Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Extension:

Official URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment Version: 1.0.0-ballot3
Standards status: Trial-use Maturity Level: 1 Computable Name: ResearchStudyM11ProtocolAmendment
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.42.163

An amendment to a study protocol matching M11 template.

Context of Use

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

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.

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: doco
Extension 0..* Extension An amendment to a study protocol
Extension.extension 2..* Extension Extension
Extension.Slices for extension Content/Rules for all slices
Extension.Slices for extension.extension:identifier 1..1 Extension Extension
Extension.Slices for extension.extension:identifier.extension 0..0 Extension
Extension.Slices for extension.extension:identifier.url 1..1 uri "identifier"
Extension.Slices for extension.extension:identifier.value[x] 0..1 Identifier Amendment identifier
Extension.Slices for extension.extension:previous 0..1 Extension Extension
Extension.Slices for extension.extension:previous.extension 0..0 Extension
Extension.Slices for extension.extension:previous.url 1..1 uri "previous"
Extension.Slices for extension.extension:previous.value[x] 0..1 CodeableConcept Statement regarding prior amendments
Binding: ICH M11 Amendment Details Statement Value Set (required)
Extension.Slices for extension.extension:scope 1..1 Extension Extension
Extension.Slices for extension.extension:scope.extension 0..0 Extension
Extension.Slices for extension.extension:scope.url 1..1 uri "scope"
Extension.Slices for extension.extension:scope.value[x] 0..1 CodeableConcept Global or Not Global
Binding: ICH M11 Amendment Scope Value Set (required)
Extension.Slices for extension.extension:country 0..* Extension Extension
Extension.Slices for extension.extension:country.extension 0..0 Extension
Extension.Slices for extension.extension:country.url 1..1 uri "country"
Extension.Slices for extension.extension:country.value[x] 0..1 CodeableConcept Country
Extension.Slices for extension.extension:region 0..* Extension Extension
Extension.Slices for extension.extension:region.extension 0..0 Extension
Extension.Slices for extension.extension:region.url 1..1 uri "region"
Extension.Slices for extension.extension:region.value[x] 0..1 CodeableConcept Region
Extension.Slices for extension.extension:site 0..* Extension Extension
Extension.Slices for extension.extension:site.extension 0..0 Extension
Extension.Slices for extension.extension:site.url 1..1 uri "site"
Extension.Slices for extension.extension:site.value[x] 0..1 Site
Extension.Slices for extension.extension:site.value[x].valueIdentifier Identifier
Extension.Slices for extension.extension:site.value[x].valueReference Reference(Any)
Extension.Slices for extension.extension:approvalDate 0..1 Extension Extension
Extension.Slices for extension.extension:approvalDate.extension 0..0 Extension
Extension.Slices for extension.extension:approvalDate.url 1..1 uri "approvalDate"
Extension.Slices for extension.extension:approvalDate.value[x] 0..1 date Approval date
Extension.Slices for extension.extension:signature 0..1 Extension Extension
Extension.Slices for extension.extension:signature.extension 0..0 Extension
Extension.Slices for extension.extension:signature.url 1..1 uri "signature"
Extension.Slices for extension.extension:signature.value[x] 0..1 Signature Signature
Extension.Slices for extension.extension:signatureUrl 0..1 Extension Extension
Extension.Slices for extension.extension:signatureUrl.extension 0..0 Extension
Extension.Slices for extension.extension:signatureUrl.url 1..1 uri "signatureUrl"
Extension.Slices for extension.extension:signatureUrl.value[x] 0..1 Signature URL
Extension.Slices for extension.extension:signatureUrl.value[x].valueString string
Extension.Slices for extension.extension:signatureUrl.value[x].valueUrl url
Extension.Slices for extension.extension:signatureMethod 0..1 Extension Extension
Extension.Slices for extension.extension:signatureMethod.extension 0..0 Extension
Extension.Slices for extension.extension:signatureMethod.url 1..1 uri "signatureMethod"
Extension.Slices for extension.extension:signatureMethod.value[x] 0..1 string Signature Method
Extension.Slices for extension.extension:scopeImpact 0..3 (Complex) Provides number or percentage of each group affected by a single amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-scope-impact
Extension.Slices for extension.extension:scopeImpact.url 1..1 uri "scopeImpact"
Extension.Slices for extension.extension:primaryReason 0..1 Extension Extension
Extension.Slices for extension.extension:primaryReason.extension 0..0 Extension
Extension.Slices for extension.extension:primaryReason.url 1..1 uri "primaryReason"
Extension.Slices for extension.extension:primaryReason.value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
Extension.Slices for extension.extension:secondaryReason 0..* Extension Extension
Extension.Slices for extension.extension:secondaryReason.extension 0..0 Extension
Extension.Slices for extension.extension:secondaryReason.url 1..1 uri "secondaryReason"
Extension.Slices for extension.extension:secondaryReason.value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
Extension.Slices for extension.extension:summary 0..1 Extension Extension
Extension.Slices for extension.extension:summary.extension 0..0 Extension
Extension.Slices for extension.extension:summary.url 1..1 uri "summary"
Extension.Slices for extension.extension:summary.value[x] 0..1 string Summary of changes
Extension.Slices for extension.extension:substantialImpactSafety 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactSafety.extension 0..0 Extension
Extension.Slices for extension.extension:substantialImpactSafety.url 1..1 uri "substantialImpactSafety"
Extension.Slices for extension.extension:substantialImpactSafety.value[x] 0..1 CodeableConcept Substantial impact on safety
Binding: ICH M11 Yes No Value Set (required)
Extension.Slices for extension.extension:substantialImpactSafetyComment 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactSafetyComment.extension 0..0 Extension
Extension.Slices for extension.extension:substantialImpactSafetyComment.url 1..1 uri "substantialImpactSafetyComment"
Extension.Slices for extension.extension:substantialImpactSafetyComment.value[x] 0..1 string Comment on substantial impact on safety
Extension.Slices for extension.extension:substantialImpactReliability 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactReliability.extension 0..0 Extension
Extension.Slices for extension.extension:substantialImpactReliability.url 1..1 uri "substantialImpactReliability"
Extension.Slices for extension.extension:substantialImpactReliability.value[x] 0..1 CodeableConcept Substantial impact on reliability
Binding: ICH M11 Yes No Value Set (required)
