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
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:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from PlanDefinition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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 |
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 | 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 |
Documentation for this format |
Path | Conformance | ValueSet | URI |
PlanDefinition.type.coding:SpecType | required | PqcmcSpecificationTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology from this IG | |
PlanDefinition.goal.addresses.coding.code | required | PqcmcTestUsageTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology from this IG | |
PlanDefinition.goal.target.detail[x]:detailQuantity | required | PqcmcUnitsMeasurehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG | |
PlanDefinition.action.code.coding.code | required | PqcmcTestMethodOriginTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology from this IG | |
PlanDefinition.action.reason.coding | required | PqcmcTestCategoryTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology from this IG |
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 |
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 | |
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 | 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 |
Documentation for this format |
Path | Conformance | ValueSet / Code | URI |
PlanDefinition.type | extensible | PlanDefinitionTypehttp://hl7.org/fhir/ValueSet/plan-definition-type from the FHIR Standard | |
PlanDefinition.type.coding:SpecType | required | PqcmcSpecificationTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology from this IG | |
PlanDefinition.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard | |
PlanDefinition.goal.description | example | SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/clinical-findings from the FHIR Standard | |
PlanDefinition.goal.addresses | example | ConditionProblemDiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard | |
PlanDefinition.goal.addresses.coding.code | required | PqcmcTestUsageTerminologyhttp://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 | PqcmcUnitsMeasurehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure from this IG | |
PlanDefinition.goal.target.detail[x]:detailQuantity.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard | |
PlanDefinition.action.code | example | ActionCodehttp://hl7.org/fhir/ValueSet/action-code from the FHIR Standard | |
PlanDefinition.action.code.coding.code | required | PqcmcTestMethodOriginTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology from this IG | |
PlanDefinition.action.reason | example | ActionReasonCodehttp://hl7.org/fhir/ValueSet/action-reason-code from the FHIR Standard | |
PlanDefinition.action.reason.coding | required | PqcmcTestCategoryTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology from this IG | |
PlanDefinition.action.documentation.type | required | Pattern: documentationhttp://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0 from the FHIR Standard | |
PlanDefinition.action.relatedAction.relationship | required | Pattern: concurrenthttp://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard | |
PlanDefinition.action.action.documentation.type | required | Pattern: documentationhttp://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 |
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 | ||||
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
| |||||
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.
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 | ||||