M11_ProtocolSummary - Clinical Study Protocol v1.0.0-ballot2

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: M11_ProtocolSummary - Detailed Descriptions

Page standards status: Trial-use

Maturity Level: 2

Definitions for the m11-protocol-summary extension

Key Elements Table
Differential Table
Snapshot Table

Guidance on how to interpret the contents of this table can be foundhere

0. Extension
Definition	Representation of summary of a study protocol. Optional Extension Element - found in all resources.
Short	Summary of a protocolOptional Extensions Element
Comments	This is Section 1 of the ICH Technical Summary and Guideline.
Control	0..*
Is Modifier	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2. Extension.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	360..*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
4. Extension.extension:objectiveAndEstimandSummary
Slice Name	objectiveAndEstimandSummary
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Extension.extension:objectiveAndEstimandSummary.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
8. Extension.extension:objectiveAndEstimandSummary.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`objectiveAndEstimandSummary`
10. Extension.extension:objectiveAndEstimandSummary.value[x]
Definition	A descriptive summary of the primary and secondary objectives and their associated estimands related to the trial. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C218839 Primary and Secondary Objectives and EstimandsValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: markdown, string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Extension.extension:interventionModel
Slice Name	interventionModel
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Extension.extension:interventionModel.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
16. Extension.extension:interventionModel.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`interventionModel`
18. Extension.extension:interventionModel.value[x]
Definition	The overall design configuration for assigning intervention to participants. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C217277 Intervention ModelValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see ICH M11 Intervention Model Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionModel-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Extension.extension:populationType
Slice Name	populationType
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Extension.extension:populationType.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
24. Extension.extension:populationType.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`populationType`
26. Extension.extension:populationType.value[x]
Definition	A characterisation or classification of the trial population. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C217278 Population TypeValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-populationType-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Extension.extension:controlType
Slice Name	controlType
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. Extension.extension:controlType.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
32. Extension.extension:controlType.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`controlType`
34. Extension.extension:controlType.value[x]
Definition	A characterization or classification of the comparator against which the study intervention is evaluated. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C217279 Control TypeValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-controlType-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. Extension.extension:populationDiagnosisOrCondition
Slice Name	populationDiagnosisOrCondition
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. Extension.extension:populationDiagnosisOrCondition.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`populationDiagnosisOrCondition`
40. Extension.extension:comparator
Slice Name	comparator
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. Extension.extension:comparator.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
44. Extension.extension:comparator.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`comparator`
46. Extension.extension:comparator.value[x]
Definition	The comparator against which the study intervention is evaluated. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	ComparatorValue of extension
Comments	M11 CC97054 requires on a narrative representation of the comparator - the name.
Control	0..1 This element is affected by the following invariants: ext-1
Type	Reference(MedicinalProductDefinition), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. Extension.extension:minimumAge
Slice Name	minimumAge
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. Extension.extension:minimumAge.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
52. Extension.extension:minimumAge.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`minimumAge`
54. Extension.extension:minimumAge.value[x]
Definition	The anticipated minimum age of the participants to be entered in a clinical trial. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C49693/C25301 Minimum Age value/unitsValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Quantity, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. Extension.extension:unitsOfMinimumAge
Slice Name	unitsOfMinimumAge
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. Extension.extension:unitsOfMinimumAge.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`unitsOfMinimumAge`
60. Extension.extension:maximumAge
Slice Name	maximumAge
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. Extension.extension:maximumAge.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
64. Extension.extension:maximumAge.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`maximumAge`
66. Extension.extension:maximumAge.value[x]
Definition	The anticipated maximum age of the participants to be entered in a clinical trial. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C49694/C25301 Minimum Age value/unitsValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Quantity, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. Extension.extension:unitsOfMaximumAge
Slice Name	unitsOfMaximumAge
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. Extension.extension:unitsOfMaximumAge.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`unitsOfMaximumAge`
72. Extension.extension:interventionAssignmentMethod
Slice Name	interventionAssignmentMethod
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. Extension.extension:interventionAssignmentMethod.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
76. Extension.extension:interventionAssignmentMethod.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`interventionAssignmentMethod`
78. Extension.extension:interventionAssignmentMethod.value[x]
Definition	The process used to assign trial participants to a trial intervention or trial arm. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C217280 Intervention Assignment MethodValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionAssignmentMethod-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. Extension.extension:randomisationType
Slice Name	randomisationType
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. Extension.extension:randomisationType.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
84. Extension.extension:randomisationType.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`randomisationType`
86. Extension.extension:randomisationType.value[x]
Definition	The type of randomisation to be used (e.g., simple randomisation, block randomisation) Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C223137 Randomisation TypeValue of extension
Comments	this is just a text description - implementers may want to provide a value set that tehe text can be drawn from.
