| ConsentManagementDomainResearchStudy (ResearchStudy) | C | | ResearchStudy | There are no (further) constraints on this element Element idResearchStudy Short descriptionInvestigation to increase healthcare-related patient-independent knowledge Alternate namesClinical Trial, Study DefinitionA process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
Need to make sure we encompass public health studies.
ResearchStudy Constraints- dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
contained.contained.empty() - dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() - dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() - dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
contained.meta.security.empty() - dom-6: A resource should have narrative for robust management
text.`div`.exists()
Mappings- rim: Entity. Role, or Act
- BRIDG5.1: ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion
- v2: OBX
- rim: Observation[classCode=CLNTRL, moodCode=EVN]
|
| id | Σ | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.id Short descriptionLogical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
string |
| meta | Σ | 0..1 | Meta | There are no (further) constraints on this element Element idResearchStudy.meta Short descriptionMetadata about the resource DefinitionThe metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
Meta Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
|
| implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idResearchStudy.implicitRules Short descriptionA set of rules under which this content was created DefinitionA reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
uri Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
|
| language | | 0..1 | codeBinding | There are no (further) constraints on this element Element idResearchStudy.language Short descriptionLanguage of the resource content DefinitionThe base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
code BindingCommonLanguages (preferred) Binding extensionsConstraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
|
| text | | 0..1 | Narrative | There are no (further) constraints on this element Element idResearchStudy.text Short descriptionText summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
Narrative Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
| contained | | 0..* | Resource | There are no (further) constraints on this element Element idResearchStudy.contained Short descriptionContained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
Resource Mappings |
| extension | C | 0..* | Extension | Element idResearchStudy.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, 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.
Extension SlicingUnordered, Open, by url(Value) Constraints- 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()
Mappings |
| versionFormat | C | 0..1 | Extension(Complex) | Element idResearchStudy.extension:versionFormat Short descriptionVersionierungsformat der Policies, Modules und Templates für diese Consent Domain Alternate namesextensions, user content DefinitionFormat von Versionsangaben
Werden sowohl formatString als auch formatExpression angegeben, müssen diese synonym sein.
Extension(Complex) Extension URLhttp://fhir.de/ConsentManagement/StructureDefinition/VersionFormat ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- 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()
Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension SlicingUnordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints- 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()
Mappings |
| formatString | C | 0..1 | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatString Short descriptionBeschreibung des Formats einer Versionsangabe in textueller Form (menschenlesbar) Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension Constraints- 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()
Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatString.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatString.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension SlicingUnordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints- 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()
Mappings |
| url | | 1..1 | uriAuto Value | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatString.url Short descriptionidentifies the meaning of the extension DefinitionSource 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.
uri Auto valueformatString Mappings |
| value[x] | | 1..1 | | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatString.value[x] Short descriptionValue of extension DefinitionValue of extension - must be one of a constrained set of the data types (see Extensibility for a list).
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
| valueString | | | string | There are no (further) constraints on this element Data typestring |
| formatExpression | C | 0..1 | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatExpression Short descriptionRegular Expression, die das erlaubte Format von Versionen bestimmt. Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension Constraints- 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()
Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatExpression.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatExpression.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension SlicingUnordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints- 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()
Mappings |
| url | | 1..1 | uriAuto Value | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatExpression.url Short descriptionidentifies the meaning of the extension DefinitionSource 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.
uri Auto valueformatExpression Mappings |
| value[x] | | 1..1 | | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatExpression.value[x] Short descriptionValue of extension DefinitionValue of extension - must be one of a constrained set of the data types (see Extensibility for a list).
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
| valueString | | | string | There are no (further) constraints on this element Data typestring |
| url | | 1..1 | uriAuto Value | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.url Short descriptionidentifies the meaning of the extension DefinitionSource 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.
uri Auto valuehttp://fhir.de/ConsentManagement/StructureDefinition/VersionFormat Mappings |
| value[x] | S | 0..0 | | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.value[x] Short descriptionValue of extension DefinitionValue of extension - must be one of a constrained set of the data types (see Extensibility for a list).
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
| logo | S C | 0..1 | Extension(Attachment) | Element idResearchStudy.extension:logo Short descriptionLogo der Studie Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources.
