Intervention and Supply

Category: Entities, definitions, material movements, and decisions
Review status: Proposed

Object hierarchy

DevelopmentProduct
└── StudyIntervention
    └── TreatmentStrategy
        └── TreatmentAssignment

SupplyProduct
├── Lot
│   └── Kit
├── DepotInventory
├── SiteInventory
├── Shipment
├── Dispensation
├── Return
└── Destruction

Important distinctions

Object	Meaning
DevelopmentProduct	Stable identity of the asset under development
StudyIntervention	The asset’s declared role and use in one Study
TreatmentStrategy	Protocol-defined intervention pattern for an arm/cohort
TreatmentAssignment	Participant-specific allocation to a treatment strategy
SupplyProduct	Manufacturable and distributable presentation
Kit	Tracked physical or logical supply unit
Dispensation	Controlled transfer of supply for participant use
Administration	Actual participant use or administration of treatment

Randomization does not prove dispensation. Dispensation does not prove administration.

Randomization behaviours

randomizationDesign.randomize(
  participant: EligibleParticipant,
  stratum: VerifiedStratum,
  authorization: RandomizationAuthorization,
): TreatmentAssignment;

treatmentAssignment.authorizeEmergencyUnblinding(
  decision: UnblindingDecision,
): AllocationRevealed;

Supply behaviours

• Release a lot for study use
• Package and label kits
• Allocate inventory to a depot or site
• Plan and release a shipment
• Receive and quarantine supply
• Make supply available
• Select and dispense a kit
• Record return or loss
• Reconcile accountability
• Authorize destruction

Rules

• Treatment assignments are disclosed according to explicit blind partitions.
• Inventory state reflects controlled material movements, not manual replacement of totals.
• Dispensation requires an applicable treatment assignment and eligible inventory.
• Expired, quarantined, damaged, or recalled supply cannot be dispensed.
• Every kit movement remains traceable through accountability.
• Emergency unblinding records the question, authority, reason, scope, and information revealed.

Product questions

• Which supply units require individual serialization?
• How are pooled, bulk, device, and non-investigational supplies represented?
• Can a dispensation occur before all scheduled clinical data are complete?
• How do replacement kits and partial dispensing affect accountability?