must
+ be consecutive in time; it is not correct to leave any gaps in time between Elements.
Document: IG v3.0
Item: Assumption 5 | Assumption 4
Section: 7.2.1.1 | 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND217
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: There are no gaps between Elements. The instant one Element
- ends, the next Element begins. A subject spends no time
- "between" Elements; The Elements in each Arm must be
- consecutive in time; it is not correct to leave any gaps in
- time between Elements.
+ - Cited Guidance:
+ There are no gaps between Elements. The instant one Element ends, the next
+ Element begins. A subject spends no time "between" Elements; The Elements in each Arm must
+ be consecutive in time; it is not correct to leave any gaps in time between Elements.
Document: IG v3.1
Item: Assumption 6 | Assumption 5
Section: 7.2.1.1 | 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND217
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: There are no gaps between Elements. The instant one Element
- ends, the next Element begins. A subject spends no time
- "between" Elements; The Elements in each Arm must be
- consecutive in time; it is not correct to leave any gaps in
- time between Elements.
+ - Cited Guidance:
+ There are no gaps between Elements. The instant one Element ends, the next
+ Element begins. A subject spends no time "between" Elements; The Elements in each Arm must
+ be consecutive in time; it is not correct to leave any gaps in time between Elements.
Document: IG v3.1.1
Item: Assumption 6 | Assumption 5
Section: 7.2.1.1 | 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND217
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: There are no gaps between Elements. The instant one Element
- ends, the next Element begins. A subject spends no time
- "between" Elements; The Elements in each Arm must be
- consecutive in time; it is not correct to leave any gaps in
- time between Elements.
+ - Cited Guidance:
+ There are no gaps between Elements. The instant one Element ends, the next
+ Element begins. A subject spends no time "between" Elements; The Elements in each Arm must
+ be consecutive in time; it is not correct to leave any gaps in time between Elements.
Document: IG v3.1.1
Item: Assumption 6 | Assumption 5
Section: 7.2.1.1 | 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND217
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: There are no gaps between Elements. The instant one Element
- ends, the next Element begins. A subject spends no time
- "between" Elements; The Elements in each Arm must be
- consecutive in time; it is not correct to leave any gaps in
- time between Elements.
+ - Cited Guidance:
+ There are no gaps between Elements. The instant one Element ends, the next
+ Element begins. A subject spends no time "between" Elements; The Elements in each Arm must
+ be consecutive in time; it is not correct to leave any gaps in time between Elements.
Document: IG v3.1
Item: Assumption 6 | Assumption 5
Section: 7.2.1.1 | 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND217
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: There are no gaps between Elements. The instant one Element
- ends, the next Element begins. A subject spends no time
- "between" Elements; The Elements in each Arm must be
- consecutive in time; it is not correct to leave any gaps in
- time between Elements.
+ - Cited Guidance:
+ There are no gaps between Elements. The instant one Element ends, the next
+ Element begins. A subject spends no time "between" Elements; The Elements in each Arm must
+ be consecutive in time; it is not correct to leave any gaps in time between Elements.
Document: IG v3.1.1
Item: Assumption 6 | Assumption 5
Section: 7.2.1.1 | 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND217
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: There are no gaps between Elements. The instant one Element
- ends, the next Element begins. A subject spends no time
- "between" Elements; The Elements in each Arm must be
- consecutive in time; it is not correct to leave any gaps in
- time between Elements.
+ - Cited Guidance:
+ There are no gaps between Elements. The instant one Element ends, the next
+ Element begins. A subject spends no time "between" Elements; The Elements in each Arm must
+ be consecutive in time; it is not correct to leave any gaps in time between Elements.
Document: IG v3.1.1
Item: Assumption 6 | Assumption 5
Section: 7.2.1.1 | 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND217
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
-
Core:
Id: CDISC.SENDIG.217
Status: Draft
- Version: '1'
+ Version: "1"
Description:
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml
index e92855e33..41ec4586d 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml
@@ -4,106 +4,113 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match
- values for the same Element in the Trial Elements dataset.
+ - Cited Guidance:
+ The values of ETCD used in the Trial Arms dataset must match values for the
+ same Element in the Trial Elements dataset.
Document: IG v3.0
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND222
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Organization: CDISC
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match
- values for the same Element in the Trial Elements dataset.
+ - Cited Guidance:
+ The values of ETCD used in the Trial Arms dataset must match values for the
+ same Element in the Trial Elements dataset.
Document: IG v3.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND222
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Organization: CDISC
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match
- values for the same Element in the Trial Elements dataset.
+ - Cited Guidance:
+ The values of ETCD used in the Trial Arms dataset must match values for the
+ same Element in the Trial Elements dataset.
Document: IG v3.1.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND222
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Organization: CDISC
Standards:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match
- values for the same Element in the Trial Elements dataset.
+ - Cited Guidance:
+ The values of ETCD used in the Trial Arms dataset must match values for the
+ same Element in the Trial Elements dataset.
Document: IG v3.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND222
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Organization: CDISC
Standards:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match
- values for the same Element in the Trial Elements dataset.
+ - Cited Guidance:
+ The values of ETCD used in the Trial Arms dataset must match values for the
+ same Element in the Trial Elements dataset.
Document: IG v3.1.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND222
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Organization: CDISC
Standards:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match
- values for the same Element in the Trial Elements dataset.
+ - Cited Guidance:
+ The values of ETCD used in the Trial Arms dataset must match values for the
+ same Element in the Trial Elements dataset.
Document: IG v3.1.1
Section: 7.2.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND222
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
# TA.ETCD non-empty. Required as otherwise the "blank" value is checked against TE
- name: ETCD
- operator: non_empty
- # TA.ETCD is not in the list of distinct values of ETCD in TE
+ operator:
+ non_empty
+ # TA.ETCD is not in the list of distinct values of ETCD in TE
- name: ETCD
operator: is_not_contained_by
value: $te_etcd
Core:
Id: CDISC.SENDIG.222
Status: Draft
- Version: '1'
-Description: The values of ETCD used in the Trial Arms dataset must match values
- for the same Element in the Trial Elements dataset.
+ Version: "1"
+Description: The values of ETCD used in the Trial Arms dataset must match values for the same
+ Element in the Trial Elements dataset.
Executability: Fully Executable
Operations:
- domain: TE
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml
index eef0d7bd3..699c3d562 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml
@@ -4,93 +4,93 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.0
Item: Specification
Section: 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND223
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1
Item: Specification
Section: 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND223
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1.1
Item: Specification
Section: 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND223
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1.1
Item: Specification
Section: 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND223
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1
Item: Specification
Section: 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND223
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1.1
Item: Specification
Section: 7.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND223
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: ARMCD
@@ -101,12 +101,11 @@ Check:
Core:
Id: CDISC.SENDIG.223
Status: Draft
- Version: '1'
-Description: When study does not use multi-stage arm assignments and ARMCD is
- populated, ARMCD must be present in TA.ARMCD. This rule has been executed to
- identify all cases when ARMCD is not present in TA.ARMCD and therefore
- acknowledges that false positives may be recorded when multi-stage arm
- assignments are in use.
+ Version: "1"
+Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must
+ be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not
+ present in TA.ARMCD and therefore acknowledges that false positives may be recorded when
+ multi-stage arm assignments are in use.
Executability: Fully Executable
Operations:
- domain: TA
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml
index 3e137f9b4..953b233cf 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml
@@ -4,93 +4,93 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.0
Item: Specification
Section: 7.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND225
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1
Item: Specification
Section: 7.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND225
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1.1
Item: Specification
Section: 7.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND225
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1.1
Item: Specification
Section: 7.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND225
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1
Item: Specification
Section: 7.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND225
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD
- are defined as the planned Trial Arms in TA, and the planned
- Arms are then applied to subjects in DM).
+ - Cited Guidance:
+ ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined
+ as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM).
Document: IG v3.1.1
Item: Specification
Section: 7.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND225
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: ARM
@@ -101,12 +101,11 @@ Check:
Core:
Id: CDISC.SENDIG.225
Status: Draft
- Version: '1'
-Description: When study does not use multi-stage arm assignments and ARMCD is
- populated, ARMCD must be present in TA.ARMCD. This rule has been executed to
- identify all cases when ARMCD is not present in TA.ARMCD and therefore
- acknowledges that false positives may be recorded when multi-stage arm
- assignments are in use.
+ Version: "1"
+Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must
+ be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not
+ present in TA.ARMCD and therefore acknowledges that false positives may be recorded when
+ multi-stage arm assignments are in use.
Executability: Fully Executable
Operations:
- domain: TA
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml
index 64f6e40d9..77fd375f0 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml
@@ -4,117 +4,111 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column
- should always be included in the Trial Summary dataset, in
- order to provide proper study definition. (AGEU, SDESIGN,
- DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER,
- SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN,
- STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM,
- TRMSAC, TRTCAS, TRTV)
+ - Cited Guidance:
+ The parameters listed as "Yes" in the "Should Include" column should always
+ be included in the Trial Summary dataset, in order to provide proper study definition.
+ (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES,
+ SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY,
+ TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV)
Document: IG v3.0
Item: Specification
Section: 7.6.1 | 7.6.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND247
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column
- should always be included in the Trial Summary dataset, in
- order to provide proper study definition. (AGEU, SDESIGN,
- DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER,
- SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN,
- STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM,
- TRMSAC, TRTCAS, TRTV)
+ - Cited Guidance:
+ The parameters listed as "Yes" in the "Should Include" column should always
+ be included in the Trial Summary dataset, in order to provide proper study definition.
+ (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES,
+ SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY,
+ TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV)
Document: IG v3.1
Item: Specification
Section: 7.6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND247.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column
- should always be included in the Trial Summary dataset, in
- order to provide proper study definition. (AGEU, SDESIGN,
- DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER,
- SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN,
- STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM,
- TRMSAC, TRTCAS, TRTV)
+ - Cited Guidance:
+ The parameters listed as "Yes" in the "Should Include" column should always
+ be included in the Trial Summary dataset, in order to provide proper study definition.
+ (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES,
+ SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY,
+ TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV)
Document: IG v3.1.1
Item: Specification
Section: 7.6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND247.1
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column
- should always be included in the Trial Summary dataset, in
- order to provide proper study definition. (AGEU, SDESIGN,
- DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER,
- SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN,
- STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM,
- TRMSAC, TRTCAS, TRTV)
+ - Cited Guidance:
+ The parameters listed as "Yes" in the "Should Include" column should always
+ be included in the Trial Summary dataset, in order to provide proper study definition.
+ (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES,
+ SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY,
+ TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV)
Document: IG v3.1.1
Item: Specification
Section: 7.6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND247.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column
- should always be included in the Trial Summary dataset, in
- order to provide proper study definition. (AGEU, SDESIGN,
- DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER,
- SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN,
- STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM,
- TRMSAC, TRTCAS, TRTV)
+ - Cited Guidance:
+ The parameters listed as "Yes" in the "Should Include" column should always
+ be included in the Trial Summary dataset, in order to provide proper study definition.
+ (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES,
+ SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY,
+ TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV)
Document: IG v3.1
Item: Specification
Section: 7.6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND247.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column
- should always be included in the Trial Summary dataset, in
- order to provide proper study definition. (AGEU, SDESIGN,
- DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER,
- SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN,
- STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM,
- TRMSAC, TRTCAS, TRTV)
+ - Cited Guidance:
+ The parameters listed as "Yes" in the "Should Include" column should always
+ be included in the Trial Summary dataset, in order to provide proper study definition.
+ (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES,
+ SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY,
+ TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV)
Document: IG v3.1.1
Item: Specification
Section: 7.6.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND247.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
any:
@@ -154,13 +148,14 @@ Check:
- name: $distinct_tsparmcd
operator: does_not_contain
value: GLPFL
- value_is_literal: true
- ## GLPTYP is only mandatory in SENDIG-3.0
- ## SO TODO? split off SENDIG-3.0 in separate file/rule
- ##- name: $distinct_tsparmcd
- ## operator: does_not_contain
- ## value: GLPTYP
- ## value_is_literal: true
+ value_is_literal:
+ true
+ ## GLPTYP is only mandatory in SENDIG-3.0
+ ## SO TODO? split off SENDIG-3.0 in separate file/rule
+ ##- name: $distinct_tsparmcd
+ ## operator: does_not_contain
+ ## value: GLPTYP
+ ## value_is_literal: true
- name: $distinct_tsparmcd
operator: does_not_contain
value: ROUTE
@@ -244,11 +239,10 @@ Check:
Core:
Id: CDISC.SENDIG.247
Status: Draft
- Version: '1'
-Description: For each TSPARMCD = AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC,
- GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT,
- STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM, TRMSAC,
- TRTCAS, TRTV, a record must be present in TS
+ Version: "1"
+Description: For each TSPARMCD = AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER,
+ SNDCTVER, SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT,
+ TFCNTRY, TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV, a record must be present in TS
Executability: Fully Executable
Operations:
- id: $distinct_tsparmcd
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml
index e2e6126ac..55499619c 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml
@@ -4,49 +4,49 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When preparing datasets based on the SENDIG domain models,
- sponsors must not add any variables other than specified
- Identifier variables (from the SDTM model 1.5).
+ - Cited Guidance:
+ When preparing datasets based on the SENDIG domain models, sponsors must not
+ add any variables other than specified Identifier variables (from the SDTM model 1.5).
Document: IG v3.1
Item: Specification
Section: 2.1 | 2.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND265.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When preparing datasets based on the SENDIG domain models,
- sponsors must not add any variables other than specified
- Identifier variables (from the SDTM model 1.5).
+ - Cited Guidance:
+ When preparing datasets based on the SENDIG domain models, sponsors must not
+ add any variables other than specified Identifier variables (from the SDTM model 1.5).
Document: IG v3.1.1
Item: Specification
Section: 2.1 | 2.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND265.1
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When preparing datasets based on the SENDIG domain models,
- sponsors must not add any variables other than specified
- Identifier variables (from the SDTM model 1.5).
+ - Cited Guidance:
+ When preparing datasets based on the SENDIG domain models, sponsors must not
+ add any variables other than specified Identifier variables (from the SDTM model 1.5).
Document: IG v3.1
Item: Specification
Section: 2.1 | 2.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND265.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
# REMARK: this will ONLY validate the define.xml dataset definitions
# for which a dataset is actually being provided
@@ -54,19 +54,20 @@ Check:
all:
- name: define_variable_role
operator: equal_to
- value: 'Identifier'
- #- name: define_variable_role
- # operator: equal_to
- # value: 'Identifier'
+ value:
+ "Identifier"
+ #- name: define_variable_role
+ # operator: equal_to
+ # value: 'Identifier'
- name: define_variable_name
operator: is_not_contained_by
value: $model_variables
Core:
Id: CDISC.SENDIG.265.1
Status: Draft
- Version: '1'
-Description: Raise an error when variable role is 'Identifier', but the variable
- is not found in the SDTM model correspond to the role in the IG
+ Version: "1"
+Description: Raise an error when variable role is 'Identifier', but the variable is not found in the
+ SDTM model correspond to the role in the IG
Executability: Fully Executable
Operations:
- id: $model_variables
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.266/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.266/rule.yml
index 109d0647b..4666df26a 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.266/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.266/rule.yml
@@ -6,73 +6,73 @@ Authorities:
- Citations:
- Cited Guidance: test
Document: IG v3.0
- Section: '2.1 | 2.3'
+ Section: "2.1 | 2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND266
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- Cited Guidance: test
Document: IG v3.1
- Section: '2.1 | 2.3'
+ Section: "2.1 | 2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND266.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- Cited Guidance: test
Document: IG v3.1.1
- Section: '2.1 | 2.3'
+ Section: "2.1 | 2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND266.1
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- Cited Guidance: test
Document: IG v3.1
- Section: '2.1 | 2.3'
+ Section: "2.1 | 2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND266.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- Cited Guidance: test
Document: IG v3.1.1
- Section: '2.1 | 2.3'
+ Section: "2.1 | 2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND266.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- Cited Guidance: test
Document: IG v3.1.1
- Section: '2.1 | 2.3'
+ Section: "2.1 | 2.3"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND266.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: variable_name
@@ -81,12 +81,13 @@ Check:
Core:
Id: CDISC.SENDIG.266
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger when variable cannot be found in the SDTM model (v.1.7 for SENDIG-3.1)
Executability: Fully Executable
Operations:
- - id: $allowed_variables
- # This works on the IG level, not on the Model level
+ - id:
+ $allowed_variables
+ # This works on the IG level, not on the Model level
operator: get_column_order_from_library
Outcome:
Message: Variable is not an allowed variable for an Observation Class
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.277/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.277/rule.yml
index 24d671146..0c23a793a 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.277/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.277/rule.yml
@@ -6,49 +6,49 @@ Authorities:
- Citations:
- Cited Guidance: SEND dataset file names are in lowercase
Document: SENDIG v3.0
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND277
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- Cited Guidance: SEND dataset file names are in lowercase
Document: SENDIG v3.1
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND277
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- Cited Guidance: SEND dataset file names are in lowercase
Document: SENDIG v3.1.1
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND277
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG-DART
References:
- Citations:
- Cited Guidance: SEND dataset file names are in lowercase
Document: SENDIG v3.1
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND277
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
- name: dataset_location
@@ -57,7 +57,7 @@ Check:
Core:
Id: CDISC.SENDIG.277
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when a file name has uppercase characters
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.299A/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.299A/rule.yml
index d8ef15a4e..143903199 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.299A/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.299A/rule.yml
@@ -5,99 +5,102 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- - name: 'variable_name'
+ - name: "variable_name"
operator: not_equal_to
- value: 'STUDYID'
- - name: 'variable_name'
+ value: "STUDYID"
+ - name: "variable_name"
operator: not_equal_to
- value: 'USUBJID'
- - name: 'variable_name'
+ value: "USUBJID"
+ - name: "variable_name"
operator: not_equal_to
- value: 'POOLID'
+ value: "POOLID"
Core:
Id: CDISC.SENDIG.299A
Status: Draft
- Version: '1'
-Description: 'No other variables than STUDYID, USUBJID and POOLID may be present
- in the POOLDEF dataset'
+ Version: "1"
+Description: "No other variables than STUDYID, USUBJID and POOLID may be present in the POOLDEF dataset"
Executability: Fully Executable
Outcome:
- Message: 'No other variables than STUDYID, USUBJID and POOLID may be present in
- POOLDEF'
+ Message: "No other variables than STUDYID, USUBJID and POOLID may be present in POOLDEF"
Rule Type: Variable Metadata Check
Scope:
Classes:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.299B/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.299B/rule.yml
index 693a3956a..1405d589d 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.299B/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.299B/rule.yml
@@ -5,124 +5,130 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.2
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.2
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.2
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.2
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.2
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- - name: 'variable_name'
+ - name: "variable_name"
operator: not_equal_to
- value: 'STUDYID'
- - name: 'variable_name'
+ value: "STUDYID"
+ - name: "variable_name"
operator: not_equal_to
- value: 'RDOMAIN'
- - name: 'variable_name'
+ value: "RDOMAIN"
+ - name: "variable_name"
operator: not_equal_to
- value: 'USUBJID'
- - name: 'variable_name'
+ value: "USUBJID"
+ - name: "variable_name"
operator: not_equal_to
- value: 'POOLID'
- - name: 'variable_name'
+ value: "POOLID"
+ - name: "variable_name"
operator: not_equal_to
- value: 'IDVAR'
- - name: 'variable_name'
+ value: "IDVAR"
+ - name: "variable_name"
operator: not_equal_to
- value: 'IDVARVAL'
- - name: 'variable_name'
+ value: "IDVARVAL"
+ - name: "variable_name"
operator: not_equal_to
- value: 'QNAM'
- - name: 'variable_name'
+ value: "QNAM"
+ - name: "variable_name"
operator: not_equal_to
- value: 'QLABEL'
- - name: 'variable_name'
+ value: "QLABEL"
+ - name: "variable_name"
operator: not_equal_to
- value: 'QVAL'
- - name: 'variable_name'
+ value: "QVAL"
+ - name: "variable_name"
operator: not_equal_to
- value: 'QORIG'
- - name: 'variable_name'
+ value: "QORIG"
+ - name: "variable_name"
operator: not_equal_to
- value: 'QEVAL'
+ value: "QEVAL"
Core:
Id: CDISC.SENDIG.299B
Status: Draft
- Version: '1'
-Description: 'No other variables other variables than STUDYID, RDOMAIN, USUBJID,
- POOLID, IDVAR, IDVARVAL, QNAM, QLABEL, QVAL, QORIG, QEVAL may be present in
- the SUPP-- dataset'
+ Version: "1"
+Description:
+ "No other variables other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR, IDVARVAL,
+ QNAM, QLABEL, QVAL, QORIG, QEVAL may be present in the SUPP-- dataset"
Executability: Fully Executable
Outcome:
- Message: 'SUPPxx may not contain any other variables than STUDYID, RDOMAIN,
- USUBJID, POOLID, IDVAR, IDVARVAL, QNAM, QLABEL, QVAL, QORIG, QEVAL'
+ Message:
+ "SUPPxx may not contain any other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR,
+ IDVARVAL, QNAM, QLABEL, QVAL, QORIG, QEVAL"
Rule Type: Variable Metadata Check
Scope:
Classes:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.299C/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.299C/rule.yml
index c56777c1d..5fe6bd49e 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.299C/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.299C/rule.yml
@@ -5,114 +5,121 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.3
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.3
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.3
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.3
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF
- are relationship datasets. These are described in Section 8."
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described
+ in Section 8."
Document: IG v3.1.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND299.3
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- - name: 'variable_name'
+ - name: "variable_name"
operator: not_equal_to
- value: 'STUDYID'
- - name: 'variable_name'
+ value: "STUDYID"
+ - name: "variable_name"
operator: not_equal_to
- value: 'RDOMAIN'
- - name: 'variable_name'
+ value: "RDOMAIN"
+ - name: "variable_name"
operator: not_equal_to
- value: 'USUBJID'
- - name: 'variable_name'
+ value: "USUBJID"
+ - name: "variable_name"
operator: not_equal_to
- value: 'POOLID'
- - name: 'variable_name'
+ value: "POOLID"
+ - name: "variable_name"
operator: not_equal_to
- value: 'IDVAR'
- - name: 'variable_name'
+ value: "IDVAR"
+ - name: "variable_name"
operator: not_equal_to
- value: 'IDVARVAL'
- - name: 'variable_name'
+ value: "IDVARVAL"
+ - name: "variable_name"
operator: not_equal_to
- value: 'RELTYPE'
- - name: 'variable_name'
+ value: "RELTYPE"
+ - name: "variable_name"
operator: not_equal_to
- value: 'RELID'
+ value: "RELID"
Core:
Id: CDISC.SENDIG.299C
Status: Draft
- Version: '1'
-Description: 'No other variables other variables than STUDYID, RDOMAIN, USUBJID,
- POOLID, IDVAR, IDVARVAL, RELTYPE, RELID may be present in the RELREC dataset'
+ Version: "1"
+Description:
+ "No other variables other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR, IDVARVAL,
+ RELTYPE, RELID may be present in the RELREC dataset"
Executability: Fully Executable
Outcome:
- Message: 'RELREC may not contain any other variables than STUDYID, RDOMAIN,
- USUBJID, POOLID, IDVAR, IDVARVAL, RELTYPE, RELID'
+ Message:
+ "RELREC may not contain any other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR,
+ IDVARVAL, RELTYPE, RELID"
Rule Type: Variable Metadata Check
Scope:
Classes:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml
index 0509e8682..c6beeb939 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml
@@ -4,76 +4,78 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: In the event that no records are present in a dataset, the empty
- dataset should not be submitted and should not be described in
- the data definition file.
