Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
| Page standards status: Draft | Maturity Level: 1 |
Definitions for the research-study-study-amendment extension.
Guidance on how to interpret the contents of this table can be found here
| 0. Extension | |
| Definition | An amendment to a study protocol. |
| Short | An amendment to a study protocol |
| 2. Extension.extension:details | |
| Slice Name | details |
| Control | 0..1 |
| 4. Extension.extension:details.extension | |
| Control | 0..0 |
| 6. Extension.extension:details.url | |
| Fixed Value | details |
| 8. Extension.extension:details.value[x] | |
| Definition | Statement regarding prior amendments. |
| Short | Statement regarding prior amendments |
| Comments | State {Not applicable. This protocol has not been amended.} or state {This protocol has been amended previously. Details of prior amendments are presented in Prior Protocol Amendment(s).} or include Current Amendment details as appropriate (See instructions). |
| 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 |
| 10. Extension.extension:scope | |
| Slice Name | scope |
| Control | 0..1 |
| 12. Extension.extension:scope.extension | |
| Control | 0..0 |
| 14. Extension.extension:scope.url | |
| Fixed Value | scope |
| 16. Extension.extension:scope.value[x] | |
| Definition | Global, Coutnry, Region, or Site. |
| Short | Global, Coutnry, Region, or Site |
| 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). |
| 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 |
| 18. Extension.extension:description | |
| Slice Name | description |
| Control | 0..1 |
| 20. Extension.extension:description.extension | |
| Control | 0..0 |
| 22. Extension.extension:description.url | |
| Fixed Value | description |
| 24. Extension.extension:description.value[x] | |
| Definition | Description. |
| Short | Description |
| 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 |
| 26. Extension.extension:rationale | |
| Slice Name | rationale |
| Control | 0..1 |
| 28. Extension.extension:rationale.extension | |
| Control | 0..0 |
| 30. Extension.extension:rationale.url | |
| Fixed Value | rationale |
| 32. Extension.extension:rationale.value[x] | |
| Definition | Rationale. |
| Short | Rationale |
| Type | string |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 34. Extension.extension:substantialImpactSafety | |
| Slice Name | substantialImpactSafety |
| Control | 0..1 |
| 36. Extension.extension:substantialImpactSafety.extension | |
| Control | 0..0 |
| 38. Extension.extension:substantialImpactSafety.url | |
| Fixed Value | substantialImpactSafety |
| 40. Extension.extension:substantialImpactSafety.value[x] | |
| Definition | Substantial impact on safety. |
| Short | Substantial impact on safety |
| Type | boolean |
| [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 |
| 42. Extension.extension:substantialImpactSafetyComment | |
| Slice Name | substantialImpactSafetyComment |
| Control | 0..1 |
| 44. Extension.extension:substantialImpactSafetyComment.extension | |
| Control | 0..0 |
| 46. Extension.extension:substantialImpactSafetyComment.url | |
| Fixed Value | substantialImpactSafetyComment |
| 48. 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 |
| 50. Extension.extension:substantialImpactReliability | |
| Slice Name | substantialImpactReliability |
| Control | 0..1 |
| 52. Extension.extension:substantialImpactReliability.extension | |
| Control | 0..0 |
| 54. Extension.extension:substantialImpactReliability.url | |
| Fixed Value | substantialImpactReliability |
| 56. Extension.extension:substantialImpactReliability.value[x] | |
| Definition | Substantial impact on reliability. |
| Short | Substantial impact on reliability |
| Type | boolean |
| [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 |
| 58. Extension.extension:substantialImpactReliabilityComment | |
| Slice Name | substantialImpactReliabilityComment |
| Control | 0..1 |
| 60. Extension.extension:substantialImpactReliabilityComment.extension | |
| Control | 0..0 |
| 62. Extension.extension:substantialImpactReliabilityComment.url | |
| Fixed Value | substantialImpactReliabilityComment |
| 64. 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 |
| 66. Extension.extension:primaryReason | |
| Slice Name | primaryReason |
| Control | 0..1 |
| 68. Extension.extension:primaryReason.extension | |
| Control | 0..0 |
| 70. Extension.extension:primaryReason.url | |
| Fixed Value | primaryReason |
| 72. Extension.extension:primaryReason.value[x] | |
| Definition | Reason for amendment, e.g. Safety. |
| Short | Reason for amendment, e.g. Safety |
| Type | CodeableConcept |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| 74. Extension.url | |
| Fixed Value | http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment |
| 76. Extension.value[x] | |
| Control | 0..0 |
Guidance on how to interpret the contents of this table can be found here
| 0. Extension | |
| Definition | An amendment to a study protocol. Optional Extension Element - found in all resources. |
| Short | An amendment to a study protocolOptional Extensions Element |
| Control | 0..* |
| Is Modifier | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 2. Extension.extension:details | |
| Slice Name | details |
| 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())) |
| 4. Extension.extension:details.extension | |
| Definition | An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | ExtensionAdditional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 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: |
| 6. Extension.extension:details.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | details |
| 8. Extension.extension:details.value[x] | |
| Definition | Statement regarding prior amendments. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Statement regarding prior amendmentsValue of extension |
| Comments | State {Not applicable. This protocol has not been amended.} or state {This protocol has been amended previously. Details of prior amendments are presented in Prior Protocol Amendment(s).} or include Current Amendment details as appropriate (See instructions). |
| Control | 0..1 This element is affected by the following invariants: ext-1 |
| 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 10. Extension.extension:scope | |
| Slice Name | scope |
| 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())) |
| 12. 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: |
| 14. 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 | false |
| Fixed Value | scope |
| 16. Extension.extension:scope.value[x] | |
| Definition | Global, Coutnry, Region, or Site. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Global, Coutnry, Region, or SiteValue 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 |
| 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 18. 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())) |
| 20. 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: |
| 22. 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 | false |
| Fixed Value | description |
| 24. Extension.extension:description.value[x] | |
| Definition | Description. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | DescriptionValue of extension |
| Control | 0..1 This element is affected by the following invariants: ext-1 |
| Type | 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 26. 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())) |
| 28. 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: |
| 30. 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 | false |
| Fixed Value | rationale |
| 32. Extension.extension:rationale.value[x] | |
| Definition | Rationale. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | RationaleValue of extension |
| Control | 0..1 This element is affected by the following invariants: ext-1 |
