IG TTP-FHIR Gateway

ConsentDomain

ResearchStudy	I		ResearchStudy	There are no (further) constraints on this element Element Id ResearchStudy Short 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. Comments Need to make sure we encompass public health studies. Data Type 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()` Mappings rim:Entity. Role, or Act BRIDG5.1:ObservationalStudyProtocolVersion; Study; StudyProtocolVersion v2:OBX rim:Observation[classCode=CLNTRL, moodCode=EVN]
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element Id ResearchStudy.meta Short 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. Data Type Meta Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element Id ResearchStudy.meta.extension Short 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 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. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type Extension Sliced: Unordered, 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 rim:n/a rim:N/A
created	S I	0..1	Extension(instant)	Element Id ResearchStudy.meta.extension:created Short description Optional Extensions Element Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type Extension(instant) Extension URL https://ths-greifswald.de/fhir/StructureDefinition/gics/Created 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 rim:n/a rim:N/A
versionId	Σ	0..1	id	There are no (further) constraints on this element Element Id ResearchStudy.meta.versionId Short description Version specific identifier Definition The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted. Comments The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes. Data Type id Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
lastUpdated	S Σ	0..1	instant	There are no (further) constraints on this element Element Id ResearchStudy.meta.lastUpdated Short description When the resource version last changed Definition When the resource last changed - e.g. when the version changed. Comments This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction. Data Type instant Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
source	Σ	0..1	uri	There are no (further) constraints on this element Element Id ResearchStudy.meta.source Short description Identifies where the resource comes from Definition A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc. Comments In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL. Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
profile	Σ	0..*	canonical(StructureDefinition)	There are no (further) constraints on this element Element Id ResearchStudy.meta.profile Short description Profiles this resource claims to conform to Definition A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url. Comments It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set. Data Type canonical(StructureDefinition) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
security	Σ	0..*	CodingBinding	There are no (further) constraints on this element Element Id ResearchStudy.meta.security Short description Security Labels applied to this resource Definition Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure. Comments The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored. Data Type Coding Binding Security Labels from the Healthcare Privacy and Security Classification System. All Security Labels (extensible) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim:CV orim:fhir:Coding rdfs:subClassOf dt:CDCoding
tag	Σ	0..*	Coding	There are no (further) constraints on this element Element Id ResearchStudy.meta.tag Short description Tags applied to this resource Definition Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource. Comments The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored. Data Type Coding Binding Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". CommonTags (example) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim:CV orim:fhir:Coding rdfs:subClassOf dt:CDCoding
extension	I	1..*	Extension	There are no (further) constraints on this element Element Id ResearchStudy.extension Short 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. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type Extension Sliced: Unordered, 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 rim:n/a rim:N/A
versionFormat	I	0..1	Extension(Complex)	There are no (further) constraints on this element Element Id ResearchStudy.extension:versionFormat Short description Versionierungsformat der Policies, Modules und Templates für diese Consent Domain Alternate names extensions, user content Definition Format von Versionsangaben Comments Werden sowohl formatString als auch formatExpression angegeben, müssen diese synonym sein. Data Type 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()` Mappings rim:n/a rim:N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element Id ResearchStudy.extension:versionFormat.extension Short 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 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. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type Extension Sliced: Unordered, 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 rim:n/a rim:N/A
formatString	I	0..1	Extension	There are no (further) constraints on this element Element Id ResearchStudy.extension:versionFormat.extension:formatString Short description 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. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type 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 rim:n/a rim:N/A
url		1..1	System.StringFixed Value	There are no (further) constraints on this element Element Id ResearchStudy.extension:versionFormat.extension:formatString.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data Type System.String Fixed Value formatString Mappings rim:N/A
value[x]		1..1		There are no (further) constraints on this element Element Id ResearchStudy.extension:versionFormat.extension:formatString.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:N/A
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 Id ResearchStudy.extension:versionFormat.extension:formatExpression Short description 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. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type 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 rim:n/a rim:N/A
url		1..1	System.StringFixed Value	There are no (further) constraints on this element Element Id ResearchStudy.extension:versionFormat.extension:formatExpression.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data Type System.String Fixed Value formatExpression Mappings rim:N/A
value[x]		1..1		There are no (further) constraints on this element Element Id ResearchStudy.extension:versionFormat.extension:formatExpression.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:N/A
valueString			string	There are no (further) constraints on this element Data Type string
url		1..1	System.StringFixed Value	There are no (further) constraints on this element Element Id ResearchStudy.extension:versionFormat.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data Type System.String Fixed Value http://fhir.de/ConsentManagement/StructureDefinition/VersionFormat Mappings rim:N/A
