Clarify the signal, owner, evidence source, and decision deadline. Create or update the tool before the meeting ends.
Tool Play
Risk register
Tracks uncertain future events.
When to open it
Planning and monitoring.
How to run it
Use the Risk register when planning and monitoring. Confirm the purpose of the review, populate the required fields, test the evidence with the accountable functional owner, document the decision or next action, and assign a review date before the forum closes.
Review whether actions moved, risks changed, vendors or sites responded, and whether the output has become decision-ready.
Escalate the Risk register when evidence shows unresolved ownership, participant-protection risk, CTQ or endpoint impact, critical-path pressure, budget or vendor-scope change, inspection-readiness gap, or a decision beyond study-team authority.
Expected output
A completed Risk register record that turns tracks uncertain future events into named owners, evidence, timing, decision logic, follow-up actions, and closure proof.
Closure evidence
Closed when the accountable owner accepts the evidence, downstream handoffs are updated, and the next review date or closure rationale is recorded.
Worked example
Use the dummy-project story where this tool is linked in the chapter to see the trigger, owner, action, and outcome.