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

Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

Extension:

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary Version: 1.0.0-ballot2
Standards status: Trial-use Maturity Level: 2 Computable Name: M11_ProtocolSummary

Copyright/Legal: Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license.

CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023)

The NCI Thesaurus is released under the CC BY 4.0 license

CDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license

For more licensing information and links see: licenses.html

Summary to a protocol.

Context of Use

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

    • Element ID: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile#ResearchStudy

Usage info

Usages:

  • This Extension is not used by any profiles in this Specification

You can also check for usages in the FHIR IG Statistics

Formal Views of Extension Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Summary of a protocol
... extension 36..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:objectiveAndEstimandSummary S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "objectiveAndEstimandSummary"
..... value[x] 0..1 C218839 Primary and Secondary Objectives and Estimands
...... valueMarkdown markdown
...... valueString string
.... extension:interventionModel S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "interventionModel"
..... value[x] 0..1 CodeableConcept C217277 Intervention Model
Binding: ICH M11 Intervention Model Value Set Terminology (required)
.... extension:populationType S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "populationType"
..... value[x] 0..1 CodeableConcept C217278 Population Type
Binding: ICH M11 ... (required)
.... extension:controlType S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "controlType"
..... value[x] 0..1 CodeableConcept C217279 Control Type
Binding: ICH M11 ... (required)
.... extension:populationDiagnosisOrCondition S 1..* Extension Extension
..... url 1..1 uri "populationDiagnosisOrCondition"
.... extension:comparator 1..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "comparator"
..... value[x] 0..1 Reference(MedicinalProductDefinition) Comparator
.... extension:minimumAge S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "minimumAge"
..... value[x] 0..1 Quantity C49693/C25301 Minimum Age value/units
.... extension:unitsOfMinimumAge S 1..1 Extension Extension
..... url 1..1 uri "unitsOfMinimumAge"
.... extension:maximumAge S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "maximumAge"
..... value[x] 0..1 Quantity C49694/C25301 Minimum Age value/units
.... extension:unitsOfMaximumAge S 1..1 Extension Extension
..... url 1..1 uri "unitsOfMaximumAge"
.... extension:interventionAssignmentMethod S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "interventionAssignmentMethod"
..... value[x] 0..1 CodeableConcept C217280 Intervention Assignment Method
Binding: ICH M11 ... (required)
.... extension:randomisationType S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "randomisationType"
..... value[x] 0..1 C223137 Randomisation Type
...... valueString string
...... valueCodeableConcept CodeableConcept
.... extension:otherInterventionAssignmentMethod S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "otherInterventionAssignmentMethod"
..... value[x] 0..1 string C223138 Other Intervention Assignment Method}
.... extension:stratificationIndicator S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "stratificationIndicator"
..... value[x] 0..1 CodeableConcept C223136 Stratification Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:siteDistribution S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "siteDistribution"
..... value[x] 0..1 CodeableConcept C217049 Site Distribution
Binding: ICH M11 ... (required)
.... extension:siteGeographicScope S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "siteGeographicScope"
..... value[x] 0..1 CodeableConcept C217050: Site geographic scope
Binding: ICH M11 ... (required)
.... extension:masterProtocolIndicator S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "masterProtocolIndicator"
..... value[x] 0..1 CodeableConcept C217046 Master Protocol Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:drug-DeviceCombinationProductIndicator S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "drug-DeviceCombinationProductIndicator"
..... value[x] 0..1 CodeableConcept C217046 Drug-Device Combination Product Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:adaptiveTrialDesignIndicator S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "adaptiveTrialDesignIndicator"
..... value[x] 0..1 CodeableConcept C217046 Adaptive Trial Design Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:numberOfArms S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "numberOfArms"
..... value[x] 0..1 integer C98771 Number of Arms
.... extension:trialBlindSchema S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "trialBlindSchema"
..... value[x] 0..1 CodeableConcept C217051 Trial Blind Schema
Binding: ICH M11 ... (required)
.... extension:blindedRoles S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "blindedRoles"
..... value[x] 0..1 CodeableConcept C217281: Blinded Roles
Binding: ICH M11 ... (required)
.... extension:targetOrMaximum S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "targetOrMaximum"
..... value[x] 0..1 CodeableConcept Target-Maximum
Binding: UDP ... (required)
.... extension:numberOfParticipants S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "numberOfParticipants"
..... value[x] 0..1 integer C49692 Number of Participants
.... extension:totalPlannedDurationOfTrialIntervention 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "totalPlannedDurationOfTrialIntervention"
..... value[x] 0..1 time C218712/C218713 total planned duration of trial intervention value/units
.... extension:totalPlannedDurationOfTrialInterventionUnitOfTime 1..1 Extension Extension
..... url 1..1 uri "totalPlannedDurationOfTrialInterventionUnitOfTime"
.... extension:alternateDescriptionOfPlannedDurationOfTrialIntervention 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "alternateDescriptionOfPlannedDurationOfTrialIntervention"
..... value[x] 0..1 string C218714 alternate description of planned duration of trial intervention if duration will vary
.... extension:totalPlannedDurationOfTrialParticipation 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "totalPlannedDurationOfTrialParticipation"
..... value[x] 0..1 time C218715/C218716 total planned duration of trial participation value/units
.... extension:totalPlannedDurationOfTrialParticipationUnitOfTime 1..1 Extension Extension
..... url 1..1 uri "totalPlannedDurationOfTrialParticipationUnitOfTime"
.... extension:alternateDescriptionOfPlannedDurationOfTrialParticipation 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "alternateDescriptionOfPlannedDurationOfTrialParticipation"
..... value[x] 0..1 string C218717 alternate description of planned duration of trial participation if duration will vary
.... extension:additionalDescriptionofDuration 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "additionalDescriptionofDuration"
..... value[x] 0..1 string C218838 Additional Description of Duration
.... extension:independentCommittees S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "independentCommittees"
..... value[x] 0..1 CodeableConcept C217282 Independent Committees
Binding: ICH M11 ... (required)
.... extension:otherCommittees 1..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "otherCommittees"
..... value[x] 0..1 string C218719 Other Committees
.... extension:trialSchema S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "trialSchema"
..... value[x] 0..1 string C93682 Trial Schema
.... extension:schemaNotes 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "schemaNotes"
..... value[x] 0..1 string C218720 Schema Notes
.... extension:scheduleofActivities S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "scheduleofActivities"
..... value[x] 0..1 string C132349 Schedule of Activities
... url 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary"