+ - Cited Guidance:
+ In the event that no records are present in a dataset, the empty dataset
+ should not be submitted and should not be described in the data definition file.
Document: SENDIG v3.0
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND300
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: In the event that no records are present in a dataset, the empty
- dataset should not be submitted and should not be described in
- the data definition file.
+ - Cited Guidance:
+ In the event that no records are present in a dataset, the empty dataset
+ should not be submitted and should not be described in the data definition file.
Document: SENDIG v3.1
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND300
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: In the event that no records are present in a dataset, the empty
- dataset should not be submitted and should not be described in
- the data definition file.
+ - Cited Guidance:
+ In the event that no records are present in a dataset, the empty dataset
+ should not be submitted and should not be described in the data definition file.
Document: SENDIG v3.1.1
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND300
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: In the event that no records are present in a dataset, the empty
- dataset should not be submitted and should not be described in
- the data definition file.
+ - Cited Guidance:
+ In the event that no records are present in a dataset, the empty dataset
+ should not be submitted and should not be described in the data definition file.
Document: SENDIG v3.1
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND300
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
- name: $record_count
operator: equal_to
- value: 0
- # check whether there is an entry for the dataset in the define.xml
- #- name: define_dataset_name
- # operator: exists
+ value:
+ 0
+ # check whether there is an entry for the dataset in the define.xml
+ #- name: define_dataset_name
+ # operator: exists
- name: define_dataset_name
- operator: exists
- #value: 'Not in dataset'
- #operator: not_equal_to
- #value: dataset_name
+ operator:
+ exists
+ #value: 'Not in dataset'
+ #operator: not_equal_to
+ #value: dataset_name
Core:
Id: CDISC.SENDIG.300
Status: Draft
- Version: '1'
+ Version: "1"
Description: Trigger error when a dataset has no records
Executability: Fully Executable
Operations:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.304/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.304/rule.yml
index 8ede25afc..e15f0a635 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.304/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.304/rule.yml
@@ -4,31 +4,31 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When there are multiple terms that express the same base
- concept, SEND CT provides the Preferred Term to include in a
- submission, and thus the term to which the synonymous term(s)
- should be mapped.
+ - Cited Guidance:
+ When there are multiple terms that express the same base concept, SEND CT
+ provides the Preferred Term to include in a submission, and thus the term to which the
+ synonymous term(s) should be mapped.
Document: IG v3.1
- Section: '4.3.7'
+ Section: "4.3.7"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND304
- Version: ''
- Version: '5.0'
- Version: '3.1'
+ Version: ""
+ Version: "5.0"
+ Version: "3.1"
Check:
all:
- name: LBTESTCD
- operator: 'equal_to'
- value: 'ALB'
+ operator: "equal_to"
+ value: "ALB"
- name: LBTEST
operator: not_equal_to
- value: 'Albumin'
+ value: "Albumin"
Core:
Id: CDISC.SENDIG.304
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Operations:
#- codelists:
@@ -41,13 +41,13 @@ Operations:
id: $extensible
operator: codelist_extensible
Outcome:
- Message: 'test message'
+ Message: "test message"
Output Variables:
- LBTESTCD
- LBTEST
- # - $codelist_terms
+ # - $codelist_terms
- $extensible
- # - $synonyms
+ # - $synonyms
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml
index 5736a7f26..70747ee01 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml
@@ -1,50 +1,51 @@
Authorities:
- - Organization: CDISC
- # REMARK: not applicable to SENDIG-3.0
- # 2023-10-22: CURRENT IMPLEMENTATION IS NOT CORRECT!
+ - Organization:
+ CDISC
+ # REMARK: not applicable to SENDIG-3.0
+ # 2023-10-22: CURRENT IMPLEMENTATION IS NOT CORRECT!
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they
- are different by set. DM records with different values for
- SPECIES cannot have the same SETCD value.
+ - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they are
+ different by set. DM records with different values for SPECIES cannot have the same SETCD
+ value.
Document: IG v3.1
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND309
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they
- are different by set. DM records with different values for
- SPECIES cannot have the same SETCD value.
+ - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they are
+ different by set. DM records with different values for SPECIES cannot have the same SETCD
+ value.
Document: IG v3.1.1
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND309
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they
- are different by set. DM records with different values for
- SPECIES cannot have the same SETCD value.
+ - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they are
+ different by set. DM records with different values for SPECIES cannot have the same SETCD
+ value.
Document: IG v3.1
Section: 5.1.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND309
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
#- name: SETCD
@@ -56,7 +57,7 @@ Check:
Core:
Id: CDISC.SENDIG.309
Status: Draft
- Version: '1'
+ Version: "1"
Description: DM records with different values for SPECIES may not have the same SETCD value.
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.318/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.318/rule.yml
index b9fa19fb0..a27fb4b35 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.318/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.318/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND318
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND318
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -34,28 +34,29 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND318
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
- name: --NOMDY
operator: non_empty
- name: --NOMDY
- operator: not_matches_regex
- # value can be a negative or positive integer, but may not be 0.
- # This is more restrictive, but approved by the SEND team
- # than the original statement "--NOMDY must be an integer"
+ operator:
+ not_matches_regex
+ # value can be a negative or positive integer, but may not be 0.
+ # This is more restrictive, but approved by the SEND team
+ # than the original statement "--NOMDY must be an integer"
value: '^-?[1-9]{1}\d*$'
Core:
Id: CDISC.SENDIG.318
Status: Draft
- Version: '1'
-Description: 'The value of -NOMDY must be a positive or negative integer other than 0'
+ Version: "1"
+Description: "The value of -NOMDY must be a positive or negative integer other than 0"
Executability: Fully Executable
Outcome:
- Message: 'The value of -NOMDY must be a positive or negative integer other than 0'
+ Message: "The value of -NOMDY must be a positive or negative integer other than 0"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.319/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.319/rule.yml
index 452582388..24920bb25 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.319/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.319/rule.yml
@@ -5,83 +5,83 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Information about the time of collection for any observation is
- needed to identify the record. CLDTC is Expected, and the data
- will, in most cases, contain CLDTC, CLDY, or both. However,
- some studies (e.g., legacy studies) may not collect CLDTC or
- CLDY; in those cases, CLNOMDY must be populated.
+ - Cited Guidance:
+ Information about the time of collection for any observation is needed to
+ identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC,
+ CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY;
+ in those cases, CLNOMDY must be populated.
Document: IG v3.1
Section: 6.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND319'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND319"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Information about the time of collection for any observation is
- needed to identify the record. CLDTC is Expected, and the data
- will, in most cases, contain CLDTC, CLDY, or both. However,
- some studies (e.g., legacy studies) may not collect CLDTC or
- CLDY; in those cases, CLNOMDY must be populated.
+ - Cited Guidance:
+ Information about the time of collection for any observation is needed to
+ identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC,
+ CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY;
+ in those cases, CLNOMDY must be populated.
Document: IG v3.1.1
Section: 6.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND319'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND319"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Information about the time of collection for any observation is
- needed to identify the record. CLDTC is Expected, and the data
- will, in most cases, contain CLDTC, CLDY, or both. However,
- some studies (e.g., legacy studies) may not collect CLDTC or
- CLDY; in those cases, CLNOMDY must be populated.
+ - Cited Guidance:
+ Information about the time of collection for any observation is needed to
+ identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC,
+ CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY;
+ in those cases, CLNOMDY must be populated.
Document: IG v3.1
Section: 6.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND319'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND319"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: Information about the time of collection for any observation is
- needed to identify the record. CLDTC is Expected, and the data
- will, in most cases, contain CLDTC, CLDY, or both. However,
- some studies (e.g., legacy studies) may not collect CLDTC or
- CLDY; in those cases, CLNOMDY must be populated.
+ - Cited Guidance:
+ Information about the time of collection for any observation is needed to
+ identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC,
+ CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY;
+ in those cases, CLNOMDY must be populated.
Document: IG v3.1.1
Section: 6.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND319'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND319"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: Information about the time of collection for any observation is
- needed to identify the record. CLDTC is Expected, and the data
- will, in most cases, contain CLDTC, CLDY, or both. However,
- some studies (e.g., legacy studies) may not collect CLDTC or
- CLDY; in those cases, CLNOMDY must be populated.
+ - Cited Guidance:
+ Information about the time of collection for any observation is needed to
+ identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC,
+ CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY;
+ in those cases, CLNOMDY must be populated.
Document: IG v3.1.1
Section: 6.3.3.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND319'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND319"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: --DTC
@@ -93,7 +93,7 @@ Check:
Core:
Id: CDISC.SENDIG.319
Status: Draft
- Version: '1'
+ Version: "1"
Description: If --DTC and --DY were not collected, --NOMDY must be populated.
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.335/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.335/rule.yml
index ef2c03349..28b50faff 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.335/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.335/rule.yml
@@ -4,77 +4,75 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: PMSTRESC should contain the finding without the location
- specified in PMLOC.
+ - Cited Guidance: PMSTRESC should contain the finding without the location specified in PMLOC.
Document: SENDIG v3.0
Section: 6.3.10
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND335
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: PMSTRESC should contain the finding without the location
- specified in PMLOC.
+ - Cited Guidance: PMSTRESC should contain the finding without the location specified in PMLOC.
Document: SENDIG v3.1
Section: 6.3.10
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND335
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: PMSTRESC should contain the finding without the location
- specified in PMLOC.
+ - Cited Guidance: PMSTRESC should contain the finding without the location specified in PMLOC.
Document: SENDIG v3.1.1
Section: 6.3.10
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND335
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: One record per test per palpable mass per observation time per
- subject
+ - Cited Guidance: One record per test per palpable mass per observation time per subject
Document: SENDIG v3.1
Section: 6.3.10
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND335
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
- name: PMLOC
operator: non_empty
- name: PMSTRESC
operator: non_empty
- - name: PMSTRESC
- # operator: contains_case_insensitive
- # EXAMPLE: PSLOC = LEFT HIND LIMB
- # PSSTRESC = NON-ULCERATED LEFT HIND LIMB
- # operator: equals_string_part - BUT we do not know at what position to start ...
+ - name:
+ PMSTRESC
+ # operator: contains_case_insensitive
+ # EXAMPLE: PSLOC = LEFT HIND LIMB
+ # PSSTRESC = NON-ULCERATED LEFT HIND LIMB
+ # operator: equals_string_part - BUT we do not know at what position to start ...
operator: equals_string_part
regex: ".{*}(..).*"
- value: PMLOC
- #operator: matches_regex
- # regex: "[a-zA-Z](..)[a-zA-Z]"
- #regex: "*(..)*"
- #value: PMLOC
+ value:
+ PMLOC
+ #operator: matches_regex
+ # regex: "[a-zA-Z](..)[a-zA-Z]"
+ #regex: "*(..)*"
+ #value: PMLOC
Core:
Id: CDISC.SENDIG.335
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when PMSTRESC contains (case insensitive) the value of PMLOC
Executability: Fully Executable
# Operations:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.356/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.356/rule.yml
index 4632d41ad..bfc2e0ed7 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.356/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.356/rule.yml
@@ -6,29 +6,27 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The value for the fetus identifier is unique per subject within
- a study.
+ - Cited Guidance: The value for the fetus identifier is unique per subject within a study.
Document: IG-DART v1.1
- Section: '5.1.1'
+ Section: "5.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND356
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The value for the fetus identifier is unique per subject within
- a study.
+ - Cited Guidance: The value for the fetus identifier is unique per subject within a study.
Document: IG-DART v1.2
- Section: '5.1.1'
+ Section: "5.1.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND356
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
@@ -41,7 +39,7 @@ Check:
Core:
Id: CDISC.SENDIG.356
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when the combination of USUBJID and FETUSID in not unique
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml
index 9ed2a6b22..ebca0bfd6 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND359
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
@@ -22,9 +22,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND359
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
any:
# REMARK that the rule does not say anything about a value being 0
@@ -40,21 +40,22 @@ Check:
value: ^[+-]?[0-9]+$
- name: --RPDY
operator: not_matches_regex
- value: ^[+-]?[0-9]+$
- #- name: --RPSTDY
- # operator: not_matches_regex
- # value: ^[+-]?[0-9]+$
- #- name: --RPENDY
- # operator: not_matches_regex
- # value: ^[+-]?[0-9]+$
+ value:
+ ^[+-]?[0-9]+$
+ #- name: --RPSTDY
+ # operator: not_matches_regex
+ # value: ^[+-]?[0-9]+$
+ #- name: --RPENDY
+ # operator: not_matches_regex
+ # value: ^[+-]?[0-9]+$
Core:
Id: CDISC.SENDIG.359
Status: Draft
- Version: '1'
-Description: 'When populated, values for all Repro Phase Day timing variables are integers'
+ Version: "1"
+Description: "When populated, values for all Repro Phase Day timing variables are integers"
Executability: Fully Executable
Outcome:
- Message: 'Repro Phase Day timing variable value must be an integer'
+ Message: "Repro Phase Day timing variable value must be an integer"
Output Variables:
- RPPLDY
- RPPLSTDY
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml
index 3401aa0f5..f3bf0804d 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml
@@ -5,36 +5,39 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When the PYTESTCD is "PREGSTAT", PYSTRESC should be populated
- with a value in the PYFINDRS controlled terminology list.
+ - Cited Guidance:
+ When the PYTESTCD is "PREGSTAT", PYSTRESC should be populated with a value
+ in the PYFINDRS controlled terminology list.
Document: IG-DART v1.1
- Section: '5.1.2'
+ Section: "5.1.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND362
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: When the PYTESTCD is "PREGSTAT", PYSTRESC should be populated
- with a value in the PYFINDRS controlled terminology list.
+ - Cited Guidance:
+ When the PYTESTCD is "PREGSTAT", PYSTRESC should be populated with a value
+ in the PYFINDRS controlled terminology list.
Document: IG-DART v1.2
- Section: '5.1.2'
+ Section: "5.1.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND362
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: PYTESTCD
operator: equal_to
- value: PREGSTAT
- # TODO: retrieve values from CDISC Library for codelist PYFINDRS
+ value:
+ PREGSTAT
+ # TODO: retrieve values from CDISC Library for codelist PYFINDRS
- name: PYSTRESC
operator: is_not_contained_by
value:
@@ -47,13 +50,12 @@ Check:
Core:
Id: CDISC.SENDIG.362
Status: Draft
- Version: '1'
-Description: Raise an error when the value of PYTESTCD = PREGSTAT and the value
- of PYSTRESC is not one of the codelist PYFINDRS
+ Version: "1"
+Description: Raise an error when the value of PYTESTCD = PREGSTAT and the value of PYSTRESC is not
+ one of the codelist PYFINDRS
Executability: Fully Executable
Outcome:
- Message: The value of PYSTRESC is not one from the codelist PYFINDRS for
- PYTESTCD 'PREGSTAT'
+ Message: The value of PYSTRESC is not one from the codelist PYFINDRS for PYTESTCD 'PREGSTAT'
Output Variables:
- PYTESTCD
- PYSTRESC
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml
index b2936bde5..510220f1a 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml
@@ -4,81 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...'
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ..."
Document: IG v3.0
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND4
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...'
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ..."
Document: IG v3.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND4
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...'
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ..."
Document: IG v3.1.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND4
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...'
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ..."
Document: IG v3.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND4
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...'
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ..."
Document: IG v3.1.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND4
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...'
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ..."
Document: IG v3.1.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND4
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
#- name: variable_data_type
@@ -86,7 +92,7 @@ Check:
# value: 'Char'
#- name: define_variable_data_type
# operator: is_contained_by
- # value:
+ # value:
# - 'integer'
# - 'float'
# Looks as define_variable_type can only have the values "Char" and "Num"
@@ -97,21 +103,21 @@ Check:
# First part: check whether variable name is defined in the define.xml
- name: variable_name
operator: equal_to
- value: define_variable_name
- # Second part: check whether the data types match
+ value:
+ define_variable_name
+ # Second part: check whether the data types match
- name: variable_data_type
operator: not_equal_to
value: define_variable_data_type
Core:
Id: CDISC.SENDIG.4
Status: Draft
- Version: '1'
-Description: Raise an error when the data type in the define.xml does not
- correspond to the data type in the dataset
+ Version: "1"
+Description: Raise an error when the data type in the define.xml does not correspond to the data
+ type in the dataset
Executability: Fully Executable
Outcome:
- Message: Variable datatype in the define.xml does not correspond to the data
- type in the dataset
+ Message: Variable datatype in the define.xml does not correspond to the data type in the dataset
Output Variables:
- variable_name
Rule Type: Variable Metadata Check against Define XML
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.40/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.40/rule.yml
index 3846c8f57..fb14b7090 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.40/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.40/rule.yml
@@ -4,41 +4,44 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Variables with controlled terminology should follow the case
- sensitivity of the Controlled Terminology List
+ - Cited Guidance:
+ Variables with controlled terminology should follow the case sensitivity of
+ the Controlled Terminology List
Document: IG v3.0
Section: 4.2.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND40
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables with controlled terminology should follow the case
- sensitivity of the Controlled Terminology List '
+ - Cited Guidance:
+ "Variables with controlled terminology should follow the case sensitivity of the
+ Controlled Terminology List "
Document: IG v3.1
Section: 4.2.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND40
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Variables with controlled terminology should follow the case
- sensitivity of the Controlled Terminology List '
+ - Cited Guidance:
+ "Variables with controlled terminology should follow the case sensitivity of the
+ Controlled Terminology List "
Document: IG v3.1.1
Section: 4.2.4
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND40
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
Check:
all:
@@ -56,14 +59,15 @@ Check:
#codelistcheck: value # can be "value" or "code"
#codelistlevel: term # can be "term" or "codelist"
- name: LBTESTCD # name: variable_name
- operator: does_not_use_valid_codelist_terms
- # Next line must become a lookup in the IG
+ operator:
+ does_not_use_valid_codelist_terms
+ # Next line must become a lookup in the IG
value: LBTESTCD # means terms of LBTESTCD codelist - TODO: replace by lookup for corresponding codelist
Core:
Id: CDISC.SENDIG.40
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: Variable does not use valid codelist terms
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.407/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.407/rule.yml
index 1974d4f9e..33e10b823 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.407/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.407/rule.yml
@@ -1,5 +1,5 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- Name: SENDIG-GENETOX
References:
@@ -10,9 +10,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND407
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
# TODO: also raise an error when GVSPEC/GVDTC (both "expected") absent
@@ -29,8 +29,8 @@ Check:
Core:
Id: CDISC.SENDIG.407
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: The combination of USUBJID, GVTESTCD, GVSPEC and GVDTC is not unique
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.408/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.408/rule.yml
index d93d0afe9..3a779d533 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.408/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.408/rule.yml
@@ -1,5 +1,5 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- Name: SENDIG-GENETOX
References:
@@ -10,23 +10,23 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND408
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
# Comet is represented at the subject level, not the gel level.
# i.e. when GVCAT = 'IN VIVO COMET' then USUBJID must be populated, not POOLID
# REMARK: but USUBJID = "required" anyway
Check:
all:
- - name: 'GVCAT'
+ - name: "GVCAT"
operator: equal_to
- value: 'IN VIVO COMET'
- - name: 'USUBJID'
+ value: "IN VIVO COMET"
+ - name: "USUBJID"
operator: empty
Core:
Id: CDISC.SENDIG.408
Status: Draft
- Version: '1'
+ Version: "1"
Description: Comet is represented at the subject level, not the gel level.
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.6A/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.6A/rule.yml
index 69f22181d..5a63a5228 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.6A/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.6A/rule.yml
@@ -5,86 +5,92 @@ Authorities:
References:
# IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE!
- Citations:
- - Cited Guidance: Metadata in Define-XML document should match both the SENDIG
- label and the label in the .xpt datasets
+ - Cited Guidance:
+ Metadata in Define-XML document should match both the SENDIG label and the
+ label in the .xpt datasets
Document: SENDIG v3.1
Section: 3.2.2 | 4.21
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND6
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
# IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE!
- Citations:
- - Cited Guidance: Metadata in Define-XML document should match both the SENDIG
- label and the label in the .xpt datasets
+ - Cited Guidance:
+ Metadata in Define-XML document should match both the SENDIG label and the
+ label in the .xpt datasets
Document: SENDIG v3.1
Section: 3.2.2 | 4.21
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND6
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
# IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE!
- Citations:
- - Cited Guidance: Metadata in Define-XML document should match both the SENDIG
- label and the label in the .xpt datasets
+ - Cited Guidance:
+ Metadata in Define-XML document should match both the SENDIG label and the
+ label in the .xpt datasets
Document: SENDIG v3.1
Section: 3.2.2 | 4.21
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND6
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
# IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE!
- Citations:
- - Cited Guidance: Metadata in Define-XML document should match both the SENDIG
- label and the label in the .xpt datasets
+ - Cited Guidance:
+ Metadata in Define-XML document should match both the SENDIG label and the
+ label in the .xpt datasets
Document: SENDIG v3.1
Section: 3.2.2 | 4.21
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND6
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
# IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE!
- Citations:
- - Cited Guidance: Metadata in Define-XML document should match both the SENDIG
- label and the label in the .xpt datasets
+ - Cited Guidance:
+ Metadata in Define-XML document should match both the SENDIG label and the
+ label in the .xpt datasets
Document: SENDIG v3.1.1
Section: 3.2.2 | 4.21
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND6
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
# IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE!
- Citations:
- - Cited Guidance: Metadata in Define-XML document should match both the SENDIG
- label and the label in the .xpt datasets
+ - Cited Guidance:
+ Metadata in Define-XML document should match both the SENDIG label and the
+ label in the .xpt datasets
Document: SENDIG v3.1.1
Section: 3.2.2 | 4.21
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND6
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
# Precondition: define variable name = library variable name
@@ -92,17 +98,18 @@ Check:
operator: equal_to
value: library_variable_name
- name: define_variable_label
- operator: not_equal_to
- # Look up in the CDISC-Library API - see https://github.com/cdisc-org/cdisc-rules-engine/issues/243
+ operator:
+ not_equal_to
+ # Look up in the CDISC-Library API - see https://github.com/cdisc-org/cdisc-rules-engine/issues/243
value: library_variable_label
Core:
Id: CDISC.SENDIG.6A
Status: Draft
- Version: '1'
-Description: 'Raise an error when the variable label in the define.xml does not
- correspond to the variable label in the Implementation Guide. NOTE: This rule
- has been split in two parts: A. check define variable label against IG label
- B. check define variable label against the label in the dataset '
+ Version: "1"
+Description:
+ "Raise an error when the variable label in the define.xml does not correspond to the variable
+ label in the Implementation Guide. NOTE: This rule has been split in two parts: A. check define variable
+ label against IG label B. check define variable label against the label in the dataset "
Executability: Fully Executable
Outcome:
Message: The label of the variable is incorrect
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml
index 5030c9cbb..d14246301 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml
@@ -4,9 +4,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1.