| Type | string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 34. 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())) |
| 36. 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: |
| 38. 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 | false |
| Fixed Value | substantialImpactSafety |
| 40. 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 |
| Type | boolean, 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, 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 42. 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())) |
| 44. 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: |
| 46. 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 | false |
| Fixed Value | substantialImpactSafetyComment |
| 48. 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 50. 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())) |
| 52. 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: |
| 54. 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 | false |
| Fixed Value | substantialImpactReliability |
| 56. 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 |
| Type | boolean, 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, 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 58. 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())) |
| 60. 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: |
| 62. 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 | false |
| Fixed Value | substantialImpactReliabilityComment |
| 64. 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 66. 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())) |
| 68. 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: |
| 70. 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 | false |
| Fixed Value | primaryReason |
| 72. 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 |
| 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 74. 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 | false |
| Fixed Value | http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment |
| 76. 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 | false |
| 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 found here
| 0. Extension | |
| Definition | An amendment to a study protocol. |
| Short | An amendment to a study protocol |
| Control | 0..* |
| Is Modifier | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2. Extension.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | id |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 4. Extension.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on Extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 6. Extension.extension:details | |
| Slice Name | details |
| 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())) |
| 8. Extension.extension:details.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | id |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 10. Extension.extension:details.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:details.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | details |
| 14. Extension.extension:details.value[x] | |
| Definition | Statement regarding prior amendments. |
| Short | Statement regarding prior amendments |
| Comments | State {Not applicable. This protocol has not been amended.} or state {This protocol has been amended previously. Details of prior amendments are presented in Prior Protocol Amendment(s).} or include Current Amendment details as appropriate (See instructions). |
| Control | 0..1 This element is affected by the following invariants: ext-1 |
| 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 16. Extension.extension:scope | |
| Slice Name | scope |
| Definition | An Extension |
| Short | Extension |
| Control | 0..1 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 18. Extension.extension: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 |
| 20. 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: |
| 22. 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 | false |
| Fixed Value | scope |
| 24. Extension.extension:scope.value[x] | |
| Definition | Global, Coutnry, Region, or Site. |
| Short | Global, Coutnry, Region, or Site |
| 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 |
| 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 26. 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())) |
| 28. 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 |
| 30. 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: |
| 32. 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 | false |
| Fixed Value | description |
| 34. Extension.extension:description.value[x] | |
| Definition | Description. |
| Short | Description |
| 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 36. 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())) |
| 38. 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 |
| 40. 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: |
| 42. 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 | false |
| Fixed Value | rationale |
| 44. Extension.extension:rationale.value[x] | |
| Definition | Rationale. |
| Short | Rationale |
| Control | 0..1 This element is affected by the following invariants: ext-1 |
| Type | string |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 46. 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())) |
| 48. 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 |
| 50. 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: |
| 52. 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 | false |
| Fixed Value | substantialImpactSafety |
| 54. 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 |
| Type | boolean |
| [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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 56. 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())) |
| 58. 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 |
| 60. 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: |
| 62. 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 | false |
| Fixed Value | substantialImpactSafetyComment |
| 64. 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 66. 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())) |
| 68. 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 |
| 70. 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: |
| 72. 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 | false |
| Fixed Value | substantialImpactReliability |
| 74. 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 |
| Type | boolean |
| [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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 76. 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())) |
| 78. 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 |
| 80. 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: |
| 82. 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 | false |
| Fixed Value | substantialImpactReliabilityComment |
| 84. 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 86. Extension.extension:primaryReason | |
| Slice Name | primaryReason |
| Definition | An Extension |
| Short | Extension |
| Control | 0..1 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 88. Extension.extension: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 |
| 90. 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: |
| 92. 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 | false |
| Fixed Value | primaryReason |
| 94. 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 |
| Type | CodeableConcept |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| 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.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 | false |
| Fixed Value | http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment |
| 98. 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 | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-11-01
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