Generated Narrative: StructureDefinition m11-protocol-amendment Name Flags Card. Type Description & Constraints Extension 0..* Extension Amendment to a protocol - from EBM #xD; extension 2..* Extension Extension #xD; Slices for extension Content/Rules for all slices #xD; extension:identifier 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "identifier" #xD; value[x] 0..1 Identifier Amendment identifier #xD; extension:previous 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "previous" #xD; value[x] 0..1 CodeableConcept Value of extension Binding: ICH M11 Amendment Details Statement Value Set Terminology (required) #xD; extension:scope S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "scope" #xD; value[x] 0..1 CodeableConcept Global, Not Global Binding: ICH M11 Amendment Scope Value Set Terminology (extensible) #xD; extension:country 0..* Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "country" #xD; value[x] 0..1 CodeableConcept Value of extension Binding: ICH M11 Study Amendment Country Value Set (extensible) #xD; extension:region 0..* Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "region" #xD; value[x] 0..1 CodeableConcept Value of extension Binding: ICH M11 Study Amendment Country Value Set (extensible) #xD; extension:site 0..* Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "site" #xD; value[x] 0..1 Value of extension #xD; valueIdentifier Identifier #xD; valueReference Reference(Any) #xD; extension:approvalDate 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "approvalDate" #xD; value[x] 0..1 date Value of extension #xD; extension:signature 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "signature" #xD; value[x] 0..1 Signature Value of extension #xD; extension:signatureUrl 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "signatureUrl" #xD; value[x] 0..1 Value of extension #xD; valueString string #xD; valueUrl url #xD; extension:signatureMethod 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "signatureMethod" #xD; value[x] 0..1 string Value of extension #xD; extension:scopeImpact S 0..3 (Complex) Extension URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact #xD; extension:primaryReason S 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "primaryReason" #xD; value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety Binding: ICH M11 Reason for Amendment Value Set Terminology (extensible) #xD; extension:secondaryReason S 0..* Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "secondaryReason" #xD; value[x] 0..1 CodeableConcept Reason for amendment, e.g. Manufacturing change Binding: ICH M11 Reason for Amendment Value Set Terminology (extensible) #xD; extension:summary S 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "summary" #xD; value[x] 0..1 string summary of changes #xD; extension:substantialImpactSafety S 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "substantialImpactSafety" #xD; value[x] 0..1 CodeableConcept Substantial impact on safety Binding: ICH M11 No Yes Value Set Terminology (required) #xD; extension:substantialImpactSafetyComment S 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "substantialImpactSafetyComment" #xD; value[x] 0..1 string Comment on substantial impact on safety #xD; extension:substantialImpactReliability 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "substantialImpactReliability" #xD; value[x] 0..1 CodeableConcept Substantial impact on reliability Binding: ICH M11 No Yes Value Set Terminology (required) #xD; extension:substantialImpactReliabilityComment 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "substantialImpactReliabilityComment" #xD; value[x] 0..1 string Comment on substantial impact on reliability #xD; extension:details S 0..* (Complex) Extension URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail #xD; extension:rationale 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "rationale" #xD; value[x] 0..1 string Value of extension #xD; extension:description 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "description" #xD; value[x] 0..1 Value of extension #xD; valueMarkdown markdown #xD; valueString string #xD; url 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment" #xD; value[x] 0..0 Value of extension #xD; Documentation for this format
HL7 International / Biomedical Research and Regulation
Amendment to a protocol. This is originally from EBM.
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](licenses.html)
Representation of amendments to a study protocol.
The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Must have either extensions or value[x], not both
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
Source of the definition for the extension code - a logical name or a URL.
The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Identifier for this amendment - if it is the current amendment the identifier is repeated from the title page
Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).
C218673 Global, Country, Region, or Site.
If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. If amending a single-country study, enter global. If the amendment does not apply to all sites in the trial, select Not Global and utilize one of the identifiers based on amendment scope. Use the ISO-3166 region or country identifier (for example, DE or EU).
Provides number or percentage of each group affected by a single amendment
Reason for amendment, e.g. Manufacturing change
Reason for amendment, e.g. Manufacturing change.
Comment on substantial impact on safety.
Comment on substantial impact on reliability
Comment on substantial impact on reliability.
Provides detail of a single amendment - repeats within the overal amendment report