Site Collaboration domain model

Product boundary

Site Collaboration owns the exchange conversation between sponsor/CRO and research site. It does not own the source document, the site’s eISF filing, the sponsor’s eTMF decision, or the safety content.

SiteConnection
├── StudySiteAccess
├── SitePackageDefinition
│   └── SitePackageDocumentDefinition
├── Distribution
│   └── DistributionRecipient
├── DocumentRequest
│   └── SiteSubmission
├── DocumentReconciliation
│   └── DocumentComparison
├── SafetyDistribution
├── StudyAnnouncement
├── SiteSystemLink
└── PaymentInformationDelivery

Key behaviours

• enable or revoke a Study Person’s site access using effective participation dates;
• assemble and send site packages with expected action per document;
• request original or revised content and track the response conversation;
• receive a site document with source identity and classification context;
• reconcile sponsor and site document versions without asserting they are one record;
• distribute safety content and retain recipient/delivery evidence;
• publish scoped announcements and system links.

A Distribution tracks exact content versions, recipients, destination and delivery outcome. Replacing source content does not rewrite what was sent.

Evidence crosswalk

Observed product behaviour	TechSol decision	Difference / question
Distribution Tasks track content, destination and status	Distribution is the exchange aggregate with immutable content manifest	should each recipient be a child or independent delivery aggregate?
Site packages combine documents and requests with expected actions	SitePackage snapshots selected definitions and target sites	can one package version be partially recalled?
Document reconciliation compares sponsor content and the site eISF	DocumentComparison records equivalence/supersession decision	what evidence proves two renditions represent the same record?