Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• XML
• JSON

Resource Profile: Quality Specification

A quality specification is for a drug product or drug substance (excipient, API or raw material).

Usage:

• Use this Resource Profile: CMC eCTD 32S23 Document and CMC eCTD SP4151 Document
• Refer to this Resource Profile: eCTD Substance Control of Materials Composition and eCTD Specification Composition

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			PlanDefinition
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
ApprovalStatus	S	1..1	CodeableConcept	Specification Status URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension Binding: Specification Status Terminology (required)
spec-additional-info		0..1	markdown	Specification Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
identifier	S	0..*	Identifier	Additional identifier for the plan definition
version	S	1..1	string	Specification Version
title	S	1..1	string	Specification Title
subtitle	S	0..1	string	Specification Subtitle
type	S	1..1	CodeableConcept	Specification Type
Slices for coding	S	2..2	Coding	Code defined by a terminology system Slice: Unordered, Closed by value:$this
coding:DefinitionType	S	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/plan-definition-type
code		1..1	code	Symbol in syntax defined by the system Fixed Value: workflow-definition
display		1..1	string	Representation defined by the system Fixed Value: Workflow Definition
coding:SpecType	S	1..1	Coding	Specification Type Binding: Specification Type Terminology (required)
status	S	1..1	code	draft | active | retired | unknown
subject[x]	S	1..1	LiteralReference(Drug Product Handle | Drug Substance Handle | Excipient Drug Substance) {b}	Type of individual the plan definition is focused on
date	S	1..1	dateTime	Specification Version Date
approvalDate	S	0..1	date	Specification Status Date
goal	S	0..*	BackboneElement	Acceptance Criteria
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
ac-additional-info		0..1	markdown	Acceptance Criteria Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
description	S	1..1	CodeableConcept	Original Text
addresses	S	1..*	CodeableConcept	Acceptance Criteria Usage Binding: Test Usage Terminology (required)
target	SC	1..*	BackboneElement	Acceptance Criteron cmc-target-range: When the Range extension is present, detail cannot be present.
Slices for modifierExtension		0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:targetRange	S	0..1	TargetRange	Target Range
measure	S	0..1	CodeableConceptTextOnly	Detailed parameter being measured if more granular than Sub-Test
Slices for detail[x]	S	0..1		The target value to be achieved Slice: Unordered, Open by type:$this
detailQuantity			Quantity
detailString			string
detailInteger			integer
detail[x]:detailQuantity	S	0..1	Quantity	ValueNumeric Binding: Units Of Measure (required)
value	S	1..1	decimal	Numerical value (with implicit precision)
comparator	S	0..1	code	< | <= | >= | > | ad - how to understand the value
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit
detail[x]:detailString	S	0..1	string	Value
detail[x]:detailInteger	S	0..1	integer	Number of Replicates
due		0..0
action	SC	1..*	BackboneElement	Method cmc-link-required: Action linkId is required for alternate tests cmc-single-or-multistage: if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes
linkId	S	0..1	string	only required for alternate tests
prefix	S	0..1	string	Stage Name
title	S	1..1	string	Test Name
description	S	0..1	markdown	Test Additional Information
code	S	1..1	CodeableConcept	Test Method Origin
coding	S	1..1	Coding	Code defined by a terminology system Binding: Test Method Origin Terminology (required)
text	S	1..1	string	Analytical Procedure
reason	S	1..2	CodeableConcept	Test Category | Test Subcategory Binding: Test Category Terminology (required)
extension		1..*	Extension	Extension
Slices for extension				Content/Rules for all slices
categoryLevel	S	1..1	positiveInt	Hierarchical Level URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
documentation	S	0..1	RelatedArtifact	Supporting documentation for the intended performer of the action
type		1..1	code	documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as Required Pattern: documentation
label	S	1..1	string	Reference to Procedure
goalId	S	0..*	id	Reference to Acceptance Criteria
relatedAction	S	0..*	BackboneElement	Alternate Test
targetId	S	1..1	id	What action is this related to
relationship	S	1..1	code	Code is concurrent Required Pattern: concurrent
action	S	0..*	BackboneElement	Groups or Stages
prefix	S	0..1	string	Stage Name
title	S	0..1	string	Test Name (only reqired if different than above)
description	S	0..1	markdown	Test Additional Information | Stage Additional Information
documentation	S	0..*	RelatedArtifact	Supporting documentation for the intended performer of the action
type		1..1	code	documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as Required Pattern: documentation
document	S	1..1	Attachment	Test or Stage Additional Information Visual Attachments
contentType	S	1..1	code	Mime type of the content, with charset etc.
data	S	1..1	base64Binary	Data inline, base64ed
title	S	1..1	string	Document file name including the file extension
goalId	S	0..*	id	Reference to Acceptance Criteria
action	SC	0..*	BackboneElement	Sub-Test cmc-subtest-rrt: a subtest's prefix represents relative retention time, should it exist
prefix	S	0..1	string	RRT
title	S	1..1	string	Test Name | RRT (complex testing)
description	S	0..1	markdown	Test Additional Information | Stage Additional Information
goalId	S	1..*	id	Reference to Acceptance Criteria
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
PlanDefinition.type.coding:SpecType	required	PqcmcSpecificationTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology from this IG
PlanDefinition.goal.addresses	required	PqcmcTestUsageTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology from this IG
PlanDefinition.goal.target.detail[x]:detailQuantity	required	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
PlanDefinition.action.code.coding	required	PqcmcTestMethodOriginTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology from this IG
PlanDefinition.action.reason	required	PqcmcTestCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-link-required	error	PlanDefinition.action	Action linkId is required for alternate tests : (action.relatedAction.count() > 0) implies action.linkId.exists()
cmc-single-or-multistage	error	PlanDefinition.action	if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes : (( prefix.exists() implies action.prefix.empty() and prefix = 'Single Stage' ) and ( prefix.empty() implies ( (action.where( prefix.exists() and prefix != 'Single Stage' ).count() = action.count()) and action.prefix.isDistinct() ) )) = true
cmc-subtest-rrt	error	PlanDefinition.action.action.action	a subtest's prefix represents relative retention time, should it exist : prefix.exists() implies prefix.single() = 'RRT'
cmc-target-range	error	PlanDefinition.goal.target	When the Range extension is present, detail cannot be present. : modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range').exists() implies detail.exists().not()

