M11_ProtocolAmendment - Clinical Study Protocol v1.0.0-ballot2

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

Extension: M11_ProtocolAmendment - Detailed Descriptions

Page standards status: Trial-use

Maturity Level: 2

Definitions for the m11-protocol-amendment extension

Key Elements Table
Differential Table
Snapshot Table

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

0. Extension
Definition	Representation of amendments to a study protocol. Optional Extension Element - found in all resources.
Short	Amendment to a protocol - from EBMOptional Extensions Element
Comments	The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases.
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 areUnordered 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 areUnordered 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	`identifier`
10. Extension.extension:identifier.value[x]
Definition	Identifier for this amendment - if it is the current amendment the identifier is repeated from the title page 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, 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 areUnordered 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	`previous`
18. Extension.extension:previous.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from For codes, see ICH M11 Amendment Details Statement Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Extension.extension:scope
Slice Name	scope
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Extension.extension: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 areUnordered 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	`scope`
26. Extension.extension:scope.value[x]
Definition	C218673 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, Not GlobalValue of extension
Comments	If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. If amending a single-country study, enter global. If the amendment does not apply to all sites in the trial, select Not Global and utilize one of the identifiers based on amendment scope. Use the ISO-3166 region or country identifier (for example, DE or EU).
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 Amendment Scope Value Set Terminology (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Extension.extension: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 areUnordered 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	`country`
34. Extension.extension:country.value[x]
Definition	C20108 Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	Unless not suitable, these codes SHALL be taken from For codes, see ICH M11 Study Amendment Country Value Set (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. Extension.extension: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 areUnordered 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	`region`
42. Extension.extension:region.value[x]
Definition	C218674 Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	Unless not suitable, these codes SHALL be taken from For codes, see ICH M11 Study Amendment Country Value Set (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
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 areUnordered 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	`site`
50. Extension.extension:site.value[x]
Definition	C83081 Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: Identifier, Reference, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
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 areUnordered 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	`approvalDate`
58. Extension.extension:approvalDate.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, 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 areUnordered 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	`signature`
66. Extension.extension:signature.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Signature, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, 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 areUnordered 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	`signatureUrl`
74. Extension.extension:signatureUrl.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: string, url, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, 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 areUnordered 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	`signatureMethod`
82. Extension.extension:signatureMethod.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. Extension.extension:scopeImpact
Slice Name	scopeImpact
Definition	Provides number or percentage of each group affected by a single amendment
Short	Extension
Control	0..3
Type	Extension(M11_AmendmentScopeImpact) (Complex Extension)
Is Modifier	false
Must Support	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
86. Extension.extension:primaryReason
Slice Name	primaryReason
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. Extension.extension: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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
90. 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	`primaryReason`
92. 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 Terminology (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. Extension.extension:secondaryReason
Slice Name	secondaryReason
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
96. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
98. 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	`secondaryReason`
100. Extension.extension:secondaryReason.value[x]
Definition	Reason for amendment, e.g. Manufacturing change. 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. Manufacturing changeValue 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 Terminology (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
102. Extension.extension:summary
Slice Name	summary
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
104. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
106. 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	`summary`
108. Extension.extension:summary.value[x]
Definition	Summary of amendmets. 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, 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()))
110. Extension.extension:substantialImpactSafety
Slice Name	substantialImpactSafety
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
112. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
114. 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	`substantialImpactSafety`
116. 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 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
118. Extension.extension:substantialImpactSafetyComment
Slice Name	substantialImpactSafetyComment
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
120. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
122. 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	`substantialImpactSafetyComment`
124. 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, 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()))
126. 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()))
128. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
130. 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	`substantialImpactReliability`
132. 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 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
134. 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()))
136. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
138. 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	`substantialImpactReliabilityComment`
140. 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, 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()))
142. Extension.extension:details
Slice Name	details
Definition	Provides detail of a single amendment - repeats within the overal amendment report
Short	Extension
Control	0..*
Type	Extension(M11_AmendmentDetails) (Complex Extension)
Is Modifier	false
Must Support	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
144. 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()))
146. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
148. 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	`rationale`
150. Extension.extension:rationale.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
152. 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()))
154. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
156. 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	`description`
158. Extension.extension:description.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: markdown, string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
160. Extension.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment`
162. Extension.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..01 This element is affected by the following invariants: ext-1
Type	Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

