Applicability
Sponsors, investigators, service providers, and other parties using computerised systems or collecting electronic data in clinical trials.
What Changed
The record adds an EMA source that addresses risk-proportionate validation, data integrity, system descriptions, interfaces, procedures, training, access, and security in clinical trials.
What Did Not Change
It does not replace the governing clinical-trial legislation, ICH GCP, or other applicable legal frameworks.
Practical Impact
Clinical-system assessments should cover system inventory, fitness for purpose, interfaces, operational responsibility, data integrity, access, and documented procedures.
Actions to Consider
Use the guideline within the actual clinical-trial role and legal context; identify additional device, privacy, signature, or national requirements separately.
Primary Source
Revision history
Version 1.2 · 12 September 2026: Terminology and source fields standardized for Version 32.