value[x]	S	0..0		There are no (further) constraints on this element Element Id ResearchStudy.extension:versionFormat.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:N/A
logo	S I	0..1	Extension(Attachment)	Element Id ResearchStudy.extension:logo Short description Logo der Studie/des Vorhabens Alternate names extensions, user content Definition Logo zur Darstellung auf Einwilligungsvorlagen Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type 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()` Mappings rim:n/a rim:N/A
url		1..1	System.StringFixed Value	There are no (further) constraints on this element Element Id ResearchStudy.extension:logo.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data Type System.String Fixed Value http://fhir.de/ConsentManagement/StructureDefinition/Logo Mappings rim:N/A
value[x]	S	1..1		There are no (further) constraints on this element Element Id ResearchStudy.extension:logo.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:N/A
valueAttachment			Attachment	There are no (further) constraints on this element Data Type Attachment
contextIdentifier	S I	1..*	Extension(Complex)	Element Id ResearchStudy.extension:contextIdentifier Short description Herstellung des Patientenbezugs je Kontext Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type 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()` Mappings rim:n/a rim:N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element Id ResearchStudy.extension:contextIdentifier.extension Short 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 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. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type Extension Sliced: Unordered, 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 rim:n/a rim:N/A
resourceType	S I	1..1	Extension	There are no (further) constraints on this element Element Id ResearchStudy.extension:contextIdentifier.extension:resourceType Short description 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. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type 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 rim:n/a rim:N/A
url		1..1	System.StringFixed Value	There are no (further) constraints on this element Element Id ResearchStudy.extension:contextIdentifier.extension:resourceType.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data Type System.String Fixed Value resourceType Mappings rim:N/A
value[x]	S	1..1	Binding	There are no (further) constraints on this element Element Id ResearchStudy.extension:contextIdentifier.extension:resourceType.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Binding ResourceType (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:N/A
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 Id ResearchStudy.extension:contextIdentifier.extension:type Short 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 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. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type 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 rim:n/a rim:N/A
url		1..1	System.StringFixed Value	There are no (further) constraints on this element Element Id ResearchStudy.extension:contextIdentifier.extension:type.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data Type System.String Fixed Value type Mappings rim:N/A
value[x]	S	1..1	Binding	There are no (further) constraints on this element Element Id ResearchStudy.extension:contextIdentifier.extension:type.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Binding ConsentManagementContextIdentifierType (extensible) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:N/A
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 Id ResearchStudy.extension:contextIdentifier.extension:system Short 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 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. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type 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 rim:n/a rim:N/A
url		1..1	System.StringFixed Value	There are no (further) constraints on this element Element Id ResearchStudy.extension:contextIdentifier.extension:system.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data Type System.String Fixed Value system Mappings rim:N/A
value[x]	S	1..1		There are no (further) constraints on this element Element Id ResearchStudy.extension:contextIdentifier.extension:system.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:N/A
valueUri			uri	There are no (further) constraints on this element Data Type uri
url		1..1	System.StringFixed Value	There are no (further) constraints on this element Element Id ResearchStudy.extension:contextIdentifier.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data Type System.String Fixed Value http://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier Mappings rim:N/A
value[x]		0..0		There are no (further) constraints on this element Element Id ResearchStudy.extension:contextIdentifier.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:N/A
policyVersionFormat	S I	0..1	Extension(string)	Element Id ResearchStudy.extension:policyVersionFormat Short description Versionierungsformat für Policies einer Consent Domain Alternate names extensions, user content Definition Versionierungsformat für Policies einer Consent Domain Comments Werden sowohl formatString als auch formatExpression angegeben, müssen diese synonym sein. Data Type Extension(string) Extension URL https://ths-greifswald.de/fhir/StructureDefinition/gics/PolicyVersionFormat 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 rim:n/a rim:N/A
moduleVersionFormat	S I	0..1	Extension(string)	Element Id ResearchStudy.extension:moduleVersionFormat Short description Versionierungsformat für Module einer Consent Domain Alternate names extensions, user content Definition Versionierungsformat für Module einer Consent Domain Comments Werden sowohl formatString als auch formatExpression angegeben, müssen diese synonym sein. Data Type Extension(string) Extension URL https://ths-greifswald.de/fhir/StructureDefinition/gics/ModuleVersionFormat 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 rim:n/a rim:N/A
templateVersionFormat	S I	0..1	Extension(string)	Element Id ResearchStudy.extension:templateVersionFormat Short description Versionierungsformat für Templates einer Consent Domain Alternate names extensions, user content Definition Versionierungsformat für Templates einer Consent Domain Comments Werden sowohl formatString als auch formatExpression angegeben, müssen diese synonym sein. Data Type Extension(string) Extension URL https://ths-greifswald.de/fhir/StructureDefinition/gics/TemplateVersionFormat 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 rim:n/a rim:N/A
