This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples

Resource Profile: ActivityDefinition - Test

This ActivityDefinition profile represents a set of tests and their acceptance criteria through the contained ObservationDefinition resources.

Usage:

• Use this Resource Profile: Bundle – Drug Stability PQ and Bundle - Product Process Validation PQ
• Examples for this Resource Profile: ActivityDefinition/LyophilizationAct and ActivityDefinition/activitydefinition-test-drug-pq-ex1

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 ActivityDefinition

Name	Flags	Card.	Type	Description & Constraints
ActivityDefinition		0..*	ActivityDefinition	The definition of a specific activity to be taken, independent of any particular patient or context
status	S	1..1	code	draft | active | retired | unknown
observationRequirement	S	0..*	canonical(ObservationDefinition)	What observations are required to perform this action
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
ActivityDefinition	C	0..*	ActivityDefinition	The definition of a specific activity to be taken, independent of any particular patient or context
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
doNotPerform	?!Σ	0..1	boolean	True if the activity should not be performed
observationRequirement	S	0..*	canonical(ObservationDefinition)	What observations are required to perform this action
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
ActivityDefinition.status	required	PublicationStatus

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	ActivityDefinition	Name should be usable as an identifier for the module by machine processing applications such as code generation : name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
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()

Name	Flags	Card.	Type	Description & Constraints
ActivityDefinition	C	0..*	ActivityDefinition	The definition of a specific activity to be taken, independent of any particular patient or context
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	ΣC	0..1	uri	Canonical identifier for this activity definition, represented as a URI (globally unique)
identifier	Σ	0..*	Identifier	Additional identifier for the activity definition
version	Σ	0..1	string	Business version of the activity definition
versionAlgorithm[x]	Σ	0..1		How to compare versions Binding: VersionAlgorithm (extensible)
versionAlgorithmString			string
versionAlgorithmCoding			Coding
name	ΣC	0..1	string	Name for this activity definition (computer friendly)
title	Σ	0..1	string	Name for this activity definition (human friendly)
subtitle		0..1	string	Subordinate title of the activity definition
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
experimental	Σ	0..1	boolean	For testing purposes, not real usage
subject[x]		0..1		Type of individual the activity definition is intended for Binding: ParticipantResourceTypes (extensible): The possible types of subjects for an activity (E.g. Patient, Practitioner, Organization, Location, etc.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group | MedicinalProductDefinition | SubstanceDefinition | AdministrableProductDefinition | ManufacturedItemDefinition | PackagedProductDefinition)
subjectCanonical			canonical(EvidenceVariable)
date	Σ	0..1	dateTime	Date last changed
publisher	Σ	0..1	string	Name of the publisher/steward (organization or individual)
contact	Σ	0..*	ContactDetail	Contact details for the publisher
description	Σ	0..1	markdown	Natural language description of the activity definition
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
jurisdiction	Σ	0..*	CodeableConcept	Intended jurisdiction for activity definition (if applicable) Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
purpose		0..1	markdown	Why this activity definition is defined
usage		0..1	markdown	Describes the clinical usage of the activity definition
copyright		0..1	markdown	Use and/or publishing restrictions
copyrightLabel		0..1	string	Copyright holder and year(s)
approvalDate		0..1	date	When the activity definition was approved by publisher
lastReviewDate		0..1	date	When the activity definition was last reviewed by the publisher
effectivePeriod	Σ	0..1	Period	When the activity definition is expected to be used
topic		0..*	CodeableConcept	E.g. Education, Treatment, Assessment, etc Binding: DefinitionTopic (example): High-level categorization of the definition, used for searching, sorting, and filtering.
author		0..*	ContactDetail	Who authored the content
editor		0..*	ContactDetail	Who edited the content
reviewer		0..*	ContactDetail	Who reviewed the content
endorser		0..*	ContactDetail	Who endorsed the content
relatedArtifact		0..*	RelatedArtifact	Additional documentation, citations, etc
library		0..*	canonical(Library)	Logic used by the activity definition
