Clarify the signal, owner, evidence source, and decision deadline. Create or update the tool before the meeting ends.
Tool Play
Safety management and reporting plan
Defines safety review, reconciliation, reporting clocks, medical review, and urgent communication paths.
When to open it
Interventional trial startup, safety signal response, inspection preparation.
How to run it
Use the Safety management and reporting plan when interventional trial startup, safety signal response, inspection preparation. 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 Safety management and reporting plan 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 Safety management and reporting plan record that turns defines safety review, reconciliation, reporting clocks, medical review, and urgent communication paths 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.
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