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 2026-04-02 | Maturity Level: 2 | Computable Name: M11_ResearchStudy | |||
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
2026-04-02
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