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: string, CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. Extension.extension:otherInterventionAssignmentMethod
Slice Name	otherInterventionAssignmentMethod
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. Extension.extension:otherInterventionAssignmentMethod.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
92. Extension.extension:otherInterventionAssignmentMethod.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`otherInterventionAssignmentMethod`
94. Extension.extension:otherInterventionAssignmentMethod.value[x]
Definition	If applicable, describe the other intervention assignment method. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C223138 Other Intervention Assignment Method}Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
96. Extension.extension:stratificationIndicator
Slice Name	stratificationIndicator
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
98. Extension.extension:stratificationIndicator.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
100. Extension.extension:stratificationIndicator.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`stratificationIndicator`
102. Extension.extension:stratificationIndicator.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C223136 Stratification IndicatorValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see ICH M11 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
104. Extension.extension:siteDistribution
Slice Name	siteDistribution
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
106. Extension.extension:siteDistribution.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
108. Extension.extension:siteDistribution.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`siteDistribution`
110. Extension.extension:siteDistribution.value[x]
Definition	An indication as to whether the occurrence applies to a single or multiple trial sites. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C217049 Site DistributionValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteDistribution-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
112. Extension.extension:siteGeographicScope
Slice Name	siteGeographicScope
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
114. Extension.extension:siteGeographicScope.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
116. Extension.extension:siteGeographicScope.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`siteGeographicScope`
118. Extension.extension:siteGeographicScope.value[x]
Definition	An indication as to whether the trial is taking place in one or more countries. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C217050: Site geographic scopeValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteGeographicscope-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
120. Extension.extension:masterProtocolIndicator
Slice Name	masterProtocolIndicator
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
122. Extension.extension:masterProtocolIndicator.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
124. Extension.extension:masterProtocolIndicator.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`masterProtocolIndicator`
126. Extension.extension:masterProtocolIndicator.value[x]
Definition	An indication as to whether the protocol is a master protocol. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C217046 Master Protocol IndicatorValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see ICH M11 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
128. Extension.extension:drug-DeviceCombinationProductIndicator
Slice Name	drug-DeviceCombinationProductIndicator
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
130. Extension.extension:drug-DeviceCombinationProductIndicator.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
132. Extension.extension:drug-DeviceCombinationProductIndicator.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`drug-DeviceCombinationProductIndicator`
134. Extension.extension:drug-DeviceCombinationProductIndicator.value[x]
Definition	An indication as to whether the clinical trial is testing a drug-device combination product. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C217046 Drug-Device Combination Product IndicatorValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see ICH M11 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
136. Extension.extension:adaptiveTrialDesignIndicator
Slice Name	adaptiveTrialDesignIndicator
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
138. Extension.extension:adaptiveTrialDesignIndicator.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
140. Extension.extension:adaptiveTrialDesignIndicator.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`adaptiveTrialDesignIndicator`
142. Extension.extension:adaptiveTrialDesignIndicator.value[x]
Definition	An indication as to whether the clinical trial uses an adaptive trial design. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C217046 Adaptive Trial Design IndicatorValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see ICH M11 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
144. Extension.extension:numberOfArms
Slice Name	numberOfArms
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
146. Extension.extension:numberOfArms.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
148. Extension.extension:numberOfArms.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`numberOfArms`
150. Extension.extension:numberOfArms.value[x]
Definition	The planned number of intervention groups. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C98771 Number of ArmsValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	integer, date, Meta, Address, Attachment, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
152. Extension.extension:trialBlindSchema
Slice Name	trialBlindSchema
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
154. Extension.extension:trialBlindSchema.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
156. Extension.extension:trialBlindSchema.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`trialBlindSchema`
158. Extension.extension:trialBlindSchema.value[x]
Definition	The type of experimental design used to describe the level of awareness of the trial participants and/ or personnel as it relates to the respective intervention(s) or assessments being observed, received or administered. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C217051 Trial Blind SchemaValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-trialBlindSchema-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
160. Extension.extension:blindedRoles
Slice Name	blindedRoles
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
162. Extension.extension:blindedRoles.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
164. Extension.extension:blindedRoles.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`blindedRoles`
166. Extension.extension:blindedRoles.value[x]
Definition	An identifying designation assigned to a blinded individual within a clinical trial that corresponds with their function Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C217281: Blinded RolesValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blindedRoles-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
168. Extension.extension:targetOrMaximum
Slice Name	targetOrMaximum
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
170. Extension.extension:targetOrMaximum.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
172. Extension.extension:targetOrMaximum.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`targetOrMaximum`
174. Extension.extension:targetOrMaximum.value[x]
Definition	A characterisation or classification of the trial participant numbers as to whether the numbers reflect a target or maximum. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Target-MaximumValue of extension
Comments	The ICH spec has this as optional boilerplate text but it has to be a variable to be processable
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see UDP ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-target-Maximum-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
176. Extension.extension:numberOfParticipants
Slice Name	numberOfParticipants
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
178. Extension.extension:numberOfParticipants.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
180. Extension.extension:numberOfParticipants.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`numberOfParticipants`
182. Extension.extension:numberOfParticipants.value[x]
Definition	The planned number of participant be entered in a clinical trial. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C49692 Number of ParticipantsValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	integer, date, Meta, Address, Attachment, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
184. Extension.extension:totalPlannedDurationOfTrialIntervention
Slice Name	totalPlannedDurationOfTrialIntervention
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
186. Extension.extension:totalPlannedDurationOfTrialIntervention.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
188. Extension.extension:totalPlannedDurationOfTrialIntervention.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`totalPlannedDurationOfTrialIntervention`
190. Extension.extension:totalPlannedDurationOfTrialIntervention.value[x]
Definition	The total planned duration of trial intervention Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C218712/C218713 total planned duration of trial intervention value/unitsValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	time, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
192. Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime
Slice Name	totalPlannedDurationOfTrialInterventionUnitOfTime
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
194. Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`totalPlannedDurationOfTrialInterventionUnitOfTime`
196. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention
Slice Name	alternateDescriptionOfPlannedDurationOfTrialIntervention
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
198. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
200. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`alternateDescriptionOfPlannedDurationOfTrialIntervention`
202. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.value[x]
