Clinical Trial Risk Register
This is a practical guide to building a risk register for a clinical trial project — the living log of risks with scores, owners and responses, adapted to the realities of planning and running a clinical trial.
What a Risk Register is
A risk register is the living log of risks with scores, owners and responses. For the full concept and how it works in general, see Risk Register. 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 risk register 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
- Risk description and category
- Probability and impact
- Risk score
- Owner
- Response and trigger
Clinical Trial-specific considerations
Tailor the risk register 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 risk register 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.