From 4e8b9964076f8e8dc7519ab8a5a4eac73b059cc1 Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Wed, 14 Jan 2026 16:10:25 +0100 Subject: [PATCH 01/10] 1345: process SUPP datasets separately --- cdisc_rules_engine/utilities/data_processor.py | 3 +-- cdisc_rules_engine/utilities/dataset_preprocessor.py | 4 +++- 2 files changed, 4 insertions(+), 3 deletions(-) diff --git a/cdisc_rules_engine/utilities/data_processor.py b/cdisc_rules_engine/utilities/data_processor.py index e94ed9c20..843443773 100644 --- a/cdisc_rules_engine/utilities/data_processor.py +++ b/cdisc_rules_engine/utilities/data_processor.py @@ -198,7 +198,6 @@ def merge_pivot_supp_dataset( left_dataset: DatasetInterface, right_dataset: DatasetInterface, ): - static_keys = ["STUDYID", "USUBJID", "APID", "POOLID", "SPDEVID"] qnam_list = right_dataset["QNAM"].unique() unique_idvar_values = right_dataset["IDVAR"].unique() @@ -232,7 +231,7 @@ def merge_pivot_supp_dataset( suffixes=("", "_supp"), ) DataProcessor._validate_qnam_dask(left_dataset, qnam_list, common_keys) - else: + else: # TODO if SUPPDM -> merge different RACE columns into one row (in data processor) left_dataset = PandasDataset( pd.merge( left_dataset.data, diff --git a/cdisc_rules_engine/utilities/dataset_preprocessor.py b/cdisc_rules_engine/utilities/dataset_preprocessor.py index 0eb2f8356..8876fc6c1 100644 --- a/cdisc_rules_engine/utilities/dataset_preprocessor.py +++ b/cdisc_rules_engine/utilities/dataset_preprocessor.py @@ -109,7 +109,9 @@ def preprocess( # noqa ) ] - if not file_infos: + if not file_infos and not ( + self._dataset_metadata.is_supp and domain_name == "SUPP--" + ): raise PreprocessingError( f"Failed to find related dataset for '{domain_name}' in preprocessor" ) From c0a72c8dfd0a0b1b8d6b9c5ce64580ede4958cbd Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Thu, 15 Jan 2026 13:25:02 +0100 Subject: [PATCH 02/10] 1345: Pre-aggregate SUPP variables to avoid row duplication on merge --- cdisc_rules_engine/utilities/data_processor.py | 13 ++++++++++++- 1 file changed, 12 insertions(+), 1 deletion(-) diff --git a/cdisc_rules_engine/utilities/data_processor.py b/cdisc_rules_engine/utilities/data_processor.py index 843443773..242864429 100644 --- a/cdisc_rules_engine/utilities/data_processor.py +++ b/cdisc_rules_engine/utilities/data_processor.py @@ -204,7 +204,7 @@ def merge_pivot_supp_dataset( if len(unique_idvar_values) == 1: right_dataset = DataProcessor.process_supp(right_dataset) dynamic_key = right_dataset["IDVAR"].iloc[0] - is_blank = pd.isna(dynamic_key) or str(dynamic_key).strip() == "" + is_blank: bool = pd.isna(dynamic_key) or str(dynamic_key).strip() == "" # Determine the common keys present in both datasets common_keys = [ key @@ -232,6 +232,17 @@ def merge_pivot_supp_dataset( ) DataProcessor._validate_qnam_dask(left_dataset, qnam_list, common_keys) else: # TODO if SUPPDM -> merge different RACE columns into one row (in data processor) + if current_supp["RDOMAIN"][0] == "DM": + group_cols = [c for c in current_supp.columns if c not in qnam_list] + current_supp = PandasDataset( + current_supp.data.groupby( + group_cols, dropna=False, as_index=False + ).agg( + lambda x: ( + x.dropna().iloc[0] if not x.dropna().empty else pd.NA + ) + ) + ) left_dataset = PandasDataset( pd.merge( left_dataset.data, From b35cc5a013ea210ad5f6131a202ecf07535ff479 Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Fri, 16 Jan 2026 10:06:29 +0100 Subject: [PATCH 03/10] 1345: regression test to confirm that there is no duplicates caused by suppdm dataset --- .../utilities/data_processor.py | 21 +- .../test_Issues/test_CoreIssue1345.py | 89 + .../subset/define_msg20_testsupp_core.xml | 11918 +++++ tests/resources/CoreIssue1345/subset/dm.json | 701 + .../subset/draft_rules/CG0019.yml | 104 + tests/resources/CoreIssue1345/subset/ec.json | 36756 ++++++++++++++++ .../CoreIssue1345/subset/suppdm.json | 134 + .../CoreIssue1345/subset/suppec.json | 182 + 8 files changed, 49893 insertions(+), 12 deletions(-) create mode 100644 tests/QARegressionTests/test_Issues/test_CoreIssue1345.py create mode 100644 tests/resources/CoreIssue1345/subset/define_msg20_testsupp_core.xml create mode 100644 tests/resources/CoreIssue1345/subset/dm.json create mode 100644 tests/resources/CoreIssue1345/subset/draft_rules/CG0019.yml create mode 100644 tests/resources/CoreIssue1345/subset/ec.json create mode 100644 tests/resources/CoreIssue1345/subset/suppdm.json create mode 100644 tests/resources/CoreIssue1345/subset/suppec.json diff --git a/cdisc_rules_engine/utilities/data_processor.py b/cdisc_rules_engine/utilities/data_processor.py index 242864429..9d2b914f1 100644 --- a/cdisc_rules_engine/utilities/data_processor.py +++ b/cdisc_rules_engine/utilities/data_processor.py @@ -231,18 +231,7 @@ def merge_pivot_supp_dataset( suffixes=("", "_supp"), ) DataProcessor._validate_qnam_dask(left_dataset, qnam_list, common_keys) - else: # TODO if SUPPDM -> merge different RACE columns into one row (in data processor) - if current_supp["RDOMAIN"][0] == "DM": - group_cols = [c for c in current_supp.columns if c not in qnam_list] - current_supp = PandasDataset( - current_supp.data.groupby( - group_cols, dropna=False, as_index=False - ).agg( - lambda x: ( - x.dropna().iloc[0] if not x.dropna().empty else pd.NA - ) - ) - ) + else: left_dataset = PandasDataset( pd.merge( left_dataset.data, @@ -362,6 +351,14 @@ def process_supp(supp_dataset): columns_to_drop = [ col for col in ["QNAM", "QVAL", "QLABEL"] if col in supp_dataset.columns ] + if supp_dataset["RDOMAIN"][0] == "DM": + excluded_columns = list(supp_dataset["QNAM"].unique()) + columns_to_drop + group_cols = [c for c in supp_dataset.columns if c not in excluded_columns] + supp_dataset = PandasDataset( + supp_dataset.data.groupby(group_cols, dropna=False, as_index=False).agg( + lambda x: (x.dropna().iloc[0] if not x.dropna().empty else pd.NA) + ) + ) if columns_to_drop: supp_dataset = supp_dataset.drop(labels=columns_to_drop, axis=1) return supp_dataset diff --git a/tests/QARegressionTests/test_Issues/test_CoreIssue1345.py b/tests/QARegressionTests/test_Issues/test_CoreIssue1345.py new file mode 100644 index 000000000..46e8429f4 --- /dev/null +++ b/tests/QARegressionTests/test_Issues/test_CoreIssue1345.py @@ -0,0 +1,89 @@ +import os +import subprocess +import unittest + +import pytest +import json +from conftest import get_python_executable + + +@pytest.mark.regression +class TestCoreIssue1501(unittest.TestCase): + def test_no_duplicates_in_supp_dm(self): + # Run the command in the terminal + command = [ + f"{get_python_executable()}", + "-m", + "core", + "validate", + "-s", + "sdtmig", + "-v", + "3-4", + "-dv", + "2-1", + "-dxp", + os.path.join( + "tests", + "resources", + "CoreIssue1345", + "subset", + "define_msg20_testsupp_core.xml", + ), + "-d", + os.path.join("tests", "resources", "CoreIssue1345", "subset"), + "-lr", + os.path.join( + "tests", "resources", "CoreIssue1345", "subset", "draft_rules" + ), + "-r", + "CDISC.SDTMIG.CG0019", + "-l", + "error", + "-ps", + "1", + "-of", + "json", + ] + subprocess.run(command, check=True) + + # Get the latest created Excel file + files = os.listdir() + json_files = [ + file + for file in files + if file.startswith("CORE-Report-") and file.endswith(".json") + ] + json_report_path = sorted(json_files)[-1] + # Open the JSON report file + json_report = json.load(open(json_report_path)) + dataset_filenames = { + d["filename"].upper() for d in json_report.get("Dataset_Details", []) + } + + assert "DM" in dataset_filenames, "DM dataset is missing from Dataset_Details" + assert ( + "SUPPDM" in dataset_filenames + ), "SUPPDM dataset is missing from Dataset_Details" + + # 2. check for DM / SUPPDM Issue_Details + dm_related_issues = [ + issue + for issue in json_report.get("Issue_Details", []) + if issue.get("dataset", "").lower() in {"dm.json", "suppdm.json"} + ] + + assert not dm_related_issues, ( + "Found issues related to DM/SUPPDM datasets:\n" f"{dm_related_issues}" + ) + + dm_related_summary = [ + s + for s in json_report.get("Issue_Summary", []) + if s.get("dataset", "").lower() in {"dm.json", "suppdm.json"} + ] + + assert not dm_related_summary, ( + "Found issue summary entries related to DM/SUPPDM:\n" + f"{dm_related_summary}" + ) diff --git a/tests/resources/CoreIssue1345/subset/define_msg20_testsupp_core.xml b/tests/resources/CoreIssue1345/subset/define_msg20_testsupp_core.xml new file mode 100644 index 000000000..70f5369ca --- /dev/null +++ b/tests/resources/CoreIssue1345/subset/define_msg20_testsupp_core.xml @@ -0,0 +1,11918 @@ + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + CDISCPILOT01 + Study Data Tabulation Model Metadata Submission Guidelines Sample Study + CDISCPILOT01 + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + 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9 + + + + + + AVLT-REY - List B Word 10 + + + + + + AVLT-REY - List B Word 11 + + + + + + AVLT-REY - List B Word 12 + + + + + + AVLT-REY - List B Word 13 + + + + + + AVLT-REY - List B Word 14 + + + + + + AVLT-REY - List B Word 15 + + + + + + AVLT-REY - List B Total + + + + + + AVLT-REY - List B Intrusions + + + + + + + + + Recalled + + + + + Not Recalled + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Primary Cause of Death + + + + + + + + + + + + + + + + + + Device Type + + + + + + Serial Number + + + + + + + + + Adverse Events + + + + + + + + + Concomitant/Prior Medications + + + + + + + + + Death Details + + + + + + + + + Device Identifiers + + + + + + + + + Demographics + + + + + + + + + Disposition + + + + + + + + + Exposure as Collected + + + + + + + + + Exposure + + + + + + + + + Findings About Events or Interventions + + + + + + + + + Functional Tests + + + + + + + + + Inclusion/Exclusion Criteria Not Met + + + + + + + + + Laboratory Test