Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot
Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot
This page is part of the Pharmaceutical Clinical Trial Protocols (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions
| Official URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail | Version: 1.0.0-ballot | |||
| Standards status: Trial-use | Maturity Level: 1 | Computable Name: ResearchStudyStudyAmendmentDetails | ||
Provides detail of a single amendment - repeats within the overal amendment report
Context of Use
This extension may be used on the following element(s)
Element
Usage info
Usages:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.
This structure is derived from Extension
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  Extension |
0..* | Extension | Extension | |
  extension |
3..* | Extension | Extension | |
  Slices for extension |
Content/Rules for all slices | |||
   extension:detail |
1..1 | Extension | Extension | |
  extension |
0..0 | |||
| url |
1..1 | uri | "detail" | |
  value[x] |
0..1 | string | Statement regarding prior amendments | |
| extension:rationale |
1..1 | Extension | Extension | |
| extension |
0..0 | |||
| url |
1..1 | uri | "rationale" | |
| value[x] |
0..1 | string | Rationale | |
 extension:section |
1..1 | Extension | Extension | |
 extension |
0..0 | |||
| url |
1..1 | uri | "section" | |
 value[x] |
0..1 | CodeableConcept | Section where the amendment was made Binding: M11 Section Codes Value Set (required) | |
| url |
1..1 | uri | "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail" | |
 value[x] |
0..0 | |||
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Extension |
0..* | Extension | Extension | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| Slices for extension |
3..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:detail |
1..1 | Extension | Extension | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | |||
| url |
Σ | 1..1 | uri | "detail" |
| value[x] |
Σ | 0..1 | string | Statement regarding prior amendments |
| extension:rationale |
1..1 | Extension | Extension | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | |||
| url |
Σ | 1..1 | uri | "rationale" |
| value[x] |
Σ | 0..1 | string | Rationale |
| extension:section |
1..1 | Extension | Extension | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | |||
| url |
Σ | 1..1 | uri | "section" |
| value[x] |
Σ | 0..1 | CodeableConcept | Section where the amendment was made Binding: M11 Section Codes Value Set (required) |
| url |
Σ | 1..1 | uri | "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail" |
| Documentation for this format | ||||
Differential View
This structure is derived from Extension
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Extension |
0..* | Extension | Extension | |
| extension |
3..* | Extension | Extension | |
| Slices for extension |
Content/Rules for all slices | |||
| extension:detail |
1..1 | Extension | Extension | |
| extension |
0..0 | |||
| url |
1..1 | uri | "detail" | |
| value[x] |
0..1 | string | Statement regarding prior amendments | |
| extension:rationale |
1..1 | Extension | Extension | |
| extension |
0..0 | |||
| url |
1..1 | uri | "rationale" | |
| value[x] |
0..1 | string | Rationale | |
| extension:section |
1..1 | Extension | Extension | |
| extension |
0..0 | |||
| url |
1..1 | uri | "section" | |
| value[x] |
0..1 | CodeableConcept | Section where the amendment was made Binding: M11 Section Codes Value Set (required) | |
| url |
1..1 | uri | "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail" | |
| value[x] |
0..0 | |||
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Extension |
0..* | Extension | Extension | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| Slices for extension |
3..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:detail |
1..1 | Extension | Extension | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | |||
| url |
Σ | 1..1 | uri | "detail" |
| value[x] |
Σ | 0..1 | string | Statement regarding prior amendments |
| extension:rationale |
1..1 | Extension | Extension | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | |||
| url |
Σ | 1..1 | uri | "rationale" |
| value[x] |
Σ | 0..1 | string | Rationale |
| extension:section |
1..1 | Extension | Extension | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | |||
| url |
Σ | 1..1 | uri | "section" |
| value[x] |
Σ | 0..1 | CodeableConcept | Section where the amendment was made Binding: M11 Section Codes Value Set (required) |
| url |
Σ | 1..1 | uri | "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail" |
| Documentation for this format | ||||
Other representations of profile: CSV, Excel, Schematron
| Path | Conformance | ValueSet | URI |
| Extension.extension:section.value[x] | required | M11SectionCodesVShttp://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vsFrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| 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() |
IG © 2025+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharmaceutical-research-protocol#1.0.0-ballot based on FHIR 6.0.0-ballot3. Generated 2025-08-01
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QA Report
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