[DE] Medizininformatik Initiative - Medizinische Forschungsvorhaben - Implementierungsleitfaden - Version 1.0

Studie (ResearchStudy)

Beschreibung

Dieses Profil beschreibt eine Studie in der Medizininformatik-Initiative.

Name	Canonical
MII_PR_Studie_Studie	https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie

Differential

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]
extension	S I	0..*	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
Label	S I	0..*	Extension(Complex)	Element Id ResearchStudy.extension:Label Short description MII EX Studie Backport Label 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://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label 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
AssociatedParty	S I	0..*	Extension(Complex)	Element Id ResearchStudy.extension:AssociatedParty Short description MII EX Studie Backport AssociatedParty 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://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty 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
Ethikvotum	S I	0..*	Extension(Complex)	Element Id ResearchStudy.extension:Ethikvotum Short description MII EX Studie Ethikvotum 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 https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum 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
Studienregister	S I	0..*	Extension(Reference(Library))	Element Id ResearchStudy.extension:Studienregister Short description MII EX Studie Studienregister 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(Reference(Library)) Extension URL https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister 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
Eligibility	S I	0..1	Extension(Reference(Group \| EvidenceVariable))	Element Id ResearchStudy.extension:Eligibility Short description MII EX Studie Eligibility 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(Reference(Group \| EvidenceVariable)) Extension URL https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility 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
Akronym	S I	0..1	Extension(string)	Element Id ResearchStudy.extension:Akronym Short description MII EX Studie Akronym 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(string) Extension URL https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym 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
Rekrutierung	S I	0..1	Extension(Complex)	Element Id ResearchStudy.extension:Rekrutierung Short description MII EX Studie Rekrutierung 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 https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung 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
Finanzierung	S I	0..*	Extension(string)	Element Id ResearchStudy.extension:Finanzierung Short description MII EX Studie Finanzierung 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(string) Extension URL https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung 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	0..*	Identifier	There are no (further) constraints on this element Element Id ResearchStudy.identifier Short description Business Identifier for study 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	0..1	uri	There are no (further) constraints on this element Element Id ResearchStudy.identifier.system Short description 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. 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())` Examples General http://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	0..1	string	There are no (further) constraints on this element Element Id ResearchStudy.identifier.value Short description 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. 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	0..1	string	There are no (further) constraints on this element Element Id ResearchStudy.title Short description Name for this study Definition A short, descriptive user-friendly label for 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: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	S 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	There are no (further) constraints on this element Element Id ResearchStudy.status Short 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. 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	S 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	S 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
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element Id ResearchStudy.focus.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data Type Coding 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 v2:CE.1-8, CE.10-22 rim:union(., ./translation) orim:fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	S Σ	0..1	string	There are no (further) constraints on this element Element Id ResearchStudy.focus.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. 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 v2:CE.9. But note many systems use CE.2 for this rim:./originalText[mediaType/code="text/plain"]/data orim:fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
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	S 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
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element Id ResearchStudy.keyword.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data Type Coding 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 v2:CE.1-8, CE.10-22 rim:union(., ./translation) orim:fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	S Σ	0..1	string	There are no (further) constraints on this element Element Id ResearchStudy.keyword.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. 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 v2:CE.9. But note many systems use CE.2 for this rim:./originalText[mediaType/code="text/plain"]/data orim:fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
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		0..1	markdown	There are no (further) constraints on this element Element Id ResearchStudy.description Short description What this is study doing Definition A full description of how the study is being conducted. 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	S	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	S	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

Hinweise

FHIR-Element	Erklärung
ResearchStudy.id	Must-support, jedoch optional
ResearchStudy.meta	Must-support, jedoch optional
ResearchStudy.meta.profile	Verpflichtend für die Abfrage im DIZ-Repository inkl. Versionsnummer des Profils. Siehe CapabilityStatement. In allen anderen Fällen optional.
ResearchStudy.identifier	In den meisten Fällen wird kein NamingSystem für die Vergabe der BusinessIDs geben. Ein eigenes lokales NamingSystem sollte daher verwendet werden.
ResearchStudy.extension:RekrutierungsstandGenauigkeit	Hausinterne Kodierung kann hier verwendet werden. Die nächste Version des vorliegenden Moduls wird hier voraussichtlich weitere Vorgaben zur Standardisierung eines ValueSets fordern.
ResearchStudy.extension:Randomisierungsmethode	Hausinterne Kodierung kann hier verwendet werden. Die nächste Version des vorliegenden Moduls wird hier voraussichtlich weitere Vorgaben zur Standardisierung eines ValueSets fordern.
ResearchStudy.extension:associatedParty	Diese Extension kann verwendet werden, falls mehr Kontaktpersonen zu der Studie angegeben werden sollen, als die Kardinalität von ResearchStudy.principalInvestigator oder ResearchStudy.sponsor dies erlaubt.
ResearchStudy.category	Hausinterne Kodierung kann hier verwendet werden. Die nächste Version des vorliegenden Moduls wird hier voraussichtlich weitere Vorgaben zur Standardisierung eines ValueSets fordern.