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Extension.extension:interventionModel.​value[x] Base required ICH M11 Intervention Model Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:populationType.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:controlType.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:interventionAssignmentMethod.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:stratificationIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:siteDistribution.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:siteGeographicScope.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:masterProtocolIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:drug-DeviceCombinationProductIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:adaptiveTrialDesignIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:trialBlindSchema.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:blindedRoles.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:targetOrMaximum.​value[x] Base required UDP ... 📦1.0.0-ballot2 This IG
Extension.extension:independentCommittees.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Summary of a protocol
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 36..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:objectiveAndEstimandSummary S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "objectiveAndEstimandSummary"
..... value[x] Σ 0..1 C218839 Primary and Secondary Objectives and Estimands
...... valueMarkdown markdown
...... valueString string
.... extension:interventionModel S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "interventionModel"
..... value[x] Σ 0..1 CodeableConcept C217277 Intervention Model
Binding: ICH M11 Intervention Model Value Set Terminology (required)
.... extension:populationType S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "populationType"
..... value[x] Σ 0..1 CodeableConcept C217278 Population Type
Binding: ICH M11 ... (required)
.... extension:controlType S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "controlType"
..... value[x] Σ 0..1 CodeableConcept C217279 Control Type
Binding: ICH M11 ... (required)
.... extension:populationDiagnosisOrCondition S 1..* Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "populationDiagnosisOrCondition"
..... value[x] Σ 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueInteger64 integer64
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueAvailability Availability
...... valueExtendedContactDetail ExtendedContactDetail
...... valueDosage Dosage
...... valueMeta Meta
.... extension:comparator 1..* Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "comparator"
..... value[x] Σ 0..1 Reference(MedicinalProductDefinition) Comparator
.... extension:minimumAge S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "minimumAge"
..... value[x] Σ 0..1 Quantity C49693/C25301 Minimum Age value/units
.... extension:unitsOfMinimumAge S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "unitsOfMinimumAge"
..... value[x] Σ 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueInteger64 integer64
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueAvailability Availability
...... valueExtendedContactDetail ExtendedContactDetail
...... valueDosage Dosage
...... valueMeta Meta
.... extension:maximumAge S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "maximumAge"
..... value[x] Σ 0..1 Quantity C49694/C25301 Minimum Age value/units
.... extension:unitsOfMaximumAge S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "unitsOfMaximumAge"
..... value[x] Σ 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueInteger64 integer64
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueAvailability Availability
...... valueExtendedContactDetail ExtendedContactDetail
...... valueDosage Dosage
...... valueMeta Meta
.... extension:interventionAssignmentMethod S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "interventionAssignmentMethod"
..... value[x] Σ 0..1 CodeableConcept C217280 Intervention Assignment Method
Binding: ICH M11 ... (required)
.... extension:randomisationType S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "randomisationType"
..... value[x] Σ 0..1 C223137 Randomisation Type
...... valueString string
...... valueCodeableConcept CodeableConcept
.... extension:otherInterventionAssignmentMethod S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "otherInterventionAssignmentMethod"
..... value[x] Σ 0..1 string C223138 Other Intervention Assignment Method}
.... extension:stratificationIndicator S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "stratificationIndicator"
..... value[x] Σ 0..1 CodeableConcept C223136 Stratification Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:siteDistribution S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "siteDistribution"
..... value[x] Σ 0..1 CodeableConcept C217049 Site Distribution
Binding: ICH M11 ... (required)
