Clarify the signal, owner, evidence source, and decision deadline. Create or update the tool before the meeting ends.
Tool Play
Work breakdown structure (WBS)
Decomposes trial work into manageable work packages.
When to open it
Building the integrated project plan.
How to run it
Use the Work breakdown structure (WBS) when building the integrated project plan. 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 Work breakdown structure (WBS) 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 Work breakdown structure (WBS) record that turns decomposes trial work into manageable work packages 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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