Medizininformatik Initiative – ImplementationGuide – Medizinisches Forschungsvorhaben v2026

Proband:in (ResearchSubject)

Beschreibung

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

Differential

MII_PR_Studie_Proband (ResearchSubject)

ResearchSubject

There are no (further) constraints on this element

Element id

ResearchSubject

Short description

Physical entity which is the primary unit of interest in the study

Alternate names

Study Subject

Definition

A physical entity which is the primary unit of operational and/or administrative interest in a study.

Comments

Need to make sure we encompass public health studies.

Data type

ResearchSubject

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: StudySubject
v2: OBX
rim: Observation[classCode=CLNTRL, moodCode=EVN]

S Σ

0..1

string

There are no (further) constraints on this element

Element id

ResearchSubject.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

string

Meta

There are no (further) constraints on this element

Element id

ResearchSubject.meta

Short description

Metadata about the resource

Definition

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

Data type

Meta

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

0..1

string

There are no (further) constraints on this element

Element id

ResearchSubject.meta.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

string

Mappings

rim: n/a

extension

0..*

Extension

There are no (further) constraints on this element

Element id

ResearchSubject.meta.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

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

Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Data type

Extension

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

versionId

0..1

There are no (further) constraints on this element

Element id

ResearchSubject.meta.versionId

Short description

Version specific identifier

Definition

The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

Comments

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

Data type

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

lastUpdated

0..1

instant

There are no (further) constraints on this element

Element id

ResearchSubject.meta.lastUpdated

Short description

When the resource version last changed

Definition

When the resource last changed - e.g. when the version changed.

Comments

This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

Data type

instant

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

source

0..1

uri

There are no (further) constraints on this element

Element id

ResearchSubject.meta.source

Short description

Identifies where the resource comes from

Definition

A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

Comments

In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

Data type

uri

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

profile

S Σ

0..*

canonical(StructureDefinition)

There are no (further) constraints on this element

Element id

ResearchSubject.meta.profile

Short description

Profiles this resource claims to conform to

Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Data type

canonical(StructureDefinition)

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

security

0..*

CodingBinding

There are no (further) constraints on this element

Element id

ResearchSubject.meta.security

Short description

Security Labels applied to this resource

Definition

Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

Comments

The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

Data type

Coding

Binding

Security Labels from the Healthcare Privacy and Security Classification System.

All Security Labels (extensible)

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

tag

0..*

Coding

There are no (further) constraints on this element

Element id

ResearchSubject.meta.tag

Short description

Tags applied to this resource

Definition

Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

Comments

The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

Data type

Coding

Binding

Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

CommonTags (example)

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

implicitRules

Σ ?!

0..1

uri

There are no (further) constraints on this element

Element id

ResearchSubject.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

uri

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

ResearchSubject.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

code

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

Narrative

There are no (further) constraints on this element

Element id

ResearchSubject.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

Narrative

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..*

Resource

There are no (further) constraints on this element

Element id

ResearchSubject.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

Resource

Mappings

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

extension

0..*

Extension

There are no (further) constraints on this element

Element id

ResearchSubject.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

Data type

Extension

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

?! C

0..*

Extension

There are no (further) constraints on this element

Element id

ResearchSubject.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

Extension

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

1..*

Identifier

Element id

ResearchSubject.identifier

Short description

Identifier des Probanden

Definition

Kennungen, die dem Probanden zugewiesen wurden.

Data type

Identifier

Slicing

Unordered, Open, by $this(Pattern)

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
w5: FiveWs.identifier
BRIDG5.1: StudySubject > Subject.identifier
rim: .identifier

subjectIdentificationCode

S Σ

1..1

IdentifierPattern

Element id

ResearchSubject.identifier:subjectIdentificationCode

Short description

Business Identifier for research subject in a study

Definition

Identifiers assigned to this research subject for a study.

Data type

Identifier

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())

Pattern

{
  "type": {
    "coding": [
      {
        "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
        "code": "ANON"
      }
    ]
  }
}

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
w5: FiveWs.identifier
BRIDG5.1: StudySubject > Subject.identifier
rim: .identifier

0..1

string

There are no (further) constraints on this element

Element id

ResearchSubject.identifier:subjectIdentificationCode.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

string

Mappings

rim: n/a

extension

0..*

Extension

There are no (further) constraints on this element

Element id

ResearchSubject.identifier:subjectIdentificationCode.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Extension

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

ResearchSubject.identifier:subjectIdentificationCode.use

Short description

usual | official | temp | secondary | old (If known)

Definition

The purpose of this identifier.

Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Data type

code

Binding

Identifies the purpose for this identifier, if known .

IdentifierUse (required)

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

S Σ

0..1

CodeableConceptBindingPattern

There are no (further) constraints on this element

Element id

ResearchSubject.identifier:subjectIdentificationCode.type

Short description

Description of identifier

Definition

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

Requirements

Allows users to make use of identifiers when the identifier system is not known.

Comments

This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

Data type

CodeableConcept

Binding

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

Identifier Type Codes (extensible)

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())

Pattern

{
  "coding": [
    {
      "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
      "code": "ANON"
    }
  ]
}

Mappings

rim: n/a
v2: CE/CNE/CWE
rim: CD
orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
v2: CX.5
rim: Role.code or implied by context

system

S Σ

1..1

uri

There are no (further) constraints on this element

Element id

ResearchSubject.identifier:subjectIdentificationCode.system

Short description

The namespace for the identifier value

Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Comments

Identifier.system is always case sensitive.

Data type

uri

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

1..1

string

There are no (further) constraints on this element

Element id

ResearchSubject.identifier:subjectIdentificationCode.value

Short description

The value that is unique

Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Data type

string

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

Period

There are no (further) constraints on this element

Element id

ResearchSubject.identifier:subjectIdentificationCode.period

Short description

Time period when id is/was valid for use

Definition

Time period during which identifier is/was valid for use.

Comments

A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times").

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

Data type

Period

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

Reference(Organization)

There are no (further) constraints on this element

Element id

ResearchSubject.identifier:subjectIdentificationCode.assigner

Short description

Organization that issued id (may be just text)

Definition

Organization that issued/manages the identifier.

Comments

The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

Data type

Reference(Organization)

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

status

S Σ ?!

1..1

codeBinding

Element id

ResearchSubject.status

Short description

Definition

Status der Teilnahme

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

code

Binding

Indicates the progression of a study subject through a study.

ResearchSubjectStatus (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
w5: FiveWs.status
BRIDG5.1: StudySubject.statusCode
rim: .status

period

S Σ C

1..1

Period

Element id

ResearchSubject.period

Short description

Anfang und Ende der Teilnahme

Alternate names

timing

Definition

Zeitrum, in denen die Teilnahme an der Studie begann und endete.

Comments

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

Data type

Period

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"]
w5: FiveWs.planned
BRIDG5.1: PerformedStudySubjectMilestone.studyReferenceDateRange

0..1

string

There are no (further) constraints on this element

Element id

ResearchSubject.period.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

string

Mappings

rim: n/a

extension

0..*

Extension

There are no (further) constraints on this element

Element id

ResearchSubject.period.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Extension

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

start

S Σ C

1..1

dateTime

There are no (further) constraints on this element

Element id

ResearchSubject.period.start

Short description

Starting time with inclusive boundary

Definition

The start of the period. The boundary is inclusive.

Comments

If the low element is missing, the meaning is that the low boundary is not known.

Data type

dateTime

Conditions

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

Constraints

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

Mappings

rim: n/a
v2: DR.1
rim: ./low

end

S Σ C

0..1

dateTime

There are no (further) constraints on this element

Element id

ResearchSubject.period.end

Short description

End time with inclusive boundary, if not ongoing

Definition

The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.

Comments

The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.

Meaning when missing

If the end of the period is missing, it means that the period is ongoing

Data type

dateTime

Conditions

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

Constraints

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

Mappings

rim: n/a
v2: DR.2
rim: ./high

study

S Σ C

1..1

Reference(ResearchStudy)

Element id

ResearchSubject.study

Short description

Studie, der der Proband angehört

Definition

Referenz auf die Studie, an der der Proband teilnimmt

Comments

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Data type

Reference(ResearchStudy)

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: StudySubjectProtocolVersionRelationship

individual

S Σ C

1..1

Reference(Patient)

Element id

ResearchSubject.individual

Short description

Wer an der Studie teilnimmt.

Definition

Der Datensatz der Person oder des Tieres, das an der Studie beteiligt ist.

