Clinical Trial Assumptions Log
This is a practical guide to building a assumptions log for a clinical trial project — a register of the assumptions the plan depends on, to be validated, adapted to the realities of planning and running a clinical trial.
What a Assumptions Log is
A assumptions log is a register of the assumptions the plan depends on, to be validated. For the full concept and how it works in general, see Project Assumption. On a clinical trial project it plays the same role, tuned to this kind of work.
Why it matters for a Clinical Trial project
Clinical Trial projects live or die on planning and running a clinical trial. A well-built assumptions log gives the team a shared, explicit reference for exactly that — reducing ambiguity, aligning stakeholders, and making problems visible early enough to act. Skipping it, or doing it generically, is how clinical trial projects drift into avoidable delay and cost.
What to include
- Assumption
- Impact if wrong
- Owner
- Validation status
Clinical Trial-specific considerations
Tailor the assumptions log to the risks that most often derail clinical trial projects:
- Regulatory and ethics approval
- Patient recruitment
- Data integrity
Example
On a real clinical trial project, the assumptions log would be shaped by planning and running a clinical trial. In particular, it should explicitly account for the project’s biggest risks — regulatory and ethics approval, patient recruitment, data integrity — rather than treating them as afterthoughts.