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 cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation pld-3: goalid should reference the id of a goal definition pld-4: targetId should reference the id of an action
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
ApprovalStatus	S	1..1	CodeableConcept	Specification Status URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension Binding: Specification Status Terminology (required)
spec-additional-info		0..1	markdown	Specification Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	Additional identifier for the plan definition
version	SΣ	1..1	string	Specification Version
title	SΣ	1..1	string	Specification Title
subtitle	S	0..1	string	Specification Subtitle
type	SΣ	1..1	CodeableConcept	Specification Type Binding: PlanDefinitionType (extensible): The type of PlanDefinition.
Slices for coding	SΣ	2..2	Coding	Code defined by a terminology system Slice: Unordered, Closed by value:$this
coding:DefinitionType	SΣ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/plan-definition-type
code		1..1	code	Symbol in syntax defined by the system Fixed Value: workflow-definition
display		1..1	string	Representation defined by the system Fixed Value: Workflow Definition
coding:SpecType	SΣ	1..1	Coding	Specification Type Binding: Specification Type Terminology (required)
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
subject[x]	S	1..1	LiteralReference(Drug Product Handle | Drug Substance Handle | Excipient Drug Substance) {b}	Type of individual the plan definition is focused on
date	SΣ	1..1	dateTime	Specification Version Date
approvalDate	S	0..1	date	Specification Status Date
goal	SC	0..*	BackboneElement	Acceptance Criteria
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
ac-additional-info		0..1	markdown	Acceptance Criteria Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
description	S	1..1	CodeableConcept	Original Text Binding: SNOMEDCTClinicalFindings (example): Describes goals that can be achieved.
addresses	S	1..*	CodeableConcept	Acceptance Criteria Usage Binding: Test Usage Terminology (required)
target	SC	1..*	BackboneElement	Acceptance Criteron cmc-target-range: When the Range extension is present, detail cannot be present.
Slices for modifierExtension	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:targetRange	?!S	0..1	TargetRange	Target Range
measure	S	0..1	CodeableConceptTextOnly	Detailed parameter being measured if more granular than Sub-Test Binding: LOINCCodes (example): Identifies types of parameters that can be tracked to determine goal achievement.
Slices for detail[x]	S	0..1		The target value to be achieved Slice: Unordered, Closed by type:$this
detailQuantity			Quantity
detailString			string
detailInteger			integer
detail[x]:detailQuantity	S	0..1	Quantity	ValueNumeric Binding: Units Of Measure (required)
value	SΣ	1..1	decimal	Numerical value (with implicit precision)
comparator	?!SΣ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
code	SΣC	1..1	code	Coded form of the unit
detail[x]:detailString	S	0..1	string	Value
detail[x]:detailInteger	S	0..1	integer	Number of Replicates
action	SC	1..*	BackboneElement	Method cmc-link-required: Action linkId is required for alternate tests cmc-single-or-multistage: if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
linkId	S	0..1	string	only required for alternate tests
prefix	S	0..1	string	Stage Name
title	S	1..1	string	Test Name
description	S	0..1	markdown	Test Additional Information
code	S	1..1	CodeableConcept	Test Method Origin Binding: ActionCode (example): Provides examples of actions to be performed.
coding	SΣ	1..1	Coding	Code defined by a terminology system Binding: Test Method Origin Terminology (required)
text	SΣ	1..1	string	Analytical Procedure
reason	S	1..2	CodeableConcept	Test Category | Test Subcategory Binding: Test Category Terminology (required)
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
categoryLevel	S	1..1	positiveInt	Hierarchical Level URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
documentation	S	0..1	RelatedArtifact	Supporting documentation for the intended performer of the action
type	Σ	1..1	code	documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as Binding: RelatedArtifactType (required): The type of relationship to the related artifact. Required Pattern: documentation
label	SΣ	1..1	string	Reference to Procedure
goalId	SC	0..*	id	Reference to Acceptance Criteria
relatedAction	SC	0..*	BackboneElement	Alternate Test
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
targetId	SC	1..1	id	What action is this related to
relationship	S	1..1	code	Code is concurrent Binding: ActionRelationshipType (required): Defines the types of relationships between actions. Required Pattern: concurrent
action	S	0..*	BackboneElement	Groups or Stages
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
prefix	S	0..1	string	Stage Name
title	S	0..1	string	Test Name (only reqired if different than above)
description	S	0..1	markdown	Test Additional Information | Stage Additional Information
documentation	S	0..*	RelatedArtifact	Supporting documentation for the intended performer of the action
type	Σ	1..1	code	documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as Binding: RelatedArtifactType (required): The type of relationship to the related artifact. Required Pattern: documentation
document	SΣ	1..1	Attachment	Test or Stage Additional Information Visual Attachments
contentType	SΣC	1..1	code	Mime type of the content, with charset etc. Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049) Example General: text/plain; charset=UTF-8, image/png
data	SC	1..1	base64Binary	Data inline, base64ed
title	SΣ	1..1	string	Document file name including the file extension Example General: Official Corporate Logo
goalId	SC	0..*	id	Reference to Acceptance Criteria
action	SC	0..*	BackboneElement	Sub-Test cmc-subtest-rrt: a subtest's prefix represents relative retention time, should it exist
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
prefix	S	0..1	string	RRT
title	S	1..1	string	Test Name | RRT (complex testing)
description	S	0..1	markdown	Test Additional Information | Stage Additional Information
goalId	SC	1..*	id	Reference to Acceptance Criteria
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
PlanDefinition.type	extensible	PlanDefinitionType http://hl7.org/fhir/ValueSet/plan-definition-type from the FHIR Standard
PlanDefinition.type.coding:SpecType	required	PqcmcSpecificationTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology from this IG
PlanDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
PlanDefinition.goal.description	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/clinical-findings from the FHIR Standard
PlanDefinition.goal.addresses	required	PqcmcTestUsageTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology from this IG
PlanDefinition.goal.target.measure	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
PlanDefinition.goal.target.detail[x]:detailQuantity	required	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
PlanDefinition.goal.target.detail[x]:detailQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
PlanDefinition.action.code	example	ActionCode http://hl7.org/fhir/ValueSet/action-code from the FHIR Standard
PlanDefinition.action.code.coding	required	PqcmcTestMethodOriginTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology from this IG
PlanDefinition.action.reason	required	PqcmcTestCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology from this IG
PlanDefinition.action.documentation.type	required	Pattern: documentation http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0 from the FHIR Standard
PlanDefinition.action.relatedAction.relationship	required	Pattern: concurrent http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.documentation.type	required	Pattern: documentation http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.documentation.document.contentType	required	MimeTypes (a valid code from urn:ietf:bcp:13) http://hl7.org/fhir/ValueSet/mimetypes|5.0.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-link-required	error	PlanDefinition.action	Action linkId is required for alternate tests : (action.relatedAction.count() > 0) implies action.linkId.exists()
cmc-single-or-multistage	error	PlanDefinition.action	if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes : (( prefix.exists() implies action.prefix.empty() and prefix = 'Single Stage' ) and ( prefix.empty() implies ( (action.where( prefix.exists() and prefix != 'Single Stage' ).count() = action.count()) and action.prefix.isDistinct() ) )) = true
cmc-subtest-rrt	error	PlanDefinition.action.action.action	a subtest's prefix represents relative retention time, should it exist : prefix.exists() implies prefix.single() = 'RRT'
cmc-target-range	error	PlanDefinition.goal.target	When the Range extension is present, detail cannot be present. : modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range').exists() implies detail.exists().not()
cnl-0	warning	PlanDefinition	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()
pld-3	warning	PlanDefinition	goalid should reference the id of a goal definition : %context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()
pld-4	warning	PlanDefinition	targetId should reference the id of an action : %context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()