Comments

Data type

Reference(Patient)

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: StudySubject

assignedArm

0..1

string

There are no (further) constraints on this element

Element id

ResearchSubject.assignedArm

Short description

What path should be followed

Definition

The name of the arm in the study the subject is expected to follow as part of this study.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

string

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: Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject

actualArm

0..1

string

There are no (further) constraints on this element

Element id

ResearchSubject.actualArm

Short description

What path was followed

Definition

The name of the arm in the study the subject actually followed as part of this study.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

string

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: Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject

consent

S C

1..1

Reference(Consent)

Element id

ResearchSubject.consent

Short description

Einverständnis zur Studienteilnahme

Definition

Ein Datensatz der informierten Zustimmung des Patienten zur Teilnahme an der Studie.

Comments

Data type

Reference(Consent)

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: ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicator in that the informedConsentIndicator can be derived from the data in the Consent resource.

Dieses Profil beschreibt eine ProbandIn in der Medizininformatik-Initiative.

Hinweise

FHIR-Element	Erklärung
ResearchSubject.id	Must-support, jedoch optional
ResearchSubject.meta	Must-support, jedoch optional
ResearchSubject.meta.profile	VERPFLICHTEND für die Abfrage im DIZ-Repsoitory inkl Versionsnummer des Profils. Siehe CapabilityStatement. In allen anderen Fällen optional.
Patient.identifier:subjectIdentificationCode	Fixes NamingSystem zur einheitlichen, standort-übergreifenden Abfrage des Identifiers (bei Auswertungen)
ResearchSubject.period.start	Startdatum (Einschluss der PatientIn in die Studie)
ResearchSubject.period.end	Enddatum (Abschluss der Studie oder Ausschluss der PatientIn)
ResearchSubject.study	Referenz auf die Metadaten der Studie an welcher die PatientIn teilnimmt.
ResearchSubject.individual	Jede ProbandIn MUSS einer PatientIn zugeordnet werden.
ResearchSubject.consent	Einwilligung in die Studie oder regulatorische Grundlage MUSS vorliegen. Weitere Vorgaben für die Modellierung des Consents können durch andere Module entstehen.

Mapping

FHIR-Element	Logischer Datensatz
ResearchSubject.identifier:subjectIdentificationCode	Person.Studienteilnehmer.SubjektIdentifizierungscode
ResearchSubject.status	Person.Studienteilnehmer.StatusDerTeilnahme
ResearchSubject.period.start	Person.Studienteilnehmer.BeginnTeilnahme
ResearchSubject.period.end	Person.Studienteilnehmer.EndeTeilnahme
ResearchSubject.consent	Person.Studienteilnehmer.Rechtsgrundlage

Snapshot

MII_PR_Studie_Proband (ResearchSubject)

ResearchSubject

There are no (further) constraints on this element

Element id

ResearchSubject

Short description

Physical entity which is the primary unit of interest in the study

Alternate names

Study Subject

Definition

A physical entity which is the primary unit of operational and/or administrative interest in a study.

Comments

Need to make sure we encompass public health studies.

Data type

ResearchSubject

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: StudySubject
v2: OBX
rim: Observation[classCode=CLNTRL, moodCode=EVN]

S Σ

0..1

string

There are no (further) constraints on this element

Element id

ResearchSubject.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

string

Meta

There are no (further) constraints on this element

Element id

ResearchSubject.meta

Short description

Metadata about the resource

Definition

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

Data type

Meta

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

0..1

string

There are no (further) constraints on this element

Element id

ResearchSubject.meta.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

string

Mappings

rim: n/a

extension

0..*

Extension

There are no (further) constraints on this element

Element id

ResearchSubject.meta.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Extension

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

versionId

0..1

There are no (further) constraints on this element

Element id

ResearchSubject.meta.versionId

Short description

Version specific identifier

Definition

The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

Comments

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

Data type

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

lastUpdated

0..1

instant

There are no (further) constraints on this element

Element id

ResearchSubject.meta.lastUpdated

Short description

When the resource version last changed

Definition

When the resource last changed - e.g. when the version changed.

Comments

Data type

instant

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

source

0..1

uri

There are no (further) constraints on this element

Element id

ResearchSubject.meta.source

Short description

Identifies where the resource comes from

Definition

Comments

This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

Data type

uri

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

profile

S Σ

0..*

canonical(StructureDefinition)

There are no (further) constraints on this element

Element id

ResearchSubject.meta.profile

Short description

Profiles this resource claims to conform to

Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Data type

canonical(StructureDefinition)

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

security

0..*

CodingBinding

There are no (further) constraints on this element

Element id

ResearchSubject.meta.security

Short description

Security Labels applied to this resource

Definition

Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

Comments

The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

Data type

Coding

Binding

Security Labels from the Healthcare Privacy and Security Classification System.

