HL7.FHIR.UV.VULCAN-SCHEDULE\StudyProtocolSoa

Clinical Study Schedule of Activities
1.0.0 - trial-use International flag

This page is part of the Clinical Study Schedule of Activities (v1.0.0: STU1) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: StudyProtocolSoa

Official URL: http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyProtocolSoa				Version: 1.0.0
Active as of 2023-04-18				Computable Name: StudyProtocolSoa

A profile that lists the data elements of a PlanDefinition that must be supported so that it can represent an entire set of visits and activities for a given study protocol.

Usage:

Refer to this Resource Profile: ResearchStudySoa
Examples for this Resource Profile: PlanDefinition/H2Q-MC-LZZT-ProtocolDesign

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

Differential Table
Key Elements Table
Snapshot Table
Statistics/References
All

This structure is derived from PlanDefinition

Name	Flags	Card.	Type	Description & Constraints
PlanDefinition		0..*	PlanDefinition	The definition of a plan for a series of actions, independent of any specific patient or context
url	S	0..1	uri	Canonical identifier for this plan definition, represented as a URI (globally unique)
name	S	0..1	string	Name for this plan definition (computer friendly)
title	S	0..1	string	Name for this plan definition (human friendly)
status	S	1..1	code	draft \| active \| retired \| unknown
subject[x]	S	0..1	CodeableConcept, Reference(Group)	Type of individual the plan definition is focused on
description	S	0..1	markdown	Natural language description of the plan definition
action	S	0..*	BackboneElement	Action defined by the plan
title	S	0..1	string	User-visible title
code	S	0..*	CodeableConcept	Code representing the meaning of the action or sub-actions
trigger	S	0..*	TriggerDefinition	When the action should be triggered
relatedAction	S	0..*	BackboneElement	Relationship to another action
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
acceptableOffsetRange		0..1	Range	Acceptable Offset Range URL: http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/AcceptableOffsetRangeSoa
actionId	S	1..1	id	What action is this related to
relationship	S	1..1	code	before-start \| before \| before-end \| concurrent-with-start \| concurrent \| concurrent-with-end \| after-start \| after \| after-end
offset[x]	S	0..1	Duration, Range	Time offset for the relationship
timing[x]	S	0..1	dateTime, Age, Period, Duration, Range, Timing	When the action should take place
requiredBehavior	S	0..1	code	must \| could \| must-unless-documented
cardinalityBehavior	S	0..1	code	single \| multiple
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
PlanDefinition	C	0..*	PlanDefinition	The definition of a plan for a series of actions, independent of any specific patient or context
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
url	SΣ	0..1	uri	Canonical identifier for this plan definition, represented as a URI (globally unique)
name	SΣC	0..1	string	Name for this plan definition (computer friendly)
title	SΣ	0..1	string	Name for this plan definition (human friendly)
status	?!SΣ	1..1	code	draft \| active \| retired \| unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
subject[x]	S	0..1		Type of individual the plan definition is focused on Binding: SubjectType (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group)
description	SΣ	0..1	markdown	Natural language description of the plan definition
action	S	0..*	BackboneElement	Action defined by the plan
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title	S	0..1	string	User-visible title
code	S	0..*	CodeableConcept	Code representing the meaning of the action or sub-actions
trigger	S	0..*	TriggerDefinition	When the action should be triggered
relatedAction	S	0..*	BackboneElement	Relationship to another action
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
acceptableOffsetRange		0..1	Range	Acceptable Offset Range URL: http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/AcceptableOffsetRangeSoa
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
actionId	S	1..1	id	What action is this related to
relationship	S	1..1	code	before-start \| before \| before-end \| concurrent-with-start \| concurrent \| concurrent-with-end \| after-start \| after \| after-end Binding: ActionRelationshipType (required): Defines the types of relationships between actions.
offset[x]	S	0..1		Time offset for the relationship
offsetDuration			Duration
offsetRange			Range
timing[x]	S	0..1		When the action should take place
timingDateTime			dateTime
timingAge			Age
timingPeriod			Period
timingDuration			Duration
timingRange			Range
timingTiming			Timing
requiredBehavior	S	0..1	code	must \| could \| must-unless-documented Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.
cardinalityBehavior	S	0..1	code	single \| multiple Binding: ActionCardinalityBehavior (required): Defines behavior for an action or a group for how many times that item may be repeated.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
PlanDefinition.status	required	PublicationStatus
PlanDefinition.subject[x]	extensible	SubjectType
PlanDefinition.action.relatedAction.relationship	required	ActionRelationshipType
PlanDefinition.action.requiredBehavior	required	ActionRequiredBehavior
PlanDefinition.action.cardinalityBehavior	required	ActionCardinalityBehavior

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	PlanDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	PlanDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	PlanDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	PlanDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	PlanDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	ALL elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	ALL extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
pdf-0	warning	PlanDefinition	Name should be usable as an identifier for the module by machine processing applications such as code generation : name.matches('[A-Z]([A-Za-z0-9_]){0,254}')