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-research-study | Version: 1.0.0-ballot2 | ||||
| Standards status: Trial-use Active as of 2026-04-08 | Maturity Level: 2 | Computable Name: M11_ResearchStudy | |||
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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Additions for M11 not otherwise dealt with
Context of Use
This extension may be used on the following element(s)
http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile#ResearchStudy
Both originalProtocol and versionDate SHALL be populated§12
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 | Additional concepts for M11 | |
  extension |
2..* | Extension | Extension | |
  Slices for extension |
Content/Rules for all slices | |||
   extension:originalProtocol |
S | 1..1 | Extension | Extension |
  extension |
0..0 | Extension | ||
| url |
1..1 | uri | "originalProtocol" | |
  value[x] |
0..1 | CodeableConcept | Original Protocol Indicator Binding: ICH M11 Amendment Details Statement Value Set Terminology (required) | |
 extension:versionDate |
1..1 | Extension | Extension | |
 extension |
0..0 | Extension | ||
| url |
1..1 | uri | "versionDate" | |
 value[x] |
0..1 | date | Protocol version date | |
| url |
1..1 | uri | "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study" | |
 value[x] |
0..0 | Value of extension | ||
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Extension.extension:originalProtocol.value[x] | Base | required | ICH M11 Amendment Details Statement Value Set Terminology | 📦1.0.0-ballot2 | This IG |
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
 Extension |
0..* | Extension | Additional concepts for M11 | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| Slices for extension |
2..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:originalProtocol |
S | 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 | "originalProtocol" |
| value[x] |
Σ | 0..1 | CodeableConcept | Original Protocol Indicator Binding: ICH M11 Amendment Details Statement Value Set Terminology (required) |
| extension:versionDate |
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 | "versionDate" |
| value[x] |
Σ | 0..1 | date | Protocol version date |
| url |
Σ | 1..1 | uri | "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study" |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Extension.extension:originalProtocol.value[x] | Base | required | ICH M11 Amendment Details Statement 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: Additions for M11 not otherwise dealt with
Maturity: 2
Differential ViewDifferential View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Extension |
0..* | Extension | Additional concepts for M11 | |
| extension |
2..* | Extension | Extension | |
| Slices for extension |
Content/Rules for all slices | |||
| extension:originalProtocol |
S | 1..1 | Extension | Extension |
| extension |
0..0 | Extension | ||
| url |
1..1 | uri | "originalProtocol" | |
| value[x] |
0..1 | CodeableConcept | Original Protocol Indicator Binding: ICH M11 Amendment Details Statement Value Set Terminology (required) | |
| extension:versionDate |
1..1 | Extension | Extension | |
| extension |
0..0 | Extension | ||
| url |
1..1 | uri | "versionDate" | |
| value[x] |
0..1 | date | Protocol version date | |
| url |
1..1 | uri | "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study" | |
| value[x] |
0..0 | Value of extension | ||
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Extension.extension:originalProtocol.value[x] | Base | required | ICH M11 Amendment Details Statement Value Set Terminology | 📦1.0.0-ballot2 | This IG |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Extension |
0..* | Extension | Additional concepts for M11 | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| Slices for extension |
2..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:originalProtocol |
S | 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 | "originalProtocol" |
| value[x] |
Σ | 0..1 | CodeableConcept | Original Protocol Indicator Binding: ICH M11 Amendment Details Statement Value Set Terminology (required) |
| extension:versionDate |
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 | "versionDate" |
| value[x] |
Σ | 0..1 | date | Protocol version date |
| url |
Σ | 1..1 | uri | "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study" |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Extension.extension:originalProtocol.value[x] | Base | required | ICH M11 Amendment Details Statement 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: Additions for M11 not otherwise dealt with
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 |
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