.... extension:siteGeographicScope S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "siteGeographicScope"
..... value[x] Σ 0..1 CodeableConcept C217050: Site geographic scope
Binding: ICH M11 ... (required)
.... extension:masterProtocolIndicator S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "masterProtocolIndicator"
..... value[x] Σ 0..1 CodeableConcept C217046 Master Protocol Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:drug-DeviceCombinationProductIndicator S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "drug-DeviceCombinationProductIndicator"
..... value[x] Σ 0..1 CodeableConcept C217046 Drug-Device Combination Product Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:adaptiveTrialDesignIndicator S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "adaptiveTrialDesignIndicator"
..... value[x] Σ 0..1 CodeableConcept C217046 Adaptive Trial Design Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:numberOfArms S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "numberOfArms"
..... value[x] Σ 0..1 integer C98771 Number of Arms
.... extension:trialBlindSchema S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "trialBlindSchema"
..... value[x] Σ 0..1 CodeableConcept C217051 Trial Blind Schema
Binding: ICH M11 ... (required)
.... extension:blindedRoles S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "blindedRoles"
..... value[x] Σ 0..1 CodeableConcept C217281: Blinded Roles
Binding: ICH M11 ... (required)
.... extension:targetOrMaximum S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "targetOrMaximum"
..... value[x] Σ 0..1 CodeableConcept Target-Maximum
Binding: UDP ... (required)
.... extension:numberOfParticipants S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "numberOfParticipants"
..... value[x] Σ 0..1 integer C49692 Number of Participants
.... extension:totalPlannedDurationOfTrialIntervention 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "totalPlannedDurationOfTrialIntervention"
..... value[x] Σ 0..1 time C218712/C218713 total planned duration of trial intervention value/units
.... extension:totalPlannedDurationOfTrialInterventionUnitOfTime 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "totalPlannedDurationOfTrialInterventionUnitOfTime"
..... value[x] Σ 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueInteger64 integer64
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueAvailability Availability
...... valueExtendedContactDetail ExtendedContactDetail
...... valueDosage Dosage
...... valueMeta Meta
.... extension:alternateDescriptionOfPlannedDurationOfTrialIntervention 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "alternateDescriptionOfPlannedDurationOfTrialIntervention"
..... value[x] Σ 0..1 string C218714 alternate description of planned duration of trial intervention if duration will vary
.... extension:totalPlannedDurationOfTrialParticipation 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "totalPlannedDurationOfTrialParticipation"
..... value[x] Σ 0..1 time C218715/C218716 total planned duration of trial participation value/units
.... extension:totalPlannedDurationOfTrialParticipationUnitOfTime 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "totalPlannedDurationOfTrialParticipationUnitOfTime"
..... value[x] Σ 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueInteger64 integer64
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueAvailability Availability
...... valueExtendedContactDetail ExtendedContactDetail
...... valueDosage Dosage
...... valueMeta Meta
.... extension:alternateDescriptionOfPlannedDurationOfTrialParticipation 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "alternateDescriptionOfPlannedDurationOfTrialParticipation"
..... value[x] Σ 0..1 string C218717 alternate description of planned duration of trial participation if duration will vary
.... extension:additionalDescriptionofDuration 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "additionalDescriptionofDuration"
..... value[x] Σ 0..1 string C218838 Additional Description of Duration
.... extension:independentCommittees S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "independentCommittees"
..... value[x] Σ 0..1 CodeableConcept C217282 Independent Committees
Binding: ICH M11 ... (required)
.... extension:otherCommittees 1..* Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "otherCommittees"
..... value[x] Σ 0..1 string C218719 Other Committees
.... extension:trialSchema S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "trialSchema"
..... value[x] Σ 0..1 string C93682 Trial Schema
.... extension:schemaNotes 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "schemaNotes"
..... value[x] Σ 0..1 string C218720 Schema Notes
.... extension:scheduleofActivities S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "scheduleofActivities"
..... value[x] Σ 0..1 string C132349 Schedule of Activities
... url Σ 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary"

