Data Corrections Section
A Data Corrections section sets the rules for changing recorded trial data after entry: authorization, attribution, reason/support, timeliness, and retained traceability. It is narrower than the overall Audit Trail or Data Management sections.
A Data Corrections section explains who may correct trial data, how corrections are attributed and justified, and how the original record and change history remain traceable.
Key details
Important caveats
Scope Boundary
Keep correction workflow distinct from the technical Audit Trail section and from general data review. Exact electronic controls depend on the computerized system and applicable requirements.
Further guidance
Content
State who may make or authorize corrections, required reason or supporting information, preservation of the original value, timestamps/attribution, review of material changes, and escalation when corrections reveal broader issues.
Purpose
Prevent legitimate data cleaning from becoming an opaque rewrite of the record and preserve confidence in the history of changes.
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