Direct Access to Source Records Section
A Direct Access to Source Records section documents the permissions and safeguards that allow authorized monitors, auditors, regulators, and relevant oversight bodies to verify trial information against source records. It is different from defining what counts as source data.
A Direct Access to Source Records section explains who may obtain authorized direct access, for what oversight purposes, and how participant confidentiality is protected.
Key details
Important caveats
Scope Boundary
Keep this distinct from Source Data, which defines the records themselves, and from general Data Access or sharing policies. Legal access rights and consent requirements vary by jurisdiction.
Further guidance
Content
Identify authorized oversight roles, permitted purposes, access arrangements, confidentiality/privacy safeguards, participant-consent implications where applicable, and site responsibilities for making records available.
Purpose
Enable verification and oversight while making the limits and privacy safeguards around source-record access explicit.
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