kind	Σ	0..1	code	Kind of resource Binding: RequestResourceTypes (required): The kind of activity the definition is describing.
profile		0..1	canonical(StructureDefinition)	What profile the resource needs to conform to
code	Σ	0..1	CodeableConcept	Detail type of activity Binding: ProcedureCodesSNOMEDCT (example): Detailed type of the activity; e.g. CBC.
intent		0..1	code	proposal | plan | directive | order | original-order | reflex-order | filler-order | instance-order | option Binding: RequestIntent (required): Codes indicating the degree of authority/intentionality associated with a request.
priority		0..1	code	routine | urgent | asap | stat Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.
doNotPerform	?!Σ	0..1	boolean	True if the activity should not be performed
timing[x]		0..1		When activity is to occur
timingTiming			Timing
timingAge			Age
timingRange			Range
timingDuration			Duration
asNeeded[x]	Σ	0..1		Preconditions for service Binding: SNOMEDCTMedicationAsNeededReasonCodes (example): A coded concept identifying the pre-condition that should hold prior to performing a procedure. For example "pain", "on flare-up", etc.
asNeededBoolean			boolean
asNeededCodeableConcept			CodeableConcept
location		0..1	CodeableReference(Location)	Where it should happen
participant		0..*	BackboneElement	Who should participate in the action
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		0..1	code	careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson Binding: ActionParticipantType (required): The type of participant in the activity.
typeCanonical		0..1	canonical(CapabilityStatement)	Who or what can participate
typeReference		0..1	Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)	Who or what can participate
role		0..1	CodeableConcept	E.g. Nurse, Surgeon, Parent, etc Binding: Action Participant Role (example): Defines roles played by participants for the action.
function		0..1	CodeableConcept	E.g. Author, Reviewer, Witness, etc Binding: ActionParticipantFunction (example)
product[x]		0..1		What's administered/supplied Binding: SNOMEDCTMedicationCodes (example): Code describing the type of substance or medication.
productReference			Reference(Medication | Ingredient | Substance | SubstanceDefinition)
productCodeableConcept			CodeableConcept
quantity		0..1	SimpleQuantity	How much is administered/consumed/supplied
dosage		0..*	Dosage	Detailed dosage instructions
bodySite		0..*	CodeableConcept	What part of body to perform on Binding: SNOMEDCTBodyStructures (example): A code that identifies the anatomical location.
specimenRequirement		0..*	canonical(SpecimenDefinition)	What specimens are required to perform this action
observationRequirement	S	0..*	canonical(ObservationDefinition)	What observations are required to perform this action
observationResultRequirement		0..*	canonical(ObservationDefinition)	What observations must be produced by this action
transform		0..1	canonical(StructureMap)	Transform to apply the template
dynamicValue		0..*	BackboneElement	Dynamic aspects of the definition
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
path		1..1	string	The path to the element to be set dynamically
expression		1..1	Expression	An expression that provides the dynamic value for the customization
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
ActivityDefinition.language	required	AllLanguages
ActivityDefinition.versionAlgorithm[x]	extensible	VersionAlgorithm
ActivityDefinition.status	required	PublicationStatus
ActivityDefinition.subject[x]	extensible	ParticipantResourceTypes
ActivityDefinition.jurisdiction	extensible	JurisdictionValueSet
ActivityDefinition.topic	example	DefinitionTopic
ActivityDefinition.kind	required	RequestResourceTypes
ActivityDefinition.code	example	ProcedureCodesSNOMEDCT
ActivityDefinition.intent	required	RequestIntent
ActivityDefinition.priority	required	RequestPriority
ActivityDefinition.asNeeded[x]	example	SNOMEDCTMedicationAsNeededReasonCodes
ActivityDefinition.participant.type	required	ActionParticipantType
ActivityDefinition.participant.role	example	ActionParticipantRole
ActivityDefinition.participant.function	example	ActionParticipantFunction
ActivityDefinition.product[x]	example	SNOMEDCTMedicationCodes
ActivityDefinition.bodySite	example	SNOMEDCTBodyStructures

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	ActivityDefinition	Name should be usable as an identifier for the module by machine processing applications such as code generation : name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
cnl-1	warning	ActivityDefinition.url	URL should not contain | or # - these characters make processing canonical references problematic : exists() implies matches('^[^|# ]+$')
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()

