Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2 International flag

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

Extension:

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval Version: 1.0.0-ballot2
Standards status: Trial-use Active as of 2026-04-08 Maturity Level: 2 Computable Name: M11_Approval

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

Approval and sign off

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

At least one of approvalDate or signatureUrl SHOULD be populated§1

Usage info

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Extension Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension C 0..* Extension Sign-off details
Constraints: date-required
... Slices for extension Content/Rules for all slices
.... extension:approvalDate S 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "approvalDate"
..... value[x] 0..1 date Value of extension
.... extension:signature 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signature"
..... value[x] 0..1 Signature Value of extension
.... extension:signatureUrl S 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureUrl"
..... value[x] 0..1 Value of extension
...... valueString string
...... valueUrl url
.... extension:signatureMethod 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureMethod"
..... value[x] 0..1 string Value of extension
... url 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"
... value[x] 0..0 Value of extension

doco Documentation for this format

Constraints

Id Grade Path(s) Description Expression
date-required warning Extension At least one of approvalDate or signatureUrl SHOULD be populated. extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension C 0..* Extension Sign-off details
Constraints: date-required
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... extension:approvalDate S 0..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 "approvalDate"
..... value[x] Σ 0..1 date Value of extension
.... extension:signature 0..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 "signature"
..... value[x] Σ 0..1 Signature Value of extension
.... extension:signatureUrl S 0..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 "signatureUrl"
..... value[x] Σ 0..1 Value of extension
...... valueString string
...... valueUrl url
.... extension:signatureMethod 0..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 "signatureMethod"
..... value[x] Σ 0..1 string Value of extension
... url Σ 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"

doco Documentation for this format

Constraints

Id Grade Path(s) Description Expression
date-required warning Extension At least one of approvalDate or signatureUrl SHOULD be populated. extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()
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: Approval and sign off

  • approvalDate: date: An Extension
  • signature: Signature: An Extension
  • signatureUrl: string, url: An Extension
  • signatureMethod: string: An Extension

Maturity: 2

Differential ViewDifferential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension C 0..* Extension Sign-off details
Constraints: date-required
... Slices for extension Content/Rules for all slices
.... extension:approvalDate S 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "approvalDate"
..... value[x] 0..1 date Value of extension
.... extension:signature 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signature"
..... value[x] 0..1 Signature Value of extension
.... extension:signatureUrl S 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureUrl"
..... value[x] 0..1 Value of extension
...... valueString string
...... valueUrl url
.... extension:signatureMethod 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureMethod"
..... value[x] 0..1 string Value of extension
... url 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"
... value[x] 0..0 Value of extension

doco Documentation for this format

Constraints

Id Grade Path(s) Description Expression
date-required warning Extension At least one of approvalDate or signatureUrl SHOULD be populated. extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension C 0..* Extension Sign-off details
Constraints: date-required
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... extension:approvalDate S 0..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 "approvalDate"
..... value[x] Σ 0..1 date Value of extension
.... extension:signature 0..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 "signature"
..... value[x] Σ 0..1 Signature Value of extension
.... extension:signatureUrl S 0..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 "signatureUrl"
..... value[x] Σ 0..1 Value of extension
...... valueString string
...... valueUrl url
.... extension:signatureMethod 0..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 "signatureMethod"
..... value[x] Σ 0..1 string Value of extension
... url Σ 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"

doco Documentation for this format

Constraints

Id Grade Path(s) Description Expression
date-required warning Extension At least one of approvalDate or signatureUrl SHOULD be populated. extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()
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: Approval and sign off

  • approvalDate: date: An Extension
  • signature: Signature: An Extension
  • signatureUrl: string, url: An Extension
  • signatureMethod: string: An Extension

Maturity: 2

 

Other representations of profile: CSV, Excel, Schematron