edc-core
A modern, open-source Electronic Data Capture system for clinical research
Commercial EDC platforms are expensive, closed, and dated. The open-source alternatives run on legacy stacks. edc-core is a from-scratch EDC built on modern web technology, an analytics-native data architecture, and CDISC standards, designed so that regulatory expectations (21 CFR Part 11, ICH E6(R3)) are structural properties of the system rather than afterthoughts.
Why edc-core
No vendor lock-in. AGPL-3.0 licensed: nobody can take this code and sell it back to you as a closed platform.
Programmable study builds. First-class CDISC ODM v2.0 import/export means study builds can be file-driven, code-driven, and LLM-assisted. The visual builder writes through exactly the same versioned-metadata API.
Self-service analytics, in the EDC. Data managers query published study snapshots with real SQL, R, and Python, not a bespoke, vendor-locked reporting layer. Every execution is read-only, sandboxed, version-pinned, and audited.
Compliance by construction. Append-only audit trails enforced at the database level, Part 11 e-signatures bound to record versions, an audit-trail review UI, and a validation pack shipped with every release.
Standards as the interface. ODM v2.0 (XML + JSON) for metadata, Dataset-JSON v1.1 for data exchange, CDASH-aligned demo CRFs, and a self-contained study archive that outlives the running system.
Where to start
| Installation | Run the full stack locally with Podman or Docker, or deploy the published container images. |
| Five-minute tour | Seed the demo study and walk the whole lifecycle: entry → query → verify → sign → snapshot → analyze. |
| User guide | Study builds, data capture, review workflows, and the analytics workbench. |
| Compliance | How edc-core maps to 21 CFR Part 11 and ICH E6(R3), and what the validation pack contains. |