Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

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 1.1.6 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

Resource Profile: Quality Specification

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification Version: 1.1.6
Active as of 2024-09-22 Computable Name: QualitySpecification
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.30

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

Usage:

Formal Views of Profile Content

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

This structure is derived from PlanDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. PlanDefinition PlanDefinition
... meta
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... 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
... 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:$this
..... coding:DefinitionType S 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/plan-definition-type
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: workflow-definition
...... display 1..1 string Representation defined by the system
Fixed Value: Workflow Definition
..... coding:SpecType S 1..1 Coding Specification Type
Binding: Specification Type Terminology (required)
... status S 1..1 code draft | active | retired | unknown
... subject[x] S 1..1 Reference(Drug Product Handle | Drug Substance Handle | Excipient Drug Substance) Type of individual the plan definition is focused on
... date S 1..1 dateTime Specification Version Date
... approvalDate S 0..1 date Specification Status Date
... goal S 0..* BackboneElement Acceptance Criteria
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... ac-additional-info 0..1 markdown Acceptance Criteria Additional Information
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
.... description S 1..1 CodeableConcept Original Text
.... addresses S 1..* CodeableConcept What does the goal address
..... coding
...... code S 1..1 code Acceptance Criteria Usage
Binding: Test Usage Terminology (required)
..... text 0..1 string Accpetance Criteria Usage
.... target SC 1..* BackboneElement Acceptance Criteron
cmc-target-range: When the Range extension is present, detail cannot be present.
..... Slices for modifierExtension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... modifierExtension:targetRange S 0..1 TargetRange Target Range
..... measure
...... text S 0..1 string Detailed parameter being measured if more granular than Sub-Test
..... Slices for detail[x] S 0..1 The target value to be achieved
Slice: Unordered, Open by type:$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
...... code S 1..1 code Symbol in syntax defined by the system
Binding: Test Method Origin Terminology (required)
..... text S 1..1 string Analytical Procedure
.... reason S 1..2 CodeableConcept Test Category | Test Subcategory
..... extension 1..* Extension Extension
..... Slices for extension Content/Rules for all slices
...... categoryLevel S 1..1 integer Hierarchical Level
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
..... coding S 0..* Coding Code defined by a terminology system
Binding: Test Category Terminology (required)
...... code S 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... 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

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
PlanDefinition.type.coding:SpecTyperequiredPqcmcSpecificationTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology
from this IG
PlanDefinition.goal.addresses.coding.coderequiredPqcmcTestUsageTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailQuantityrequiredPqcmcUnitsMeasure
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure
from this IG
PlanDefinition.action.code.coding.coderequiredPqcmcTestMethodOriginTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology
from this IG
PlanDefinition.action.reason.codingrequiredPqcmcTestCategoryTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology
from this IG

Constraints

IdGradePath(s)DetailsRequirements
cmc-link-requirederrorPlanDefinition.actionAction linkId is required for alternate tests
: (action.relatedAction.count() > 0) implies action.linkId.exists()
cmc-single-or-multistageerrorPlanDefinition.actionif 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-rrterrorPlanDefinition.action.action.actiona subtest's prefix represents relative retention time, should it exist
: prefix.exists() implies prefix.single() = 'RRT'
cmc-target-rangeerrorPlanDefinition.goal.targetWhen 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()
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
.... 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 Reference(Drug Product Handle | Drug Substance Handle | Excipient Drug Substance) 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 What does the goal address
Binding: ConditionProblemDiagnosisCodes (example): Identifies problems, conditions, issues, or concerns that goals may address.


..... coding Σ 0..* Coding Code defined by a terminology system
...... code SΣC 1..1 code Acceptance Criteria Usage
Binding: Test Usage Terminology (required)
..... text Σ 0..1 string Accpetance Criteria Usage
.... 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 0..1 CodeableConcept The parameter whose value is to be tracked
Binding: LOINCCodes (example): Identifies types of parameters that can be tracked to determine goal achievement.