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.
Extension(Attachment) Extension URLhttp://fhir.de/ConsentManagement/StructureDefinition/Logo ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- 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()
Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:logo.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:logo.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension SlicingUnordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints- 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()
Mappings |
| url | | 1..1 | uriAuto Value | There are no (further) constraints on this element Element idResearchStudy.extension:logo.url Short descriptionidentifies the meaning of the extension DefinitionSource 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.
uri Auto valuehttp://fhir.de/ConsentManagement/StructureDefinition/Logo Mappings |
| value[x] | S | 1..1 | | There are no (further) constraints on this element Element idResearchStudy.extension:logo.value[x] Short descriptionValue of extension DefinitionValue of extension - must be one of a constrained set of the data types (see Extensibility for a list).
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
| valueAttachment | | | Attachment | There are no (further) constraints on this element Data typeAttachment |
| contextIdentifier | S C | 1..* | Extension(Complex) | Element idResearchStudy.extension:contextIdentifier Short descriptionOptional Extensions Element Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources.
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.
Extension(Complex) Extension URLhttp://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- 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()
Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | Element idResearchStudy.extension:contextIdentifier.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension SlicingUnordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints- 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()
Mappings |
| resourceType | S C | 1..1 | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:resourceType Short descriptionRessource, in der ein Identifier Verwendung findet. Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension Constraints- 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()
Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:resourceType.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:resourceType.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension SlicingUnordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints- 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()
Mappings |
| url | | 1..1 | uriAuto Value | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:resourceType.url Short descriptionidentifies the meaning of the extension DefinitionSource 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.
uri Auto valueresourceType Mappings |
| value[x] | S | 1..1 | Binding | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:resourceType.value[x] Short descriptionValue of extension DefinitionValue of extension - must be one of a constrained set of the data types (see Extensibility for a list).
ResourceType (required) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
| valueCoding | | | Coding | There are no (further) constraints on this element Data typeCoding |
| type | S C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:type Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension Constraints- 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()
Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:type.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:type.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension SlicingUnordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints- 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()
Mappings |
| url | | 1..1 | uriAuto Value | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:type.url Short descriptionidentifies the meaning of the extension DefinitionSource 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.
uri Auto valuetype Mappings |
| value[x] | S | 1..1 | Binding | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:type.value[x] Short descriptionValue of extension DefinitionValue of extension - must be one of a constrained set of the data types (see Extensibility for a list).
ConsentManagementContextIdentifierType (extensible) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
| valueCodeableConcept | | | CodeableConcept | There are no (further) constraints on this element Data typeCodeableConcept |
| system | S C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:system Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension Constraints- 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()
Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:system.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:system.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension SlicingUnordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints- 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()
Mappings |
| url | | 1..1 | uriAuto Value | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:system.url Short descriptionidentifies the meaning of the extension DefinitionSource 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.
uri Auto valuesystem Mappings |
| value[x] | S | 1..1 | | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:system.value[x] Short descriptionValue of extension DefinitionValue of extension - must be one of a constrained set of the data types (see Extensibility for a list).
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
| valueUri | | | uri | There are no (further) constraints on this element Data typeuri |
| url | | 1..1 | uriAuto Value | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.url Short descriptionidentifies the meaning of the extension DefinitionSource 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.
uri Auto valuehttp://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier Mappings |
| value[x] | | 0..0 | | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.value[x] Short descriptionValue of extension DefinitionValue of extension - must be one of a constrained set of the data types (see Extensibility for a list).
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
| consentMode | S C | 0..1 | Extension(Coding) | Element idResearchStudy.extension:consentMode Short descriptionStandardverfahren für die Domäne Alternate namesextensions, user content DefinitionStandardverfahren für die Domäne
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.
Extension(Coding) Extension URLhttp://fhir.de/ConsentManagement/StructureDefinition/ConsentMode ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- 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()
Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension SlicingUnordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints- 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()
Mappings |
| url | | 1..1 | uriAuto Value | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.url Short descriptionidentifies the meaning of the extension DefinitionSource 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.
uri Auto valuehttp://fhir.de/ConsentManagement/StructureDefinition/ConsentMode Mappings |
| value[x] | S | 1..1 | Binding | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.value[x] Short descriptionValue of extension DefinitionValue of extension - must be one of a constrained set of the data types (see Extensibility for a list).
