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: Filtersdoco
.. Extension 0..* Extension An amendment to a study protocol
... extension 2..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:identifier 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "identifier"
..... value[x] 0..1 Identifier Amendment identifier
.... extension:previous 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "previous"
..... value[x] 0..1 CodeableConcept Statement regarding prior amendments
Binding: ICH M11 Amendment Details Statement Value Set (required)
.... extension:scope 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "scope"
..... value[x] 0..1 CodeableConcept Global or Not Global
Binding: ICH M11 Amendment Scope Value Set (required)
.... extension:country 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "country"
..... value[x] 0..1 CodeableConcept Country
.... extension:region 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "region"
..... value[x] 0..1 CodeableConcept Region
.... extension:site 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "site"
..... value[x] 0..1 Site
...... valueIdentifier Identifier
...... valueReference Reference(Any)
.... extension:approvalDate 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "approvalDate"
..... value[x] 0..1 date Approval date
.... extension:signature 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signature"
..... value[x] 0..1 Signature Signature
.... extension:signatureUrl 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureUrl"
..... value[x] 0..1 Signature URL
...... valueString string
...... valueUrl url
.... extension:signatureMethod 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureMethod"
..... value[x] 0..1 string Signature Method
.... 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
..... url 1..1 uri "scopeImpact"
.... extension:primaryReason 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "primaryReason"
..... value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:secondaryReason 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "secondaryReason"
..... value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:summary 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "summary"
..... value[x] 0..1 string Summary of changes
.... extension:substantialImpactSafety 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactSafety"
..... value[x] 0..1 CodeableConcept Substantial impact on safety
Binding: ICH M11 Yes No Value Set (required)
.... extension:substantialImpactSafetyComment 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactSafetyComment"
..... value[x] 0..1 string Comment on substantial impact on safety
.... extension:substantialImpactReliability 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactReliability"
..... value[x] 0..1 CodeableConcept Substantial impact on reliability
Binding: ICH M11 Yes No Value Set (required)
.... extension:substantialImpactReliabilityComment 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactReliabilityComment"
..... value[x] 0..1 string Comment on substantial impact on reliability
.... extension:details 0..* (Complex) Provides detail of a single change within an amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-detail
..... url 1..1 uri "details"
.... extension:rationale 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Rationale
.... extension:description 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "description"
..... value[x] 0..1 Description
...... valueMarkdown markdown
...... valueString string
... 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: Filtersdoco
.. Extension 0..* Extension An amendment to a study protocol
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:identifier 1..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "identifier"
..... value[x] Σ 0..1 Identifier Amendment identifier
.... extension:previous 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "previous"
..... value[x] Σ 0..1 CodeableConcept Statement regarding prior amendments
Binding: ICH M11 Amendment Details Statement Value Set (required)
.... extension:scope 1..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "scope"
..... value[x] Σ 0..1 CodeableConcept Global or Not Global
Binding: ICH M11 Amendment Scope Value Set (required)
.... extension:country 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "country"
..... value[x] Σ 0..1 CodeableConcept Country
.... extension:region 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "region"
..... value[x] Σ 0..1 CodeableConcept Region
.... extension:site 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "site"
..... value[x] Σ 0..1 Site
...... valueIdentifier Identifier
...... valueReference Reference(Any)
.... extension:approvalDate 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "approvalDate"
..... value[x] Σ 0..1 date Approval date
.... extension:signature 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "signature"
..... value[x] Σ 0..1 Signature Signature
.... extension:signatureUrl 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "signatureUrl"
..... value[x] Σ 0..1 Signature URL
...... valueString string
...... valueUrl url
.... extension:signatureMethod 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "signatureMethod"
..... value[x] Σ 0..1 string Signature Method
.... 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
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
..... Slices for extension Content/Rules for all slices
...... extension:number 1..1 Extension Extension
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..0 Extension
Slice: Unordered, Open by value:url
....... url Σ 1..1 uri "number"
....... value[x] Σ 0..1 Number of participants, or % of participants
........ valuePositiveInt positiveInt
........ valueQuantity Quantity
...... extension:scope 1..1 Extension Extension