Results + + + + + + + + + Medical History + + + + + + + + + Nervous Sysytem Findings + + + + + + + + + Ophthalmic Examinations + + + + + + + + + Questionnaires + + + + + + + + + Disease Response and Clin Classification + + + + + + + + + Subject Elements + + + + + + + + + Subject Visits + + + + + + + + + Trial Arms + + + + + + + + + Trial Elements + + + + + + + + + Trial Inclusion + + + + + + + + + Trial Summary + + + + + + + + + Trial Visits + + + + + + + + + Vital Signs + + + + + + + + + Disposition Event + + + + + + Protocol Milestone + + + + + + + + + Study Treatment + + + + + Study Participation + + + + + + + + + + + + + + Ongoing + + + + + + + + + Screening + + + + + + Treatment + + + + + + + + + Zanomaline 81 mg + + + + + Zanomaline 54 mg + + + + + Placebo + + + + + Screening + + + + + Zanomaline 54 mg Titration + + + + + + + Hispanic or Latino + + + + + + Not Hispanic or Latino + + + + + + + + + Placebo + + + + + Zanomaline + + + + + + + Injection Site Reaction + + + + + + + Erythema + + + + + Pain + + + + + Induration + + + + + Pruritus + + + + + Edema + + + + + + + No + + + + + + Yes + + + + + + + + + Mild + + + + + + Moderate + + + + + + Severe + + + + + + + + + + + + + Occurrence Indicator + + + + + Severity/Intensity + + + + + + + Daily + + + + + + As Needed + + + + + + Twice Daily + + + + + + Every Four Hours + + + + + + Four Times Daily + + + + + + Every Six Hours + + + + + + + + + Daily + + + + + + + + + Injectable Dosage Form + + + + + + + + + Rey Auditory Verbal Learning Functional Test + + + + + + + + + + + + + + + + Absent. + + + + + These feeling states indicated only on questioning. + + + + + These feeling states spontaneously reported verbally. + + + + + Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep. + + + + + Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication. + + + + + + + + + + + + + + Absent. + + + + + Self reproach, feels he/she has let people down. + + + + + Ideas of guilt or rumination over past errors or sinful deeds. + + + + + Present illness is a punishment. Delusions of guilt. + + + + + Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations. + + + + + + + + + + + + + + Absent. + + + + + Feels life is not worth living. + + + + + Wishes he/she were dead or any thoughts of possible death to self. + + + + + Ideas or gestures of suicide. + + + + + Attempts at suicide (any serious attempt rate 4). + + + + + + + + + + + + No difficulty falling asleep. + + + + + Complains of occasional difficulty falling asleep, i.e. more than 1/2 hour + + + + + Complains of nightly difficulty falling asleep. + + + + + + + + + + + + No difficulty. + + + + + Patient complains of being restless and disturbed during the night. + + + + + Waking during the night - any getting out of bed rates 2 (except for purposes of voiding). + + + + + + + + + + + + No difficulty. + + + + + Waking in early hours of the morning but goes back to sleep. + + + + + Unable to fall asleep again if he/she gets out of bed. + + + + + + + + + + + + + + No difficulty. + + + + + Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies. + + + + + Loss of interest in activity, hobbies or work - either directly reported by the patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities). + + + + + Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not spend at least three hours a day in activities (job or hobbies) excluding routine chores. + + + + + Stopped working because of present illness. Rate 4 if patient engages in no activities except routine chores, or if patient fails to perform routine chores unassisted. + + + + + + + + + + + + + + Normal speech and thought. + + + + + Slight retardation during the interview. + + + + + Obvious retardation during the interview. + + + + + Interview difficult. + + + + + Complete stupor. + + + + + + + + + + + + + + None. + + + + + Fidgetiness. + + + + + Playing with hands, hair, etc. + + + + + Moving about, cannot sit still. + + + + + Hand wringing, nail biting, hair-pulling, biting of lips. + + + + + + + + + + + + + + No difficulty. + + + + + Subjective tension and irritability. + + + + + Worrying about minor matters. + + + + + Apprehensive attitude apparent in face or speech. + + + + + Fears expressed without questioning. + + + + + + + + + + + + + + Absent. + + + + + Mild. + + + + + Moderate. + + + + + Severe. + + + + + Incapacitating. + + + + + + + + + + + + None. + + + + + Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen. + + + + + Difficulty eating without staff urging. Requests or requires laxatives or medication for bowels or medication for gastro-intestinal symptoms. + + + + + + + + + + + + None. + + + + + Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability. + + + + + Any clear-cut symptom rates 2. + + + + + + + + + + + + Absent. + + + + + Mild. + + + + + Severe. + + + + + + + + + + + + + + Not present. + + + + + Self-absorption (bodily). + + + + + Preoccupation with health. + + + + + Frequent complaints, requests for help, etc. + + + + + Hypochondriacal delusions. + + + + + + + + + + + + + No weight loss. + + + + + Probable weight loss associated with present illness. + + + + + Definite (according to patient) weight loss. + + + + + Not assessed. + + + + + + + + + + + + + Less than 1 lb weight loss in week. + + + + + Greater than 1 lb weight loss within week. + + + + + Greater than 2 lb weight loss in week. + + + + + Not assessed. + + + + + + + + + + + + Acknowledges being depressed and ill. + + + + + Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc. + + + + + Denies being ill at all. + + + + + + + HAMD1-Depressed Mood + + + + + + HAMD1-Feelings of Guilt + + + + + + HAMD1-Suicide + + + + + + HAMD1-Insomnia Early - Early Night + + + + + + HAMD1-Insomnia Middle - Middle Night + + + + + + HAMD1-Insomnia Early Hours - Morning + + + + + + HAMD1-Work and Activities + + + + + + HAMD1-Retardation + + + + + + HAMD1-Agitation + + + + + + HAMD1-Anxiety Psychic + + + + + + HAMD1-Anxiety Somatic + + + + + + HAMD1-Somatic Symptoms GI + + + + + + HAMD1-General Somatic Symptoms + + + + + + HAMD1-Genital Symptoms + + + + + + HAMD1-Hypochondriasis + + + + + + HAMD1-Loss of WT According to Patient + + + + + + HAMD1-Loss of WT According to WK Meas + + + + + + HAMD1-Insight + + + + + + HAMD1-Total Score + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Exclusion + + + + + + Inclusion + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Males and postmenopausal females at least 50 years of age. + + + + + Diagnosis of probable AD as defined by NINCDS and the ADRDA guidelines. + + + + + MMSE score of 10 to 23. + + + + + Modified Hachinski Ischemic Scale score of <= 4. + + + + + CNS imaging (CT scan or MRI of brain) compatible with AD within past 1 year. (See Protocol for incompatible findings.) + + + + + Investigator has obtained informed consent signed by the patient (and/or legal representative) and by the caregiver. + + + + + Geographic proximity to investigator's site that allows adequate follow-up. + + + + + Caregiver will monitor administration of prescribed medications, and will be responsible for the overall care of the patient at home. + + + + + Persons who have previously completed or withdrawn from this study or any other investigating xanomeline TTS or the oral formulation of Zanomaline. + + + + + Use of any investigational agent or approved Alzheimer's therapeutic medication within 30 days prior to enrollment into the study. + + + + + Serious illness which required hospitalization within 3 months of screening. + + + + + Diagnosis of serious neurological conditions + + + + + Episode of depression meeting DSM-IV criteria within 3 months of screening. + + + + + A history within the last 5 years of the following: a) Schizophrenia b) Bipolar Disease c) Ethanol or psychoactive drug abuse or dependence. + + + + + A history of syncope within the last 5 years. + + + + + 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) + + + + + A history within the last 5 years of a serious cardiovascular disorder, including a) Clinically significant arrhythmia (See Protocol for Remainder) + + + + + A history within the last 5 years of a serious gastrointestinal disorder, including +a) Chronic peptic/duodenal/gastric/esophageal ulcer that are untreated or refractory to treatment(See Protocol) + + + + + A history within the last 5 years of a serious endocrine disorder, including +a) Uncontrolled Insulin Dependent Diabetes Mellitus (IDDM) (See Protocol for other excluded disorders) + + + + + A history within the last 5 years of a serious respiratory disorder, including a) Asthma with bronchospasm refractory to treatment b) Decompensated chronic obstructive pulmonary disease. + + + + + A history within the last 5 years of a serious genitourinary disorder, including a) Renal failure b) Uncontrolled urinary retention + + + + + A history within the last 5 years of a serious rheumatologic disorder, including a) Lupus b) Temporal arteritis c) Severe rheumatoid arthritis + + + + + A known history of human immunodeficiency virus (HIV) within the last 5 years. + + + + + A history within the last 5 years of a serious infectious disease including a) Neurosyphilis b) Meningitis c) Encephalitis + + + + + A history within the last 5 years of a primary or recurrent malignant disease (See Exceptions in Protocol). + + + + + Visual, hearing, or communication disabilities impairing the ability to participate in the study; (for example, inability to speak or understand English, illiteracy). + + + + + Laboratory test values exceeding the Reference Range III for the patient's age in any of the following analytes: creatinine, total bilirubin, SGOT, SGPT, (See Protocol for Additional Analytes) + + + + + Central laboratory test values below reference range for folate, and vitamin B12, and outside reference