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 cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation pld-3: goalid should reference the id of a goal definition pld-4: targetId should reference the id of an action
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
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
ApprovalStatus	S	1..1	CodeableConcept	Specification Status URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension Binding: Specification Status Terminology (required)
spec-additional-info		0..1	markdown	Specification Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	ΣC	0..1	uri	Canonical identifier for this plan definition, represented as a URI (globally unique) cnl-1: URL should not contain | or # - these characters make processing canonical references problematic
identifier	SΣ	0..*	Identifier	Additional identifier for the plan definition
version	SΣ	1..1	string	Specification Version
versionAlgorithm[x]	Σ	0..1		How to compare versions Binding: VersionAlgorithm (extensible)
versionAlgorithmString			string
versionAlgorithmCoding			Coding
name	ΣC	0..1	string	Name for this plan definition (computer friendly)
title	SΣ	1..1	string	Specification Title
subtitle	S	0..1	string	Specification Subtitle
type	SΣ	1..1	CodeableConcept	Specification Type Binding: PlanDefinitionType (extensible): The type of PlanDefinition.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	SΣ	2..2	Coding	Code defined by a terminology system Slice: Unordered, Closed by value:$this
coding:DefinitionType	SΣ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/plan-definition-type
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: workflow-definition
display		1..1	string	Representation defined by the system Fixed Value: Workflow Definition
userSelected		0..1	boolean	If this coding was chosen directly by the user
coding:SpecType	SΣ	1..1	Coding	Specification Type Binding: Specification Type Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
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]	S	1..1	LiteralReference(Drug Product Handle | Drug Substance Handle | Excipient Drug Substance) {b}	Type of individual the plan definition is focused on
date	SΣ	1..1	dateTime	Specification Version Date
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 plan definition
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
jurisdiction	Σ	0..*	CodeableConcept	Intended jurisdiction for plan definition (if applicable) Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
purpose		0..1	markdown	Why this plan definition is defined
usage		0..1	markdown	Describes the clinical usage of the plan
copyright		0..1	markdown	Use and/or publishing restrictions
copyrightLabel		0..1	string	Copyright holder and year(s)
approvalDate	S	0..1	date	Specification Status Date
lastReviewDate		0..1	date	When the plan definition was last reviewed by the publisher
effectivePeriod	Σ	0..1	Period	When the plan definition is expected to be used
topic		0..*	CodeableConcept	E.g. Education, Treatment, Assessment 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
library		0..*	canonical(Library)	Logic used by the plan definition
goal	SC	0..*	BackboneElement	Acceptance Criteria
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
ac-additional-info		0..1	markdown	Acceptance Criteria Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
category		0..1	CodeableConcept	E.g. Treatment, dietary, behavioral Binding: GoalCategory (example): Example codes for grouping goals for filtering or presentation.
description	S	1..1	CodeableConcept	Original Text Binding: SNOMEDCTClinicalFindings (example): Describes goals that can be achieved.
priority		0..1	CodeableConcept	high-priority | medium-priority | low-priority Binding: GoalPriority (preferred): Indicates the level of importance associated with reaching or sustaining a goal.
start		0..1	CodeableConcept	When goal pursuit begins Binding: GoalStartEvent (example): Identifies the types of events that might trigger the start of a goal.
addresses	S	1..*	CodeableConcept	Acceptance Criteria Usage Binding: Test Usage Terminology (required)
documentation		0..*	RelatedArtifact	Supporting documentation for the goal
target	SC	1..*	BackboneElement	Acceptance Criteron cmc-target-range: When the Range extension is present, detail cannot be present.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
Slices for modifierExtension	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:targetRange	?!S	0..1	TargetRange	Target Range
measure	S	0..1	CodeableConceptTextOnly	Detailed parameter being measured if more granular than Sub-Test Binding: LOINCCodes (example): Identifies types of parameters that can be tracked to determine goal achievement.
Slices for detail[x]	S	0..1		The target value to be achieved Slice: Unordered, Closed by type:$this
detailQuantity			Quantity
detailString			string
detailInteger			integer
detail[x]:detailQuantity	S	0..1	Quantity	ValueNumeric Binding: Units Of Measure (required)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Numerical value (with implicit precision)
comparator	?!SΣ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit
detail[x]:detailString	S	0..1	string	Value
detail[x]:detailInteger	S	0..1	integer	Number of Replicates
actor		0..*	BackboneElement	Actors within the plan
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
title		0..1	string	User-visible title
description		0..1	markdown	Describes the actor
option		1..*	BackboneElement	Who or what can be this actor
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 Binding: Action Participant Role (example)
action	SC	1..*	BackboneElement	Method cmc-link-required: Action linkId is required for alternate tests cmc-single-or-multistage: if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes
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
linkId	S	0..1	string	only required for alternate tests
prefix	S	0..1	string	Stage Name
title	S	1..1	string	Test Name
description	S	0..1	markdown	Test Additional Information
textEquivalent		0..1	markdown	Static text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system
priority		0..1	code	routine | urgent | asap | stat Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.
code	S	1..1	CodeableConcept	Test Method Origin Binding: ActionCode (example): Provides examples of actions to be performed.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..1	Coding	Code defined by a terminology system Binding: Test Method Origin Terminology (required)
text	SΣ	1..1	string	Analytical Procedure
reason	S	1..2	CodeableConcept	Test Category | Test Subcategory Binding: Test Category Terminology (required)
id		0..1	id	Unique id for inter-element referencing
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
categoryLevel	S	1..1	positiveInt	Hierarchical Level URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
documentation	S	0..1	RelatedArtifact	Supporting documentation for the intended performer of the action
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
type	Σ	1..1	code	documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as Binding: RelatedArtifactType (required): The type of relationship to the related artifact. Required Pattern: documentation
classifier	Σ	0..*	CodeableConcept	Additional classifiers Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
label	SΣ	1..1	string	Reference to Procedure
display	Σ	0..1	string	Brief description of the related artifact
citation	Σ	0..1	markdown	Bibliographic citation for the artifact
document	Σ	0..1	Attachment	What document is being referenced
resource	Σ	0..1	canonical(Resource)	What artifact is being referenced
resourceReference	Σ	0..1	Reference(Resource)	What artifact, if not a conformance resource
publicationStatus	Σ	0..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Publication status of an artifact being referred to.
publicationDate	Σ	0..1	date	Date of publication of the artifact being referred to
goalId	SC	0..*	id	Reference to Acceptance Criteria
subject[x]		0..1		Type of individual the action is focused on Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group)
subjectCanonical			canonical(Any)
trigger		0..*	TriggerDefinition	When the action should be triggered
condition		0..*	BackboneElement	Whether or not the action is applicable
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
kind		1..1	code	applicability | start | stop Binding: ActionConditionKind (required): Defines the kinds of conditions that can appear on actions.
expression		0..1	Expression	Boolean-valued expression
input	C	0..*	BackboneElement	Input data requirements pld-0: Input data elements must have a requirement or a relatedData, but not both
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
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	id	What data is provided
output	C	0..*	BackboneElement	Output data definition pld-1: Output data element must have a requirement or a relatedData, but not both
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
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	string	What data is provided
relatedAction	SC	0..*	BackboneElement	Alternate Test
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
targetId	SC	1..1	id	What action is this related to
relationship	S	1..1	code	Code is concurrent Binding: ActionRelationshipType (required): Defines the types of relationships between actions. Required Pattern: concurrent
endRelationship		0..1	code	before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end Binding: ActionRelationshipType (required): Defines the types of relationships between actions.
offset[x]		0..1		Time offset for the relationship
offsetDuration			Duration
offsetRange			Range
timing[x]		0..1		When the action should take place
timingAge			Age
timingDuration			Duration
timingRange			Range
timingTiming			Timing
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
actorId		0..1	string	What actor
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 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)
type		0..1	CodeableConcept	create | update | remove | fire-event Binding: ActionType (extensible): The type of action to be performed.
groupingBehavior		0..1	code	visual-group | logical-group | sentence-group Binding: ActionGroupingBehavior (required): Defines organization behavior of a group.
selectionBehavior		0..1	code	any | all | all-or-none | exactly-one | at-most-one | one-or-more Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.
requiredBehavior		0..1	code	must | could | must-unless-documented Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.
precheckBehavior		0..1	code	yes | no Binding: ActionPrecheckBehavior (required): Defines selection frequency behavior for an action or group.
cardinalityBehavior		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.
definition[x]		0..1		Description of the activity to be performed
definitionCanonical			canonical(ActivityDefinition | MessageDefinition | ObservationDefinition | PlanDefinition | Questionnaire | SpecimenDefinition)
definitionUri			uri
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		0..1	string	The path to the element to be set dynamically
expression		0..1	Expression	An expression that provides the dynamic value for the customization
action	S	0..*	BackboneElement	Groups or Stages
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
linkId		0..1	string	Unique id for the action in the PlanDefinition
prefix	S	0..1	string	Stage Name
title	S	0..1	string	Test Name (only reqired if different than above)
description	S	0..1	markdown	Test Additional Information | Stage Additional Information
textEquivalent		0..1	markdown	Static text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system
priority		0..1	code	routine | urgent | asap | stat Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.
code		0..1	CodeableConcept	Code representing the meaning of the action or sub-actions Binding: ActionCode (example): Provides examples of actions to be performed.
reason		0..*	CodeableConcept	Why the action should be performed Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.
documentation	S	0..*	RelatedArtifact	Supporting documentation for the intended performer of the action
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
type	Σ	1..1	code	documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as Binding: RelatedArtifactType (required): The type of relationship to the related artifact. Required Pattern: documentation
classifier	Σ	0..*	CodeableConcept	Additional classifiers Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
label	Σ	0..1	string	Short label
display	Σ	0..1	string	Brief description of the related artifact
citation	Σ	0..1	markdown	Bibliographic citation for the artifact
document	SΣ	1..1	Attachment	Test or Stage Additional Information Visual Attachments
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
contentType	SΣC	1..1	code	Mime type of the content, with charset etc. Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049) Example General: text/plain; charset=UTF-8, image/png
language	Σ	0..1	code	Human language of the content (BCP-47) Binding: AllLanguages (required): IETF language tag for a human language. Additional Bindings Purpose CommonLanguages Starter Set Example General: en-AU
data	SC	1..1	base64Binary	Data inline, base64ed
url	Σ	0..1	url	Uri where the data can be found Example General: http://www.acme.com/logo-small.png
size	Σ	0..1	integer64	Number of bytes of content (if url provided)
hash	Σ	0..1	base64Binary	Hash of the data (sha-1, base64ed)
title	SΣ	1..1	string	Document file name including the file extension Example General: Official Corporate Logo
creation	Σ	0..1	dateTime	Date attachment was first created
height		0..1	positiveInt	Height of the image in pixels (photo/video)
width		0..1	positiveInt	Width of the image in pixels (photo/video)
frames		0..1	positiveInt	Number of frames if > 1 (photo)
duration		0..1	decimal	Length in seconds (audio / video)
pages		0..1	positiveInt	Number of printed pages
resource	Σ	0..1	canonical(Resource)	What artifact is being referenced
resourceReference	Σ	0..1	Reference(Resource)	What artifact, if not a conformance resource
publicationStatus	Σ	0..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Publication status of an artifact being referred to.
publicationDate	Σ	0..1	date	Date of publication of the artifact being referred to
goalId	SC	0..*	id	Reference to Acceptance Criteria
subject[x]		0..1		Type of individual the action is focused on Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group)
subjectCanonical			canonical(Any)
trigger		0..*	TriggerDefinition	When the action should be triggered
condition		0..*	BackboneElement	Whether or not the action is applicable
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
kind		1..1	code	applicability | start | stop Binding: ActionConditionKind (required): Defines the kinds of conditions that can appear on actions.
expression		0..1	Expression	Boolean-valued expression
input	C	0..*	BackboneElement	Input data requirements pld-0: Input data elements must have a requirement or a relatedData, but not both
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
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	id	What data is provided
output	C	0..*	BackboneElement	Output data definition pld-1: Output data element must have a requirement or a relatedData, but not both
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
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	string	What data is provided
relatedAction	C	0..*	BackboneElement	Relationship to another 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
targetId	C	1..1	id	What action is this related to
relationship		1..1	code	before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end Binding: ActionRelationshipType (required): Defines the types of relationships between actions.
endRelationship		0..1	code	before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end Binding: ActionRelationshipType (required): Defines the types of relationships between actions.
offset[x]		0..1		Time offset for the relationship
offsetDuration			Duration
offsetRange			Range
timing[x]		0..1		When the action should take place
timingAge			Age
timingDuration			Duration
timingRange			Range
timingTiming			Timing
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
actorId		0..1	string	What actor
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 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)
type		0..1	CodeableConcept	create | update | remove | fire-event Binding: ActionType (extensible): The type of action to be performed.
groupingBehavior		0..1	code	visual-group | logical-group | sentence-group Binding: ActionGroupingBehavior (required): Defines organization behavior of a group.
