Study

Category: Entity
Review status: Proposed

Meaning

A Study is the stable identity of one clinical research undertaking. It remains the same Study across protocol versions, operational replanning, participating countries, and software systems.

Fields

Field	Type	Meaning
identity	StudyIdentity	Stable identity independent of study number corrections
officialTitle	StudyTitle	Governed title of the Study
shortTitle	StudyShortTitle?	Operationally useful name
sponsor	OrganizationReference	Organization with sponsor responsibility
developmentProgram	DevelopmentProgramReference?	Program to which the Study contributes
developmentProducts	DevelopmentProductReference[]	Development assets investigated by the Study
phase	StudyPhase?	Applicable development phase
studyType	StudyType	Interventional, observational, or another governed type
identifiers	StudyIdentifier[]	Protocol, registry, authority, and sponsor identifiers
status	StudyLifecycleStatus	High-level lifecycle of the Study identity

Relationships

Study
├── has Protocol
├── participates in Development Program
├── investigates Development Product through Study Intervention
├── contains Study Countries
├── contains Study Sites
├── has Study Participants
├── has Operational Plans
└── produces Study Evidence and Results

Behaviours

• Register the Study
• Correct an identifier or title
• Associate a Development Product
• Establish a Study Intervention
• Add a Study Country
• Associate a Facility as a Study Site
• Adopt an approved Protocol Version
• Suspend conduct
• Close the Study
• Archive the Study record

Rules

• Stable identity does not change when a study number or title is corrected.
• A Study can have several identifiers, each with an issuer and effective history.
• A Protocol Version governs scientific intent; it is not embedded as mutable Study fields.
• Closing a Study does not delete participants, data, decisions, or evidence.
• Product-specific status must not be collapsed into one universal Study status.

Outcomes

StudyRegistered, StudyIdentifierCorrected, StudyCountryAdded, StudySiteAssociated, ProtocolVersionAdopted, StudyConductSuspended, StudyClosed, StudyArchived.

Product questions

• Can one Protocol govern more than one independently identified Study?
• Which changes correct Study identity, and which require a new Study?
• Which high-level lifecycle states are genuinely meaningful across all study types?
• How should umbrella, basket, platform, and master-protocol relationships be represented?