+ - Cited Guidance:
+ The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1.
Document: IG v3.0
Section: 4.4.4
Origin: SEND Conformance Rules
@@ -18,9 +18,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1.
+ - Cited Guidance:
+ The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1.
Document: IG v3.1
Section: 4.4.4
Origin: SEND Conformance Rules
@@ -32,9 +32,9 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1.
+ - Cited Guidance:
+ The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1.
Document: IG v3.1.1
Section: 4.4.4
Origin: SEND Conformance Rules
@@ -46,9 +46,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1.
+ - Cited Guidance:
+ The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1.
Document: IG v3.1
Section: 4.4.4
Origin: SEND Conformance Rules
@@ -60,9 +60,9 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1.
+ - Cited Guidance:
+ The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1.
Document: IG v3.1.1
Section: 4.4.4
Origin: SEND Conformance Rules
@@ -74,9 +74,9 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY)
- describe the relative day of the observation starting with the
- reference date as Day 1.
+ - Cited Guidance:
+ The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
+ relative day of the observation starting with the reference date as Day 1.
Document: IG v3.1.1
Section: 4.4.4
Origin: SEND Conformance Rules
@@ -100,9 +100,8 @@ Core:
Id: CDISC.SENDIG.71
Status: Draft
Version: "1"
-Description: --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if
- --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion
- of RFSTDTC) if --DTC precedes RFSTDTC
+Description: --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after
+ RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC
Executability: Fully Executable
Match Datasets:
- Keys:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.80/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.80/rule.yml
index c7c21d239..5789768b4 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.80/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.80/rule.yml
@@ -2,19 +2,20 @@ Authorities:
- Organization: CDISC
Standards:
- Name: SENDIG
- Version: '3.0'
References:
- - Origin: SEND Conformance Rules
- Rule Identifier:
- Id: SEND80
- Version: '1'
- Version: '5.0'
- Citations:
- - Cited Guidance: When using time points, at least one corresponding
- timing variable should be provided (e.g., VISITDY, --DTC, --DY).
+ - Citations:
+ - Cited Guidance:
+ When using time points, at least one corresponding timing variable should be
+ provided (e.g., VISITDY, --DTC, --DY).
Document: IG v3.0
Item: Specification
Section: 4.2.1
+ Origin: SEND Conformance Rules
+ Rule Identifier:
+ Id: SEND80
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
Check:
all:
- name: --TPT
@@ -30,9 +31,8 @@ Check:
Core:
Id: CDISC.SENDIG.80
Status: Draft
- Version: '1'
-Description: When --TPT is populated, at least one of VISITDY, --DTC or --DY must
- be populated
+ Version: "1"
+Description: When --TPT is populated, at least one of VISITDY, --DTC or --DY must be populated
Executability: Fully Executable
Outcome:
Message: --TPT is populated, but none of of VISITDY, --DTC or --DY is populated
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND1/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND1/rule.yml
index 94884f4ad..a8f378a26 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.SEND1/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND1/rule.yml
@@ -4,16 +4,15 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: SDTM datasets are normally named to be consistent with the
- domain code.
+ - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code.
Document: SENDIG v3.1
Section: 4.1.4
Origin: SENDIG Conformance Rules
Rule Identifier:
- Id: 'SEND1'
- Version: '1'
- Version: '5'
- Version: '3.1'
+ Id: "SEND1"
+ Version: "1"
+ Version: "5"
+ Version: "3.1"
Check:
all:
- name: dataset_name
@@ -22,7 +21,7 @@ Check:
Core:
Id: CDISC.SENDIG.SEND1
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when the filename is not equal to the value of DOMAIN.
Outcome:
Message: The filename is not equal to the 2-character domain code.
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml
index 8d55acc33..6c6cb391d 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml
@@ -3,78 +3,78 @@ Authorities:
Standards:
- Name: SENDIG
References:
- - #need to determine what can be done with catalog version 5 if anything
- Citations:
- - Cited Guidance: One record per test per observation time per subject,
- Tabulation.
- #SMEs do we want to keep "Tabulation" for any reason?
+ #need to determine what can be done with catalog version 5 if anything
+ - Citations:
+ - Cited Guidance:
+ One record per test per observation time per subject, Tabulation.
+ #SMEs do we want to keep "Tabulation" for any reason?
Document: SENDIG v3.1
Section: 6.3.1
Origin: SENDIG Conformance Rules
Rule Identifier:
- Id: 'SEND142'
- Version: '1'
- Version: '5'
- Version: '3.0'
+ Id: "SEND142"
+ Version: "1"
+ Version: "5"
+ Version: "3.0"
- Name: SENDIG
References:
- - #need to determine what can be done with catalog version 5 if anything
- Citations:
- - Cited Guidance: One record per test per observation time per subject,
- Tabulation.
- #SMEs do we want to keep "Tabulation" for any reason?
+ #need to determine what can be done with catalog version 5 if anything
+ - Citations:
+ - Cited Guidance:
+ One record per test per observation time per subject, Tabulation.
+ #SMEs do we want to keep "Tabulation" for any reason?
Document: SENDIG v3.1
Section: 6.3.1
Origin: SENDIG Conformance Rules
Rule Identifier:
- Id: 'SEND142'
- Version: '1'
- Version: '5'
- Version: '3.1'
+ Id: "SEND142"
+ Version: "1"
+ Version: "5"
+ Version: "3.1"
- Name: SENDIG-DART
References:
- - #need to determine what can be done with catalog version 5 if anything
- Citations:
- - Cited Guidance: One record per test per observation time per subject,
- Tabulation.
- #SMEs do we want to keep "Tabulation" for any reason?
+ #need to determine what can be done with catalog version 5 if anything
+ - Citations:
+ - Cited Guidance:
+ One record per test per observation time per subject, Tabulation.
+ #SMEs do we want to keep "Tabulation" for any reason?
Document: SENDIG v3.1
Section: 6.3.1
Origin: SENDIG Conformance Rules
Rule Identifier:
- Id: 'SEND142'
- Version: '1'
- Version: '5'
+ Id: "SEND142"
+ Version: "1"
+ Version: "5"
Version: v1.1
- Name: SENDIG-DART
References:
- - #need to determine what can be done with catalog version 5 if anything
- Citations:
- - Cited Guidance: One record per test per observation time per subject,
- Tabulation.
- #SMEs do we want to keep "Tabulation" for any reason?
+ #need to determine what can be done with catalog version 5 if anything
+ - Citations:
+ - Cited Guidance:
+ One record per test per observation time per subject, Tabulation.
+ #SMEs do we want to keep "Tabulation" for any reason?
Document: SENDIG v3.1
Section: 6.3.1
Origin: SENDIG Conformance Rules
Rule Identifier:
- Id: 'SEND142'
- Version: '1'
- Version: '5'
+ Id: "SEND142"
+ Version: "1"
+ Version: "5"
Version: v1.2
- Name: SENDID-GENETOX
References:
- - #need to determine what can be done with catalog version 5 if anything
- Citations:
- - Cited Guidance: One record per test per observation time per subject,
- Tabulation.
- #SMEs do we want to keep "Tabulation" for any reason?
+ #need to determine what can be done with catalog version 5 if anything
+ - Citations:
+ - Cited Guidance:
+ One record per test per observation time per subject, Tabulation.
+ #SMEs do we want to keep "Tabulation" for any reason?
Document: SENDIG v3.1
Section: 6.3.1
Origin: SENDIG Conformance Rules
Rule Identifier:
- Id: 'SEND142'
- Version: '1'
- Version: '5'
+ Id: "SEND142"
+ Version: "1"
+ Version: "5"
Version: v1.0 #double check the last few
Check:
all:
@@ -88,10 +88,9 @@ Check:
Core:
Id: CDISC.SENDIG.SEND142
Status: Draft
- Version: '1'
-Description: Raise an error when there is more than one record present for any
- particular Body Weight test, in the BW Domain, for a subject on a particular
- date.
+ Version: "1"
+Description: Raise an error when there is more than one record present for any particular Body
+ Weight test, in the BW Domain, for a subject on a particular date.
#The check for this rule was revised to NOT check the records where BWDTC is null
Outcome:
Message: The Body Weight test is not unique for this subject and date/time.
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml
index 71d83e4a9..43b6ef1ee 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml
@@ -4,107 +4,122 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.0
Section: 6.3.3
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.1
Section: 6.3.3
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.1.1
Section: 6.3.3
Origin: SENDIG Conformance Rules
Rule Identifier:
- Id: 'SEND157'
- Version: '1'
- Version: '5'
- Version: '3.0'
+ Id: "SEND157"
+ Version: "1"
+ Version: "5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.0
Section: 6.3.3
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.1
Section: 6.3.3
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.1.1
Section: 6.3.3
Origin: SENDIG Conformance Rules
Rule Identifier:
- Id: 'SEND157'
- Version: '1'
- Version: '5'
- Version: '3.1'
+ Id: "SEND157"
+ Version: "1"
+ Version: "5"
+ Version: "3.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.0
Section: 6.3.3
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.1
Section: 6.3.3
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.1.1
Section: 6.3.3
Origin: SENDIG Conformance Rules
Rule Identifier:
- Id: 'SEND157'
- Version: '1'
- Version: '5'
+ Id: "SEND157"
+ Version: "1"
+ Version: "5"
Version: v1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.0
Section: 6.3.3
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.1
Section: 6.3.3
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.1.1
Section: 6.3.3
Origin: SENDIG Conformance Rules
Rule Identifier:
- Id: 'SEND157'
- Version: '1'
- Version: '5'
+ Id: "SEND157"
+ Version: "1"
+ Version: "5"
Version: v1.2
- Name: SENDID-GENETOX
References:
- Citations:
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.0
Section: 6.3.3
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.1
Section: 6.3.3
- - Cited Guidance: The mass identification should be unique within the subject,
- regardless of mass location.
+ - Cited Guidance:
+ The mass identification should be unique within the subject, regardless of
+ mass location.
Document: SENDIG v3.1.1
Section: 6.3.3
Origin: SENDIG Conformance Rules
Rule Identifier:
- Id: 'SEND157'
- Version: '1'
- Version: '5'
+ Id: "SEND157"
+ Version: "1"
+ Version: "5"
Version: v1.0
Check:
any:
@@ -114,12 +129,11 @@ Check:
Core:
Id: CDISC.SENDIG.SEND157
Status: Draft
- Version: '1'
-Description: Raise an error when the mass identification is not unique within
- the subject, regardless of the mass location.
+ Version: "1"
+Description: Raise an error when the mass identification is not unique within the subject,
+ regardless of the mass location.
Outcome:
- Message: The mass identification is not unique within the subject regardless of
- the mass location.
+ Message: The mass identification is not unique within the subject regardless of the mass location.
Output Variables:
- --SPID
- USUBJID
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND293/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND293/rule.yml
index e94c5f2a2..39c93e2d5 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.SEND293/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND293/rule.yml
@@ -5,103 +5,93 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND293'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND293"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND293'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND293"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND293'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Id: "SEND293"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND293'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND293"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: For each unique planned time point (--TPT), there must be a
- one-to-one relationship between the values of --TPT and
- --TPTNUM. Uniqueness for these time points is determined by a
- combination of the domain, study day, and, if present,
- category and/or subcategory (--CAT/--SCAT). Other variables,
- such as --TESTCD and --METHOD, may also be needed in some
- cases to define uniqueness. When this occurs, clarification
- should be provided as a comment to --TPTNUM in the define
- file.
+ - Cited Guidance:
+ For each unique planned time point (--TPT), there must be a one-to-one
+ relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is
+ determined by a combination of the domain, study day, and, if present, category and/or
+ subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be
+ needed in some cases to define uniqueness. When this occurs, clarification should be
+ provided as a comment to --TPTNUM in the define file.
Document: IG v3.1.1
Section: 4.4.7.2.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND293'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND293"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
- name: --TPT
@@ -111,7 +101,7 @@ Check:
Core:
Id: CDISC.SENDIG.SEND293
Status: Draft
- Version: '1'
+ Version: "1"
Description: Raise an error when --TPT is populated but --TPTNUM is not populated.
Executability: Fully Executable
Outcome:
diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND411/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND411/rule.yml
index 58c83eb03..dfd2b47fc 100644
--- a/Unpublished/SENDIG/CDISC.SENDIG.SEND411/rule.yml
+++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND411/rule.yml
@@ -1,5 +1,5 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- Name: SENDIG-GENETOX
References:
@@ -10,22 +10,22 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND411
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
# GVSCAT must be populated with the analysis intention
all:
- - name: 'GVSCAT'
+ - name: "GVSCAT"
operator: empty
Core:
Id: CDISC.SENDIG.SEND411
Status: Draft
- Version: '1'
-Description: 'GVSCAT must be populated with the analysis intention'
+ Version: "1"
+Description: "GVSCAT must be populated with the analysis intention"
Executability: Partially Executable - Possible Underreporting
Outcome:
- Message: 'GVSCAT must be populated with the analysis intention'
+ Message: "GVSCAT must be populated with the analysis intention"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml b/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml
index 51f520eb6..72af22b1e 100644
--- a/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml
+++ b/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml
@@ -7,220 +7,219 @@ Authorities:
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and
- punctuation) used by the terminology maintenance organizations
- (e.g., MedDRA, CDISC controlled terminology).'
+ - Cited Guidance:
+ "Controlled terms should use the exact term (case, spelling, and punctuation)
+ used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)."
Document: FDA
Section: FDAB017
Origin: FDA Business Rules
Rule Identifier:
Id: FB1701
- Version: '1'
- Version: '1.5'
- Version: '3.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.2"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and
- punctuation) used by the terminology maintenance organizations
- (e.g., MedDRA, CDISC controlled terminology).'
+ - Cited Guidance:
+ "Controlled terms should use the exact term (case, spelling, and punctuation)
+ used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)."
Document: FDA
Section: FDAB017
Origin: FDA Business Rules
Rule Identifier:
Id: FB1701
- Version: '1'
- Version: '1.5'
- Version: '3.3'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.3"
- Name: SDTMIG
References:
- Citations:
- - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and
- punctuation) used by the terminology maintenance organizations
- (e.g., MedDRA, CDISC controlled terminology).'
+ - Cited Guidance:
+ "Controlled terms should use the exact term (case, spelling, and punctuation)
+ used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)."
Document: FDA
Section: FDAB017
Origin: FDA Business Rules
Rule Identifier:
Id: FB1701
- Version: '1'
- Version: '1.5'
- Version: '3.4'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.4"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and
- punctuation) used by the terminology maintenance organizations
- (e.g., MedDRA, CDISC controlled terminology).'
+ - Cited Guidance:
+ "Controlled terms should use the exact term (case, spelling, and punctuation)
+ used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)."
Document: FDA
Section: FDAB017
Origin: FDA Business Rules
Rule Identifier:
Id: FB1701
- Version: '1'
- Version: '1.5'
- Version: '3.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and
- punctuation) used by the terminology maintenance organizations
- (e.g., MedDRA, CDISC controlled terminology).'
+ - Cited Guidance:
+ "Controlled terms should use the exact term (case, spelling, and punctuation)
+ used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)."
Document: FDA
Section: FDAB017
Origin: FDA Business Rules
Rule Identifier:
Id: FB1701
- Version: '1'
- Version: '1.5'
- Version: '3.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and
- punctuation) used by the terminology maintenance organizations
- (e.g., MedDRA, CDISC controlled terminology).'
+ - Cited Guidance:
+ "Controlled terms should use the exact term (case, spelling, and punctuation)
+ used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)."
Document: FDA
Section: FDAB017
Origin: FDA Business Rules
Rule Identifier:
Id: FB1701
- Version: '1'
- Version: '1.5'
- Version: '3.1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and
- punctuation) used by the terminology maintenance organizations
- (e.g., MedDRA, CDISC controlled terminology).'
+ - Cited Guidance:
+ "Controlled terms should use the exact term (case, spelling, and punctuation)
+ used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)."
Document: FDA
Section: FDAB017
Origin: FDA Business Rules
Rule Identifier:
Id: FB1701
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and
- punctuation) used by the terminology maintenance organizations
- (e.g., MedDRA, CDISC controlled terminology).'
+ - Cited Guidance:
+ "Controlled terms should use the exact term (case, spelling, and punctuation)
+ used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)."
Document: FDA
Section: FDAB017
Origin: FDA Business Rules
Rule Identifier:
Id: FB1701
- Version: '1'
- Version: '1.5'
- Version: '1.1'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and
- punctuation) used by the terminology maintenance organizations
- (e.g., MedDRA, CDISC controlled terminology).'
+ - Cited Guidance:
+ "Controlled terms should use the exact term (case, spelling, and punctuation)
+ used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)."
Document: FDA
Section: FDAB017
Origin: FDA Business Rules
Rule Identifier:
Id: FB1701
- Version: '1'
- Version: '1.5'
- Version: '1.2'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.2"
- Name: SENDIG-AR
References:
- Citations:
- - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and
- punctuation) used by the terminology maintenance organizations
- (e.g., MedDRA, CDISC controlled terminology).'
+ - Cited Guidance:
+ "Controlled terms should use the exact term (case, spelling, and punctuation)
+ used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)."
Document: FDA
Section: FDAB017
Origin: FDA Business Rules
Rule Identifier:
Id: FB1701
- Version: '1'
- Version: '1.5'
- Version: '1.0'
+ Version: "1"
+ Version: "1.5"
+ Version: "1.0"
- Organization: CDISC
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The SEND CT indicates whether a particular codelist is
- extensible or not.
+ - Cited Guidance: The SEND CT indicates whether a particular codelist is extensible or not.
Document: IG v3.0
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND296
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The SEND CT indicates whether a particular codelist is
- extensible or not.
+ - Cited Guidance: The SEND CT indicates whether a particular codelist is extensible or not.
Document: IG v3.1
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND296
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The SEND CT indicates whether a particular codelist is
- extensible or not.
+ - Cited Guidance: The SEND CT indicates whether a particular codelist is extensible or not.
Document: IG v3.1.1
Section: 4.1.3
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND296
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
-# Comment/Answer Christy Kubin:
-# The intent of this rule is to check the values in the dataset against the CT in the CDISC library.
+# Comment/Answer Christy Kubin:
+# The intent of this rule is to check the values in the dataset against the CT in the CDISC library.
# The define file should not be checked in this case.
Check:
all:
- name: LBTESTCD ## only for exploring
operator: not_equal_to
- value: 'test variable'
- # See DDF00110 (Richard Marshall)
+ value:
+ "test variable"
+ # See DDF00110 (Richard Marshall)
- name: $codelist_extensible
operator: equal_to
- value: false
- #- codelistcheck: value
- # codelistlevel: term
- # name: --STAT
- # operator: does_not_use_valid_codelist_terms
- # value: true
- #- name: $variable
- # operator: empty
- #- name: library_variable_has_codelist
- # operator: equal_to
- # value: true
- #- codelist: 'LBTESTCD'
- # name: $codelist_extensible
- # operator: equal_to
- # value: false
- #- name: $column_order_from_dataset
- # operator: is_not_ordered_by
- # order: asc
- # value: $column_order_from_library
+ value:
+ false
+ #- codelistcheck: value
+ # codelistlevel: term
+ # name: --STAT
+ # operator: does_not_use_valid_codelist_terms
+ # value: true
+ #- name: $variable
+ # operator: empty
+ #- name: library_variable_has_codelist
+ # operator: equal_to
+ # value: true
+ #- codelist: 'LBTESTCD'
+ # name: $codelist_extensible
+ # operator: equal_to
+ # value: false
+ #- name: $column_order_from_dataset
+ # operator: is_not_ordered_by
+ # order: asc
+ # value: $column_order_from_library
Core:
Id: FDA.SDTMIG.FB1901
Status: Draft
- Version: '1'
-Description: When CDISC published Controlled Terminology indicates that a
- codelist is non-extensible then only terms from the codelist should be used.
+ Version: "1"
+Description: When CDISC published Controlled Terminology indicates that a codelist is non-extensible
+ then only terms from the codelist should be used.
Executability: Fully Executable
Operations:
# See DDF00110 (Richard Marshall)
@@ -228,35 +227,36 @@ Operations:
ct_package_type: SDTM
id: $codelist_extensible
operator: codelist_extensible
- version: category.codeSystemVersion
- #- id: $column_order_from_library
- # operator: get_column_order_from_library
- # P.S. it would be nice whem instead of the codelist name, one could also provide the NCI Code of the codelist
- # TODO: as we need to iterate over ALL variables that do have a codelist
- # How do I pass the variable name and/or its codelist name as an argument to this?
- # - codelist: 'NOT DONE' # Can ignore schema warning - it IS required, and is name of the Codelist for which CT is checked
- # id: $codelist_extensible
- # operator: codelist_extensible
- #
+ version:
+ category.codeSystemVersion
+ #- id: $column_order_from_library
+ # operator: get_column_order_from_library
+ # P.S. it would be nice whem instead of the codelist name, one could also provide the NCI Code of the codelist
+ # TODO: as we need to iterate over ALL variables that do have a codelist
+ # How do I pass the variable name and/or its codelist name as an argument to this?
+ # - codelist: 'NOT DONE' # Can ignore schema warning - it IS required, and is name of the Codelist for which CT is checked
+ # id: $codelist_extensible
+ # operator: codelist_extensible
+ #
- # - id: $codelist_terms
- # operator: codelist_terms
- # ct_packages:
- # - sdtmct-2020-03-27
- # ct_version: LBVERSION
- # id: $CODELISTEXTENSIBLE
- # name: LBTESTCD
- # operator: get_codelist_attributes
- #- id: $column_order_from_library
- # operator: get_column_order_from_library
+ # - id: $codelist_terms
+ # operator: codelist_terms
+ # ct_packages:
+ # - sdtmct-2020-03-27
+ # ct_version: LBVERSION
+ # id: $CODELISTEXTENSIBLE
+ # name: LBTESTCD
+ # operator: get_codelist_attributes
+ #- id: $column_order_from_library
+ # operator: get_column_order_from_library
- # - ct_attribute: extensible
- # ct_packages:
- # - sdtmct-2020-03-27
- # ct_version: 'LBVERSION'
- # id: $CODELISTEXTENSIBLE
- # name: LBTESTCD
- # operator: get_codelist_attributes
+ # - ct_attribute: extensible
+ # ct_packages:
+ # - sdtmct-2020-03-27
+ # ct_version: 'LBVERSION'
+ # id: $CODELISTEXTENSIBLE
+ # name: LBTESTCD
+ # operator: get_codelist_attributes
Outcome:
Message: A new term has been added to a non-extensible code list.
@@ -264,9 +264,9 @@ Outcome:
# - $column_order_from_library
- $codelist_extensible
- $codelist_code
- # - variable_name
- # - $var_codelist
- # - $CODELISTEXTENSIBLE
+ # - variable_name
+ # - $var_codelist
+ # - $CODELISTEXTENSIBLE
Rule Type: Record Data
# Rule Type: Variable Metadata Check against Library Metadata
Scope:
diff --git a/Unpublished/SENDIG/SEND100/rule.yml b/Unpublished/SENDIG/SEND100/rule.yml
index e131dc7c4..0b33578ea 100644
--- a/Unpublished/SENDIG/SEND100/rule.yml
+++ b/Unpublished/SENDIG/SEND100/rule.yml
@@ -4,99 +4,105 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The sponsor must define what collected date is used to populate
- RFSTDTC in the data define file.
