ResearchStudyM11ProtocolAmendment - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot3

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

Extension: ResearchStudyM11ProtocolAmendment - Detailed Descriptions

Page standards status: Trial-use

Maturity Level: 1

Definitions for the research-study-m11-protocol-amendment extension

Key Elements Table
Differential Table
Snapshot Table

See the documentation on how to interpret the contents of this table

0. Extension
Definition	An amendment to a study protocol. Optional Extension Element - found in all resources.
Short	An amendment to a study protocolOptional Extensions Element
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	20..*
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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
4. Extension.extension:identifier
Slice Name	identifier
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()))
6. Extension.extension:identifier.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
8. Extension.extension:identifier.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	`{ "url" : "identifier" }` `<url value="identifier"/>`
10. Extension.extension:identifier.value[x]
Definition	Amendment identifier. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Amendment identifierValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Identifier, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, VirtualServiceDetail, 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
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Extension.extension:previous
Slice Name	previous
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..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()))
14. Extension.extension:previous.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
16. Extension.extension:previous.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	`{ "url" : "previous" }` `<url value="previous"/>`
18. Extension.extension:previous.value[x]
Definition	Statement regarding prior amendments. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Statement regarding prior amendmentsValue of extension
Comments	State {Not applicable. This protocol has not been amended.} or state {This protocol has been amended previously. Details of prior amendments are presented in Prior Protocol Amendment(s).} or include Current Amendment details as appropriate (See instructions).
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 Amendment Details Statement Value Set (required to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-details-statement`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, VirtualServiceDetail, 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:scope
Slice Name	scope
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()))
22. Extension.extension:scope.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
24. Extension.extension:scope.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	`{ "url" : "scope" }` `<url value="scope"/>`
26. Extension.extension:scope.value[x]
Definition	Global or Not Global (Country, Region, or Site). Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Global or Not GlobalValue 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 Amendment Scope Value Set (required to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, VirtualServiceDetail, 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:country
Slice Name	country
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	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()))
30. Extension.extension:country.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
32. Extension.extension:country.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	`{ "url" : "country" }` `<url value="country"/>`
34. Extension.extension:country.value[x]
Definition	Country. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	CountryValue of extension
Comments	Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; country/region codes. ICH M11 Study Amendment Country Value Set posted at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-country-region-vs.html.
Control	0..1 This element is affected by the following invariants: ext-1
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, VirtualServiceDetail, 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:region
Slice Name	region
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	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()))
38. Extension.extension:region.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
40. Extension.extension:region.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	`{ "url" : "region" }` `<url value="region"/>`
42. Extension.extension:region.value[x]
Definition	Region. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	RegionValue of extension
Comments	Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; country/region codes. ICH M11 Study Amendment Country Value Set posted at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-country-region-vs.html.
Control	0..1 This element is affected by the following invariants: ext-1
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, VirtualServiceDetail, 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()))
44. Extension.extension:site
Slice Name	site
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	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()))
46. Extension.extension:site.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
48. Extension.extension:site.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	`{ "url" : "site" }` `<url value="site"/>`
50. Extension.extension:site.value[x]
Definition	Site. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	SiteValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: Identifier, Reference, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, VirtualServiceDetail, 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()))
52. Extension.extension:approvalDate
Slice Name	approvalDate
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..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()))
54. Extension.extension:approvalDate.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
56. Extension.extension:approvalDate.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	`{ "url" : "approvalDate" }` `<url value="approvalDate"/>`
58. Extension.extension:approvalDate.value[x]
Definition	Approval date. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Approval dateValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, VirtualServiceDetail, 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()))
60. Extension.extension:signature
Slice Name	signature
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..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()))
62. Extension.extension:signature.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
64. Extension.extension:signature.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	`{ "url" : "signature" }` `<url value="signature"/>`
66. Extension.extension:signature.value[x]
Definition	Signature. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	SignatureValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Signature, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, VirtualServiceDetail, 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, 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:signatureUrl
Slice Name	signatureUrl
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..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()))
70. Extension.extension:signatureUrl.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
72. Extension.extension:signatureUrl.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	`{ "url" : "signatureUrl" }` `<url value="signatureUrl"/>`
74. Extension.extension:signatureUrl.value[x]
Definition	Signature URL. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Signature URLValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: string, url, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, VirtualServiceDetail, 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, 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()))
76. Extension.extension:signatureMethod
Slice Name	signatureMethod
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..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()))
78. Extension.extension:signatureMethod.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
80. Extension.extension:signatureMethod.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	`{ "url" : "signatureMethod" }` `<url value="signatureMethod"/>`
82. Extension.extension:signatureMethod.value[x]
Definition	Signature Method. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Signature MethodValue 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, VirtualServiceDetail, 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()))
84. Extension.extension:scopeImpact
Slice Name	scopeImpact
Definition	Provides number or percentage of each group affected by a single amendment.