Extension.Slices for extension.extension:substantialImpactReliabilityComment 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactReliabilityComment.extension 0..0 Extension
Extension.Slices for extension.extension:substantialImpactReliabilityComment.url 1..1 uri "substantialImpactReliabilityComment"
Extension.Slices for extension.extension:substantialImpactReliabilityComment.value[x] 0..1 string Comment on substantial impact on reliability
Extension.Slices for extension.extension:details 0..* (Complex) Provides detail of a single change within an amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-detail
Extension.Slices for extension.extension:details.url 1..1 uri "details"
Extension.Slices for extension.extension:rationale 0..1 Extension Extension
Extension.Slices for extension.extension:rationale.extension 0..0 Extension
Extension.Slices for extension.extension:rationale.url 1..1 uri "rationale"
Extension.Slices for extension.extension:rationale.value[x] 0..1 string Rationale
Extension.Slices for extension.extension:description 0..1 Extension Extension
Extension.Slices for extension.extension:description.extension 0..0 Extension
Extension.Slices for extension.extension:description.url 1..1 uri "description"
Extension.Slices for extension.extension:description.value[x] 0..1 Description
Extension.Slices for extension.extension:description.value[x].valueMarkdown markdown
Extension.Slices for extension.extension:description.value[x].valueString string
Extension.url 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Extension.extension:previous.​value[x] Base required ICH M11 Amendment Details Statement Value Set 📦1.0.0-ballot3 This IG
Extension.extension:scope.​value[x] Base required ICH M11 Amendment Scope Value Set 📦1.0.0-ballot3 This IG
Extension.extension:primaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:secondaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactSafety.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactReliability.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: doco
Extension 0..* Extension An amendment to a study protocol
Extension.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:identifier 1..1 Extension Extension
Extension.Slices for extension.extension:identifier.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:identifier.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:identifier.url This element is included in summaries. 1..1 uri "identifier"
Extension.Slices for extension.extension:identifier.value[x] This element is included in summaries. 0..1 Identifier Amendment identifier
Extension.Slices for extension.extension:previous 0..1 Extension Extension
Extension.Slices for extension.extension:previous.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:previous.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:previous.url This element is included in summaries. 1..1 uri "previous"
Extension.Slices for extension.extension:previous.value[x] This element is included in summaries. 0..1 CodeableConcept Statement regarding prior amendments
Binding: ICH M11 Amendment Details Statement Value Set (required)
Extension.Slices for extension.extension:scope 1..1 Extension Extension
Extension.Slices for extension.extension:scope.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:scope.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:scope.url This element is included in summaries. 1..1 uri "scope"
Extension.Slices for extension.extension:scope.value[x] This element is included in summaries. 0..1 CodeableConcept Global or Not Global
Binding: ICH M11 Amendment Scope Value Set (required)
Extension.Slices for extension.extension:country 0..* Extension Extension
Extension.Slices for extension.extension:country.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:country.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:country.url This element is included in summaries. 1..1 uri "country"
Extension.Slices for extension.extension:country.value[x] This element is included in summaries. 0..1 CodeableConcept Country
Extension.Slices for extension.extension:region 0..* Extension Extension
Extension.Slices for extension.extension:region.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:region.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:region.url This element is included in summaries. 1..1 uri "region"
Extension.Slices for extension.extension:region.value[x] This element is included in summaries. 0..1 CodeableConcept Region
Extension.Slices for extension.extension:site 0..* Extension Extension
Extension.Slices for extension.extension:site.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:site.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:site.url This element is included in summaries. 1..1 uri "site"
Extension.Slices for extension.extension:site.value[x] This element is included in summaries. 0..1 Site
Extension.Slices for extension.extension:site.value[x].valueIdentifier Identifier
Extension.Slices for extension.extension:site.value[x].valueReference Reference(Any)
Extension.Slices for extension.extension:approvalDate 0..1 Extension Extension
Extension.Slices for extension.extension:approvalDate.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:approvalDate.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:approvalDate.url This element is included in summaries. 1..1 uri "approvalDate"
Extension.Slices for extension.extension:approvalDate.value[x] This element is included in summaries. 0..1 date Approval date
Extension.Slices for extension.extension:signature 0..1 Extension Extension
Extension.Slices for extension.extension:signature.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:signature.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:signature.url This element is included in summaries. 1..1 uri "signature"
Extension.Slices for extension.extension:signature.value[x] This element is included in summaries. 0..1 Signature Signature
Extension.Slices for extension.extension:signatureUrl 0..1 Extension Extension
Extension.Slices for extension.extension:signatureUrl.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:signatureUrl.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:signatureUrl.url This element is included in summaries. 1..1 uri "signatureUrl"
Extension.Slices for extension.extension:signatureUrl.value[x] This element is included in summaries. 0..1 Signature URL
Extension.Slices for extension.extension:signatureUrl.value[x].valueString string
Extension.Slices for extension.extension:signatureUrl.value[x].valueUrl url
Extension.Slices for extension.extension:signatureMethod 0..1 Extension Extension
Extension.Slices for extension.extension:signatureMethod.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:signatureMethod.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:signatureMethod.url This element is included in summaries. 1..1 uri "signatureMethod"
Extension.Slices for extension.extension:signatureMethod.value[x] This element is included in summaries. 0..1 string Signature Method