property	S I	0..*	Extension(Complex)	Element Id ResearchStudy.extension:property Short description properties Alternate names extensions, user content Definition Liste frei konfigurierbarer Properties nach dem KeyValuePrinzip zur Auswertung durch den gICS Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type Extension(Complex) Extension URL https://ths-greifswald.de/fhir/StructureDefinition/gics/Property 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 rim:n/a rim:N/A
externalProperty	S I	0..*	Extension(Complex)	Element Id ResearchStudy.extension:externalProperty Short description externalProperties Alternate names extensions, user content Definition Liste frei konfigurierbarer external Properties nach dem KeyValuePrinzip zur Auswertung durch externe Anwendersysteme Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type Extension(Complex) Extension URL https://ths-greifswald.de/fhir/StructureDefinition/gics/ExternalProperty 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 rim:n/a rim:N/A
expirationProperty	S I	0..*	Extension(Complex)	Element Id ResearchStudy.extension:expirationProperty Short description expirationProperties Alternate names extensions, user content Definition Liste von automatisierbaren Ablaufeigenschaften der nach dem KeyValuePrinzip Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type Extension(Complex) Extension URL https://ths-greifswald.de/fhir/StructureDefinition/gics/ExpirationProperty 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 rim:n/a rim:N/A
identifier	S Σ	1..*	Identifier	Element Id ResearchStudy.identifier Short description Domänen-Name Definition Identifiers assigned to this research study by the sponsor or other systems. Requirements Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers. Data Type Identifier Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings 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
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element Id ResearchStudy.identifier.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data Type code Binding Identifies 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 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 Id ResearchStudy.identifier.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments 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. Data Type CodeableConcept Binding A 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 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	uriFixed Value	Element Id ResearchStudy.identifier.system Short description Instanzspezifischer Gültigkeitsbereich des Domänen-Namens Definition Instanzspezifischer Gültigkeitsbereich des Domänen-Namens Requirements 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. Comments Identifier.system is always case sensitive. Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed Value https://ths-greifswald.de/fhir/gics/ 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	Element Id ResearchStudy.identifier.value Short description Name der Consent Domain Definition Maschinenlesbarer Name der Consent Domain, innerhalb der gICS Instanz eindeutig Comments 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. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 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 Id ResearchStudy.identifier.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Comments 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. Data Type 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)` Mappings 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 Id ResearchStudy.identifier.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments 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. Data Type 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'))` Mappings 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 Id ResearchStudy.title Short description Label der Consent Domain Definition Menschenlesbarer Name der Consent Domain, sollte innerhalb der gICS Instanz eindeutig sein. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings 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 Id ResearchStudy.protocol Short description Steps followed in executing study Definition The set of steps expected to be performed as part of the execution of the study. Comments 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. Data Type 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'))` Mappings 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 Id ResearchStudy.partOf Short description Part of larger study Alternate names container Definition A larger research study of which this particular study is a component or step. Requirements Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc. Comments 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. Data Type 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'))` Mappings 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	Element Id ResearchStudy.status Short description active \| in-review Definition Finalisierungsstatus der Consent Domain Configuration. (Finalized=true ->status=active; Finalized=false->status=in-review) Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type code Binding Codes 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 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 Id ResearchStudy.primaryPurposeType Short description 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. Comments 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. Data Type CodeableConcept Binding Codes 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 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 Id ResearchStudy.phase Short 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. Comments 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. Data Type 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. ResearchStudyPhase (example) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings 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 Id ResearchStudy.category Short 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. Comments 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. Data Type CodeableConcept Binding Codes 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 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 Id ResearchStudy.focus Short 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. Comments 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. Data Type CodeableConcept Binding Codes 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 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 Id ResearchStudy.condition Short 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. Comments 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. Data Type CodeableConcept Binding Identification 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 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 Id ResearchStudy.contact Short description Contact details for the study Definition Contact details to assist a user in learning more about or engaging with the study. Data Type ContactDetail Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings 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 Id ResearchStudy.relatedArtifact Short description References and dependencies Definition Citations, references and other related documents. Comments Each related artifact is either an attachment, or a reference to another knowledge resource, but not both. Data Type RelatedArtifact Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings 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 Id ResearchStudy.keyword Short description Used to search for the study Definition Key terms to aid in searching for or filtering the study. Comments 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. Data Type CodeableConcept Binding Words 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 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