Short	Provides number or percentage of each group affected by a single amendment
Control	0..3
Type	Extension(M11AmendmentScopeImpact) (Complex Extension)
Is Modifier	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
86. Extension.extension:scopeImpact.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	20..*
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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
88. Extension.extension:scopeImpact.extension:number
Slice Name	number
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()))
90. Extension.extension:scopeImpact.extension:number.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.extension`. The slices are Unordered and Open, and can be differentiated using the following discriminators: value @ url
92. Extension.extension:scopeImpact.extension:number.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	`{ "url" : "number" }` `<url value="number"/>`
94. Extension.extension:scopeImpact.extension:scope
Slice Name	scope
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()))
96. Extension.extension:scopeImpact.extension:scope.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.extension`. The slices are Unordered and Open, and can be differentiated using the following discriminators: value @ url
98. Extension.extension:scopeImpact.extension:scope.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	`{ "url" : "scope" }` `<url value="scope"/>`
100. Extension.extension:scopeImpact.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	`{ "url" : "scopeImpact" }` `<url value="scopeImpact"/>`
102. Extension.extension:scopeImpact.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, VirtualServiceDetail, 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()))
104. Extension.extension:primaryReason
Slice Name	primaryReason
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..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()))
106. Extension.extension:primaryReason.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
108. Extension.extension:primaryReason.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	`{ "url" : "primaryReason" }` `<url value="primaryReason"/>`
110. Extension.extension:primaryReason.value[x]
Definition	Reason for amendment, e.g. Safety. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Reason for amendment, e.g. SafetyValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	Unless not suitable, these codes SHALL be taken from For codes, see ICH M11 Reason for Amendment Value Set (extensible to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, VirtualServiceDetail, 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:secondaryReason
Slice Name	secondaryReason
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	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()))
114. Extension.extension:secondaryReason.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
116. Extension.extension:secondaryReason.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	`{ "url" : "secondaryReason" }` `<url value="secondaryReason"/>`
118. Extension.extension:secondaryReason.value[x]
Definition	Reason for amendment, e.g. Safety. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Reason for amendment, e.g. SafetyValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	Unless not suitable, these codes SHALL be taken from For codes, see ICH M11 Reason for Amendment Value Set (extensible to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, VirtualServiceDetail, 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:summary
Slice Name	summary
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..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()))
122. Extension.extension:summary.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
124. Extension.extension:summary.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	`{ "url" : "summary" }` `<url value="summary"/>`
126. Extension.extension:summary.value[x]
Definition	Summary of changes. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Summary of changesValue 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, VirtualServiceDetail, 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()))
128. Extension.extension:substantialImpactSafety
Slice Name	substantialImpactSafety
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..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()))
130. Extension.extension:substantialImpactSafety.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
132. Extension.extension:substantialImpactSafety.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	`{ "url" : "substantialImpactSafety" }` `<url value="substantialImpactSafety"/>`
134. Extension.extension:substantialImpactSafety.value[x]
Definition	Substantial impact on safety. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Substantial impact on safetyValue 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 Yes No Value Set (required to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, VirtualServiceDetail, 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:substantialImpactSafetyComment
Slice Name	substantialImpactSafetyComment
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..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()))
138. Extension.extension:substantialImpactSafetyComment.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
140. Extension.extension:substantialImpactSafetyComment.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	`{ "url" : "substantialImpactSafetyComment" }` `<url value="substantialImpactSafetyComment"/>`
142. Extension.extension:substantialImpactSafetyComment.value[x]
Definition	Comment on substantial impact on safety. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Comment on substantial impact on safetyValue 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, VirtualServiceDetail, 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()))
144. Extension.extension:substantialImpactReliability
Slice Name	substantialImpactReliability
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..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()))
146. Extension.extension:substantialImpactReliability.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
148. Extension.extension:substantialImpactReliability.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	`{ "url" : "substantialImpactReliability" }` `<url value="substantialImpactReliability"/>`
150. Extension.extension:substantialImpactReliability.value[x]
Definition	Substantial impact on reliability. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Substantial impact on reliabilityValue 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 Yes No Value Set (required to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, VirtualServiceDetail, 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()))
152. Extension.extension:substantialImpactReliabilityComment
Slice Name	substantialImpactReliabilityComment
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..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()))
154. Extension.extension:substantialImpactReliabilityComment.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
156. Extension.extension:substantialImpactReliabilityComment.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	`{ "url" : "substantialImpactReliabilityComment" }` `<url value="substantialImpactReliabilityComment"/>`
158. Extension.extension:substantialImpactReliabilityComment.value[x]
Definition	Comment on substantial impact on reliability. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Comment on substantial impact on reliabilityValue 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, VirtualServiceDetail, 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()))
160. Extension.extension:details
Slice Name	details
Definition	Provides detail of a single change within an amendment.