Extension.Slices for extension.extension:scopeImpact 0..3 (Complex) Provides number or percentage of each group affected by a single amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-scope-impact
Extension.Slices for extension.extension:scopeImpact.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:scopeImpact.Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:scopeImpact.Slices for extension Content/Rules for all slices
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:number 1..1 Extension Extension
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:number.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:number.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:number.url This element is included in summaries. 1..1 uri "number"
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:number.value[x] This element is included in summaries. 0..1 Number of participants, or % of participants
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:number.value[x].valuePositiveInt positiveInt
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:number.value[x].valueQuantity Quantity
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:scope 1..1 Extension Extension
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:scope.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:scope.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:scope.url This element is included in summaries. 1..1 uri "scope"
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:scope.value[x] This element is included in summaries. 0..1 CodeableConcept Global, Locally, or By Cohort
Binding: ICH M11 Amendment Scope Enrollment Value Set (required)
Extension.Slices for extension.extension:scopeImpact.url This element is included in summaries. 1..1 uri "scopeImpact"
Extension.Slices for extension.extension:primaryReason 0..1 Extension Extension
Extension.Slices for extension.extension:primaryReason.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:primaryReason.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:primaryReason.url This element is included in summaries. 1..1 uri "primaryReason"
Extension.Slices for extension.extension:primaryReason.value[x] This element is included in summaries. 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
Extension.Slices for extension.extension:secondaryReason 0..* Extension Extension
Extension.Slices for extension.extension:secondaryReason.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:secondaryReason.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:secondaryReason.url This element is included in summaries. 1..1 uri "secondaryReason"
Extension.Slices for extension.extension:secondaryReason.value[x] This element is included in summaries. 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
Extension.Slices for extension.extension:summary 0..1 Extension Extension
Extension.Slices for extension.extension:summary.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:summary.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:summary.url This element is included in summaries. 1..1 uri "summary"
Extension.Slices for extension.extension:summary.value[x] This element is included in summaries. 0..1 string Summary of changes
Extension.Slices for extension.extension:substantialImpactSafety 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactSafety.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:substantialImpactSafety.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:substantialImpactSafety.url This element is included in summaries. 1..1 uri "substantialImpactSafety"
Extension.Slices for extension.extension:substantialImpactSafety.value[x] This element is included in summaries. 0..1 CodeableConcept Substantial impact on safety
Binding: ICH M11 Yes No Value Set (required)
Extension.Slices for extension.extension:substantialImpactSafetyComment 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactSafetyComment.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:substantialImpactSafetyComment.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:substantialImpactSafetyComment.url This element is included in summaries. 1..1 uri "substantialImpactSafetyComment"
Extension.Slices for extension.extension:substantialImpactSafetyComment.value[x] This element is included in summaries. 0..1 string Comment on substantial impact on safety
Extension.Slices for extension.extension:substantialImpactReliability 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactReliability.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:substantialImpactReliability.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:substantialImpactReliability.url This element is included in summaries. 1..1 uri "substantialImpactReliability"
Extension.Slices for extension.extension:substantialImpactReliability.value[x] This element is included in summaries. 0..1 CodeableConcept Substantial impact on reliability
Binding: ICH M11 Yes No Value Set (required)
Extension.Slices for extension.extension:substantialImpactReliabilityComment 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactReliabilityComment.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:substantialImpactReliabilityComment.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:substantialImpactReliabilityComment.url This element is included in summaries. 1..1 uri "substantialImpactReliabilityComment"
Extension.Slices for extension.extension:substantialImpactReliabilityComment.value[x] This element is included in summaries. 0..1 string Comment on substantial impact on reliability
Extension.Slices for extension.extension:details 0..* (Complex) Provides detail of a single change within an amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-detail
Extension.Slices for extension.extension:details.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:details.Slices for extension 3..* Extension Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:details.Slices for extension Content/Rules for all slices
Extension.Slices for extension.extension:details.Slices for extension.extension:detail 1..1 Extension Extension
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.url This element is included in summaries. 1..1 uri "detail"
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x] This element is included in summaries. 0..1 Detail
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueBase64Binary base64Binary
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueBoolean boolean
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueCanonical canonical(Any)
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueCode code
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueDate date
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueDateTime dateTime
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueDecimal decimal
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueId id