selectionBehavior		0..1	code	any | all | all-or-none | exactly-one | at-most-one | one-or-more Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.
requiredBehavior		0..1	code	must | could | must-unless-documented Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.
precheckBehavior		0..1	code	yes | no Binding: ActionPrecheckBehavior (required): Defines selection frequency behavior for an action or group.
cardinalityBehavior		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.
definition[x]		0..1		Description of the activity to be performed
definitionCanonical			canonical(ActivityDefinition | MessageDefinition | ObservationDefinition | PlanDefinition | Questionnaire | SpecimenDefinition)
definitionUri			uri
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		0..1	string	The path to the element to be set dynamically
expression		0..1	Expression	An expression that provides the dynamic value for the customization
action	SC	0..*	BackboneElement	Sub-Test cmc-subtest-rrt: a subtest's prefix represents relative retention time, should it exist
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
linkId		0..1	string	Unique id for the action in the PlanDefinition
prefix	S	0..1	string	RRT
title	S	1..1	string	Test Name | RRT (complex testing)
description	S	0..1	markdown	Test Additional Information | Stage Additional Information
textEquivalent		0..1	markdown	Static text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system
priority		0..1	code	routine | urgent | asap | stat Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.
code		0..1	CodeableConcept	Code representing the meaning of the action or sub-actions Binding: ActionCode (example): Provides examples of actions to be performed.
reason		0..*	CodeableConcept	Why the action should be performed Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.
documentation		0..*	RelatedArtifact	Supporting documentation for the intended performer of the action
goalId	SC	1..*	id	Reference to Acceptance Criteria
subject[x]		0..1		Type of individual the action is focused on Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group)
subjectCanonical			canonical(Any)
trigger		0..*	TriggerDefinition	When the action should be triggered
condition		0..*	BackboneElement	Whether or not the action is applicable
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
kind		1..1	code	applicability | start | stop Binding: ActionConditionKind (required): Defines the kinds of conditions that can appear on actions.
expression		0..1	Expression	Boolean-valued expression
input	C	0..*	BackboneElement	Input data requirements pld-0: Input data elements must have a requirement or a relatedData, but not both
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
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	id	What data is provided
output	C	0..*	BackboneElement	Output data definition pld-1: Output data element must have a requirement or a relatedData, but not both
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
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	string	What data is provided
relatedAction	C	0..*	BackboneElement	Relationship to another 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
targetId	C	1..1	id	What action is this related to
relationship		1..1	code	before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end Binding: ActionRelationshipType (required): Defines the types of relationships between actions.
endRelationship		0..1	code	before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end Binding: ActionRelationshipType (required): Defines the types of relationships between actions.
offset[x]		0..1		Time offset for the relationship
offsetDuration			Duration
offsetRange			Range
timing[x]		0..1		When the action should take place
timingAge			Age
timingDuration			Duration
timingRange			Range
timingTiming			Timing
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
actorId		0..1	string	What actor
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 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)
type		0..1	CodeableConcept	create | update | remove | fire-event Binding: ActionType (extensible): The type of action to be performed.
groupingBehavior		0..1	code	visual-group | logical-group | sentence-group Binding: ActionGroupingBehavior (required): Defines organization behavior of a group.
selectionBehavior		0..1	code	any | all | all-or-none | exactly-one | at-most-one | one-or-more Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.
requiredBehavior		0..1	code	must | could | must-unless-documented Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.
precheckBehavior		0..1	code	yes | no Binding: ActionPrecheckBehavior (required): Defines selection frequency behavior for an action or group.
cardinalityBehavior		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.
definition[x]		0..1		Description of the activity to be performed
definitionCanonical			canonical(ActivityDefinition | MessageDefinition | ObservationDefinition | PlanDefinition | Questionnaire | SpecimenDefinition)
definitionUri			uri
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		0..1	string	The path to the element to be set dynamically
expression		0..1	Expression	An expression that provides the dynamic value for the customization
action		0..*	See action (PlanDefinition)	A sub-action
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
PlanDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
PlanDefinition.versionAlgorithm[x]	extensible	VersionAlgorithm http://hl7.org/fhir/ValueSet/version-algorithm from the FHIR Standard
PlanDefinition.type	extensible	PlanDefinitionType http://hl7.org/fhir/ValueSet/plan-definition-type from the FHIR Standard
PlanDefinition.type.coding:SpecType	required	PqcmcSpecificationTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology from this IG
PlanDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
PlanDefinition.jurisdiction	extensible	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
PlanDefinition.topic	example	DefinitionTopic http://hl7.org/fhir/ValueSet/definition-topic from the FHIR Standard
PlanDefinition.goal.category	example	GoalCategory http://hl7.org/fhir/ValueSet/goal-category from the FHIR Standard
PlanDefinition.goal.description	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/clinical-findings from the FHIR Standard
PlanDefinition.goal.priority	preferred	GoalPriority http://hl7.org/fhir/ValueSet/goal-priority from the FHIR Standard
PlanDefinition.goal.start	example	GoalStartEvent http://hl7.org/fhir/ValueSet/goal-start-event from the FHIR Standard
PlanDefinition.goal.addresses	required	PqcmcTestUsageTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology from this IG
PlanDefinition.goal.target.measure	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
PlanDefinition.goal.target.detail[x]:detailQuantity	required	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
PlanDefinition.goal.target.detail[x]:detailQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
PlanDefinition.actor.option.type	required	ActionParticipantType http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0 from the FHIR Standard
PlanDefinition.actor.option.role	example	ActionParticipantRole http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.priority	required	RequestPriority http://hl7.org/fhir/ValueSet/request-priority|5.0.0 from the FHIR Standard
PlanDefinition.action.code	example	ActionCode http://hl7.org/fhir/ValueSet/action-code from the FHIR Standard
PlanDefinition.action.code.coding	required	PqcmcTestMethodOriginTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology from this IG
PlanDefinition.action.reason	required	PqcmcTestCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology from this IG
PlanDefinition.action.documentation.type	required	Pattern: documentation http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0 from the FHIR Standard
PlanDefinition.action.documentation.classifier	example	CitationArtifactClassifier http://hl7.org/fhir/ValueSet/citation-artifact-classifier from the FHIR Standard
PlanDefinition.action.documentation.publicationStatus	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
PlanDefinition.action.subject[x]	extensible	ParticipantResourceTypes http://hl7.org/fhir/ValueSet/participant-resource-types from the FHIR Standard
PlanDefinition.action.condition.kind	required	ActionConditionKind http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0 from the FHIR Standard
PlanDefinition.action.relatedAction.relationship	required	Pattern: concurrent http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.relatedAction.endRelationship	required	ActionRelationshipType http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.participant.type	required	ActionParticipantType http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0 from the FHIR Standard
PlanDefinition.action.participant.role	example	ActionParticipantRole http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.participant.function	example	ActionParticipantFunction http://hl7.org/fhir/ValueSet/action-participant-function from the FHIR Standard
PlanDefinition.action.type	extensible	ActionType http://hl7.org/fhir/ValueSet/action-type from the FHIR Standard
PlanDefinition.action.groupingBehavior	required	ActionGroupingBehavior http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.selectionBehavior	required	ActionSelectionBehavior http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.requiredBehavior	required	ActionRequiredBehavior http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.precheckBehavior	required	ActionPrecheckBehavior http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.cardinalityBehavior	required	ActionCardinalityBehavior http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.priority	required	RequestPriority http://hl7.org/fhir/ValueSet/request-priority|5.0.0 from the FHIR Standard
PlanDefinition.action.action.code	example	ActionCode http://hl7.org/fhir/ValueSet/action-code from the FHIR Standard
PlanDefinition.action.action.reason	example	ActionReasonCode http://hl7.org/fhir/ValueSet/action-reason-code from the FHIR Standard
PlanDefinition.action.action.documentation.type	required	Pattern: documentation http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.documentation.classifier	example	CitationArtifactClassifier http://hl7.org/fhir/ValueSet/citation-artifact-classifier from the FHIR Standard
PlanDefinition.action.action.documentation.document.contentType	required	MimeTypes (a valid code from urn:ietf:bcp:13) http://hl7.org/fhir/ValueSet/mimetypes|5.0.0 from the FHIR Standard
PlanDefinition.action.action.documentation.document.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
PlanDefinition.action.action.documentation.publicationStatus	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
PlanDefinition.action.action.subject[x]	extensible	ParticipantResourceTypes http://hl7.org/fhir/ValueSet/participant-resource-types from the FHIR Standard
PlanDefinition.action.action.condition.kind	required	ActionConditionKind http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0 from the FHIR Standard
PlanDefinition.action.action.relatedAction.relationship	required	ActionRelationshipType http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.relatedAction.endRelationship	required	ActionRelationshipType http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.participant.type	required	ActionParticipantType http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.participant.role	example	ActionParticipantRole http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.action.participant.function	example	ActionParticipantFunction http://hl7.org/fhir/ValueSet/action-participant-function from the FHIR Standard
PlanDefinition.action.action.type	extensible	ActionType http://hl7.org/fhir/ValueSet/action-type from the FHIR Standard
PlanDefinition.action.action.groupingBehavior	required	ActionGroupingBehavior http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.selectionBehavior	required	ActionSelectionBehavior http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.requiredBehavior	required	ActionRequiredBehavior http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.precheckBehavior	required	ActionPrecheckBehavior http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.cardinalityBehavior	required	ActionCardinalityBehavior http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.priority	required	RequestPriority http://hl7.org/fhir/ValueSet/request-priority|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.code	example	ActionCode http://hl7.org/fhir/ValueSet/action-code from the FHIR Standard
PlanDefinition.action.action.action.reason	example	ActionReasonCode http://hl7.org/fhir/ValueSet/action-reason-code from the FHIR Standard
PlanDefinition.action.action.action.subject[x]	extensible	ParticipantResourceTypes http://hl7.org/fhir/ValueSet/participant-resource-types from the FHIR Standard
PlanDefinition.action.action.action.condition.kind	required	ActionConditionKind http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.relatedAction.relationship	required	ActionRelationshipType http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.relatedAction.endRelationship	required	ActionRelationshipType http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.participant.type	required	ActionParticipantType http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.participant.role	example	ActionParticipantRole http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.action.action.participant.function	example	ActionParticipantFunction http://hl7.org/fhir/ValueSet/action-participant-function from the FHIR Standard
PlanDefinition.action.action.action.type	extensible	ActionType http://hl7.org/fhir/ValueSet/action-type from the FHIR Standard
PlanDefinition.action.action.action.groupingBehavior	required	ActionGroupingBehavior http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.selectionBehavior	required	ActionSelectionBehavior http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.requiredBehavior	required	ActionRequiredBehavior http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.precheckBehavior	required	ActionPrecheckBehavior http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.cardinalityBehavior	required	ActionCardinalityBehavior http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0 from the FHIR Standard
PlanDefinition.asNeeded[x]	example	SNOMEDCTMedicationAsNeededReasonCodes http://hl7.org/fhir/ValueSet/medication-as-needed-reason from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-link-required	error	PlanDefinition.action	Action linkId is required for alternate tests : (action.relatedAction.count() > 0) implies action.linkId.exists()
cmc-single-or-multistage	error	PlanDefinition.action	if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes : (( prefix.exists() implies action.prefix.empty() and prefix = 'Single Stage' ) and ( prefix.empty() implies ( (action.where( prefix.exists() and prefix != 'Single Stage' ).count() = action.count()) and action.prefix.isDistinct() ) )) = true
cmc-subtest-rrt	error	PlanDefinition.action.action.action	a subtest's prefix represents relative retention time, should it exist : prefix.exists() implies prefix.single() = 'RRT'
cmc-target-range	error	PlanDefinition.goal.target	When the Range extension is present, detail cannot be present. : modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range').exists() implies detail.exists().not()
cnl-0	warning	PlanDefinition	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}$')
cnl-1	warning	PlanDefinition.url	URL should not contain | or # - these characters make processing canonical references problematic : exists() implies matches('^[^|# ]+$')
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()
pld-0	error	PlanDefinition.action.input, PlanDefinition.action.action.input, PlanDefinition.action.action.action.input	Input data elements must have a requirement or a relatedData, but not both : requirement.exists() xor relatedData.exists()
pld-1	error	PlanDefinition.action.output, PlanDefinition.action.action.output, PlanDefinition.action.action.action.output	Output data element must have a requirement or a relatedData, but not both : requirement.exists() xor relatedData.exists()
pld-3	warning	PlanDefinition	goalid should reference the id of a goal definition : %context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()
pld-4	warning	PlanDefinition	targetId should reference the id of an action : %context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()