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Extension.extension:interventionModel.​value[x] Base required ICH M11 Intervention Model Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:populationType.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:controlType.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:interventionAssignmentMethod.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:stratificationIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:siteDistribution.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:siteGeographicScope.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:masterProtocolIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:drug-DeviceCombinationProductIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:adaptiveTrialDesignIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:trialBlindSchema.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:blindedRoles.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:targetOrMaximum.​value[x] Base required UDP ... 📦1.0.0-ballot2 This IG
Extension.extension:independentCommittees.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG

Constraints

Id Grade Path(s) Description Expression
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Complex Extension: Summary to a protocol.

  • objectiveAndEstimandSummary: markdown, string: An Extension
  • interventionModel: CodeableConcept: An Extension
  • populationType: CodeableConcept: An Extension
  • controlType: CodeableConcept: An Extension
  • populationDiagnosisOrCondition: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta: An Extension
  • comparator: Reference: An Extension
  • minimumAge: Quantity: An Extension
  • unitsOfMinimumAge: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta: An Extension
  • maximumAge: Quantity: An Extension
  • unitsOfMaximumAge: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta: An Extension
  • interventionAssignmentMethod: CodeableConcept: An Extension
  • randomisationType: string, CodeableConcept: An Extension
  • otherInterventionAssignmentMethod: string: An Extension
  • stratificationIndicator: CodeableConcept: An Extension
  • siteDistribution: CodeableConcept: An Extension
  • siteGeographicScope: CodeableConcept: An Extension
  • masterProtocolIndicator: CodeableConcept: An Extension
  • drug-DeviceCombinationProductIndicator: CodeableConcept: An Extension
  • adaptiveTrialDesignIndicator: CodeableConcept: An Extension
  • numberOfArms: integer: An Extension
  • trialBlindSchema: CodeableConcept: An Extension
  • blindedRoles: CodeableConcept: An Extension
  • targetOrMaximum: CodeableConcept: An Extension
  • numberOfParticipants: integer: An Extension
  • totalPlannedDurationOfTrialIntervention: time: An Extension
  • totalPlannedDurationOfTrialInterventionUnitOfTime: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta: An Extension
  • alternateDescriptionOfPlannedDurationOfTrialIntervention: string: An Extension
  • totalPlannedDurationOfTrialParticipation: time: An Extension
  • totalPlannedDurationOfTrialParticipationUnitOfTime: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta: An Extension
  • alternateDescriptionOfPlannedDurationOfTrialParticipation: string: An Extension
  • additionalDescriptionofDuration: string: An Extension
  • independentCommittees: CodeableConcept: An Extension
  • otherCommittees: string: An Extension
  • trialSchema: string: An Extension
  • schemaNotes: string: An Extension
  • scheduleofActivities: string: An Extension