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueInstant instant
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueInteger integer
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueInteger64 integer64
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueMarkdown markdown
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueOid oid
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valuePositiveInt positiveInt
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueString string
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueTime time
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueUnsignedInt unsignedInt
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueUri uri
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueUrl url
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueUuid uuid
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueAddress Address
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueAge Age
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueAnnotation Annotation
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueAttachment Attachment
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueCodeableConcept CodeableConcept
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueCodeableReference CodeableReference
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueCoding Coding
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueContactPoint ContactPoint
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueCount Count
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueDistance Distance
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueDuration Duration
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueHumanName HumanName
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueIdentifier Identifier
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueMoney Money
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valuePeriod Period
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueQuantity Quantity
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueRange Range
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueRatio Ratio
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueRatioRange RatioRange
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueReference Reference(Any)
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueSampledData SampledData
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueSignature Signature
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueTiming Timing
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueContactDetail ContactDetail
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueDataRequirement DataRequirement
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueExpression Expression
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueParameterDefinition ParameterDefinition
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueRelatedArtifact RelatedArtifact
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueTriggerDefinition TriggerDefinition
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueUsageContext UsageContext
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueAvailability Availability
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueExtendedContactDetail ExtendedContactDetail
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueVirtualServiceDetail VirtualServiceDetail
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueDosage Dosage
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueMeta Meta
Extension.Slices for extension.extension:details.Slices for extension.extension:rationale 1..1 Extension Extension
Extension.Slices for extension.extension:details.Slices for extension.extension:rationale.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:details.Slices for extension.extension:rationale.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:details.Slices for extension.extension:rationale.url This element is included in summaries. 1..1 uri "rationale"
Extension.Slices for extension.extension:details.Slices for extension.extension:rationale.value[x] This element is included in summaries. 0..1 string Rationale
Extension.Slices for extension.extension:details.Slices for extension.extension:section 1..1 Extension Extension
Extension.Slices for extension.extension:details.Slices for extension.extension:section.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:details.Slices for extension.extension:section.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:details.Slices for extension.extension:section.url This element is included in summaries. 1..1 uri "section"
Extension.Slices for extension.extension:details.Slices for extension.extension:section.value[x] This element is included in summaries. 0..1 CodeableConcept Section where the amendment was made
Binding: Limited M11 Section Codes Value Set (required)
Extension.Slices for extension.extension:details.url This element is included in summaries. 1..1 uri "details"
Extension.Slices for extension.extension:rationale 0..1 Extension Extension
Extension.Slices for extension.extension:rationale.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:rationale.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:rationale.url This element is included in summaries. 1..1 uri "rationale"
Extension.Slices for extension.extension:rationale.value[x] This element is included in summaries. 0..1 string Rationale
Extension.Slices for extension.extension:description 0..1 Extension Extension
Extension.Slices for extension.extension:description.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:description.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:description.url This element is included in summaries. 1..1 uri "description"
Extension.Slices for extension.extension:description.value[x] This element is included in summaries. 0..1 Description
Extension.Slices for extension.extension:description.value[x].valueMarkdown markdown
Extension.Slices for extension.extension:description.value[x].valueString string
Extension.url This element is included in summaries. 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Extension.extension:previous.​value[x] Base required ICH M11 Amendment Details Statement Value Set 📦1.0.0-ballot3 This IG
Extension.extension:scope.​value[x] Base required ICH M11 Amendment Scope Value Set 📦1.0.0-ballot3 This IG
Extension.extension:scopeImpact.​extension:scope.value[x] Base required ICH M11 Amendment Scope Enrollment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:primaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:secondaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactSafety.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactReliability.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG
Extension.extension:details.​extension:section.value[x] Base required Limited M11 Section Codes Value Set 📦1.0.0-ballot3 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()