This structure is derived from PlanDefinition

Summary

Mandatory: 17 elements(12 nested mandatory elements)
Must-Support: 58 elements
Prohibited: 1 element

Structures

This structure refers to these other structures:

• Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
• Drug Product Handle (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle)
• Drug Substance Handle (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance)
• Excipient Drug Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient)
• Text Only Codeable Concept (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension
• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range (Modifier)
• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of PlanDefinition.type.coding (Closed)
• The element 1 is sliced based on the value of PlanDefinition.goal.target.detail[x]

Differential View

This structure is derived from PlanDefinition

Name	Flags	Card.	Type	Description & Constraints
PlanDefinition			PlanDefinition
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
ApprovalStatus	S	1..1	CodeableConcept	Specification Status URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension Binding: Specification Status Terminology (required)
spec-additional-info		0..1	markdown	Specification Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
identifier	S	0..*	Identifier	Additional identifier for the plan definition
version	S	1..1	string	Specification Version
title	S	1..1	string	Specification Title
subtitle	S	0..1	string	Specification Subtitle
type	S	1..1	CodeableConcept	Specification Type
Slices for coding	S	2..2	Coding	Code defined by a terminology system Slice: Unordered, Closed by value:$this
coding:DefinitionType	S	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/plan-definition-type
code		1..1	code	Symbol in syntax defined by the system Fixed Value: workflow-definition
display		1..1	string	Representation defined by the system Fixed Value: Workflow Definition
coding:SpecType	S	1..1	Coding	Specification Type Binding: Specification Type Terminology (required)
status	S	1..1	code	draft | active | retired | unknown
subject[x]	S	1..1	LiteralReference(Drug Product Handle | Drug Substance Handle | Excipient Drug Substance) {b}	Type of individual the plan definition is focused on
date	S	1..1	dateTime	Specification Version Date
approvalDate	S	0..1	date	Specification Status Date
goal	S	0..*	BackboneElement	Acceptance Criteria
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
ac-additional-info		0..1	markdown	Acceptance Criteria Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
description	S	1..1	CodeableConcept	Original Text
addresses	S	1..*	CodeableConcept	Acceptance Criteria Usage Binding: Test Usage Terminology (required)
target	SC	1..*	BackboneElement	Acceptance Criteron cmc-target-range: When the Range extension is present, detail cannot be present.
Slices for modifierExtension		0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:targetRange	S	0..1	TargetRange	Target Range
measure	S	0..1	CodeableConceptTextOnly	Detailed parameter being measured if more granular than Sub-Test
Slices for detail[x]	S	0..1		The target value to be achieved Slice: Unordered, Open by type:$this
detailQuantity			Quantity
detailString			string
detailInteger			integer
detail[x]:detailQuantity	S	0..1	Quantity	ValueNumeric Binding: Units Of Measure (required)
value	S	1..1	decimal	Numerical value (with implicit precision)
comparator	S	0..1	code	< | <= | >= | > | ad - how to understand the value
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit
detail[x]:detailString	S	0..1	string	Value
detail[x]:detailInteger	S	0..1	integer	Number of Replicates
due		0..0
action	SC	1..*	BackboneElement	Method cmc-link-required: Action linkId is required for alternate tests cmc-single-or-multistage: if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes
linkId	S	0..1	string	only required for alternate tests
prefix	S	0..1	string	Stage Name
title	S	1..1	string	Test Name
description	S	0..1	markdown	Test Additional Information
code	S	1..1	CodeableConcept	Test Method Origin
coding	S	1..1	Coding	Code defined by a terminology system Binding: Test Method Origin Terminology (required)
text	S	1..1	string	Analytical Procedure
reason	S	1..2	CodeableConcept	Test Category | Test Subcategory Binding: Test Category Terminology (required)
extension		1..*	Extension	Extension
Slices for extension				Content/Rules for all slices
categoryLevel	S	1..1	positiveInt	Hierarchical Level URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
documentation	S	0..1	RelatedArtifact	Supporting documentation for the intended performer of the action
type		1..1	code	documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as Required Pattern: documentation
label	S	1..1	string	Reference to Procedure
goalId	S	0..*	id	Reference to Acceptance Criteria
relatedAction	S	0..*	BackboneElement	Alternate Test
targetId	S	1..1	id	What action is this related to
relationship	S	1..1	code	Code is concurrent Required Pattern: concurrent
action	S	0..*	BackboneElement	Groups or Stages
prefix	S	0..1	string	Stage Name
title	S	0..1	string	Test Name (only reqired if different than above)
description	S	0..1	markdown	Test Additional Information | Stage Additional Information
documentation	S	0..*	RelatedArtifact	Supporting documentation for the intended performer of the action
type		1..1	code	documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as Required Pattern: documentation
document	S	1..1	Attachment	Test or Stage Additional Information Visual Attachments
contentType	S	1..1	code	Mime type of the content, with charset etc.
data	S	1..1	base64Binary	Data inline, base64ed
title	S	1..1	string	Document file name including the file extension
goalId	S	0..*	id	Reference to Acceptance Criteria
action	SC	0..*	BackboneElement	Sub-Test cmc-subtest-rrt: a subtest's prefix represents relative retention time, should it exist
prefix	S	0..1	string	RRT
title	S	1..1	string	Test Name | RRT (complex testing)
description	S	0..1	markdown	Test Additional Information | Stage Additional Information
goalId	S	1..*	id	Reference to Acceptance Criteria
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
PlanDefinition.type.coding:SpecType	required	PqcmcSpecificationTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology from this IG
PlanDefinition.goal.addresses	required	PqcmcTestUsageTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology from this IG
PlanDefinition.goal.target.detail[x]:detailQuantity	required	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
PlanDefinition.action.code.coding	required	PqcmcTestMethodOriginTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology from this IG
PlanDefinition.action.reason	required	PqcmcTestCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-link-required	error	PlanDefinition.action	Action linkId is required for alternate tests : (action.relatedAction.count() > 0) implies action.linkId.exists()
cmc-single-or-multistage	error	PlanDefinition.action	if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes : (( prefix.exists() implies action.prefix.empty() and prefix = 'Single Stage' ) and ( prefix.empty() implies ( (action.where( prefix.exists() and prefix != 'Single Stage' ).count() = action.count()) and action.prefix.isDistinct() ) )) = true
cmc-subtest-rrt	error	PlanDefinition.action.action.action	a subtest's prefix represents relative retention time, should it exist : prefix.exists() implies prefix.single() = 'RRT'
cmc-target-range	error	PlanDefinition.goal.target	When the Range extension is present, detail cannot be present. : modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range').exists() implies detail.exists().not()

Key Elements View

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 cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation pld-3: goalid should reference the id of a goal definition pld-4: targetId should reference the id of an action
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
ApprovalStatus	S	1..1	CodeableConcept	Specification Status URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension Binding: Specification Status Terminology (required)
spec-additional-info		0..1	markdown	Specification Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	Additional identifier for the plan definition
version	SΣ	1..1	string	Specification Version
title	SΣ	1..1	string	Specification Title
subtitle	S	0..1	string	Specification Subtitle
type	SΣ	1..1	CodeableConcept	Specification Type Binding: PlanDefinitionType (extensible): The type of PlanDefinition.
Slices for coding	SΣ	2..2	Coding	Code defined by a terminology system Slice: Unordered, Closed by value:$this
coding:DefinitionType	SΣ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/plan-definition-type
code		1..1	code	Symbol in syntax defined by the system Fixed Value: workflow-definition
display		1..1	string	Representation defined by the system Fixed Value: Workflow Definition
coding:SpecType	SΣ	1..1	Coding	Specification Type Binding: Specification Type Terminology (required)
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
subject[x]	S	1..1	LiteralReference(Drug Product Handle | Drug Substance Handle | Excipient Drug Substance) {b}	Type of individual the plan definition is focused on
date	SΣ	1..1	dateTime	Specification Version Date
approvalDate	S	0..1	date	Specification Status Date
goal	SC	0..*	BackboneElement	Acceptance Criteria
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
ac-additional-info		0..1	markdown	Acceptance Criteria Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
description	S	1..1	CodeableConcept	Original Text Binding: SNOMEDCTClinicalFindings (example): Describes goals that can be achieved.
addresses	S	1..*	CodeableConcept	Acceptance Criteria Usage Binding: Test Usage Terminology (required)
target	SC	1..*	BackboneElement	Acceptance Criteron cmc-target-range: When the Range extension is present, detail cannot be present.
Slices for modifierExtension	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:targetRange	?!S	0..1	TargetRange	Target Range
measure	S	0..1	CodeableConceptTextOnly	Detailed parameter being measured if more granular than Sub-Test Binding: LOINCCodes (example): Identifies types of parameters that can be tracked to determine goal achievement.
Slices for detail[x]	S	0..1		The target value to be achieved Slice: Unordered, Closed by type:$this
detailQuantity			Quantity
detailString			string
detailInteger			integer
detail[x]:detailQuantity	S	0..1	Quantity	ValueNumeric Binding: Units Of Measure (required)
value	SΣ	1..1	decimal	Numerical value (with implicit precision)
comparator	?!SΣ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
code	SΣC	1..1	code	Coded form of the unit
detail[x]:detailString	S	0..1	string	Value
detail[x]:detailInteger	S	0..1	integer	Number of Replicates
action	SC	1..*	BackboneElement	Method cmc-link-required: Action linkId is required for alternate tests cmc-single-or-multistage: if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
linkId	S	0..1	string	only required for alternate tests
prefix	S	0..1	string	Stage Name
title	S	1..1	string	Test Name
description	S	0..1	markdown	Test Additional Information
code	S	1..1	CodeableConcept	Test Method Origin Binding: ActionCode (example): Provides examples of actions to be performed.
coding	SΣ	1..1	Coding	Code defined by a terminology system Binding: Test Method Origin Terminology (required)
text	SΣ	1..1	string	Analytical Procedure
reason	S	1..2	CodeableConcept	Test Category | Test Subcategory Binding: Test Category Terminology (required)
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
categoryLevel	S	1..1	positiveInt	Hierarchical Level URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
documentation	S	0..1	RelatedArtifact	Supporting documentation for the intended performer of the action
type	Σ	1..1	code	documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as Binding: RelatedArtifactType (required): The type of relationship to the related artifact. Required Pattern: documentation
label	SΣ	1..1	string	Reference to Procedure
goalId	SC	0..*	id	Reference to Acceptance Criteria
relatedAction	SC	0..*	BackboneElement	Alternate Test
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
targetId	SC	1..1	id	What action is this related to
relationship	S	1..1	code	Code is concurrent Binding: ActionRelationshipType (required): Defines the types of relationships between actions. Required Pattern: concurrent
action	S	0..*	BackboneElement	Groups or Stages
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
prefix	S	0..1	string	Stage Name
title	S	0..1	string	Test Name (only reqired if different than above)
description	S	0..1	markdown	Test Additional Information | Stage Additional Information
documentation	S	0..*	RelatedArtifact	Supporting documentation for the intended performer of the action
type	Σ	1..1	code	documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as Binding: RelatedArtifactType (required): The type of relationship to the related artifact. Required Pattern: documentation
document	SΣ	1..1	Attachment	Test or Stage Additional Information Visual Attachments
contentType	SΣC	1..1	code	Mime type of the content, with charset etc. Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049) Example General: text/plain; charset=UTF-8, image/png
data	SC	1..1	base64Binary	Data inline, base64ed
title	SΣ	1..1	string	Document file name including the file extension Example General: Official Corporate Logo
goalId	SC	0..*	id	Reference to Acceptance Criteria
action	SC	0..*	BackboneElement	Sub-Test cmc-subtest-rrt: a subtest's prefix represents relative retention time, should it exist
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
prefix	S	0..1	string	RRT
title	S	1..1	string	Test Name | RRT (complex testing)
description	S	0..1	markdown	Test Additional Information | Stage Additional Information
goalId	SC	1..*	id	Reference to Acceptance Criteria
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
PlanDefinition.type	extensible	PlanDefinitionType http://hl7.org/fhir/ValueSet/plan-definition-type from the FHIR Standard
PlanDefinition.type.coding:SpecType	required	PqcmcSpecificationTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology from this IG
PlanDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
PlanDefinition.goal.description	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/clinical-findings from the FHIR Standard
PlanDefinition.goal.addresses	required	PqcmcTestUsageTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology from this IG
PlanDefinition.goal.target.measure	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
PlanDefinition.goal.target.detail[x]:detailQuantity	required	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
PlanDefinition.goal.target.detail[x]:detailQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
PlanDefinition.action.code	example	ActionCode http://hl7.org/fhir/ValueSet/action-code from the FHIR Standard
PlanDefinition.action.code.coding	required	PqcmcTestMethodOriginTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology from this IG
PlanDefinition.action.reason	required	PqcmcTestCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology from this IG
PlanDefinition.action.documentation.type	required	Pattern: documentation http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0 from the FHIR Standard
PlanDefinition.action.relatedAction.relationship	required	Pattern: concurrent http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.documentation.type	required	Pattern: documentation http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.documentation.document.contentType	required	MimeTypes (a valid code from urn:ietf:bcp:13) http://hl7.org/fhir/ValueSet/mimetypes|5.0.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-link-required	error	PlanDefinition.action	Action linkId is required for alternate tests : (action.relatedAction.count() > 0) implies action.linkId.exists()
cmc-single-or-multistage	error	PlanDefinition.action	if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes : (( prefix.exists() implies action.prefix.empty() and prefix = 'Single Stage' ) and ( prefix.empty() implies ( (action.where( prefix.exists() and prefix != 'Single Stage' ).count() = action.count()) and action.prefix.isDistinct() ) )) = true
cmc-subtest-rrt	error	PlanDefinition.action.action.action	a subtest's prefix represents relative retention time, should it exist : prefix.exists() implies prefix.single() = 'RRT'
cmc-target-range	error	PlanDefinition.goal.target	When the Range extension is present, detail cannot be present. : modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range').exists() implies detail.exists().not()
cnl-0	warning	PlanDefinition	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()
pld-3	warning	PlanDefinition	goalid should reference the id of a goal definition : %context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()
pld-4	warning	PlanDefinition	targetId should reference the id of an action : %context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()

