01
Name the assumption.
Describe the working assumption in plain language. For example: whether two assessments can take place within the same visit. Keep that statement distinct from a confirmed requirement or established fact.
02
Connect it to the schedule.
Identify the affected visit, assessment or collection requirement. An assumption is easier to examine when reviewers can see the design choice that depends on it.
03
Identify the basis and the gap.
Record the information available, its limitations and what still needs checking. Site input, procedural requirements and scientific considerations may answer different parts of the question; one does not automatically establish the others.
04
Revisit it when the design changes.
A proposed change in timing can reopen an earlier planning assumption. Ask which related requirements and disciplines need another look. A link between study choices does not predict whether the study will work or how much it will ask of participants.
Keep the reasoning in view.
Schedule choice → explicit assumption → basis and limitations → review question
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 →