location	Σ	0..*	CodeableConceptBinding	There are no (further) constraints on this element Element Id ResearchStudy.location Short description Geographic region(s) for study Definition Indicates a country, state or other region where the study is taking place. Comments 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. Data Type CodeableConcept Binding Countries 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 rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD BRIDG5.1:StudyProtocolVersion.participatingLocationCode
description	S	1..1	markdown	Element Id ResearchStudy.description Short description Zweckbeschreibung der Consent Domain Definition Administrativer Kommentar zur Zweckbeschreibung der Consent Domain Comments 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/ Data Type markdown Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a clinicaltrials-gov:Detailed Description BRIDG5.1:StudyProtocolDocumentVersion.publicDescription
enrollment	Σ I	0..*	Reference(Group)	There are no (further) constraints on this element Element Id ResearchStudy.enrollment Short 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". Comments The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource. Data Type 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'))` Mappings 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
period	Σ I	0..1	Period	There are no (further) constraints on this element Element Id ResearchStudy.period Short 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. Comments 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. Data Type 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)` Mappings 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
sponsor	Σ I	0..1	Reference(Organization)	There are no (further) constraints on this element Element Id ResearchStudy.sponsor Short description Organization that initiates and is legally responsible for the study Definition An organization that initiates the investigation and is legally responsible for the study. Comments 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. Data Type 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'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity) clinicaltrials-gov:Sponsor w5:FiveWs.actor BRIDG5.1:RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode rim:.participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
principalInvestigator	Σ I	0..1	Reference(Practitioner \| PractitionerRole)	There are no (further) constraints on this element Element Id ResearchStudy.principalInvestigator Short description 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. Comments 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. Data Type 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'))` Mappings 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
site	Σ I	0..*	Reference(Location)	There are no (further) constraints on this element Element Id ResearchStudy.site Short description Facility where study activities are conducted Definition A facility in which study activities are conducted. Comments 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. Data Type 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'))` Mappings 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
reasonStopped	Σ	0..1	CodeableConcept	There are no (further) constraints on this element Element Id ResearchStudy.reasonStopped Short description 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. Comments 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. Data Type CodeableConcept Binding Codes 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 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
note		0..*	Annotation	There are no (further) constraints on this element Element Id ResearchStudy.note Short description Comments made about the study Definition Comments made about the study by the performer, subject or other participants. Comments 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). Data Type Annotation Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings 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]
arm		0..*	BackboneElement	There are no (further) constraints on this element Element Id ResearchStudy.arm Short 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. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a clinicaltrials-gov:Arms BRIDG5.1:Arm
name		1..1	string	There are no (further) constraints on this element Element Id ResearchStudy.arm.name Short description Label for study arm Definition Unique, human-readable label for this arm of the study. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a clinicaltrials-gov:Arm Label BRIDG5.1:Arm.name
type		0..1	CodeableConcept	There are no (further) constraints on this element Element Id ResearchStudy.arm.type Short description Categorization of study arm Definition Categorization of study arm, e.g. experimental, active comparator, placebo comparater. Comments 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. Data Type CodeableConcept Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov:Arm Type BRIDG5.1:Arm.typeCode
description		0..1	string	There are no (further) constraints on this element Element Id ResearchStudy.arm.description Short 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. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a clinicaltrials-gov:Arm Description BRIDG5.1:Arm.description
objective		0..*	BackboneElement	There are no (further) constraints on this element Element Id ResearchStudy.objective Short 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. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a BRIDG5.1:StudyObjective
name		0..1	string	There are no (further) constraints on this element Element Id ResearchStudy.objective.name Short description Label for the objective Definition Unique, human-readable label for this objective of the study. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings 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 Id ResearchStudy.objective.type Short description primary \| secondary \| exploratory Definition The kind of study objective. Comments 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. Data Type CodeableConcept Binding Codes 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 rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD BRIDG5.1:StudyObjective.typeCode