+ - Cited Guidance:
+ The sponsor must define what collected date is used to populate RFSTDTC in
+ the data define file.
Document: IG v3.0
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND100
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The sponsor must define what collected date is used to populate
- RFSTDTC in the data define file.
+ - Cited Guidance:
+ The sponsor must define what collected date is used to populate RFSTDTC in
+ the data define file.
Document: IG v3.1
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND100
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The sponsor must define what collected date is used to populate
- RFSTDTC in the data define file.
+ - Cited Guidance:
+ The sponsor must define what collected date is used to populate RFSTDTC in
+ the data define file.
Document: IG v3.1
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND100
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The sponsor must define what collected date is used to populate
- RFSTDTC in the data define file.
+ - Cited Guidance:
+ The sponsor must define what collected date is used to populate RFSTDTC in
+ the data define file.
Document: IG v3.1.1
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND100
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The sponsor must define what collected date is used to populate
- RFSTDTC in the data define file.
+ - Cited Guidance:
+ The sponsor must define what collected date is used to populate RFSTDTC in
+ the data define file.
Document: IG v3.1
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND100
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The sponsor must define what collected date is used to populate
- RFSTDTC in the data define file.
+ - Cited Guidance:
+ The sponsor must define what collected date is used to populate RFSTDTC in
+ the data define file.
Document: IG v3.1.1
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND100
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: RFSTDTC
- operator: non_empty
- # TODO: change into "has_method" (function requested: https://github.com/cdisc-org/cdisc-rules-engine/issues/1047)
+ operator:
+ non_empty
+ # TODO: change into "has_method" (function requested: https://github.com/cdisc-org/cdisc-rules-engine/issues/1047)
- name: define_variable_has_comment
operator: equal_to
value: false
Core:
Id: SEND100
Status: Draft
- Version: '1'
-Description: Check in the define.xml whether there is a "Method"
- (@MethodOID/MethodDef) attached to the DM variable DM
+ Version: "1"
+Description: Check in the define.xml whether there is a "Method" (@MethodOID/MethodDef) attached to
+ the DM variable DM
Executability: Fully Executable
Outcome:
- Message: No 'method' (through @MethodOID/MethodDef) has been assigned to the
- variable RFSTDTC
+ Message: No 'method' (through @MethodOID/MethodDef) has been assigned to the variable RFSTDTC
Output Variables:
- RFSTDTC
- RFENDTC
diff --git a/Unpublished/SENDIG/SEND106.1/rule.yml b/Unpublished/SENDIG/SEND106.1/rule.yml
index ff062852f..51d2780c1 100644
--- a/Unpublished/SENDIG/SEND106.1/rule.yml
+++ b/Unpublished/SENDIG/SEND106.1/rule.yml
@@ -5,73 +5,73 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If this variable is excluded in the DM domain, the information
- must be present at a higher level (either Trial Sets or Trial
- Summary).
+ - Cited Guidance:
+ If this variable is excluded in the DM domain, the information must be
+ present at a higher level (either Trial Sets or Trial Summary).
Document: IG v3.1
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND106.1
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If this variable is excluded in the DM domain, the information
- must be present at a higher level (either Trial Sets or Trial
- Summary).
+ - Cited Guidance:
+ If this variable is excluded in the DM domain, the information must be
+ present at a higher level (either Trial Sets or Trial Summary).
Document: IG v3.1.1
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND106.1
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If this variable is excluded in the DM domain, the information
- must be present at a higher level (either Trial Sets or Trial
- Summary).
+ - Cited Guidance:
+ If this variable is excluded in the DM domain, the information must be
+ present at a higher level (either Trial Sets or Trial Summary).
Document: IG v3.1
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND106.1
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If this variable is excluded in the DM domain, the information
- must be present at a higher level (either Trial Sets or Trial
- Summary).
+ - Cited Guidance:
+ If this variable is excluded in the DM domain, the information must be
+ present at a higher level (either Trial Sets or Trial Summary).
Document: IG v3.1.1
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND106.1
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: If this variable is excluded in the DM domain, the information
- must be present at a higher level (either Trial Sets or Trial
- Summary).
+ - Cited Guidance:
+ If this variable is excluded in the DM domain, the information must be
+ present at a higher level (either Trial Sets or Trial Summary).
Document: IG v3.1.1
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND106.1
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
# 2025-02-25: NOT TESTED AT ALL YET - first need to resolve issues for SEND106
all:
@@ -80,10 +80,11 @@ Check:
- name: STRAIN
operator: not_exists
- name: STRAIN
- operator: empty
- # Either TSPARMCD=STRAIN is missing from TS
- # or TSVAL is null when TSPARMCD=STRAIN
- # or TXVAL is null when TXPARMCD=STRAIN
+ operator:
+ empty
+ # Either TSPARMCD=STRAIN is missing from TS
+ # or TSVAL is null when TSPARMCD=STRAIN
+ # or TXVAL is null when TXPARMCD=STRAIN
- all:
- any:
- name: $distinct_tsparmcd
@@ -112,9 +113,9 @@ Check:
Core:
Id: SEND106.1
Status: Draft
- Version: '1'
-Description: When "STRAIN" is absent in DM, and also absent as a parameter in TS
- and TX, report an error
+ Version: "1"
+Description: When "STRAIN" is absent in DM, and also absent as a parameter in TS and TX, report an
+ error
Executability: Fully Executable
# 2025-02-25: Jozef: what is this doing?
Match Datasets:
@@ -126,11 +127,11 @@ Operations:
- domain: TS
id: $distinct_tsparmcd
name: TSPARMCD
- operator: distinct
- # gets the distinct values of TXPARMCD
+ operator:
+ distinct
+ # gets the distinct values of TXPARMCD
Outcome:
- Message: Missing STRAIN Trial Summary and Trial Sets Parameter when STRAIN is
- not present in DM
+ Message: Missing STRAIN Trial Summary and Trial Sets Parameter when STRAIN is not present in DM
Output Variables:
- TSPARMCD
- TSVAL
diff --git a/Unpublished/SENDIG/SEND238/rule.yml b/Unpublished/SENDIG/SEND238/rule.yml
index 06d45d04c..00e507806 100644
--- a/Unpublished/SENDIG/SEND238/rule.yml
+++ b/Unpublished/SENDIG/SEND238/rule.yml
@@ -4,129 +4,124 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: In general, each Set should have a distinct combination of
- TXPARMCD, TXPARM, and TXVAL whenever possible. If two Trial
- Sets (identified by distinct SETCD values) have the same set
- of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must
- contain nformation that distinguishes the two Trial Sets from
- each other.
+ - Cited Guidance:
+ In general, each Set should have a distinct combination of TXPARMCD, TXPARM,
+ and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have
+ the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain
+ nformation that distinguishes the two Trial Sets from each other.
Document: IG v3.0
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND238
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: In general, each Set should have a distinct combination of
- TXPARMCD, TXPARM, and TXVAL whenever possible. If two Trial
- Sets (identified by distinct SETCD values) have the same set
- of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must
- contain nformation that distinguishes the two Trial Sets from
- each other.
+ - Cited Guidance:
+ In general, each Set should have a distinct combination of TXPARMCD, TXPARM,
+ and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have
+ the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain
+ nformation that distinguishes the two Trial Sets from each other.
Document: IG v3.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND238
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: In general, each Set should have a distinct combination of
- TXPARMCD, TXPARM, and TXVAL whenever possible. If two Trial
- Sets (identified by distinct SETCD values) have the same set
- of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must
- contain nformation that distinguishes the two Trial Sets from
- each other.
+ - Cited Guidance:
+ In general, each Set should have a distinct combination of TXPARMCD, TXPARM,
+ and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have
+ the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain
+ nformation that distinguishes the two Trial Sets from each other.
Document: IG v3.1.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND238
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: In general, each Set should have a distinct combination of
- TXPARMCD, TXPARM, and TXVAL whenever possible. If two Trial
- Sets (identified by distinct SETCD values) have the same set
- of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must
- contain nformation that distinguishes the two Trial Sets from
- each other.
+ - Cited Guidance:
+ In general, each Set should have a distinct combination of TXPARMCD, TXPARM,
+ and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have
+ the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain
+ nformation that distinguishes the two Trial Sets from each other.
Document: IG v3.1.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND238
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: In general, each Set should have a distinct combination of
- TXPARMCD, TXPARM, and TXVAL whenever possible. If two Trial
- Sets (identified by distinct SETCD values) have the same set
- of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must
- contain nformation that distinguishes the two Trial Sets from
- each other.
+ - Cited Guidance:
+ In general, each Set should have a distinct combination of TXPARMCD, TXPARM,
+ and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have
+ the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain
+ nformation that distinguishes the two Trial Sets from each other.
Document: IG v3.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND238
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: In general, each Set should have a distinct combination of
- TXPARMCD, TXPARM, and TXVAL whenever possible. If two Trial
- Sets (identified by distinct SETCD values) have the same set
- of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must
- contain nformation that distinguishes the two Trial Sets from
- each other.
+ - Cited Guidance:
+ In general, each Set should have a distinct combination of TXPARMCD, TXPARM,
+ and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have
+ the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain
+ nformation that distinguishes the two Trial Sets from each other.
Document: IG v3.1.1
Item: Specification
Section: 7.4.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND238
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
# We only report a violation when the texts in SET are identical.
# This is very probably underreporting
- - name: 'SET'
- operator: 'is_not_unique_set'
+ - name: "SET"
+ operator: "is_not_unique_set"
value:
- TXPARMCD
- TXPARM
- TXVAL
Core:
Status: Draft
- Version: '1'
-Description: 'Report a violation when the texts in SET are identical for the
- combination of SET, TXPARMCD, TXPARM'
+ Version: "1"
+Description:
+ "Report a violation when the texts in SET are identical for the combination of SET, TXPARMCD,
+ TXPARM"
Executability: Fully Executable
Outcome:
- Message: 'The combination of SET, TXPARMCD, TXPARM and TXVAL must be unique'
+ Message: "The combination of SET, TXPARMCD, TXPARM and TXVAL must be unique"
Output Variables:
- SETCD
- SET
diff --git a/Unpublished/SENDIG/SEND239/rule.yml b/Unpublished/SENDIG/SEND239/rule.yml
index 360531760..c32b577ac 100644
--- a/Unpublished/SENDIG/SEND239/rule.yml
+++ b/Unpublished/SENDIG/SEND239/rule.yml
@@ -4,10 +4,10 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include"
- column in Section 7.4.2 should be included in a well-formed TX
- domain submission. These TXPARMCD values are expected to occur
- in almost all studies and may be necessary for clear
+ - Cited Guidance:
+ The TXPARMCD values marked as "Yes" in the "Should Include" column in
+ Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD
+ values are expected to occur in almost all studies and may be necessary for clear
interpretation of the data package.
Document: IG v3.0
Item: Specification
@@ -15,16 +15,16 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND239
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include"
- column in Section 7.4.2 should be included in a well-formed TX
- domain submission. These TXPARMCD values are expected to occur
- in almost all studies and may be necessary for clear
+ - Cited Guidance:
+ The TXPARMCD values marked as "Yes" in the "Should Include" column in
+ Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD
+ values are expected to occur in almost all studies and may be necessary for clear
interpretation of the data package.
Document: IG v3.1
Item: Specification
@@ -32,16 +32,16 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND239
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include"
- column in Section 7.4.2 should be included in a well-formed TX
- domain submission. These TXPARMCD values are expected to occur
- in almost all studies and may be necessary for clear
+ - Cited Guidance:
+ The TXPARMCD values marked as "Yes" in the "Should Include" column in
+ Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD
+ values are expected to occur in almost all studies and may be necessary for clear
interpretation of the data package.
Document: IG v3.1.1
Item: Specification
@@ -49,16 +49,16 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND239
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include"
- column in Section 7.4.2 should be included in a well-formed TX
- domain submission. These TXPARMCD values are expected to occur
- in almost all studies and may be necessary for clear
+ - Cited Guidance:
+ The TXPARMCD values marked as "Yes" in the "Should Include" column in
+ Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD
+ values are expected to occur in almost all studies and may be necessary for clear
interpretation of the data package.
Document: IG v3.1.1
Item: Specification
@@ -66,16 +66,16 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND239
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include"
- column in Section 7.4.2 should be included in a well-formed TX
- domain submission. These TXPARMCD values are expected to occur
- in almost all studies and may be necessary for clear
+ - Cited Guidance:
+ The TXPARMCD values marked as "Yes" in the "Should Include" column in
+ Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD
+ values are expected to occur in almost all studies and may be necessary for clear
interpretation of the data package.
Document: IG v3.1
Item: Specification
@@ -83,16 +83,16 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND239
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include"
- column in Section 7.4.2 should be included in a well-formed TX
- domain submission. These TXPARMCD values are expected to occur
- in almost all studies and may be necessary for clear
+ - Cited Guidance:
+ The TXPARMCD values marked as "Yes" in the "Should Include" column in
+ Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD
+ values are expected to occur in almost all studies and may be necessary for clear
interpretation of the data package.
Document: IG v3.1.1
Item: Specification
@@ -100,9 +100,9 @@ Authorities:
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND239
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
# all:
# count the number of TRTDOC records within each group
@@ -127,10 +127,10 @@ Check:
value: 0
Core:
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
-# Within each SETCD group, we must have at least one record
+# Within each SETCD group, we must have at least one record
# with TXPARMCD = TRTDOS, TRTDOSU, ARMCD, SPGRPCD, and GRPLBL
Operations:
# count the number of records for TXPARMCD=TRTDOS within each SETCD group
@@ -139,29 +139,33 @@ Operations:
group:
- SETCD
id: $num_trtdos
- operator: record_count
- # count the number of records for TXOARMCD=TRTDOSU within each SETCD group
+ operator:
+ record_count
+ # count the number of records for TXOARMCD=TRTDOSU within each SETCD group
- filter:
TXPARMCD: TRTDOSU
group:
- SETCD
id: $num_trtdosu
- operator: record_count
- # count the number of records for TXPARMCD=ARMCD within each SETCD group
+ operator:
+ record_count
+ # count the number of records for TXPARMCD=ARMCD within each SETCD group
- filter:
TXPARMCD: ARMCD
group:
- SETCD
id: $num_armcd
- operator: record_count
- # count the number of records for TXPARMCD=SPGRPCD within each SETCD group
+ operator:
+ record_count
+ # count the number of records for TXPARMCD=SPGRPCD within each SETCD group
- filter:
TXPARMCD: SPGRPCD
group:
- SETCD
id: $num_spgrpcd
- operator: record_count
- # count the number of records for TXPARMCD=GRPLBL within each SETCD group
+ operator:
+ record_count
+ # count the number of records for TXPARMCD=GRPLBL within each SETCD group
- filter:
TXPARMCD: GRPLBL
group:
@@ -169,8 +173,9 @@ Operations:
id: $num_grplbl
operator: record_count
Outcome:
- Message: 'For each set, a record with TXPARMCD=ARMCD, TXPARMCD=SPGRPCD,
- TXPARMCD=GRPLBL, TXPARMCD=TRTDOC and TXPARMCD=TRTDOSU must be provided'
+ Message:
+ "For each set, a record with TXPARMCD=ARMCD, TXPARMCD=SPGRPCD, TXPARMCD=GRPLBL, TXPARMCD=TRTDOC
+ and TXPARMCD=TRTDOSU must be provided"
Output Variables:
- SETCD
- $num_trtdos
@@ -186,6 +191,6 @@ Scope:
Domains:
Include:
- TX
-# When set to "Dataset" only the first violation is
+# When set to "Dataset" only the first violation is
# When set to "Record", EVERY row within the set that violates the rule is reported
Sensitivity: Record
diff --git a/Unpublished/SENDIG/SEND261/rule.yml b/Unpublished/SENDIG/SEND261/rule.yml
index 8385a9194..297776999 100644
--- a/Unpublished/SENDIG/SEND261/rule.yml
+++ b/Unpublished/SENDIG/SEND261/rule.yml
@@ -4,93 +4,93 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: It is important to note that POOLID values are unique for a
- given set of subjects. While the same value of POOLID may not
- be re-used to refer to different sets of subjects, different
- POOLIDs may be used to refer to the same set of subjects.
+ - Cited Guidance:
+ It is important to note that POOLID values are unique for a given set of
+ subjects. While the same value of POOLID may not be re-used to refer to different sets of
+ subjects, different POOLIDs may be used to refer to the same set of subjects.
Document: IG v3.0
- Section: '8.7'
+ Section: "8.7"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND261
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: It is important to note that POOLID values are unique for a
- given set of subjects. While the same value of POOLID may not
- be re-used to refer to different sets of subjects, different
- POOLIDs may be used to refer to the same set of subjects.
+ - Cited Guidance:
+ It is important to note that POOLID values are unique for a given set of
+ subjects. While the same value of POOLID may not be re-used to refer to different sets of
+ subjects, different POOLIDs may be used to refer to the same set of subjects.
Document: IG v3.1
- Section: '8.5'
+ Section: "8.5"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND261
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: It is important to note that POOLID values are unique for a
- given set of subjects. While the same value of POOLID may not
- be re-used to refer to different sets of subjects, different
- POOLIDs may be used to refer to the same set of subjects.
+ - Cited Guidance:
+ It is important to note that POOLID values are unique for a given set of
+ subjects. While the same value of POOLID may not be re-used to refer to different sets of
+ subjects, different POOLIDs may be used to refer to the same set of subjects.
Document: IG v3.1.1
- Section: '8.5'
+ Section: "8.5"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND261
- Version: '1'
- Version: '5.0'
+ Version: "1"
+ Version: "5.0"
Version: 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: It is important to note that POOLID values are unique for a
- given set of subjects. While the same value of POOLID may not
- be re-used to refer to different sets of subjects, different
- POOLIDs may be used to refer to the same set of subjects.
+ - Cited Guidance:
+ It is important to note that POOLID values are unique for a given set of
+ subjects. While the same value of POOLID may not be re-used to refer to different sets of
+ subjects, different POOLIDs may be used to refer to the same set of subjects.
Document: IG v3.1
- Section: '8.5'
+ Section: "8.5"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND261
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: It is important to note that POOLID values are unique for a
- given set of subjects. While the same value of POOLID may not
- be re-used to refer to different sets of subjects, different
- POOLIDs may be used to refer to the same set of subjects.
+ - Cited Guidance:
+ It is important to note that POOLID values are unique for a given set of
+ subjects. While the same value of POOLID may not be re-used to refer to different sets of
+ subjects, different POOLIDs may be used to refer to the same set of subjects.
Document: IG v3.1.1
- Section: '8.5'
+ Section: "8.5"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND261
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: It is important to note that POOLID values are unique for a
- given set of subjects. While the same value of POOLID may not
- be re-used to refer to different sets of subjects, different
- POOLIDs may be used to refer to the same set of subjects.
+ - Cited Guidance:
+ It is important to note that POOLID values are unique for a given set of
+ subjects. While the same value of POOLID may not be re-used to refer to different sets of
+ subjects, different POOLIDs may be used to refer to the same set of subjects.
Document: IG v3.1.1
- Section: '8.5'
+ Section: "8.5"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND261
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
# IMPORTANT REMARK 2025-09-10: The code of this rule is identical to that of SEND262.1
# as we believe that both rules have essentially the same meaning.
# TODO: discuss with the team whether 261 and 262.1 must be merged (216 is published ...)
@@ -101,11 +101,11 @@ Check:
value: USUBJID
Core:
Status: Draft
- Version: '1'
-Description: 'A POOLID can only refer to one set of subjects'
+ Version: "1"
+Description: "A POOLID can only refer to one set of subjects"
Executability: Fully Executable
Outcome:
- Message: 'POOLID does not refer to one single set of subjects'
+ Message: "POOLID does not refer to one single set of subjects"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SENDIG/SEND283/rule.yml b/Unpublished/SENDIG/SEND283/rule.yml
index 697521f57..188312095 100644
--- a/Unpublished/SENDIG/SEND283/rule.yml
+++ b/Unpublished/SENDIG/SEND283/rule.yml
@@ -5,107 +5,104 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: There are, by definition, no time gaps between Elements;
- therefore, the value of SEENDTC for one Element will always be
- immediately before or the same as the value of SESTDTC for the
- next Element. Each Element continues until the time at which
- the next Element begins, and a subject must be in only one
- element at a time.
+ - Cited Guidance:
+ There are, by definition, no time gaps between Elements; therefore, the
+ value of SEENDTC for one Element will always be immediately before or the same as the
+ value of SESTDTC for the next Element. Each Element continues until the time at which the
+ next Element begins, and a subject must be in only one element at a time.
Document: IG v3.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND283
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: There are, by definition, no time gaps between Elements;
- therefore, the value of SEENDTC for one Element will always be
- immediately before or the same as the value of SESTDTC for the
- next Element. Each Element continues until the time at which
- the next Element begins, and a subject must be in only one
- element at a time.
+ - Cited Guidance:
+ There are, by definition, no time gaps between Elements; therefore, the
+ value of SEENDTC for one Element will always be immediately before or the same as the
+ value of SESTDTC for the next Element. Each Element continues until the time at which the
+ next Element begins, and a subject must be in only one element at a time.
Document: IG v3.1.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND283
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: There are, by definition, no time gaps between Elements;
- therefore, the value of SEENDTC for one Element will always be
- immediately before or the same as the value of SESTDTC for the
- next Element. Each Element continues until the time at which
- the next Element begins, and a subject must be in only one
- element at a time.
+ - Cited Guidance:
+ There are, by definition, no time gaps between Elements; therefore, the
+ value of SEENDTC for one Element will always be immediately before or the same as the
+ value of SESTDTC for the next Element. Each Element continues until the time at which the
+ next Element begins, and a subject must be in only one element at a time.
Document: IG v3.1.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND283
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: There are, by definition, no time gaps between Elements;
- therefore, the value of SEENDTC for one Element will always be
- immediately before or the same as the value of SESTDTC for the
- next Element. Each Element continues until the time at which
- the next Element begins, and a subject must be in only one
- element at a time.
+ - Cited Guidance:
+ There are, by definition, no time gaps between Elements; therefore, the
+ value of SEENDTC for one Element will always be immediately before or the same as the
+ value of SESTDTC for the next Element. Each Element continues until the time at which the
+ next Element begins, and a subject must be in only one element at a time.
Document: IG v3.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND283
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: There are, by definition, no time gaps between Elements;
- therefore, the value of SEENDTC for one Element will always be
- immediately before or the same as the value of SESTDTC for the
- next Element. Each Element continues until the time at which
- the next Element begins, and a subject must be in only one
- element at a time.
+ - Cited Guidance:
+ There are, by definition, no time gaps between Elements; therefore, the
+ value of SEENDTC for one Element will always be immediately before or the same as the
+ value of SESTDTC for the next Element. Each Element continues until the time at which the
+ next Element begins, and a subject must be in only one element at a time.