Short	Provides detail of a single change within an amendment
Control	0..*
Type	Extension(M11AmendmentDetail) (Complex Extension)
Is Modifier	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
162. Extension.extension:details.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	30..*
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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
164. Extension.extension:details.extension:detail
Slice Name	detail
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()))
166. Extension.extension:details.extension:detail.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.extension`. The slices are Unordered and Open, and can be differentiated using the following discriminators: value @ url
168. Extension.extension:details.extension:detail.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	`{ "url" : "detail" }` `<url value="detail"/>`
170. Extension.extension:details.extension:rationale
Slice Name	rationale
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()))
172. Extension.extension:details.extension:rationale.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.extension`. The slices are Unordered and Open, and can be differentiated using the following discriminators: value @ url
174. Extension.extension:details.extension:rationale.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	`{ "url" : "rationale" }` `<url value="rationale"/>`
176. Extension.extension:details.extension:section
Slice Name	section
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()))
178. Extension.extension:details.extension:section.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.extension`. The slices are Unordered and Open, and can be differentiated using the following discriminators: value @ url
180. Extension.extension:details.extension:section.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	`{ "url" : "section" }` `<url value="section"/>`
182. Extension.extension:details.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	`{ "url" : "details" }` `<url value="details"/>`
184. Extension.extension:details.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, VirtualServiceDetail, 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()))
186. Extension.extension:rationale
Slice Name	rationale
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..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()))
188. Extension.extension:rationale.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
190. Extension.extension:rationale.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	`{ "url" : "rationale" }` `<url value="rationale"/>`
192. Extension.extension:rationale.value[x]
Definition	Rationale. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	RationaleValue 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, VirtualServiceDetail, 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()))
194. Extension.extension:description
Slice Name	description
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..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()))
196. Extension.extension:description.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
198. Extension.extension:description.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	`{ "url" : "description" }` `<url value="description"/>`
200. Extension.extension:description.value[x]
Definition	Description. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	DescriptionValue 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, VirtualServiceDetail, 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()))
202. 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	`{ "url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment" }` `<url value="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"/>`
204. 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, VirtualServiceDetail, 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()))

See the documentation on how to interpret the contents of this table

0. Extension
Definition	An amendment to a study protocol.
Short	An amendment to a study protocol
2. Extension.extension
Control	2..?
4. Extension.extension:identifier
Slice Name	identifier
Control	1..1
6. Extension.extension:identifier.extension
Control	0..0
8. Extension.extension:identifier.url
Fixed Value	`{ "url" : "identifier" }` `<url value="identifier"/>`
10. Extension.extension:identifier.value[x]
Definition	Amendment identifier.
Short	Amendment identifier
Type	Identifier
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
12. Extension.extension:previous
Slice Name	previous
Control	0..1
14. Extension.extension:previous.extension
Control	0..0
16. Extension.extension:previous.url
Fixed Value	`{ "url" : "previous" }` `<url value="previous"/>`
18. Extension.extension:previous.value[x]
Definition	Statement regarding prior amendments.
Short	Statement regarding prior amendments
Comments	State {Not applicable. This protocol has not been amended.} or state {This protocol has been amended previously. Details of prior amendments are presented in Prior Protocol Amendment(s).} or include Current Amendment details as appropriate (See instructions).
Binding	The codes SHALL be taken from ICH M11 Amendment Details Statement Value Set (required to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-details-statement`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
20. Extension.extension:scope
Slice Name	scope
Control	1..1
22. Extension.extension:scope.extension
Control	0..0
24. Extension.extension:scope.url
Fixed Value	`{ "url" : "scope" }` `<url value="scope"/>`
26. Extension.extension:scope.value[x]
Definition	Global or Not Global (Country, Region, or Site).