All Security Labels (extensible)

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

tag

0..*

Coding

There are no (further) constraints on this element

Element id

ResearchSubject.meta.tag

Short description

Tags applied to this resource

Definition

Comments

The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

Data type

Coding

Binding

Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

CommonTags (example)

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

implicitRules

Σ ?!

0..1

uri

There are no (further) constraints on this element

Element id

ResearchSubject.implicitRules

Short description

A set of rules under which this content was created

Definition

Comments

Data type

uri

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

ResearchSubject.language

Short description

Language of the resource content

Definition

The base language in which the resource is written.

Comments

Data type

code

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

Narrative

There are no (further) constraints on this element

Element id

ResearchSubject.text

Short description

Text summary of the resource, for human interpretation

Alternate names

narrative, html, xhtml, display

Definition

Comments

Data type

Narrative

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..*

Resource

There are no (further) constraints on this element

Element id

ResearchSubject.contained

Short description

Contained, inline Resources

Alternate names

inline resources, anonymous resources, contained resources

Definition

Comments

Data type

Resource

Mappings

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

extension

0..*

Extension

There are no (further) constraints on this element

Element id

ResearchSubject.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Extension

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

?! C

0..*

Extension

There are no (further) constraints on this element

Element id

ResearchSubject.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

Extension

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

1..*

Identifier

Element id

ResearchSubject.identifier

Short description

Identifier des Probanden

Definition

Kennungen, die dem Probanden zugewiesen wurden.

Data type

Identifier

Slicing

Unordered, Open, by $this(Pattern)

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
w5: FiveWs.identifier
BRIDG5.1: StudySubject > Subject.identifier
rim: .identifier

subjectIdentificationCode

S Σ

1..1

IdentifierPattern

Element id

ResearchSubject.identifier:subjectIdentificationCode

Short description

Business Identifier for research subject in a study

Definition

Identifiers assigned to this research subject for a study.

Data type

Identifier

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())

Pattern

{
  "type": {
    "coding": [
      {
        "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
        "code": "ANON"
      }
    ]
  }
}

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
w5: FiveWs.identifier
BRIDG5.1: StudySubject > Subject.identifier
rim: .identifier

0..1

string

There are no (further) constraints on this element

Element id

ResearchSubject.identifier:subjectIdentificationCode.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

string

Mappings

rim: n/a

extension

0..*

Extension

There are no (further) constraints on this element

Element id

ResearchSubject.identifier:subjectIdentificationCode.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Extension

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

ResearchSubject.identifier:subjectIdentificationCode.use

Short description

usual | official | temp | secondary | old (If known)

Definition

The purpose of this identifier.

Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Data type

code

Binding

Identifies the purpose for this identifier, if known .

IdentifierUse (required)

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

S Σ

0..1

CodeableConceptBindingPattern

There are no (further) constraints on this element

Element id

ResearchSubject.identifier:subjectIdentificationCode.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

CodeableConcept

Binding

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

Identifier Type Codes (extensible)

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())

Pattern

{
  "coding": [
    {
      "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
      "code": "ANON"
    }
  ]
}

Mappings

rim: n/a
v2: CE/CNE/CWE
rim: CD
orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
v2: CX.5
rim: Role.code or implied by context

system

S Σ

1..1

uri

There are no (further) constraints on this element

Element id

ResearchSubject.identifier:subjectIdentificationCode.system

Short description

The namespace for the identifier value

Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Comments

Identifier.system is always case sensitive.

Data type

uri

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

1..1

string

There are no (further) constraints on this element

Element id

ResearchSubject.identifier:subjectIdentificationCode.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

string

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

Period

There are no (further) constraints on this element

Element id

ResearchSubject.identifier:subjectIdentificationCode.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

Period

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

Reference(Organization)

There are no (further) constraints on this element

Element id

ResearchSubject.identifier:subjectIdentificationCode.assigner

Short description

Organization that issued id (may be just text)

Definition

Organization that issued/manages the identifier.

Comments

The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

Data type

Reference(Organization)

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

status

S Σ ?!

1..1

codeBinding

Element id

ResearchSubject.status

Short description

Definition

Status der Teilnahme

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

code

Binding

Indicates the progression of a study subject through a study.

