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CLINICAL-RESEARCH-MANAGEMENT5 MIN READ

Commit to One Premortem Action Before a Study Milestone

Create a trackable premortem action for an upcoming clinical study milestone.

Commit to one preventive action from a mini-premortem. Use this for a milestone such as SIV readiness, first-patient-in, amendment training launch, database lock, vendor UAT, inspection-readiness review, or DSMB data cut. If the most plausible failure path has no owner, date, or evidence by tomorrow noon... Milestone: [clinical milestone]. Imagine it failed on [date]. It failed because [specific operational cause]. Preventive action: [one action I will complete]. Owner: [person]. Evidence: [artifact, screenshot, filed document, decision email, or metric]. Check date: [within 3 days]. SIV is scheduled but pharmacy has not completed the temperature-excursion drill. Database lock is planned but ePRO…

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