This structure is derived from Extension

Summary

Complex Extension: An amendment to a study protocol matching M11 template.

  • identifier: Identifier: An Extension
  • previous: CodeableConcept: An Extension
  • scope: CodeableConcept: An Extension
  • country: CodeableConcept: An Extension
  • region: CodeableConcept: An Extension
  • site: Identifier, Reference: An Extension
  • approvalDate: date: An Extension
  • signature: Signature: An Extension
  • signatureUrl: string, url: An Extension
  • signatureMethod: string: An Extension
  • number: positiveInt, Quantity: An Extension
  • scope: CodeableConcept: An Extension
  • primaryReason: CodeableConcept: An Extension
  • secondaryReason: CodeableConcept: An Extension
  • summary: string: An Extension
  • substantialImpactSafety: CodeableConcept: An Extension
  • substantialImpactSafetyComment: string: An Extension
  • substantialImpactReliability: CodeableConcept: An Extension
  • substantialImpactReliabilityComment: string: An Extension
  • 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, VirtualServiceDetail, Dosage, Meta: An Extension
  • rationale: string: An Extension
  • section: CodeableConcept: An Extension
  • rationale: string: An Extension
  • description: markdown, string: An Extension

Maturity: 1

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: doco
Extension 0..* Extension An amendment to a study protocol
Extension.extension 2..* Extension Extension
Extension.Slices for extension Content/Rules for all slices
Extension.Slices for extension.extension:identifier 1..1 Extension Extension
Extension.Slices for extension.extension:identifier.extension 0..0 Extension
Extension.Slices for extension.extension:identifier.url 1..1 uri "identifier"
Extension.Slices for extension.extension:identifier.value[x] 0..1 Identifier Amendment identifier
Extension.Slices for extension.extension:previous 0..1 Extension Extension
Extension.Slices for extension.extension:previous.extension 0..0 Extension
Extension.Slices for extension.extension:previous.url 1..1 uri "previous"
Extension.Slices for extension.extension:previous.value[x] 0..1 CodeableConcept Statement regarding prior amendments
Binding: ICH M11 Amendment Details Statement Value Set (required)
Extension.Slices for extension.extension:scope 1..1 Extension Extension
Extension.Slices for extension.extension:scope.extension 0..0 Extension
Extension.Slices for extension.extension:scope.url 1..1 uri "scope"
Extension.Slices for extension.extension:scope.value[x] 0..1 CodeableConcept Global or Not Global
Binding: ICH M11 Amendment Scope Value Set (required)
Extension.Slices for extension.extension:country 0..* Extension Extension
Extension.Slices for extension.extension:country.extension 0..0 Extension
Extension.Slices for extension.extension:country.url 1..1 uri "country"
Extension.Slices for extension.extension:country.value[x] 0..1 CodeableConcept Country
Extension.Slices for extension.extension:region 0..* Extension Extension
Extension.Slices for extension.extension:region.extension 0..0 Extension
Extension.Slices for extension.extension:region.url 1..1 uri "region"
Extension.Slices for extension.extension:region.value[x] 0..1 CodeableConcept Region
Extension.Slices for extension.extension:site 0..* Extension Extension
Extension.Slices for extension.extension:site.extension 0..0 Extension
Extension.Slices for extension.extension:site.url 1..1 uri "site"
Extension.Slices for extension.extension:site.value[x] 0..1 Site
Extension.Slices for extension.extension:site.value[x].valueIdentifier Identifier
Extension.Slices for extension.extension:site.value[x].valueReference Reference(Any)
Extension.Slices for extension.extension:approvalDate 0..1 Extension Extension
Extension.Slices for extension.extension:approvalDate.extension 0..0 Extension
Extension.Slices for extension.extension:approvalDate.url 1..1 uri "approvalDate"
Extension.Slices for extension.extension:approvalDate.value[x] 0..1 date Approval date
Extension.Slices for extension.extension:signature 0..1 Extension Extension
Extension.Slices for extension.extension:signature.extension 0..0 Extension
Extension.Slices for extension.extension:signature.url 1..1 uri "signature"
Extension.Slices for extension.extension:signature.value[x] 0..1 Signature Signature
Extension.Slices for extension.extension:signatureUrl 0..1 Extension Extension
Extension.Slices for extension.extension:signatureUrl.extension 0..0 Extension
Extension.Slices for extension.extension:signatureUrl.url 1..1 uri "signatureUrl"
Extension.Slices for extension.extension:signatureUrl.value[x] 0..1 Signature URL
Extension.Slices for extension.extension:signatureUrl.value[x].valueString string
