01
Make the question specific.
Identify the design object, exact version and decision under review. Explain why this person is involved. The same screening requirement may need Medical, Operations, Statistics and Data Management input; a section boundary should not hide those shared responsibilities.
02
Make disagreement useful.
Keep scientific purpose and practical concerns side by side. Record each concern, the source or assumption behind it, and the alternatives considered. Ask for a response that explains the trade-off rather than simply closing a comment.
03
Distinguish attention from approval.
Opening a section does not demonstrate substantive review. A role label does not establish authority. Define required contributions and sign-offs through the responsible organisation’s workflow, and keep unresolved obligations visible.
04
Revisit the review when the decision changes.
An earlier review belongs to the version it assessed. When the rationale or design changes, identify affected reviews and request the necessary reconsideration. Retain the earlier concern and decision history. Measure useful coverage and unnecessary flags as well as time saved.
Keep the reasoning in view.
Decision → relevant expertise → concern and response → required review → version-bound rationale
Use this discussion framework with the evidence and information from your study. The accountable study team decides which sources and questions apply.
See this review approach in a connected example →