range for thyroid function tests. + + + + + Positive syphilis screening with confirmatory testing. + + + + + Central laboratory test value above reference range for glycosylated hemoglobin (A1C) (insulin dependent diabetes mellitus patients only). + + + + + Treatment with medications within 1 month prior to enrollment a) Anticonvulsants b) Alpha receptor blockers c) Calcium channel blockers that are CNS active + + + + + Diagnosis of serious neurological conditions (Amend 1) + + + + + Treatment with medications within 1 month prior to enrollment a) Anticonvulsants b) Alpha receptor blockers c) Calcium channel blockers that are CNS active (Amend 1) + + + + + + + Parallel + + + + + + + + + Drug + + + + + + + + + Left + + + + + + Right + + + + + + + + + Chemistry + + + + + Hematology + + + + + Urinalysis + + + + + Other + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Albumin Measurement + + + + + + Alkaline Phosphatase Measurement + + + + + + Alanine Aminotransferase Measurement + + + + + + Anisocyte Measurement + + + + + + Aspartate Aminotransferase Measurement + + + + + + Total Basophil Count + + + + + + Total Bilirubin Measurement + + + + + + Calcium Measurement + + + + + + Cholesterol Measurement + + + + + + Creatine Kinase Measurement + + + + + + Chloride Measurement + + + + + + Color Assessment + + + + + + Creatinine Measurement + + + + + + Eosinophil Count + + + + + + Gamma Glutamyl Transpeptidase Measurement + + + + + + Glucose Measurement + + + + + + Hematocrit Measurement + + + + + + Hemoglobin Measurement + + + + + + Potassium Measurement + + + + + + Ketone Measurement + + + + + + Lymphocyte Count + + + + + + Macrocyte Count + + + + + + Erythrocyte Mean Corpuscular Hemoglobin + + + + + + Erythrocyte Mean Corpuscular Hemoglobin Concentration + + + + + + Erythrocyte Mean Corpuscular Volume + + + + + + Monocyte Count + + + + + + pH + + + + + + Phosphate Measurement + + + + + + Platelet Count + + + + + + Poikilocyte Measurement + + + + + + Total Protein Measurement + + + + + + Erythrocyte Count + + + + + + Sodium Measurement + + + + + + Specific Gravity + + + + + + Thyrotropin Measurement + + + + + + Urate Measurement + + + + + + Urea Nitrogen Measurement + + + + + + Urobilinogen Measurement + + + + + + Vitamin B12 Measurement + + + + + + Leukocyte Count + + + + + + + + + + + + + + + Conjunctiva + + + + + + Eye + + + + + + Anterior Chamber of the Eye + + + + + + Iris + + + + + + Cornea + + + + + + + + + Ear + + + + + + Oral Cavity + + + + + + + + + Symptom Onset + + + + + + + + + Alzheimer's Disease + + + + + + + Adverse Event + + + + + + Completed + + + + + + Death + + + + + + Lack of Efficacy + + + + + + Lost to Follow-Up + + + + + + Other + + + + + + Physician Decision + + + + + + Pregnancy + + + + + + Protocol Deviation + + + + + + Screen Failure + + + + + + Study Terminated By Sponsor + + + + + + Withdrawal By Parent/Guardian + + + + + + Withdrawal By Subject + + + + + + + + + Not Done + + + + + + + + + Abnormal + + + + + + Normal + + + + + + + + + Abnormal + + + + + + High + + + + + + Low + + + + + + Normal + + + + + + + + + + + + + Interpretation + + + + + + + + No + + + + + + Yes + + + + + + + + + Yes + + + + + + + + + Right Eye + + + + + + Left Eye + + + + + + + + + Slit-lamp Examination + + + + + + + + + + + + + + + + Abnormality Detail + + + + + Interpretation + + + + + + + + + Fatal + + + + + + Not Recovered/Not Resolved + + + + + + Recovered/Resolved + + + + + + Recovered/Resolved With Sequelae + + + + + + Recovering/Resolving + + + + + + Unknown + + + + + + + + + PHQ01-Little Interest/Pleasure in Things + + + + + + PHQ01-Feeling Down Depressed or Hopeless + + + + + + PHQ01-Trouble Falling or Staying Asleep + + + + + + PHQ01-Feeling Tired or Little Energy + + + + + + PHQ01-Poor Appetite or Overeating + + + + + + PHQ01-Feeling Bad About Yourself + + + + + + PHQ01-Trouble Concentrating on Things + + + + + + PHQ01-Moving Slowly or Fidgety/Restless + + + + + + PHQ01-Thoughts You Be Better Off Dead + + + + + + PHQ01-Difficult to Work/Take Care Things + + + + + + PHQ01-Total Score + + + + + + + + + + + + + + + + + + + + + Not at all + + + + + Several days + + + + + More than half the days + + + + + Nearly every day + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Standing + + + + + + Supine + + + + + + + + + Informed Consent + + + + + + + + + Patient Health Questionnaire - 9 Item + + + + + + + + + Satisfaction With Life Scale Questionnaire + + + + + + + + + American Indian Or Alaska Native + + + + + + Asian + + + + + + Black Or African American + + + + + + Native Hawaiian Or Other Pacific Islander + + + + + + White + + + + + + + + + Multiple + + + + + + + Adverse Events + + + + + + Disposition + + + + + + Death Details + + + + + + Findings About Events or Interventions + + + + + + + + + Many + + + + + + One + + + + + + + + + Oral + + + + + + Topical + + + + + + Intravenous + + + + + + Nasal + + + + + + Inhalation Route of Administration + + + + + + Transdermal + + + + + + + + + Subcutaneous Route of Administration + + + + + + + + + Hamilton Depression Rating Scale 17 Item Clinical Classification + + + + + + + + + Female + + + + + + Male + + + + + + + + + + + + + + + + + Interventional + + + + + + + + + SWLS01-Have Gotten Important Things + + + + + + SWLS01-I Am Satisfied with My Life + + + + + + SWLS01-Live Life Over Change Nothing + + + + + + SWLS01-My Life Conditions are Excellent + + + + + + SWLS01-My Life is Close to Ideal + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Strongly disagree + + + + + Disagree + + + + + Slightly disagree + + + + + Neither agree nor disagree + + + + + Slightly agree + + + + + Agree + + + + + Strongly agree + + + + + + + Double Blind + + + + + + + + + Placebo + + + + + + + + + Treatment + + + + + + + + + Phase II Trial + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Actual Subject Number + + + + + + Adaptive Study Design Indicator + + + + + + Test Product Added to Existing Treatment + + + + + + Planned Maximum Age of Subjects + + + + + + Planned Minimum Age of Subjects + + + + + + Data Cutoff Date Description + + + + + + Data Cutoff Date + + + + + + Dose + + + + + + Pharmaceutical Dosage Form + + + + + + Dose Frequency + + + + + + Dosage Form Unit + + + + + + Planned Country of Investigational Site + + + + + + Healthy Subject Indicator + + + + + + Trial Indication + + + + + + Intervention Model + + + + + + Intervention Type + + + + + + Trial Length + + + + + + Planned Number of Arms + + + + + + Trial Primary Objective + + + + + + Trial Secondary Objective + + + + + + Primary Outcome Measure + + + + + + Secondary Outcome Measure + + + + + + Pharmacological Class of Investigational Therapy + + + + + + Planned Subject Number + + + + + + Randomization + + + + + + Randomization Quotient + + + + + + Clinical Trial Registry Identifier + + + + + + Route of Administration + + + + + + Study Data Tabulation Model Implementation Guide Version + + + + + + Study Data Tabulation Model Version + + + + + + Clinical Study End Date + + + + + + Sex of Study Group + + + + + + Clinical Study Sponsor + + + + + + Study Start Date + + + + + + Study Stop Rule + + + + + + Study Type + + + + + + Trial Blinding Schema + + + + + + Control Type + + + + + + Diagnosis Group + + + + + + Clinical Study by Intent + + + + + + Trial Title + + + + + + Trial Phase + + + + + + Protocol Agent + + + + + + Trial Type + + + + + + + + + Efficacy + + + + + + Pharmacokinetic + + + + + + Safety + + + + + + + + + Milligram + + + + + + Nanogram + + + + + + Tablet + + + + + + + + + Milliliter + + + + + + + + + Gram per Liter + + + + + + + + + Milligram + + + + + + + + + Million per Microliter + + + + + + + + + Billion per Liter + + + + + + + + + Percentage + + + + + + + + + Unit per Liter + + + + + + + + + Femtoliter + + + + + + + + + Femtomole + + + + + + + + + Femtomole + + + + + + + + + Gram per Deciliter + + + + + + + + + Milliequivalent Per Liter + + + + + + + + + Microinternational Unit per Milliliter + + + + + + + + + Microunit per Milliliter + + + + + + + + + Milligram per Deciliter + + + + + + + + + Millimole per Liter + + + + + + + + + Nanogram per Liter + + + + + + + + + Picogram + + + + + + + + + Picomole per Liter + + + + + + + + + Micromole per Liter + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Diastolic Blood Pressure + + + + + + Pulse Rate + + + + + + Height + + + + + + Systolic Blood Pressure + + + + + + Temperature + + + + + + Weight + + + + + + + + + Millimeter of Mercury + + + + + + + + + Millimeter of Mercury + + + + + + + + + Inch + + + + + + + + + Centimeter + + + + + + + + + Beats per Minute + + + + + + + + + Beats per Minute + + + + + + + + + Degree Fahrenheit + + + + + + + + + Degree Celsius + + + + + + + + + Pound + + + + + + + + + Kilogram + + + + + + + + + + + + + + + + + + + + + + + + + + If AEENRTPT is populated, AEENTPT is DM.RFPENDTC for the subject. + + + + + If CMENRTPT is populated, CMENTPT is DM.RFPENDTC for the subject. + + + + + Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC. + + + + + Starts at "1" for first device identifier and increments by one for each DIPARM + + + + + If DTHDTC is populated then DTHFL='Y' + + + + + EPOCH from SE where date >= SESTDTC and date < SEENDTC + + + + + EXDOSE = ECDOSE * ECPSTRG expressed in mg. + + + + + If FTSTRESC is numeric then FTSTRESN=FTSTRESC in numeric format, else null. + + + + + If IECAT=INCLUSION then IEORRES=N, else if IECAT=EXCLUSION then IEORRES=Y + + + + + LBSTRESC is equal to LBORRES or the value in standard units if a conversion is necessary. + + + + + Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise. + + + + + If QSORRES="Not at all" then 0 +If QSORRES="Several days" then 1 +If QSORRES="More than half the days" then 2 +If QSORRES="Nearly every day" then 3 + + + + + QSSTRESC=QSORRES + + + + + If