Extension.Slices for extension.extension:signatureUrl.value[x].valueUrl url
Extension.Slices for extension.extension:signatureMethod 0..1 Extension Extension
Extension.Slices for extension.extension:signatureMethod.extension 0..0 Extension
Extension.Slices for extension.extension:signatureMethod.url 1..1 uri "signatureMethod"
Extension.Slices for extension.extension:signatureMethod.value[x] 0..1 string Signature Method
Extension.Slices for extension.extension:scopeImpact 0..3 (Complex) Provides number or percentage of each group affected by a single amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-scope-impact
Extension.Slices for extension.extension:scopeImpact.url 1..1 uri "scopeImpact"
Extension.Slices for extension.extension:primaryReason 0..1 Extension Extension
Extension.Slices for extension.extension:primaryReason.extension 0..0 Extension
Extension.Slices for extension.extension:primaryReason.url 1..1 uri "primaryReason"
Extension.Slices for extension.extension:primaryReason.value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
Extension.Slices for extension.extension:secondaryReason 0..* Extension Extension
Extension.Slices for extension.extension:secondaryReason.extension 0..0 Extension
Extension.Slices for extension.extension:secondaryReason.url 1..1 uri "secondaryReason"
Extension.Slices for extension.extension:secondaryReason.value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
Extension.Slices for extension.extension:summary 0..1 Extension Extension
Extension.Slices for extension.extension:summary.extension 0..0 Extension
Extension.Slices for extension.extension:summary.url 1..1 uri "summary"
Extension.Slices for extension.extension:summary.value[x] 0..1 string Summary of changes
Extension.Slices for extension.extension:substantialImpactSafety 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactSafety.extension 0..0 Extension
Extension.Slices for extension.extension:substantialImpactSafety.url 1..1 uri "substantialImpactSafety"
Extension.Slices for extension.extension:substantialImpactSafety.value[x] 0..1 CodeableConcept Substantial impact on safety
Binding: ICH M11 Yes No Value Set (required)
Extension.Slices for extension.extension:substantialImpactSafetyComment 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactSafetyComment.extension 0..0 Extension
Extension.Slices for extension.extension:substantialImpactSafetyComment.url 1..1 uri "substantialImpactSafetyComment"
Extension.Slices for extension.extension:substantialImpactSafetyComment.value[x] 0..1 string Comment on substantial impact on safety
Extension.Slices for extension.extension:substantialImpactReliability 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactReliability.extension 0..0 Extension
Extension.Slices for extension.extension:substantialImpactReliability.url 1..1 uri "substantialImpactReliability"
Extension.Slices for extension.extension:substantialImpactReliability.value[x] 0..1 CodeableConcept Substantial impact on reliability
Binding: ICH M11 Yes No Value Set (required)
Extension.Slices for extension.extension:substantialImpactReliabilityComment 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactReliabilityComment.extension 0..0 Extension
Extension.Slices for extension.extension:substantialImpactReliabilityComment.url 1..1 uri "substantialImpactReliabilityComment"
Extension.Slices for extension.extension:substantialImpactReliabilityComment.value[x] 0..1 string Comment on substantial impact on reliability
Extension.Slices for extension.extension:details 0..* (Complex) Provides detail of a single change within an amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-detail
Extension.Slices for extension.extension:details.url 1..1 uri "details"
Extension.Slices for extension.extension:rationale 0..1 Extension Extension
Extension.Slices for extension.extension:rationale.extension 0..0 Extension
Extension.Slices for extension.extension:rationale.url 1..1 uri "rationale"
Extension.Slices for extension.extension:rationale.value[x] 0..1 string Rationale
Extension.Slices for extension.extension:description 0..1 Extension Extension
Extension.Slices for extension.extension:description.extension 0..0 Extension
Extension.Slices for extension.extension:description.url 1..1 uri "description"
Extension.Slices for extension.extension:description.value[x] 0..1 Description
Extension.Slices for extension.extension:description.value[x].valueMarkdown markdown
Extension.Slices for extension.extension:description.value[x].valueString string
Extension.url 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"
Extension.value[x] 0..0 Value of extension