Short	Global or Not Global
Binding	The codes SHALL be taken from ICH M11 Amendment Scope Value Set (required to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
28. Extension.extension:country
Slice Name	country
Control	0..*
30. Extension.extension:country.extension
Control	0..0
32. Extension.extension:country.url
Fixed Value	`{ "url" : "country" }` `<url value="country"/>`
34. Extension.extension:country.value[x]
Definition	Country.
Short	Country
Comments	Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; country/region codes. ICH M11 Study Amendment Country Value Set posted at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-country-region-vs.html.
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
36. Extension.extension:region
Slice Name	region
Control	0..*
38. Extension.extension:region.extension
Control	0..0
40. Extension.extension:region.url
Fixed Value	`{ "url" : "region" }` `<url value="region"/>`
42. Extension.extension:region.value[x]
Definition	Region.
Short	Region
Comments	Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; country/region codes. ICH M11 Study Amendment Country Value Set posted at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-country-region-vs.html.
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
44. Extension.extension:site
Slice Name	site
Control	0..*
46. Extension.extension:site.extension
Control	0..0
48. Extension.extension:site.url
Fixed Value	`{ "url" : "site" }` `<url value="site"/>`
50. Extension.extension:site.value[x]
Definition	Site.
Short	Site
Type	Choice of: Identifier, Reference
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
52. Extension.extension:approvalDate
Slice Name	approvalDate
Control	0..1
54. Extension.extension:approvalDate.extension
Control	0..0
56. Extension.extension:approvalDate.url
Fixed Value	`{ "url" : "approvalDate" }` `<url value="approvalDate"/>`
58. Extension.extension:approvalDate.value[x]
Definition	Approval date.
Short	Approval date
Type	date
[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
60. Extension.extension:signature
Slice Name	signature
Control	0..1
62. Extension.extension:signature.extension
Control	0..0
64. Extension.extension:signature.url
Fixed Value	`{ "url" : "signature" }` `<url value="signature"/>`
66. Extension.extension:signature.value[x]
Definition	Signature.
Short	Signature
Type	Signature
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
68. Extension.extension:signatureUrl
Slice Name	signatureUrl
Control	0..1
70. Extension.extension:signatureUrl.extension
Control	0..0
72. Extension.extension:signatureUrl.url
Fixed Value	`{ "url" : "signatureUrl" }` `<url value="signatureUrl"/>`
74. Extension.extension:signatureUrl.value[x]
Definition	Signature URL.
Short	Signature URL
Type	Choice of: string, url
[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
76. Extension.extension:signatureMethod
Slice Name	signatureMethod
Control	0..1
78. Extension.extension:signatureMethod.extension
Control	0..0
80. Extension.extension:signatureMethod.url
Fixed Value	`{ "url" : "signatureMethod" }` `<url value="signatureMethod"/>`
82. Extension.extension:signatureMethod.value[x]
Definition	Signature Method.
Short	Signature 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
84. Extension.extension:scopeImpact
Slice Name	scopeImpact
Control	0..3
Type	Extension(M11AmendmentScopeImpact) (Complex Extension)
86. Extension.extension:scopeImpact.url
Fixed Value	`{ "url" : "scopeImpact" }` `<url value="scopeImpact"/>`
88. Extension.extension:primaryReason
Slice Name	primaryReason
Control	0..1
90. Extension.extension:primaryReason.extension
Control	0..0
92. Extension.extension:primaryReason.url
Fixed Value	`{ "url" : "primaryReason" }` `<url value="primaryReason"/>`
94. Extension.extension:primaryReason.value[x]
Definition	Reason for amendment, e.g. Safety.
Short	Reason for amendment, e.g. Safety
Binding	Unless not suitable, these codes SHALL be taken from ICH M11 Reason for Amendment Value Set (extensible to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
96. Extension.extension:secondaryReason
Slice Name	secondaryReason
Control	0..*
98. Extension.extension:secondaryReason.extension
Control	0..0
100. Extension.extension:secondaryReason.url
Fixed Value	`{ "url" : "secondaryReason" }` `<url value="secondaryReason"/>`
102. Extension.extension:secondaryReason.value[x]
Definition	Reason for amendment, e.g. Safety.