QSORRES="Strongly disagree" then 1 +If QSORRES="Disagree" then 2 +If QSORRES="Slightly disagree" then 3 +If QSORRES="Neither agree nor disagree" then 4 +If QSORRES="Slightly agree" then 5 +If QSORRES="Agree" then 6 +If QSORRES="Strongly agree" then 7 + + + + + If QSSTRESC is numeric then QSSTRESN=QSSTRESC in numeric format, else null. + + + + + The Date of Study Completion or Early Termination. Null for screen failures. + + + + + The latest date of assessment for the subject as determined by the End of Study Form, any scheduled assessments, Adverse Events, or Concomitant Medications. + + + + + The first date/time of study drug. Null for screen failures. + + + + + The last date/time of study drug administration. Null for subjects with no treatment data. + + + + + The first date/time of study drug administration. Null for subjects with no treatment data. + + + + + RSSTRESC is the corresponding numeric value of RSORRES according the values shown on the HAMD-17 CRF page. + + + + + SEENDTC is set to the start of the next Element, or RFPENDTC for the last Element. + + + + + Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data. + + + + + SESTDTC if set to the --DTC for that subject which exists in the data for the defined start of the Element, such as DSSTDTC when DSDECOD=INFORMED CONSENT OBTAINED for Screening Elements or min(EXSTDTC) for Dosing Elements. + + + + + If --STRESC represents a numeric value then --STRESN is the numeric version of --STRESC, else null. "--" represents the domain code. + + + + + For each scheduled visit, SVENDTC = the last (max) date associated with a subject for that visit. For unplanned visits, SVENDTC is the date of the visit. + + + + + For each scheduled visit, SVSTDTC = the first (min) date associated with a subject for that visit. For unplanned visits, SVSTDTC is the date of the visit. + + + + + Unique sequence number within each TSPARM, restarting at 1 for per TSPARM, applied to sorted data. + + + + + Data collected in conventional units (i.e. F, lbs, inches) is converted using standard conversion factors to standard units (C, kg, cm). + + + + + + + + + + + Even though the variable is 'Assigned' an annotation has been added to page 23 to clarify the assignment. + + + + + Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required. + + + + + Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required. Note CDISC Conformance Rule CG0014 would fire for this variable due to the decision not to populate coding variables. + + + + + Subject CDISC003 had an AE of Epistaxis on 2013-09-30 with AESER set to 'Y' without any of the individual serious qualifiers set to 'Y' also. The site was queried several times but the data were not updated. Note Conformance Rule CG0041 would fire for this subject. + + + + + If the CM is not taken for a 'Primary Study Condition' then CMINDC would be 'Prophylaxis or Non-therapeutic use' + + + + + Since no collected data was subjective then QEVAL was not populated. It is an 'Expected' variable and so is included. + + + + + Since no subjects had more than 3 Races, RACE4 was not used. + + + + + Since no subjects had more than 3 Races, RACE5 was not used. + + + + + Variable is Assigned but there are annotations to help understand the data and so references to the proper pages are included + + + + + DataType is 'partialDatetime' instead of 'datetime' since datetime values are planned to be collected without seconds for this study. + + + + + All values are null as the findings are not visit based. The variable is Expected and so is included. + + + + + The FA domain contains Findings About Injection Site Reaction Adverse Events + + + + + IEDY is needed if IEDTC is included. Note RFSTDTC is not populated for not randomized subjects then IEDY could not be populated in those cases. + + + + + Please see Appendix 1 of the cSDRG for complete versions of IETESTCD and IETEST. + + + + + Standard's Conformance Notes: +1) The SDTM v1.7/SDTMIG v3.3 datasets were evaluated manually and programmatically by the CDISC SDS MSG Team. At the completion of the SDTM-MSG v2.0, the CDISC SDTM v1.7/SDTMIG v3.3 conformance rules were recently published, but not available by any validation tools to validate. +2) The Define-XML document was evaluated manually and programmatically by the CDISC SDS MSG Team. At the completion of the SDTM-MSG v2.0, the CDISC +Define-XML v2.1 conformance rules were not published, nor available by any validation tools to validate. Please ensure that any official regulatory submission of an Define-XML v2.1 document and accompanying data is done in accordance to the respective regulatory health authorities requirements/guidance. + + + + + Per protocol, electroencephalograms are only performed after such an event were to occur. No subjects within the trial had an occurrence of an electroencephalogram event. Therefore, no data exists for the NV dataset and as such was not submitted. + + + + + Per protocol, electroencephalograms are only performed after such an event were to occur. No subjects within the trial had an occurrence of an electroencephalogram event. Therefore, no data exists for the NV dataset and as such SUPPNV was not submitted. + + + + + No subjects within the trial had an ophthalmic examination of clinical significance to report. Therefore, no data exists for the SUPPOE dataset and as such was not submitted. + + + + + QSPH contains the PATIENT HEALTH QUESTIONNAIRE-9 (PHQ-9) questionnaire data. + + + + + QSSL contains the SATISFACTION WITH LIFE SURVEY (SWLS) questionnaire data. + + + + + Study Data Tabulation Model Implementation Guide: Human Clinical Trials Version 3.3 + + + + + Study Data Tabulation Model Implementation Guide for Medical Devices Version 1.0 + + + + + This was the latest release of CDISC CT available when this sample submission was completed. + + + + + This was the CDISC CT Package associated to the CDISC Define-XML Specification Version 2.1 when this sample submission was completed. + + + + + All vital signs were performed as expected, so VSSTAT was never populated. The variable is included as it was possible to populate it in this study. + + + + + + + + + + Annotated CRF + + + + Reviewers Guide + + + + + + + + + + diff --git a/tests/resources/CoreIssue1345/subset/dm.json b/tests/resources/CoreIssue1345/subset/dm.json new file mode 100644 index 000000000..4841d1682 --- /dev/null +++ b/tests/resources/CoreIssue1345/subset/dm.json @@ -0,0 +1,701 @@ +{ + "datasetJSONCreationDateTime": "2024-11-11T15:09:15", + "datasetJSONVersion": "1.1.0", + "fileOID": "www.cdisc.org/StudyMSGv2/1/Define-XML_2.1.0/2024-11-11/dm", + "dbLastModifiedDateTime": "2020-08-21T09:14:29", + "originator": "CDISC SDTM MSG Team", + "sourceSystem": { + "name": "SAS on X64_10PRO", + "version": "9.0401M7" + }, + "studyOID": "cdisc.com/CDISCPILOT01", + "metaDataVersionOID": "MDV.MSGv2.0.SDTMIG.3.3.SDTM.1.7", + "metaDataRef": "define.xml", + "itemGroupOID": "IG.DM", + "records": 18, + "name": "DM", + "label": "Demographics", + "columns": [ + { + "itemOID": "IT.DM.STUDYID", + "name": "STUDYID", + "label": "Study Identifier", + "dataType": "string", + "length": 12, + "keySequence": 1 + }, + { + "itemOID": "IT.DM.DOMAIN", + "name": "DOMAIN", + "label": "Domain Abbreviation", + "dataType": "string", + "length": 2 + }, + { + "itemOID": "IT.DM.USUBJID", + "name": "USUBJID", + "label": "Unique Subject Identifier", + "dataType": "string", + "length": 8, + "keySequence": 2 + }, + { + "itemOID": "IT.DM.SUBJID", + "name": "SUBJID", + "label": "Subject Identifier for the Study", + "dataType": "string", + "length": 4 + }, + { + "itemOID": "IT.DM.RFSTDTC", + "name": "RFSTDTC", + "label": "Subject Reference Start Date/Time", + "dataType": "date" + }, + { + "itemOID": "IT.DM.RFENDTC", + "name": "RFENDTC", + "label": "Subject Reference End Date/Time", + "dataType": "date" + }, + { + "itemOID": "IT.DM.RFXSTDTC", + "name": "RFXSTDTC", + "label": "Date/Time of First Study Treatment", + "dataType": "date" + }, + { + "itemOID": "IT.DM.RFXENDTC", + "name": "RFXENDTC", + "label": "Date/Time of Last Study Treatment", + "dataType": "date" + }, + { + "itemOID": "IT.DM.RFICDTC", + "name": "RFICDTC", + "label": "Date/Time of Informed Consent", + "dataType": "date" + }, + { + "itemOID": "IT.DM.RFPENDTC", + "name": "RFPENDTC", + "label": "Date/Time of End of Participation", + "dataType": "date" + }, + { + "itemOID": "IT.DM.DTHDTC", + "name": "DTHDTC", + "label": "Date/Time of Death", + "dataType": "date" + }, + { + "itemOID": "IT.DM.DTHFL", + "name": "DTHFL", + "label": "Subject Death Flag", + "dataType": "string", + "length": 1 + }, + { + "itemOID": "IT.DM.SITEID", + "name": "SITEID", + "label": "Study Site Identifier", + "dataType": "string", + "length": 3 + }, + { + "itemOID": "IT.DM.BRTHDTC", + "name": "BRTHDTC", + "label": "Date/Time of Birth", + "dataType": "date" + }, + { + "itemOID": "IT.DM.AGE", + "name": "AGE", + "label": "Age", + "dataType": "integer" + }, + { + "itemOID": "IT.DM.AGEU", + "name": "AGEU", + "label": "Age Units", + "dataType": "string", + "length": 5 + }, + { + "itemOID": "IT.DM.SEX", + "name": "SEX", + "label": "Sex", + "dataType": "string", + "length": 1 + }, + { + "itemOID": "IT.DM.RACE", + "name": "RACE", + "label": "Race", + "dataType": "string", + "length": 41 + }, + { + "itemOID": "IT.DM.ETHNIC", + "name": "ETHNIC", + "label": "Ethnicity", + "dataType": "string", + "length": 22 + }, + { + "itemOID": "IT.DM.ARMCD", + "name": "ARMCD", + "label": "Planned Arm Code", + "dataType": "string", + "length": 8 + }, + { + "itemOID": "IT.DM.ARM", + "name": "ARM", + "label": "Description of Planned Arm", + "dataType": "string", + "length": 28 + }, + { + "itemOID": "IT.DM.ACTARMCD", + "name": "ACTARMCD", + "label": "Actual Arm Code", + "dataType": "string", + "length": 8 + }, + { + "itemOID": "IT.DM.ACTARM", + "name": "ACTARM", + "label": "Description of Actual Arm", + "dataType": "string", + "length": 28 + }, + { + "itemOID": "IT.DM.ARMNRS", + "name": "ARMNRS", + "label": "Reason Arm and/or Actual Arm is Null", + "dataType": "string", + "length": 14 + }, + { + "itemOID": "IT.DM.ACTARMUD", + "name": "ACTARMUD", + "label": "Description of Unplanned Actual Arm", + "dataType": "string", + "length": 200 + }, + { + "itemOID": "IT.DM.COUNTRY", + "name": "COUNTRY", + "label": "Country", + "dataType": "string", + "length": 3 + } + ], + "rows": [ + [ + "CDISCPILOT01", + "DM", + "CDISC001", + "1115", + "2012-11-30", + "2013-01-23", + "2012-11-30", + "2013-01-23", + "2012-11-23", + "2013-05-20", + "", + "", + "701", + "1928", + 84, + "YEARS", + "M", + "WHITE", + "NOT HISPANIC OR LATINO", + "ZAN_LOW", + "Zanomaline Low Dose (54 mg)", + "ZAN_LOW", + "Zanomaline Low Dose (54 mg)", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC002", + "1211", + "2012-11-15", + "2013-01-14", + "2012-11-15", + "2013-01-12", + "2012-10-30", + "2013-01-14", + "2013-01-14", + "Y", + "701", + "1936", + 76, + "YEARS", + "F", + "WHITE", + "NOT HISPANIC OR LATINO", + "ZAN_LOW", + "Zanomaline Low Dose (54 mg)", + "ZAN_LOW", + "Zanomaline Low Dose (54 mg)", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC003", + "1302", + "2013-08-29", + "2013-11-05", + "2013-08-29", + "2013-11-05", + "2013-08-20", + "2014-02-13", + "", + "", + "701", + "1951", + 61, + "YEARS", + "M", + "WHITE", + "NOT HISPANIC OR LATINO", + "ZAN_HIGH", + "Zanomaline High Dose (81 mg)", + "ZAN_HIGH", + "Zanomaline High Dose (81 mg)", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC004", + "1345", + "2013-10-08", + "2014-03-18", + "2013-10-08", + "2014-03-18", + "2013-10-01", + "2014-03-18", + "", + "", + "701", + "1950", + 63, + "YEARS", + "F", + "WHITE", + "NOT HISPANIC OR LATINO", + "PLACEBO", + "Placebo", + "PLACEBO", + "Placebo", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC005", + "1383", + "2013-02-04", + "2013-08-06", + "2013-02-04", + "2013-08-06", + "2013-01-22", + "2013-08-06", + "", + "", + "701", + "1941", + 72, + "YEARS", + "F", + "WHITE", + "NOT HISPANIC OR LATINO", + "ZAN_HIGH", + "Zanomaline High Dose (81 mg)", + "ZAN_HIGH", + "Zanomaline High Dose (81 mg)", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC006", + "1429", + "2013-03-19", + "2013-04-30", + "2013-03-19", + "2013-04-30", + "2013-02-25", + "2013-04-30", + "", + "", + "701", + "1929", + 84, + "YEARS", + "F", + "WHITE", + "NOT HISPANIC OR LATINO", + "ZAN_LOW", + "Zanomaline Low Dose (54 mg)", + "ZAN_LOW", + "Zanomaline Low Dose (54 mg)", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC007", + "1444", + "2013-01-05", + "2013-02-13", + "2013-01-05", + "2013-02-12", + "2012-12-31", + "2013-06-20", + "", + "", + "701", + "1949", + 63, + "YEARS", + "M", + "WHITE", + "HISPANIC OR LATINO", + "ZAN_HIGH", + "Zanomaline High Dose (81 mg)", + "ZAN_HIGH", + "Zanomaline High Dose (81 mg)", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC008", + "1445", + "2014-05-11", + "2014-11-01", + "2014-05-11", + "2014-11-01", + "2014-05-01", + "2014-11-01", + "2014-11-01", + "Y", + "704", + "1939", + 75, + "YEARS", + "M", + "MULTIPLE", + "NOT HISPANIC OR LATINO", + "PLACEBO", + "Placebo", + "PLACEBO", + "Placebo", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC009", + "1087", + "2012-10-22", + "2013-04-28", + "2012-10-22", + "2013-04-28", + "2012-10-06", + "2013-04-28", + "", + "", + "708", + "1938", + 74, + "YEARS", + "F", + "WHITE", + "NOT HISPANIC OR LATINO", + "PLACEBO", + "Placebo", + "PLACEBO", + "Placebo", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC010", + "1236", + "2013-09-21", + "2013-09-26", + "2013-09-21", + "2013-09-21", + "2013-09-08", + "2013-09-26", + "", + "", + "708", + "1927", + 86, + "YEARS", + "F", + "WHITE", + "NOT HISPANIC OR LATINO", + "ZAN_HIGH", + "Zanomaline High Dose (81 mg)", + "ZAN_HIGH", + "Zanomaline High Dose (81 mg)", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC011", + "1336", + "2012-12-07", + "2013-06-05", + "2012-12-07", + "2013-06-05", + "2012-11-21", + "2013-07-05", + "", + "", + "708", + "1939", + 73, + "YEARS", + "M", + "WHITE", + "NOT HISPANIC OR LATINO", + "ZAN_HIGH", + "Zanomaline High Dose (81 mg)", + "ZAN_HIGH", + "Zanomaline High Dose (81 mg)", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC012", + "1378", + "2013-09-03", + "2014-01-28", + "2013-09-03", + "2014-01-28", + "2013-08-24", + "2014-01-28", + "", + "", + "708", + "1946", + 67, + "YEARS", + "M", + "BLACK OR AFRICAN AMERICAN", + "NOT HISPANIC OR LATINO", + "PLACEBO", + "Placebo", + "PLACEBO", + "Placebo", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC013", + "1083", + "2013-07-22", + "2013-08-03", + "2013-07-22", + "2013-08-01", + "2013-07-09", + "2013-08-03", + "2013-08-03", + "Y", + "710", + "1924", + 89, + "YEARS", + "F", + "WHITE", + "NOT HISPANIC OR LATINO", + "PLACEBO", + "Placebo", + "PLACEBO", + "Placebo", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC014", + "1012", + "2013-04-03", + "2013-05-02", + "2013-04-03", + "2013-04-29", + "2013-03-20", + "2013-09-18", + "", + "", + "711", + "1945", + 67, + "YEARS", + "F", + "WHITE", + "NOT HISPANIC OR LATINO", + "ZAN_HIGH", + "Zanomaline High Dose (81 mg)", + "ZAN_HIGH", + "Zanomaline High Dose (81 mg)", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC015", + "1022", + "", + "", + "", + "", + "2014-03-17", + "2014-03-17", + "", + "", + "711", + "1928", + 86, + "YEARS", + "F", + "WHITE", + "NOT HISPANIC OR LATINO", + "", + "", + "", + "", + "SCREEN FAILURE", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC016", + "1143", + "2013-04-03", + "2013-06-01", + "2013-04-03", + "2013-05-30", + "2013-03-30", + "2013-09-22", + "", + "", + "711", + "1936", + 76, + "YEARS", + "F", + "WHITE", + "NOT HISPANIC OR LATINO", + "ZAN_LOW", + "Zanomaline Low Dose (54 mg)", + "ZAN_LOW", + "Zanomaline Low Dose (54 mg)", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC017", + "1250", + "2013-09-21", + "2014-02-08", + "2013-09-21", + "2014-01-31", + "2013-08-21", + "2014-03-08", + "", + "", + "718", + "1931", + 82, + "YEARS", + "F", + "WHITE", + "HISPANIC OR LATINO", + "ZAN_LOW", + "Zanomaline Low Dose (54 mg)", + "ZAN_LOW", + "Zanomaline Low Dose (54 mg)", + "", + "", + "USA" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC018", + "1427", + "2012-12-17", + "2013-02-18", + "2012-12-17", + "2013-02-11", + "2012-12-13", + "2013-06-03", + "", + "", + "718", + "1938", + 74, + "YEARS", + "F", + "BLACK OR AFRICAN AMERICAN", + "NOT HISPANIC OR LATINO", + "ZAN_HIGH", + "Zanomaline High Dose (81 mg)", + "ZAN_HIGH", + "Zanomaline High Dose (81 mg)", + "", + "", + "USA" + ] + ] +} diff --git a/tests/resources/CoreIssue1345/subset/draft_rules/CG0019.yml b/tests/resources/CoreIssue1345/subset/draft_rules/CG0019.yml new file mode 100644 index 000000000..44997aa83 --- /dev/null +++ b/tests/resources/CoreIssue1345/subset/draft_rules/CG0019.yml @@ -0,0 +1,104 @@ +# Variable: GEN +# Condition: +# Rule: Each record is unique per sponsor defined key variables as documented in the define.xml +# Marcelina Hungria: testing with the CLI and a define.xml that includes a key from a supp dataset (ec/suppec), +# plus dm/suppdm and relrec +Authorities: + - Organization: CDISC + Standards: + - 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. + 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. + 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" + - 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 + 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" + - 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 + 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" +Check: + all: + - name: define_dataset_key_sequence + operator: is_not_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 +Executability: Fully Executable +Match Datasets: + - Is Relationship: true + Keys: + - USUBJID + Name: SUPP-- +Outcome: + Message: Records are not unique as per sponsor defined key variables as + documented in the define.xml + # define_dataset_key_sequence doesn't appear to grab all variables needed. See define xml plus data included + Output Variables: + - define_dataset_key_sequence +Rule Type: Dataset Contents Check against Define XML +Scope: + Classes: + Include: + - ALL + Domains: + Include: + - ALL +Sensitivity: Record diff --git a/tests/resources/CoreIssue1345/subset/ec.json b/tests/resources/CoreIssue1345/subset/ec.json new file mode 100644 index 000000000..a1a5c833b --- /dev/null +++ b/tests/resources/CoreIssue1345/subset/ec.json @@ -0,0 +1,36756 @@ +{ + "datasetJSONCreationDateTime": "2024-11-11T15:09:15", + "datasetJSONVersion": "1.1.0", + "fileOID": "www.cdisc.org/StudyMSGv2/1/Define-XML_2.1.0/2024-11-11/ec", + "dbLastModifiedDateTime": "2020-08-21T09:14:26", + "originator": "CDISC SDTM MSG Team", + "sourceSystem": { "name": "SAS on X64_10PRO", "version": "9.0401M7" }, + "studyOID": "cdisc.com/CDISCPILOT01", + "metaDataVersionOID": "MDV.MSGv2.0.SDTMIG.3.3.SDTM.1.7", + "metaDataRef": "define.xml", + "itemGroupOID": "IG.EC", + "records": 1590, + "name": "EC", + "label": "Exposure as Collected", + "columns": [ + { + "itemOID": "IT.EC.STUDYID", + "name": "STUDYID", + "label": "Study Identifier", + "dataType": "string", + "length": 12, + "keySequence": 1 + }, + { + "itemOID": "IT.EC.DOMAIN", + "name": "DOMAIN", + "label": "Domain Abbreviation", + "dataType": "string", + "length": 2 + }, + { + "itemOID": "IT.EC.USUBJID", + "name": "USUBJID", + "label": "Unique Subject Identifier", + "dataType": "string", + "length": 8, + "keySequence": 2 + }, + { + "itemOID": "IT.EC.SPDEVID", + "name": "SPDEVID", + "label": "Sponsor Device Identifier", + "dataType": "string", + "length": 200 + }, + { + "itemOID": "IT.EC.ECSEQ", + "name": "ECSEQ", + "label": "Sequence Number", + "dataType": "integer" + }, + { + "itemOID": "IT.EC.ECTRT", + "name": "ECTRT", + "label": "Name of Treatment", + "dataType": "string", + "length": 10, + "keySequence": 3 + }, + { + "itemOID": "IT.EC.ECPRESP", + "name": "ECPRESP", + "label": "Pre-Specified", + "dataType": "string", + "length": 1 + }, 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"www.cdisc.org/StudyMSGv2/1/Define-XML_2.1.0/2024-11-11/suppdm", + "dbLastModifiedDateTime": "2020-08-21T09:14:27", + "originator": "CDISC SDTM MSG Team", + "sourceSystem": { + "name": "SAS on X64_10PRO", + "version": "9.0401M7" + }, + "studyOID": "cdisc.com/CDISCPILOT01", + "metaDataVersionOID": "MDV.MSGv2.0.SDTMIG.3.3.SDTM.1.7", + "metaDataRef": "define.xml", + "itemGroupOID": "IG.SUPPDM", + "records": 3, + "name": "SUPPDM", + "label": "Supplemental Qualifiers for DM", + "columns": [ + { + "itemOID": "IT.SUPPDM.STUDYID", + "name": "STUDYID", + "label": "Study Identifier", + "dataType": "string", + "length": 12, + "keySequence": 1 + }, + { + "itemOID": "IT.SUPPDM.RDOMAIN", + "name": "RDOMAIN", + "label": "Related Domain Abbreviation", + "dataType": "string", + "length": 6, + "keySequence": 2 + }, + { + "itemOID": "IT.SUPPDM.USUBJID", + "name": "USUBJID", + "label": "Unique Subject Identifier", + "dataType": "string", + "length": 8, + "keySequence": 3 + }, + { + "itemOID": "IT.SUPPDM.IDVAR", + "name": "IDVAR", + "label": "Identifying Variable", + "dataType": "string", + "length": 200, + "keySequence": 4 + }, + { + "itemOID": "IT.SUPPDM.IDVARVAL", + "name": "IDVARVAL", + "label": "Identifying Variable Value", + "dataType": "string", + "length": 200, + "keySequence": 5 + }, + { + "itemOID": "IT.SUPPDM.QNAM", + "name": "QNAM", + "label": "Qualifier Variable Name", + "dataType": "string", + "length": 5, + "keySequence": 6 + }, + { + "itemOID": "IT.SUPPDM.QLABEL", + "name": "QLABEL", + "label": "Qualifier Variable Label", + "dataType": "string", + "length": 40 + }, + { + "itemOID": "IT.SUPPDM.QVAL", + "name": "QVAL", + "label": "Data Value", + "dataType": "string", + "length": 41 + }, + { + "itemOID": "IT.SUPPDM.QORIG", + "name": "QORIG", + "label": "Origin", + "dataType": "string", + "length": 13 + }, + { + "itemOID": "IT.SUPPDM.QEVAL", + "name": "QEVAL", + "label": "Evaluator", + "dataType": "string", + "length": 200 + } + ], + "rows": [ + [ + "CDISCPILOT01", + "DM", + "CDISC008", + "", + "", + "RACE1", + "Race 1", + "ASIAN", + "CRF", + "" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC008", + "", + "", + "RACE2", + "Race 2", + "BLACK OR AFRICAN AMERICAN", + "CRF", + "" + ], + [ + "CDISCPILOT01", + "DM", + "CDISC008", + "", + "", + "RACE3", + "Race 3", + "WHITE", + "CRF", + "" + ] + ] +} diff --git a/tests/resources/CoreIssue1345/subset/suppec.json b/tests/resources/CoreIssue1345/subset/suppec.json new file mode 100644 index 000000000..1c29fb473 --- /dev/null +++ b/tests/resources/CoreIssue1345/subset/suppec.json @@ -0,0 +1,182 @@ +{ + "datasetJSONCreationDateTime": "2025-04-04T15:09:18", + "datasetJSONVersion": "1.1.0", + "fileOID": "www.cdisc.org/StudyMSGv2/1/Define-XML_2.1.0/2024-11-11/suppec", + "dbLastModifiedDateTime": "2020-08-21T09:14:22", + "originator": "CDISC SDTM MSG Team", + "sourceSystem": { + "name": "SAS on X64_10PRO", + "version": "9.0401M7" + }, + "studyOID": "cdisc.com/CDISCPILOT01", + "metaDataVersionOID": "MDV.MSGv2.0.SDTMIG.3.3.SDTM.1.7", + "metaDataRef": "define_msg20_testsupp_core.xml", + "itemGroupOID": "IG.SUPPEC", + "records": 7, + "name": "SUPPEC", + "label": "Supplemental Qualifiers for EC", + "columns": [ + { + "itemOID": "IT.SUPPEC.STUDYID", + "name": "STUDYID", + "label": "Study Identifier", + "dataType": "string", + "length": 12, + "keySequence": 1 + }, + { + "itemOID": "IT.SUPPEC.RDOMAIN", + "name": "RDOMAIN", + "label": "Related Domain Abbreviation", + "dataType": "string", + "length": 6, + "keySequence": 2 + }, + { + "itemOID": "IT.SUPPEC.USUBJID", + "name": "USUBJID", + "label": "Unique Subject Identifier", + "dataType": "string", + "length": 8, + "keySequence": 3 + }, + { + "itemOID": "IT.SUPPEC.IDVAR", + "name": "IDVAR", + "label": "Identifying Variable", + "dataType": "string", + "length": 200, + "keySequence": 4 + }, + { + "itemOID": "IT.SUPPEC.IDVARVAL", + "name": "IDVARVAL", + "label": "Identifying Variable Value", + "dataType": "string", + "length": 200, + "keySequence": 5 + }, + { + "itemOID": "IT.SUPPEC.QNAM", + "name": "QNAM", + "label": "Qualifier Variable Name", + "dataType": "string", + "length": 8, + "keySequence": 6 + }, + { + "itemOID": "IT.SUPPEC.QLABEL", + "name": "QLABEL", + "label": "Qualifier Variable Label", + "dataType": "string", + "length": 40 + }, + { + "itemOID": "IT.SUPPEC.QVAL", + "name": "QVAL", + "label": "Data Value", + "dataType": "string", + "length": 200 + }, + { + "itemOID": "IT.SUPPEC.QORIG", + "name": "QORIG", + "label": "Origin", + "dataType": "string", + "length": 13 + }, + { + "itemOID": "IT.SUPPEC.QEVAL", + "name": "QEVAL", + "label": "Evaluator", + "dataType": "string", + "length": 200 + } + ], + "rows": [ + [ + "CDISCPILOT01", + "EC", + "CDISC009", + "ECSEQ", + "122", + "ECREASOC", + "Reason for Occur Value", + "INVESTIGATOR DECISION", + "COLLECTED", + "INVESTIGATOR" + ], + [ + "CDISCPILOT01", + "EC", + "CDISC009", + "ECSEQ", + "123", + "ECREASOC", + "Reason for Occur Value", + "INVESTIGATOR DECISION", + "COLLECTED", + "INVESTIGATOR" + ], + [ + "CDISCPILOT01", + "EC", + "CDISC009", + "ECSEQ", + "124", + "ECREASOC", + "Reason for Occur Value", + "INVESTIGATOR DECISION2", + "COLLECTED", + "INVESTIGATOR" + ], + [ + "CDISCPILOT01", + "EC", + "CDISC009", + "ECSEQ", + "125", + "ECREASOC", + "Reason for Occur Value", + "INVESTIGATOR DECISION", + "COLLECTED", + "INVESTIGATOR" + ], + [ + "CDISCPILOT01", + "EC", + "CDISC009", + "ECSEQ", + "126", + "ECREASOC", + "Reason for Occur Value", + "INVESTIGATOR DECISION", + "COLLECTED", + "INVESTIGATOR" + ], + [ + "CDISCPILOT01", + "EC", + "CDISC909", + "ECSEQ", + "127", + "ECREASOC", + "Reason for Occur Value", + "INVESTIGATOR DECISION", + "COLLECTED", + "INVESTIGATOR" + ], + [ + "CDISCPILOT02", + "EC", + "CDISC909", + "ECSEQ", + "127", + "ECREASOC", + "Reason for Occur Value", + "INVESTIGATOR DECISION2", + "COLLECTED", + "INVESTIGATOR" + ] + ] +} From 56fdf2e0fd18f06a6f9eb69f5e5e0ee8a55ee6a4 Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Fri, 16 Jan 2026 10:18:08 +0100 Subject: [PATCH 04/10] 1345: added RDOMAIN column presence check. --- cdisc_rules_engine/utilities/data_processor.py | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/cdisc_rules_engine/utilities/data_processor.py b/cdisc_rules_engine/utilities/data_processor.py index 9d2b914f1..04d6dbe46 100644 --- a/cdisc_rules_engine/utilities/data_processor.py +++ b/cdisc_rules_engine/utilities/data_processor.py @@ -351,7 +351,7 @@ def process_supp(supp_dataset): columns_to_drop = [ col for col in ["QNAM", "QVAL", "QLABEL"] if col in supp_dataset.columns ] - if supp_dataset["RDOMAIN"][0] == "DM": + if "RDOMAIN" in supp_dataset.columns and supp_dataset["RDOMAIN"][0] == "DM": excluded_columns = list(supp_dataset["QNAM"].unique()) + columns_to_drop group_cols = [c for c in supp_dataset.columns if c not in excluded_columns] supp_dataset = PandasDataset( From 5501ac27aef92f2455676fe39cdab6d237dbf74e Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Fri, 16 Jan 2026 13:44:55 +0100 Subject: [PATCH 05/10] 1345: added check for EC dataset errors presence. --- .../test_Issues/test_CoreIssue1345.py | 39 +++++++++++++++++-- .../{subset/draft_rules => }/CG0019.yml | 0 .../define_msg20_testsupp_core.xml | 0 .../CoreIssue1345/{subset => }/dm.json | 0 .../CoreIssue1345/{subset => }/ec.json | 0 .../CoreIssue1345/{subset => }/suppdm.json | 0 .../CoreIssue1345/{subset => }/suppec.json | 0 7 files changed, 35 insertions(+), 4 deletions(-) rename tests/resources/CoreIssue1345/{subset/draft_rules => }/CG0019.yml (100%) rename tests/resources/CoreIssue1345/{subset => }/define_msg20_testsupp_core.xml (100%) rename tests/resources/CoreIssue1345/{subset => }/dm.json (100%) rename tests/resources/CoreIssue1345/{subset => }/ec.json (100%) rename tests/resources/CoreIssue1345/{subset => }/suppdm.json (100%) rename tests/resources/CoreIssue1345/{subset => }/suppec.json (100%) diff --git a/tests/QARegressionTests/test_Issues/test_CoreIssue1345.py b/tests/QARegressionTests/test_Issues/test_CoreIssue1345.py index 46e8429f4..0d74b0c57 100644 --- a/tests/QARegressionTests/test_Issues/test_CoreIssue1345.py +++ b/tests/QARegressionTests/test_Issues/test_CoreIssue1345.py @@ -9,7 +9,7 @@ @pytest.mark.regression class TestCoreIssue1501(unittest.TestCase): - def test_no_duplicates_in_supp_dm(self): + def test_engine_correctly_merges_datasets_and_flags_row_uniqueness_issues(self): # Run the command in the terminal command = [ f"{get_python_executable()}", @@ -27,14 +27,19 @@ def test_no_duplicates_in_supp_dm(self): "tests", "resources", "CoreIssue1345", - "subset", "define_msg20_testsupp_core.xml", ), "-d", - os.path.join("tests", "resources", "CoreIssue1345", "subset"), + os.path.join( + "tests", + "resources", + "CoreIssue1345", + ), "-lr", os.path.join( - "tests", "resources", "CoreIssue1345", "subset", "draft_rules" + "tests", + "resources", + "CoreIssue1345", ), "-r", "CDISC.SDTMIG.CG0019", @@ -87,3 +92,29 @@ def test_no_duplicates_in_supp_dm(self): "Found issue summary entries related to DM/SUPPDM:\n" f"{dm_related_summary}" ) + + ec_detail_issues = [ + i + for i in json_report.get("Issue_Details", []) + if i.get("dataset", "").lower() == "ec.json" + ] + + assert ( + ec_detail_issues + ), "Expected EC-related issues in Issue_Details, but none found" + assert ( + len(ec_detail_issues) == 2 + ), f"Expected 2 issues for EC dataset, but {len(ec_detail_issues)} found in