Name the problem, affected CTQ, current evidence, accountable owner, and decision needed.
Problem Play
High Screen Failure
Use eligibility feasibility review, enrollment funnel analysis, assumption log, risk register, and change-control impact assessment.
What to do first
Open the linked tools, confirm owner dates, update the project record, and decide whether escalation is required.
Escalate when participant protection, endpoint credibility, protocol compliance, safety, critical path, budget, vendor scope, or inspection evidence is affected.
Expected output
Leave the first review with a named owner, dated action, evidence source, escalation threshold, and closure proof. If the issue affects participant protection, endpoint credibility, safety reporting, protocol compliance, critical path, budget authority, vendor scope, or inspection evidence, prepare a decision-ready escalation rather than a status update.