Pharmaceutical Research Protocol (Vulcan UDP), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions
Page standards status: Trial-use | Maturity Level: 1 |
Definitions for the protocol-amendment extension.
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 | 10..* |
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: |
4. Extension.extension:scope | |
Slice Name | scope |
Definition | An Extension |
Short | ExtensionAdditional content defined by implementations |
Control | 10..1* |
Type | Extension |
Is Modifier | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
6. 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: |
8. 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 |
10. 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 Study Amendment Scope Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-scope-vs ) |
Type | code, 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, 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())) |
12. 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())) |
14. 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: |
16. 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 |
18. 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 Study Amendment Country Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs ) |
Type | code, 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, 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())) |
20. 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())) |
22. 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: |
24. 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 |
26. 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 Study Amendment Country Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs ) |
Type | code, 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, 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())) |
28. 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())) |
30. 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: |
32. 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 |
34. 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 | 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())) |
36. 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())) |
38. 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: |
40. 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 |
42. 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())) |
44. 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())) |
46. 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: |
48. 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 |
50. 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 |
Comments | //TODO Need to review the example |
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())) |
52. 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())) |
54. 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: |
56. 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 |
58. 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 | 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())) |
60. 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())) |
62. 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: |
64. 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 |
66. 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())) |
68. 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(ResearchStudyStudyAmendmentScopeImpact) (Complex Extension) |
Is Modifier | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
70. Extension.extension:primaryReason | |
Slice Name | primaryReason |
Definition | An Extension |
Short | ExtensionAdditional content defined by implementations |
Control | 0..1* |
Type | Extension |
Is Modifier | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
72. 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: |
74. 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 |
76. 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 Study Amendment Reason Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-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())) |
78. Extension.extension:secondaryReason | |
Slice Name | secondaryReason |
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())) |
80. 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: |
82. 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 |
84. 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 Study Amendment Reason Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-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())) |
86. Extension.extension:summary | |
Slice Name | summary |
Definition | An Extension |
Short | ExtensionAdditional content defined by implementations |
Control | 0..1* |
Type | Extension |
Is Modifier | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
88. 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: |
90. 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 |
92. 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())) |
94. Extension.extension:substantialImpactSafety | |
Slice Name | substantialImpactSafety |
Definition | An Extension |
Short | ExtensionAdditional content defined by implementations |
Control | 0..1* |
Type | Extension |
Is Modifier | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
96. 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: |
98. 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 |
100. 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 CDISC Yes No Unknown Not Applicable Value Set (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs ) |
Type | code, 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, 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())) |
102. Extension.extension:substantialImpactSafetyComment | |
Slice Name | substantialImpactSafetyComment |
Definition | An Extension |
Short | ExtensionAdditional content defined by implementations |
Control | 0..1* |
Type | Extension |
Is Modifier | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
104. 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: |
106. 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 |
108. 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())) |
110. 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())) |
112. 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: |
114. 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 |
116. 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 CDISC Yes No Unknown Not Applicable Value Set (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs ) |
Type | code, 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, 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())) |
118. 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())) |
120. 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: |
122. 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 |
124. 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())) |
126. 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(ResearchStudyStudyAmendmentDetails) (Complex Extension) |
Is Modifier | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
128. 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())) |
130. 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: |
132. 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 |
134. 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())) |
136. 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())) |
138. 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: |
140. 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 |
142. 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 | 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())) |
144. 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/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment |
146. 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 | 1..? |
4. Extension.extension:scope | |
Slice Name | scope |
Control | 1..1 |
6. Extension.extension:scope.extension | |
Control | 0..0 |
8. Extension.extension:scope.url | |
Fixed Value | scope |
10. 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 Study Amendment Scope Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-scope-vs ) |
Type | code |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
12. Extension.extension:country | |
Slice Name | country |
Control | 0..* |
14. Extension.extension:country.extension | |
Control | 0..0 |
16. Extension.extension:country.url | |
Fixed Value | country |
18. Extension.extension:country.value[x] | |
Definition | C20108 |
Binding | Unless not suitable, these codes SHALL be taken from Study Amendment Country Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs ) |
Type | code |
[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 |
20. Extension.extension:region | |
Slice Name | region |
Control | 0..* |
22. Extension.extension:region.extension | |
Control | 0..0 |
24. Extension.extension:region.url | |
Fixed Value | region |
26. Extension.extension:region.value[x] | |
Definition | C218674 |
Binding | Unless not suitable, these codes SHALL be taken from Study Amendment Country Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs ) |
Type | code |
[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 |
28. Extension.extension:site | |
Slice Name | site |
Control | 0..* |
30. Extension.extension:site.extension | |
Control | 0..0 |
32. Extension.extension:site.url | |
Fixed Value | site |
34. Extension.extension:site.value[x] | |
Definition | C83081 |
Type | Identifier |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
36. Extension.extension:approvalDate | |
Slice Name | approvalDate |
Control | 0..1 |
38. Extension.extension:approvalDate.extension | |
Control | 0..0 |
40. Extension.extension:approvalDate.url | |
Fixed Value | approvalDate |
42. 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 |
44. Extension.extension:signature | |
Slice Name | signature |
Control | 0..1 |
46. Extension.extension:signature.extension | |
Control | 0..0 |
48. Extension.extension:signature.url | |
Fixed Value | signature |
50. Extension.extension:signature.value[x] | |
Comments | //TODO Need to review the example |
Type | Signature |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
52. Extension.extension:signatureURL | |
Slice Name | signatureURL |
Control | 0..1 |
54. Extension.extension:signatureURL.extension | |
Control | 0..0 |
56. Extension.extension:signatureURL.url | |
Fixed Value | signatureURL |
58. Extension.extension:signatureURL.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 |
60. Extension.extension:signatureMethod | |
Slice Name | signatureMethod |
Control | 0..1 |
62. Extension.extension:signatureMethod.extension | |
Control | 0..0 |
64. Extension.extension:signatureMethod.url | |
Fixed Value | signatureMethod |
66. 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 |
68. Extension.extension:scopeImpact | |
Slice Name | scopeImpact |
Control | 0..3 |
Type | Extension(ResearchStudyStudyAmendmentScopeImpact) (Complex Extension) |
70. Extension.extension:primaryReason | |
Slice Name | primaryReason |
Control | 0..1 |
72. Extension.extension:primaryReason.extension | |
Control | 0..0 |
74. Extension.extension:primaryReason.url | |
Fixed Value | primaryReason |
76. 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 Study Amendment Reason Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs ) |
Type | CodeableConcept |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
78. Extension.extension:secondaryReason | |
Slice Name | secondaryReason |
Control | 0..1 |
80. Extension.extension:secondaryReason.extension | |
Control | 0..0 |
82. Extension.extension:secondaryReason.url | |
Fixed Value | secondaryReason |
84. 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 Study Amendment Reason Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs ) |
Type | CodeableConcept |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
86. Extension.extension:summary | |
Slice Name | summary |
Control | 0..1 |
88. Extension.extension:summary.extension | |
Control | 0..0 |
90. Extension.extension:summary.url | |
Fixed Value | summary |
92. 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 |
94. Extension.extension:substantialImpactSafety | |
Slice Name | substantialImpactSafety |
Control | 0..1 |
96. Extension.extension:substantialImpactSafety.extension | |
Control | 0..0 |
98. Extension.extension:substantialImpactSafety.url | |
Fixed Value | substantialImpactSafety |
100. Extension.extension:substantialImpactSafety.value[x] | |
Definition | Substantial impact on safety. |
Short | Substantial impact on safety |
Binding | The codes SHALL be taken from CDISC Yes No Unknown Not Applicable Value Set (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs ) |
Type | code |
[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 |
102. Extension.extension:substantialImpactSafetyComment | |
Slice Name | substantialImpactSafetyComment |
Control | 0..1 |
104. Extension.extension:substantialImpactSafetyComment.extension | |
Control | 0..0 |
106. Extension.extension:substantialImpactSafetyComment.url | |
Fixed Value | substantialImpactSafetyComment |
108. 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 |
110. Extension.extension:substantialImpactReliability | |
Slice Name | substantialImpactReliability |
Control | 0..1 |
112. Extension.extension:substantialImpactReliability.extension | |
Control | 0..0 |
114. Extension.extension:substantialImpactReliability.url | |
Fixed Value | substantialImpactReliability |
116. Extension.extension:substantialImpactReliability.value[x] | |
Definition | Substantial impact on reliability. |
Short | Substantial impact on reliability |
Binding | The codes SHALL be taken from CDISC Yes No Unknown Not Applicable Value Set (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs ) |
Type | code |
[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 |
118. Extension.extension:substantialImpactReliabilityComment | |
Slice Name | substantialImpactReliabilityComment |
Control | 0..1 |
120. Extension.extension:substantialImpactReliabilityComment.extension | |
Control | 0..0 |
122. Extension.extension:substantialImpactReliabilityComment.url | |
Fixed Value | substantialImpactReliabilityComment |
124. 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 |
126. Extension.extension:details | |
Slice Name | details |
Control | 0..* |
Type | Extension(ResearchStudyStudyAmendmentDetails) (Complex Extension) |
128. Extension.extension:rationale | |
Slice Name | rationale |
Control | 0..1 |
130. Extension.extension:rationale.extension | |
Control | 0..0 |
132. Extension.extension:rationale.url | |
Fixed Value | rationale |
134. 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 |
136. Extension.extension:description | |
Slice Name | description |
Control | 0..1 |
138. Extension.extension:description.extension | |
Control | 0..0 |
140. Extension.extension:description.url | |
Fixed Value | description |
142. Extension.extension:description.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 |
144. Extension.url | |
Fixed Value | http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment |
146. 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 | 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()) ) |
Slicing | This element introduces a set of slices on Extension.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
6. Extension.extension:scope | |
Slice Name | scope |
Definition | An Extension |
Short | Extension |
Control | 1..1 |
Type | Extension |
Is Modifier | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
8. 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 |