ResearchSubjectStatus (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
w5: FiveWs.status
BRIDG5.1: StudySubject.statusCode
rim: .status

period

S Σ C

1..1

Period

Element id

ResearchSubject.period

Short description

Anfang und Ende der Teilnahme

Alternate names

timing

Definition

Zeitrum, in denen die Teilnahme an der Studie begann und endete.

Comments

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

Data type

Period

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"]
w5: FiveWs.planned
BRIDG5.1: PerformedStudySubjectMilestone.studyReferenceDateRange

0..1

string

There are no (further) constraints on this element

Element id

ResearchSubject.period.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

string

Mappings

rim: n/a

extension

0..*

Extension

There are no (further) constraints on this element

Element id

ResearchSubject.period.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Extension

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

start

S Σ C

1..1

dateTime

There are no (further) constraints on this element

Element id

ResearchSubject.period.start

Short description

Starting time with inclusive boundary

Definition

The start of the period. The boundary is inclusive.

Comments

If the low element is missing, the meaning is that the low boundary is not known.

Data type

dateTime

Conditions

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

Constraints

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

Mappings

rim: n/a
v2: DR.1
rim: ./low

end

S Σ C

0..1

dateTime

There are no (further) constraints on this element

Element id

ResearchSubject.period.end

Short description

End time with inclusive boundary, if not ongoing

Definition

Comments

The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.

Meaning when missing

If the end of the period is missing, it means that the period is ongoing

Data type

dateTime

Conditions

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

Constraints

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

Mappings

rim: n/a
v2: DR.2
rim: ./high

study

S Σ C

1..1

Reference(ResearchStudy)

Element id

ResearchSubject.study

Short description

Studie, der der Proband angehört

Definition

Referenz auf die Studie, an der der Proband teilnimmt

Comments

Data type

Reference(ResearchStudy)

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: StudySubjectProtocolVersionRelationship

individual

S Σ C

1..1

Reference(Patient)

Element id

ResearchSubject.individual

Short description

Wer an der Studie teilnimmt.

Definition

Der Datensatz der Person oder des Tieres, das an der Studie beteiligt ist.

Comments

Data type

Reference(Patient)

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: StudySubject

assignedArm

0..1

string

There are no (further) constraints on this element

Element id

ResearchSubject.assignedArm

Short description

What path should be followed

Definition

The name of the arm in the study the subject is expected to follow as part of this study.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

string

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: Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject

actualArm

0..1

string

There are no (further) constraints on this element

Element id

ResearchSubject.actualArm

Short description

What path was followed

Definition

The name of the arm in the study the subject actually followed as part of this study.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

string

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: Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject

consent

S C

1..1

Reference(Consent)

Element id

ResearchSubject.consent

Short description

Einverständnis zur Studienteilnahme

Definition

Ein Datensatz der informierten Zustimmung des Patienten zur Teilnahme an der Studie.

Comments

Data type

Reference(Consent)

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: ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicator in that the informedConsentIndicator can be derived from the data in the Consent resource.

Suchparameter

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

Der Suchparameter "_id" MUSS unterstützt werden:

Beispiele:

GET [base]/ResearchSubject?_id=103270

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

Beispiele:

GET [base]/ResearchSubject?_profile=https://www.medizininformatik-initiative.de/fhir/core/modul-person/StructureDefinition/ResearchSubject

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

Beispiele:

GET [base]/ResearchSubject?identifier=http://fhir.krankenhaus.example/sid/subjectIdentificationCode|1032702

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchSubject.identifier" finden sich in der FHIR-Basisspezifikation - Abschnitt "Token Search".
Der Suchparameter "status" MUSS unterstützt werden:

Beispiele:

GET [base]/ResearchSubject?status=candidate

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchSubject.status" finden sich in der FHIR-Basisspezifikation - Abschnitt "Token Search".
Der Suchparameter "date" MUSS unterstützt werden:

Beispiele:

GET [base]/ResearchSubject?date=2022-01-01

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchSubject.period" finden sich in der FHIR-Basisspezifikation - Abschnitt "Date Search".
Der Suchparameter "study" MUSS unterstützt werden:

Beispiele:

GET [base]/ResearchSubject?study=ResearchStudy/study

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

Beispiele:

GET [base]/ResearchSubject?individual=Patient/test

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

Beispiele:

GET [base]/ResearchSubject?consent=Consent/test

Anwendungshinweise: Weitere Informationen zur Suche nach "ResearchStudy.consent" finden sich in der FHIR-Basisspezifikation - Abschnitt "reference".