Short	Reason for amendment, e.g. Safety
Binding	Unless not suitable, these codes SHALL be taken from ICH M11 Reason for Amendment Value Set (extensible to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
104. Extension.extension:summary
Slice Name	summary
Control	0..1
106. Extension.extension:summary.extension
Control	0..0
108. Extension.extension:summary.url
Fixed Value	`{ "url" : "summary" }` `<url value="summary"/>`
110. Extension.extension:summary.value[x]
Definition	Summary of changes.
Short	Summary of changes
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
112. Extension.extension:substantialImpactSafety
Slice Name	substantialImpactSafety
Control	0..1
114. Extension.extension:substantialImpactSafety.extension
Control	0..0
116. Extension.extension:substantialImpactSafety.url
Fixed Value	`{ "url" : "substantialImpactSafety" }` `<url value="substantialImpactSafety"/>`
118. Extension.extension:substantialImpactSafety.value[x]
Definition	Substantial impact on safety.
Short	Substantial impact on safety
Binding	The codes SHALL be taken from ICH M11 Yes No Value Set (required to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
120. Extension.extension:substantialImpactSafetyComment
Slice Name	substantialImpactSafetyComment
Control	0..1
122. Extension.extension:substantialImpactSafetyComment.extension
Control	0..0
124. Extension.extension:substantialImpactSafetyComment.url
Fixed Value	`{ "url" : "substantialImpactSafetyComment" }` `<url value="substantialImpactSafetyComment"/>`
126. Extension.extension:substantialImpactSafetyComment.value[x]
Definition	Comment on substantial impact on safety.
Short	Comment on substantial impact on safety
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
128. Extension.extension:substantialImpactReliability
Slice Name	substantialImpactReliability
Control	0..1
130. Extension.extension:substantialImpactReliability.extension
Control	0..0
132. Extension.extension:substantialImpactReliability.url
Fixed Value	`{ "url" : "substantialImpactReliability" }` `<url value="substantialImpactReliability"/>`
134. Extension.extension:substantialImpactReliability.value[x]
Definition	Substantial impact on reliability.
Short	Substantial impact on reliability
Binding	The codes SHALL be taken from ICH M11 Yes No Value Set (required to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
136. Extension.extension:substantialImpactReliabilityComment
Slice Name	substantialImpactReliabilityComment
Control	0..1
138. Extension.extension:substantialImpactReliabilityComment.extension
Control	0..0
140. Extension.extension:substantialImpactReliabilityComment.url
Fixed Value	`{ "url" : "substantialImpactReliabilityComment" }` `<url value="substantialImpactReliabilityComment"/>`
142. Extension.extension:substantialImpactReliabilityComment.value[x]
Definition	Comment on substantial impact on reliability.
Short	Comment on substantial impact on reliability
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
144. Extension.extension:details
Slice Name	details
Control	0..*
Type	Extension(M11AmendmentDetail) (Complex Extension)
146. Extension.extension:details.url
Fixed Value	`{ "url" : "details" }` `<url value="details"/>`
148. Extension.extension:rationale
Slice Name	rationale
Control	0..1
150. Extension.extension:rationale.extension
Control	0..0
152. Extension.extension:rationale.url
Fixed Value	`{ "url" : "rationale" }` `<url value="rationale"/>`
154. Extension.extension:rationale.value[x]
Definition	Rationale.
Short	Rationale
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
156. Extension.extension:description
Slice Name	description
Control	0..1
158. Extension.extension:description.extension
Control	0..0
160. Extension.extension:description.url
Fixed Value	`{ "url" : "description" }` `<url value="description"/>`
162. Extension.extension:description.value[x]
Definition	Description.
Short	Description
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
164. Extension.url
Fixed Value	`{ "url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment" }` `<url value="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"/>`
166. Extension.value[x]
Control	0..0

See the documentation on how to interpret the contents of this table

0. Extension
Definition	An amendment to a study protocol.
Short	An amendment to a study protocol
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	string
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	2..*
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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
6. Extension.extension:identifier
Slice Name	identifier
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())`)
8. Extension.extension:identifier.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
10. Extension.extension:identifier.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
12. Extension.extension:identifier.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	`{ "url" : "identifier" }` `<url value="identifier"/>`
14. Extension.extension:identifier.value[x]
Definition	Amendment identifier.
Short	Amendment identifier
Control	0..1 This element is affected by the following invariants: ext-1
Type	Identifier
[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())`)
16. Extension.extension:previous
Slice Name	previous
Definition	An Extension
Short	Extension
Control	0..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())`)
18. Extension.extension:previous.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
20. Extension.extension:previous.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
22. Extension.extension:previous.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	`{ "url" : "previous" }` `<url value="previous"/>`
24. Extension.extension:previous.value[x]
Definition	Statement regarding prior amendments.
