Source Data Section
ICH E6(R3) treats source records as the original evidence underlying trial data and emphasizes attributable, legible, contemporaneous, original, accurate, complete, and traceable records. A focused Source Data section can state what the trial treats as source and how it is captured without duplicating the broader data-management plan.
A Source Data section defines which records are treated as source, where they originate or reside, how they are captured, and how traceability to reported trial data is maintained.
Key details
Important caveats
Scope Boundary
Keep source-data definition separate from general Data Management, statistical analysis, and data-sharing policy. Exact source-record expectations depend on the trial design, technology, and applicable requirements.
Further guidance
Content
Identify source record types or systems, data-capture methods and locations, direct-entry situations, relevant certified-copy practices, and how corrections remain traceable.
Purpose
Make the origin and traceability of trial observations explicit before data flow and verification procedures are described elsewhere.
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
- E6(R3) Good Clinical Practice (GCP) — September 2025 (opens in a new tab)U.S. Food and Drug Administration · Current FDA final-guidance overview for ICH E6(R3), including quality by design, risk-based quality management, technology, proportionality, and clarified sponsor/investigator responsibilities