Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2
Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2
Clinical Study Protocol, 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-ballot2 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/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact | Version: 1.0.0-ballot2 | ||||
| Standards status: Trial-use Active as of 2026-04-08 | Maturity Level: 2 | Computable Name: M11_AmendmentScopeImpact | |||
Copyright/Legal: Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license CDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license For more licensing information and links see: licenses.html |
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Provides number or percentage of each group affected by a single amendment
Context of Use
This extension may be used on the following element(s)
Usage info
Usages:
You can also check for usages in the FHIR IG Statistics
Description Differentials, Snapshots, and other representations.
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  Extension |
0..* | Extension | Extension | |
  extension |
2..* | Extension | Extension | |
  Slices for extension |
Content/Rules for all slices | |||
   extension:number |
1..1 | Extension | Extension | |
  extension |
0..0 | Extension | ||
| url |
1..1 | uri | "number" | |
  value[x] |
0..1 | Number of participants, or % of participants | ||
  valuePositiveInt |
positiveInt | |||
  valueQuantity |
Quantity | |||
 extension:scope |
1..1 | Extension | Extension | |
| extension |
0..0 | Extension | ||
| url |
1..1 | uri | "scope" | |
 value[x] |
0..1 | CodeableConcept | Value of extension Binding: ICH M11 Amendment Scope Enrollment Description Value Set Terminology (required) | |
| url |
1..1 | uri | "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact" | |
| value[x] |
0..0 | Value of extension | ||
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Extension.extension:scope.value[x] | Base | required | ICH M11 Amendment Scope Enrollment Description Value Set Terminology | 📦1.0.0-ballot2 | This IG |
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
 Extension |
0..* | Extension | Extension | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| Slices for extension |
2..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:number |
1..1 | Extension | Extension | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| url |
Σ | 1..1 | uri | "number" |
| value[x] |
Σ | 0..1 | Number of participants, or % of participants | |
| valuePositiveInt |
positiveInt | |||
| valueQuantity |
Quantity | |||
| extension:scope |
1..1 | Extension | Extension | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| url |
Σ | 1..1 | uri | "scope" |
| value[x] |
Σ | 0..1 | CodeableConcept | Value of extension Binding: ICH M11 Amendment Scope Enrollment Description Value Set Terminology (required) |
| url |
Σ | 1..1 | uri | "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact" |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Extension.extension:scope.value[x] | Base | required | ICH M11 Amendment Scope Enrollment Description Value Set Terminology | 📦1.0.0-ballot2 | This IG |
| Id | Grade | Path(s) | Description | Expression |
| 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()
|
Summary
Complex Extension: Provides number or percentage of each group affected by a single amendment
Maturity: 2
Differential ViewDifferential View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Extension |
0..* | Extension | Extension | |
| extension |
2..* | Extension | Extension | |
| Slices for extension |
Content/Rules for all slices | |||
| extension:number |
1..1 | Extension | Extension | |
| extension |
0..0 | Extension | ||
| url |
1..1 | uri | "number" | |
| value[x] |
0..1 | Number of participants, or % of participants | ||
| valuePositiveInt |
positiveInt | |||
| valueQuantity |
Quantity | |||
| extension:scope |
1..1 | Extension | Extension | |
| extension |
0..0 | Extension | ||
| url |
1..1 | uri | "scope" | |
| value[x] |
0..1 | CodeableConcept | Value of extension Binding: ICH M11 Amendment Scope Enrollment Description Value Set Terminology (required) | |
| url |
1..1 | uri | "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact" | |
| value[x] |
0..0 | Value of extension | ||
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Extension.extension:scope.value[x] | Base | required | ICH M11 Amendment Scope Enrollment Description Value Set Terminology | 📦1.0.0-ballot2 | This IG |
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 |
2..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:number |
1..1 | Extension | Extension | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| url |
Σ | 1..1 | uri | "number" |
| value[x] |
Σ | 0..1 | Number of participants, or % of participants | |
| valuePositiveInt |
positiveInt | |||
| valueQuantity |
Quantity | |||
| extension:scope |
1..1 | Extension | Extension | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| url |
Σ | 1..1 | uri | "scope" |
| value[x] |
Σ | 0..1 | CodeableConcept | Value of extension Binding: ICH M11 Amendment Scope Enrollment Description Value Set Terminology (required) |
| url |
Σ | 1..1 | uri | "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact" |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Extension.extension:scope.value[x] | Base | required | ICH M11 Amendment Scope Enrollment Description Value Set Terminology | 📦1.0.0-ballot2 | This IG |
| Id | Grade | Path(s) | Description | Expression |
| 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()
|
Summary
Complex Extension: Provides number or percentage of each group affected by a single amendment
Maturity: 2
Other representations of profile: CSV, Excel, Schematron
IG © 2026+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.clinical-study-protocol#1.0.0-ballot2 based on FHIR 6.0.0-ballot3.
Generated
2026-04-08
Links: Table of Contents |
QA Report
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