| ConsentManagementDomainResearchStudy (ResearchStudy) | I | | ResearchStudy | There are no (further) constraints on this element Element idShort description Investigation to increase healthcare-related patient-independent knowledge Alternate names Clinical Trial, Study Definition A 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-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-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-6: A resource should have narrative for robust management
text.`div`.exists() - dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
contained.meta.security.empty()
- rim: Entity. Role, or Act
- BRIDG5.1: ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion
- v2: OBX
- rim: Observation[classCode=CLNTRL, moodCode=EVN]
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| id | Σ | 0..1 | string | There are no (further) constraints on this element Element idShort description Logical id of this artifact Definition The 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 idShort description Metadata about the resource Definition The 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 A set of rules under which this content was created Definition A 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())
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| language | | 0..1 | codeBinding | There are no (further) constraints on this element Element idShort description Language of the resource content Definition The 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 Binding CommonLanguages (preferred)Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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| text | | 0..1 | Narrative | There are no (further) constraints on this element Element idShort description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A 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())
- rim: n/a
- rim: N/A
- rim: Act.text?
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| contained | | 0..* | Resource | There are no (further) constraints on this element Element idShort description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These 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- rim: Entity. Role, or Act
- rim: N/A
|
| extension | I | 0..* | Extension | Element idShort description Additional content defined by implementations Alternate names extensions, user content Definition May 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 Sliced: Unordered, 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()
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| versionFormat | I | 0..1 | Extension(Complex) | Element idResearchStudy.extension:versionFormat Versionierungsformat der Policies, Modules und Templates für diese Consent Domain Alternate names extensions, user content Definition Format von Versionsangaben
Werden sowohl formatString als auch formatExpression angegeben, müssen diese synonym sein.
Extension(Complex) Extension URL http://fhir.de/ConsentManagement/StructureDefinition/VersionFormat 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()
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| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.id Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 Sliced: Unordered, 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()
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| formatString | I | 0..1 | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatString Beschreibung des Formats einer Versionsangabe in textueller Form (menschenlesbar) Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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()
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatString.id Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatString.extension Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 Sliced: Unordered, 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()
|
| url | | 1..1 | uriFixed Value | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatString.url identifies the meaning of the extension Definition 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.
uri Fixed value Mappings |
| value[x] | | 1..1 | | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatString.value[x] Value of extension Definition Value 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())
|
| valueString | | | string | There are no (further) constraints on this element Data type string |
| formatExpression | I | 0..1 | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatExpression Regular Expression, die das erlaubte Format von Versionen bestimmt. Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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()
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatExpression.id Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatExpression.extension Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 Sliced: Unordered, 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()
|
| url | | 1..1 | uriFixed Value | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatExpression.url identifies the meaning of the extension Definition 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.
uri Fixed value Mappings |
| value[x] | | 1..1 | | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.extension:formatExpression.value[x] Value of extension Definition Value 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())
|
| valueString | | | string | There are no (further) constraints on this element Data type string |
| url | | 1..1 | uriFixed Value | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.url identifies the meaning of the extension Definition 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.
uri Fixed value http://fhir.de/ConsentManagement/StructureDefinition/VersionFormat |
| value[x] | S | 0..0 | | There are no (further) constraints on this element Element idResearchStudy.extension:versionFormat.value[x] Value of extension Definition Value 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())
|
| logo | S I | 0..1 | Extension(Attachment) | Element idResearchStudy.extension:logo Logo der Studie Alternate names extensions, user content Definition Optional 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 URL http://fhir.de/ConsentManagement/StructureDefinition/Logo 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()
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:logo.id Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:logo.extension Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 Sliced: Unordered, 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()
|
| url | | 1..1 | uriFixed Value | There are no (further) constraints on this element Element idResearchStudy.extension:logo.url identifies the meaning of the extension Definition 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.