Document: IG v3.1.1
Item: Specification
Section: 5.3.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND283
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
# 2025-05-06: IMPORTANT: The implementation CURRENTLY ONLY checks that DSSTDTC is LATER
- # than the highest date value of SEENDTC for the subject.
+ # than the highest date value of SEENDTC for the subject.
# As such, the rule is currently "partially executable".
- - name: 'DSSTDTC'
- operator: 'date_less_than'
- value: '$max_seendtc'
- # TODO in FUTURE: part that states that DSSTDTC may not be larger than max(SEENDTC) + small fraction
+ - name: "DSSTDTC"
+ operator: "date_less_than"
+ value:
+ "$max_seendtc"
+ # TODO in FUTURE: part that states that DSSTDTC may not be larger than max(SEENDTC) + small fraction
Core:
Status: Draft
- Version: '1'
-Description: 'The value of SEENDTC for the last Element must immediately precede
- or be the same as the date/time of disposition (DSSTDTC) for the subject.'
+ Version: "1"
+Description:
+ "The value of SEENDTC for the last Element must immediately precede or be the same as the
+ date/time of disposition (DSSTDTC) for the subject."
Executability: Partially Executable - Possible Underreporting
Operations:
- domain: SE
@@ -116,8 +113,7 @@ Operations:
operator: max_date
Outcome:
# TODO? Should we reverse this?
- Message: 'Date/time of disposition event DSSTDTC is not equal to or immediately
- after last element date/time'
+ Message: "Date/time of disposition event DSSTDTC is not equal to or immediately after last element date/time"
Output Variables:
- DSSTDTC
- $max_seendtc
diff --git a/Unpublished/SENDIG/SEND298/rule.yml b/Unpublished/SENDIG/SEND298/rule.yml
index 02c04ab32..1e642215a 100644
--- a/Unpublished/SENDIG/SEND298/rule.yml
+++ b/Unpublished/SENDIG/SEND298/rule.yml
@@ -5,93 +5,88 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ... Trial Design Model
- datasets, consisting of Trial Elements (TE), Trial Arms (TA),
- Trial Sets (TX), and Trial Summary (TS), contain information
- about the study design but do not contain subject data. These
- are described in Section 7 ...'
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial
+ Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design
+ but do not contain subject data. These are described in Section 7 ..."
Document: IG v3.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND298
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: rial Design Model datasets,
- consisting of Trial Elements (TE), Trial Arms (TA), Trial Sets
- (TX), and Trial Summary (TS), contain information about the
- study design but do not contain subject data. These are
- described in Section 7 ...'
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: rial Design Model datasets, consisting of Trial Elements (TE), Trial Arms
+ (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design but
+ do not contain subject data. These are described in Section 7 ..."
Document: IG v3.1.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND298
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ... Trial Design Model
- datasets, consisting of Trial Elements (TE), Trial Arms (TA),
- Trial Sets (TX), and Trial Summary (TS), contain information
- about the study design but do not contain subject data. These
- are described in Section 7 ...'
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial
+ Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design
+ but do not contain subject data. These are described in Section 7 ..."
Document: IG v3.1.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND298
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ... Trial Design Model
- datasets, consisting of Trial Elements (TE), Trial Arms (TA),
- Trial Sets (TX), and Trial Summary (TS), contain information
- about the study design but do not contain subject data. These
- are described in Section 7 ...'
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial
+ Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design
+ but do not contain subject data. These are described in Section 7 ..."
Document: IG v3.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND298
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each
- of which has a fixed structure: ... Trial Design Model
- datasets, consisting of Trial Elements (TE), Trial Arms (TA),
- Trial Sets (TX), and Trial Summary (TS), contain information
- about the study design but do not contain subject data. These
- are described in Section 7 ...'
+ - Cited Guidance:
+ "The SDTM includes three types of special-purpose datasets, each of which has
+ a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial
+ Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design
+ but do not contain subject data. These are described in Section 7 ..."
Document: IG v3.1.1
Item: Specification
- Section: '2.2'
+ Section: "2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND298
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: variable_name
@@ -99,16 +94,16 @@ Check:
value: $allowed_variables
Core:
Status: Draft
- Version: '1'
-Description: 'Trigger error when variable is not an allowed variable for the TE,
- TA, TX, or TS domain'
+ Version: "1"
+Description: "Trigger error when variable is not an allowed variable for the TE, TA, TX, or TS domain"
Executability: Fully Executable
Operations:
- - id: $allowed_variables
- # operator: get_model_column_order - NO !!!
+ - id:
+ $allowed_variables
+ # operator: get_model_column_order - NO !!!
operator: get_column_order_from_library
Outcome:
- Message: 'The variable is not an allowed variable for the domain'
+ Message: "The variable is not an allowed variable for the domain"
Rule Type: Variable Metadata Check
# Rule Type: Variable Metadata Check against Library Metadata
Scope:
diff --git a/Unpublished/SENDIG/SEND300/rule.yml b/Unpublished/SENDIG/SEND300/rule.yml
index d8dc51026..344708ab9 100644
--- a/Unpublished/SENDIG/SEND300/rule.yml
+++ b/Unpublished/SENDIG/SEND300/rule.yml
@@ -5,37 +5,38 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'In the event that no records are present in a dataset, the
- empty dataset should not be submitted and should not be
- described in the data definition file.'
+ - Cited Guidance:
+ "In the event that no records are present in a dataset, the empty dataset should
+ not be submitted and should not be described in the data definition file."
Document: IG v3.1
Item: Specification
- Section: '3.2.1'
+ Section: "3.2.1"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND300
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
Check:
all:
- name: $records_in_dataset
operator: equal_to
- value: 0
- # check whether the dataset is described in the define.xml
+ value:
+ 0
+ # check whether the dataset is described in the define.xml
- name: define_dataset_name
operator: not_equal_to
- value: 'test'
+ value: "test"
Core:
Status: Draft
- Version: '1'
-Description: 'Empty datasets may not be described in the define.xml'
+ Version: "1"
+Description: "Empty datasets may not be described in the define.xml"
Executability: Fully Executable
Operations:
- id: $records_in_dataset
operator: record_count
Outcome:
- Message: 'Empty dataset may not be described in the define.xml'
+ Message: "Empty dataset may not be described in the define.xml"
Output Variables:
- dataset_name
- define_dataset_name
diff --git a/Unpublished/SENDIG/SEND310/rule.yml b/Unpublished/SENDIG/SEND310/rule.yml
index c718e6322..30fea40a2 100644
--- a/Unpublished/SENDIG/SEND310/rule.yml
+++ b/Unpublished/SENDIG/SEND310/rule.yml
@@ -1,83 +1,89 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
# Not applicable to SENDIG 3.0
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND310'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
- - Name: 'SENDIG'
+ Id: "SEND310"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND310'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "SEND310"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND310'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "SEND310"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND310'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "SEND310"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if
- they are different by set.'
- Document: 'IG v3.1.1'
- Section: '5.1.1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "Trial Sets (TX) can have multiple species and/or strains if they are different
+ by set."
+ Document: "IG v3.1.1"
+ Section: "5.1.1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND310'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND310"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
any:
# First case: STRAIN
- all:
# Only apply when STRAIN is present, as it is "permissible"
- - name: 'STRAIN'
+ - name: "STRAIN"
operator: exists
- name: STRAIN
operator: is_inconsistent_across_dataset
- value: SETCD
- # Second case: SPECIES
+ value:
+ SETCD
+ # Second case: SPECIES
- all:
# only apply when SPECIES is present, as it is "permissible"
- name: SPECIES
@@ -88,9 +94,8 @@ Check:
Core:
Status: Draft
- Version: '1'
-Description: 'DM records with different values for DM.STRAIN must have different
- values for DM.SETCD.'
+ Version: "1"
+Description: "DM records with different values for DM.STRAIN must have different values for DM.SETCD."
Executability: Fully Executable
# Operations:
# The following operations, only used for reporting purposes,
@@ -110,13 +115,12 @@ Executability: Fully Executable
# name: SPECIES
# operator: distinct
Outcome:
- Message: 'Within each SETCD, only a single STRAIN and only a single SPECIES is
- allowed'
+ Message: "Within each SETCD, only a single STRAIN and only a single SPECIES is allowed"
Output Variables:
- STRAIN
- SPECIES
- #- $distinct_strain
- #- $distinct_species
+ #- $distinct_strain
+ #- $distinct_species
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SENDIG/SEND313/rule.yml b/Unpublished/SENDIG/SEND313/rule.yml
index 46fbf5073..63cc0e1cc 100644
--- a/Unpublished/SENDIG/SEND313/rule.yml
+++ b/Unpublished/SENDIG/SEND313/rule.yml
@@ -1,19 +1,20 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'When using COVAL1-COVALn, the variable label should match the
- corresponding variable name (e.g., Comment1, Comment2).'
+ - Cited Guidance:
+ "When using COVAL1-COVALn, the variable label should match the corresponding variable
+ name (e.g., Comment1, Comment2)."
Document: IG v3.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND313'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND313"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
Check:
all:
# The first two checks select COVALn variables, excluding "COVAL" itself
@@ -22,31 +23,34 @@ Check:
value: COVAL
- name: variable_name
operator: longer_than
- value: 5
- # check whether 6th and 7th character represent a digit
+ value:
+ 5
+ # check whether 6th and 7th character represent a digit
- any:
# 6th character
- name: variable_name
operator: matches_regex
- value: ^.{5}\d{1}
- # 6th and 7th character
+ value:
+ ^.{5}\d{1}
+ # 6th and 7th character
- name: variable_name
operator: matches_regex
value: ^.{5}\d{2}
- name: variable_name
operator: suffix_not_equal_to
suffix: 1
- value: '1' # this need to be replaced by the last 1 or 2 charaters of the label
- # Proposal Els
- #- name: variable_label
- # operator: does_not_equal_string_part
- # regex: (\d+)$
- # value: variable_name
+ value:
+ "1" # this need to be replaced by the last 1 or 2 charaters of the label
+ # Proposal Els
+ #- name: variable_label
+ # operator: does_not_equal_string_part
+ # regex: (\d+)$
+ # value: variable_name
Core:
Id: SEND313
Status: Draft
- Version: '1'
-Description: 'Variable Label for COVALn must end with n (as a number from COVALn)'
+ Version: "1"
+Description: "Variable Label for COVALn must end with n (as a number from COVALn)"
Executability: Fully Executable
Operations:
# we need something here to retrieve the last character of the label
@@ -57,7 +61,7 @@ Operations:
value: ".$"
Outcome:
- Message: 'Variable Label must end with the number n in the variable name'
+ Message: "Variable Label must end with the number n in the variable name"
Rule Type: Variable Metadata Check
Scope:
Classes:
diff --git a/Unpublished/SENDIG/SEND321/rule.yml b/Unpublished/SENDIG/SEND321/rule.yml
index 01c9ab16c..1090dd59c 100644
--- a/Unpublished/SENDIG/SEND321/rule.yml
+++ b/Unpublished/SENDIG/SEND321/rule.yml
@@ -4,38 +4,40 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Neoplastic findings must be populated using the NEOPLASM
- controlled list.
+ - Cited Guidance: Neoplastic findings must be populated using the NEOPLASM controlled list.
Document: IG v3.1
Section: 6.3.8
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND321'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Id: "SEND321"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
Check:
all:
- any:
- name: MIRESCAT
operator: equal_to
- value: 'MALIGNANT'
+ value: "MALIGNANT"
- name: MIRESCAT
operator: equal_to
- value: 'BENIGN'
+ value: "BENIGN"
- name: MISTRESC
- operator: is_not_contained_by
- # REMARK: the NEOPLASM codelist is NOT the standard codelist for MISTRESC !!!
- value: $NEOPASM_CODELIST
- # The following does not seem to work => "invalid operator"
- #- name: MISTRESC
- # operator: does_not_use_valid_codelist_terms
- # value: NEOPLASM
+ operator:
+ is_not_contained_by
+ # REMARK: the NEOPLASM codelist is NOT the standard codelist for MISTRESC !!!
+ value:
+ $NEOPASM_CODELIST
+ # The following does not seem to work => "invalid operator"
+ #- name: MISTRESC
+ # operator: does_not_use_valid_codelist_terms
+ # value: NEOPLASM
Core:
Status: Draft
- Version: '1'
-Description: 'Report an issue when MIRESCAT is either MALIGNANT or BENIGN, and
- the value in MISTRESC is not from the NEOPLASM codelist (NCI C88025)'
+ Version: "1"
+Description:
+ "Report an issue when MIRESCAT is either MALIGNANT or BENIGN, and the value in MISTRESC is
+ not from the NEOPLASM codelist (NCI C88025)"
Executability: Fully Executable
Operations:
# 2025-09-11: This still returns an EMPTY list!
@@ -44,15 +46,18 @@ Operations:
- NEOPLASM
ct_package_type: SEND
id: $NEOPASM_CODELIST
- level: term
- # level: codelist
+ level:
+ term
+ # level: codelist
operator: codelist_terms
- returntype: value
- # version: '2024-03-29'
- #version: codeSystemVersion
+ returntype:
+ value
+ # version: '2024-03-29'
+ #version: codeSystemVersion
Outcome:
- Message: 'The term for the record is not present in the NEOPLASM codelist and
- may be a term added to the extensible list'
+ Message:
+ "The term for the record is not present in the NEOPLASM codelist and may be a term added to
+ the extensible list"
Output Variables:
- MISTRESC
- $NEOPASM_CODELIST
diff --git a/Unpublished/SENDIG/SEND327/rule.yml b/Unpublished/SENDIG/SEND327/rule.yml
index da95cd00f..73275a61c 100644
--- a/Unpublished/SENDIG/SEND327/rule.yml
+++ b/Unpublished/SENDIG/SEND327/rule.yml
@@ -1,85 +1,88 @@
Authorities:
# Only applicable to SENDIG-3.1.1, SENDIG-GENETOX-1.0 and SENDIG-DART-1.2
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'When a predose sample is collected as part of the profile
- analysis, then PCELTM must be populated as "PT0H" because
- negative elapsed time would lead to an incorrect area under
+ - Cited Guidance:
+ 'When a predose sample is collected as part of the profile analysis, then PCELTM
+ must be populated as "PT0H" because negative elapsed time would lead to an incorrect area under
the curve.'
Document: IG v3.1.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND327'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND327"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'When a predose sample is collected as part of the profile
- analysis, then PCELTM must be populated as "PT0H" because
- negative elapsed time would lead to an incorrect area under
+ - Cited Guidance:
+ 'When a predose sample is collected as part of the profile analysis, then PCELTM
+ must be populated as "PT0H" because negative elapsed time would lead to an incorrect area under
the curve.'
Document: IG v3.1.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND327'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND327"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'When a predose sample is collected as part of the profile
- analysis, then PCELTM must be populated as "PT0H" because
- negative elapsed time would lead to an incorrect area under
+ - Cited Guidance:
+ 'When a predose sample is collected as part of the profile analysis, then PCELTM
+ must be populated as "PT0H" because negative elapsed time would lead to an incorrect area under
the curve.'
Document: IG v3.1.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND327'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND327"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: PCTESTCD
operator: is_contained_by
value: $pp_ppcat
- name: PCELTM
- operator: non_empty
- # value of PCELTM may not start with a dash (minus-character)
+ operator:
+ non_empty
+ # value of PCELTM may not start with a dash (minus-character)
- name: PCELTM
operator: starts_with
- value: '-'
- # Alternative test for first character being "-"
- # - name: PCELTM
- # operator: prefix_equal_to
- # prefix: 1
- # value: '-'
+ value:
+ "-"
+ # Alternative test for first character being "-"
+ # - name: PCELTM
+ # operator: prefix_equal_to
+ # prefix: 1
+ # value: '-'
Core:
Status: Draft
- Version: '1'
-Description: 'Duration in PCELTM may not be negative when record used in
- concentration profile in PP'
+ Version: "1"
+Description: "Duration in PCELTM may not be negative when record used in concentration profile in PP"
Executability: Fully Executable
Operations:
- - domain: PP
- # TODO: ensure that we do NEED OR NOT NEED to use "group", as "distinct" is already on the subject level?
+ - domain:
+ PP
+ # TODO: ensure that we do NEED OR NOT NEED to use "group", as "distinct" is already on the subject level?
group:
- USUBJID
id: $pp_ppcat
name: PPCAT
operator: distinct
Outcome:
- Message: 'A negative value for PCELTM is not allowed as the record is used in a
- concentration profile in PP'
+ Message:
+ "A negative value for PCELTM is not allowed as the record is used in a concentration profile
+ in PP"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SENDIG/SEND328-1/rule.yml b/Unpublished/SENDIG/SEND328-1/rule.yml
index c85986e53..776805fef 100644
--- a/Unpublished/SENDIG/SEND328-1/rule.yml
+++ b/Unpublished/SENDIG/SEND328-1/rule.yml
@@ -1,99 +1,103 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2
- PT0H records for the same profile; instead, the immediate
- postdose sample should be separated from predose samples with
- a different PCELTM value so that each is uniquely
- identifiable.'
- Document: 'IG v3.1.1'
- Section: '6.3.11.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "In case of immediate postdose sampling, there should not be 2 PT0H records for
+ the same profile; instead, the immediate postdose sample should be separated from predose samples
+ with a different PCELTM value so that each is uniquely identifiable."
+ Document: "IG v3.1.1"
+ Section: "6.3.11.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND328-1'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "SEND328-1"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2
- PT0H records for the same profile; instead, the immediate
- postdose sample should be separated from predose samples with
- a different PCELTM value so that each is uniquely
- identifiable.'
- Document: 'IG v3.1.1'
- Section: '6.3.11.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "In case of immediate postdose sampling, there should not be 2 PT0H records for
+ the same profile; instead, the immediate postdose sample should be separated from predose samples
+ with a different PCELTM value so that each is uniquely identifiable."
+ Document: "IG v3.1.1"
+ Section: "6.3.11.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND328-1'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "SEND328-1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2
- PT0H records for the same profile; instead, the immediate
- postdose sample should be separated from predose samples with
- a different PCELTM value so that each is uniquely
- identifiable.'
- Document: 'IG v3.1.1'
- Section: '6.3.11.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "In case of immediate postdose sampling, there should not be 2 PT0H records for
+ the same profile; instead, the immediate postdose sample should be separated from predose samples
+ with a different PCELTM value so that each is uniquely identifiable."
+ Document: "IG v3.1.1"
+ Section: "6.3.11.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND328-1'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND328-1"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
# Part 1, USUBJID is present and populated, and PCSCAT is present
all:
- name: USUBJID
operator: exists
- name: USUBJID
- operator: non_empty
- # case that PCSCAT is present
+ operator:
+ non_empty
+ # case that PCSCAT is present
- name: PCSCAT
- operator: exists
- # 2025-07-09: JUST TRYING: only check rows with PCELTM='PT0H'
+ operator:
+ exists
+ # 2025-07-09: JUST TRYING: only check rows with PCELTM='PT0H'
- name: PCELTM
operator: equal_to
- value: 'PT0H'
- # 2025-07-09: PPCAT must correspond to PCTESTCD
- # 2025-07-09: Somehow, this doesn't work as it always leads to "success" (i.e. no violation)
- # and when commented out, causes a false positive for e.g. PCTESTCD='NOT FOR PROFILE'
- #- name: PCTESTCD
- # operator: is_contained_by
- # value: $pp_cat
- # reference of measurement in PC must be equal to reference of profile in PP
- # TODO: This must be for the GIVEN SUBJECT!
+ value:
+ "PT0H"
+ # 2025-07-09: PPCAT must correspond to PCTESTCD
+ # 2025-07-09: Somehow, this doesn't work as it always leads to "success" (i.e. no violation)
+ # and when commented out, causes a false positive for e.g. PCTESTCD='NOT FOR PROFILE'
+ #- name: PCTESTCD
+ # operator: is_contained_by
+ # value: $pp_cat
+ # reference of measurement in PC must be equal to reference of profile in PP
+ # TODO: This must be for the GIVEN SUBJECT!
- name: PCTPTREF
operator: is_contained_by
- value: $pp_tptref
- # reference time (time point) must be equal to reference time of profile in PP
+ value:
+ $pp_tptref
+ # reference time (time point) must be equal to reference time of profile in PP
- name: PCRFTDTC
operator: is_contained_by
- value: $pp_rftdtc
- # Report a violation when the number of records for PCELTM=PT0H is not 1
+ value:
+ $pp_rftdtc
+ # Report a violation when the number of records for PCELTM=PT0H is not 1
- name: $pc_group
operator: not_equal_to
value: 1
Core:
Id: SEND328-1
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Operations:
- - domain: PC
- # we will count the number of records for which PCELTM = PT0H within each group
+ - domain:
+ PC
+ # we will count the number of records for which PCELTM = PT0H within each group
filter:
- PCELTM: PT0H
- # The group consists of USUBJID, PCTESTCD, PCCAT, PCSCAT (must be present) and PCTPTREF
+ PCELTM:
+ PT0H
+ # The group consists of USUBJID, PCTESTCD, PCCAT, PCSCAT (must be present) and PCTPTREF
group:
- USUBJID
- PCTESTCD
@@ -102,25 +106,30 @@ Operations:
- PCSPEC # added 2025-07-09
- PCTPTREF
id: $pc_group
- operator: record_count
- # 2025-07-09: PPCAT and PCTESTCD must correspond
- - domain: PP
- # we only want it for the current subject
+ operator:
+ record_count
+ # 2025-07-09: PPCAT and PCTESTCD must correspond
+ - domain:
+ PP
+ # we only want it for the current subject
group:
- USUBJID
id: $pp_cat
name: PPCAT
- operator: distinct
- # Value of PCTPTREF must be present in PPTPTREF (for the same USUBJID, so we need "group")
- - domain: PP
- # we only want it for the current subject
+ operator:
+ distinct
+ # Value of PCTPTREF must be present in PPTPTREF (for the same USUBJID, so we need "group")
+ - domain:
+ PP
+ # we only want it for the current subject
group:
- USUBJID
id: $pp_tptref
name: PPTPTREF
operator: distinct
- - domain: PP
- # we only want it for the current subject
+ - domain:
+ PP
+ # we only want it for the current subject
group:
- USUBJID
id: $pp_rftdtc
@@ -128,8 +137,9 @@ Operations:
operator: distinct
Outcome:
- Message: 'specimen concentrations to calculate a time concentration profile may
- only have one record with PCELTM=PT0H'
+ Message:
+ "specimen concentrations to calculate a time concentration profile may only have one record
+ with PCELTM=PT0H"
Output Variables:
- USUBJID
- PCTESTCD
diff --git a/Unpublished/SENDIG/SEND328-2/rule.yml b/Unpublished/SENDIG/SEND328-2/rule.yml
index 8284fb897..f646a4ac0 100644
--- a/Unpublished/SENDIG/SEND328-2/rule.yml
+++ b/Unpublished/SENDIG/SEND328-2/rule.yml
@@ -1,54 +1,51 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SENDIG'
+ - Name: "SENDIG"
References:
- Citations:
- - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2
- PT0H records for the same profile; instead, the immediate
- postdose sample should be separated from predose samples with
- a different PCELTM value so that each is uniquely
- identifiable.'