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..0 Extension
Slice: Unordered, Open by value:url
....... url Σ 1..1 uri "scope"
....... value[x] Σ 0..1 CodeableConcept Global, Locally, or By Cohort
Binding: ICH M11 Amendment Scope Enrollment Value Set (required)
..... url Σ 1..1 uri "scopeImpact"
.... extension:primaryReason 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "primaryReason"
..... value[x] Σ 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:secondaryReason 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "secondaryReason"
..... value[x] Σ 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:summary 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "summary"
..... value[x] Σ 0..1 string Summary of changes
.... extension:substantialImpactSafety 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactSafety"
..... value[x] Σ 0..1 CodeableConcept Substantial impact on safety
Binding: ICH M11 Yes No Value Set (required)
.... extension:substantialImpactSafetyComment 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactSafetyComment"
..... value[x] Σ 0..1 string Comment on substantial impact on safety
.... extension:substantialImpactReliability 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactReliability"
..... value[x] Σ 0..1 CodeableConcept Substantial impact on reliability
Binding: ICH M11 Yes No Value Set (required)
.... extension:substantialImpactReliabilityComment 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactReliabilityComment"
..... value[x] Σ 0..1 string Comment on substantial impact on reliability
.... extension:details 0..* (Complex) Provides detail of a single change within an amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-detail
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 3..* Extension Extension
Slice: Unordered, Open by value:url
..... Slices for extension Content/Rules for all slices
...... extension:detail 1..1 Extension Extension
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..0 Extension
Slice: Unordered, Open by value:url
....... url Σ 1..1 uri "detail"
....... value[x] Σ 0..1 Detail
........ 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
........ valueVirtualServiceDetail VirtualServiceDetail
........ valueDosage Dosage
........ valueMeta Meta
...... extension:rationale 1..1 Extension Extension
....... id 0..1 string 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 string 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: Limited M11 Section Codes Value Set (required)
..... url Σ 1..1 uri "details"
.... extension:rationale 0..1 Extension Extension
..... id 0..1 string 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:description 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "description"
..... value[x] Σ 0..1 Description
...... valueMarkdown markdown
...... valueString string
... url Σ 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: Filtersdoco
.. Extension 0..* Extension An amendment to a study protocol
... extension 2..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:identifier 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "identifier"
..... value[x] 0..1 Identifier Amendment identifier
.... extension:previous 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "previous"
..... value[x] 0..1 CodeableConcept Statement regarding prior amendments
Binding: ICH M11 Amendment Details Statement Value Set (required)
.... extension:scope 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "scope"
..... value[x] 0..1 CodeableConcept Global or Not Global
Binding: ICH M11 Amendment Scope Value Set (required)
.... extension:country 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "country"
..... value[x] 0..1 CodeableConcept Country
.... extension:region 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "region"
..... value[x] 0..1 CodeableConcept Region
.... extension:site 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "site"
..... value[x] 0..1 Site
...... valueIdentifier Identifier
...... valueReference Reference(Any)
.... extension:approvalDate 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "approvalDate"
..... value[x] 0..1 date Approval date
.... extension:signature 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signature"
..... value[x] 0..1 Signature Signature
.... extension:signatureUrl 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureUrl"
..... value[x] 0..1 Signature URL
...... valueString string
...... valueUrl url
.... extension:signatureMethod 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureMethod"
..... value[x] 0..1 string Signature Method
.... 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
..... url 1..1 uri "scopeImpact"
.... extension:primaryReason 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "primaryReason"
..... value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:secondaryReason 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "secondaryReason"
..... value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:summary 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "summary"
..... value[x] 0..1 string Summary of changes
.... extension:substantialImpactSafety 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactSafety"
..... value[x] 0..1 CodeableConcept Substantial impact on safety
Binding: ICH M11 Yes No Value Set (required)
.... extension:substantialImpactSafetyComment 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactSafetyComment"
..... value[x] 0..1 string Comment on substantial impact on safety
.... extension:substantialImpactReliability 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactReliability"
..... value[x] 0..1 CodeableConcept Substantial impact on reliability
Binding: ICH M11 Yes No Value Set (required)
.... extension:substantialImpactReliabilityComment 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactReliabilityComment"