...... text SΣ 0..1 string 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, 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 Σ 0..* Coding Code defined by a terminology system
...... code SΣC 1..1 code Symbol in syntax defined by the system
Binding: Test Method Origin Terminology (required)
..... text SΣ 1..1 string Analytical Procedure
.... reason S 1..2 CodeableConcept Test Category | Test Subcategory
Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.


..... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
...... categoryLevel S 1..1 integer Hierarchical Level
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
..... coding SΣ 0..* Coding Code defined by a terminology system
Binding: Test Category Terminology (required)
...... code SΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
.... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
PlanDefinition.typeextensiblePlanDefinitionType
http://hl7.org/fhir/ValueSet/plan-definition-type
from the FHIR Standard
PlanDefinition.type.coding:SpecTyperequiredPqcmcSpecificationTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology
from this IG
PlanDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
PlanDefinition.goal.descriptionexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/clinical-findings
from the FHIR Standard
PlanDefinition.goal.addressesexampleConditionProblemDiagnosisCodes
http://hl7.org/fhir/ValueSet/condition-code
from the FHIR Standard
PlanDefinition.goal.addresses.coding.coderequiredPqcmcTestUsageTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology
from this IG
PlanDefinition.goal.target.measureexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
PlanDefinition.goal.target.detail[x]:detailQuantityrequiredPqcmcUnitsMeasure
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure
from this IG
PlanDefinition.goal.target.detail[x]:detailQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PlanDefinition.action.codeexampleActionCode
http://hl7.org/fhir/ValueSet/action-code
from the FHIR Standard
PlanDefinition.action.code.coding.coderequiredPqcmcTestMethodOriginTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology
from this IG
PlanDefinition.action.reasonexampleActionReasonCode
http://hl7.org/fhir/ValueSet/action-reason-code
from the FHIR Standard
PlanDefinition.action.reason.codingrequiredPqcmcTestCategoryTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology
from this IG
PlanDefinition.action.documentation.typerequiredPattern: documentation
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
PlanDefinition.action.relatedAction.relationshiprequiredPattern: concurrent
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.documentation.typerequiredPattern: documentation
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.documentation.document.contentTyperequiredMimeTypes (a valid code from urn:ietf:bcp:13)
http://hl7.org/fhir/ValueSet/mimetypes|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-link-requirederrorPlanDefinition.actionAction linkId is required for alternate tests
: (action.relatedAction.count() > 0) implies action.linkId.exists()
cmc-single-or-multistageerrorPlanDefinition.actionif 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-rrterrorPlanDefinition.action.action.actiona subtest's prefix represents relative retention time, should it exist
: prefix.exists() implies prefix.single() = 'RRT'
cmc-target-rangeerrorPlanDefinition.goal.targetWhen 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-0warningPlanDefinitionName 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-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
pld-3warningPlanDefinitiongoalid should reference the id of a goal definition
: %context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()
pld-4warningPlanDefinitiontargetId should reference the id of an action
: %context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... 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 BindingsPurpose
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 Reference(Drug Product Handle | Drug Substance Handle | Excipient Drug Substance) 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 What does the goal address
Binding: ConditionProblemDiagnosisCodes (example): Identifies problems, conditions, issues, or concerns that goals may address.


..... 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 Σ 0..* Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 0..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code SΣC 1..1 code Acceptance Criteria Usage
Binding: Test Usage Terminology (required)
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Accpetance Criteria Usage
.... 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 0..1 CodeableConcept The parameter whose value is to be tracked
Binding: LOINCCodes (example): Identifies types of parameters that can be tracked to determine goal achievement.

...... 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 Σ 0..* Coding Code defined by a terminology system
...... text SΣ 0..1 string 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, 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 Σ 0..* Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 0..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code SΣC 1..1 code Symbol in syntax defined by the system
Binding: Test Method Origin Terminology (required)
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text SΣ 1..1 string Analytical Procedure
.... reason S 1..2 CodeableConcept Test Category | Test Subcategory
Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.


..... 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 integer Hierarchical Level
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
..... coding SΣ 0..* Coding Code defined by a terminology system
Binding: Test Category Terminology (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
...... system Σ 0..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code SΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... 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 BindingsPurpose
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