Protocol

Category: Entity with governed versions
Review status: Proposed

Meaning

A Protocol is the continuing governed specification of a Study. A ProtocolVersion is one immutable approved or controlled draft expression of that intent.

Core objects

Object	Meaning
Protocol	Stable continuity of the governing specification
ProtocolVersion	Exact immutable version of protocol intent
ProtocolAmendment	Approved change relationship between versions
StudyObjective	Scientific question the Study intends to address
Endpoint	Defined outcome used to evaluate an objective
StudyPopulation	Intended participant population
EligibilityCriterion	Inclusion or exclusion rule
StudyArm	Planned intervention strategy
Cohort	Planned participant grouping and entry rules
StudyEpoch	Planned period in participant experience
ActivityDefinition	Protocol-required assessment, procedure, contact, or administration
ActivityPlacement	Contextual use of an activity in the schedule

Protocol Version fields

Field	Type	Meaning
identity	ProtocolVersionIdentity	Stable identity of the exact version
protocol	ProtocolReference	Continuing Protocol identity
versionLabel	ProtocolVersionLabel	Business-facing version label
status	DefinitionStatus	Draft, approved, effective, superseded, or withdrawn
effectivePeriod	EffectivePeriod?	When the version may govern conduct
objectives	StudyObjective[]	Scientific objectives
population	StudyPopulation	Intended participant population
arms	StudyArm[]	Planned intervention strategies
epochs	StudyEpoch[]	Planned participant periods
activities	ActivityDefinition[]	Required or permitted protocol activities
schedule	ScheduleOfActivities	Activity placements and timing relationships
criticalToQualityFactors	CriticalToQualityFactor[]	Factors essential to participant protection and reliable results

Behaviours

protocol.startDraftVersion(base?: ProtocolVersion): ProtocolVersionDraft;
protocol.validate(version: ProtocolVersionDraft): ProtocolValidation;
protocol.approve(version: ValidProtocolVersion, decision: ApprovalDecision): ProtocolVersionApproved;
protocol.proposeAmendment(base: ProtocolVersion, changes: ProtocolChangeSet): ProtocolAmendmentDraft;
protocol.approveAmendment(amendment: ReviewedAmendment): ProtocolAmendmentApproved;

Rules

• Approved Protocol Versions are immutable.
• Every amendment identifies its predecessor, rationale, changes, and expected impact.
• Schedule order, timing, applicability, and requiredness are different meanings.
• An activity definition is separate from each contextual placement in the schedule.
• Operational configurations identify the exact Protocol Version they realize.
• Amendment approval does not automatically migrate participants or downstream systems.

Outcomes

ProtocolDraftStarted, ProtocolVersionValidated, ProtocolVersionApproved, ProtocolAmendmentProposed, ProtocolAmendmentApproved, ProtocolVersionSuperseded.

Product questions

• Is the Protocol the authority for all cross-product schedule semantics?
• Which protocol elements must be computable versus retained as governed narrative?
• How are country-specific versions or local adaptations represented?
• Can different participant cohorts concurrently follow different Protocol Versions?