Clinical Trial Change Log
This is a practical guide to building a change log for a clinical trial project — a record of change requests and their decisions, adapted to the realities of planning and running a clinical trial.
What a Change Log is
A change log is a record of change requests and their decisions. For the full concept and how it works in general, see Change 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 change 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
- Change ID and description
- Impact assessment
- Decision and date
- Updated baselines
Clinical Trial-specific considerations
Tailor the change 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 change 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.