Clarify the signal, owner, evidence source, and decision deadline. Create or update the tool before the meeting ends.
Tool Play
IMP/pharmacy and supply readiness plan
Confirms investigational product release, pharmacy workflow, storage, dispensing, returns, and excursion handling.
When to open it
Startup, blinded trials, vaccines, BA/BE and biosimilar trials.
How to run it
Use the IMP/pharmacy and supply readiness plan when startup, blinded trials, vaccines, ba/be and biosimilar trials. 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 IMP/pharmacy and supply readiness 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 IMP/pharmacy and supply readiness plan record that turns confirms investigational product release, pharmacy workflow, storage, dispensing, returns, and excursion handling 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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