Definition	An alternative textual narrative for the planned duration of trial intervention. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C218714 alternate description of planned duration of trial intervention if duration will varyValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
204. Extension.extension:totalPlannedDurationOfTrialParticipation
Slice Name	totalPlannedDurationOfTrialParticipation
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
206. Extension.extension:totalPlannedDurationOfTrialParticipation.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
208. Extension.extension:totalPlannedDurationOfTrialParticipation.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`totalPlannedDurationOfTrialParticipation`
210. Extension.extension:totalPlannedDurationOfTrialParticipation.value[x]
Definition	The total planned duration of trial participation Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C218715/C218716 total planned duration of trial participation value/unitsValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	time, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
212. Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime
Slice Name	totalPlannedDurationOfTrialParticipationUnitOfTime
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
214. Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`totalPlannedDurationOfTrialParticipationUnitOfTime`
216. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation
Slice Name	alternateDescriptionOfPlannedDurationOfTrialParticipation
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
218. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
220. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`alternateDescriptionOfPlannedDurationOfTrialParticipation`
222. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.value[x]
Definition	An alternative narrative for the planned duration of trial participation. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C218717 alternate description of planned duration of trial participation if duration will varyValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
224. Extension.extension:additionalDescriptionofDuration
Slice Name	additionalDescriptionofDuration
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
226. Extension.extension:additionalDescriptionofDuration.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
228. Extension.extension:additionalDescriptionofDuration.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`additionalDescriptionofDuration`
230. Extension.extension:additionalDescriptionofDuration.value[x]
Definition	A narrative providing additional details about the duration of an participant's use of a trial intervention or their planned participation time in the trial. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C218838 Additional Description of DurationValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
232. Extension.extension:independentCommittees
Slice Name	independentCommittees
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
234. Extension.extension:independentCommittees.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
236. Extension.extension:independentCommittees.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`independentCommittees`
238. Extension.extension:independentCommittees.value[x]
Definition	An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C217282 Independent CommitteesValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-independentCommittees-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
240. Extension.extension:otherCommittees
Slice Name	otherCommittees
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
242. Extension.extension:otherCommittees.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
244. Extension.extension:otherCommittees.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`otherCommittees`
246. Extension.extension:otherCommittees.value[x]
Definition	A committee that is different than the one(s) previously specified or mentioned. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C218719 Other CommitteesValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
248. Extension.extension:trialSchema
Slice Name	trialSchema
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
250. Extension.extension:trialSchema.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
252. Extension.extension:trialSchema.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`trialSchema`
254. Extension.extension:trialSchema.value[x]
Definition	A diagram that outlines the decision points (e.g. randomisation, response evaluation) that define the different paths a participant could take through the trial. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C93682 Trial SchemaValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
256. Extension.extension:schemaNotes
Slice Name	schemaNotes
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
258. Extension.extension:schemaNotes.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
260. Extension.extension:schemaNotes.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`schemaNotes`
262. Extension.extension:schemaNotes.value[x]
Definition	A brief written record describing the trial schematic. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C218720 Schema NotesValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
264. Extension.extension:scheduleofActivities
Slice Name	scheduleofActivities
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
266. Extension.extension:scheduleofActivities.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
268. Extension.extension:scheduleofActivities.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`scheduleofActivities`
270. Extension.extension:scheduleofActivities.value[x]
Definition	The schedule of activities captures the procedures that will be accomplished at each trial visit, contact with participants. A tabular format is recommended. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C132349 Schedule of ActivitiesValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
272. Extension.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary`
274. Extension.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..01 This element is affected by the following invariants: ext-1
Type	Choice of: 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
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be foundhere

0. Extension
Definition	Representation of summary of a study protocol.
Short	Summary of a protocol
Comments	This is Section 1 of the ICH Technical Summary and Guideline.
2. Extension.extension
Control	36..?
4. Extension.extension:objectiveAndEstimandSummary
Slice Name	objectiveAndEstimandSummary
Control	1..1
Must Support	true
6. Extension.extension:objectiveAndEstimandSummary.extension
Control	0..0
8. Extension.extension:objectiveAndEstimandSummary.url
Fixed Value	`objectiveAndEstimandSummary`
10. Extension.extension:objectiveAndEstimandSummary.value[x]
Definition	A descriptive summary of the primary and secondary objectives and their associated estimands related to the trial.
Short	C218839 Primary and Secondary Objectives and Estimands
Type	Choice of: markdown, string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
12. Extension.extension:interventionModel
Slice Name	interventionModel
Control	1..1
Must Support	true
14. Extension.extension:interventionModel.extension
Control	0..0
16. Extension.extension:interventionModel.url
Fixed Value	`interventionModel`
18. Extension.extension:interventionModel.value[x]
Definition	The overall design configuration for assigning intervention to participants.
Short	C217277 Intervention Model
Binding	The codes SHALL be taken from ICH M11 Intervention Model Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionModel-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
20. Extension.extension:populationType
Slice Name	populationType
Control	1..1
Must Support	true
22. Extension.extension:populationType.extension
Control	0..0
24. Extension.extension:populationType.url
Fixed Value	`populationType`
26. Extension.extension:populationType.value[x]
Definition	A characterisation or classification of the trial population.
Short	C217278 Population Type
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-populationType-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
28. Extension.extension:controlType
Slice Name	controlType
Control	1..1
Must Support	true
30. Extension.extension:controlType.extension
Control	0..0
32. Extension.extension:controlType.url
Fixed Value	`controlType`
34. Extension.extension:controlType.value[x]
Definition	A characterization or classification of the comparator against which the study intervention is evaluated.
Short	C217279 Control Type
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-controlType-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
36. Extension.extension:populationDiagnosisOrCondition
Slice Name	populationDiagnosisOrCondition
Control	1..*
Must Support	true
38. Extension.extension:populationDiagnosisOrCondition.url
Fixed Value	`populationDiagnosisOrCondition`
40. Extension.extension:comparator
Slice Name	comparator
Control	1..*
42. Extension.extension:comparator.extension
Control	0..0
44. Extension.extension:comparator.url
Fixed Value	`comparator`
46. Extension.extension:comparator.value[x]
Definition	The comparator against which the study intervention is evaluated.
Short	Comparator
Comments	M11 CC97054 requires on a narrative representation of the comparator - the name.
Type	Reference(MedicinalProductDefinition)
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
48. Extension.extension:minimumAge
Slice Name	minimumAge
Control	1..1
Must Support	true
50. Extension.extension:minimumAge.extension
Control	0..0
52. Extension.extension:minimumAge.url
Fixed Value	`minimumAge`
54. Extension.extension:minimumAge.value[x]
Definition	The anticipated minimum age of the participants to be entered in a clinical trial.
Short	C49693/C25301 Minimum Age value/units
Type	Quantity
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
56. Extension.extension:unitsOfMinimumAge
Slice Name	unitsOfMinimumAge
Control	1..1
Must Support	true
58. Extension.extension:unitsOfMinimumAge.url
Fixed Value	`unitsOfMinimumAge`
60. Extension.extension:maximumAge
Slice Name	maximumAge
Control	1..1
Must Support	true
62. Extension.extension:maximumAge.extension
Control	0..0
64. Extension.extension:maximumAge.url
Fixed Value	`maximumAge`
66. Extension.extension:maximumAge.value[x]
Definition	The anticipated maximum age of the participants to be entered in a clinical trial.
