A better first
discussion.

0 of 12 topics reviewed

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1. Protocol & populationStudy synopsis, phase, indication and intended population
2. Protocol & populationInclusion/exclusion criteria and expected screening constraints
3. Protocol & populationVisit schedule, procedures and participant burden
4. Site & investigator fitProposed geography, institution type and investigator qualifications
5. Site & investigator fitEvidence supporting access to the intended patient population
6. Site & investigator fitFacilities, equipment, competing studies and available capacity
7. Operational readinessRequired documentation, training and system permissions
8. Operational readinessStart-up dependencies and proposed milestones
9. Operational readinessSupply, data, query and participant communication workflows
10. Scope & accountabilitySponsor, investigator, institution and coordinator responsibilities
11. Scope & accountabilityDecision rights, escalation routes and review cadence
12. Scope & accountabilityQualified providers, agreements, budget and unresolved assumptions