- Document: 'IG v3.1.1'
- Section: '6.3.11.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "In case of immediate postdose sampling, there should not be 2 PT0H records for
+ the same profile; instead, the immediate postdose sample should be separated from predose samples
+ with a different PCELTM value so that each is uniquely identifiable."
+ Document: "IG v3.1.1"
+ Section: "6.3.11.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND328-2'
- Version: '1'
- Version: '5.0'
- Version: '3.1'
- - Name: 'SENDIG-GENETOX'
+ Id: "SEND328-2"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
+ - Name: "SENDIG-GENETOX"
References:
- Citations:
- - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2
- PT0H records for the same profile; instead, the immediate
- postdose sample should be separated from predose samples with
- a different PCELTM value so that each is uniquely
- identifiable.'
- Document: 'IG v3.1.1'
- Section: '6.3.11.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "In case of immediate postdose sampling, there should not be 2 PT0H records for
+ the same profile; instead, the immediate postdose sample should be separated from predose samples
+ with a different PCELTM value so that each is uniquely identifiable."
+ Document: "IG v3.1.1"
+ Section: "6.3.11.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND328-2'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
- - Name: 'SENDIG-DART'
+ Id: "SEND328-2"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2
- PT0H records for the same profile; instead, the immediate
- postdose sample should be separated from predose samples with
- a different PCELTM value so that each is uniquely
- identifiable.'
- Document: 'IG v3.1.1'
- Section: '6.3.11.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "In case of immediate postdose sampling, there should not be 2 PT0H records for
+ the same profile; instead, the immediate postdose sample should be separated from predose samples
+ with a different PCELTM value so that each is uniquely identifiable."
+ Document: "IG v3.1.1"
+ Section: "6.3.11.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND328-2'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND328-2"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
# Part 2, USUBJID is present and populated, and PCSCAT is absent
all:
@@ -57,42 +54,48 @@ Check:
- name: USUBJID
operator: non_empty
- name: PCSCAT
- operator: not_exists
- # 2025-07-09: JUST TRYING: only check rows with PCELTM='PT0H'
+ operator:
+ not_exists
+ # 2025-07-09: JUST TRYING: only check rows with PCELTM='PT0H'
- name: PCELTM
operator: equal_to
- value: 'PT0H'
- # 2025-07-09: PPCAT must correspond to PCTESTCD
- # 2025-07-09: Somehow, this doesn't work as it always leads to "success" (i.e. no violation)
- # and when commented out, causes a false positive for e.g. PCTESTCD='NOT FOR PROFILE'
- #- name: PCTESTCD
- # operator: is_contained_by
- # value: $pp_cat
- # reference of measurement in PC must be equal to reference of profile in PP
- # P.S. This must be for the GIVEN SUBJECT!
+ value:
+ "PT0H"
+ # 2025-07-09: PPCAT must correspond to PCTESTCD
+ # 2025-07-09: Somehow, this doesn't work as it always leads to "success" (i.e. no violation)
+ # and when commented out, causes a false positive for e.g. PCTESTCD='NOT FOR PROFILE'
+ #- name: PCTESTCD
+ # operator: is_contained_by
+ # value: $pp_cat
+ # reference of measurement in PC must be equal to reference of profile in PP
+ # P.S. This must be for the GIVEN SUBJECT!
- name: PCTPTREF
operator: is_contained_by
- value: $pp_tptref
- # reference time (time point) must be equal to reference time of profile in PP
+ value:
+ $pp_tptref
+ # reference time (time point) must be equal to reference time of profile in PP
- name: PCRFTDTC
operator: is_contained_by
- value: $pp_rftdtc
- # Report a violation when the number of records for PCELTM=PT0H is not 1
+ value:
+ $pp_rftdtc
+ # Report a violation when the number of records for PCELTM=PT0H is not 1
- name: $pc_group_no_pcscat
operator: not_equal_to
value: 1
Core:
Id: SEND328-2
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Operations:
- - domain: PC
- # we will count the number of records for which PCELTM = PT0H within each group
+ - domain:
+ PC
+ # we will count the number of records for which PCELTM = PT0H within each group
filter:
- PCELTM: PT0H
- # The group consists of USUBJID, PCTESTCD, PCCAT, and PCTPTREF - PCSCAT is absent
+ PCELTM:
+ PT0H
+ # The group consists of USUBJID, PCTESTCD, PCCAT, and PCTPTREF - PCSCAT is absent
group:
- USUBJID
- PCTESTCD
@@ -100,33 +103,39 @@ Operations:
- PCSPEC # added 2025-07-09
- PCTPTREF
id: $pc_group_no_pcscat
- operator: record_count
- # 2025-07-09: PPCAT and PCTESTCD must correspond
- - domain: PP
- # we only want it for the current subject
+ operator:
+ record_count
+ # 2025-07-09: PPCAT and PCTESTCD must correspond
+ - domain:
+ PP
+ # we only want it for the current subject
group:
- USUBJID
id: $pp_cat
name: PPCAT
- operator: distinct
- # Value of PCTPTREF must be present in PPTPTREF (for the same USUBJID, so we need "group")
- - domain: PP
- # we only want it for the current subject
+ operator:
+ distinct
+ # Value of PCTPTREF must be present in PPTPTREF (for the same USUBJID, so we need "group")
+ - domain:
+ PP
+ # we only want it for the current subject
group:
- USUBJID
id: $pp_tptref
name: PPTPTREF
operator: distinct
- - domain: PP
- # we only want it for the current subject
+ - domain:
+ PP
+ # we only want it for the current subject
group:
- USUBJID
id: $pp_rftdtc
name: PPRFTDTC
operator: distinct
Outcome:
- Message: 'specimen concentrations to calculate a time concentration profile may
- only have one record with PCELTM=PT0H'
+ Message:
+ "specimen concentrations to calculate a time concentration profile may only have one record
+ with PCELTM=PT0H"
Output Variables:
- USUBJID
- PCTESTCD
diff --git a/Unpublished/SENDIG/SEND333/rule.yml b/Unpublished/SENDIG/SEND333/rule.yml
index 56d7abc18..77f2d4b64 100644
--- a/Unpublished/SENDIG/SEND333/rule.yml
+++ b/Unpublished/SENDIG/SEND333/rule.yml
@@ -1,59 +1,60 @@
Authorities:
# Only applicable to SENDIG-3.1.1, SENDIG-GENETOX-1.0 and SENDIG-DART-1.2
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'For PC records contributing to a single time concentration
- profile, the PCNOMDY and PCTPTREF pair must be the same as the
- PPNOMDY and PPTPTREF pair for that same profile.'
+ - Cited Guidance:
+ "For PC records contributing to a single time concentration profile, the PCNOMDY
+ and PCTPTREF pair must be the same as the PPNOMDY and PPTPTREF pair for that same profile."
Document: IG v3.1.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND333'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND333"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'For PC records contributing to a single time concentration
- profile, the PCNOMDY and PCTPTREF pair must be the same as the
- PPNOMDY and PPTPTREF pair for that same profile.'
+ - Cited Guidance:
+ "For PC records contributing to a single time concentration profile, the PCNOMDY
+ and PCTPTREF pair must be the same as the PPNOMDY and PPTPTREF pair for that same profile."
Document: IG v3.1.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND333'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND333"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'For PC records contributing to a single time concentration
- profile, the PCNOMDY and PCTPTREF pair must be the same as the
- PPNOMDY and PPTPTREF pair for that same profile.'
+ - Cited Guidance:
+ "For PC records contributing to a single time concentration profile, the PCNOMDY
+ and PCTPTREF pair must be the same as the PPNOMDY and PPTPTREF pair for that same profile."
Document: IG v3.1.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND333'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND333"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- name: PCTESTCD
operator: is_contained_by
- value: $pp_ppcat
- # TODO: count number of distinct values of PPCAT for this subject
- #- name: $pp_cat
- # operator: equal_to
- # value: 'blabla'
- # TODO: when count = 1, check that PCNOMDY=PPNOMDY and PPCTPTREF=PPTPTREF
+ value:
+ $pp_ppcat
+ # TODO: count number of distinct values of PPCAT for this subject
+ #- name: $pp_cat
+ # operator: equal_to
+ # value: 'blabla'
+ # TODO: when count = 1, check that PCNOMDY=PPNOMDY and PPCTPTREF=PPTPTREF
- any:
- name: PCNOMDY # old
operator: empty
@@ -63,9 +64,10 @@ Check:
operator: empty
Core:
Status: Draft
- Version: '1'
-Description: 'When PC record is used in only 1 concentration profile, ensure
- that PCNOMDY=PPNOMDY and PPCTPTREF=PPTPTREF'
+ Version: "1"
+Description:
+ "When PC record is used in only 1 concentration profile, ensure that PCNOMDY=PPNOMDY and
+ PPCTPTREF=PPTPTREF"
Executability: Fully Executable
Operations:
# get the distinct values of PPCAT per subject in domain PP
@@ -75,14 +77,15 @@ Operations:
- USUBJID
id: $pp_ppcat
name: PPCAT
- operator: distinct
- #- id: $countppcat
- # name: $pp_ppcat
- # operator: record_count
+ operator:
+ distinct
+ #- id: $countppcat
+ # name: $pp_ppcat
+ # operator: record_count
- # just trying something else
- #- group:
- # - PCTESTCD
+ # just trying something else
+ #- group:
+ # - PCTESTCD
- domain: PP
filter:
PPCAT: PCTESTCD # This would mean that the value of PPCAT must be the string 'PSTESTCD', not the value of the variable PCTESTCD
@@ -91,8 +94,9 @@ Operations:
id: $profile_count
operator: record_count
Outcome:
- Message: 'PCNOMDY, PCTPTREF and PCELTM must be populated as the record
- contributes to a concentration profile in PP'
+ Message:
+ "PCNOMDY, PCTPTREF and PCELTM must be populated as the record contributes to a concentration
+ profile in PP"
Output Variables:
- USUBJID
- PCNOMDY
@@ -100,7 +104,7 @@ Outcome:
- PCELTM
- $pp_ppcat
- $profile_count
- #- $countppcat
+ #- $countppcat
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SENDIG/SEND340/rule.yml b/Unpublished/SENDIG/SEND340/rule.yml
index ab0de48c3..b38529561 100644
--- a/Unpublished/SENDIG/SEND340/rule.yml
+++ b/Unpublished/SENDIG/SEND340/rule.yml
@@ -4,16 +4,16 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If expected variables in a domain are all null, a comment should
- be included in the Define-XML document to explain why all
- records are null.
+ - Cited Guidance:
+ If expected variables in a domain are all null, a comment should be included
+ in the Define-XML document to explain why all records are null.
Document: SENDIG
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND340
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
Check:
all:
#- name: variable_name
@@ -26,33 +26,35 @@ Check:
# This checks on the individual record, not for an empty column
- metadata: $var_perm
operator: variable_metadata_not_equal_to
- value: 'Exp'
- #- operator: non_empty
- #- name: USUBJID
- # operator: not_equal_to
- # value: BLABLA
- #- name: $VARIABLE_NULL
- # operator: equal_to
- # value: TRUE
- #- name: define_variable_has_comment
- # operator: equal_to
- # value: false
+ value:
+ "Exp"
+ #- operator: non_empty
+ #- name: USUBJID
+ # operator: not_equal_to
+ # value: BLABLA
+ #- name: $VARIABLE_NULL
+ # operator: equal_to
+ # value: TRUE
+ #- name: define_variable_has_comment
+ # operator: equal_to
+ # value: false
Core:
Id: SEND340
Status: Draft
- Version: '1'
-Description: If expected variables in a domain are all null, a comment should be
- included in the Define-XML document to explain why all records are null.
+ Version: "1"
+Description: If expected variables in a domain are all null, a comment should be included in the
+ Define-XML document to explain why all records are null.
Executability: Fully Executable
Operations:
- id: $var_perm
name: core
- operator: variable_library_metadata
- #- id: $expected_variables
- # operator: expected_variables
- #- id: $VARIABLE_NULL
- # what do we need for "name" here?
- #operator: variable_is_null
+ operator:
+ variable_library_metadata
+ #- id: $expected_variables
+ # operator: expected_variables
+ #- id: $VARIABLE_NULL
+ # what do we need for "name" here?
+ #operator: variable_is_null
Outcome:
Message: Expected variable with missing value for all records
Output Variables:
@@ -68,5 +70,4 @@ Scope:
Include:
- ALL
Sensitivity: Record
-
#Sensitivity: Dataset
diff --git a/Unpublished/SENDIG/SEND348/rule.yml b/Unpublished/SENDIG/SEND348/rule.yml
index df3663830..8860275fa 100644
--- a/Unpublished/SENDIG/SEND348/rule.yml
+++ b/Unpublished/SENDIG/SEND348/rule.yml
@@ -1,49 +1,49 @@
Authorities:
# Only applicable to SENDIG-3.1.1, SENDIG-GENETOX-1.0 and SENDIG-DART-1.2
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'For PC records contributing to a time concentration profile,
- the timing variables PCNOMDY, PCTPTREF, and PCELTM must all be
- populated.'
+ - Cited Guidance:
+ "For PC records contributing to a time concentration profile, the timing variables
+ PCNOMDY, PCTPTREF, and PCELTM must all be populated."
Document: IG v3.1.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND348'
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Id: "SEND348"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'For PC records contributing to a time concentration profile,
- the timing variables PCNOMDY, PCTPTREF, and PCELTM must all be
- populated.'
+ - Cited Guidance:
+ "For PC records contributing to a time concentration profile, the timing variables
+ PCNOMDY, PCTPTREF, and PCELTM must all be populated."
Document: IG v3.1.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND348'
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Id: "SEND348"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'For PC records contributing to a time concentration profile,
- the timing variables PCNOMDY, PCTPTREF, and PCELTM must all be
- populated.'
+ - Cited Guidance:
+ "For PC records contributing to a time concentration profile, the timing variables
+ PCNOMDY, PCTPTREF, and PCELTM must all be populated."
Document: IG v3.1.1
Section: 6.3.11.1
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND348'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND348"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
any:
# Case that USUBJID is populated
@@ -58,13 +58,15 @@ Check:
- name: PCTPTREF
operator: empty
- name: PCELTM
- operator: empty
- # case that POOLID is populated. ATTENTION: POOLID is permissible!
+ operator:
+ empty
+ # case that POOLID is populated. ATTENTION: POOLID is permissible!
- all:
# PC-POOLID column is present
- name: POOLID
- operator: exists
- # PC-POOLID is populated
+ operator:
+ exists
+ # PC-POOLID is populated
- name: POOLID
operator: non_empty
- name: PCTESTCD
@@ -79,19 +81,21 @@ Check:
operator: empty
Core:
Status: Draft
- Version: '1'
-Description: 'When PCTESTCD = PPCAT, then PCNOMDY, PCTPTREF and PCELTM must be populated'
+ Version: "1"
+Description: "When PCTESTCD = PPCAT, then PCNOMDY, PCTPTREF and PCELTM must be populated"
Executability: Fully Executable
Operations:
- - domain: PP
- # group by USUBJID
+ - domain:
+ PP
+ # group by USUBJID
group:
- USUBJID
id: $pp_ppcat_usubjid
name: PPCAT
operator: distinct
- - domain: PP
- # group by POOLID
+ - domain:
+ PP
+ # group by POOLID
group:
- POOLID
id: $pp_ppcat_poolid
@@ -99,8 +103,9 @@ Operations:
operator: distinct
Outcome:
- Message: 'PCNOMDY, PCTPTREF and PCELTM must be populated as the record
- contributes to a concentration profile in PP'
+ Message:
+ "PCNOMDY, PCTPTREF and PCELTM must be populated as the record contributes to a concentration
+ profile in PP"
Output Variables:
- USUBJID
- POOLID # can this lead to a "skip" when POOLID column absent?
diff --git a/Unpublished/SENDIG/SEND362/rule.yml b/Unpublished/SENDIG/SEND362/rule.yml
index e6f7740a3..15a9e4008 100644
--- a/Unpublished/SENDIG/SEND362/rule.yml
+++ b/Unpublished/SENDIG/SEND362/rule.yml
@@ -4,50 +4,53 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: FETUSID should be populated for implantations that have
- individual fetal examinations or measurements that will be
- captured in other domains. The USUBJID / FETUSID combination
- must be consistent across domains within a study.
+ - Cited Guidance:
+ FETUSID should be populated for implantations that have individual fetal
+ examinations or measurements that will be captured in other domains. The USUBJID / FETUSID
+ combination must be consistent across domains within a study.
Document: DART-IG v1.1
- Section: '5.1.2'
+ Section: "5.1.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND362
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: FETUSID should be populated for implantations that have
- individual fetal examinations or measurements that will be
- captured in other domains. The USUBJID / FETUSID combination
- must be consistent across domains within a study.
+ - Cited Guidance:
+ FETUSID should be populated for implantations that have individual fetal
+ examinations or measurements that will be captured in other domains. The USUBJID / FETUSID
+ combination must be consistent across domains within a study.
Document: DART-IG v1.2
- Section: '5.1.2'
+ Section: "5.1.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND362
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
- any:
- name: USUBJID
- operator: non_empty
- #- name: FETUSID
- # operator: empty
+ operator:
+ non_empty
+ #- name: FETUSID
+ # operator: empty
Core:
Status: Draft
- Version: '1'
-Description: 'Report an issue when a USUBJID-FETUSID in FM (Fetus Measurements)
- is not found in IC (Implantation Classification)'
+ Version: "1"
+Description:
+ "Report an issue when a USUBJID-FETUSID in FM (Fetus Measurements) is not found in IC (Implantation
+ Classification)"
# Also see Christy's mail 2025-10-13 - issues the question of the difference between SEND262 and SEND263
Executability: Fully Executable
Outcome:
- Message: 'The combination of USUBJID and FETUSID in FM (Fetus Measurements) was
- not found in IC (Implantation Classification)'
+ Message:
+ "The combination of USUBJID and FETUSID in FM (Fetus Measurements) was not found in IC (Implantation
+ Classification)"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SENDIG/SEND399/rule.yml b/Unpublished/SENDIG/SEND399/rule.yml
index c506fa835..861037f57 100644
--- a/Unpublished/SENDIG/SEND399/rule.yml
+++ b/Unpublished/SENDIG/SEND399/rule.yml
@@ -1,52 +1,49 @@
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'SENDIG-DART'
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'This Implementation Guide (IG) defines recommended standards
- for the submission of data from nonclinical Developmental and
- Reproductive Toxicology (DART) studies, and is referred to as
- the SENDIG-DART. This IG is based on and should be used in
- close concert with Version 3.1 of the Standard for Exchange of
- Nonclinical Data Implementation Guide (SENDIG) and Version 1.6
- of the CDISC Study Data Tabulation Model (SDTM), available at
- https://www.cdisc.org/standards/.'
- Document: 'SENDIG DART'
- Section: '1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "This Implementation Guide (IG) defines recommended standards for the submission
+ of data from nonclinical Developmental and Reproductive Toxicology (DART) studies, and is referred
+ to as the SENDIG-DART. This IG is based on and should be used in close concert with Version
+ 3.1 of the Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) and Version
+ 1.6 of the CDISC Study Data Tabulation Model (SDTM), available at https://www.cdisc.org/standards/."
+ Document: "SENDIG DART"
+ Section: "1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND399'
- Version: '1'
- Version: '5.0'
- Version: '1.1'
- - Name: 'SENDIG-DART'
+ Id: "SEND399"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
+ - Name: "SENDIG-DART"
References:
- Citations:
- - Cited Guidance: 'This Implementation Guide (IG) defines recommended standards
- for the submission of data from nonclinical Developmental and
- Reproductive Toxicology (DART) studies, and is referred to as
- the SENDIG-DART. This IG is based on and should be used in
- close concert with Version 3.1 of the Standard for Exchange of
- Nonclinical Data Implementation Guide (SENDIG) and Version 1.6
- of the CDISC Study Data Tabulation Model (SDTM), available at
- https://www.cdisc.org/standards/.'
- Document: 'SENDIG DART'
- Section: '1.1'
- Origin: 'SEND Conformance Rules'
+ - Cited Guidance:
+ "This Implementation Guide (IG) defines recommended standards for the submission
+ of data from nonclinical Developmental and Reproductive Toxicology (DART) studies, and is referred
+ to as the SENDIG-DART. This IG is based on and should be used in close concert with Version
+ 3.1 of the Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) and Version
+ 1.6 of the CDISC Study Data Tabulation Model (SDTM), available at https://www.cdisc.org/standards/."
+ Document: "SENDIG DART"
+ Section: "1.1"
+ Origin: "SEND Conformance Rules"
Rule Identifier:
- Id: 'SEND399'
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Id: "SEND399"
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
any:
# check on whether there is a record with TSPARMCD=SNDIGVER
- name: $distinct_tsparmcd
operator: does_not_contain
- value: SNDIGVER
- # when there is a record with TSPARMCD=SNDIGVER,
- # then TSVAL must be one from the SNDIGVER for DART-1.1 or DART-1.2
+ value:
+ SNDIGVER
+ # when there is a record with TSPARMCD=SNDIGVER,
+ # then TSVAL must be one from the SNDIGVER for DART-1.1 or DART-1.2
- all:
- name: TSPARMCD
operator: equal_to
@@ -54,24 +51,23 @@ Check:
- name: TSVAL
operator: is_not_contained_by
value:
- - SEND DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY IMPLEMENTATION
- GUIDE VERSION 1.1
- - SEND DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY IMPLEMENTATION
- GUIDE VERSION 1.2
+ - SEND DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY IMPLEMENTATION GUIDE VERSION 1.1
+ - SEND DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY IMPLEMENTATION GUIDE VERSION 1.2
Core:
Status: Draft
- Version: '1'
-Description: 'A record exists in TS where TSPARMCD = "SNDIGVER" and TSVAL =
- Controlled Terminology term for SENDIG-DART from the SNDIGVER codelist'
+ Version: "1"
+Description:
+ 'A record exists in TS where TSPARMCD = "SNDIGVER" and TSVAL = Controlled Terminology term
+ for SENDIG-DART from the SNDIGVER codelist'
Executability: Fully Executable
Operations:
- id: $distinct_tsparmcd
name: TSPARMCD
operator: distinct
Outcome:
- Message: 'A record with TSPARMCD=SNDIGVER must be present in TS and the TSVAL
- for SNDIGVER must be the Controlled Terminology term for SENDIG-DART from
- the SNDIGVER codelist.'
+ Message:
+ "A record with TSPARMCD=SNDIGVER must be present in TS and the TSVAL for SNDIGVER must be the
+ Controlled Terminology term for SENDIG-DART from the SNDIGVER codelist."
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SENDIG/SEND4/rule.yml b/Unpublished/SENDIG/SEND4/rule.yml
index a207dc7a1..cafb29fd4 100644
--- a/Unpublished/SENDIG/SEND4/rule.yml
+++ b/Unpublished/SENDIG/SEND4/rule.yml
@@ -4,81 +4,87 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'The define.xml specification includes seven distinct attributes
- to describe variable-level metadata; ...The data Type.'
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata; ...The data Type."
Document: SENDIG v3.0
- Section: '3.2.2'
+ Section: "3.2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND4
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'The define.xml specification includes seven distinct attributes
- to describe variable-level metadata; ... The data Type.'
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata; ... The data Type."