Short	C49694/C25301 Minimum Age value/units
Type	Quantity
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
68. Extension.extension:unitsOfMaximumAge
Slice Name	unitsOfMaximumAge
Control	1..1
Must Support	true
70. Extension.extension:unitsOfMaximumAge.url
Fixed Value	`unitsOfMaximumAge`
72. Extension.extension:interventionAssignmentMethod
Slice Name	interventionAssignmentMethod
Control	1..1
Must Support	true
74. Extension.extension:interventionAssignmentMethod.extension
Control	0..0
76. Extension.extension:interventionAssignmentMethod.url
Fixed Value	`interventionAssignmentMethod`
78. Extension.extension:interventionAssignmentMethod.value[x]
Definition	The process used to assign trial participants to a trial intervention or trial arm.
Short	C217280 Intervention Assignment Method
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionAssignmentMethod-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
80. Extension.extension:randomisationType
Slice Name	randomisationType
Control	1..1
Must Support	true
82. Extension.extension:randomisationType.extension
Control	0..0
84. Extension.extension:randomisationType.url
Fixed Value	`randomisationType`
86. Extension.extension:randomisationType.value[x]
Definition	The type of randomisation to be used (e.g., simple randomisation, block randomisation)
Short	C223137 Randomisation Type
Comments	this is just a text description - implementers may want to provide a value set that tehe text can be drawn from.
Type	Choice of: string, CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
88. Extension.extension:otherInterventionAssignmentMethod
Slice Name	otherInterventionAssignmentMethod
Control	1..1
Must Support	true
90. Extension.extension:otherInterventionAssignmentMethod.extension
Control	0..0
92. Extension.extension:otherInterventionAssignmentMethod.url
Fixed Value	`otherInterventionAssignmentMethod`
94. Extension.extension:otherInterventionAssignmentMethod.value[x]
Definition	If applicable, describe the other intervention assignment method.
Short	C223138 Other Intervention Assignment Method}
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
96. Extension.extension:stratificationIndicator
Slice Name	stratificationIndicator
Control	1..1
Must Support	true
98. Extension.extension:stratificationIndicator.extension
Control	0..0
100. Extension.extension:stratificationIndicator.url
Fixed Value	`stratificationIndicator`
102. Extension.extension:stratificationIndicator.value[x]
Short	C223136 Stratification Indicator
Binding	The codes SHALL be taken from ICH M11 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
104. Extension.extension:siteDistribution
Slice Name	siteDistribution
Control	1..1
Must Support	true
106. Extension.extension:siteDistribution.extension
Control	0..0
108. Extension.extension:siteDistribution.url
Fixed Value	`siteDistribution`
110. Extension.extension:siteDistribution.value[x]
Definition	An indication as to whether the occurrence applies to a single or multiple trial sites.
Short	C217049 Site Distribution
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteDistribution-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
112. Extension.extension:siteGeographicScope
Slice Name	siteGeographicScope
Control	1..1
Must Support	true
114. Extension.extension:siteGeographicScope.extension
Control	0..0
116. Extension.extension:siteGeographicScope.url
Fixed Value	`siteGeographicScope`
118. Extension.extension:siteGeographicScope.value[x]
Definition	An indication as to whether the trial is taking place in one or more countries.
Short	C217050: Site geographic scope
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteGeographicscope-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
120. Extension.extension:masterProtocolIndicator
Slice Name	masterProtocolIndicator
Control	1..1
Must Support	true
122. Extension.extension:masterProtocolIndicator.extension
Control	0..0
124. Extension.extension:masterProtocolIndicator.url
Fixed Value	`masterProtocolIndicator`
126. Extension.extension:masterProtocolIndicator.value[x]
Definition	An indication as to whether the protocol is a master protocol.
Short	C217046 Master Protocol Indicator
Binding	The codes SHALL be taken from ICH M11 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
128. Extension.extension:drug-DeviceCombinationProductIndicator
Slice Name	drug-DeviceCombinationProductIndicator
Control	1..1
Must Support	true
130. Extension.extension:drug-DeviceCombinationProductIndicator.extension
Control	0..0
132. Extension.extension:drug-DeviceCombinationProductIndicator.url
Fixed Value	`drug-DeviceCombinationProductIndicator`
134. Extension.extension:drug-DeviceCombinationProductIndicator.value[x]
Definition	An indication as to whether the clinical trial is testing a drug-device combination product.
Short	C217046 Drug-Device Combination Product Indicator
Binding	The codes SHALL be taken from ICH M11 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
136. Extension.extension:adaptiveTrialDesignIndicator
Slice Name	adaptiveTrialDesignIndicator
Control	1..1
Must Support	true
138. Extension.extension:adaptiveTrialDesignIndicator.extension
Control	0..0
140. Extension.extension:adaptiveTrialDesignIndicator.url
Fixed Value	`adaptiveTrialDesignIndicator`
142. Extension.extension:adaptiveTrialDesignIndicator.value[x]
Definition	An indication as to whether the clinical trial uses an adaptive trial design.
Short	C217046 Adaptive Trial Design Indicator
Binding	The codes SHALL be taken from ICH M11 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
144. Extension.extension:numberOfArms
Slice Name	numberOfArms
Control	1..1
Must Support	true
146. Extension.extension:numberOfArms.extension
Control	0..0
148. Extension.extension:numberOfArms.url
Fixed Value	`numberOfArms`
150. Extension.extension:numberOfArms.value[x]
Definition	The planned number of intervention groups.
Short	C98771 Number of Arms
Type	integer
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
152. Extension.extension:trialBlindSchema
Slice Name	trialBlindSchema
Control	1..1
Must Support	true
154. Extension.extension:trialBlindSchema.extension
Control	0..0
156. Extension.extension:trialBlindSchema.url
Fixed Value	`trialBlindSchema`
158. Extension.extension:trialBlindSchema.value[x]
Definition	The type of experimental design used to describe the level of awareness of the trial participants and/ or personnel as it relates to the respective intervention(s) or assessments being observed, received or administered.
