Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## Extension: M11 Research Study Extension

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study | Version: 1.0.0-ballot2 | Highlight text changes?
Standards status: Trial-use Active as of 2026-04-09 | 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

Additions for M11 not otherwise dealt with

Context of Use

This extension may be used on the following element(s)

- Element ID: `http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile#ResearchStudy`

### Must Support Elements

Both originalProtocol and versionDate SHALL be populated§12

Usage info

Usages:

- Use this Extension: M11 Research Study Profile
- Examples for this Extension: ResearchStudy/Exemplar-ResearchStudy-001, ResearchStudy/Exemplar-ResearchStudy-Current-Amendment, ResearchStudy/JPMA0001-eng, ResearchStudy/JPMA0001-jpn... Show 4 more, ResearchStudy/ResearchStudy-Composition-Section-Per-Section-001, ResearchStudy/ResearchStudy-Narrative-Comp-Per-M11-001, ResearchStudy/ResearchStudy-Narrative-Complex-001 and ResearchStudy/ResearchStudy-Single-Composition-001

You can also check for usages in the FHIR IG Statistics

### Formal Views of Extension Content

Description Differentials, Snapshots, and other representations.

- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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

#### Terminology Bindings (Differential)

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: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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

#### Terminology Bindings

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

#### Constraints

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

- originalProtocol: CodeableConcept: An Extension
- versionDate: date: An Extension

Maturity: 2

Differential ViewDifferential View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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

#### Terminology Bindings (Differential)

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: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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

#### Terminology Bindings

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

#### Constraints

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

- originalProtocol: CodeableConcept: An Extension
- versionDate: date: An Extension

Maturity: 2

Other representations of profile: CSV, Excel, Schematron