Medizininformatik Initiative – ImplementationGuide – Medizinisches Forschungsvorhaben v2026

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

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]

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.id

Short description

Logical id of this artifact

Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Data type

There are no (further) constraints on this element

Element id

ResearchStudy.meta

Short description

Metadata about the resource

Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
rim: N/A

implicitRules

Σ ?!

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.implicitRules

Short description

A set of rules under which this content was created

Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

language

0..1

codeBinding

There are no (further) constraints on this element

Element id

ResearchStudy.language

Short description

Language of the resource content

Definition

The base language in which the resource is written.

Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Data type

Binding

A human language.

CommonLanguages (preferred)

Binding extensions

maxValueSet	AllLanguages

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

text

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.text

Short description

Text summary of the resource, for human interpretation

Alternate names

narrative, html, xhtml, display

Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
rim: N/A
rim: Act.text?

contained

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.contained

Short description

Contained, inline Resources

Alternate names

inline resources, anonymous resources, contained resources

Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

Data type

Mappings

rim: Entity. Role, or Act
rim: N/A

extension

S C

0..*

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

http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

Label

S C

0..*

Extension(Complex)

Element id

ResearchStudy.extension:Label

Short description

Label

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

Extension(Complex)

Extension URL

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

AssociatedParty

S C

0..*

Extension(Complex)

Element id

ResearchStudy.extension:AssociatedParty

Short description

AssociatedParty

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

Extension(Complex)

Extension URL

http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

Ethikvotum

S C

0..*

Extension(Complex)

Element id

ResearchStudy.extension:Ethikvotum

Short description

Ethikvotum

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

Extension(Complex)

Extension URL

https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

Studienregister

S C

0..*

Element id

ResearchStudy.extension:Studienregister

Short description

Studienregister

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister

Extension URL

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

Eligibility

S C

0..1

Element id

ResearchStudy.extension:Eligibility

Short description

Eligibility

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility

Extension URL

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

Akronym

S C

0..1

Element id

ResearchStudy.extension:Akronym

Short description

Akronym

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym

Extension URL

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

Rekrutierung

S C

0..1

Extension(Complex)

Element id

ResearchStudy.extension:Rekrutierung

Short description

Rekrutierung

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

Extension(Complex)

Extension URL

https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

Finanzierung

S C

0..*

Element id

ResearchStudy.extension:Finanzierung

Short description

Finanzierung

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung

Extension URL

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

modifierExtension

?! C

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.modifierExtension

Short description

Extensions that cannot be ignored

Alternate names

extensions, user content

Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

identifier

S Σ

0..*

Element id

ResearchStudy.identifier

Short description

Name für diese Studie

Definition

Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden.

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.identifier.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.identifier.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

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

Binding

Identifies the purpose for this identifier, if known .

IdentifierUse (required)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: N/A
rim: Role.code or implied by context

type

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

Identifier Type Codes (extensible)

Binding

A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Examples
General

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 C

0..1

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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 C

0..1

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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

Element id

ResearchStudy.title

Short description

Name für diese Studie

Definition

Ein kurzer, beschreibender und benutzerfreundlicher Bezeichner für die Studie.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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 C

0..*

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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 C

0..*

Element id

ResearchStudy.partOf

Short description

Teil einer größeren Studie.

Alternate names

container

Definition

Eine größere Forschungsstudie, von der diese spezielle Studie ein Bestandteil oder ein Schritt ist.

Requirements

Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ref-1: SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

Mappings

rim: n/a
rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
BRIDG5.1: CompanionStudyRelationship
rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]

status

S Σ ?!

1..1

codeBinding

Element id

ResearchStudy.status

Short description

Definition

Der aktuelle Status der Studie.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

ResearchStudyStatus (required)

Binding

Codes that convey the current status of the research study.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
w5: FiveWs.status
BRIDG5.1: StudyOverallStatus.code
rim: .status

primaryPurposeType

0..1

CodeableConceptBinding

There are no (further) constraints on this element

Element id

ResearchStudy.primaryPurposeType

Short description

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

ResearchStudyPrimaryPurposeType (extensible)

Binding

Codes for the main intent of the study.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: CE/CNE/CWE
rim: CD
orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
BRIDG5.1: StudyProtocolVersion.primaryPurposeTypeCode

phase

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.phase

Short description

Definition

The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

Comments

Data type

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)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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..*

Element id

ResearchStudy.category

Short description

Klassifikationen für die Studie.