This structure is derived from ActivityDefinition

Summary

Must-Support: 2 elements

Differential View

This structure is derived from ActivityDefinition

Name	Flags	Card.	Type	Description & Constraints
ActivityDefinition		0..*	ActivityDefinition	The definition of a specific activity to be taken, independent of any particular patient or context
status	S	1..1	code	draft | active | retired | unknown
observationRequirement	S	0..*	canonical(ObservationDefinition)	What observations are required to perform this action
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
ActivityDefinition	C	0..*	ActivityDefinition	The definition of a specific activity to be taken, independent of any particular patient or context
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
doNotPerform	?!Σ	0..1	boolean	True if the activity should not be performed
observationRequirement	S	0..*	canonical(ObservationDefinition)	What observations are required to perform this action
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
ActivityDefinition.status	required	PublicationStatus

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	ActivityDefinition	Name should be usable as an identifier for the module by machine processing applications such as code generation : name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
ActivityDefinition	C	0..*	ActivityDefinition	The definition of a specific activity to be taken, independent of any particular patient or context
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	ΣC	0..1	uri	Canonical identifier for this activity definition, represented as a URI (globally unique)
identifier	Σ	0..*	Identifier	Additional identifier for the activity definition
version	Σ	0..1	string	Business version of the activity definition
versionAlgorithm[x]	Σ	0..1		How to compare versions Binding: VersionAlgorithm (extensible)
versionAlgorithmString			string
versionAlgorithmCoding			Coding
name	ΣC	0..1	string	Name for this activity definition (computer friendly)
title	Σ	0..1	string	Name for this activity definition (human friendly)
subtitle		0..1	string	Subordinate title of the activity definition
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
experimental	Σ	0..1	boolean	For testing purposes, not real usage
subject[x]		0..1		Type of individual the activity definition is intended for Binding: ParticipantResourceTypes (extensible): The possible types of subjects for an activity (E.g. Patient, Practitioner, Organization, Location, etc.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group | MedicinalProductDefinition | SubstanceDefinition | AdministrableProductDefinition | ManufacturedItemDefinition | PackagedProductDefinition)
subjectCanonical			canonical(EvidenceVariable)
date	Σ	0..1	dateTime	Date last changed
publisher	Σ	0..1	string	Name of the publisher/steward (organization or individual)
contact	Σ	0..*	ContactDetail	Contact details for the publisher
description	Σ	0..1	markdown	Natural language description of the activity definition
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
jurisdiction	Σ	0..*	CodeableConcept	Intended jurisdiction for activity definition (if applicable) Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
purpose		0..1	markdown	Why this activity definition is defined
usage		0..1	markdown	Describes the clinical usage of the activity definition
copyright		0..1	markdown	Use and/or publishing restrictions
copyrightLabel		0..1	string	Copyright holder and year(s)
approvalDate		0..1	date	When the activity definition was approved by publisher
lastReviewDate		0..1	date	When the activity definition was last reviewed by the publisher
effectivePeriod	Σ	0..1	Period	When the activity definition is expected to be used
topic		0..*	CodeableConcept	E.g. Education, Treatment, Assessment, etc Binding: DefinitionTopic (example): High-level categorization of the definition, used for searching, sorting, and filtering.
author		0..*	ContactDetail	Who authored the content
editor		0..*	ContactDetail	Who edited the content
reviewer		0..*	ContactDetail	Who reviewed the content
endorser		0..*	ContactDetail	Who endorsed the content
relatedArtifact		0..*	RelatedArtifact	Additional documentation, citations, etc
library		0..*	canonical(Library)	Logic used by the activity definition
kind	Σ	0..1	code	Kind of resource Binding: RequestResourceTypes (required): The kind of activity the definition is describing.
profile		0..1	canonical(StructureDefinition)	What profile the resource needs to conform to
code	Σ	0..1	CodeableConcept	Detail type of activity Binding: ProcedureCodesSNOMEDCT (example): Detailed type of the activity; e.g. CBC.