Short	C217051 Trial Blind Schema
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-trialBlindSchema-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
160. Extension.extension:blindedRoles
Slice Name	blindedRoles
Control	1..1
Must Support	true
162. Extension.extension:blindedRoles.extension
Control	0..0
164. Extension.extension:blindedRoles.url
Fixed Value	`blindedRoles`
166. Extension.extension:blindedRoles.value[x]
Definition	An identifying designation assigned to a blinded individual within a clinical trial that corresponds with their function
Short	C217281: Blinded Roles
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blindedRoles-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
168. Extension.extension:targetOrMaximum
Slice Name	targetOrMaximum
Control	1..1
Must Support	true
170. Extension.extension:targetOrMaximum.extension
Control	0..0
172. Extension.extension:targetOrMaximum.url
Fixed Value	`targetOrMaximum`
174. Extension.extension:targetOrMaximum.value[x]
Definition	A characterisation or classification of the trial participant numbers as to whether the numbers reflect a target or maximum.
Short	Target-Maximum
Comments	The ICH spec has this as optional boilerplate text but it has to be a variable to be processable
Binding	The codes SHALL be taken from UDP ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-target-Maximum-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
176. Extension.extension:numberOfParticipants
Slice Name	numberOfParticipants
Control	1..1
Must Support	true
178. Extension.extension:numberOfParticipants.extension
Control	0..0
180. Extension.extension:numberOfParticipants.url
Fixed Value	`numberOfParticipants`
182. Extension.extension:numberOfParticipants.value[x]
Definition	The planned number of participant be entered in a clinical trial.
Short	C49692 Number of Participants
Type	integer
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
184. Extension.extension:totalPlannedDurationOfTrialIntervention
Slice Name	totalPlannedDurationOfTrialIntervention
Control	1..1
186. Extension.extension:totalPlannedDurationOfTrialIntervention.extension
Control	0..0
188. Extension.extension:totalPlannedDurationOfTrialIntervention.url
Fixed Value	`totalPlannedDurationOfTrialIntervention`
190. Extension.extension:totalPlannedDurationOfTrialIntervention.value[x]
Definition	The total planned duration of trial intervention
Short	C218712/C218713 total planned duration of trial intervention value/units
Type	time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
192. Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime
Slice Name	totalPlannedDurationOfTrialInterventionUnitOfTime
Control	1..1
194. Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime.url
Fixed Value	`totalPlannedDurationOfTrialInterventionUnitOfTime`
196. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention
Slice Name	alternateDescriptionOfPlannedDurationOfTrialIntervention
Control	1..1
198. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.extension
Control	0..0
200. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.url
Fixed Value	`alternateDescriptionOfPlannedDurationOfTrialIntervention`
202. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.value[x]
Definition	An alternative textual narrative for the planned duration of trial intervention.
Short	C218714 alternate description of planned duration of trial intervention if duration will vary
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
204. Extension.extension:totalPlannedDurationOfTrialParticipation
Slice Name	totalPlannedDurationOfTrialParticipation
Control	1..1
206. Extension.extension:totalPlannedDurationOfTrialParticipation.extension
Control	0..0
208. Extension.extension:totalPlannedDurationOfTrialParticipation.url
Fixed Value	`totalPlannedDurationOfTrialParticipation`
210. Extension.extension:totalPlannedDurationOfTrialParticipation.value[x]
Definition	The total planned duration of trial participation
Short	C218715/C218716 total planned duration of trial participation value/units
Type	time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
212. Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime
Slice Name	totalPlannedDurationOfTrialParticipationUnitOfTime
Control	1..1
214. Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime.url
Fixed Value	`totalPlannedDurationOfTrialParticipationUnitOfTime`
216. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation
Slice Name	alternateDescriptionOfPlannedDurationOfTrialParticipation
Control	1..1
218. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.extension
Control	0..0
220. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.url
Fixed Value	`alternateDescriptionOfPlannedDurationOfTrialParticipation`
222. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.value[x]
Definition	An alternative narrative for the planned duration of trial participation.
Short	C218717 alternate description of planned duration of trial participation if duration will vary
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
224. Extension.extension:additionalDescriptionofDuration
Slice Name	additionalDescriptionofDuration
Control	1..1
226. Extension.extension:additionalDescriptionofDuration.extension
Control	0..0
228. Extension.extension:additionalDescriptionofDuration.url
Fixed Value	`additionalDescriptionofDuration`
230. Extension.extension:additionalDescriptionofDuration.value[x]
Definition	A narrative providing additional details about the duration of an participant's use of a trial intervention or their planned participation time in the trial.
Short	C218838 Additional Description of Duration
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
232. Extension.extension:independentCommittees
Slice Name	independentCommittees
Control	1..1
Must Support	true
234. Extension.extension:independentCommittees.extension
Control	0..0
236. Extension.extension:independentCommittees.url
Fixed Value	`independentCommittees`
238. Extension.extension:independentCommittees.value[x]
Definition	An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities.
Short	C217282 Independent Committees
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-independentCommittees-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
240. Extension.extension:otherCommittees
Slice Name	otherCommittees
Control	1..*
242. Extension.extension:otherCommittees.extension
Control	0..0
244. Extension.extension:otherCommittees.url
Fixed Value	`otherCommittees`
246. Extension.extension:otherCommittees.value[x]
Definition	A committee that is different than the one(s) previously specified or mentioned.
Short	C218719 Other Committees
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
248. Extension.extension:trialSchema
Slice Name	trialSchema
Control	1..1
Must Support	true
250. Extension.extension:trialSchema.extension
Control	0..0
252. Extension.extension:trialSchema.url
Fixed Value	`trialSchema`
254. Extension.extension:trialSchema.value[x]
Definition	A diagram that outlines the decision points (e.g. randomisation, response evaluation) that define the different paths a participant could take through the trial.
Short	C93682 Trial Schema
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
256. Extension.extension:schemaNotes
Slice Name	schemaNotes
Control	1..1
258. Extension.extension:schemaNotes.extension
Control	0..0
260. Extension.extension:schemaNotes.url
Fixed Value	`schemaNotes`
262. Extension.extension:schemaNotes.value[x]
Definition	A brief written record describing the trial schematic.
