Regulatory
EAEU GCP Rules and computerized systems
What changed in Union law and what it means for electronic data capture.
What changed
The current edition of the EAEU Rules of Good Clinical Practice (EEC Council Decision No. 79, as amended by Decision No. 63) entered into force on 10.03.2026 and is aligned with ICH E6(R2). Union law now for the first time includes: validation of computerized systems (cl. 1.4), the ALCOA requirement for source data (cl. 4.9.0), data integrity across software updates (cl. 5.5.3), and a ban on the sponsor's exclusive control over site data (cl. 8.1).
What that means for an EDC
The electronic system must demonstrably keep an audit trail, segregate access, preserve data integrity across updates and give the sponsor no sole control over the investigative site's data.
How the core is designed for it
An audit trail with a cryptographic hash chain; policy-based access with deny by default; the data schema changes through expanding migrations only; clinical data is never physically deleted. The “invariant → test” traceability matrix is available on request.
The clause-by-clause “norm → mechanism” map: Regulatory landscape
Next — in the documentation: Audit trailInspection packet
We will walk you through the product on a demo study and answer your questions.
Request a demo