Maturity: 2

Differential ViewDifferential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Summary of a protocol
... extension 36..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:objectiveAndEstimandSummary S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "objectiveAndEstimandSummary"
..... value[x] 0..1 C218839 Primary and Secondary Objectives and Estimands
...... valueMarkdown markdown
...... valueString string
.... extension:interventionModel S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "interventionModel"
..... value[x] 0..1 CodeableConcept C217277 Intervention Model
Binding: ICH M11 Intervention Model Value Set Terminology (required)
.... extension:populationType S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "populationType"
..... value[x] 0..1 CodeableConcept C217278 Population Type
Binding: ICH M11 ... (required)
.... extension:controlType S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "controlType"
..... value[x] 0..1 CodeableConcept C217279 Control Type
Binding: ICH M11 ... (required)
.... extension:populationDiagnosisOrCondition S 1..* Extension Extension
..... url 1..1 uri "populationDiagnosisOrCondition"
.... extension:comparator 1..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "comparator"
..... value[x] 0..1 Reference(MedicinalProductDefinition) Comparator
.... extension:minimumAge S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "minimumAge"
..... value[x] 0..1 Quantity C49693/C25301 Minimum Age value/units
.... extension:unitsOfMinimumAge S 1..1 Extension Extension
..... url 1..1 uri "unitsOfMinimumAge"
.... extension:maximumAge S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "maximumAge"
..... value[x] 0..1 Quantity C49694/C25301 Minimum Age value/units
.... extension:unitsOfMaximumAge S 1..1 Extension Extension
..... url 1..1 uri "unitsOfMaximumAge"
.... extension:interventionAssignmentMethod S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "interventionAssignmentMethod"
..... value[x] 0..1 CodeableConcept C217280 Intervention Assignment Method
Binding: ICH M11 ... (required)
.... extension:randomisationType S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "randomisationType"
..... value[x] 0..1 C223137 Randomisation Type
...... valueString string
...... valueCodeableConcept CodeableConcept
.... extension:otherInterventionAssignmentMethod S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "otherInterventionAssignmentMethod"
..... value[x] 0..1 string C223138 Other Intervention Assignment Method}
.... extension:stratificationIndicator S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "stratificationIndicator"
..... value[x] 0..1 CodeableConcept C223136 Stratification Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:siteDistribution S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "siteDistribution"
..... value[x] 0..1 CodeableConcept C217049 Site Distribution
Binding: ICH M11 ... (required)
.... extension:siteGeographicScope S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "siteGeographicScope"
..... value[x] 0..1 CodeableConcept C217050: Site geographic scope
Binding: ICH M11 ... (required)
.... extension:masterProtocolIndicator S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "masterProtocolIndicator"
..... value[x] 0..1 CodeableConcept C217046 Master Protocol Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:drug-DeviceCombinationProductIndicator S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "drug-DeviceCombinationProductIndicator"
..... value[x] 0..1 CodeableConcept C217046 Drug-Device Combination Product Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:adaptiveTrialDesignIndicator S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "adaptiveTrialDesignIndicator"
..... value[x] 0..1 CodeableConcept C217046 Adaptive Trial Design Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:numberOfArms S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "numberOfArms"
..... value[x] 0..1 integer C98771 Number of Arms
.... extension:trialBlindSchema S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "trialBlindSchema"
..... value[x] 0..1 CodeableConcept C217051 Trial Blind Schema
Binding: ICH M11 ... (required)
.... extension:blindedRoles S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "blindedRoles"
..... value[x] 0..1 CodeableConcept C217281: Blinded Roles
Binding: ICH M11 ... (required)
.... extension:targetOrMaximum S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "targetOrMaximum"
..... value[x] 0..1 CodeableConcept Target-Maximum
Binding: UDP ... (required)
.... extension:numberOfParticipants S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "numberOfParticipants"
..... value[x] 0..1 integer C49692 Number of Participants
.... extension:totalPlannedDurationOfTrialIntervention 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "totalPlannedDurationOfTrialIntervention"
..... value[x] 0..1 time C218712/C218713 total planned duration of trial intervention value/units
.... extension:totalPlannedDurationOfTrialInterventionUnitOfTime 1..1 Extension Extension
..... url 1..1 uri "totalPlannedDurationOfTrialInterventionUnitOfTime"
.... extension:alternateDescriptionOfPlannedDurationOfTrialIntervention 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "alternateDescriptionOfPlannedDurationOfTrialIntervention"
..... value[x] 0..1 string C218714 alternate description of planned duration of trial intervention if duration will vary
.... extension:totalPlannedDurationOfTrialParticipation 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "totalPlannedDurationOfTrialParticipation"
..... value[x] 0..1 time C218715/C218716 total planned duration of trial participation value/units
.... extension:totalPlannedDurationOfTrialParticipationUnitOfTime 1..1 Extension Extension
..... url 1..1 uri "totalPlannedDurationOfTrialParticipationUnitOfTime"
.... extension:alternateDescriptionOfPlannedDurationOfTrialParticipation 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "alternateDescriptionOfPlannedDurationOfTrialParticipation"
..... value[x] 0..1 string C218717 alternate description of planned duration of trial participation if duration will vary
.... extension:additionalDescriptionofDuration 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "additionalDescriptionofDuration"
..... value[x] 0..1 string C218838 Additional Description of Duration
.... extension:independentCommittees S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "independentCommittees"
..... value[x] 0..1 CodeableConcept C217282 Independent Committees
Binding: ICH M11 ... (required)
.... extension:otherCommittees 1..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "otherCommittees"
..... value[x] 0..1 string C218719 Other Committees
.... extension:trialSchema S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "trialSchema"
..... value[x] 0..1 string C93682 Trial Schema
.... extension:schemaNotes 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "schemaNotes"
..... value[x] 0..1 string C218720 Schema Notes
.... extension:scheduleofActivities S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "scheduleofActivities"
..... value[x] 0..1 string C132349 Schedule of Activities
... url 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary"