Definition

Codes zur Kategorisierung des Studientyps, wie z. B. experimentell vs. beobachtend, Art der Verblindung, Art der Randomisierung, Sicherheit vs. Wirksamkeit usw.

Comments

Data type

Binding

Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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..*

Element id

ResearchStudy.focus

Short description

Untersuchte Medikamente, Geräte usw.

Definition

Die Medikamente, Nahrungsmittel, Therapien, Geräte oder andere Anliegen oder Interventionen, über die die Studie mehr Informationen gewinnen möchte.

Comments

Data type

Binding

Codes for medications, devices and other interventions.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.focus.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.focus.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

coding

0..*

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

text

S Σ

0..1

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: C*E.9. But note many systems use C*E.2 for this
rim: ./originalText[mediaType/code="text/plain"]/data
orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

condition

0..*

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

Data type

Condition/Problem/DiagnosisCodes (example)

Binding

Identification of the condition or diagnosis.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

0..*

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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..*

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
clinicaltrials-gov: Citations, Links, Available Study Data/Documents
BRIDG5.1: StudyProtocolDocument, StudyProtocolDocumentVersion

keyword

S Σ

0..*

Element id

ResearchStudy.keyword

Short description

Wird verwendet, um nach der Studie zu suchen.

Definition

Schlüsselbegriffe, die bei der Suche nach oder Filterung der Studie helfen.

Comments

Data type

Binding

Words associated with the study that may be useful in discovery.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.keyword.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.keyword.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

coding

0..*

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

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

text

S Σ

0..1

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

Comments

Very often the text is the same as a displayName of one of the codings.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: C*E.9. But note many systems use C*E.2 for this
rim: ./originalText[mediaType/code="text/plain"]/data
orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

location

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

Data type

Jurisdiction ValueSet (extensible)

Binding

Countries and regions within which this artifact is targeted for use.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: CE/CNE/CWE
rim: CD
orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
BRIDG5.1: StudyProtocolVersion.participatingLocationCode

description

0..1

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
clinicaltrials-gov: Detailed Description
BRIDG5.1: StudyProtocolDocumentVersion.publicDescription

enrollment

Σ C

0..*

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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 C

0..1

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

Period is not used for a duration (a measure of elapsed time). See Duration.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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 C

0..1

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

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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 C

0..1

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

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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 C

0..*

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

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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

0..1

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

Data type

ResearchStudyReasonStopped (example)

Binding

Codes for why the study ended prematurely.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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..*

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: N/A
rim: Act
BRIDG5.1: No BRIDG mapping
rim: .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]

arm

0..*

Element id

ResearchStudy.arm

Short description

Definierter Weg durch die Studie für ein Subjekt.

Definition

Beschreibt eine erwartete Abfolge von Ereignissen für einen der Teilnehmer einer Studie. Z. B. Exposition gegenüber Medikament A, Auswaschphase, Exposition gegenüber Medikament B, Auswaschphase, Nachverfolgung.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
clinicaltrials-gov: Arms
BRIDG5.1: Arm

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.arm.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.arm.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

modifierExtension

Σ ?! C

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.arm.modifierExtension

Short description

Extensions that cannot be ignored even if unrecognized

Alternate names

extensions, user content, modifiers

Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Requirements

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

name

1..1

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
clinicaltrials-gov: Arm Label
BRIDG5.1: Arm.name

type

0..1

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

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
clinicaltrials-gov: Arm Description
BRIDG5.1: Arm.description

objective

0..*

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
BRIDG5.1: StudyObjective

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.objective.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.objective.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

modifierExtension

Σ ?! C

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.objective.modifierExtension

Short description

Extensions that cannot be ignored even if unrecognized

Alternate names

extensions, user content, modifiers

Definition

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Requirements

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

name

0..1

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

Data type

ResearchStudyObjectiveType (preferred)

Binding

Codes for the kind of study objective.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

MII_PR_Studie_Studie (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

Comments

Need to make sure we encompass public health studies.

