CORE is the open-source offering of the CDISC Conformance Rules Engine — a tool for validating clinical trial data against CDISC data standards.
At present, rule validation is split across two engines while work is underway to merge the SQL 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 refactored SQL Engine — verisianHQ/cdisc-rules-engine |
| TIG, USDM, or SEND | The CDISC Engine (this repository), as described below |
This split is temporary and reflects differing underlying architectures — the refactored 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 Refactored SQL Engine (installation, environment configuration, CLI options, etc.), please follow the instructions in their README rather than this one, since its setup steps (e.g. SQL/Postgres configuration) differ from those below.
CORE validates study datasets against published CDISC conformance rules for the following standards:
| Standard | Description |
|---|---|
| SDTMIG | Study Data Tabulation Model Implementation Guide |
| SENDIG | Standard for Exchange of Nonclinical Data |
| ADaM | Analysis Data Model |
| TIG | Tobacco Implementation Guide |
| 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 Refactored SQL Engine (see Which Engine Should I Use? above). This repository currently handles TIG, USDM, and SEND (incomplete) validations. SEND validations are not still a work in progress and the standard is not fully validated and automated.
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.
| I want to… | Go to… |
|---|---|
| Run CORE without installing Python | Quick Start → Executable |
| Run from source / contribute code | Quick Start → From Source |
| See all CLI options | CLI Reference |
| Integrate CORE into my Python project | Development → PyPI |
| Build or test CORE | Development |
| Contribute rules or code | Contributing |
| Get help or ask a question | FAQ & Troubleshooting |
- Questions & Discussions: GitHub Discussions — Q&A
- Bug Reports & Feature Requests: GitHub Issues
- Rule Contributions: cdisc-open-rules
- CDISC Library API: wiki.cdisc.org — Getting Started
- Published CDISC Conformance Rules GitHub: cdisc-open-rules