Snapshot View

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 cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation pld-3: goalid should reference the id of a goal definition pld-4: targetId should reference the id of an action
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
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
ApprovalStatus	S	1..1	CodeableConcept	Specification Status URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension Binding: Specification Status Terminology (required)
spec-additional-info		0..1	markdown	Specification Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	ΣC	0..1	uri	Canonical identifier for this plan definition, represented as a URI (globally unique) cnl-1: URL should not contain | or # - these characters make processing canonical references problematic
identifier	SΣ	0..*	Identifier	Additional identifier for the plan definition
version	SΣ	1..1	string	Specification Version
versionAlgorithm[x]	Σ	0..1		How to compare versions Binding: VersionAlgorithm (extensible)
versionAlgorithmString			string
versionAlgorithmCoding			Coding
name	ΣC	0..1	string	Name for this plan definition (computer friendly)
title	SΣ	1..1	string	Specification Title
subtitle	S	0..1	string	Specification Subtitle
type	SΣ	1..1	CodeableConcept	Specification Type Binding: PlanDefinitionType (extensible): The type of PlanDefinition.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	SΣ	2..2	Coding	Code defined by a terminology system Slice: Unordered, Closed by value:$this
coding:DefinitionType	SΣ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/plan-definition-type
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: workflow-definition
display		1..1	string	Representation defined by the system Fixed Value: Workflow Definition
userSelected		0..1	boolean	If this coding was chosen directly by the user
coding:SpecType	SΣ	1..1	Coding	Specification Type Binding: Specification Type Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
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]	S	1..1	LiteralReference(Drug Product Handle | Drug Substance Handle | Excipient Drug Substance) {b}	Type of individual the plan definition is focused on
date	SΣ	1..1	dateTime	Specification Version Date
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 plan definition
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
jurisdiction	Σ	0..*	CodeableConcept	Intended jurisdiction for plan definition (if applicable) Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
purpose		0..1	markdown	Why this plan definition is defined
usage		0..1	markdown	Describes the clinical usage of the plan
copyright		0..1	markdown	Use and/or publishing restrictions
copyrightLabel		0..1	string	Copyright holder and year(s)
approvalDate	S	0..1	date	Specification Status Date
lastReviewDate		0..1	date	When the plan definition was last reviewed by the publisher
effectivePeriod	Σ	0..1	Period	When the plan definition is expected to be used
topic		0..*	CodeableConcept	E.g. Education, Treatment, Assessment 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
library		0..*	canonical(Library)	Logic used by the plan definition
goal	SC	0..*	BackboneElement	Acceptance Criteria
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
ac-additional-info		0..1	markdown	Acceptance Criteria Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
category		0..1	CodeableConcept	E.g. Treatment, dietary, behavioral Binding: GoalCategory (example): Example codes for grouping goals for filtering or presentation.
description	S	1..1	CodeableConcept	Original Text Binding: SNOMEDCTClinicalFindings (example): Describes goals that can be achieved.
priority		0..1	CodeableConcept	high-priority | medium-priority | low-priority Binding: GoalPriority (preferred): Indicates the level of importance associated with reaching or sustaining a goal.
start		0..1	CodeableConcept	When goal pursuit begins Binding: GoalStartEvent (example): Identifies the types of events that might trigger the start of a goal.
addresses	S	1..*	CodeableConcept	Acceptance Criteria Usage Binding: Test Usage Terminology (required)
documentation		0..*	RelatedArtifact	Supporting documentation for the goal
target	SC	1..*	BackboneElement	Acceptance Criteron cmc-target-range: When the Range extension is present, detail cannot be present.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
Slices for modifierExtension	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:targetRange	?!S	0..1	TargetRange	Target Range
measure	S	0..1	CodeableConceptTextOnly	Detailed parameter being measured if more granular than Sub-Test Binding: LOINCCodes (example): Identifies types of parameters that can be tracked to determine goal achievement.
Slices for detail[x]	S	0..1		The target value to be achieved Slice: Unordered, Closed by type:$this
detailQuantity			Quantity
detailString			string
detailInteger			integer
detail[x]:detailQuantity	S	0..1	Quantity	ValueNumeric Binding: Units Of Measure (required)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Numerical value (with implicit precision)
comparator	?!SΣ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit
detail[x]:detailString	S	0..1	string	Value
detail[x]:detailInteger	S	0..1	integer	Number of Replicates
actor		0..*	BackboneElement	Actors within the plan
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
title		0..1	string	User-visible title
description		0..1	markdown	Describes the actor
option		1..*	BackboneElement	Who or what can be this actor
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 Binding: Action Participant Role (example)
action	SC	1..*	BackboneElement	Method cmc-link-required: Action linkId is required for alternate tests cmc-single-or-multistage: if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes
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
linkId	S	0..1	string	only required for alternate tests
prefix	S	0..1	string	Stage Name
title	S	1..1	string	Test Name
description	S	0..1	markdown	Test Additional Information
textEquivalent		0..1	markdown	Static text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system
priority		0..1	code	routine | urgent | asap | stat Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.
code	S	1..1	CodeableConcept	Test Method Origin Binding: ActionCode (example): Provides examples of actions to be performed.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..1	Coding	Code defined by a terminology system Binding: Test Method Origin Terminology (required)
text	SΣ	1..1	string	Analytical Procedure
reason	S	1..2	CodeableConcept	Test Category | Test Subcategory Binding: Test Category Terminology (required)
id		0..1	id	Unique id for inter-element referencing
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
categoryLevel	S	1..1	positiveInt	Hierarchical Level URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
documentation	S	0..1	RelatedArtifact	Supporting documentation for the intended performer of the action
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
type	Σ	1..1	code	documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as Binding: RelatedArtifactType (required): The type of relationship to the related artifact. Required Pattern: documentation
classifier	Σ	0..*	CodeableConcept	Additional classifiers Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
label	SΣ	1..1	string	Reference to Procedure
display	Σ	0..1	string	Brief description of the related artifact
citation	Σ	0..1	markdown	Bibliographic citation for the artifact
document	Σ	0..1	Attachment	What document is being referenced
resource	Σ	0..1	canonical(Resource)	What artifact is being referenced
resourceReference	Σ	0..1	Reference(Resource)	What artifact, if not a conformance resource
publicationStatus	Σ	0..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Publication status of an artifact being referred to.
publicationDate	Σ	0..1	date	Date of publication of the artifact being referred to
goalId	SC	0..*	id	Reference to Acceptance Criteria
subject[x]		0..1		Type of individual the action is focused on Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group)
subjectCanonical			canonical(Any)
trigger		0..*	TriggerDefinition	When the action should be triggered
condition		0..*	BackboneElement	Whether or not the action is applicable
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
kind		1..1	code	applicability | start | stop Binding: ActionConditionKind (required): Defines the kinds of conditions that can appear on actions.
expression		0..1	Expression	Boolean-valued expression
input	C	0..*	BackboneElement	Input data requirements pld-0: Input data elements must have a requirement or a relatedData, but not both
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
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	id	What data is provided
output	C	0..*	BackboneElement	Output data definition pld-1: Output data element must have a requirement or a relatedData, but not both
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
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	string	What data is provided
relatedAction	SC	0..*	BackboneElement	Alternate Test
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
targetId	SC	1..1	id	What action is this related to
relationship	S	1..1	code	Code is concurrent Binding: ActionRelationshipType (required): Defines the types of relationships between actions. Required Pattern: concurrent
endRelationship		0..1	code	before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end Binding: ActionRelationshipType (required): Defines the types of relationships between actions.
offset[x]		0..1		Time offset for the relationship
offsetDuration			Duration
offsetRange			Range
timing[x]		0..1		When the action should take place
timingAge			Age
timingDuration			Duration
timingRange			Range
timingTiming			Timing
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
actorId		0..1	string	What actor
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 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)
type		0..1	CodeableConcept	create | update | remove | fire-event Binding: ActionType (extensible): The type of action to be performed.
groupingBehavior		0..1	code	visual-group | logical-group | sentence-group Binding: ActionGroupingBehavior (required): Defines organization behavior of a group.
selectionBehavior		0..1	code	any | all | all-or-none | exactly-one | at-most-one | one-or-more Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.
requiredBehavior		0..1	code	must | could | must-unless-documented Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.
precheckBehavior		0..1	code	yes | no Binding: ActionPrecheckBehavior (required): Defines selection frequency behavior for an action or group.
cardinalityBehavior		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.
definition[x]		0..1		Description of the activity to be performed
definitionCanonical			canonical(ActivityDefinition | MessageDefinition | ObservationDefinition | PlanDefinition | Questionnaire | SpecimenDefinition)
definitionUri			uri
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		0..1	string	The path to the element to be set dynamically
expression		0..1	Expression	An expression that provides the dynamic value for the customization
action	S	0..*	BackboneElement	Groups or Stages
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
linkId		0..1	string	Unique id for the action in the PlanDefinition
