Disclosures domain model

Product boundary

Disclosures owns the determination, preparation, approval, submission and maintenance of clinical trial registry and results-disclosure obligations. It consumes authoritative study/country status and product data; it does not own those source records.

DisclosureRuleSet
└── DisclosureObligation
    ├── RegistryRegistration
    │   └── RegistrationVersion
    ├── ResultsDisclosure
    │   └── ResultsVersion
    ├── DisclosureTask
    ├── ValidationFinding
    ├── ApprovalDecision
    └── RegistrySubmission
        └── AuthorityAcknowledgement

Key rules

• Obligation assessment records jurisdiction/registry, triggering facts, due-date rule and rule version.
• Each submission is an immutable version with exact disclosed values and documents.
• Validation distinguishes syntax, registry business rule and cross-record consistency findings.
• Study milestone changes may create or reschedule tasks but cannot silently edit an approved disclosure.
• Registry acknowledgement, rejection and correction are separate outcomes.

Evidence crosswalk

Observed product behaviour	TechSol decision	Difference / question
CTMS data can prepopulate disclosures	disclosed fields reference a source snapshot and can be deliberately overridden	which fields require source re-attestation after change?
Registry rules and alerts drive tasks/deadlines	DisclosureObligation retains rule version and triggering facts	how are conflicting country and registry obligations reconciled?
Validation and version control precede submission	each DisclosureSubmission has immutable payload and validation result	is registry correction a new submission or a version of one filing?