Data type

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]

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.id

Short description

Logical id of this artifact

Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Data type

There are no (further) constraints on this element

Element id

ResearchStudy.meta

Short description

Metadata about the resource

Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
rim: N/A

implicitRules

Σ ?!

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.implicitRules

Short description

A set of rules under which this content was created

Definition

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

language

0..1

codeBinding

There are no (further) constraints on this element

Element id

ResearchStudy.language

Short description

Language of the resource content

Definition

The base language in which the resource is written.

Comments

Data type

Binding

A human language.

CommonLanguages (preferred)

Binding extensions

maxValueSet	AllLanguages

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

text

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.text

Short description

Text summary of the resource, for human interpretation

Alternate names

narrative, html, xhtml, display

Definition

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
rim: N/A
rim: Act.text?

contained

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.contained

Short description

Contained, inline Resources

Alternate names

inline resources, anonymous resources, contained resources

Definition

Comments

Data type

Mappings

rim: Entity. Role, or Act
rim: N/A

extension

S C

0..*

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

Comments

Data type

http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

Label

S C

0..*

Extension(Complex)

Element id

ResearchStudy.extension:Label

Short description

Label

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

Extension(Complex)

Extension URL

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

AssociatedParty

S C

0..*

Extension(Complex)

Element id

ResearchStudy.extension:AssociatedParty

Short description

AssociatedParty

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

Extension(Complex)

Extension URL

http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

Ethikvotum

S C

0..*

Extension(Complex)

Element id

ResearchStudy.extension:Ethikvotum

Short description

Ethikvotum

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

Extension(Complex)

Extension URL

https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

Studienregister

S C

0..*

Element id

ResearchStudy.extension:Studienregister

Short description

Studienregister

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister

Extension URL

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

Eligibility

S C

0..1

Element id

ResearchStudy.extension:Eligibility

Short description

Eligibility

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility

Extension URL

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

Akronym

S C

0..1

Element id

ResearchStudy.extension:Akronym

Short description

Akronym

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym

Extension URL

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

Rekrutierung

S C

0..1

Extension(Complex)

Element id

ResearchStudy.extension:Rekrutierung

Short description

Rekrutierung

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

Extension(Complex)

Extension URL

https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

Finanzierung

S C

0..*

Element id

ResearchStudy.extension:Finanzierung

Short description

Finanzierung

Alternate names

extensions, user content

Definition

Optionales Erweiterungselement – in allen Ressourcen vorhanden.

Comments

Data type

https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung

Extension URL

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

modifierExtension

?! C

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.modifierExtension

Short description

Extensions that cannot be ignored

Alternate names

extensions, user content

Definition

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Requirements

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

identifier

S Σ

0..*

Element id

ResearchStudy.identifier

Short description

Name für diese Studie

Definition

Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden.

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.identifier.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.identifier.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

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

Binding

Identifies the purpose for this identifier, if known .

IdentifierUse (required)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: N/A
rim: Role.code or implied by context

type

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

Data type

Identifier Type Codes (extensible)

Binding

A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

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

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Examples
General

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 C

0..1

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

Period is not used for a duration (a measure of elapsed time). See Duration.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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 C

0..1

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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

Element id

ResearchStudy.title

Short description

Name für diese Studie

Definition

Ein kurzer, beschreibender und benutzerfreundlicher Bezeichner für die Studie.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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 C

0..*

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

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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 C

0..*

Element id

ResearchStudy.partOf

Short description

Teil einer größeren Studie.

Alternate names

container

Definition

Eine größere Forschungsstudie, von der diese spezielle Studie ein Bestandteil oder ein Schritt ist.

Requirements

Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ref-1: SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

Mappings

rim: n/a
rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
BRIDG5.1: CompanionStudyRelationship
rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]

status

S Σ ?!

1..1

codeBinding

Element id

ResearchStudy.status

Short description

Definition

Der aktuelle Status der Studie.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

ResearchStudyStatus (required)

Binding

Codes that convey the current status of the research study.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
w5: FiveWs.status
BRIDG5.1: StudyOverallStatus.code
rim: .status

primaryPurposeType

0..1

CodeableConceptBinding

There are no (further) constraints on this element

Element id

ResearchStudy.primaryPurposeType

Short description

Definition

The type of study based upon the intent of the study's activities. A classification of the intent of the study.