Zweck

Erweitertes Profil der Consent Management Domain Research Study (Arbeitsgruppe Einwilligungsmanagement) zur Abbildung aller relevanten Domain-Infos für gICS über entsprechende Extensions

Suchparameter

Name	Typ	Beschreibung	Pfad
identifier	token	Eindeutiger Name (Identifikator) der Domäne	ResearchStudy.identifier
_profile	reference	Angabe um Ausgabeprofil festzulegen. default: https://ths-greifswald.de/fhir/StructureDefinition/gics/ResearchStudy/ConsentDomain alternativ: http://fhir.de/ConsentManagement/StructureDefinition/Domain/ResearchStudy	ResearchStudy.meta.profile

Zulässige Kombinationen von Suchparametern:

alle ConsentDomains
GET [base]/gics/ResearchStudy
alle ConsentDomains, profiliert nach IG Einwilligungsmanagement
GET [base]/gics/ResearchStudy?_profile=http://fhir.de/ConsentManagement/StructureDefinition/Domain/ResearchStudy
spezifische ConsentDomain
GET [base]/gics/ResearchStudy?identifier=MIRACUM
GET [base]/gics/ResearchStudy?identifier=MIRACUM&_profile=http://fhir.de/ConsentManagement/StructureDefinition/Domain/ResearchStudy

Beispiel

<ResearchStudy xmlns="http://hl7.org/fhir">
    <id value="ConsentDomain-example-1" />
    <meta>
        <extension url="https://ths-greifswald.de/fhir/StructureDefinition/gics/Created">
            <valueInstant value="2020-01-02T04:05:06+01:00" />
        </extension>
        <profile value="https://ths-greifswald.de/fhir/StructureDefinition/ConsentDomain" />
    </meta>
    <extension url="http://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier">
        <extension url="resourceType">
            <valueCoding>
                <system value="http://hl7.org/fhir/resource-types" />
                <code value="Patient" />
            </valueCoding>
        </extension>
        <extension url="system">
            <valueUri value="https://ths-greifswald.de/fhir/gics/identifiers/CaseId" />
        </extension>
    </extension>
    <extension url="http://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier">
        <extension url="resourceType">
            <valueCoding>
                <system value="http://hl7.org/fhir/resource-types" />
                <code value="Patient" />
            </valueCoding>
        </extension>
        <extension url="system">
            <valueUri value="https://ths-greifswald.de/fhir/gics/identifiers/SapId" />
        </extension>
    </extension>
    <extension url="https://ths-greifswald.de/fhir/StructureDefinition/gics/PolicyVersionFormat">
        <valueString value="major.minor" />
    </extension>
    <extension url="https://ths-greifswald.de/fhir/StructureDefinition/gics/ModuleVersionFormat">
        <valueString value="major.minor" />
    </extension>
    <extension url="https://ths-greifswald.de/fhir/StructureDefinition/gics/TemplateVersionFormat">
        <valueString value="major.minor.char" />
    </extension>
    <extension url="https://ths-greifswald.de/fhir/StructureDefinition/gics/Property">
        <extension url="key">
            <valueString value="REVOKE_IS_PERMANENT" />
        </extension>
        <extension url="value">
            <valueString value="true" />
        </extension>
    </extension>
    <extension url="https://ths-greifswald.de/fhir/StructureDefinition/gics/ExternalProperty">
        <extension url="key">
            <valueString value="containsHtml" />
        </extension>
        <extension url="value">
            <valueString value="true" />
        </extension>
    </extension>
    <identifier>
        <system value="https://ths-greifswald.de/fhir/gics/" />
        <value value="MIRACUM" />
    </identifier>
    <title value="MIRACUM" />
    <status value="in-review" />
    <description value="Test-Dom&#228;ne zur Veranschaulichung von FHIR-Aufrufen" />
</ResearchStudy>