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gerrycampion merged 5 commits into from
Jul 9, 2026
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docs #1795

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SFJohnson24 Jun 30, 2026
220c50a
Merge branch 'main' into docs
SFJohnson24 Jul 8, 2026
0bebf78
Update architecture explanation in index.md
gerrycampion Jul 9, 2026
dfb18f1
Merge branch 'main' into docs
gerrycampion Jul 9, 2026
3625227
Remove duplicate link to cdisc-open-rules
gerrycampion Jul 9, 2026
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29 changes: 28 additions & 1 deletion docs/index.md
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Expand Up @@ -13,6 +13,29 @@ validating clinical trial data against CDISC data standards.

---

## Which Engine Should I Use?

> **At present**, rule validation is split across two engines while work is underway to merge
> the Verisian fork back into this repository. Until that merge is complete, please select the
> engine based on the rules you're running:

| If you're running… | Use… |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| **SDTM** or **FDA Business Rules** | The **Verisian Engine** — [verisianHQ/cdisc-rules-engine](https://github.com/verisianHQ/cdisc-rules-engine) |
| **TIG**, **USDM**, **ADaM**, or **SEND** | The **CDISC Engine** (this repository), as described below |

This split is temporary and reflects differing underlying architectures — the Verisian Engine is
built on SQL, while the CDISC Engine (this repository) is built on pandas/dask/jsonata. These
implementations will be harmonized over time, at which point this section will be
updated to reflect the change.

For setup and usage of the **Verisian Engine** (installation, environment configuration,
CLI options, etc.), please follow the instructions in their
[README](https://github.com/verisianHQ/cdisc-rules-engine/blob/main/README.md) rather than
this one, since its setup steps (e.g. SQL/Postgres configuration) differ from those below.

---

## Scope

CORE validates study datasets against published CDISC conformance rules for the following
Expand All @@ -27,6 +50,11 @@ standards:
| **FDA Business Rules** | FDA submission conformance rules |
| **USDM** | Unified Study Definitions Model |

> **Note:** At present, SDTMIG and FDA Business Rules validation should be performed via the
> **Verisian Engine** (see [Which Engine Should I Use?](#which-engine-should-i-use) above).
> This repository currently handles **TIG**, **USDM**, and **SEND** validations, plus **ADaM**
> unless/until noted otherwise.

CORE validates data _structure and conformance_ against published rules. It is not a
replacement for clinical review, statistical analysis, or submission readiness assessment.
Rule logic is defined in [`cdisc-open-rules`](https://github.com/cdisc-org/cdisc-open-rules).
Expand Down Expand Up @@ -59,4 +87,3 @@ Rule logic is defined in [`cdisc-open-rules`](https://github.com/cdisc-org/cdisc
[wiki.cdisc.org — Getting Started](https://wiki.cdisc.org/display/LIBSUPRT/Getting+Started%3A+Access+to+CDISC+Library+API+using+API+Key+Authentication)
- **Published CDISC Conformance Rules GitHub:**
[cdisc-open-rules](https://github.com/cdisc-org/cdisc-open-rules)

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