Short	Statement regarding prior amendments
Comments	State {Not applicable. This protocol has not been amended.} or state {This protocol has been amended previously. Details of prior amendments are presented in Prior Protocol Amendment(s).} or include Current Amendment details as appropriate (See instructions).
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 Amendment Details Statement Value Set (required to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-details-statement`)
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:scope
Slice Name	scope
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())`)
28. Extension.extension:scope.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
30. Extension.extension:scope.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
32. Extension.extension:scope.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	`{ "url" : "scope" }` `<url value="scope"/>`
34. Extension.extension:scope.value[x]
Definition	Global or Not Global (Country, Region, or Site).
Short	Global or Not Global
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 Amendment Scope Value Set (required to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope`)
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:country
Slice Name	country
Definition	An Extension
Short	Extension
Control	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())`)
38. Extension.extension:country.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
40. Extension.extension:country.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
42. Extension.extension:country.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	`{ "url" : "country" }` `<url value="country"/>`
44. Extension.extension:country.value[x]
Definition	Country.
Short	Country
Comments	Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; country/region codes. ICH M11 Study Amendment Country Value Set posted at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-country-region-vs.html.
Control	0..1 This element is affected by the following invariants: ext-1
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:region
Slice Name	region
Definition	An Extension
Short	Extension
Control	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())`)
48. Extension.extension:region.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
50. Extension.extension:region.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
52. Extension.extension:region.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	`{ "url" : "region" }` `<url value="region"/>`
54. Extension.extension:region.value[x]
Definition	Region.
Short	Region
Comments	Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; country/region codes. ICH M11 Study Amendment Country Value Set posted at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-country-region-vs.html.
Control	0..1 This element is affected by the following invariants: ext-1
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())`)
56. Extension.extension:site
Slice Name	site
Definition	An Extension
Short	Extension
Control	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())`)
58. Extension.extension:site.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
60. Extension.extension:site.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
62. Extension.extension:site.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	`{ "url" : "site" }` `<url value="site"/>`
64. Extension.extension:site.value[x]
Definition	Site.
Short	Site
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: Identifier, Reference
[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:approvalDate
Slice Name	approvalDate
Definition	An Extension
Short	Extension
Control	0..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())`)
68. Extension.extension:approvalDate.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
70. Extension.extension:approvalDate.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
72. Extension.extension:approvalDate.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	`{ "url" : "approvalDate" }` `<url value="approvalDate"/>`
74. Extension.extension:approvalDate.value[x]
Definition	Approval date.
Short	Approval date
Control	0..1 This element is affected by the following invariants: ext-1
Type	date
[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())`)
76. Extension.extension:signature
Slice Name	signature
Definition	An Extension
Short	Extension
Control	0..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())`)
78. Extension.extension:signature.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
80. Extension.extension:signature.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
82. Extension.extension:signature.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	`{ "url" : "signature" }` `<url value="signature"/>`
84. Extension.extension:signature.value[x]
Definition	Signature.
Short	Signature
Control	0..1 This element is affected by the following invariants: ext-1
Type	Signature
[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())`)
86. Extension.extension:signatureUrl
Slice Name	signatureUrl
Definition	An Extension
Short	Extension
Control	0..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())`)
88. Extension.extension:signatureUrl.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
90. Extension.extension:signatureUrl.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
92. Extension.extension:signatureUrl.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	`{ "url" : "signatureUrl" }` `<url value="signatureUrl"/>`
94. Extension.extension:signatureUrl.value[x]
Definition	Signature URL.
Short	Signature URL
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: string, url
[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:signatureMethod
Slice Name	signatureMethod
Definition	An Extension
Short	Extension
Control	0..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())`)
98. Extension.extension:signatureMethod.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
100. Extension.extension:signatureMethod.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
102. Extension.extension:signatureMethod.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	`{ "url" : "signatureMethod" }` `<url value="signatureMethod"/>`
104. Extension.extension:signatureMethod.value[x]
Definition	Signature Method.
Short	Signature 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())`)
106. Extension.extension:scopeImpact
Slice Name	scopeImpact
Definition	Provides number or percentage of each group affected by a single amendment.