intent		0..1	code	proposal | plan | directive | order | original-order | reflex-order | filler-order | instance-order | option Binding: RequestIntent (required): Codes indicating the degree of authority/intentionality associated with a request.
priority		0..1	code	routine | urgent | asap | stat Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.
doNotPerform	?!Σ	0..1	boolean	True if the activity should not be performed
timing[x]		0..1		When activity is to occur
timingTiming			Timing
timingAge			Age
timingRange			Range
timingDuration			Duration
asNeeded[x]	Σ	0..1		Preconditions for service Binding: SNOMEDCTMedicationAsNeededReasonCodes (example): A coded concept identifying the pre-condition that should hold prior to performing a procedure. For example "pain", "on flare-up", etc.
asNeededBoolean			boolean
asNeededCodeableConcept			CodeableConcept
location		0..1	CodeableReference(Location)	Where it should happen
participant		0..*	BackboneElement	Who should participate in the action
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		0..1	code	careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson Binding: ActionParticipantType (required): The type of participant in the activity.
typeCanonical		0..1	canonical(CapabilityStatement)	Who or what can participate
typeReference		0..1	Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)	Who or what can participate
role		0..1	CodeableConcept	E.g. Nurse, Surgeon, Parent, etc Binding: Action Participant Role (example): Defines roles played by participants for the action.
function		0..1	CodeableConcept	E.g. Author, Reviewer, Witness, etc Binding: ActionParticipantFunction (example)
product[x]		0..1		What's administered/supplied Binding: SNOMEDCTMedicationCodes (example): Code describing the type of substance or medication.
productReference			Reference(Medication | Ingredient | Substance | SubstanceDefinition)
productCodeableConcept			CodeableConcept
quantity		0..1	SimpleQuantity	How much is administered/consumed/supplied
dosage		0..*	Dosage	Detailed dosage instructions
bodySite		0..*	CodeableConcept	What part of body to perform on Binding: SNOMEDCTBodyStructures (example): A code that identifies the anatomical location.
specimenRequirement		0..*	canonical(SpecimenDefinition)	What specimens are required to perform this action
observationRequirement	S	0..*	canonical(ObservationDefinition)	What observations are required to perform this action
observationResultRequirement		0..*	canonical(ObservationDefinition)	What observations must be produced by this action
transform		0..1	canonical(StructureMap)	Transform to apply the template
dynamicValue		0..*	BackboneElement	Dynamic aspects of the definition
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
path		1..1	string	The path to the element to be set dynamically
expression		1..1	Expression	An expression that provides the dynamic value for the customization
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
ActivityDefinition.language	required	AllLanguages
ActivityDefinition.versionAlgorithm[x]	extensible	VersionAlgorithm
ActivityDefinition.status	required	PublicationStatus
ActivityDefinition.subject[x]	extensible	ParticipantResourceTypes
ActivityDefinition.jurisdiction	extensible	JurisdictionValueSet
ActivityDefinition.topic	example	DefinitionTopic
ActivityDefinition.kind	required	RequestResourceTypes
ActivityDefinition.code	example	ProcedureCodesSNOMEDCT
ActivityDefinition.intent	required	RequestIntent
ActivityDefinition.priority	required	RequestPriority
ActivityDefinition.asNeeded[x]	example	SNOMEDCTMedicationAsNeededReasonCodes
ActivityDefinition.participant.type	required	ActionParticipantType
ActivityDefinition.participant.role	example	ActionParticipantRole
ActivityDefinition.participant.function	example	ActionParticipantFunction
ActivityDefinition.product[x]	example	SNOMEDCTMedicationCodes
ActivityDefinition.bodySite	example	SNOMEDCTBodyStructures

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	ActivityDefinition	Name should be usable as an identifier for the module by machine processing applications such as code generation : name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
cnl-1	warning	ActivityDefinition.url	URL should not contain | or # - these characters make processing canonical references problematic : exists() implies matches('^[^|# ]+$')
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()

This structure is derived from ActivityDefinition

Summary

Must-Support: 2 elements

Other representations of profile: CSV, Excel, Schematron