prefix	S	0..1	string	Stage Name
title	S	0..1	string	Test Name (only reqired if different than above)
description	S	0..1	markdown	Test Additional Information | Stage Additional Information
textEquivalent		0..1	markdown	Static text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system
priority		0..1	code	routine | urgent | asap | stat Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.
code		0..1	CodeableConcept	Code representing the meaning of the action or sub-actions Binding: ActionCode (example): Provides examples of actions to be performed.
reason		0..*	CodeableConcept	Why the action should be performed Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.
documentation	S	0..*	RelatedArtifact	Supporting documentation for the intended performer of the action
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
type	Σ	1..1	code	documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as Binding: RelatedArtifactType (required): The type of relationship to the related artifact. Required Pattern: documentation
classifier	Σ	0..*	CodeableConcept	Additional classifiers Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
label	Σ	0..1	string	Short label
display	Σ	0..1	string	Brief description of the related artifact
citation	Σ	0..1	markdown	Bibliographic citation for the artifact
document	SΣ	1..1	Attachment	Test or Stage Additional Information Visual Attachments
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
contentType	SΣC	1..1	code	Mime type of the content, with charset etc. Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049) Example General: text/plain; charset=UTF-8, image/png
language	Σ	0..1	code	Human language of the content (BCP-47) Binding: AllLanguages (required): IETF language tag for a human language. Additional Bindings Purpose CommonLanguages Starter Set Example General: en-AU
data	SC	1..1	base64Binary	Data inline, base64ed
url	Σ	0..1	url	Uri where the data can be found Example General: http://www.acme.com/logo-small.png
size	Σ	0..1	integer64	Number of bytes of content (if url provided)
hash	Σ	0..1	base64Binary	Hash of the data (sha-1, base64ed)
title	SΣ	1..1	string	Document file name including the file extension Example General: Official Corporate Logo
creation	Σ	0..1	dateTime	Date attachment was first created
height		0..1	positiveInt	Height of the image in pixels (photo/video)
width		0..1	positiveInt	Width of the image in pixels (photo/video)
frames		0..1	positiveInt	Number of frames if > 1 (photo)
duration		0..1	decimal	Length in seconds (audio / video)
pages		0..1	positiveInt	Number of printed pages
resource	Σ	0..1	canonical(Resource)	What artifact is being referenced
resourceReference	Σ	0..1	Reference(Resource)	What artifact, if not a conformance resource
publicationStatus	Σ	0..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Publication status of an artifact being referred to.
publicationDate	Σ	0..1	date	Date of publication of the artifact being referred to
goalId	SC	0..*	id	Reference to Acceptance Criteria
subject[x]		0..1		Type of individual the action is focused on Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group)
subjectCanonical			canonical(Any)
trigger		0..*	TriggerDefinition	When the action should be triggered
condition		0..*	BackboneElement	Whether or not the action is applicable
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
kind		1..1	code	applicability | start | stop Binding: ActionConditionKind (required): Defines the kinds of conditions that can appear on actions.
expression		0..1	Expression	Boolean-valued expression
input	C	0..*	BackboneElement	Input data requirements pld-0: Input data elements must have a requirement or a relatedData, but not both
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
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	id	What data is provided
output	C	0..*	BackboneElement	Output data definition pld-1: Output data element must have a requirement or a relatedData, but not both
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
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	string	What data is provided
relatedAction	C	0..*	BackboneElement	Relationship to another 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
targetId	C	1..1	id	What action is this related to
relationship		1..1	code	before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end Binding: ActionRelationshipType (required): Defines the types of relationships between actions.
endRelationship		0..1	code	before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end Binding: ActionRelationshipType (required): Defines the types of relationships between actions.
offset[x]		0..1		Time offset for the relationship
offsetDuration			Duration
offsetRange			Range
timing[x]		0..1		When the action should take place
timingAge			Age
timingDuration			Duration
timingRange			Range
timingTiming			Timing
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
actorId		0..1	string	What actor
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 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)
type		0..1	CodeableConcept	create | update | remove | fire-event Binding: ActionType (extensible): The type of action to be performed.
groupingBehavior		0..1	code	visual-group | logical-group | sentence-group Binding: ActionGroupingBehavior (required): Defines organization behavior of a group.
selectionBehavior		0..1	code	any | all | all-or-none | exactly-one | at-most-one | one-or-more Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.
requiredBehavior		0..1	code	must | could | must-unless-documented Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.
precheckBehavior		0..1	code	yes | no Binding: ActionPrecheckBehavior (required): Defines selection frequency behavior for an action or group.
cardinalityBehavior		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.
definition[x]		0..1		Description of the activity to be performed
definitionCanonical			canonical(ActivityDefinition | MessageDefinition | ObservationDefinition | PlanDefinition | Questionnaire | SpecimenDefinition)
definitionUri			uri
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		0..1	string	The path to the element to be set dynamically
expression		0..1	Expression	An expression that provides the dynamic value for the customization
action	SC	0..*	BackboneElement	Sub-Test cmc-subtest-rrt: a subtest's prefix represents relative retention time, should it exist
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
linkId		0..1	string	Unique id for the action in the PlanDefinition
prefix	S	0..1	string	RRT
title	S	1..1	string	Test Name | RRT (complex testing)
description	S	0..1	markdown	Test Additional Information | Stage Additional Information
textEquivalent		0..1	markdown	Static text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system
priority		0..1	code	routine | urgent | asap | stat Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.
code		0..1	CodeableConcept	Code representing the meaning of the action or sub-actions Binding: ActionCode (example): Provides examples of actions to be performed.
reason		0..*	CodeableConcept	Why the action should be performed Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.
documentation		0..*	RelatedArtifact	Supporting documentation for the intended performer of the action
goalId	SC	1..*	id	Reference to Acceptance Criteria
subject[x]		0..1		Type of individual the action is focused on Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group)
subjectCanonical			canonical(Any)
trigger		0..*	TriggerDefinition	When the action should be triggered
condition		0..*	BackboneElement	Whether or not the action is applicable
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
kind		1..1	code	applicability | start | stop Binding: ActionConditionKind (required): Defines the kinds of conditions that can appear on actions.
expression		0..1	Expression	Boolean-valued expression
input	C	0..*	BackboneElement	Input data requirements pld-0: Input data elements must have a requirement or a relatedData, but not both
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
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	id	What data is provided
output	C	0..*	BackboneElement	Output data definition pld-1: Output data element must have a requirement or a relatedData, but not both
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
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	string	What data is provided
relatedAction	C	0..*	BackboneElement	Relationship to another 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
targetId	C	1..1	id	What action is this related to
relationship		1..1	code	before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end Binding: ActionRelationshipType (required): Defines the types of relationships between actions.
endRelationship		0..1	code	before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end Binding: ActionRelationshipType (required): Defines the types of relationships between actions.
offset[x]		0..1		Time offset for the relationship
offsetDuration			Duration
offsetRange			Range
timing[x]		0..1		When the action should take place
timingAge			Age
timingDuration			Duration
timingRange			Range
timingTiming			Timing
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
actorId		0..1	string	What actor
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 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)
type		0..1	CodeableConcept	create | update | remove | fire-event Binding: ActionType (extensible): The type of action to be performed.
groupingBehavior		0..1	code	visual-group | logical-group | sentence-group Binding: ActionGroupingBehavior (required): Defines organization behavior of a group.
selectionBehavior		0..1	code	any | all | all-or-none | exactly-one | at-most-one | one-or-more Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.
requiredBehavior		0..1	code	must | could | must-unless-documented Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.
precheckBehavior		0..1	code	yes | no Binding: ActionPrecheckBehavior (required): Defines selection frequency behavior for an action or group.
cardinalityBehavior		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.
definition[x]		0..1		Description of the activity to be performed
definitionCanonical			canonical(ActivityDefinition | MessageDefinition | ObservationDefinition | PlanDefinition | Questionnaire | SpecimenDefinition)
definitionUri			uri
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		0..1	string	The path to the element to be set dynamically
expression		0..1	Expression	An expression that provides the dynamic value for the customization
action		0..*	See action (PlanDefinition)	A sub-action
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
PlanDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
PlanDefinition.versionAlgorithm[x]	extensible	VersionAlgorithm http://hl7.org/fhir/ValueSet/version-algorithm from the FHIR Standard
PlanDefinition.type	extensible	PlanDefinitionType http://hl7.org/fhir/ValueSet/plan-definition-type from the FHIR Standard
PlanDefinition.type.coding:SpecType	required	PqcmcSpecificationTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology from this IG
PlanDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
PlanDefinition.jurisdiction	extensible	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
PlanDefinition.topic	example	DefinitionTopic http://hl7.org/fhir/ValueSet/definition-topic from the FHIR Standard
