CORE is the open-source offering of the CDISC Conformance Rules Engine — a tool for validating clinical trial data against CDISC data standards.
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 | Therapeutic Area Implementation Guide |
| FDA Business Rules | FDA submission conformance rules |
| USDM | Unified Study Definitions Model |
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