Generated Narrative: StructureDefinition research-study-study-amendment Name Flags Card. Type Description & Constraints Extension 0..* Extension An amendment to a study protocol #xD; Slices for extension Content/Rules for all slices #xD; extension:details 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "details" #xD; value[x] 0..1 string Statement regarding prior amendments #xD; extension:scope 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "scope" #xD; value[x] 0..1 string Global, Coutnry, Region, or Site #xD; extension:description 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "description" #xD; value[x] 0..1 string Description #xD; extension:rationale 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "rationale" #xD; value[x] 0..1 string Rationale #xD; extension:substantialImpactSafety 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "substantialImpactSafety" #xD; value[x] 0..1 boolean Substantial impact on safety #xD; extension:substantialImpactSafetyComment 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "substantialImpactSafetyComment" #xD; value[x] 0..1 string Comment on substantial impact on safety #xD; extension:substantialImpactReliability 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "substantialImpactReliability" #xD; value[x] 0..1 boolean Substantial impact on reliability #xD; extension:substantialImpactReliabilityComment 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "substantialImpactReliabilityComment" #xD; value[x] 0..1 string Comment on substantial impact on reliability #xD; extension:primaryReason 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "primaryReason" #xD; value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety #xD; url 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment" #xD; value[x] 0..0 Value of extension #xD; Documentation for this format
HL7 International / Clinical Decision Support
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Must have either extensions or value[x], not both
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
Additional content defined by implementations
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.
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.
Source of the definition for the extension code - a logical name or a URL.
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.
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).
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).
Comment on substantial impact on safety.
Comment on substantial impact on reliability
Comment on substantial impact on reliability.
Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).