Clarify the signal, owner, evidence source, and decision deadline. Create or update the tool before the meeting ends.
Tool Play
Root-cause analysis
Identifies the underlying process, ownership, training, system, vendor, protocol, or feasibility cause behind a recurring or high-impact issue.
When to open it
A deviation trend, vendor failure, data-quality signal, safety-process concern, recruitment miss, inspection observation, or repeated site issue cannot be solved by assigning another action item.
How to run it
Define the problem narrowly, separate symptoms from evidence, collect cross-functional facts before blame language appears, test candidate causes against records, document why causes were accepted or rejected, and connect the confirmed root cause to corrective and preventive actions.
Review whether actions moved, risks changed, vendors or sites responded, and whether the output has become decision-ready.
Escalate when the root cause affects participant protection, primary endpoint credibility, safety reporting, protocol compliance, inspection evidence, repeated vendor underperformance, or a process owner cannot accept accountability.
Expected output
A controlled RCA record that links the problem, evidence, root cause, actions, owners, due dates, and effectiveness check.
Closure evidence
Closed only when the accountable owner accepts the root cause, actions are completed, effectiveness has been checked, and records are filed in the appropriate quality/project location.
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