Pharmaceutical Research Protocol (Vulcan UDP), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. 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: ![]() ![]() |
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0..* | Extension | Extension | |
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3..* | Extension | Extension | |
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Content/Rules for all slices | |||
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1..1 | Extension | Extension | |
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0..0 | |||
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1..1 | uri | "detail" | |
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0..1 | string | Statement regarding prior amendments | |
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1..1 | Extension | Extension | |
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0..0 | |||
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1..1 | uri | "rationale" | |
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0..1 | string | Rationale | |
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1..1 | Extension | Extension | |
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0..0 | |||
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1..1 | uri | "section" | |
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0..1 | CodeableConcept | Section where the amendment was made Binding: M11 Section Codes Value Set (required) | |
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1..1 | uri | "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail" | |
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0..0 | |||
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Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
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0..* | Extension | Extension | |
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0..1 | id | Unique id for inter-element referencing | |
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3..* | Extension | Extension Slice: Unordered, Open by value:url | |
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1..1 | Extension | Extension | |
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0..1 | id | Unique id for inter-element referencing | |
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0..0 | |||
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Σ | 1..1 | uri | "detail" |
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Σ | 0..1 | string | Statement regarding prior amendments |
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1..1 | Extension | Extension | |
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0..1 | id | Unique id for inter-element referencing | |
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0..0 | |||
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Σ | 1..1 | uri | "rationale" |
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Σ | 0..1 | string | Rationale |
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1..1 | Extension | Extension | |
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0..1 | id | Unique id for inter-element referencing | |
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0..0 | |||
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Σ | 1..1 | uri | "section" |
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Σ | 0..1 | CodeableConcept | Section where the amendment was made Binding: M11 Section Codes Value Set (required) |
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Σ | 1..1 | uri | "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail" |
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Differential View
This structure is derived from Extension
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
---|---|---|---|---|
![]() ![]() |
0..* | Extension | Extension | |
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3..* | Extension | Extension | |
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Content/Rules for all slices | |||
![]() ![]() ![]() ![]() |
1..1 | Extension | Extension | |
![]() ![]() ![]() ![]() ![]() |
0..0 | |||
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1..1 | uri | "detail" | |
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0..1 | string | Statement regarding prior amendments | |
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1..1 | Extension | Extension | |
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0..0 | |||
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1..1 | uri | "rationale" | |
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0..1 | string | Rationale | |
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1..1 | Extension | Extension | |
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0..0 | |||
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1..1 | uri | "section" | |
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0..1 | CodeableConcept | Section where the amendment was made Binding: M11 Section Codes Value Set (required) | |
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1..1 | uri | "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail" | |
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0..0 | |||
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Snapshot View
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
---|---|---|---|---|
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0..* | Extension | Extension | |
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0..1 | id | Unique id for inter-element referencing | |
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3..* | Extension | Extension Slice: Unordered, Open by value:url | |
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1..1 | Extension | Extension | |
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0..1 | id | Unique id for inter-element referencing | |
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0..0 | |||
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Σ | 1..1 | uri | "detail" |
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Σ | 0..1 | string | Statement regarding prior amendments |
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1..1 | Extension | Extension | |
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0..1 | id | Unique id for inter-element referencing | |
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0..0 | |||
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Σ | 1..1 | uri | "rationale" |
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Σ | 0..1 | string | Rationale |
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1..1 | Extension | Extension | |
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0..1 | id | Unique id for inter-element referencing | |
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0..0 | |||
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Σ | 1..1 | uri | "section" |
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Σ | 0..1 | CodeableConcept | Section where the amendment was made Binding: M11 Section Codes Value Set (required) |
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Σ | 1..1 | uri | "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail" |
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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-vs From 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() |