uri Fixed value http://fhir.de/ConsentManagement/StructureDefinition/Logo |
| value[x] | S | 1..1 | | There are no (further) constraints on this element Element idResearchStudy.extension:logo.value[x] Value of extension Definition Value 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())
|
| valueAttachment | | | Attachment | There are no (further) constraints on this element Data type Attachment |
| contextIdentifier | S I | 1..* | Extension(Complex) | Element idResearchStudy.extension:contextIdentifier Optional Extensions Element Alternate names extensions, user content Definition Optional 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 URL http://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier 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()
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.id Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | I | 0..* | Extension | Element idResearchStudy.extension:contextIdentifier.extension Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 Sliced: Unordered, 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()
|
| resourceType | S I | 1..1 | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:resourceType Ressource, in der ein Identifier Verwendung findet. Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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()
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:resourceType.id Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:resourceType.extension Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 Sliced: Unordered, 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()
|
| url | | 1..1 | uriFixed Value | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:resourceType.url identifies the meaning of the extension Definition 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.
uri Fixed value Mappings |
| value[x] | S | 1..1 | Binding | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:resourceType.value[x] Value of extension Definition Value 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())
|
| valueCoding | | | Coding | There are no (further) constraints on this element Data type Coding |
| type | S I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:type Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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()
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:type.id Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:type.extension Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 Sliced: Unordered, 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()
|
| url | | 1..1 | uriFixed Value | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:type.url identifies the meaning of the extension Definition 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.
uri Fixed value Mappings |
| value[x] | S | 1..1 | Binding | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:type.value[x] Value of extension Definition Value 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())
|
| valueCodeableConcept | | | CodeableConcept | There are no (further) constraints on this element Data type CodeableConcept |
| system | S I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:system Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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()
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:system.id Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:system.extension Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 Sliced: Unordered, 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()
|
| url | | 1..1 | uriFixed Value | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:system.url identifies the meaning of the extension Definition 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.
uri Fixed value Mappings |
| value[x] | S | 1..1 | | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.extension:system.value[x] Value of extension Definition Value 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())
|
| valueUri | | | uri | There are no (further) constraints on this element Data type uri |
| url | | 1..1 | uriFixed Value | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.url identifies the meaning of the extension Definition 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.
uri Fixed value http://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier |
| value[x] | | 0..0 | | There are no (further) constraints on this element Element idResearchStudy.extension:contextIdentifier.value[x] Value of extension Definition Value 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())
|
| consentMode | S I | 0..1 | Extension(Coding) | Element idResearchStudy.extension:consentMode Standardverfahren für die Domäne Alternate names extensions, user content Definition Standardverfahren 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 URL http://fhir.de/ConsentManagement/StructureDefinition/ConsentMode 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()
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.id Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.extension Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 Sliced: Unordered, 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()
|
| url | | 1..1 | uriFixed Value | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.url identifies the meaning of the extension Definition 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.
uri Fixed value http://fhir.de/ConsentManagement/StructureDefinition/ConsentMode |
| value[x] | S | 1..1 | Binding | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.value[x] Value of extension Definition Value 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())
|
| valueCoding | | | Coding | There are no (further) constraints on this element Data type Coding |
| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.value[x].id Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.value[x].extension Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 Sliced: Unordered, 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()
|
| system | S Σ | 1..1 | uri | There are no (further) constraints on this element Element idResearchStudy.extension:consentMode.value[x].system Identity of the terminology system Definition The 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())
- rim: n/a
- 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 Version of the system - if relevant Definition The 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())
- rim: n/a
- 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 Symbol in syntax defined by the system Definition A 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.
Note that FHIR strings SHALL NOT exceed 1MB in size
code Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- 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 Representation defined by the system Definition A 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.
Note that FHIR strings SHALL NOT exceed 1MB in size
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- 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 If this coding was chosen directly by the user Definition Indicates 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())
- rim: n/a
- 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 | ?! I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.modifierExtension Extensions that cannot be ignored Alternate names extensions, user content Definition May 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 Sliced: Unordered, 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()
|
| identifier | S Σ | 1..* | Identifier | Element idShort description Eindeutiger Identifikator des Projekts, der Studie oder des Anwendungsbereichs der Einwilligungen Definition Identifiers 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())
- rim: n/a
- v2: CX / EI (occasionally, more often EI maps to a resource id or a URL)
- rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
- servd: Identifier
- 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 Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.identifier.extension Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 Sliced: Unordered, 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()
|
| use | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element idResearchStudy.identifier.use usual | official | temp | secondary | old (If known) Definition The 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 Binding Identifies the purpose for this identifier, if known .