ConsentManagementConsentMode (required) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
| valueCoding | | | Coding | There are no (further) constraints on this element Data typeCoding |
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.value[x].id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.value[x].extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension SlicingUnordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints- 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()
Mappings |
| system | S Σ | 1..1 | uri | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.value[x].system Short descriptionIdentity of the terminology system DefinitionThe identification of the code system that defines the meaning of the symbol in the code.
Need to be unambiguous about the source of the definition of the symbol.
The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.
uri Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: C*E.3
- rim: ./codeSystem
- orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
|
| version | Σ | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.value[x].version Short descriptionVersion of the system - if relevant DefinitionThe version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: C*E.7
- rim: ./codeSystemVersion
- orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
|
| code | S Σ | 1..1 | code | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.value[x].code Short descriptionSymbol in syntax defined by the system DefinitionA symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Need to refer to a particular code in the system.
code Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: C*E.1
- rim: ./code
- orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
|
| display | Σ | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.value[x].display Short descriptionRepresentation defined by the system DefinitionA representation of the meaning of the code in the system, following the rules of the system.
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: C*E.2 - but note this is not well followed
- rim: CV.displayName
- orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
|
| userSelected | Σ | 0..1 | boolean | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.value[x].userSelected Short descriptionIf this coding was chosen directly by the user DefinitionIndicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
boolean Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: Sometimes implied by being first
- rim: CD.codingRationale
- orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
|
| modifierExtension | ?! C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.modifierExtension Short descriptionExtensions that cannot be ignored Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
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.
Extension Constraints- 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()
Mappings |
| identifier | S Σ | 1..* | Identifier | Element idResearchStudy.identifier Short descriptionEindeutiger Identifikator des Projekts, der Studie oder des Anwendungsbereichs der Einwilligungen DefinitionIdentifiers assigned to this research study by the sponsor or other systems.
Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
Identifier Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs
- w5: FiveWs.identifier
- BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
- rim: .identifier
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.identifier.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.identifier.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension SlicingUnordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints- 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()
Mappings |
| use | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element idResearchStudy.identifier.use Short descriptionusual | official | temp | secondary | old (If known) DefinitionThe purpose of this identifier.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
code BindingIdentifies the purpose for this identifier, if known .
IdentifierUse (required) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: N/A
- rim: Role.code or implied by context
|
| type | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.identifier.type Short descriptionDescription of identifier DefinitionA coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Allows users to make use of identifiers when the identifier system is not known.
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
CodeableConcept BindingA coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Identifier Type Codes (extensible) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.5
- rim: Role.code or implied by context
|
| system | S Σ | 1..1 | uri | There are no (further) constraints on this element Element idResearchStudy.identifier.system Short descriptionThe namespace for the identifier value DefinitionEstablishes the namespace for the value - that is, a URL that describes a set values that are unique.
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
Identifier.system is always case sensitive.
uri Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Examples
Generalhttp://www.acme.com/identifiers/patient Mappings- v2: CX.4 / EI-2-4
- rim: II.root or Role.id.root
- servd: ./IdentifierType
|
| value | S Σ | 1..1 | string | There are no (further) constraints on this element Element idResearchStudy.identifier.value Short descriptionThe value that is unique DefinitionThe portion of the identifier typically relevant to the user and which is unique within the context of the system.
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Examples
General123456 Mappings- v2: CX.1 / EI.1
- rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
- servd: ./Value
|
| period | Σ | 0..1 | Period | There are no (further) constraints on this element Element idResearchStudy.identifier.period Short descriptionTime period when id is/was valid for use DefinitionTime period during which identifier is/was valid for use.