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Extension.extension:interventionModel.​value[x] Base required ICH M11 Intervention Model Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:populationType.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:controlType.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:interventionAssignmentMethod.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:stratificationIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:siteDistribution.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:siteGeographicScope.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:masterProtocolIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:drug-DeviceCombinationProductIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:adaptiveTrialDesignIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:trialBlindSchema.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:blindedRoles.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:targetOrMaximum.​value[x] Base required UDP ... 📦1.0.0-ballot2 This IG
Extension.extension:independentCommittees.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Summary of a protocol
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 36..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:objectiveAndEstimandSummary S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "objectiveAndEstimandSummary"
..... value[x] Σ 0..1 C218839 Primary and Secondary Objectives and Estimands
...... valueMarkdown markdown
...... valueString string
.... extension:interventionModel S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "interventionModel"
..... value[x] Σ 0..1 CodeableConcept C217277 Intervention Model
Binding: ICH M11 Intervention Model Value Set Terminology (required)
.... extension:populationType S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "populationType"
..... value[x] Σ 0..1 CodeableConcept C217278 Population Type
Binding: ICH M11 ... (required)
.... extension:controlType S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "controlType"
..... value[x] Σ 0..1 CodeableConcept C217279 Control Type
Binding: ICH M11 ... (required)
.... extension:populationDiagnosisOrCondition S 1..* Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "populationDiagnosisOrCondition"
..... value[x] Σ 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueInteger64 integer64
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueAvailability Availability
...... valueExtendedContactDetail ExtendedContactDetail
...... valueDosage Dosage
...... valueMeta Meta
.... extension:comparator 1..* Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "comparator"
..... value[x] Σ 0..1 Reference(MedicinalProductDefinition) Comparator
.... extension:minimumAge S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "minimumAge"
..... value[x] Σ 0..1 Quantity C49693/C25301 Minimum Age value/units
.... extension:unitsOfMinimumAge S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "unitsOfMinimumAge"
..... value[x] Σ 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueInteger64 integer64
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueAvailability Availability
...... valueExtendedContactDetail ExtendedContactDetail
...... valueDosage Dosage
...... valueMeta Meta
.... extension:maximumAge S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "maximumAge"
..... value[x] Σ 0..1 Quantity C49694/C25301 Minimum Age value/units
.... extension:unitsOfMaximumAge S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "unitsOfMaximumAge"
..... value[x] Σ 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueInteger64 integer64
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueAvailability Availability
...... valueExtendedContactDetail ExtendedContactDetail
...... valueDosage Dosage
...... valueMeta Meta
.... extension:interventionAssignmentMethod S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "interventionAssignmentMethod"
..... value[x] Σ 0..1 CodeableConcept C217280 Intervention Assignment Method
Binding: ICH M11 ... (required)
.... extension:randomisationType S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "randomisationType"
..... value[x] Σ 0..1 C223137 Randomisation Type
...... valueString string
...... valueCodeableConcept CodeableConcept
.... extension:otherInterventionAssignmentMethod S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "otherInterventionAssignmentMethod"
..... value[x] Σ 0..1 string C223138 Other Intervention Assignment Method}
.... extension:stratificationIndicator S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "stratificationIndicator"
..... value[x] Σ 0..1 CodeableConcept C223136 Stratification Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:siteDistribution S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "siteDistribution"
..... value[x] Σ 0..1 CodeableConcept C217049 Site Distribution
Binding: ICH M11 ... (required)