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- 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 Description of identifier Definition A 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 Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
- 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 The namespace for the identifier value Definition Establishes 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())
Generalhttp://www.acme.com/identifiers/patient
Mappings- rim: n/a
- 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 The value that is unique Definition The 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())
Mappings- rim: n/a
- 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 I | 0..1 | Period | There are no (further) constraints on this element Element idResearchStudy.identifier.period Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use.
A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times").
Period is not used for a duration (a measure of elapsed time). See Duration.
Period Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - per-1: If present, start SHALL have a lower value than end
start.hasValue().not() or end.hasValue().not() or (start <= end)
- rim: n/a
- v2: DR
- rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
- v2: CX.7 + CX.8
- rim: Role.effectiveTime or implied by context
- servd: ./StartDate and ./EndDate
|
| assigner | Σ I | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element idResearchStudy.identifier.assigner Organization that issued id (may be just text) Definition Organization 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()) - ref-1: SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
- rim: n/a
- rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- 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 idShort description Name der Consent Domain Definition A short, descriptive user-friendly label for the study.
Note that FHIR strings SHALL NOT exceed 1MB in size
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- 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 I | 0..* | Reference(PlanDefinition) | There are no (further) constraints on this element Element idShort description Steps followed in executing study Definition The set of steps expected to be performed as part of the execution of the study.
References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Reference(PlanDefinition) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1: SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
- rim: n/a
- rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- clinicaltrials-gov: Interventions; Arm/Intervention Cross-Reference
- BRIDG5.1: StudyProtocolDocumentVersionPublicTitle.name
- rim: .outboundRelationship[typeCode=DEFN].target
|
| partOf | Σ I | 0..* | Reference(ResearchStudy) | There are no (further) constraints on this element Element idShort description Part of larger study Alternate names container Definition A 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.
References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Reference(ResearchStudy) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1: SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
- rim: n/a
- rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- 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 idShort description active | 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 Definition The current state of the study.
Note that FHIR strings SHALL NOT exceed 1MB in size
code Binding Codes that convey the current status of the research study.
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- 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 treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Definition The type of study based upon the intent of the study's activities. A classification of the intent of the study.
Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
CodeableConcept Binding Codes for the main intent of the study.
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
- BRIDG5.1: StudyProtocolVersion.primaryPurposeTypeCode
|
| phase | Σ | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idShort description n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Definition The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
CodeableConcept Binding Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
- clinicaltrials-gov: Study Phase
- BRIDG5.1: StudyProtocolVersion.phaseCode
|
| category | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element idShort description Classifications for the study Definition Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
CodeableConcept Binding Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
- 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 idShort description Drugs, devices, etc. under study Definition The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
CodeableConcept Binding Codes for medications, devices and other interventions.
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
- 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 idShort description Condition being studied Definition The 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.
Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
CodeableConcept Binding Identification of the condition or diagnosis.
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
- clinicaltrials-gov: Conditions
- w5: FiveWs.what[x]
- BRIDG5.1: StudyCondition.code
|
| contact | Σ | 0..* | ContactDetail | There are no (further) constraints on this element Element idShort description Contact details for the study Definition Contact 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())
- rim: n/a
- 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 References and dependencies Definition Citations, references and other related documents.
Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.
RelatedArtifact Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- 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 idShort description Used to search for the study Definition Key terms to aid in searching for or filtering the study.
Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
CodeableConcept Binding Words associated with the study that may be useful in discovery.
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
- clinicaltrials-gov: Keywords
- BRIDG5.1: DocumentVersion.keywordCode; DocumentVersion.keywordText
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| location | Σ | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idShort description Geographic region(s) for study Definition Indicates a country, state or other region where the study is taking place.
Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
CodeableConcept Binding Countries and regions within which this artifact is targeted for use.