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

0. Extension
Definition	Representation of amendments to a study protocol.
Short	Amendment to a protocol - from EBM
Comments	The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases.
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	`identifier`
10. Extension.extension:identifier.value[x]
Definition	Identifier for this amendment - if it is the current amendment the identifier is repeated from the title page
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	`previous`
18. Extension.extension:previous.value[x]
Binding	The codes SHALL be taken from ICH M11 Amendment Details Statement Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs`)
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
Must Support	true
22. Extension.extension:scope.extension
Control	0..0
24. Extension.extension:scope.url
Fixed Value	`scope`
26. Extension.extension:scope.value[x]
Definition	C218673 Global, Country, Region, or Site.
Short	Global, Not Global
Comments	If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. If amending a single-country study, enter global. If the amendment does not apply to all sites in the trial, select Not Global and utilize one of the identifiers based on amendment scope. Use the ISO-3166 region or country identifier (for example, DE or EU).
Binding	Unless not suitable, these codes SHALL be taken from ICH M11 Amendment Scope Value Set Terminology (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs`)
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	`country`
34. Extension.extension:country.value[x]
Definition	C20108
Binding	Unless not suitable, these codes SHALL be taken from ICH M11 Study Amendment Country Value Set (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs`)
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	`region`
42. Extension.extension:region.value[x]
Definition	C218674
Binding	Unless not suitable, these codes SHALL be taken from ICH M11 Study Amendment Country Value Set (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs`)
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	`site`
50. Extension.extension:site.value[x]
Definition	C83081
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	`approvalDate`
58. Extension.extension:approvalDate.value[x]
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	`signature`
66. Extension.extension:signature.value[x]
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	`signatureUrl`
74. Extension.extension:signatureUrl.value[x]
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	`signatureMethod`
82. Extension.extension:signatureMethod.value[x]
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(M11_AmendmentScopeImpact) (Complex Extension)
Must Support	true
86. Extension.extension:primaryReason
Slice Name	primaryReason
Control	0..1
Must Support	true
88. Extension.extension:primaryReason.extension
Control	0..0
90. Extension.extension:primaryReason.url
Fixed Value	`primaryReason`
92. 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 Terminology (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
94. Extension.extension:secondaryReason
Slice Name	secondaryReason
Control	0..*
Must Support	true
96. Extension.extension:secondaryReason.extension
Control	0..0
98. Extension.extension:secondaryReason.url
Fixed Value	`secondaryReason`
100. Extension.extension:secondaryReason.value[x]
Definition	Reason for amendment, e.g. Manufacturing change.
Short	Reason for amendment, e.g. Manufacturing change
Binding	Unless not suitable, these codes SHALL be taken from ICH M11 Reason for Amendment Value Set Terminology (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
102. Extension.extension:summary
Slice Name	summary
Control	0..1
Must Support	true
104. Extension.extension:summary.extension
Control	0..0
106. Extension.extension:summary.url
Fixed Value	`summary`
108. Extension.extension:summary.value[x]
Definition	Summary of amendmets.
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
110. Extension.extension:substantialImpactSafety
Slice Name	substantialImpactSafety
Control	0..1
Must Support	true
112. Extension.extension:substantialImpactSafety.extension
Control	0..0
114. Extension.extension:substantialImpactSafety.url
Fixed Value	`substantialImpactSafety`
116. Extension.extension:substantialImpactSafety.value[x]
Definition	Substantial impact on safety.
Short	Substantial impact on safety
Binding	The codes SHALL be taken from ICH M11 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
118. Extension.extension:substantialImpactSafetyComment
Slice Name	substantialImpactSafetyComment
Control	0..1
Must Support	true
120. Extension.extension:substantialImpactSafetyComment.extension
Control	0..0
122. Extension.extension:substantialImpactSafetyComment.url
Fixed Value	`substantialImpactSafetyComment`
124. 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
126. Extension.extension:substantialImpactReliability
Slice Name	substantialImpactReliability
Control	0..1
128. Extension.extension:substantialImpactReliability.extension
Control	0..0
130. Extension.extension:substantialImpactReliability.url
Fixed Value	`substantialImpactReliability`
132. Extension.extension:substantialImpactReliability.value[x]
Definition	Substantial impact on reliability.
Short	Substantial impact on reliability
Binding	The codes SHALL be taken from ICH M11 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
134. Extension.extension:substantialImpactReliabilityComment
Slice Name	substantialImpactReliabilityComment
Control	0..1
136. Extension.extension:substantialImpactReliabilityComment.extension
Control	0..0
138. Extension.extension:substantialImpactReliabilityComment.url
Fixed Value	`substantialImpactReliabilityComment`
140. 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
142. Extension.extension:details
Slice Name	details
Control	0..*
Type	Extension(M11_AmendmentDetails) (Complex Extension)
Must Support	true
144. Extension.extension:rationale
Slice Name	rationale
Control	0..1
146. Extension.extension:rationale.extension
Control	0..0
148. Extension.extension:rationale.url
Fixed Value	`rationale`
150. Extension.extension:rationale.value[x]
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
152. Extension.extension:description
Slice Name	description
Control	0..1
154. Extension.extension:description.extension
Control	0..0
156. Extension.extension:description.url
Fixed Value	`description`
158. Extension.extension:description.value[x]
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
160. Extension.url
Fixed Value	`http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment`
162. Extension.value[x]
Control	0..0