Short	Provides number or percentage of each group affected by a single amendment
Control	0..3
Type	Extension(M11AmendmentScopeImpact) (Complex Extension)
Is Modifier	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
108. Extension.extension:scopeImpact.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
110. Extension.extension:scopeImpact.extension
Definition	An Extension
Short	Extension
Control	2..*
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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
112. Extension.extension:scopeImpact.extension:number
Slice Name	number
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())`)
114. Extension.extension:scopeImpact.extension:number.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
116. Extension.extension:scopeImpact.extension:number.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.extension`. The slices are Unordered and Open, and can be differentiated using the following discriminators: value @ url
118. Extension.extension:scopeImpact.extension:number.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	`{ "url" : "number" }` `<url value="number"/>`
120. Extension.extension:scopeImpact.extension:number.value[x]
Definition	Number of participants, or % of participants.
Short	Number of participants, or % of participants
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: positiveInt, Quantity
[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())`)
122. Extension.extension:scopeImpact.extension:scope
Slice Name	scope
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())`)
124. Extension.extension:scopeImpact.extension:scope.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
126. Extension.extension:scopeImpact.extension:scope.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.extension`. The slices are Unordered and Open, and can be differentiated using the following discriminators: value @ url
128. Extension.extension:scopeImpact.extension:scope.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	`{ "url" : "scope" }` `<url value="scope"/>`
130. Extension.extension:scopeImpact.extension:scope.value[x]
Definition	Global, Locally, or By Cohort.
Short	Global, Locally, or By Cohort
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 Amendment Scope Enrollment Value Set (required to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope-enrollment`)
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())`)
132. Extension.extension:scopeImpact.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	`{ "url" : "scopeImpact" }` `<url value="scopeImpact"/>`
134. Extension.extension:scopeImpact.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, VirtualServiceDetail, 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())`)
136. Extension.extension:primaryReason
Slice Name	primaryReason
Definition	An Extension
Short	Extension
Control	0..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())`)
138. Extension.extension:primaryReason.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
140. Extension.extension:primaryReason.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
142. Extension.extension:primaryReason.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	`{ "url" : "primaryReason" }` `<url value="primaryReason"/>`
144. Extension.extension:primaryReason.value[x]
Definition	Reason for amendment, e.g. Safety.
Short	Reason for amendment, e.g. Safety
Control	0..1 This element is affected by the following invariants: ext-1
Binding	Unless not suitable, these codes SHALL be taken from ICH M11 Reason for Amendment Value Set (extensible to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason`)
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:secondaryReason
Slice Name	secondaryReason
Definition	An Extension
Short	Extension
Control	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())`)
148. Extension.extension:secondaryReason.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
150. Extension.extension:secondaryReason.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
152. Extension.extension:secondaryReason.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	`{ "url" : "secondaryReason" }` `<url value="secondaryReason"/>`
154. Extension.extension:secondaryReason.value[x]
Definition	Reason for amendment, e.g. Safety.
Short	Reason for amendment, e.g. Safety
Control	0..1 This element is affected by the following invariants: ext-1
Binding	Unless not suitable, these codes SHALL be taken from ICH M11 Reason for Amendment Value Set (extensible to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason`)
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:summary
Slice Name	summary
Definition	An Extension
Short	Extension
Control	0..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())`)
158. Extension.extension:summary.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
160. Extension.extension:summary.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
162. Extension.extension:summary.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	`{ "url" : "summary" }` `<url value="summary"/>`
164. Extension.extension:summary.value[x]
Definition	Summary of changes.
Short	Summary of changes
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())`)
166. Extension.extension:substantialImpactSafety
Slice Name	substantialImpactSafety
Definition	An Extension
Short	Extension
Control	0..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())`)
168. Extension.extension:substantialImpactSafety.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
170. Extension.extension:substantialImpactSafety.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
172. Extension.extension:substantialImpactSafety.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	`{ "url" : "substantialImpactSafety" }` `<url value="substantialImpactSafety"/>`
174. Extension.extension:substantialImpactSafety.value[x]
Definition	Substantial impact on safety.
Short	Substantial impact on safety
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 Yes No Value Set (required to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no`)
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:substantialImpactSafetyComment
Slice Name	substantialImpactSafetyComment
Definition	An Extension
Short	Extension
Control	0..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())`)
178. Extension.extension:substantialImpactSafetyComment.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
180. Extension.extension:substantialImpactSafetyComment.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
182. Extension.extension:substantialImpactSafetyComment.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	`{ "url" : "substantialImpactSafetyComment" }` `<url value="substantialImpactSafetyComment"/>`
184. Extension.extension:substantialImpactSafetyComment.value[x]
Definition	Comment on substantial impact on safety.
