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
Official URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment | Version: 2.0.0-ballot | |||
Standards status: Draft | Maturity Level: 1 | Computable Name: ResearchStudyStudyAmendment | ||
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.42.88 |
An amendment to a study protocol.
Context of Use
This extension may be used on the following element(s):
Usage info
Usage:
Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.
This structure is derived from Extension
Summary
Complex Extension: An amendment to a study protocol.
Maturity: 1
This structure is derived from Extension
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Extension | 0..* | Extension | An amendment to a study protocol | |
Slices for extension | Content/Rules for all slices | |||
extension:details | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "details" | |
value[x] | 0..1 | string | Statement regarding prior amendments | |
extension:scope | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "scope" | |
value[x] | 0..1 | string | Global, Coutnry, Region, or Site | |
extension:description | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "description" | |
value[x] | 0..1 | string | Description | |
extension:rationale | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "rationale" | |
value[x] | 0..1 | string | Rationale | |
extension:substantialImpactSafety | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactSafety" | |
value[x] | 0..1 | boolean | Substantial impact on safety | |
extension:substantialImpactSafetyComment | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactSafetyComment" | |
value[x] | 0..1 | string | Comment on substantial impact on safety | |
extension:substantialImpactReliability | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactReliability" | |
value[x] | 0..1 | boolean | Substantial impact on reliability | |
extension:substantialImpactReliabilityComment | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactReliabilityComment" | |
value[x] | 0..1 | string | Comment on substantial impact on reliability | |
extension:primaryReason | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "primaryReason" | |
value[x] | 0..1 | CodeableConcept | Reason for amendment, e.g. Safety | |
url | 1..1 | uri | "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment" | |
value[x] | 0..0 | |||
Documentation for this format |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Extension | 0..* | Extension | An amendment to a study protocol | |
id | 0..1 | id | Unique id for inter-element referencing | |
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
extension:details | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "details" | |
value[x] | 0..1 | string | Statement regarding prior amendments | |
extension:scope | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "scope" | |
value[x] | 0..1 | string | Global, Coutnry, Region, or Site | |
extension:description | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "description" | |
value[x] | 0..1 | string | Description | |
extension:rationale | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "rationale" | |
value[x] | 0..1 | string | Rationale | |
extension:substantialImpactSafety | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactSafety" | |
value[x] | 0..1 | boolean | Substantial impact on safety | |
extension:substantialImpactSafetyComment | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactSafetyComment" | |
value[x] | 0..1 | string | Comment on substantial impact on safety | |
extension:substantialImpactReliability | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactReliability" | |
value[x] | 0..1 | boolean | Substantial impact on reliability | |
extension:substantialImpactReliabilityComment | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactReliabilityComment" | |
value[x] | 0..1 | string | Comment on substantial impact on reliability | |
extension:primaryReason | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "primaryReason" | |
value[x] | 0..1 | CodeableConcept | Reason for amendment, e.g. Safety | |
url | 1..1 | uri | "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment" | |
Documentation for this format |
This structure is derived from Extension
Summary
Complex Extension: An amendment to a study protocol.
Maturity: 1
Differential View
This structure is derived from Extension
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Extension | 0..* | Extension | An amendment to a study protocol | |
Slices for extension | Content/Rules for all slices | |||
extension:details | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "details" | |
value[x] | 0..1 | string | Statement regarding prior amendments | |
extension:scope | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "scope" | |
value[x] | 0..1 | string | Global, Coutnry, Region, or Site | |
extension:description | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "description" | |
value[x] | 0..1 | string | Description | |
extension:rationale | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "rationale" | |
value[x] | 0..1 | string | Rationale | |
extension:substantialImpactSafety | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactSafety" | |
value[x] | 0..1 | boolean | Substantial impact on safety | |
extension:substantialImpactSafetyComment | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactSafetyComment" | |
value[x] | 0..1 | string | Comment on substantial impact on safety | |
extension:substantialImpactReliability | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactReliability" | |
value[x] | 0..1 | boolean | Substantial impact on reliability | |
extension:substantialImpactReliabilityComment | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactReliabilityComment" | |
value[x] | 0..1 | string | Comment on substantial impact on reliability | |
extension:primaryReason | 0..1 | Extension | Extension | |
extension | 0..0 | |||
url | 1..1 | uri | "primaryReason" | |
value[x] | 0..1 | CodeableConcept | Reason for amendment, e.g. Safety | |
url | 1..1 | uri | "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment" | |
value[x] | 0..0 | |||
Documentation for this format |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Extension | 0..* | Extension | An amendment to a study protocol | |
id | 0..1 | id | Unique id for inter-element referencing | |
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
extension:details | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "details" | |
value[x] | 0..1 | string | Statement regarding prior amendments | |
extension:scope | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "scope" | |
value[x] | 0..1 | string | Global, Coutnry, Region, or Site | |
extension:description | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "description" | |
value[x] | 0..1 | string | Description | |
extension:rationale | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "rationale" | |
value[x] | 0..1 | string | Rationale | |
extension:substantialImpactSafety | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactSafety" | |
value[x] | 0..1 | boolean | Substantial impact on safety | |
extension:substantialImpactSafetyComment | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactSafetyComment" | |
value[x] | 0..1 | string | Comment on substantial impact on safety | |
extension:substantialImpactReliability | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactReliability" | |
value[x] | 0..1 | boolean | Substantial impact on reliability | |
extension:substantialImpactReliabilityComment | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "substantialImpactReliabilityComment" | |
value[x] | 0..1 | string | Comment on substantial impact on reliability | |
extension:primaryReason | 0..1 | Extension | Extension | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "primaryReason" | |
value[x] | 0..1 | CodeableConcept | Reason for amendment, e.g. Safety | |
url | 1..1 | uri | "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment" | |
Documentation for this format |
Other representations of profile: CSV, Excel, Schematron
Id | Grade | Path(s) | Details | Requirements |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |