Clinical Trial Decision Log
This is a practical guide to building a decision log for a clinical trial project — a record of the key decisions made, by whom and why, adapted to the realities of planning and running a clinical trial.
What a Decision Log is
A decision log is a record of the key decisions made, by whom and why. For the full concept and how it works in general, see Decision Log. 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 decision 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
- Decision
- Date and owner
- Rationale
- Alternatives considered
- Impact
Clinical Trial-specific considerations
Tailor the decision 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 decision 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.