..... value[x] 0..1 string Comment on substantial impact on reliability
.... extension:details 0..* (Complex) Provides detail of a single change within an amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-detail
..... url 1..1 uri "details"
.... extension:rationale 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Rationale
.... extension:description 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "description"
..... value[x] 0..1 Description
...... valueMarkdown markdown
...... valueString string
... 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

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension An amendment to a study protocol
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:identifier 1..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "identifier"
..... value[x] Σ 0..1 Identifier Amendment identifier
.... extension:previous 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "previous"
..... value[x] Σ 0..1 CodeableConcept Statement regarding prior amendments
Binding: ICH M11 Amendment Details Statement Value Set (required)
.... extension:scope 1..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "scope"
..... value[x] Σ 0..1 CodeableConcept Global or Not Global
Binding: ICH M11 Amendment Scope Value Set (required)
.... extension:country 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "country"
..... value[x] Σ 0..1 CodeableConcept Country
.... extension:region 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "region"
..... value[x] Σ 0..1 CodeableConcept Region
.... extension:site 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "site"
..... value[x] Σ 0..1 Site
...... valueIdentifier Identifier
...... valueReference Reference(Any)
.... extension:approvalDate 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "approvalDate"
..... value[x] Σ 0..1 date Approval date
.... extension:signature 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "signature"
..... value[x] Σ 0..1 Signature Signature
.... extension:signatureUrl 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "signatureUrl"
..... value[x] Σ 0..1 Signature URL
...... valueString string
...... valueUrl url
.... extension:signatureMethod 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "signatureMethod"
..... value[x] Σ 0..1 string Signature Method
.... 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
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
..... Slices for extension Content/Rules for all slices
...... extension:number 1..1 Extension Extension
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..0 Extension
Slice: Unordered, Open by value:url
....... url Σ 1..1 uri "number"
....... value[x] Σ 0..1 Number of participants, or % of participants
........ valuePositiveInt positiveInt
........ valueQuantity Quantity
...... extension:scope 1..1 Extension Extension
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..0 Extension
Slice: Unordered, Open by value:url
....... url Σ 1..1 uri "scope"
....... value[x] Σ 0..1 CodeableConcept Global, Locally, or By Cohort
Binding: ICH M11 Amendment Scope Enrollment Value Set (required)
..... url Σ 1..1 uri "scopeImpact"
.... extension:primaryReason 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "primaryReason"
..... value[x] Σ 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:secondaryReason 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "secondaryReason"
..... value[x] Σ 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:summary 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "summary"
..... value[x] Σ 0..1 string Summary of changes
.... extension:substantialImpactSafety 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactSafety"
..... value[x] Σ 0..1 CodeableConcept Substantial impact on safety
Binding: ICH M11 Yes No Value Set (required)
.... extension:substantialImpactSafetyComment 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactSafetyComment"
..... value[x] Σ 0..1 string Comment on substantial impact on safety
.... extension:substantialImpactReliability 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactReliability"
..... value[x] Σ 0..1 CodeableConcept Substantial impact on reliability
Binding: ICH M11 Yes No Value Set (required)
.... extension:substantialImpactReliabilityComment 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactReliabilityComment"
..... value[x] Σ 0..1 string Comment on substantial impact on reliability
.... extension:details 0..* (Complex) Provides detail of a single change within an amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-detail
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 3..* Extension Extension
Slice: Unordered, Open by value:url
..... Slices for extension Content/Rules for all slices
...... extension:detail 1..1 Extension Extension
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..0 Extension
Slice: Unordered, Open by value:url
....... url Σ 1..1 uri "detail"
....... value[x] Σ 0..1 Detail
........ 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
........ valueVirtualServiceDetail VirtualServiceDetail
........ valueDosage Dosage
........ valueMeta Meta
...... extension:rationale 1..1 Extension Extension
....... id 0..1 string 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 string 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: Limited M11 Section Codes Value Set (required)
..... url Σ 1..1 uri "details"
.... extension:rationale 0..1 Extension Extension
..... id 0..1 string 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:description 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "description"
..... value[x] Σ 0..1 Description
...... valueMarkdown markdown
...... valueString string
... url Σ 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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