01
Start with purpose.
Identify the objective, endpoint or other stated purpose the assessment supports. Keep the relevant protocol section beside the question. If that relationship is unclear, record the uncertainty rather than guessing the reason.
02
Separate the source from the assumption.
Record what material supports the assessment and what it actually establishes. A procedure used in an earlier protocol is worth examining. Its use there does not, by itself, justify using it in this study.
03
Bring the practical questions into review.
Consider what the proposed test, procedure or questionnaire asks of participants, sites and data collection. Record where scientific purpose and operational assumptions need discussion together. The relevant clinical, operational and data specialists determine which questions apply.
04
Keep the decision with its basis.
The useful result is an explanation others can check: the question, the material considered, unresolved points and the responsible person’s decision. A missing rationale is a reason to investigate, not an instruction to remove a procedure.
Keep the reasoning in view.
Test or procedure → purpose → supporting evidence → open question → responsible specialist decision
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 →