.... extension:siteGeographicScope S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "siteGeographicScope"
..... value[x] Σ 0..1 CodeableConcept C217050: Site geographic scope
Binding: ICH M11 ... (required)
.... extension:masterProtocolIndicator S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "masterProtocolIndicator"
..... value[x] Σ 0..1 CodeableConcept C217046 Master Protocol Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:drug-DeviceCombinationProductIndicator S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "drug-DeviceCombinationProductIndicator"
..... value[x] Σ 0..1 CodeableConcept C217046 Drug-Device Combination Product Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:adaptiveTrialDesignIndicator S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "adaptiveTrialDesignIndicator"
..... value[x] Σ 0..1 CodeableConcept C217046 Adaptive Trial Design Indicator
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:numberOfArms S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "numberOfArms"
..... value[x] Σ 0..1 integer C98771 Number of Arms
.... extension:trialBlindSchema S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "trialBlindSchema"
..... value[x] Σ 0..1 CodeableConcept C217051 Trial Blind Schema
Binding: ICH M11 ... (required)
.... extension:blindedRoles S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "blindedRoles"
..... value[x] Σ 0..1 CodeableConcept C217281: Blinded Roles
Binding: ICH M11 ... (required)
.... extension:targetOrMaximum S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "targetOrMaximum"
..... value[x] Σ 0..1 CodeableConcept Target-Maximum
Binding: UDP ... (required)
.... extension:numberOfParticipants S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "numberOfParticipants"
..... value[x] Σ 0..1 integer C49692 Number of Participants
.... extension:totalPlannedDurationOfTrialIntervention 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "totalPlannedDurationOfTrialIntervention"
..... value[x] Σ 0..1 time C218712/C218713 total planned duration of trial intervention value/units
.... extension:totalPlannedDurationOfTrialInterventionUnitOfTime 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "totalPlannedDurationOfTrialInterventionUnitOfTime"
..... value[x] Σ 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueInteger64 integer64
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueAvailability Availability
...... valueExtendedContactDetail ExtendedContactDetail
...... valueDosage Dosage
...... valueMeta Meta
.... extension:alternateDescriptionOfPlannedDurationOfTrialIntervention 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "alternateDescriptionOfPlannedDurationOfTrialIntervention"
..... value[x] Σ 0..1 string C218714 alternate description of planned duration of trial intervention if duration will vary
.... extension:totalPlannedDurationOfTrialParticipation 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "totalPlannedDurationOfTrialParticipation"
..... value[x] Σ 0..1 time C218715/C218716 total planned duration of trial participation value/units
.... extension:totalPlannedDurationOfTrialParticipationUnitOfTime 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "totalPlannedDurationOfTrialParticipationUnitOfTime"
..... value[x] Σ 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueInteger64 integer64
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueAvailability Availability
...... valueExtendedContactDetail ExtendedContactDetail
...... valueDosage Dosage
...... valueMeta Meta
.... extension:alternateDescriptionOfPlannedDurationOfTrialParticipation 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "alternateDescriptionOfPlannedDurationOfTrialParticipation"
..... value[x] Σ 0..1 string C218717 alternate description of planned duration of trial participation if duration will vary
.... extension:additionalDescriptionofDuration 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "additionalDescriptionofDuration"
..... value[x] Σ 0..1 string C218838 Additional Description of Duration
.... extension:independentCommittees S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "independentCommittees"
..... value[x] Σ 0..1 CodeableConcept C217282 Independent Committees
Binding: ICH M11 ... (required)
.... extension:otherCommittees 1..* Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "otherCommittees"
..... value[x] Σ 0..1 string C218719 Other Committees
.... extension:trialSchema S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "trialSchema"
..... value[x] Σ 0..1 string C93682 Trial Schema
.... extension:schemaNotes 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "schemaNotes"
..... value[x] Σ 0..1 string C218720 Schema Notes
.... extension:scheduleofActivities S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "scheduleofActivities"
..... value[x] Σ 0..1 string C132349 Schedule of Activities
... url Σ 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary"