PlanDefinition.goal.category	example	GoalCategory http://hl7.org/fhir/ValueSet/goal-category from the FHIR Standard
PlanDefinition.goal.description	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/clinical-findings from the FHIR Standard
PlanDefinition.goal.priority	preferred	GoalPriority http://hl7.org/fhir/ValueSet/goal-priority from the FHIR Standard
PlanDefinition.goal.start	example	GoalStartEvent http://hl7.org/fhir/ValueSet/goal-start-event from the FHIR Standard
PlanDefinition.goal.addresses	required	PqcmcTestUsageTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology from this IG
PlanDefinition.goal.target.measure	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
PlanDefinition.goal.target.detail[x]:detailQuantity	required	PqcmcUnitsMeasure http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG
PlanDefinition.goal.target.detail[x]:detailQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
PlanDefinition.actor.option.type	required	ActionParticipantType http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0 from the FHIR Standard
PlanDefinition.actor.option.role	example	ActionParticipantRole http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.priority	required	RequestPriority http://hl7.org/fhir/ValueSet/request-priority|5.0.0 from the FHIR Standard
PlanDefinition.action.code	example	ActionCode http://hl7.org/fhir/ValueSet/action-code from the FHIR Standard
PlanDefinition.action.code.coding	required	PqcmcTestMethodOriginTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology from this IG
PlanDefinition.action.reason	required	PqcmcTestCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology from this IG
PlanDefinition.action.documentation.type	required	Pattern: documentation http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0 from the FHIR Standard
PlanDefinition.action.documentation.classifier	example	CitationArtifactClassifier http://hl7.org/fhir/ValueSet/citation-artifact-classifier from the FHIR Standard
PlanDefinition.action.documentation.publicationStatus	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
PlanDefinition.action.subject[x]	extensible	ParticipantResourceTypes http://hl7.org/fhir/ValueSet/participant-resource-types from the FHIR Standard
PlanDefinition.action.condition.kind	required	ActionConditionKind http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0 from the FHIR Standard
PlanDefinition.action.relatedAction.relationship	required	Pattern: concurrent http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.relatedAction.endRelationship	required	ActionRelationshipType http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.participant.type	required	ActionParticipantType http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0 from the FHIR Standard
PlanDefinition.action.participant.role	example	ActionParticipantRole http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.participant.function	example	ActionParticipantFunction http://hl7.org/fhir/ValueSet/action-participant-function from the FHIR Standard
PlanDefinition.action.type	extensible	ActionType http://hl7.org/fhir/ValueSet/action-type from the FHIR Standard
PlanDefinition.action.groupingBehavior	required	ActionGroupingBehavior http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.selectionBehavior	required	ActionSelectionBehavior http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.requiredBehavior	required	ActionRequiredBehavior http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.precheckBehavior	required	ActionPrecheckBehavior http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.cardinalityBehavior	required	ActionCardinalityBehavior http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.priority	required	RequestPriority http://hl7.org/fhir/ValueSet/request-priority|5.0.0 from the FHIR Standard
PlanDefinition.action.action.code	example	ActionCode http://hl7.org/fhir/ValueSet/action-code from the FHIR Standard
PlanDefinition.action.action.reason	example	ActionReasonCode http://hl7.org/fhir/ValueSet/action-reason-code from the FHIR Standard
PlanDefinition.action.action.documentation.type	required	Pattern: documentation http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.documentation.classifier	example	CitationArtifactClassifier http://hl7.org/fhir/ValueSet/citation-artifact-classifier from the FHIR Standard
PlanDefinition.action.action.documentation.document.contentType	required	MimeTypes (a valid code from urn:ietf:bcp:13) http://hl7.org/fhir/ValueSet/mimetypes|5.0.0 from the FHIR Standard
PlanDefinition.action.action.documentation.document.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
PlanDefinition.action.action.documentation.publicationStatus	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
PlanDefinition.action.action.subject[x]	extensible	ParticipantResourceTypes http://hl7.org/fhir/ValueSet/participant-resource-types from the FHIR Standard
PlanDefinition.action.action.condition.kind	required	ActionConditionKind http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0 from the FHIR Standard
PlanDefinition.action.action.relatedAction.relationship	required	ActionRelationshipType http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.relatedAction.endRelationship	required	ActionRelationshipType http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.participant.type	required	ActionParticipantType http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.participant.role	example	ActionParticipantRole http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.action.participant.function	example	ActionParticipantFunction http://hl7.org/fhir/ValueSet/action-participant-function from the FHIR Standard
PlanDefinition.action.action.type	extensible	ActionType http://hl7.org/fhir/ValueSet/action-type from the FHIR Standard
PlanDefinition.action.action.groupingBehavior	required	ActionGroupingBehavior http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.selectionBehavior	required	ActionSelectionBehavior http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.requiredBehavior	required	ActionRequiredBehavior http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.precheckBehavior	required	ActionPrecheckBehavior http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.cardinalityBehavior	required	ActionCardinalityBehavior http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.priority	required	RequestPriority http://hl7.org/fhir/ValueSet/request-priority|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.code	example	ActionCode http://hl7.org/fhir/ValueSet/action-code from the FHIR Standard
PlanDefinition.action.action.action.reason	example	ActionReasonCode http://hl7.org/fhir/ValueSet/action-reason-code from the FHIR Standard
PlanDefinition.action.action.action.subject[x]	extensible	ParticipantResourceTypes http://hl7.org/fhir/ValueSet/participant-resource-types from the FHIR Standard
PlanDefinition.action.action.action.condition.kind	required	ActionConditionKind http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.relatedAction.relationship	required	ActionRelationshipType http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.relatedAction.endRelationship	required	ActionRelationshipType http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.participant.type	required	ActionParticipantType http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.participant.role	example	ActionParticipantRole http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.action.action.participant.function	example	ActionParticipantFunction http://hl7.org/fhir/ValueSet/action-participant-function from the FHIR Standard
PlanDefinition.action.action.action.type	extensible	ActionType http://hl7.org/fhir/ValueSet/action-type from the FHIR Standard
PlanDefinition.action.action.action.groupingBehavior	required	ActionGroupingBehavior http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.selectionBehavior	required	ActionSelectionBehavior http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.requiredBehavior	required	ActionRequiredBehavior http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.precheckBehavior	required	ActionPrecheckBehavior http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.action.action.cardinalityBehavior	required	ActionCardinalityBehavior http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0 from the FHIR Standard
PlanDefinition.asNeeded[x]	example	SNOMEDCTMedicationAsNeededReasonCodes http://hl7.org/fhir/ValueSet/medication-as-needed-reason from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-link-required	error	PlanDefinition.action	Action linkId is required for alternate tests : (action.relatedAction.count() > 0) implies action.linkId.exists()
cmc-single-or-multistage	error	PlanDefinition.action	if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes : (( prefix.exists() implies action.prefix.empty() and prefix = 'Single Stage' ) and ( prefix.empty() implies ( (action.where( prefix.exists() and prefix != 'Single Stage' ).count() = action.count()) and action.prefix.isDistinct() ) )) = true
cmc-subtest-rrt	error	PlanDefinition.action.action.action	a subtest's prefix represents relative retention time, should it exist : prefix.exists() implies prefix.single() = 'RRT'
cmc-target-range	error	PlanDefinition.goal.target	When the Range extension is present, detail cannot be present. : modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range').exists() implies detail.exists().not()
cnl-0	warning	PlanDefinition	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}$')
cnl-1	warning	PlanDefinition.url	URL should not contain | or # - these characters make processing canonical references problematic : exists() implies matches('^[^|# ]+$')
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()
pld-0	error	PlanDefinition.action.input, PlanDefinition.action.action.input, PlanDefinition.action.action.action.input	Input data elements must have a requirement or a relatedData, but not both : requirement.exists() xor relatedData.exists()
pld-1	error	PlanDefinition.action.output, PlanDefinition.action.action.output, PlanDefinition.action.action.action.output	Output data element must have a requirement or a relatedData, but not both : requirement.exists() xor relatedData.exists()
pld-3	warning	PlanDefinition	goalid should reference the id of a goal definition : %context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()
pld-4	warning	PlanDefinition	targetId should reference the id of an action : %context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()

This structure is derived from PlanDefinition

Summary

Mandatory: 17 elements(12 nested mandatory elements)
Must-Support: 58 elements
Prohibited: 1 element

Structures

This structure refers to these other structures:

• Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
• Drug Product Handle (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle)
• Drug Substance Handle (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance)
• Excipient Drug Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient)
• Text Only Codeable Concept (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension
• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range (Modifier)
• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of PlanDefinition.type.coding (Closed)
• The element 1 is sliced based on the value of PlanDefinition.goal.target.detail[x]