Short	C218720 Schema Notes
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
264. Extension.extension:scheduleofActivities
Slice Name	scheduleofActivities
Control	1..1
Must Support	true
266. Extension.extension:scheduleofActivities.extension
Control	0..0
268. Extension.extension:scheduleofActivities.url
Fixed Value	`scheduleofActivities`
270. Extension.extension:scheduleofActivities.value[x]
Definition	The schedule of activities captures the procedures that will be accomplished at each trial visit, contact with participants. A tabular format is recommended.
Short	C132349 Schedule of Activities
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
272. Extension.url
Fixed Value	`http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary`
274. Extension.value[x]
Control	0..0

Guidance on how to interpret the contents of this table can be foundhere

0. Extension
Definition	Representation of summary of a study protocol.
Short	Summary of a protocol
Comments	This is Section 1 of the ICH Technical Summary and Guideline.
Control	0..*
Is Modifier	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
2. Extension.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
4. Extension.extension
Definition	An Extension
Short	Extension
Control	36..*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
6. Extension.extension:objectiveAndEstimandSummary
Slice Name	objectiveAndEstimandSummary
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
8. Extension.extension:objectiveAndEstimandSummary.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
10. Extension.extension:objectiveAndEstimandSummary.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
12. Extension.extension:objectiveAndEstimandSummary.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`objectiveAndEstimandSummary`
14. Extension.extension:objectiveAndEstimandSummary.value[x]
Definition	A descriptive summary of the primary and secondary objectives and their associated estimands related to the trial.
Short	C218839 Primary and Secondary Objectives and Estimands
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: markdown, string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
16. Extension.extension:interventionModel
Slice Name	interventionModel
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
18. Extension.extension:interventionModel.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
20. Extension.extension:interventionModel.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
22. Extension.extension:interventionModel.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`interventionModel`
24. Extension.extension:interventionModel.value[x]
Definition	The overall design configuration for assigning intervention to participants.
Short	C217277 Intervention Model
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 Intervention Model Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionModel-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
26. Extension.extension:populationType
Slice Name	populationType
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
28. Extension.extension:populationType.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
30. Extension.extension:populationType.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
32. Extension.extension:populationType.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`populationType`
34. Extension.extension:populationType.value[x]
Definition	A characterisation or classification of the trial population.
Short	C217278 Population Type
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-populationType-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
36. Extension.extension:controlType
Slice Name	controlType
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
38. Extension.extension:controlType.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
40. Extension.extension:controlType.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
42. Extension.extension:controlType.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`controlType`
44. Extension.extension:controlType.value[x]
Definition	A characterization or classification of the comparator against which the study intervention is evaluated.
Short	C217279 Control Type
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-controlType-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
46. Extension.extension:populationDiagnosisOrCondition
Slice Name	populationDiagnosisOrCondition
Definition	An Extension
Short	Extension
Control	1..*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
48. Extension.extension:populationDiagnosisOrCondition.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
50. Extension.extension:populationDiagnosisOrCondition.extension
Definition	May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	Additional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
52. Extension.extension:populationDiagnosisOrCondition.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`populationDiagnosisOrCondition`
54. Extension.extension:populationDiagnosisOrCondition.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: 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
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
56. Extension.extension:comparator
Slice Name	comparator
Definition	An Extension
Short	Extension
Control	1..*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
58. Extension.extension:comparator.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
60. Extension.extension:comparator.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
62. Extension.extension:comparator.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`comparator`
64. Extension.extension:comparator.value[x]
Definition	The comparator against which the study intervention is evaluated.
Short	Comparator
Comments	M11 CC97054 requires on a narrative representation of the comparator - the name.
Control	0..1 This element is affected by the following invariants: ext-1
Type	Reference(MedicinalProductDefinition)
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
66. Extension.extension:minimumAge
Slice Name	minimumAge
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
68. Extension.extension:minimumAge.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
70. Extension.extension:minimumAge.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
72. Extension.extension:minimumAge.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`minimumAge`
74. Extension.extension:minimumAge.value[x]
Definition	The anticipated minimum age of the participants to be entered in a clinical trial.
Short	C49693/C25301 Minimum Age value/units
Control	0..1 This element is affected by the following invariants: ext-1
Type	Quantity
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
76. Extension.extension:unitsOfMinimumAge
Slice Name	unitsOfMinimumAge
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
78. Extension.extension:unitsOfMinimumAge.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
80. Extension.extension:unitsOfMinimumAge.extension
Definition	May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	Additional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
82. Extension.extension:unitsOfMinimumAge.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`unitsOfMinimumAge`
84. Extension.extension:unitsOfMinimumAge.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: 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
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
86. Extension.extension:maximumAge
Slice Name	maximumAge
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
88. Extension.extension:maximumAge.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
90. Extension.extension:maximumAge.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
92. Extension.extension:maximumAge.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`maximumAge`
94. Extension.extension:maximumAge.value[x]
Definition	The anticipated maximum age of the participants to be entered in a clinical trial.
Short	C49694/C25301 Minimum Age value/units
Control	0..1 This element is affected by the following invariants: ext-1
Type	Quantity
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
96. Extension.extension:unitsOfMaximumAge
Slice Name	unitsOfMaximumAge
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
98. Extension.extension:unitsOfMaximumAge.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
100. Extension.extension:unitsOfMaximumAge.extension
Definition	May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	Additional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
102. Extension.extension:unitsOfMaximumAge.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`unitsOfMaximumAge`
104. Extension.extension:unitsOfMaximumAge.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: 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
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
106. Extension.extension:interventionAssignmentMethod
Slice Name	interventionAssignmentMethod
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
108. Extension.extension:interventionAssignmentMethod.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
110. Extension.extension:interventionAssignmentMethod.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
112. Extension.extension:interventionAssignmentMethod.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`interventionAssignmentMethod`
114. Extension.extension:interventionAssignmentMethod.value[x]
Definition	The process used to assign trial participants to a trial intervention or trial arm.