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
- BRIDG5.1: StudyProtocolVersion.participatingLocationCode
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| description | S | 1..1 | markdown | Element idResearchStudy.description Zweckbeschreibung der Consent Domain Definition A full description of how the study is being conducted.
Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
markdown Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- clinicaltrials-gov: Detailed Description
- BRIDG5.1: StudyProtocolDocumentVersion.publicDescription
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| enrollment | Σ I | 0..* | Reference(Group) | There are no (further) constraints on this element Element idShort description Inclusion & exclusion criteria Alternate names patient Definition Reference 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()) - ref-1: SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
- rim: n/a
- rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- 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
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| period | Σ I | 0..1 | Period | There are no (further) constraints on this element Element idShort description When the study began and ended Alternate names timing Definition Identifies the start date and the expected (or actual, depending on status) end date for the study.
A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times").
Period is not used for a duration (a measure of elapsed time). See Duration.
Period Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - per-1: If present, start SHALL have a lower value than end
start.hasValue().not() or end.hasValue().not() or (start <= end)
- rim: n/a
- v2: DR
- rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
- clinicaltrials-gov: Study Start Date (start); Study Completion Date (end)
- w5: FiveWs.done[x]
- BRIDG5.1: ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
- rim: .effectiveTime
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| principalInvestigator | Σ I | 0..1 | Reference(Practitioner | PractitionerRole) | There are no (further) constraints on this element Element idResearchStudy.principalInvestigator Researcher who oversees multiple aspects of the study Definition A 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.
References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Reference(Practitioner | PractitionerRole) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1: SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
- rim: n/a
- rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- clinicaltrials-gov: Principal Investigator
- w5: FiveWs.actor
- BRIDG5.1: StudyInvestigator
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| site | Σ I | 0..* | Reference(Location) | There are no (further) constraints on this element Element idShort description Facility where study activities are conducted Definition A facility in which study activities are conducted.
References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Reference(Location) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1: SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
- rim: n/a
- rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- 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 accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Definition A description and/or code explaining the premature termination of the study.
Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
CodeableConcept Binding Codes for why the study ended prematurely.
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
- 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 idShort description Comments made about the study Definition Comments made about the study by the performer, subject or other participants.
For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
Annotation Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- v2: N/A
- rim: Act
- 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 idShort description Defined path through the study for a subject Definition Describes 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())
- rim: n/a
- clinicaltrials-gov: Arms
- BRIDG5.1: Arm
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| id | | 0..1 | string | There are no (further) constraints on this element Element idShort description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.arm.extension Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 Sliced: Unordered, 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()
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| modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.arm.modifierExtension Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May 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()
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| name | | 1..1 | string | There are no (further) constraints on this element Element idShort description Label for study arm Definition Unique, human-readable label for this arm of the study.
Note that FHIR strings SHALL NOT exceed 1MB in size
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- 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 idShort description Categorization of study arm Definition Categorization of study arm, e.g. experimental, active comparator, placebo comparater.
Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
CodeableConcept Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
- 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 explanation of study path Definition A succinct description of the path through the study that would be followed by a subject adhering to this arm.
Note that FHIR strings SHALL NOT exceed 1MB in size
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- clinicaltrials-gov: Arm Description
- BRIDG5.1: Arm.description
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| objective | | 0..* | BackboneElement | There are no (further) constraints on this element Element idShort description A goal for the study Definition A 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())
- rim: n/a
- BRIDG5.1: StudyObjective
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| id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.objective.id Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
string Mappings |
| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.objective.extension Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 Sliced: Unordered, 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()
|
| modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.objective.modifierExtension Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May 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()
|
| name | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.objective.name Label for the objective Definition Unique, human-readable label for this objective of the study.
Note that FHIR strings SHALL NOT exceed 1MB in size
string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- BRIDG5.1: No BRIDG mapping (BRIDG has a description, but not a name)
|
| type | | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.objective.type primary | secondary | exploratory Definition The kind of study objective.
Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
CodeableConcept Binding Codes for the kind of study objective.
- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
- BRIDG5.1: StudyObjective.typeCode
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