Issue_Details" + + ec_summary_issues = [ + s + for s in json_report.get("Issue_Summary", []) + if s.get("dataset", "").lower() == "ec.json" + ] + + assert ( + ec_summary_issues + ), "Expected issues for EC dataset, but none found in Issue_Summary" + + if os.path.exists(json_report_path): + os.remove(json_report_path) diff --git a/tests/resources/CoreIssue1345/subset/draft_rules/CG0019.yml b/tests/resources/CoreIssue1345/CG0019.yml similarity index 100% rename from tests/resources/CoreIssue1345/subset/draft_rules/CG0019.yml rename to tests/resources/CoreIssue1345/CG0019.yml diff --git a/tests/resources/CoreIssue1345/subset/define_msg20_testsupp_core.xml b/tests/resources/CoreIssue1345/define_msg20_testsupp_core.xml similarity index 100% rename from tests/resources/CoreIssue1345/subset/define_msg20_testsupp_core.xml rename to tests/resources/CoreIssue1345/define_msg20_testsupp_core.xml diff --git a/tests/resources/CoreIssue1345/subset/dm.json b/tests/resources/CoreIssue1345/dm.json similarity index 100% rename from tests/resources/CoreIssue1345/subset/dm.json rename to tests/resources/CoreIssue1345/dm.json diff --git a/tests/resources/CoreIssue1345/subset/ec.json b/tests/resources/CoreIssue1345/ec.json similarity index 100% rename from tests/resources/CoreIssue1345/subset/ec.json rename to tests/resources/CoreIssue1345/ec.json diff --git a/tests/resources/CoreIssue1345/subset/suppdm.json b/tests/resources/CoreIssue1345/suppdm.json similarity index 100% rename from tests/resources/CoreIssue1345/subset/suppdm.json rename to tests/resources/CoreIssue1345/suppdm.json diff --git a/tests/resources/CoreIssue1345/subset/suppec.json b/tests/resources/CoreIssue1345/suppec.json similarity index 100% rename from tests/resources/CoreIssue1345/subset/suppec.json rename to tests/resources/CoreIssue1345/suppec.json From a65d443fa03a4faf585c8b566417644fb8ac2337 Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Tue, 20 Jan 2026 10:56:56 +0100 Subject: [PATCH 06/10] 1345: relrec processing fix --- .../utilities/dataset_preprocessor.py | 8 +- .../test_Issues/test_CoreIssue1345.py | 159 ++++++++++++------ tests/resources/CoreIssue1345/relrec.json | 85 ++++++++++ 3 files changed, 195 insertions(+), 57 deletions(-) create mode 100644 tests/resources/CoreIssue1345/relrec.json diff --git a/cdisc_rules_engine/utilities/dataset_preprocessor.py b/cdisc_rules_engine/utilities/dataset_preprocessor.py index 8876fc6c1..33416586d 100644 --- a/cdisc_rules_engine/utilities/dataset_preprocessor.py +++ b/cdisc_rules_engine/utilities/dataset_preprocessor.py @@ -94,6 +94,9 @@ def preprocess( # noqa else: if self._is_split_domain(domain_name): continue + target_domain_name: str = ( + self._dataset_metadata.domain or self._dataset_metadata.name + ) file_infos: list[SDTMDatasetMetadata] = [ item for item in datasets @@ -104,13 +107,14 @@ def preprocess( # noqa or ( domain_name == "SUPP--" and (not self._dataset_metadata.is_supp) - and item.rdomain == self._dataset_metadata.domain + and item.rdomain == target_domain_name ) ) ] if not file_infos and not ( - self._dataset_metadata.is_supp and domain_name == "SUPP--" + (self._dataset_metadata.is_supp and domain_name == "SUPP--") + or self._dataset_metadata.name == "RELREC" ): raise PreprocessingError( f"Failed to find related dataset for '{domain_name}' in preprocessor" diff --git a/tests/QARegressionTests/test_Issues/test_CoreIssue1345.py b/tests/QARegressionTests/test_Issues/test_CoreIssue1345.py index 0d74b0c57..5ac320c88 100644 --- a/tests/QARegressionTests/test_Issues/test_CoreIssue1345.py +++ b/tests/QARegressionTests/test_Issues/test_CoreIssue1345.py @@ -1,67 +1,72 @@ import os import subprocess -import unittest import pytest import json from conftest import get_python_executable +@pytest.fixture +def generate_report(): + # Run the command in the terminal + command = [ + f"{get_python_executable()}", + "-m", + "core", + "validate", + "-s", + "sdtmig", + "-v", + "3-4", + "-dv", + "2-1", + "-dxp", + os.path.join( + "tests", + "resources", + "CoreIssue1345", + "define_msg20_testsupp_core.xml", + ), + "-d", + os.path.join( + "tests", + "resources", + "CoreIssue1345", + ), + "-lr", + os.path.join( + "tests", + "resources", + "CoreIssue1345", + ), + "-r", + "CDISC.SDTMIG.CG0019", + "-l", + "error", + "-ps", + "1", + "-of", + "json", + ] + subprocess.run(command, check=True) + # Get the latest created Excel file + files = os.listdir() + json_files = [ + file + for file in files + if file.startswith("CORE-Report-") and file.endswith(".json") + ] + json_report_path = sorted(json_files)[-1] + json_report = json.load(open(json_report_path)) + return json_report_path, json_report + + @pytest.mark.regression -class TestCoreIssue1501(unittest.TestCase): - def test_engine_correctly_merges_datasets_and_flags_row_uniqueness_issues(self): - # Run the command in the terminal - command = [ - f"{get_python_executable()}", - "-m", - "core", - "validate", - "-s", - "sdtmig", - "-v", - "3-4", - "-dv", - "2-1", - "-dxp", - os.path.join( - "tests", - "resources", - "CoreIssue1345", - "define_msg20_testsupp_core.xml", - ), - "-d", - os.path.join( - "tests", - "resources", - "CoreIssue1345", - ), - "-lr", - os.path.join( - "tests", - "resources", - "CoreIssue1345", - ), - "-r", - "CDISC.SDTMIG.CG0019", - "-l", - "error", - "-ps", - "1", - "-of", - "json", - ] - subprocess.run(command, check=True) - - # Get the latest created Excel file - files = os.listdir() - json_files = [ - file - for file in files - if file.startswith("CORE-Report-") and file.endswith(".json") - ] - json_report_path = sorted(json_files)[-1] - # Open the JSON report file - json_report = json.load(open(json_report_path)) +class TestCoreIssue1345: + def test_engine_correctly_merges_datasets_and_flags_row_uniqueness_issues( + self, generate_report + ): + json_report_path, json_report = generate_report dataset_filenames = { d["filename"].upper() for d in json_report.get("Dataset_Details", []) } @@ -118,3 +123,47 @@ def test_engine_correctly_merges_datasets_and_flags_row_uniqueness_issues(self): if os.path.exists(json_report_path): os.remove(json_report_path) + + def test_engine_correctly_processes_relrec_when_supp_datasets_provided( + self, generate_report + ): + json_report_path, json_report = generate_report + # Open the JSON report file + dataset_filenames = { + d["filename"].upper() for d in json_report.get("Dataset_Details", []) + } + + assert "DM" in dataset_filenames, "DM dataset is missing from Dataset_Details" + assert ( + "SUPPDM" in dataset_filenames + ), "SUPPDM dataset is missing from Dataset_Details" + assert "EC" in dataset_filenames, "EC dataset is missing from Dataset_Details" + assert ( + "SUPPEC" in dataset_filenames + ), "SUPPEC dataset is missing from Dataset_Details" + + # check that relrec was processed and rule checked the data + assert ( + "RELREC" in dataset_filenames + ), "RELREC dataset is missing from Dataset_Details" + relrec_issues = [ + i + for i in json_report.get("Issue_Details", []) + if i.get("dataset", "").lower() == "relrec.json" + ] + assert ( + len(relrec_issues) == 2 + ), f"Expected 2 issues for RELREC dataset, but {len(relrec_issues)} found" + + # to confirm that EC is still processed and contains issues + ec_detail_issues = [ + i + for i in json_report.get("Issue_Details", []) + if i.get("dataset", "").lower() == "ec.json" + ] + assert ( + len(ec_detail_issues) == 2 + ), f"Expected 2 issues for EC dataset, but {len(ec_detail_issues)} found in Issue_Details" + + if os.path.exists(json_report_path): + os.remove(json_report_path) diff --git a/tests/resources/CoreIssue1345/relrec.json b/tests/resources/CoreIssue1345/relrec.json new file mode 100644 index 000000000..7b75267a8 --- /dev/null +++ b/tests/resources/CoreIssue1345/relrec.json @@ -0,0 +1,85 @@ +{ + "datasetJSONCreationDateTime": "2024-11-11T15:09:17", + "datasetJSONVersion": "1.1.0", + "fileOID": "www.cdisc.org/StudyMSGv2/1/Define-XML_2.1.0/2024-11-11/relrec", + "dbLastModifiedDateTime": "2020-08-21T09:14:25", + "originator": "CDISC SDTM MSG Team", + "sourceSystem": { + "name": "SAS on X64_10PRO", + "version": "9.0401M7" + }, + "studyOID": "cdisc.com/CDISCPILOT01", + "metaDataVersionOID": "MDV.MSGv2.0.SDTMIG.3.3.SDTM.1.7", + "metaDataRef": "define.xml", + "itemGroupOID": "IG.RELREC", + "records": 6, + "name": "RELREC", + "label": "Related Records", + "columns": [ + { + "itemOID": "IT.RELREC.STUDYID", + "name": "STUDYID", + "label": "Study Identifier", + "dataType": "string", + "length": 12, + "keySequence": 1 + }, + { + "itemOID": "IT.RELREC.RDOMAIN", + "name": "RDOMAIN", + "label": "Related Domain Abbreviation", + "dataType": "string", + "length": 6, + "keySequence": 2 + }, + { + "itemOID": "IT.RELREC.USUBJID", + "name": "USUBJID", + "label": "Unique Subject Identifier", + "dataType": "string", + "length": 8, + "keySequence": 3 + }, + { + "itemOID": "IT.RELREC.IDVAR", + "name": "IDVAR", + "label": "Identifying Variable", + "dataType": "string", + "length": 200, + "keySequence": 4 + }, + { + "itemOID": "IT.RELREC.IDVARVAL", + "name": "IDVARVAL", + "label": "Identifying Variable Value", + "dataType": "string", + "length": 200, + "keySequence": 5 + }, + { + "itemOID": "IT.RELREC.RELTYPE", + "name": "RELTYPE", + "label": "Relationship Type", + "dataType": "string", + "length": 4 + }, + { + "itemOID": "IT.RELREC.RELID", + "name": "RELID", + "label": "Relationship Identifier", + "dataType": "string", + "length": 200, + "keySequence": 6 + } + ], + "rows": [ + ["CDISCPILOT01", "AE", "", "AELNKID", "", "ONE", "AEDS"], + ["CDISCPILOT01", "DS", "", "DSLNKID", "", "ONE", "AEDS"], + ["CDISCPILOT01", "AE", "", "AELNKID", "", "ONE", "AEDD"], + ["CDISCPILOT01", "DD", "", "DDLNKID", "", "ONE", "AEDD"], + ["CDISCPILOT01", "AE", "", "AELNKID", "", "ONE", "AEFA"], + ["CDISCPILOT01", "FA", "", "FALNKGRP", "", "MANY", "AEFA"], + ["CDISCPILOT01", "FA", "", "FALNKGRP", "", "MANY", "AEFA"], + ["CDISCPILOT01", "FA", "", "FALNKGRP", "", "MANY", "AEFA1"] + ] +} From 