Data Review Section
A Data Review section defines the risk-based review activity applied to accumulating trial data and metadata before final analysis. It should complement Data Management by explaining review responsibilities, triggers, checks, issue handling, and documentation.
A Data Review section describes what trial data and metadata are reviewed, by whom, when, using which checks or signals, and how identified issues are resolved.
Key details
Important caveats
Scope Boundary
Keep data review separate from the overall Data Management lifecycle and from Statistical/Data Analysis. The intensity and tools used should be proportionate to the trial and critical data/processes.
Further guidance
Content
Describe the data/metadata in scope, review roles, timing or frequency, risk-based checks, query/escalation routes, issue resolution, and documentation of review outcomes.
Purpose
Show how the trial detects and resolves important data problems early enough to protect reliability and participant safety.
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