Short	C217280 Intervention Assignment Method
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionAssignmentMethod-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
116. Extension.extension:randomisationType
Slice Name	randomisationType
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
118. Extension.extension:randomisationType.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
120. Extension.extension:randomisationType.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
122. Extension.extension:randomisationType.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`randomisationType`
124. Extension.extension:randomisationType.value[x]
Definition	The type of randomisation to be used (e.g., simple randomisation, block randomisation)
Short	C223137 Randomisation Type
Comments	this is just a text description - implementers may want to provide a value set that tehe text can be drawn from.
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: string, CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
126. Extension.extension:otherInterventionAssignmentMethod
Slice Name	otherInterventionAssignmentMethod
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
128. Extension.extension:otherInterventionAssignmentMethod.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
130. Extension.extension:otherInterventionAssignmentMethod.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
132. Extension.extension:otherInterventionAssignmentMethod.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`otherInterventionAssignmentMethod`
134. Extension.extension:otherInterventionAssignmentMethod.value[x]
Definition	If applicable, describe the other intervention assignment method.
Short	C223138 Other Intervention Assignment Method}
Control	0..1 This element is affected by the following invariants: ext-1
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
136. Extension.extension:stratificationIndicator
Slice Name	stratificationIndicator
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
138. Extension.extension:stratificationIndicator.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
140. Extension.extension:stratificationIndicator.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
142. Extension.extension:stratificationIndicator.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`stratificationIndicator`
144. Extension.extension:stratificationIndicator.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	C223136 Stratification Indicator
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
146. Extension.extension:siteDistribution
Slice Name	siteDistribution
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
148. Extension.extension:siteDistribution.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
150. Extension.extension:siteDistribution.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
152. Extension.extension:siteDistribution.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`siteDistribution`
154. Extension.extension:siteDistribution.value[x]
Definition	An indication as to whether the occurrence applies to a single or multiple trial sites.
Short	C217049 Site Distribution
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteDistribution-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
156. Extension.extension:siteGeographicScope
Slice Name	siteGeographicScope
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
158. Extension.extension:siteGeographicScope.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
160. Extension.extension:siteGeographicScope.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
162. Extension.extension:siteGeographicScope.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`siteGeographicScope`
164. Extension.extension:siteGeographicScope.value[x]
Definition	An indication as to whether the trial is taking place in one or more countries.
Short	C217050: Site geographic scope
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteGeographicscope-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
166. Extension.extension:masterProtocolIndicator
Slice Name	masterProtocolIndicator
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
168. Extension.extension:masterProtocolIndicator.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
170. Extension.extension:masterProtocolIndicator.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
172. Extension.extension:masterProtocolIndicator.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`masterProtocolIndicator`
174. Extension.extension:masterProtocolIndicator.value[x]
Definition	An indication as to whether the protocol is a master protocol.
Short	C217046 Master Protocol Indicator
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
176. Extension.extension:drug-DeviceCombinationProductIndicator
Slice Name	drug-DeviceCombinationProductIndicator
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
178. Extension.extension:drug-DeviceCombinationProductIndicator.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
180. Extension.extension:drug-DeviceCombinationProductIndicator.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
182. Extension.extension:drug-DeviceCombinationProductIndicator.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`drug-DeviceCombinationProductIndicator`
184. Extension.extension:drug-DeviceCombinationProductIndicator.value[x]
Definition	An indication as to whether the clinical trial is testing a drug-device combination product.
Short	C217046 Drug-Device Combination Product Indicator
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
186. Extension.extension:adaptiveTrialDesignIndicator
Slice Name	adaptiveTrialDesignIndicator
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
188. Extension.extension:adaptiveTrialDesignIndicator.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
190. Extension.extension:adaptiveTrialDesignIndicator.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
192. Extension.extension:adaptiveTrialDesignIndicator.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`adaptiveTrialDesignIndicator`
194. Extension.extension:adaptiveTrialDesignIndicator.value[x]
Definition	An indication as to whether the clinical trial uses an adaptive trial design.
Short	C217046 Adaptive Trial Design Indicator
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
196. Extension.extension:numberOfArms
Slice Name	numberOfArms
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
198. Extension.extension:numberOfArms.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
200. Extension.extension:numberOfArms.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
202. Extension.extension:numberOfArms.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`numberOfArms`
204. Extension.extension:numberOfArms.value[x]
Definition	The planned number of intervention groups.
Short	C98771 Number of Arms
Control	0..1 This element is affected by the following invariants: ext-1
Type	integer
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
206. Extension.extension:trialBlindSchema
Slice Name	trialBlindSchema
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
208. Extension.extension:trialBlindSchema.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
210. Extension.extension:trialBlindSchema.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
212. Extension.extension:trialBlindSchema.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`trialBlindSchema`
214. Extension.extension:trialBlindSchema.value[x]
Definition	The type of experimental design used to describe the level of awareness of the trial participants and/ or personnel as it relates to the respective intervention(s) or assessments being observed, received or administered.
Short	C217051 Trial Blind Schema
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-trialBlindSchema-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
216. Extension.extension:blindedRoles
Slice Name	blindedRoles
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
218. Extension.extension:blindedRoles.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
220. Extension.extension:blindedRoles.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
222. Extension.extension:blindedRoles.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`blindedRoles`
224. Extension.extension:blindedRoles.value[x]
Definition	An identifying designation assigned to a blinded individual within a clinical trial that corresponds with their function
Short	C217281: Blinded Roles
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blindedRoles-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
226. Extension.extension:targetOrMaximum
Slice Name	targetOrMaximum
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
228. Extension.extension:targetOrMaximum.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
230. Extension.extension:targetOrMaximum.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
232. Extension.extension:targetOrMaximum.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`targetOrMaximum`
234. Extension.extension:targetOrMaximum.value[x]
Definition	A characterisation or classification of the trial participant numbers as to whether the numbers reflect a target or maximum.
Short	Target-Maximum
Comments	The ICH spec has this as optional boilerplate text but it has to be a variable to be processable
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from UDP ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-target-Maximum-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
236. Extension.extension:numberOfParticipants
Slice Name	numberOfParticipants
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
238. Extension.extension:numberOfParticipants.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
240. Extension.extension:numberOfParticipants.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
242. Extension.extension:numberOfParticipants.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`numberOfParticipants`
244. Extension.extension:numberOfParticipants.value[x]
Definition	The planned number of participant be entered in a clinical trial.
