Open a Study Site

Goal

Move one candidate Facility from feasibility to a Study Site that may enroll participants, while preserving the distinct meaning of selection, approval, activation, and opening.

Object progression

FacilityProfile
  -> CandidateSite
    -> SiteSelectionDecision
      -> StudySite
        -> StartupPackage
          -> ApprovalRequirement[]
          -> ExecutedAgreement
          -> QualificationSet
          -> EssentialEvidenceSet
            -> SiteReadinessAssessment
              -> SiteActivationDecision
                -> EnrollmentOpeningDecision

Behaviours

1. FeasibilityCampaign.nominate(facility) creates a CandidateSite.
2. CandidateSite.submit(response) records attributable feasibility evidence.
3. SiteSelectionPolicy.assess(candidate) produces a SiteSelectionAssessment.
4. An authorized actor records a positive SiteSelectionDecision.
5. Study.associateSite(facility, country) creates the StudySite identity.
6. StudySite.beginStartup(plan) establishes applicable startup work.
7. Approval, agreement, training, delegation, and record objects progress independently.
8. SiteReadinessPolicy.assess(...) explains satisfied and unsatisfied requirements.
9. StudySite.activate(readiness, decision) records activation.
10. StudySite.openEnrollment(decision) allows participant enrollment.

Rules to verify

• Selection does not equal activation.
• Activation does not necessarily equal open enrollment.
• Readiness is an assessment; activation is a decision.
• Each prerequisite identifies its evidence and effective version.
• Site identity survives investigator replacement and later suspension.
• Enrollment suspension does not erase site activation history.

Product review questions

• Who can override an unsatisfied readiness requirement?
• Are contract execution and investigational supply required for activation or only opening?
• Can a site be activated before every Study team member is qualified?
• Which decisions are country-specific rather than site-specific?