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Extension.extension:interventionModel.​value[x] Base required ICH M11 Intervention Model Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:populationType.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:controlType.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:interventionAssignmentMethod.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:stratificationIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:siteDistribution.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:siteGeographicScope.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:masterProtocolIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:drug-DeviceCombinationProductIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:adaptiveTrialDesignIndicator.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:trialBlindSchema.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:blindedRoles.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG
Extension.extension:targetOrMaximum.​value[x] Base required UDP ... 📦1.0.0-ballot2 This IG
Extension.extension:independentCommittees.​value[x] Base required ICH M11 ... 📦1.0.0-ballot2 This IG

Constraints

Id Grade Path(s) Description Expression
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Complex Extension: Summary to a protocol.

  • objectiveAndEstimandSummary: markdown, string: An Extension
  • interventionModel: CodeableConcept: An Extension
  • populationType: CodeableConcept: An Extension
  • controlType: CodeableConcept: An Extension
  • populationDiagnosisOrCondition: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta: An Extension
  • comparator: Reference: An Extension
  • minimumAge: Quantity: An Extension
  • unitsOfMinimumAge: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta: An Extension
  • maximumAge: Quantity: An Extension
  • unitsOfMaximumAge: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta: An Extension
  • interventionAssignmentMethod: CodeableConcept: An Extension
  • randomisationType: string, CodeableConcept: An Extension
  • otherInterventionAssignmentMethod: string: An Extension
  • stratificationIndicator: CodeableConcept: An Extension
  • siteDistribution: CodeableConcept: An Extension
  • siteGeographicScope: CodeableConcept: An Extension
  • masterProtocolIndicator: CodeableConcept: An Extension
  • drug-DeviceCombinationProductIndicator: CodeableConcept: An Extension
  • adaptiveTrialDesignIndicator: CodeableConcept: An Extension
  • numberOfArms: integer: An Extension
  • trialBlindSchema: CodeableConcept: An Extension
  • blindedRoles: CodeableConcept: An Extension
  • targetOrMaximum: CodeableConcept: An Extension
  • numberOfParticipants: integer: An Extension
  • totalPlannedDurationOfTrialIntervention: time: An Extension
  • totalPlannedDurationOfTrialInterventionUnitOfTime: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta: An Extension
  • alternateDescriptionOfPlannedDurationOfTrialIntervention: string: An Extension
  • totalPlannedDurationOfTrialParticipation: time: An Extension
  • totalPlannedDurationOfTrialParticipationUnitOfTime: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta: An Extension
  • alternateDescriptionOfPlannedDurationOfTrialParticipation: string: An Extension
  • additionalDescriptionofDuration: string: An Extension
  • independentCommittees: CodeableConcept: An Extension
  • otherCommittees: string: An Extension
  • trialSchema: string: An Extension
  • schemaNotes: string: An Extension
  • scheduleofActivities: string: An Extension

Maturity: 2

 

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