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-amendment-detail Version: 1.0.0-ballot2
Standards status: Trial-use Active as of 2026-04-08 Maturity Level: 2 Computable Name: M11_AmendmentDetails

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

Provides detail of a single amendment - repeats within the overal amendment report

Context of Use

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 0..* Extension Extension
... extension 3..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:detail 1..1 Extension Extension
..... url 1..1 uri "detail"
.... extension:rationale 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Rationale
.... extension:section 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "section"
..... value[x] 0..1 CodeableConcept Section where the amendment was made
Binding: UDP Section Codes Value Set (required)
... url 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail"

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Extension.extension:section.​value[x] Base required UDP Section Codes Value Set 📦1.0.0-ballot2 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Extension
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 3..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:detail 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "detail"
..... value[x] Σ 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueInteger64 integer64
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueAvailability Availability
...... valueExtendedContactDetail ExtendedContactDetail
...... valueDosage Dosage
...... valueMeta Meta
.... extension:rationale 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 "rationale"
..... value[x] Σ 0..1 string Rationale
.... extension:section 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 "section"
..... value[x] Σ 0..1 CodeableConcept Section where the amendment was made
Binding: UDP Section Codes Value Set (required)
... url Σ 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail"

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Extension.extension:section.​value[x] Base required UDP Section Codes Value Set 📦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: Provides detail of a single amendment - repeats within the overal amendment report

  • detail: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta: An Extension
  • rationale: string: An Extension
  • section: CodeableConcept: An Extension

Maturity: 2

Differential ViewDifferential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Extension
... extension 3..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:detail 1..1 Extension Extension
..... url 1..1 uri "detail"
.... extension:rationale 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Rationale
.... extension:section 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "section"
..... value[x] 0..1 CodeableConcept Section where the amendment was made
Binding: UDP Section Codes Value Set (required)
... url 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail"

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Extension.extension:section.​value[x] Base required UDP Section Codes Value Set 📦1.0.0-ballot2 This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Extension
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 3..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:detail 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "detail"
..... value[x] Σ 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueInteger64 integer64
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueAvailability Availability
...... valueExtendedContactDetail ExtendedContactDetail
...... valueDosage Dosage
...... valueMeta Meta
.... extension:rationale 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 "rationale"
..... value[x] Σ 0..1 string Rationale
.... extension:section 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 "section"
..... value[x] Σ 0..1 CodeableConcept Section where the amendment was made
Binding: UDP Section Codes Value Set (required)
... url Σ 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail"

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Extension.extension:section.​value[x] Base required UDP Section Codes Value Set 📦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: Provides detail of a single amendment - repeats within the overal amendment report

  • detail: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta: An Extension
  • rationale: string: An Extension
  • section: CodeableConcept: An Extension

Maturity: 2

 

Other representations of profile: CSV, Excel, Schematron