Period Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.7 + CX.8
- rim: Role.effectiveTime or implied by context
- servd: ./StartDate and ./EndDate
|
| assigner | Σ | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element idResearchStudy.identifier.assigner Short descriptionOrganization that issued id (may be just text) DefinitionOrganization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
Reference(Organization) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- v2: CX.4 / (CX.4,CX.9,CX.10)
- rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
- servd: ./IdentifierIssuingAuthority
|
| title | S Σ | 1..1 | string | Element idResearchStudy.title Short descriptionName der Consent Domain DefinitionA short, descriptive user-friendly label for the study.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Brief Title
- BRIDG5.1: No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
|
| protocol | Σ | 0..* | Reference(PlanDefinition) | There are no (further) constraints on this element Element idResearchStudy.protocol Short descriptionSteps followed in executing study DefinitionThe set of steps expected to be performed as part of the execution of the study.
Reference(PlanDefinition) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Interventions; Arm/Intervention Cross-Reference
- BRIDG5.1: StudyProtocolDocumentVersionPublicTitle.name
- rim: .outboundRelationship[typeCode=DEFN].target
|
| partOf | Σ | 0..* | Reference(ResearchStudy) | There are no (further) constraints on this element Element idResearchStudy.partOf Short descriptionPart of larger study Alternate namescontainer DefinitionA larger research study of which this particular study is a component or step.
Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.
Reference(ResearchStudy) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: CompanionStudyRelationship
- rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
|
| status | S Σ ?! | 1..1 | codeBinding | There are no (further) constraints on this element Element idResearchStudy.status Short descriptionactive | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn DefinitionThe current state of the study.
code BindingCodes that convey the current status of the research study.
ResearchStudyStatus (required) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- w5: FiveWs.status
- BRIDG5.1: StudyOverallStatus.code
- rim: .status
|
| primaryPurposeType | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.primaryPurposeType Short descriptiontreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility DefinitionThe type of study based upon the intent of the study's activities. A classification of the intent of the study.
CodeableConcept BindingCodes for the main intent of the study.
ResearchStudyPrimaryPurposeType (extensible) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: StudyProtocolVersion.primaryPurposeTypeCode
|
| phase | Σ | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.phase Short descriptionn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 DefinitionThe stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
CodeableConcept BindingCodes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
ResearchStudyPhase (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Study Phase
- BRIDG5.1: StudyProtocolVersion.phaseCode
|
| category | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.category Short descriptionClassifications for the study DefinitionCodes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
CodeableConcept BindingCodes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
(unbound) (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
- BRIDG5.1: InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
|
| focus | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.focus Short descriptionDrugs, devices, etc. under study DefinitionThe medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
CodeableConcept BindingCodes for medications, devices and other interventions.
(unbound) (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Focus of Study
- w5: FiveWs.what[x]
- BRIDG5.1: InterventionalStudyProtocol.interventionTypeCode
|
| condition | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.condition Short descriptionCondition being studied DefinitionThe condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.
CodeableConcept BindingIdentification of the condition or diagnosis.
Condition/Problem/DiagnosisCodes (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Conditions
- w5: FiveWs.what[x]
- BRIDG5.1: StudyCondition.code
|
| contact | Σ | 0..* | ContactDetail | There are no (further) constraints on this element Element idResearchStudy.contact Short descriptionContact details for the study DefinitionContact details to assist a user in learning more about or engaging with the study.
ContactDetail Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
- BRIDG5.1: PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
|
| relatedArtifact | | 0..* | RelatedArtifact | There are no (further) constraints on this element Element idResearchStudy.relatedArtifact Short descriptionReferences and dependencies DefinitionCitations, references and other related documents.
RelatedArtifact Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Citations, Links, Available Study Data/Documents
- BRIDG5.1: StudyProtocolDocument, StudyProtocolDocumentVersion
|
| keyword | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.keyword Short descriptionUsed to search for the study DefinitionKey terms to aid in searching for or filtering the study.
CodeableConcept BindingWords associated with the study that may be useful in discovery.
(unbound) (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Keywords
- BRIDG5.1: DocumentVersion.keywordCode; DocumentVersion.keywordText
|
| location | Σ | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.location Short descriptionGeographic region(s) for study DefinitionIndicates a country, state or other region where the study is taking place.
CodeableConcept BindingCountries and regions within which this artifact is targeted for use.