Comments

Data type

ResearchStudyPrimaryPurposeType (extensible)

Binding

Codes for the main intent of the study.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: CE/CNE/CWE
rim: CD
orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
BRIDG5.1: StudyProtocolVersion.primaryPurposeTypeCode

phase

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.phase

Short description

Definition

The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

Comments

Data type

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)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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..*

Element id

ResearchStudy.category

Short description

Klassifikationen für die Studie.

Definition

Codes zur Kategorisierung des Studientyps, wie z. B. experimentell vs. beobachtend, Art der Verblindung, Art der Randomisierung, Sicherheit vs. Wirksamkeit usw.

Comments

Data type

Binding

Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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..*

Element id

ResearchStudy.focus

Short description

Untersuchte Medikamente, Geräte usw.

Definition

Die Medikamente, Nahrungsmittel, Therapien, Geräte oder andere Anliegen oder Interventionen, über die die Studie mehr Informationen gewinnen möchte.

Comments

Data type

Binding

Codes for medications, devices and other interventions.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.focus.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.focus.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

coding

0..*

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

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

text

S Σ

0..1

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

Comments

Very often the text is the same as a displayName of one of the codings.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: C*E.9. But note many systems use C*E.2 for this
rim: ./originalText[mediaType/code="text/plain"]/data
orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

condition

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.condition

Short description

Condition being studied

Definition

Comments

Data type

Condition/Problem/DiagnosisCodes (example)

Binding

Identification of the condition or diagnosis.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

0..*

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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..*

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
clinicaltrials-gov: Citations, Links, Available Study Data/Documents
BRIDG5.1: StudyProtocolDocument, StudyProtocolDocumentVersion

keyword

S Σ

0..*

Element id

ResearchStudy.keyword

Short description

Wird verwendet, um nach der Studie zu suchen.

Definition

Schlüsselbegriffe, die bei der Suche nach oder Filterung der Studie helfen.

Comments

Data type

Binding

Words associated with the study that may be useful in discovery.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.keyword.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.keyword.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

coding

0..*

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

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

text

S Σ

0..1

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

Comments

Very often the text is the same as a displayName of one of the codings.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: C*E.9. But note many systems use C*E.2 for this
rim: ./originalText[mediaType/code="text/plain"]/data
orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

location

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

Data type

Jurisdiction ValueSet (extensible)

Binding

Countries and regions within which this artifact is targeted for use.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: CE/CNE/CWE
rim: CD
orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
BRIDG5.1: StudyProtocolVersion.participatingLocationCode

description

0..1

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
clinicaltrials-gov: Detailed Description
BRIDG5.1: StudyProtocolDocumentVersion.publicDescription

enrollment

Σ C

0..*

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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 C

0..1

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

Period is not used for a duration (a measure of elapsed time). See Duration.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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 C

0..1

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

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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 C

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.principalInvestigator

Short description

Researcher who oversees multiple aspects of the study

Definition

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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 C

0..*

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

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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

0..1

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

Data type

ResearchStudyReasonStopped (example)

Binding

Codes for why the study ended prematurely.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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..*

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

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: N/A
rim: Act
BRIDG5.1: No BRIDG mapping
rim: .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]

arm

0..*

Element id

ResearchStudy.arm

Short description

Definierter Weg durch die Studie für ein Subjekt.

Definition

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
clinicaltrials-gov: Arms
BRIDG5.1: Arm

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.arm.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.arm.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

modifierExtension

Σ ?! C

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.arm.modifierExtension

Short description

Extensions that cannot be ignored even if unrecognized

Alternate names

extensions, user content, modifiers

Definition

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Requirements

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

name

1..1

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
clinicaltrials-gov: Arm Label
BRIDG5.1: Arm.name

type

0..1

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

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
clinicaltrials-gov: Arm Description
BRIDG5.1: Arm.description

objective

0..*

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
BRIDG5.1: StudyObjective

0..1

There are no (further) constraints on this element

Element id

ResearchStudy.objective.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.objective.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

modifierExtension

Σ ?! C

0..*

There are no (further) constraints on this element

Element id

ResearchStudy.objective.modifierExtension

Short description

Extensions that cannot be ignored even if unrecognized

Alternate names

extensions, user content, modifiers

Definition

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Requirements

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

name

0..1

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

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

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

Data type