Document: SENDIG v3.1
- Section: '3.2.2'
+ Section: "3.2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND4
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: 'The define.xml specification includes seven distinct attributes
- to describe variable-level metadata; ...The data Type.'
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata; ...The data Type."
Document: SENDIG v3.1.1
- Section: '3.2.2'
+ Section: "3.2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND4
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: 'The define.xml specification includes seven distinct attributes
- to describe variable-level metadata; ...The data Type.'
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata; ...The data Type."
Document: SENDIG v3.1.1
- Section: '3.2.2'
+ Section: "3.2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND4
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'The define.xml specification includes seven distinct attributes
- to describe variable-level metadata; ...The data Type.'
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata; ...The data Type."
Document: SENDIG v3.1
- Section: '3.2.2'
+ Section: "3.2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND4
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: 'The define.xml specification includes seven distinct attributes
- to describe variable-level metadata; ...The data Type.'
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata; ...The data Type."
Document: SENDIG v3.1.1
- Section: '3.2.2'
+ Section: "3.2.2"
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND4
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
#- name: variable_data_type
@@ -88,31 +94,33 @@ Check:
- name: variable_name # JUST TRYING ...
operator: equal_to
value: define_variable_name
- - name: variable_data_type
- # ALTHOUGH equivalent: variable_data_type equal_to "Char" DOES NOT WORK !!!
- #operator: equal_to
- #value: "Char"
+ - name:
+ variable_data_type
+ # ALTHOUGH equivalent: variable_data_type equal_to "Char" DOES NOT WORK !!!
+ #operator: equal_to
+ #value: "Char"
operator: not_equal_to # Character
- value: "Num"
- #- all:
- # # ALTHOUGH mostly equivalent, define_variable_data_type equal_to "text" DOES NOT WORK !!!
- # - name: define_variable_data_type
- # operator: not_equal_to
- # value: "integer"
- #- any:
- # - name: define_variable_data_type
- # operator: equal_to
- # value: 'integer'
- # - name: define_variable_data_type
- # operator: equal_to
- # value: 'float'
+ value:
+ "Num"
+ #- all:
+ # # ALTHOUGH mostly equivalent, define_variable_data_type equal_to "text" DOES NOT WORK !!!
+ # - name: define_variable_data_type
+ # operator: not_equal_to
+ # value: "integer"
+ #- any:
+ # - name: define_variable_data_type
+ # operator: equal_to
+ # value: 'integer'
+ # - name: define_variable_data_type
+ # operator: equal_to
+ # value: 'float'
Core:
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'variable data type mismatch'
+ Message: "variable data type mismatch"
Output Variables:
- variable_name
- define_variable_name
diff --git a/Unpublished/SENDIG/SEND41/rule.yml b/Unpublished/SENDIG/SEND41/rule.yml
index e3638fb48..cdf820084 100644
--- a/Unpublished/SENDIG/SEND41/rule.yml
+++ b/Unpublished/SENDIG/SEND41/rule.yml
@@ -4,29 +4,29 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: When extending a controlled terminology list, the
- case-sensitivity convention of that list should be followed.
+ - Cited Guidance: When extending a controlled terminology list, the case-sensitivity
+ convention of that list should be followed.
Document: IG v3.0
Item: Specification
Section: 4.2.4 | 4.3.2
Origin: SEND Conformance Rules
Rule Identifier:
- Id: 'SEND41'
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Id: "SEND41"
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
Check:
all:
- name: SITEID
- operator: 'equal_to'
- value: '701'
+ operator: "equal_to"
+ value: "701"
Core:
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'Value may not be 701'
+ Message: "Value may not be 701"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SENDIG/SEND49/rule.yml b/Unpublished/SENDIG/SEND49/rule.yml
index 216127f60..74f083cf0 100644
--- a/Unpublished/SENDIG/SEND49/rule.yml
+++ b/Unpublished/SENDIG/SEND49/rule.yml
@@ -4,113 +4,114 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If a controlled terminology codelist exists for a variable in a
- SEND domain, the name of the codelist will be populated in the
- Controlled Terms, Codelist, or Format column of the domain
- model to indicate that a distinct set of controlled values
- exist and is expected to be used.
+ - Cited Guidance:
+ If a controlled terminology codelist exists for a variable in a SEND domain,
+ the name of the codelist will be populated in the Controlled Terms, Codelist, or Format
+ column of the domain model to indicate that a distinct set of controlled values exist and
+ is expected to be used.
Document: IG v3.0
Item: Specification
Section: 4.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND49
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If a controlled terminology codelist exists for a variable in a
- SEND domain, the name of the codelist will be populated in the
- Controlled Terms, Codelist, or Format column of the domain
- model to indicate that a distinct set of controlled values
- exist and is expected to be used.
+ - Cited Guidance:
+ If a controlled terminology codelist exists for a variable in a SEND domain,
+ the name of the codelist will be populated in the Controlled Terms, Codelist, or Format
+ column of the domain model to indicate that a distinct set of controlled values exist and
+ is expected to be used.
Document: IG v3.1
Item: Specification
Section: 4.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND49
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: If a controlled terminology codelist exists for a variable in a
- SEND domain, the name of the codelist will be populated in the
- Controlled Terms, Codelist, or Format column of the domain
- model to indicate that a distinct set of controlled values
- exist and is expected to be used.
+ - Cited Guidance:
+ If a controlled terminology codelist exists for a variable in a SEND domain,
+ the name of the codelist will be populated in the Controlled Terms, Codelist, or Format
+ column of the domain model to indicate that a distinct set of controlled values exist and
+ is expected to be used.
Document: IG v3.1.1
Item: Specification
Section: 4.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND49
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: If a controlled terminology codelist exists for a variable in a
- SEND domain, the name of the codelist will be populated in the
- Controlled Terms, Codelist, or Format column of the domain
- model to indicate that a distinct set of controlled values
- exist and is expected to be used.
+ - Cited Guidance:
+ If a controlled terminology codelist exists for a variable in a SEND domain,
+ the name of the codelist will be populated in the Controlled Terms, Codelist, or Format
+ column of the domain model to indicate that a distinct set of controlled values exist and
+ is expected to be used.
Document: IG v3.1.1
Item: Specification
Section: 4.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND49
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If a controlled terminology codelist exists for a variable in a
- SEND domain, the name of the codelist will be populated in the
- Controlled Terms, Codelist, or Format column of the domain
- model to indicate that a distinct set of controlled values
- exist and is expected to be used.
+ - Cited Guidance:
+ If a controlled terminology codelist exists for a variable in a SEND domain,
+ the name of the codelist will be populated in the Controlled Terms, Codelist, or Format
+ column of the domain model to indicate that a distinct set of controlled values exist and
+ is expected to be used.
Document: IG v3.1.0
Item: Specification
Section: 4.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND49
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: If a controlled terminology codelist exists for a variable in a
- SEND domain, the name of the codelist will be populated in the
- Controlled Terms, Codelist, or Format column of the domain
- model to indicate that a distinct set of controlled values
- exist and is expected to be used.
+ - Cited Guidance:
+ If a controlled terminology codelist exists for a variable in a SEND domain,
+ the name of the codelist will be populated in the Controlled Terms, Codelist, or Format
+ column of the domain model to indicate that a distinct set of controlled values exist and
+ is expected to be used.
Document: IG v3.1.1
Item: Specification
Section: 4.3.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND49
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
Check:
all:
# This first condition (define_variable_name != 'STUDYID') seems to be necessary to select the variables
- name: define_variable_name
operator: not_equal_to
- value: 'STUDYID'
- # 2025-08-16: library_variable_code looks to work well
- - name: 'library_variable_ccode'
+ value:
+ "STUDYID"
+ # 2025-08-16: library_variable_code looks to work well
+ - name: "library_variable_ccode"
operator: non_empty
- any:
# - name: define_vlm_ccode
@@ -124,15 +125,16 @@ Check:
Core:
Status: Draft
- Version: '1'
-Description: 'For a variable identified in the SENDIG as being subject to CDISC
- published Controlled Terminology, the Codelist listed in the Define-XML
- document must properly reference the Controlled Terminology Codelist used.'
+ Version: "1"
+Description:
+ "For a variable identified in the SENDIG as being subject to CDISC published Controlled Terminology,
+ the Codelist listed in the Define-XML document must properly reference the Controlled Terminology Codelist
+ used."
Executability: Fully Executable
Outcome:
- Message: 'As a controlled terminology codelist exists for the variable in the
- SEND domain, the codelist must be referenced for the variable in the
- define.xml'
+ Message:
+ "As a controlled terminology codelist exists for the variable in the SEND domain, the codelist
+ must be referenced for the variable in the define.xml"
Output Variables:
- define_variable_name
- define_variable_ccode
diff --git a/Unpublished/SENDIG/SEND5/rule.yml b/Unpublished/SENDIG/SEND5/rule.yml
index 296fb6778..f607217dc 100644
--- a/Unpublished/SENDIG/SEND5/rule.yml
+++ b/Unpublished/SENDIG/SEND5/rule.yml
@@ -4,10 +4,10 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The Variable Name
- (limited to 8 characters for compatibility with the SAS v5
- Transport format)"
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport
+ format)"
Document: IG v3.0
Item: Specification
Section: 3.2.2
@@ -20,10 +20,10 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The Variable Name
- (limited to 8 characters for compatibility with the SAS v5
- Transport format)"
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport
+ format)"
Document: IG v3.1
Item: Specification
Section: 3.2.2
@@ -36,10 +36,10 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The Variable Name
- (limited to 8 characters for compatibility with the SAS v5
- Transport format)"
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport
+ format)"
Document: IG v3.1.1
Item: Specification
Section: 3.2.2
@@ -52,10 +52,10 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The Variable Name
- (limited to 8 characters for compatibility with the SAS v5
- Transport format)"
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport
+ format)"
Document: IG v3.1
Item: Specification
Section: 3.2.2
@@ -68,10 +68,10 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The Variable Name
- (limited to 8 characters for compatibility with the SAS v5
- Transport format)"
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport
+ format)"
Document: IG v3.1.1
Item: Specification
Section: 3.2.2
@@ -84,10 +84,10 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The Variable Name
- (limited to 8 characters for compatibility with the SAS v5
- Transport format)"
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport
+ format)"
Document: IG v3.1.1
Item: Specification
Section: 3.2.2
@@ -100,17 +100,19 @@ Authorities:
Check:
all:
- name: define_variable_name
- operator: not_equal_to
- # P.S.: library_variable_name points to the IG plus to the model.
+ operator:
+ not_equal_to
+ # P.S.: library_variable_name points to the IG plus to the model.
value: library_variable_name
Core:
Status: Draft
- Version: '1'
-Description: 'Checks the variable name in the define.xml for its existence in
- the CDISC Library for the provided SENDIG version'
+ Version: "1"
+Description:
+ "Checks the variable name in the define.xml for its existence in the CDISC Library for the
+ provided SENDIG version"
Executability: Fully Executable
Outcome:
- Message: 'The variable in the define.xml is not from the SENDIG'
+ Message: "The variable in the define.xml is not from the SENDIG"
Rule Type: Define Item Metadata Check against Library Metadata
Scope:
Classes:
diff --git a/Unpublished/SENDIG/SEND50.99/rule.yml b/Unpublished/SENDIG/SEND50.99/rule.yml
index 3de4bc11a..e779a92de 100644
--- a/Unpublished/SENDIG/SEND50.99/rule.yml
+++ b/Unpublished/SENDIG/SEND50.99/rule.yml
@@ -4,11 +4,10 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The controlled terminology or a link to the controlled
- terminology should be included in the data definition file
- wherever applicable. See the define.xml specification for
- details on including or referencing controlled terminology
- lists. Transport format)"
+ - Cited Guidance:
+ The controlled terminology or a link to the controlled terminology should be
+ included in the data definition file wherever applicable. See the define.xml specification
+ for details on including or referencing controlled terminology lists. Transport format)"
Document: IG v3.0
Item: Specification
Section: 4.3.3
@@ -24,15 +23,15 @@ Check:
operator: not_equal_to
value: STUDYID
- name: define_vlm_ccode
- operator: 'not_equal_to'
- value: '99999'
+ operator: "not_equal_to"
+ value: "99999"
Core:
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'test message'
+ Message: "test message"
Rule Type: Define Item Metadata Check against Library Metadata
Scope:
Classes:
diff --git a/Unpublished/SENDIG/SEND50/rule.yml b/Unpublished/SENDIG/SEND50/rule.yml
index fb26183ee..e2c4574d3 100644
--- a/Unpublished/SENDIG/SEND50/rule.yml
+++ b/Unpublished/SENDIG/SEND50/rule.yml
@@ -4,11 +4,10 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The controlled terminology or a link to the controlled
- terminology should be included in the data definition file
- wherever applicable. See the define.xml specification for
- details on including or referencing controlled terminology
- lists. Transport format)"
+ - Cited Guidance:
+ The controlled terminology or a link to the controlled terminology should be
+ included in the data definition file wherever applicable. See the define.xml specification
+ for details on including or referencing controlled terminology lists. Transport format)"
Document: IG v3.0
Item: Specification
Section: 4.3.3
@@ -21,11 +20,10 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The controlled terminology or a link to the controlled
- terminology should be included in the data definition file
- wherever applicable. See the define.xml specification for
- details on including or referencing controlled terminology
- lists. Transport format)"
+ - Cited Guidance:
+ The controlled terminology or a link to the controlled terminology should be
+ included in the data definition file wherever applicable. See the define.xml specification
+ for details on including or referencing controlled terminology lists. Transport format)"
Document: IG v3.1
Item: Specification
Section: 4.3.3
@@ -38,11 +36,10 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: The controlled terminology or a link to the controlled
- terminology should be included in the data definition file
- wherever applicable. See the define.xml specification for
- details on including or referencing controlled terminology
- lists.
+ - Cited Guidance:
+ The controlled terminology or a link to the controlled terminology should be
+ included in the data definition file wherever applicable. See the define.xml specification
+ for details on including or referencing controlled terminology lists.
Document: IG v3.1.1
Item: Specification
Section: 4.3.3
@@ -55,11 +52,10 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The controlled terminology or a link to the controlled
- terminology should be included in the data definition file
- wherever applicable. See the define.xml specification for
- details on including or referencing controlled terminology
- lists.
+ - Cited Guidance:
+ The controlled terminology or a link to the controlled terminology should be
+ included in the data definition file wherever applicable. See the define.xml specification
+ for details on including or referencing controlled terminology lists.
Document: IG v3.1
Item: Specification
Section: 4.3.3
@@ -72,11 +68,10 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: The controlled terminology or a link to the controlled
- terminology should be included in the data definition file
- wherever applicable. See the define.xml specification for
- details on including or referencing controlled terminology
- lists.
+ - Cited Guidance:
+ The controlled terminology or a link to the controlled terminology should be
+ included in the data definition file wherever applicable. See the define.xml specification
+ for details on including or referencing controlled terminology lists.
Document: IG v3.1.1
Item: Specification
Section: 4.3.3
@@ -89,11 +84,10 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: The controlled terminology or a link to the controlled
- terminology should be included in the data definition file
- wherever applicable. See the define.xml specification for
- details on including or referencing controlled terminology
- lists.
+ - Cited Guidance:
+ The controlled terminology or a link to the controlled terminology should be
+ included in the data definition file wherever applicable. See the define.xml specification
+ for details on including or referencing controlled terminology lists.
Document: IG v3.1.1
Item: Specification
Section: 4.3.3
@@ -110,27 +104,29 @@ Check:
# ALSO: the current implementation only reports the FIRST violation per dataset
- name: library_variable_ccode
operator: not_equal_to
- value: ''
- # 2025-11-08: TEMPORARY solution:
- #- name: define_variable_has_codelist
- # operator: equal_to
- # value: true
- # better would be to also have a "define_variable_has_valuelist"
- # so that the rule can be implemented as:
- # "do not check when there is no codelist referenced on the Variable level,
- # but there is a ValueList referenced".
- # Remark however this may lead to false negatives
+ value:
+ ""
+ # 2025-11-08: TEMPORARY solution:
+ #- name: define_variable_has_codelist
+ # operator: equal_to
+ # value: true
+ # better would be to also have a "define_variable_has_valuelist"
+ # so that the rule can be implemented as:
+ # "do not check when there is no codelist referenced on the Variable level,
+ # but there is a ValueList referenced".
+ # Remark however this may lead to false negatives
- name: library_variable_ccode
operator: not_equal_to
value: define_variable_ccode
Core:
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: 'The associated codelist for this variable does not match the codelist
- provided in the define.xml through the CDISC-NCI Code'
+ Message:
+ "The associated codelist for this variable does not match the codelist provided in the define.xml
+ through the CDISC-NCI Code"
Output Variables:
- define_variable_name
- library_variable_ccode
diff --git a/Unpublished/SENDIG/SEND57.1/rule.yml b/Unpublished/SENDIG/SEND57.1/rule.yml
index 62daa8916..aa579631a 100644
--- a/Unpublished/SENDIG/SEND57.1/rule.yml
+++ b/Unpublished/SENDIG/SEND57.1/rule.yml
@@ -4,13 +4,12 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "In some cases, a variable value may comprise multiple
- individual values. In these cases, each contributing value is
- a separately collected or analyzed item...In these scenarios,
- when controlled terminology applies to the corresponding
- variable, each contributing value must be included as its
- controlled terminology submission value, and delimited from
- other terms by a semicolon."
+ - Cited Guidance:
+ "In some cases, a variable value may comprise multiple individual values. In these
+ cases, each contributing value is a separately collected or analyzed item...In these scenarios,
+ when controlled terminology applies to the corresponding variable, each contributing value must
+ be included as its controlled terminology submission value, and delimited from other terms by
+ a semicolon."
Document: IG v3.1
Section: 4.3.6.2
Origin: SEND Conformance Rules
@@ -22,13 +21,12 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "In some cases, a variable value may comprise multiple
- individual values. In these cases, each contributing value is
- a separately collected or analyzed item...In these scenarios,
- when controlled terminology applies to the corresponding
- variable, each contributing value must be included as its
- controlled terminology submission value, and delimited from
- other terms by a semicolon."
+ - Cited Guidance:
+ "In some cases, a variable value may comprise multiple individual values. In these
+ cases, each contributing value is a separately collected or analyzed item...In these scenarios,
+ when controlled terminology applies to the corresponding variable, each contributing value must
+ be included as its controlled terminology submission value, and delimited from other terms by
+ a semicolon."
Document: IG v3.1.1
Section: 4.3.6.2
Origin: SEND Conformance Rules
@@ -40,13 +38,12 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "In some cases, a variable value may comprise multiple
- individual values. In these cases, each contributing value is
- a separately collected or analyzed item...In these scenarios,
- when controlled terminology applies to the corresponding
- variable, each contributing value must be included as its
- controlled terminology submission value, and delimited from
- other terms by a semicolon."
+ - Cited Guidance:
+ "In some cases, a variable value may comprise multiple individual values. In these
+ cases, each contributing value is a separately collected or analyzed item...In these scenarios,
+ when controlled terminology applies to the corresponding variable, each contributing value must
+ be included as its controlled terminology submission value, and delimited from other terms by
+ a semicolon."
Document: IG v3.1.1
Section: 4.3.6.2
Origin: SEND Conformance Rules
@@ -58,13 +55,12 @@ Authorities:
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: "In some cases, a variable value may comprise multiple
- individual values. In these cases, each contributing value is
- a separately collected or analyzed item...In these scenarios,
- when controlled terminology applies to the corresponding
- variable, each contributing value must be included as its
- controlled terminology submission value, and delimited from
- other terms by a semicolon."
+ - Cited Guidance:
+ "In some cases, a variable value may comprise multiple individual values. In these
+ cases, each contributing value is a separately collected or analyzed item...In these scenarios,
+ when controlled terminology applies to the corresponding variable, each contributing value must
+ be included as its controlled terminology submission value, and delimited from other terms by
+ a semicolon."
Document: IG v3.1.1
Section: 4.3.6.2
Origin: SEND Conformance Rules
@@ -76,13 +72,12 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "In some cases, a variable value may comprise multiple
- individual values. In these cases, each contributing value is
- a separately collected or analyzed item...In these scenarios,
- when controlled terminology applies to the corresponding
- variable, each contributing value must be included as its
- controlled terminology submission value, and delimited from
- other terms by a semicolon."
+ - Cited Guidance:
+ "In some cases, a variable value may comprise multiple individual values. In these
+ cases, each contributing value is a separately collected or analyzed item...In these scenarios,
+ when controlled terminology applies to the corresponding variable, each contributing value must
+ be included as its controlled terminology submission value, and delimited from other terms by
+ a semicolon."
Document: IG v3.1
Section: 4.3.6.2
Origin: SEND Conformance Rules
@@ -94,13 +89,12 @@ Authorities:
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "In some cases, a variable value may comprise multiple
- individual values. In these cases, each contributing value is
- a separately collected or analyzed item...In these scenarios,
- when controlled terminology applies to the corresponding
- variable, each contributing value must be included as its
- controlled terminology submission value, and delimited from
- other terms by a semicolon."
+ - Cited Guidance:
+ "In some cases, a variable value may comprise multiple individual values. In these
+ cases, each contributing value is a separately collected or analyzed item...In these scenarios,
+ when controlled terminology applies to the corresponding variable, each contributing value must
+ be included as its controlled terminology submission value, and delimited from other terms by
+ a semicolon."
Document: IG v3.1.1
Section: 4.3.6.2
Origin: SEND Conformance Rules
@@ -119,30 +113,31 @@ Check:
operator: equal_to
value: Char
- name: variable_value
- operator: non_empty
- ## The following works for FB1502 test data
- #- name: variable_value
- # operator: equal_to
- # value: '.'
- # value_is_literal: true
- ## The following DOES NOT work
- #- name: variable_value
- # operator: contains
- # value: ';'
- # value_is_literal: true
- # Trying with a regex: does not return anything even when value has a semicolon
+ operator:
+ non_empty
+ ## The following works for FB1502 test data
+ #- name: variable_value
+ # operator: equal_to
+ # value: '.'
+ # value_is_literal: true
+ ## The following DOES NOT work
+ #- name: variable_value
+ # operator: contains
+ # value: ';'
+ # value_is_literal: true
+ # Trying with a regex: does not return anything even when value has a semicolon
- name: variable_value
operator: matches_regex
- value: ';'
+ value: ";"
Core:
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
- Message: "The variable value is a list of values separated by a semicolon, and
- the variable is under controlled terminology, but not all values after
- splitting are in the controlled terminology list"
+ Message:
+ "The variable value is a list of values separated by a semicolon, and the variable is under
+ controlled terminology, but not all values after splitting are in the controlled terminology list"
# Rule Type: Record Data
Rule Type: Value Check with Variable Metadata
Scope:
diff --git a/Unpublished/SENDIG/SEND7/rule.yml b/Unpublished/SENDIG/SEND7/rule.yml
index 22ac5d78e..b35528c11 100644
--- a/Unpublished/SENDIG/SEND7/rule.yml
+++ b/Unpublished/SENDIG/SEND7/rule.yml
@@ -4,99 +4,99 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The set of controlled
- terminology for the value or the presentation format of the
- variable (Controlled Term, Codelist or Format). Refer to
- Section 4.3 for more information on Controlled Terminology."
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The set of controlled terminology for the value or the presentation format of the
+ variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on
+ Controlled Terminology."
