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Some values in a clinical project plan come from observation, while others remain untested assumptions. Presenting both with equal certainty can distort sponsor decisions about time and money. An assumptions register explains which belief supports the plan, when it will be tested and which decision changes if it is wrong.
Decision framework
Distinguish assumptions about site recruitment, translation revisions and contract negotiation time at the outset. Assign a rationale, confidence level, review point and owner to each. A forecast borrowed from an earlier study has not automatically been validated for a new protocol or country setting.
Worked example
For example, a budget assumes one translation review round in every country. The first two countries require a second round because investigators use different terminology. The register reveals both the added cost and whether remaining countries share the same exposure. The plan is updated with new information instead of forcing teams to defend the original estimate.
Implementation checks
- Write each critical assumption alongside the observation or event that could disprove it; avoid vague expressions of optimism.
- Tie its review point to the study stage when relevant information becomes available, rather than a meeting date alone.
- Record which budget, deliverable and resource decisions were reconsidered after an assumption changed.
Acceptance and boundaries
Begin with a small set of consequential assumptions. An exhaustive undifferentiated list hides important effects. Revising an assumption is an adaptation to evidence, not an admission that planning was pointless. Mark values supported by observed information, while avoiding automatic extrapolation to another country or protocol.
Frequently asked questions
- Is an assumption the same as a risk?
- No. An assumption underpins the plan; a risk concerns possible effects of an uncertain event or condition on objectives.
- Should obsolete assumptions be deleted?
- Where decision history matters, retain the previous assumption and the reason for its replacement in a traceable record.