Short	C49692 Number of Participants
Control	0..1 This element is affected by the following invariants: ext-1
Type	integer
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
246. Extension.extension:totalPlannedDurationOfTrialIntervention
Slice Name	totalPlannedDurationOfTrialIntervention
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
248. Extension.extension:totalPlannedDurationOfTrialIntervention.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
250. Extension.extension:totalPlannedDurationOfTrialIntervention.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
252. Extension.extension:totalPlannedDurationOfTrialIntervention.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`totalPlannedDurationOfTrialIntervention`
254. Extension.extension:totalPlannedDurationOfTrialIntervention.value[x]
Definition	The total planned duration of trial intervention
Short	C218712/C218713 total planned duration of trial intervention value/units
Control	0..1 This element is affected by the following invariants: ext-1
Type	time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
256. Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime
Slice Name	totalPlannedDurationOfTrialInterventionUnitOfTime
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
258. Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
260. Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime.extension
Definition	May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	Additional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
262. Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`totalPlannedDurationOfTrialInterventionUnitOfTime`
264. Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: 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
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
266. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention
Slice Name	alternateDescriptionOfPlannedDurationOfTrialIntervention
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
268. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
270. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
272. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`alternateDescriptionOfPlannedDurationOfTrialIntervention`
274. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.value[x]
Definition	An alternative textual narrative for the planned duration of trial intervention.
Short	C218714 alternate description of planned duration of trial intervention if duration will vary
Control	0..1 This element is affected by the following invariants: ext-1
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
276. Extension.extension:totalPlannedDurationOfTrialParticipation
Slice Name	totalPlannedDurationOfTrialParticipation
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
278. Extension.extension:totalPlannedDurationOfTrialParticipation.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
280. Extension.extension:totalPlannedDurationOfTrialParticipation.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
282. Extension.extension:totalPlannedDurationOfTrialParticipation.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`totalPlannedDurationOfTrialParticipation`
284. Extension.extension:totalPlannedDurationOfTrialParticipation.value[x]
Definition	The total planned duration of trial participation
Short	C218715/C218716 total planned duration of trial participation value/units
Control	0..1 This element is affected by the following invariants: ext-1
Type	time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
286. Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime
Slice Name	totalPlannedDurationOfTrialParticipationUnitOfTime
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
288. Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
290. Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime.extension
Definition	May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	Additional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
292. Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`totalPlannedDurationOfTrialParticipationUnitOfTime`
294. Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: 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
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
296. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation
Slice Name	alternateDescriptionOfPlannedDurationOfTrialParticipation
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
298. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
300. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
302. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`alternateDescriptionOfPlannedDurationOfTrialParticipation`
304. Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.value[x]
Definition	An alternative narrative for the planned duration of trial participation.
Short	C218717 alternate description of planned duration of trial participation if duration will vary
Control	0..1 This element is affected by the following invariants: ext-1
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
306. Extension.extension:additionalDescriptionofDuration
Slice Name	additionalDescriptionofDuration
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
308. Extension.extension:additionalDescriptionofDuration.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
310. Extension.extension:additionalDescriptionofDuration.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
312. Extension.extension:additionalDescriptionofDuration.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`additionalDescriptionofDuration`
314. Extension.extension:additionalDescriptionofDuration.value[x]
Definition	A narrative providing additional details about the duration of an participant's use of a trial intervention or their planned participation time in the trial.
Short	C218838 Additional Description of Duration
Control	0..1 This element is affected by the following invariants: ext-1
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
316. Extension.extension:independentCommittees
Slice Name	independentCommittees
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
318. Extension.extension:independentCommittees.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
320. Extension.extension:independentCommittees.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
322. Extension.extension:independentCommittees.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`independentCommittees`
324. Extension.extension:independentCommittees.value[x]
Definition	An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities.
Short	C217282 Independent Committees
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 ... (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-independentCommittees-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
326. Extension.extension:otherCommittees
Slice Name	otherCommittees
Definition	An Extension
Short	Extension
Control	1..*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
328. Extension.extension:otherCommittees.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
330. Extension.extension:otherCommittees.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
332. Extension.extension:otherCommittees.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`otherCommittees`
334. Extension.extension:otherCommittees.value[x]
Definition	A committee that is different than the one(s) previously specified or mentioned.
Short	C218719 Other Committees
Control	0..1 This element is affected by the following invariants: ext-1
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
336. Extension.extension:trialSchema
Slice Name	trialSchema
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
338. Extension.extension:trialSchema.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
340. Extension.extension:trialSchema.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
342. Extension.extension:trialSchema.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`trialSchema`
344. Extension.extension:trialSchema.value[x]
Definition	A diagram that outlines the decision points (e.g. randomisation, response evaluation) that define the different paths a participant could take through the trial.
Short	C93682 Trial Schema
Control	0..1 This element is affected by the following invariants: ext-1
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
346. Extension.extension:schemaNotes
Slice Name	schemaNotes
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
348. Extension.extension:schemaNotes.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
350. Extension.extension:schemaNotes.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
352. Extension.extension:schemaNotes.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`schemaNotes`
354. Extension.extension:schemaNotes.value[x]
Definition	A brief written record describing the trial schematic.
Short	C218720 Schema Notes
Control	0..1 This element is affected by the following invariants: ext-1
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
356. Extension.extension:scheduleofActivities
Slice Name	scheduleofActivities
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
358. Extension.extension:scheduleofActivities.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
360. Extension.extension:scheduleofActivities.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
362. Extension.extension:scheduleofActivities.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`scheduleofActivities`
364. Extension.extension:scheduleofActivities.value[x]
Definition	The schedule of activities captures the procedures that will be accomplished at each trial visit, contact with participants. A tabular format is recommended.
Short	C132349 Schedule of Activities
Control	0..1 This element is affected by the following invariants: ext-1
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
366. Extension.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary`
368. Extension.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..0 This element is affected by the following invariants: ext-1
Type	Choice of: 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
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)