ICH E6(R3) - Good Clinical Practice 4.3-operations: Release trial-specific systems to a site only after all its approvals, keep contingency procedures against data loss or inaccessibility, run help desk support with periodic review and criticality-based defect resolution, and control user access with role-based, promptly revoked, periodically reviewed and documented permissions

What does 4.3-operations require?

Trial-specific systems, including updates from protocol amendments, should be released or activated for a site only after all approvals relevant to that site are in place. Contingency procedures should stop data needed for participant safety, trial decisions or outcomes from being lost or becoming inaccessible. Where appropriate, mechanisms such as a help desk should document, evaluate and manage system issues, with periodic review of cumulative issues to find repeated or systemic ones, and defects resolved by criticality, high-criticality ones promptly. Access controls should limit access to authorised users and ensure attributability, with permissions assigned by duties, blinding and organisation, revoked when no longer needed, reviewed periodically where relevant, and documented and retained with updates and time stamps.