Document: SENDIG v3.0
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND7
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The set of controlled
- terminology for the value or the presentation format of the
- variable (Controlled Term, Codelist or Format). Refer to
- Section 4.3 for more information on Controlled Terminology."
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The set of controlled terminology for the value or the presentation format of the
+ variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on
+ Controlled Terminology."
Document: SENDIG v3.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND7
- Version: '1'
- Version: '5.0'
- Version: '3.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1"
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The set of controlled
- terminology for the value or the presentation format of the
- variable (Controlled Term, Codelist or Format). Refer to
- Section 4.3 for more information on Controlled Terminology."
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The set of controlled terminology for the value or the presentation format of the
+ variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on
+ Controlled Terminology."
Document: SENDIG v3.1.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND7
- Version: '1'
- Version: '5.0'
- Version: '3.1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The set of controlled
- terminology for the value or the presentation format of the
- variable (Controlled Term, Codelist or Format). Refer to
- Section 4.3 for more information on Controlled Terminology."
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The set of controlled terminology for the value or the presentation format of the
+ variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on
+ Controlled Terminology."
Document: SENDIG v3.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND7
- Version: '1'
- Version: '5.0'
- Version: '1.1'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.1"
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The set of controlled
- terminology for the value or the presentation format of the
- variable (Controlled Term, Codelist or Format). Refer to
- Section 4.3 for more information on Controlled Terminology."
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The set of controlled terminology for the value or the presentation format of the
+ variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on
+ Controlled Terminology."
Document: SENDIG v3.1.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND7
- Version: '1'
- Version: '5.0'
- Version: '1.2'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.2"
- Name: SENDIG-GENETOX
References:
- Citations:
- - Cited Guidance: "The define.xml specification includes seven distinct attributes
- to describe variable-level metadata: ...The set of controlled
- terminology for the value or the presentation format of the
- variable (Controlled Term, Codelist or Format). Refer to
- Section 4.3 for more information on Controlled Terminology."
+ - Cited Guidance:
+ "The define.xml specification includes seven distinct attributes to describe variable-level
+ metadata: ...The set of controlled terminology for the value or the presentation format of the
+ variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on
+ Controlled Terminology."
Document: SENDIG v3.1.1
Section: 3.2.2
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND7
- Version: '1'
- Version: '5.0'
- Version: '1.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "1.0"
Check:
all:
#- name: library_variable_has_codelist
@@ -107,16 +107,16 @@ Check:
value: library_variable_ccode
Core:
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Outcome:
Message: Variable Codelist does not match with the one provided by the CDISC Library
Output Variables:
- define_variable_name
- define_variable_ccode
- # THE FOLLOWING causes "not in dataset"
- # - library_variable_ccode
+ # THE FOLLOWING causes "not in dataset"
+ # - library_variable_ccode
Rule Type: Define Item Metadata Check against Library Metadata
Scope:
Classes:
diff --git a/Unpublished/SENDIG/SEND98/rule.yml b/Unpublished/SENDIG/SEND98/rule.yml
index 562b0cdd6..7aad7cb61 100644
--- a/Unpublished/SENDIG/SEND98/rule.yml
+++ b/Unpublished/SENDIG/SEND98/rule.yml
@@ -4,16 +4,17 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: Unique identifier for a study site within a submission. Use only
- if subjects are housed at different sites.
+ - Cited Guidance:
+ Unique identifier for a study site within a submission. Use only if subjects
+ are housed at different sites.
Document: IG v3.0
Section: 5.1.1
Origin: SEND Conformance Rules
Rule Identifier:
Id: SEND98
- Version: '1'
- Version: '5.0'
- Version: '3.0'
+ Version: "1"
+ Version: "5.0"
+ Version: "3.0"
# SITEID should only be used if the in-life portion of the study is conducted at different sites
# When in-life portion is conducted at a single site, SITEID must me null
Check:
@@ -25,8 +26,8 @@ Check:
operator: has_same_values
Core:
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Operations:
- domain: DM
@@ -34,8 +35,9 @@ Operations:
name: SITEID
operator: distinct
Outcome:
- Message: 'SITEID may only be populated when there is more than one site where
- the in-life portion of the study was conducted'
+ Message:
+ "SITEID may only be populated when there is more than one site where the in-life portion of
+ the study was conducted"
Rule Type: Record Data
Scope:
Classes:
diff --git a/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml b/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml
index 057bb4f4e..5cbc3dfc6 100644
--- a/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml
+++ b/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml
@@ -4,691 +4,692 @@ Authorities:
- Name: SENDIG
References:
- Citations:
- - Cited Guidance: ''
- Document: ''
- Item: ''
- Section: ''
+ - Cited Guidance: ""
+ Document: ""
+ Item: ""
+ Section: ""
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: This is where you describe the rule in human
- readable sentence(s).
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: This is where you describe the rule in human readable
+ sentence(s).
Type: Success
Origin: SEND Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Predecessor | Related | Successor
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
Id: SEND_AUTHORING_TEMPLATE
- Version: '0.1'
- Validator Rule Message: This is where you enter the message that will
- be output when this rule is triggered.
- Version: '5.0'
+ Version: "0.1"
+ Validator Rule Message:
+ This is where you enter the message that will be output when this rule
+ is triggered.
+ Version: "5.0"
Version: 3.0 | 3.1 | 3.1.1
- Name: SENDIG-DART
References:
- Citations:
- - Cited Guidance: ''
- Document: ''
- Item: ''
- Section: ''
+ - Cited Guidance: ""
+ Document: ""
+ Item: ""
+ Section: ""
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
Type: Success
Origin: SEND Conformance Rules
Related Rules:
- - Id: ''
+ - Id: ""
Relationship: Predecessor | Related | Successor
- Release Notes: ''
+ Release Notes: ""
Rule Identifier:
- Id: ''
- Version: ''
- Validator Rule Message: ''
- Version: '5.0'
- Version: '1.1'
+ Id: ""
+ Version: ""
+ Validator Rule Message: ""
+ Version: "5.0"
+ Version: "1.1"
Check:
all:
- operator: variable_metadata_not_equal_to
- - '...': ''
+ - "...": ""
any:
- operator: variable_metadata_not_equal_to
- - '...': ''
+ - "...": ""
not:
operator: variable_metadata_not_equal_to
Core:
- Id: ''
+ Id: ""
Status: Draft
-Description: ''
+Description: ""
Executability: >-
Fully Executable | Partially Executable | Partially Executable - Possible
Overreporting | Partially Executable - Possible Underreporting
Match Datasets:
- Is Relationship: true
Keys:
- - ''
+ - ""
Name: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
Operations:
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: define_variable_metadata
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: distinct
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: domain_is_custom
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: domain_label
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: dy
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: extract_metadata
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: expected_variables
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: get_codelist_attributes
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: get_column_order_from_dataset
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: get_column_order_from_library
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: get_model_column_order
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: get_model_filtered_variables
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: get_parent_model_column_order
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: label_referenced_variable_metadata
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: max
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: max_date
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: mean
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: min
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: min_date
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: name_referenced_variable_metadata
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: permissible_variables
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: record_count
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: required_variables
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: study_domains
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: valid_codelist_dates
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: valid_meddra_code_references
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: valid_meddra_code_term_pairs
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: valid_meddra_term_references
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: valid_whodrug_references
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: variable_count
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: variable_exists
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: variable_is_null
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: variable_library_metadata
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: variable_names
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: variable_value_count
- attribute_name: variable_value_length
- ct_attribute: ''
+ ct_attribute: ""
ct_packages:
- - ''
- ct_version: ''
+ - ""
+ ct_version: ""
domain: >-
ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- |
ADAM OTHER | BASIC DATA STRUCTURE | ...
group:
- - ''
- id: ''
+ - ""
+ id: ""
key_name: >-
definition | examples | label | name | notes | ordinal | role |
simpleDatatype | variableCcode
- key_value: ''
- name: ''
+ key_value: ""
+ name: ""
operator: whodrug_code_hierarchy
Outcome:
- Message: ''
+ Message: ""
Output Variables:
- variable_value_length
Rule Type: Variable Metadata Check against Library Metadata
diff --git a/Unpublished/TIG/TIG0031/rule.yml b/Unpublished/TIG/TIG0031/rule.yml
index b86893fc4..75062fe53 100644
--- a/Unpublished/TIG/TIG0031/rule.yml
+++ b/Unpublished/TIG/TIG0031/rule.yml
@@ -1,24 +1,25 @@
# Variable: LEVEL
# Condition: Record has an associated PARENT record
-# Rule: Value for LEVEL = value for PARENT LEVEL + 1
+# Rule: Value for LEVEL = value for PARENT LEVEL + 1
Authorities:
- - Organization: 'CDISC'
+ - Organization: "CDISC"
Standards:
- - Name: 'TIG'
+ - Name: "TIG"
References:
- Citations:
- - Cited Guidance: If a record has a PARENT, LEVEL must be populated with a LEVEL
- that is sequentially one greater than the PARENT record (e.g.,
- value for LEVEL = value for PARENT LEVEL + 1).
- Document: 'TIG 1.0'
- Item: 'assumption 6'
- Section: '2.8.9.23'
+ - Cited Guidance:
+ If a record has a PARENT, LEVEL must be populated with a LEVEL that is
+ sequentially one greater than the PARENT record (e.g., value for LEVEL = value for PARENT
+ LEVEL + 1).
+ Document: "TIG 1.0"
+ Item: "assumption 6"
+ Section: "2.8.9.23"
Origin: TIG Conformance Rules
Rule Identifier:
- Id: 'TIG0031'
- Version: '1'
- Version: '1.0'
- Version: '1.0'
+ Id: "TIG0031"
+ Version: "1"
+ Version: "1.0"
+ Version: "1.0"
Check:
all:
- name: PARENT
@@ -28,9 +29,9 @@ Check:
value: $LEVEL_join + 1
Core:
Status: Draft
- Version: '1'
-Description: Raise an error when a record has a PARENT record but the value for
- LEVEL does not equal the level of the PARENT LEVEL + 1.
+ Version: "1"
+Description: Raise an error when a record has a PARENT record but the value for LEVEL does not equal
+ the level of the PARENT LEVEL + 1.
Executability: Fully Executable
Match Datasets:
- Keys:
@@ -39,8 +40,8 @@ Match Datasets:
Right: REFID
Name: RELREF
Outcome:
- Message: Record has a PARENT record but the value for LEVEL does not equal the
- level of the PARENT LEVEL + 1.
+ Message: Record has a PARENT record but the value for LEVEL does not equal the level of the PARENT
+ LEVEL + 1.
Output Variables:
- LEVEL
- PARENT
diff --git a/Unpublished/TIG/TIG0044/rule.yml b/Unpublished/TIG/TIG0044/rule.yml
index a31db5a16..e48722fd4 100644
--- a/Unpublished/TIG/TIG0044/rule.yml
+++ b/Unpublished/TIG/TIG0044/rule.yml
@@ -6,19 +6,19 @@ Authorities:
- Name: TIG
References:
- Citations:
- - Cited Guidance: If this variable is excluded in the DM domain, the information
- must be present at a higher level (either Trial Sets or Trial
- Summary).
+ - Cited Guidance:
+ If this variable is excluded in the DM domain, the information must be
+ present at a higher level (either Trial Sets or Trial Summary).
Document: TIG 1.0
Item: STRAIN CDISC Notes
Section: 2.8.9.6 SEND Demographics (DM)
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0044
- Version: '1'
- Version: '1.0'
+ Version: "1"
+ Version: "1.0"
Substandard: SEND
- Version: '1.0'
+ Version: "1.0"
Check:
all:
- name: $tsparmcdstrain_count
@@ -30,10 +30,10 @@ Check:
Core:
Id:
Status: Draft
- Version: '1'
-Description: Part A - Raise an error when there is no record with TSPARMCD =
- "STRAIN" present in TS or TSVAL is not completed and no record with TXPARMCD =
- "STRAIN" present in TX or TXVAL is not completed.
+ Version: "1"
+Description: Part A - Raise an error when there is no record with TSPARMCD = "STRAIN" present in TS
+ or TSVAL is not completed and no record with TXPARMCD = "STRAIN" present in TX or TXVAL is not
+ completed.
Executability: Fully Executable
Operations:
- domain: TX
@@ -51,8 +51,8 @@ Operations:
name: TSPARMCD
operator: record_count
Outcome:
- Message: There should be a record in TS with TSPARMCD = "STRAIN" and completed
- TSVAL or a record in TX with TXPARMCD = "STRAIN" and completed TXVAL.
+ Message: There should be a record in TS with TSPARMCD = "STRAIN" and completed TSVAL or a record
+ in TX with TXPARMCD = "STRAIN" and completed TXVAL.
Output Variables:
- $txparmcdstrain_count
- $tsparmcdstrain_count
diff --git a/Unpublished/USDM/DDF00262/rule.yml b/Unpublished/USDM/DDF00262/rule.yml
index df86fd990..14276b746 100644
--- a/Unpublished/USDM/DDF00262/rule.yml
+++ b/Unpublished/USDM/DDF00262/rule.yml
@@ -4,15 +4,16 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: 'Referenced id values must be valid according to the USDM schema
- based on the API specification.'
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance:
+ "Referenced id values must be valid according to the USDM schema based on the
+ API specification."
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'DDF00262'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "DDF00262"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check: |-
(
$idl := **[id and instanceType]{id:$distinct(instanceType)};
@@ -325,22 +326,22 @@ Check: |-
) ~> $reduce($append)
)
Core:
- Id: ''
+ Id: ""
Status: Draft
- Version: '1'
-Description: 'Referenced id values must be valid according to the USDM schema
- based on the API specification.'
+ Version: "1"
+Description: "Referenced id values must be valid according to the USDM schema based on the API specification."
Executability: Fully Executable
Outcome:
- Message: 'The referenced id value is not valid - the id value doesn''t match any
- object or the id value refers to an instance of an incorrect entity.'
+ Message:
+ "The referenced id value is not valid - the id value doesn't match any object or the id value
+ refers to an instance of an incorrect entity."
Output Variables:
- - 'Id Attribute'
- - 'Id Value'
+ - "Id Attribute"
+ - "Id Value"
- Issue
Rule Type: JSONata
Scope:
Entities:
Include:
- - 'ALL'
+ - "ALL"
Sensitivity: Record
diff --git a/Unpublished/USDM/USDM_TEMPLATE/rule.yml b/Unpublished/USDM/USDM_TEMPLATE/rule.yml
index b428d021c..6b4d61c57 100644
--- a/Unpublished/USDM/USDM_TEMPLATE/rule.yml
+++ b/Unpublished/USDM/USDM_TEMPLATE/rule.yml
@@ -4,39 +4,39 @@ Authorities:
- Name: USDM
References:
- Citations:
- - Cited Guidance: ''
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: ""
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'USDM_TEMPLATE'
- Version: '1'
- Version: '1.0'
- Version: '3.0'
+ Id: "USDM_TEMPLATE"
+ Version: "1"
+ Version: "1.0"
+ Version: "3.0"
- Name: USDM
References:
- Citations:
- - Cited Guidance: ''
- Document: 'USDM_CORE_Rules.xlsx'
- Origin: 'USDM Conformance Rules'
+ - Cited Guidance: ""
+ Document: "USDM_CORE_Rules.xlsx"
+ Origin: "USDM Conformance Rules"
Rule Identifier:
- Id: 'USDM_TEMPLATE'
- Version: '1'
- Version: '1.0'
- Version: '4.0'
+ Id: "USDM_TEMPLATE"
+ Version: "1"
+ Version: "1.0"
+ Version: "4.0"
Check:
all:
- operator: variable_metadata_not_equal_to
- - ...: ''
+ - "...": ""
any:
- operator: variable_metadata_not_equal_to
- - ...: ''
+ - "...": ""
not:
operator: variable_metadata_not_equal_to
Core:
- Id: ''
+ Id: ""
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: >-
Fully Executable | Not Executable | Partially Executable | Partially
Executable - Possible Overreporting | Partially Executable - Possible
@@ -46,18 +46,18 @@ Executability: >-
# - if not needed, remove the Match Datasets section
Match Datasets:
- Keys:
- - ''
- - Left: ''
- Right: ''
+ - ""
+ - Left: ""
+ Right: ""
Name: >-
...
# Operations is optional
# - if needed, remove this comment
# - if not needed, remove the Operations section
Operations:
- - ...: ''
+ - "...": ""
Outcome:
- Message: ''
+ Message: ""
Output Variables:
- parent_entity
- parent_id
@@ -68,7 +68,7 @@ Rule Type: Record Data
Scope:
Entities:
Exclude:
- - ''
+ - ""
Include:
- - ''
+ - ""
Sensitivity: Record
diff --git a/scripts/sort_yaml.py b/scripts/sort_yaml.py
index d929eeb9a..bc5d5c04b 100644
--- a/scripts/sort_yaml.py
+++ b/scripts/sort_yaml.py
@@ -1,17 +1,23 @@
#!/usr/bin/env python3
"""
-Sort and format rule YAML files alphabetically and recursively by key name.
+Sort rule YAML files alphabetically and recursively by key name, preserving comments.
-This matches the auto-format/auto-sort behavior of the CDISC conformance rules editor.
+This matches the auto-sort behavior of the CDISC conformance rules editor.
+Prettier formatting is handled separately (via the VS Code extension locally,
+or in CI) — this script only handles key sorting.
+
+Check mode (--check) verifies key order structurally, independent of exact
+formatting bytes, so it agrees regardless of whether Prettier, ruamel, or an
+editor last touched the file's whitespace/quotes/wrapping.
Usage:
- # Format files in-place (default: all rule.yml under Published/ and Unpublished/)
+ # Sort files in-place (default: all rule.yml under Published/ and Unpublished/)
python scripts/sort_yaml.py
- # Format specific files
+ # Sort specific files
python scripts/sort_yaml.py path/to/rule.yml another/rule.yml
- # Check mode: exit with code 1 if any file is not formatted correctly
+ # Check mode: exit with code 1 if any file's keys are not sorted
python scripts/sort_yaml.py --check [files...]
"""
@@ -66,8 +72,27 @@ def sort_recursive(obj):
return obj
+def is_sorted_recursive(obj) -> bool:
+ """Check whether dict keys are already alphabetically sorted at every level.
+
+ This is a structural check on key order only — it says nothing about
+ whitespace, quote style, or line wrapping, so it agrees with the file
+ regardless of which tool (Prettier, ruamel, an editor) last formatted it.
+ """
+ if isinstance(obj, CommentedMap):
+ keys = list(obj.keys())
+ if [str(k) for k in keys] != sorted(str(k) for k in keys):
+ return False
+ return all(is_sorted_recursive(v) for v in obj.values())
+
+ if isinstance(obj, CommentedSeq):
+ return all(is_sorted_recursive(item) for item in obj)
+
+ return True
+
+
def canonical(content: str) -> str:
- """Return the canonical (sorted + formatted) representation of a YAML string."""
+ """Return the canonical (sorted) representation of a YAML string."""
data = _yaml.load(content)
if data is None:
return content
@@ -88,23 +113,40 @@ def find_rule_files(root: Path) -> list[Path]:
def process_files(files: list[Path], check_mode: bool) -> int:
- """Format (or check) the given files. Returns exit code."""
+ """Sort (or check) the given files. Returns exit code."""
changed = []
errors = []
for path in files:
try:
original = path.read_text(encoding="utf-8")
- formatted = canonical(original)
except Exception as exc:
errors.append(f" {path}: {exc}")
continue
- if original != formatted:
- changed.append(path)
- if not check_mode:
+ if check_mode:
+ try:
+ data = _yaml.load(original)
+ except Exception as exc:
+ errors.append(f" {path}: {exc}")
+ continue
+
+ if data is None:
+ continue
+
+ if not is_sorted_recursive(data):
+ changed.append(path)
+ else:
+ try:
+ formatted = canonical(original)
+ except Exception as exc:
+ errors.append(f" {path}: {exc}")
+ continue
+
+ if original != formatted:
+ changed.append(path)
path.write_text(formatted, encoding="utf-8")
- print(f" Formatted: {path}")
+ print(f" Sorted: {path}")
if errors:
print("\nERROR: Failed to process the following files:", file=sys.stderr)
@@ -115,7 +157,7 @@ def process_files(files: list[Path], check_mode: bool) -> int:
if check_mode:
if changed:
print(
- "\nThe following rule.yml files are not correctly sorted/formatted:\n",
+ "\nThe following rule.yml files are not correctly sorted:\n",
file=sys.stderr,
)
for p in changed:
@@ -126,10 +168,10 @@ def process_files(files: list[Path], check_mode: bool) -> int:
)
return 1
else:
- print("All rule.yml files are correctly sorted and formatted.")
+ print("All rule.yml files are correctly sorted.")
else:
if not changed:
- print("All rule.yml files are already correctly sorted and formatted.")
+ print("All rule.yml files are already correctly sorted.")
return 0
@@ -143,7 +185,7 @@ def main():
parser.add_argument(
"--check",
action="store_true",
- help="Check mode: exit 1 if any file needs formatting, without modifying files.",
+ help="Check mode: exit 1 if any file's keys are not sorted, without modifying files.",
)
parser.add_argument(
"files",
@@ -164,7 +206,7 @@ def main():
print("No rule.yml files found.")
return 0
- mode = "Checking" if args.check else "Formatting"
+ mode = "Checking" if args.check else "Sorting"
print(f"{mode} {len(files)} rule.yml file(s)...")
sys.exit(process_files(files, check_mode=args.check))
diff --git a/template/template-rule.yml b/template/template-rule.yml
index 4e257135f..fc9874f34 100644
--- a/template/template-rule.yml
+++ b/template/template-rule.yml
@@ -1,46 +1,46 @@
Authorities:
- - Organization: ''
+ - Organization: ""
Standards:
- - Name: ''
+ - Name: ""
References:
- Citations:
- - Cited Guidance: ''
- Document: ''
- Item: ''
- Section: ''
+ - Cited Guidance: ""
+ Document: ""
+ Item: ""
+ Section: ""
Criteria:
Logical Expression:
- Condition: ''
- Rule: ''
- Plain Language Expression: ''
- Type: ''
- Origin: ''
- Release Notes: ''
+ Condition: ""
+ Rule: ""
+ Plain Language Expression: ""
+ Type: ""
+ Origin: ""
+ Release Notes: ""
Rule Identifier:
- Id: ''
- Version: ''
- Validator Rule Message: ''
- Version: ''
- Version: ''
+ Id: ""
+ Version: ""
+ Validator Rule Message: ""
+ Version: ""
+ Version: ""
Check:
all:
- - operator: ''
- name: ''
- value: ''
+ - operator: ""
+ name: ""
+ value: ""
Core:
- Id: ''
+ Id: ""
Status: Draft
- Version: '1'
-Description: ''
+ Version: "1"
+Description: ""
Executability: Fully Executable
Operations:
- - id: ''
- operator: ''
+ - id: ""
+ operator: ""
Outcome:
- Message: ''
+ Message: ""
Output Variables:
- - ''
-Rule Type: ''
+ - ""
+Rule Type: ""
Scope:
Classes:
Include:
@@ -48,4 +48,4 @@ Scope:
Domains:
Include:
- ALL
-Sensitivity: ''
+Sensitivity: ""