10. 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: |
12. 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 |
14. 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 Study Amendment Scope Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-scope-vs ) |
Type | code |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
16. Extension.extension: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()) ) |
18. 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 |
20. 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: |
22. 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 |
24. 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 Study Amendment Country Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs ) |
Type | code |
[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()) ) |
26. 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()) ) |
28. 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 |
30. 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: |
32. 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 |
34. 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 Study Amendment Country Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs ) |
Type | code |
[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()) ) |
36. 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()) ) |
38. 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 |
40. 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: |
42. 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 |
44. 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 | 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()) ) |
46. 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()) ) |
48. 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 |
50. 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: |
52. 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 |
54. 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()) ) |
56. 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()) ) |
58. 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 |
60. 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: |
62. 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 |
64. 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 |
Comments | //TODO Need to review the example |
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()) ) |
66. 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()) ) |
68. 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 |
70. 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: |
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 | 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()) ) |
76. 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()) ) |
78. 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 |
80. 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: |
82. 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 |
84. 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()) ) |
86. 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(ResearchStudyStudyAmendmentScopeImpact) (Complex Extension) |
Is Modifier | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
88. Extension.extension:primaryReason | |
Slice Name | primaryReason |
Definition | An Extension |
Short | Extension |
Control | 0..1 |
Type | Extension |
Is Modifier | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
90. 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 |
92. 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: |
94. 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 |
96. 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 Study Amendment Reason Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-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()) ) |
98. Extension.extension:secondaryReason | |
Slice Name | secondaryReason |
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()) ) |
100. 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 |
102. 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: |
104. 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 |
106. 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 Study Amendment Reason Value Set (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-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()) ) |
108. Extension.extension:summary | |
Slice Name | summary |
Definition | An Extension |
Short | Extension |
Control | 0..1 |
Type | Extension |
Is Modifier | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
110. 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 |
112. 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: |
114. 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 |
116. 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()) ) |
118. Extension.extension:substantialImpactSafety | |
Slice Name | substantialImpactSafety |
Definition | An Extension |
Short | Extension |
Control | 0..1 |
Type | Extension |
Is Modifier | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
120. 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 |
122. 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: |
124. 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 |
126. 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 CDISC Yes No Unknown Not Applicable Value Set (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs ) |
Type | code |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
128. Extension.extension:substantialImpactSafetyComment | |
Slice Name | substantialImpactSafetyComment |
Definition | An Extension |
Short | Extension |
Control | 0..1 |
Type | Extension |
Is Modifier | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
130. 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 |
132. 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: |
134. 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 |
136. 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()) ) |
138. 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()) ) |
140. 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 |
142. 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: |
144. 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 |
146. 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 CDISC Yes No Unknown Not Applicable Value Set (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs ) |
Type | code |
[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()) ) |
148. 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()) ) |
150. 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 |
152. 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: |
154. 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 |
156. 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()) ) |
158. 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(ResearchStudyStudyAmendmentDetails) (Complex Extension) |
Is Modifier | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
160. 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()) ) |
162. 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 |
164. 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: |
166. 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 |
168. 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()) ) |
170. 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()) ) |
172. 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 |
174. 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: |
176. 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 |
178. 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 | 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()) ) |
180. 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/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment |
182. 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()) ) |