136ef84bffa031d4a8014f115778f3b395a9159f Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Thu, 22 Jan 2026 12:57:26 +0100 Subject: [PATCH 07/10] wip: unit tests --- tests/unit/test_dataset_preprocessor.py | 43 ++++++++++++++++++++++++- 1 file changed, 42 insertions(+), 1 deletion(-) diff --git a/tests/unit/test_dataset_preprocessor.py b/tests/unit/test_dataset_preprocessor.py index 319038eff..13ac46cc7 100644 --- a/tests/unit/test_dataset_preprocessor.py +++ b/tests/unit/test_dataset_preprocessor.py @@ -7,6 +7,7 @@ InMemoryCacheService, ) from cdisc_rules_engine.services.data_services import LocalDataService +from cdisc_rules_engine.utilities.data_processor import DataProcessor from cdisc_rules_engine.utilities.dataset_preprocessor import DatasetPreprocessor from cdisc_rules_engine.constants.rule_constants import ALL_KEYWORD from cdisc_rules_engine.models.rule_conditions import ConditionCompositeFactory @@ -1125,7 +1126,6 @@ def test_preprocess_supp_wildcard_matches_all_supp_datasets( def test_preprocess_specific_suppae_dataset( mock_get_dataset: MagicMock, ): - ae_dataset = PandasDataset( pd.DataFrame.from_dict( { @@ -1196,3 +1196,44 @@ def test_preprocess_specific_suppae_dataset( assert result.data["AESPID"].values[0] == "SP001" assert "QNAM" not in result.data.columns assert "QVAL" not in result.data.columns + + +@pytest.fixture +def suppdm_with_race(): + suppdm_data = { + "IDVAR": {0: "", 1: "", 2: ""}, + "IDVARVAL": {0: "", 1: "", 2: ""}, + "QEVAL": {0: "", 1: "", 2: ""}, + "QLABEL": {0: "Race 1", 1: "Race 2", 2: "Race 3"}, + "QNAM": {0: "RACE1", 1: "RACE2", 2: "RACE3"}, + "QORIG": {0: "CRF", 1: "CRF", 2: "CRF"}, + "QVAL": {0: "ASIAN", 1: "BLACK OR AFRICAN AMERICAN", 2: "WHITE"}, + "RACE1": {0: "ASIAN", 1: None, 2: None}, + "RACE2": {0: None, 1: "BLACK OR AFRICAN AMERICAN", 2: None}, + "RACE3": {0: None, 1: None, 2: "WHITE"}, + "RDOMAIN": {0: "DM", 1: "DM", 2: "DM"}, + "STUDYID": {0: "CDISCPILOT01", 1: "CDISCPILOT01", 2: "CDISCPILOT01"}, + "USUBJID": {0: "CDISC008", 1: "CDISC008", 2: "CDISC008"}, + } + suppdm_df = PandasDataset(pd.DataFrame(suppdm_data)) + return suppdm_df + + +def test_data_processor_groups_qnam_suppdm_qvals(suppdm_with_race): + assert suppdm_with_race.shape[0] == 3 + suppdm_df = DataProcessor().process_supp(suppdm_with_race).data + # expected to group data + assert suppdm_df.shape[0] == 1 + assert {"RACE1", "RACE2", "RACE3"}.issubset(set(suppdm_df.columns)) + assert suppdm_df.loc[0, ["RACE1", "RACE2", "RACE3"]].notna().all() + + +def test_dm_merged_with_suppdm_without_dupes(suppdm_with_race): + dm = { + "STUDYID": {7: "CDISCPILOT01"}, + "DOMAIN": {7: "DM"}, + "USUBJID": {7: "CDISC008"}, + "SUBJID": {7: "1445"}, + } + + assert dm.shape[0] == 3 From 7404dc749da5ad4616ebee16bfa3477ca8a347ab Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Fri, 23 Jan 2026 09:58:17 +0100 Subject: [PATCH 08/10] #1345: unit tests for dm and suppdm processing --- tests/unit/test_dataset_preprocessor.py | 48 +++++++++++++++++++++++-- 1 file changed, 46 insertions(+), 2 deletions(-) diff --git a/tests/unit/test_dataset_preprocessor.py b/tests/unit/test_dataset_preprocessor.py index 13ac46cc7..fa6b56cc7 100644 --- a/tests/unit/test_dataset_preprocessor.py +++ b/tests/unit/test_dataset_preprocessor.py @@ -1228,12 +1228,56 @@ def test_data_processor_groups_qnam_suppdm_qvals(suppdm_with_race): assert suppdm_df.loc[0, ["RACE1", "RACE2", "RACE3"]].notna().all() -def test_dm_merged_with_suppdm_without_dupes(suppdm_with_race): +@patch("cdisc_rules_engine.services.data_services.LocalDataService.get_dataset") +def test_dm_merged_with_suppdm_without_dupes(mock_get_dataset, suppdm_with_race): + mock_get_dataset.return_value = suppdm_with_race + dm = { "STUDYID": {7: "CDISCPILOT01"}, "DOMAIN": {7: "DM"}, "USUBJID": {7: "CDISC008"}, "SUBJID": {7: "1445"}, } + dm_meta = SDTMDatasetMetadata( + name="DM", + first_record={"DOMAIN": "DM"}, + filename="dm.json", + full_path="dm.json", + ) - assert dm.shape[0] == 3 + supp_dm_meta = SDTMDatasetMetadata( + name="SUPPDM", + first_record={"RDOMAIN": "DM"}, + filename="suppdm.json", + full_path="suppdm.json", + ) + dm_ds = PandasDataset(pd.DataFrame(dm)) + rule_with_specific_supp = { + "core_id": "TestSupplementalIDVAR", + "datasets": [ + {"domain_name": "SUPP--", "match_key": ["USUBJID"], "wildcard": "**"} + ], + "conditions": ConditionCompositeFactory.get_condition_composite( + { + "all": [ + { + "name": "get_dataset", + "operator": "equal_to", + "value": {"target": "QVAL", "comparator": "test_value"}, + } + ] + } + ), + } + assert suppdm_with_race.data.shape[0] == 3 + data_service = LocalDataService(MagicMock(), MagicMock(), MagicMock()) + preprocessor = DatasetPreprocessor( + dm_ds, + dm_meta, + data_service, + InMemoryCacheService(), + ) + result = preprocessor.preprocess(rule_with_specific_supp, [supp_dm_meta]) + assert result.data.shape[0] == 1 + assert {"RACE1", "RACE2", "RACE3"}.issubset(set(result.columns)) + assert result.data.loc[0, ["RACE1", "RACE2", "RACE3"]].notna().all() From 6b44d0da05b7b84a30d4f04faf9d6894a6e4fa30 Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Fri, 23 Jan 2026 10:24:16 +0100 Subject: [PATCH 09/10] #1345: unit tests for relrec processing --- tests/unit/test_dataset_preprocessor.py | 92 ++++++++++++++++++++----- 1 file changed, 74 insertions(+), 18 deletions(-) diff --git a/tests/unit/test_dataset_preprocessor.py b/tests/unit/test_dataset_preprocessor.py index fa6b56cc7..41c048716 100644 --- a/tests/unit/test_dataset_preprocessor.py +++ b/tests/unit/test_dataset_preprocessor.py @@ -1219,6 +1219,28 @@ def suppdm_with_race(): return suppdm_df +@pytest.fixture +def rule_with_specific_supp(): + rule_with_specific_supp = { + "core_id": "TestSupplementalIDVAR", + "datasets": [ + {"domain_name": "SUPP--", "match_key": ["USUBJID"], "wildcard": "**"} + ], + "conditions": ConditionCompositeFactory.get_condition_composite( + { + "all": [ + { + "name": "get_dataset", + "operator": "equal_to", + "value": {"target": "QVAL", "comparator": "test_value"}, + } + ] + } + ), + } + return rule_with_specific_supp + + def test_data_processor_groups_qnam_suppdm_qvals(suppdm_with_race): assert suppdm_with_race.shape[0] == 3 suppdm_df = DataProcessor().process_supp(suppdm_with_race).data @@ -1229,7 +1251,9 @@ def test_data_processor_groups_qnam_suppdm_qvals(suppdm_with_race): @patch("cdisc_rules_engine.services.data_services.LocalDataService.get_dataset") -def test_dm_merged_with_suppdm_without_dupes(mock_get_dataset, suppdm_with_race): +def test_dm_merged_with_suppdm_without_dupes( + mock_get_dataset, suppdm_with_race, rule_with_specific_supp +): mock_get_dataset.return_value = suppdm_with_race dm = { @@ -1252,23 +1276,7 @@ def test_dm_merged_with_suppdm_without_dupes(mock_get_dataset, suppdm_with_race) full_path="suppdm.json", ) dm_ds = PandasDataset(pd.DataFrame(dm)) - rule_with_specific_supp = { - "core_id": "TestSupplementalIDVAR", - "datasets": [ - {"domain_name": "SUPP--", "match_key": ["USUBJID"], "wildcard": "**"} - ], - "conditions": ConditionCompositeFactory.get_condition_composite( - { - "all": [ - { - "name": "get_dataset", - "operator": "equal_to", - "value": {"target": "QVAL", "comparator": "test_value"}, - } - ] - } - ), - } + assert suppdm_with_race.data.shape[0] == 3 data_service = LocalDataService(MagicMock(), MagicMock(), MagicMock()) preprocessor = DatasetPreprocessor( @@ -1281,3 +1289,51 @@ def test_dm_merged_with_suppdm_without_dupes(mock_get_dataset, suppdm_with_race) assert result.data.shape[0] == 1 assert {"RACE1", "RACE2", "RACE3"}.issubset(set(result.columns)) assert result.data.loc[0, ["RACE1", "RACE2", "RACE3"]].notna().all() + + +def test_relrec_processed_correctly_with_others(rule_with_specific_supp): + ec_meta = SDTMDatasetMetadata( + name="EC", + first_record={"STUDYID": "CDISCPILOT01", "DOMAIN": "EC"}, + filename="ec.json", + full_path="ec.json", + ) + + supp_ec_meta = SDTMDatasetMetadata( + name="SUPPEC", + first_record={"STUDYID": "CDISCPILOT01", "RDOMAIN": "EC"}, + filename="suppec.json", + full_path="suppec.json", + ) + + relrec_meta = SDTMDatasetMetadata( + first_record={"IDVAR": "AELNKID", "RDOMAIN": "AE"}, + filename="relrec.json", + full_path="relrec.json", + name="RELREC", + ) + + relrec_ds = PandasDataset( + pd.DataFrame( + { + "IDVAR": {0: "AELNKID", 1: "DSLNKID"}, + "RDOMAIN": {0: "AE", 1: "DS"}, + "RELTYPE": {0: "ONE", 1: "ONE"}, + "STUDYID": {0: "CDISCPILOT01", 1: "CDISCPILOT01"}, + } + ) + ) + + preprocessor = DatasetPreprocessor( + relrec_ds, + relrec_meta, + LocalDataService(MagicMock(), MagicMock(), MagicMock()), + InMemoryCacheService(), + ) + result = preprocessor.preprocess( + rule_with_specific_supp, [ec_meta, supp_ec_meta, relrec_meta] + ) + + # relrec preprocessing did not change data + assert result.data.shape[0] == 2 + assert all(result.data == relrec_ds.data) From d89e02cf1bd2a905f47319c814883d399840c3b7 Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Fri, 23 Jan 2026 14:36:36 +0100 Subject: [PATCH 10/10] #1345: fix test --- tests/unit/test_dataset_preprocessor.py | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/tests/unit/test_dataset_preprocessor.py b/tests/unit/test_dataset_preprocessor.py index 41c048716..2b238ce9d 100644 --- a/tests/unit/test_dataset_preprocessor.py +++ b/tests/unit/test_dataset_preprocessor.py @@ -1242,7 +1242,7 @@ def rule_with_specific_supp(): def test_data_processor_groups_qnam_suppdm_qvals(suppdm_with_race): - assert suppdm_with_race.shape[0] == 3 + assert suppdm_with_race.data.shape[0] == 3 suppdm_df = DataProcessor().process_supp(suppdm_with_race).data # expected to group data assert suppdm_df.shape[0] == 1