Jurisdiction ValueSet (extensible) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: StudyProtocolVersion.participatingLocationCode
|
| description | S | 1..1 | markdown | Element idResearchStudy.description Short descriptionZweckbeschreibung der Consent Domain DefinitionA full description of how the study is being conducted.
markdown Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Detailed Description
- BRIDG5.1: StudyProtocolDocumentVersion.publicDescription
|
| enrollment | Σ | 0..* | Reference(Group) | There are no (further) constraints on this element Element idResearchStudy.enrollment Short descriptionInclusion & exclusion criteria Alternate namespatient DefinitionReference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".
The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.
Reference(Group) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
- w5: FiveWs.subject[x]
- BRIDG5.1: InterventionalStudyProtocol.interventionGroupQuantity
- rim: .participation[typeCode=SBJ].role
- w5: FiveWs.subject
|
| period | Σ | 0..1 | Period | There are no (further) constraints on this element Element idResearchStudy.period Short descriptionWhen the study began and ended Alternate namestiming DefinitionIdentifies the start date and the expected (or actual, depending on status) end date for the study.
Period Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Study Start Date (start); Study Completion Date (end)
- w5: FiveWs.done[x]
- BRIDG5.1: ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
- rim: .effectiveTime
|
| principalInvestigator | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | There are no (further) constraints on this element Element idResearchStudy.principalInvestigator Short descriptionResearcher who oversees multiple aspects of the study DefinitionA researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.
Reference(Practitioner | PractitionerRole) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Principal Investigator
- w5: FiveWs.actor
- BRIDG5.1: StudyInvestigator
|
| site | Σ | 0..* | Reference(Location) | There are no (further) constraints on this element Element idResearchStudy.site Short descriptionFacility where study activities are conducted DefinitionA facility in which study activities are conducted.
Reference(Location) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Facility
- w5: FiveWs.where[x]
- BRIDG5.1: PlannedStudySite; StudySite
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| reasonStopped | Σ | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.reasonStopped Short descriptionaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design DefinitionA description and/or code explaining the premature termination of the study.
CodeableConcept BindingCodes for why the study ended prematurely.
ResearchStudyReasonStopped (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Why Study Stopped
- w5: FiveWs.why[x]
- BRIDG5.1: StudyOverallStatus.studyStoppedReasonCode
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| note | | 0..* | Annotation | There are no (further) constraints on this element Element idResearchStudy.note Short descriptionComments made about the study DefinitionComments made about the study by the performer, subject or other participants.
Annotation Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: No BRIDG mapping
- rim: .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
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| arm | | 0..* | BackboneElement | There are no (further) constraints on this element Element idResearchStudy.arm Short descriptionDefined path through the study for a subject DefinitionDescribes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.
BackboneElement Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Arms
- BRIDG5.1: Arm
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| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.arm.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.arm.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension Constraints- 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()
Mappings |
| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.arm.modifierExtension Short descriptionExtensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, 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. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
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.
Extension Constraints- 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()
Mappings |
| name | | 1..1 | string | There are no (further) constraints on this element Element idResearchStudy.arm.name Short descriptionLabel for study arm DefinitionUnique, human-readable label for this arm of the study.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Arm Label
- BRIDG5.1: Arm.name
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| type | | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.arm.type Short descriptionCategorization of study arm DefinitionCategorization of study arm, e.g. experimental, active comparator, placebo comparater.
CodeableConcept Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Arm Type
- BRIDG5.1: Arm.typeCode
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| description | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.arm.description Short descriptionShort explanation of study path DefinitionA succinct description of the path through the study that would be followed by a subject adhering to this arm.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Arm Description
- BRIDG5.1: Arm.description
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| objective | | 0..* | BackboneElement | There are no (further) constraints on this element Element idResearchStudy.objective Short descriptionA goal for the study DefinitionA goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.
BackboneElement Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.objective.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.objective.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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 manageable, 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.
Extension Constraints- 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()
Mappings |
| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.objective.modifierExtension Short descriptionExtensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, 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. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
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.
Extension Constraints- 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()
Mappings |
| name | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.objective.name Short descriptionLabel for the objective DefinitionUnique, human-readable label for this objective of the study.
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: No BRIDG mapping (BRIDG has a description, but not a name)
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| type | | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.objective.type Short descriptionprimary | secondary | exploratory DefinitionThe kind of study objective.
CodeableConcept BindingCodes for the kind of study objective.
ResearchStudyObjectiveType (preferred) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: StudyObjective.typeCode
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