Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 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())`)