Trial Documentation Section
ICH E6(R3) identifies essential records as a distinct trial-governance function used to evaluate conduct and result reliability. Their management includes timely filing, identifiable/version-controlled records, known locations, accessible repositories, and required retention.
A Trial Documentation section explains which essential trial records will be created and maintained, where they are kept, and how version control, filing, access, retrieval, and retention are handled.
Key details
Important caveats
Scope Boundary
This topic concerns essential trial records and documentation governance. Data collection variables, database processing, privacy law, and journal reporting are related but separate topics.
Further guidance
Content
Describe the essential-record repositories or filing approach, responsibilities, version/traceability controls, access arrangements, and retention or transfer processes relevant to the trial.
Purpose
Make the essential-record system auditable without confusing it with the scientific data-analysis plan.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- E6(R3) Good Clinical Practice Guidance for Industry — September 2025 (opens in a new tab)U.S. Food and Drug Administration · Current ICH E6(R3) GCP guidance on investigator oversight, training/delegation, participant withdrawal, investigational-product accountability, site close-out, essential records, and insurance/indemnification