Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
| Active as of 2024-12-04 |
Definitions for the literal-codeable-reference data type profile.
Guidance on how to interpret the contents of this table can be found here
| 0. CodeableReference | |
| 2. CodeableReference.reference | |
| Control | 1..? |
| Type | Reference(Literal Reference) |
| Must Support | true |
Guidance on how to interpret the contents of this table can be found here
| 0. CodeableReference | |
| Definition | A reference to a resource (by instance), or instead, a reference to a concept defined in a terminology or ontology (by class). |
| Short | Reference to a resource or a concept |
| Control | 0..* |
| Is Modifier | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2. CodeableReference.reference | |
| Definition | A reference to a resource the provides exact details about the information being referenced. |
| Short | Reference to a resource (by instance) |
| Control | 10..1 |
| Type | Reference(Literal Reference) |
| Is Modifier | false |
| Must Support | true |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be found here
| 0. CodeableReference | |
| Definition | A reference to a resource (by instance), or instead, a reference to a concept defined in a terminology or ontology (by class). |
| Short | Reference to a resource or a concept |
| Control | 0..* |
| Is Modifier | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2. CodeableReference.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | id |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 4. CodeableReference.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on CodeableReference.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 6. CodeableReference.concept | |
| Definition | A reference to a concept - e.g. the information is identified by its general class to the degree of precision found in the terminology. |
| Short | Reference to a concept (by class) |
| Control | 0..1 |
| Type | CodeableConcept |
| Is Modifier | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 8. CodeableReference.reference | |
| Definition | A reference to a resource the provides exact details about the information being referenced. |
| Short | Reference to a resource (by instance) |
| Control | 1..1 |
| Type | Reference(Literal Reference) |
| Is Modifier | false |
| Must Support | true |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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