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

0. Extension
Definition	Representation of amendments to a study protocol.
Short	Amendment to a protocol - from EBM
Comments	The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases.
Control	0..*
Is Modifier	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
2. Extension.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
4. Extension.extension
Definition	An Extension
Short	Extension
Control	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 areUnordered 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	id
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 areUnordered 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	`identifier`
14. Extension.extension:identifier.value[x]
Definition	Identifier for this amendment - if it is the current amendment the identifier is repeated from the title page
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	id
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 areUnordered 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	`previous`
24. Extension.extension:previous.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHALL be taken from ICH M11 Amendment Details Statement Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
26. Extension.extension:scope
Slice Name	scope
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
28. Extension.extension: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	id
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 areUnordered 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	`scope`
34. Extension.extension:scope.value[x]
Definition	C218673 Global, Country, Region, or Site.
Short	Global, Not Global
Comments	If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. If amending a single-country study, enter global. If the amendment does not apply to all sites in the trial, select Not Global and utilize one of the identifiers based on amendment scope. Use the ISO-3166 region or country identifier (for example, DE or EU).
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 Amendment Scope Value Set Terminology (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
36. Extension.extension: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	id
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 areUnordered 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	`country`
44. Extension.extension:country.value[x]
Definition	C20108
Short	Value 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 ICH M11 Study Amendment Country Value Set (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
46. Extension.extension: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	id
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 areUnordered 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	`region`
54. Extension.extension:region.value[x]
Definition	C218674
Short	Value 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 ICH M11 Study Amendment Country Value Set (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
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	id
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 areUnordered 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	`site`
64. Extension.extension:site.value[x]
Definition	C83081
Short	Value of extension
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	id
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 areUnordered 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	`approvalDate`
74. Extension.extension:approvalDate.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	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	id
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 areUnordered 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	`signature`
84. Extension.extension:signature.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	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	id
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 areUnordered 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	`signatureUrl`
94. Extension.extension:signatureUrl.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: 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	id
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 areUnordered 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	`signatureMethod`
104. Extension.extension:signatureMethod.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	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	Extension
Control	0..3
Type	Extension(M11_AmendmentScopeImpact) (Complex Extension)
Is Modifier	false
Must Support	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
108. Extension.extension:primaryReason
Slice Name	primaryReason
Definition	An Extension
Short	Extension
Control	0..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
110. 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	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
112. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
114. 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	`primaryReason`
116. 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 Terminology (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
118. Extension.extension:secondaryReason
Slice Name	secondaryReason
Definition	An Extension
Short	Extension
Control	0..*
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
120. 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	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
122. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
124. 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	`secondaryReason`
126. Extension.extension:secondaryReason.value[x]
Definition	Reason for amendment, e.g. Manufacturing change.
Short	Reason for amendment, e.g. Manufacturing change
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 Terminology (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
128. Extension.extension:summary
Slice Name	summary
Definition	An Extension
Short	Extension
Control	0..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
130. Extension.extension: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	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
132. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
134. 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	`summary`
136. Extension.extension:summary.value[x]
Definition	Summary of amendmets.
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())`)
138. Extension.extension:substantialImpactSafety
Slice Name	substantialImpactSafety
Definition	An Extension
Short	Extension
Control	0..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
140. 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	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
142. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
144. 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	`substantialImpactSafety`
146. 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 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
148. Extension.extension:substantialImpactSafetyComment
Slice Name	substantialImpactSafetyComment
Definition	An Extension
Short	Extension
Control	0..1
Type	Extension
Is Modifier	false
Must Support	true
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
150. 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	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
152. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
154. 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	`substantialImpactSafetyComment`
156. 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())`)
158. 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())`)
160. 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	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
162. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
164. 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	`substantialImpactReliability`
166. 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 No Yes Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
168. 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())`)
170. 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	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
172. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
174. 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	`substantialImpactReliabilityComment`
176. 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())`)
178. Extension.extension:details
Slice Name	details
Definition	Provides detail of a single amendment - repeats within the overal amendment report
Short	Extension
Control	0..*
Type	Extension(M11_AmendmentDetails) (Complex Extension)
Is Modifier	false
Must Support	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
180. 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())`)
182. 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	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
184. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
186. 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	`rationale`
188. Extension.extension:rationale.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	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())`)
190. 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())`)
192. 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	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
194. 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 areUnordered and Open, and can be differentiated using the following discriminators: value @ url
196. 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	`description`
198. Extension.extension:description.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Choice of: 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())`)
200. Extension.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	true
Fixed Value	`http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment`
202. Extension.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..0 This element is affected by the following invariants: ext-1
Type	Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	true
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)