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Extension.extension:previous.​value[x] Base required ICH M11 Amendment Details Statement Value Set 📦1.0.0-ballot3 This IG
Extension.extension:scope.​value[x] Base required ICH M11 Amendment Scope Value Set 📦1.0.0-ballot3 This IG
Extension.extension:primaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:secondaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactSafety.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactReliability.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: doco
Extension 0..* Extension An amendment to a study protocol
Extension.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:identifier 1..1 Extension Extension
Extension.Slices for extension.extension:identifier.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:identifier.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:identifier.url This element is included in summaries. 1..1 uri "identifier"
Extension.Slices for extension.extension:identifier.value[x] This element is included in summaries. 0..1 Identifier Amendment identifier
Extension.Slices for extension.extension:previous 0..1 Extension Extension
Extension.Slices for extension.extension:previous.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:previous.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:previous.url This element is included in summaries. 1..1 uri "previous"
Extension.Slices for extension.extension:previous.value[x] This element is included in summaries. 0..1 CodeableConcept Statement regarding prior amendments
Binding: ICH M11 Amendment Details Statement Value Set (required)
Extension.Slices for extension.extension:scope 1..1 Extension Extension
Extension.Slices for extension.extension:scope.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:scope.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:scope.url This element is included in summaries. 1..1 uri "scope"
Extension.Slices for extension.extension:scope.value[x] This element is included in summaries. 0..1 CodeableConcept Global or Not Global
Binding: ICH M11 Amendment Scope Value Set (required)
Extension.Slices for extension.extension:country 0..* Extension Extension
Extension.Slices for extension.extension:country.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:country.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:country.url This element is included in summaries. 1..1 uri "country"
Extension.Slices for extension.extension:country.value[x] This element is included in summaries. 0..1 CodeableConcept Country
Extension.Slices for extension.extension:region 0..* Extension Extension
Extension.Slices for extension.extension:region.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:region.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:region.url This element is included in summaries. 1..1 uri "region"
Extension.Slices for extension.extension:region.value[x] This element is included in summaries. 0..1 CodeableConcept Region
Extension.Slices for extension.extension:site 0..* Extension Extension
Extension.Slices for extension.extension:site.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:site.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:site.url This element is included in summaries. 1..1 uri "site"
Extension.Slices for extension.extension:site.value[x] This element is included in summaries. 0..1 Site
Extension.Slices for extension.extension:site.value[x].valueIdentifier Identifier
Extension.Slices for extension.extension:site.value[x].valueReference Reference(Any)
Extension.Slices for extension.extension:approvalDate 0..1 Extension Extension
Extension.Slices for extension.extension:approvalDate.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:approvalDate.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:approvalDate.url This element is included in summaries. 1..1 uri "approvalDate"
Extension.Slices for extension.extension:approvalDate.value[x] This element is included in summaries. 0..1 date Approval date
Extension.Slices for extension.extension:signature 0..1 Extension Extension
Extension.Slices for extension.extension:signature.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:signature.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:signature.url This element is included in summaries. 1..1 uri "signature"
Extension.Slices for extension.extension:signature.value[x] This element is included in summaries. 0..1 Signature Signature
Extension.Slices for extension.extension:signatureUrl 0..1 Extension Extension
Extension.Slices for extension.extension:signatureUrl.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:signatureUrl.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:signatureUrl.url This element is included in summaries. 1..1 uri "signatureUrl"
Extension.Slices for extension.extension:signatureUrl.value[x] This element is included in summaries. 0..1 Signature URL
Extension.Slices for extension.extension:signatureUrl.value[x].valueString string
Extension.Slices for extension.extension:signatureUrl.value[x].valueUrl url
Extension.Slices for extension.extension:signatureMethod 0..1 Extension Extension
Extension.Slices for extension.extension:signatureMethod.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:signatureMethod.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:signatureMethod.url This element is included in summaries. 1..1 uri "signatureMethod"
Extension.Slices for extension.extension:signatureMethod.value[x] This element is included in summaries. 0..1 string Signature Method
Extension.Slices for extension.extension:scopeImpact 0..3 (Complex) Provides number or percentage of each group affected by a single amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-scope-impact
Extension.Slices for extension.extension:scopeImpact.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:scopeImpact.Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:scopeImpact.Slices for extension Content/Rules for all slices
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:number 1..1 Extension Extension
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:number.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:number.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:number.url This element is included in summaries. 1..1 uri "number"
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:number.value[x] This element is included in summaries. 0..1 Number of participants, or % of participants
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:number.value[x].valuePositiveInt positiveInt
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:number.value[x].valueQuantity Quantity
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:scope 1..1 Extension Extension
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:scope.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:scope.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:scope.url This element is included in summaries. 1..1 uri "scope"
Extension.Slices for extension.extension:scopeImpact.Slices for extension.extension:scope.value[x] This element is included in summaries. 0..1 CodeableConcept Global, Locally, or By Cohort
Binding: ICH M11 Amendment Scope Enrollment Value Set (required)
Extension.Slices for extension.extension:scopeImpact.url This element is included in summaries. 1..1 uri "scopeImpact"
Extension.Slices for extension.extension:primaryReason 0..1 Extension Extension
Extension.Slices for extension.extension:primaryReason.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:primaryReason.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:primaryReason.url This element is included in summaries. 1..1 uri "primaryReason"
Extension.Slices for extension.extension:primaryReason.value[x] This element is included in summaries. 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
Extension.Slices for extension.extension:secondaryReason 0..* Extension Extension
Extension.Slices for extension.extension:secondaryReason.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:secondaryReason.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:secondaryReason.url This element is included in summaries. 1..1 uri "secondaryReason"
Extension.Slices for extension.extension:secondaryReason.value[x] This element is included in summaries. 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
Extension.Slices for extension.extension:summary 0..1 Extension Extension
Extension.Slices for extension.extension:summary.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:summary.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:summary.url This element is included in summaries. 1..1 uri "summary"
Extension.Slices for extension.extension:summary.value[x] This element is included in summaries. 0..1 string Summary of changes
Extension.Slices for extension.extension:substantialImpactSafety 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactSafety.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:substantialImpactSafety.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:substantialImpactSafety.url This element is included in summaries. 1..1 uri "substantialImpactSafety"
Extension.Slices for extension.extension:substantialImpactSafety.value[x] This element is included in summaries. 0..1 CodeableConcept Substantial impact on safety
Binding: ICH M11 Yes No Value Set (required)
Extension.Slices for extension.extension:substantialImpactSafetyComment 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactSafetyComment.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:substantialImpactSafetyComment.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:substantialImpactSafetyComment.url This element is included in summaries. 1..1 uri "substantialImpactSafetyComment"
Extension.Slices for extension.extension:substantialImpactSafetyComment.value[x] This element is included in summaries. 0..1 string Comment on substantial impact on safety
Extension.Slices for extension.extension:substantialImpactReliability 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactReliability.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:substantialImpactReliability.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:substantialImpactReliability.url This element is included in summaries. 1..1 uri "substantialImpactReliability"
Extension.Slices for extension.extension:substantialImpactReliability.value[x] This element is included in summaries. 0..1 CodeableConcept Substantial impact on reliability
