Study Startup domain model

Product boundary

Study Startup owns the progression from candidate site through qualification, selection, country/site requirements, submissions, approvals, essential-document readiness and greenlight. CTMS consumes the operational result; eTMF owns enduring essential-record completeness.

CandidateStudySite
├── FeasibilityAssessment
├── QualificationActivity
└── SiteSelectionDecision
     └── StudySiteStartup
         ├── StartupMilestone
         ├── StartupRequirement
         │   └── ExpectedStartupDocument
         ├── SubmissionPackage
         │   └── AuthorityDecision / EthicsDecision
         ├── AgreementReadiness
         ├── InitiationReadiness
         └── SiteGreenlightDecision

Lifecycle

candidate → qualifying ↔ qualifying-hold → initiating ↔ initiating-hold → active → closing → closed

“Selected,” “greenlit,” “initiated,” “active,” and “open for enrollment” are separate decisions or milestones. The model must not compress them into one site status.

Key rules

• Selection requires a recorded feasibility/qualification decision, not merely completion of a questionnaire.
• Country and Site requirement sets are versioned from global/country templates and can be tailored explicitly.
• Document completeness is evaluated against expected requirements linked to milestones.
• Greenlight requires satisfied mandatory approvals, executed agreements where required, essential-document readiness, training/readiness evidence, and an accountable decision.
• An approval expiry or withdrawal can revoke readiness without deleting the original greenlight evidence.

Evidence crosswalk

Observed product behaviour	TechSol decision	Difference / question
Site lifecycle includes Candidate, Qualifying, Initiating, Active and Closed	candidate evaluation and activated Study Site are connected but distinct lifecycles	should one aggregate span selection and activation?
Qualifying state can create milestones, EDLs and tasks	QualificationStarted invokes policies that establish requirements	generated work is not part of site identity
Site Activation Progress combines milestone-linked EDL items by site	ActivationReadinessAssessment evaluates requirements and evidence at a cut-off	which missing items can be waived, and by whom?