Short	Comment on substantial impact on safety
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())`)
186. Extension.extension:substantialImpactReliability
Slice Name	substantialImpactReliability
Definition	An Extension
Short	Extension
Control	0..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())`)
188. Extension.extension:substantialImpactReliability.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
190. Extension.extension:substantialImpactReliability.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
192. Extension.extension:substantialImpactReliability.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	`{ "url" : "substantialImpactReliability" }` `<url value="substantialImpactReliability"/>`
194. Extension.extension:substantialImpactReliability.value[x]
Definition	Substantial impact on reliability.
Short	Substantial impact on reliability
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 Yes No Value Set (required to `http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no`)
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:substantialImpactReliabilityComment
Slice Name	substantialImpactReliabilityComment
Definition	An Extension
Short	Extension
Control	0..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:substantialImpactReliabilityComment.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
200. Extension.extension:substantialImpactReliabilityComment.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
202. Extension.extension:substantialImpactReliabilityComment.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	`{ "url" : "substantialImpactReliabilityComment" }` `<url value="substantialImpactReliabilityComment"/>`
204. Extension.extension:substantialImpactReliabilityComment.value[x]
Definition	Comment on substantial impact on reliability.
Short	Comment on substantial impact on reliability
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())`)
206. Extension.extension:details
Slice Name	details
Definition	Provides detail of a single change within an amendment.
Short	Provides detail of a single change within an amendment
Control	0..*
Type	Extension(M11AmendmentDetail) (Complex Extension)
Is Modifier	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
208. Extension.extension:details.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
210. Extension.extension:details.extension
Definition	An Extension
Short	Extension
Control	3..*
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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
212. Extension.extension:details.extension:detail
Slice Name	detail
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())`)
214. Extension.extension:details.extension:detail.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
216. Extension.extension:details.extension:detail.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.extension`. The slices are Unordered and Open, and can be differentiated using the following discriminators: value @ url
218. Extension.extension:details.extension:detail.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	`{ "url" : "detail" }` `<url value="detail"/>`
220. Extension.extension:details.extension:detail.value[x]
Definition	Detail of change.
Short	Detail
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, VirtualServiceDetail, 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())`)
222. Extension.extension:details.extension:rationale
Slice Name	rationale
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())`)
224. Extension.extension:details.extension:rationale.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
226. Extension.extension:details.extension:rationale.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.extension`. The slices are Unordered and Open, and can be differentiated using the following discriminators: value @ url
228. Extension.extension:details.extension:rationale.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	`{ "url" : "rationale" }` `<url value="rationale"/>`
230. Extension.extension:details.extension:rationale.value[x]
Definition	Rationale for change.
Short	Rationale
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())`)
232. Extension.extension:details.extension:section
Slice Name	section
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())`)
234. Extension.extension:details.extension:section.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
236. Extension.extension:details.extension:section.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.extension`. The slices are Unordered and Open, and can be differentiated using the following discriminators: value @ url
238. Extension.extension:details.extension:section.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	`{ "url" : "section" }` `<url value="section"/>`
240. Extension.extension:details.extension:section.value[x]
Definition	Section where the amendment was made.
Short	Section where the amendment was made
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from Limited M11 Section Codes Value Set (required to `http://hl7.org/fhir/uv/ebm/ValueSet/limited-m11-section-codes`)
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())`)
242. Extension.extension:details.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	`{ "url" : "details" }` `<url value="details"/>`
244. Extension.extension:details.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, VirtualServiceDetail, 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())`)
246. Extension.extension:rationale
Slice Name	rationale
Definition	An Extension
Short	Extension
Control	0..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:rationale.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
250. Extension.extension:rationale.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
252. Extension.extension:rationale.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	`{ "url" : "rationale" }` `<url value="rationale"/>`
254. Extension.extension:rationale.value[x]
Definition	Rationale.
Short	Rationale
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())`)
256. Extension.extension:description
Slice Name	description
Definition	An Extension
Short	Extension
Control	0..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:description.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	string
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
260. Extension.extension:description.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 are Unordered and Open, and can be differentiated using the following discriminators: value @ url
262. Extension.extension:description.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	`{ "url" : "description" }` `<url value="description"/>`
264. Extension.extension:description.value[x]
Definition	Description.
Short	Description
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())`)
266. 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	`{ "url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment" }` `<url value="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"/>`
268. 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, VirtualServiceDetail, 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())`)