Binding: ICH M11 Yes No Value Set (required)
Extension.Slices for extension.extension:substantialImpactReliabilityComment 0..1 Extension Extension
Extension.Slices for extension.extension:substantialImpactReliabilityComment.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:substantialImpactReliabilityComment.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:substantialImpactReliabilityComment.url This element is included in summaries. 1..1 uri "substantialImpactReliabilityComment"
Extension.Slices for extension.extension:substantialImpactReliabilityComment.value[x] This element is included in summaries. 0..1 string Comment on substantial impact on reliability
Extension.Slices for extension.extension:details 0..* (Complex) Provides detail of a single change within an amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-detail
Extension.Slices for extension.extension:details.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:details.Slices for extension 3..* Extension Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:details.Slices for extension Content/Rules for all slices
Extension.Slices for extension.extension:details.Slices for extension.extension:detail 1..1 Extension Extension
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.url This element is included in summaries. 1..1 uri "detail"
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x] This element is included in summaries. 0..1 Detail
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueBase64Binary base64Binary
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueBoolean boolean
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueCanonical canonical(Any)
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueCode code
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueDate date
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueDateTime dateTime
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueDecimal decimal
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueId id
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueInstant instant
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueInteger integer
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueInteger64 integer64
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueMarkdown markdown
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueOid oid
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valuePositiveInt positiveInt
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueString string
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueTime time
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueUnsignedInt unsignedInt
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueUri uri
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueUrl url
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueUuid uuid
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueAddress Address
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueAge Age
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueAnnotation Annotation
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueAttachment Attachment
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueCodeableConcept CodeableConcept
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueCodeableReference CodeableReference
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueCoding Coding
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueContactPoint ContactPoint
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueCount Count
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueDistance Distance
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueDuration Duration
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueHumanName HumanName
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueIdentifier Identifier
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueMoney Money
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valuePeriod Period
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueQuantity Quantity
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueRange Range
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueRatio Ratio
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueRatioRange RatioRange
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueReference Reference(Any)
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueSampledData SampledData
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueSignature Signature
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueTiming Timing
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueContactDetail ContactDetail
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueDataRequirement DataRequirement
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueExpression Expression
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueParameterDefinition ParameterDefinition
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueRelatedArtifact RelatedArtifact
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueTriggerDefinition TriggerDefinition
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueUsageContext UsageContext
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueAvailability Availability
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueExtendedContactDetail ExtendedContactDetail
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueVirtualServiceDetail VirtualServiceDetail
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueDosage Dosage
Extension.Slices for extension.extension:details.Slices for extension.extension:detail.value[x].valueMeta Meta
Extension.Slices for extension.extension:details.Slices for extension.extension:rationale 1..1 Extension Extension
Extension.Slices for extension.extension:details.Slices for extension.extension:rationale.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:details.Slices for extension.extension:rationale.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:details.Slices for extension.extension:rationale.url This element is included in summaries. 1..1 uri "rationale"
Extension.Slices for extension.extension:details.Slices for extension.extension:rationale.value[x] This element is included in summaries. 0..1 string Rationale
Extension.Slices for extension.extension:details.Slices for extension.extension:section 1..1 Extension Extension
Extension.Slices for extension.extension:details.Slices for extension.extension:section.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:details.Slices for extension.extension:section.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:details.Slices for extension.extension:section.url This element is included in summaries. 1..1 uri "section"
Extension.Slices for extension.extension:details.Slices for extension.extension:section.value[x] This element is included in summaries. 0..1 CodeableConcept Section where the amendment was made
Binding: Limited M11 Section Codes Value Set (required)
Extension.Slices for extension.extension:details.url This element is included in summaries. 1..1 uri "details"
Extension.Slices for extension.extension:rationale 0..1 Extension Extension
Extension.Slices for extension.extension:rationale.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:rationale.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:rationale.url This element is included in summaries. 1..1 uri "rationale"
Extension.Slices for extension.extension:rationale.value[x] This element is included in summaries. 0..1 string Rationale
Extension.Slices for extension.extension:description 0..1 Extension Extension
Extension.Slices for extension.extension:description.id 0..1 string Unique id for inter-element referencing
Extension.Slices for extension.extension:description.extension 0..0 Extension
Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:description.url This element is included in summaries. 1..1 uri "description"
Extension.Slices for extension.extension:description.value[x] This element is included in summaries. 0..1 Description
Extension.Slices for extension.extension:description.value[x].valueMarkdown markdown
Extension.Slices for extension.extension:description.value[x].valueString string
Extension.url This element is included in summaries. 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Extension.extension:previous.​value[x] Base required ICH M11 Amendment Details Statement Value Set 📦1.0.0-ballot3 This IG
Extension.extension:scope.​value[x] Base required ICH M11 Amendment Scope Value Set 📦1.0.0-ballot3 This IG
Extension.extension:scopeImpact.​extension:scope.value[x] Base required ICH M11 Amendment Scope Enrollment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:primaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:secondaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactSafety.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactReliability.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG
Extension.extension:details.​extension:section.value[x] Base required Limited M11 Section Codes Value Set 📦1.0.0-ballot3 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()

This structure is derived from Extension

Summary

Complex Extension: An amendment to a study protocol matching M11 template.

  • identifier: Identifier: An Extension
  • previous: CodeableConcept: An Extension
  • scope: CodeableConcept: An Extension
  • country: CodeableConcept: An Extension
  • region: CodeableConcept: An Extension
  • site: Identifier, Reference: An Extension
  • approvalDate: date: An Extension
  • signature: Signature: An Extension
  • signatureUrl: string, url: An Extension
  • signatureMethod: string: An Extension
  • number: positiveInt, Quantity: An Extension
  • scope: CodeableConcept: An Extension
  • primaryReason: CodeableConcept: An Extension
  • secondaryReason: CodeableConcept: An Extension
  • summary: string: An Extension
  • substantialImpactSafety: CodeableConcept: An Extension
  • substantialImpactSafetyComment: string: An Extension
  • substantialImpactReliability: CodeableConcept: An Extension
  • substantialImpactReliabilityComment: string: An Extension
  • 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, VirtualServiceDetail, Dosage, Meta: An Extension
  • rationale: string: An Extension
  • section: CodeableConcept: An Extension
  • rationale: string: An Extension
  • description: markdown, string: An Extension

Maturity: 1

 

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