NamingSystems

Für folgende Studienregister werden bereits Preferred URLs für die dazugehörigen NamingSystems definiert:

Register	URL
clinicaltrials.gov	https://clinicaltrials.gov
Deutsches Register Klinischer Studien (DRKS)	https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks
Universal Trial Number (UTN)	https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/utn
EudraCT	https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract

Mapping

FHIR Element	Logischer Datensatz
ResearchStudy.title	Forschungsvorhaben.Titel
ResearchStudy.focus	Forschungsvorhaben.Studienfokus
ResearchStudy.keyword	Forschungsvorhaben.Schlagwort
ResearchStudy.extension:OeffentlicherTitel	Forschungsvorhaben.Titel.OeffentlicherTitel
ResearchStudy.extension:WissenschaftlicherTitel	Forschungsvorhaben.Titel.WissenschaftlicherTitel
ResearchStudy.extension:Akronym	Forschungsvorhaben.Titel.Akronym
ResearchStudy.extension:Rekrutierungsstart	Forschungsvorhaben.Studiendesign.Rekrutierungsstart
ResearchStudy.arm.name	Forschungsvorhaben.Studiendesign.Studienarm.Name
ResearchStudy.category	Forschungsvorhaben.Studiendesign.Studientyp
ResearchStudy.extension:Rekrutierungsziel	Forschungsvorhaben.Studiendesign.Rekrutierungsziel
ResearchStudy.extension:Rekrutierungsstand	Forschungsvorhaben.Studiendesign.Rekrutierungsstand
ResearchStudy.extension:RekrutierungsstandGenauigkeit	Forschungsvorhaben.Studiendesign.Rekrutierungsstand.RekrutierungsstandGenauigkeit
ResearchStudy.extension:RekrutierungsstandDatum	Forschungsvorhaben.Studiendesign.Rekrutierungsstand.RekrutierungsstandDatum
ResearchStudy.category	Forschungsvorhaben.Studiendesign.Randomisierungsmethode

FHIR Element	Logischer Datensatz
ResearchStudy.extension:finanzierung	Forschungsvorhaben.Finanzierung

FHIR Element	Logischer Datensatz
ResearchStudy.identifier.value	Forschungsvorhaben.BusinessID.id
ResearchStudy.identifier.system	Forschungsvorhaben.BusinessID.System

Snapshot

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]
extension	S I	0..*	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
Label	S I	0..*	Extension(Complex)	Element Id ResearchStudy.extension:Label Short description MII EX Studie Backport Label 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://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label 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
AssociatedParty	S I	0..*	Extension(Complex)	Element Id ResearchStudy.extension:AssociatedParty Short description MII EX Studie Backport AssociatedParty 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://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty 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
Ethikvotum	S I	0..*	Extension(Complex)	Element Id ResearchStudy.extension:Ethikvotum Short description MII EX Studie Ethikvotum 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 https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum 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
Studienregister	S I	0..*	Extension(Reference(Library))	Element Id ResearchStudy.extension:Studienregister Short description MII EX Studie Studienregister 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(Reference(Library)) Extension URL https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister 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
Eligibility	S I	0..1	Extension(Reference(Group \| EvidenceVariable))	Element Id ResearchStudy.extension:Eligibility Short description MII EX Studie Eligibility 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(Reference(Group \| EvidenceVariable)) Extension URL https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility 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
Akronym	S I	0..1	Extension(string)	Element Id ResearchStudy.extension:Akronym Short description MII EX Studie Akronym 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(string) Extension URL https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym 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
Rekrutierung	S I	0..1	Extension(Complex)	Element Id ResearchStudy.extension:Rekrutierung Short description MII EX Studie Rekrutierung 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 https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung 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
Finanzierung	S I	0..*	Extension(string)	Element Id ResearchStudy.extension:Finanzierung Short description MII EX Studie Finanzierung 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(string) Extension URL https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung 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	0..*	Identifier	There are no (further) constraints on this element Element Id ResearchStudy.identifier Short description Business Identifier for study 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	0..1	uri	There are no (further) constraints on this element Element Id ResearchStudy.identifier.system Short description 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. 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())` Examples General http://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	0..1	string	There are no (further) constraints on this element Element Id ResearchStudy.identifier.value Short description 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. 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	0..1	string	There are no (further) constraints on this element Element Id ResearchStudy.title Short description Name for this study Definition A short, descriptive user-friendly label for 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: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	S 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	There are no (further) constraints on this element Element Id ResearchStudy.status Short 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. 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	S 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	S 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
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element Id ResearchStudy.focus.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data Type Coding 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 v2:CE.1-8, CE.10-22 rim:union(., ./translation) orim:fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	S Σ	0..1	string	There are no (further) constraints on this element Element Id ResearchStudy.focus.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. 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 v2:CE.9. But note many systems use CE.2 for this rim:./originalText[mediaType/code="text/plain"]/data orim:fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
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	S 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
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element Id ResearchStudy.keyword.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data Type Coding 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 v2:CE.1-8, CE.10-22 rim:union(., ./translation) orim:fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	S Σ	0..1	string	There are no (further) constraints on this element Element Id ResearchStudy.keyword.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. 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 v2:CE.9. But note many systems use CE.2 for this rim:./originalText[mediaType/code="text/plain"]/data orim:fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
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		0..1	markdown	There are no (further) constraints on this element Element Id ResearchStudy.description Short description What this is study doing Definition A full description of how the study is being conducted. 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	S	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	S	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

Suchparameter

Folgende Suchparameter sind für das Modul Studie relevant, auch in Kombination:

Der Suchparameter "_id" MUSS unterstützt werden:

Beispiele:

GET [base]/ResearchStudy?_id=103270

Anwendungshinweise: Weitere Informationen zur Suche nach "_id" finden sich in der FHIR-Basisspezifikation - Abschnitt "Parameters for all resources".
Der Suchparameter "_profile" MUSS unterstützt werden:

Beispiele:

GET [base]/ResearchStudy?_profile=https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie

Anwendungshinweise: Weitere Informationen zur Suche nach "_profile" finden sich in der FHIR-Basisspezifikation - Abschnitt "Parameters for all resources".
Der Suchparameter "identifier" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?identifier=DRKS00031294

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.identifier" finden sich in der FHIR-Basisspezifikation - Abschnitt "token".
Der Suchparameter "title" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?title=Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.title" finden sich in der FHIR-Basisspezifikation - Abschnitt "string".
Der Suchparameter "status" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?status=active

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.status" finden sich in der FHIR-Basisspezifikation - Abschnitt "token".
Der Suchparameter "partOf" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?partOf=ResearchStudy/researchstudy-test

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.partOf" finden sich in der FHIR-Basisspezifikation - Abschnitt "reference".
Der Suchparameter "category" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?category=interventional

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.category" finden sich in der FHIR-Basisspezifikation - Abschnitt "token".
Der Suchparameter "armName" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?armName=frontale anodale tDCS (verum condition)

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.arm.name" finden sich in der FHIR-Basisspezifikation - Abschnitt "string".
Der Suchparameter "studienfokus" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?studienfokus=Long-COVID bedingter Fatigue

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.extension:Studienfokus" finden sich in der FHIR-Basisspezifikation - Abschnitt "string".
Der Suchparameter "schlagwort" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?schlagwort=COVID

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.extension:Schlagwort" finden sich in der FHIR-Basisspezifikation - Abschnitt "string".
Der Suchparameter "oeffentlicherTitel" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?oeffentlicherTitel=Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.extension:OeffentlicherTitel" finden sich in der FHIR-Basisspezifikation - Abschnitt "string".
Der Suchparameter "wissenschaftlicherIitel" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?wissenschaftlicherIitel=Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.extension:WissenschaftlicherTitel" finden sich in der FHIR-Basisspezifikation - Abschnitt "string".
Der Suchparameter "akronym" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?akronym=tDCS

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.extension:Akronym" finden sich in der FHIR-Basisspezifikation - Abschnitt "string".
Der Suchparameter "randomisierungsmethode" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?randomisierungsmethode=Zufallszuteilung

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.extension:Randomisierungsmethode" finden sich in der FHIR-Basisspezifikation - Abschnitt "string".
Der Suchparameter "studienregister" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?studienregister=Library/example

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.extension:Studienregister" finden sich in der FHIR-Basisspezifikation - Abschnitt "reference".
Der Suchparameter "rekrutierungsstand-datum" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?rekrutierungsstand-datum=2023-02-17

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.extension:Rekrutierung.extension:rekrutierungsstand-datum" finden sich in der FHIR-Basisspezifikation - Abschnitt "date".
Der Suchparameter "rekrutierungsstand-genauigkeit" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?rekrutierungsstand-genauigkeit=good

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.extension:Rekrutierung.extension:rekrutierungsstand-genauigkeit" finden sich in der FHIR-Basisspezifikation - Abschnitt "string".
Der Suchparameter "rekrutierungsstand-rekrutierungsstand" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?rekrutierungsstand=35

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.extension:Rekrutierung.extension:rekrutierungsstand" finden sich in der FHIR-Basisspezifikation - Abschnitt "number".
Der Suchparameter "rekrutierungsstand-rekrutierungsziel" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?rekrutierungsziel=40

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.extension:Rekrutierung.extension:rekrutierungsziel" finden sich in der FHIR-Basisspezifikation - Abschnitt "number".
Der Suchparameter "rekrutierungsstand-rekrutierungsstart" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?rekrutierungsstart=2023-01-12

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.extension:Rekrutierung.extension:rekrutierungsstart" finden sich in der FHIR-Basisspezifikation - Abschnitt "date".

Beispiele

Siehe Beispiel (minimal).