MII Implementation Guide Medizinisches Forschungsvorhaben
2027.0.0-ballot - Germany

MII Implementation Guide Medizinisches Forschungsvorhaben - Downloaded Version 2027.0.0-ballot See the Directory of published versions

Ressourcenprofil: MII PR Studie Proband - Detaillierte Beschreibungen

Active Stand: 2026-01-09

Definitionen für das mii-pr-studie-proband ressourcenprofil

Guidance on how to interpret the contents of this table can be foundhere

0. ResearchSubject
Definition

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

ShortPhysical entity which is the primary unit of interest in the study
Comments

Need to make sure we encompass public health studies.

Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesStudy Subject
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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-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-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. ResearchSubject.id
Definition

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

ShortLogical id of this artifact
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.

Control0..1
Typeidstring
Is Modifierfalse
Must Supporttrue
Summarytrue
4. ResearchSubject.meta
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.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. ResearchSubject.meta.profile
Definition

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


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

ShortProfiles this resource claims to conform to
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.

Control0..*
Typecanonical(StructureDefinition)
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. ResearchSubject.implicitRules
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.

ShortA set of rules under which this content was created
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.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. ResearchSubject.modifierExtension
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).

ShortExtensions that cannot be ignored
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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
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.

Alternate Namesextensions, user content
Invariantsele-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())
12. ResearchSubject.identifier
Definition

Kennungen, die dem Probanden vom Sponsor oder anderen Systemen zugewiesen wurden.


Identifiers assigned to this research subject for a study.

ShortIdentifier des ProbandenBusiness Identifier for research subject in a study
NoteThis is a business identifier, not a resource identifier (see discussion)
Control10..*
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ResearchSubject.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
  • 14. ResearchSubject.identifier:subjectIdentificationCode
    Slice NamesubjectIdentificationCode
    Definition

    Identifiers assigned to this research subject for a study.

    ShortBusiness Identifier for research subject in a study
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control10..1*
    TypeIdentifier
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Pattern Value{
      "type" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
          "code" : "ANON"
        }]
      }
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. ResearchSubject.identifier:subjectIdentificationCode.use
    Definition

    The purpose of this identifier.

    Shortusual | official | temp | secondary | old (If known)
    Comments

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

    Control0..1
    BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1
    (required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1)

    Identifies the purpose for this identifier, if known .

    Typecode
    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

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

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. ResearchSubject.identifier:subjectIdentificationCode.type
    Definition

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

    ShortDescription of identifier
    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.

    Control0..1
    BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codeshttp://hl7.org/fhir/ValueSet/identifier-type|4.0.1
    (extensible to http://hl7.org/fhir/ValueSet/identifier-type|4.0.1)

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

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

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

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. ResearchSubject.identifier:subjectIdentificationCode.system
    Definition

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

    ShortThe namespace for the identifier value
    Comments

    Identifier.system is always case sensitive.

    Control10..1
    Typeuri
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    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.

    ExampleGeneral: http://www.acme.com/identifiers/patient
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. ResearchSubject.identifier:subjectIdentificationCode.value
    Definition

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

    ShortThe value that is unique
    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.

    Control10..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    ExampleGeneral: 123456
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    24. ResearchSubject.status
    Definition

    Status der Teilnahme.


    The current state of the subject.

    ShortKandidat | geeignet | Nachverfolgung | ungeeignet | nicht registriert | außer Studie | in Studie | Studienintervention in Studie | Studienbeobachtung in Studie | ausstehend in Studie | potenzieller Kandidat | Screening | zurückgezogencandidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
    Control1..1
    BindingThe codes SHALL be taken from ResearchSubjectStatushttp://hl7.org/fhir/ValueSet/research-subject-status|4.0.1
    (required to http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1)

    Indicates the progression of a study subject through a study.

    Typecode
    Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. ResearchSubject.period
    Definition

    Zeitraum, in dem die Teilnahme an der Studie begann und endete.


    The dates the subject began and ended their participation in the study.

    ShortAnfang und Ende der TeilnahmeStart and end of participation
    Control10..1
    TypePeriod
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Alternate Namestiming
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    28. ResearchSubject.period.start
    Definition

    The start of the period. The boundary is inclusive.

    ShortStarting time with inclusive boundary
    Comments

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

    Control10..1
    This element is affected by the following invariants: per-1
    TypedateTime
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. ResearchSubject.period.end
    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.

    ShortEnd time with inclusive boundary, if not ongoing
    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.

    Control0..1
    This element is affected by the following invariants: per-1
    TypedateTime
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    32. ResearchSubject.study
    Definition

    Referenz auf die Studie, an der der Proband teilnimmt.


    Reference to the study the subject is participating in.

    ShortStudie, der der Proband angehörtStudy subject is part of
    Control1..1
    TypeReference(ResearchStudy)
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    34. ResearchSubject.individual
    Definition

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


    The record of the person or animal who is involved in the study.

    ShortWer an der Studie teilnimmt.Who is part of study
    Control1..1
    TypeReference(Patient)
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    36. ResearchSubject.consent
    Definition

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


    A record of the patient's informed agreement to participate in the study.

    ShortEinverständnis zur StudienteilnahmeAgreement to participate in study
    Control10..1
    TypeReference(Consent)
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

    Guidance on how to interpret the contents of this table can be foundhere

    0. ResearchSubject
    2. ResearchSubject.id
    Must Supporttrue
    4. ResearchSubject.meta
    Must Supporttrue
    6. ResearchSubject.meta.profile
    Must Supporttrue
    8. ResearchSubject.identifier
    Definition

    Kennungen, die dem Probanden vom Sponsor oder anderen Systemen zugewiesen wurden.

    ShortIdentifier des Probanden
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control1..?
    Must Supporttrue
    SlicingThis element introduces a set of slices on ResearchSubject.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • pattern @ $this
    • 10. ResearchSubject.identifier:subjectIdentificationCode
      Slice NamesubjectIdentificationCode
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control1..1
      Must Supporttrue
      Pattern Value{
        "type" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code" : "ANON"
          }]
        }
      }
      12. ResearchSubject.identifier:subjectIdentificationCode.type
      Must Supporttrue
      14. ResearchSubject.identifier:subjectIdentificationCode.system
      Control1..?
      Must Supporttrue
      16. ResearchSubject.identifier:subjectIdentificationCode.value
      Control1..?
      Must Supporttrue
      18. ResearchSubject.status
      Definition

      Status der Teilnahme.

      ShortKandidat | geeignet | Nachverfolgung | ungeeignet | nicht registriert | außer Studie | in Studie | Studienintervention in Studie | Studienbeobachtung in Studie | ausstehend in Studie | potenzieller Kandidat | Screening | zurückgezogen
      Must Supporttrue
      20. ResearchSubject.period
      Definition

      Zeitraum, in dem die Teilnahme an der Studie begann und endete.

      ShortAnfang und Ende der Teilnahme
      Control1..?
      Must Supporttrue
      22. ResearchSubject.period.start
      Control1..?
      Must Supporttrue
      24. ResearchSubject.period.end
      Must Supporttrue
      26. ResearchSubject.study
      Definition

      Referenz auf die Studie, an der der Proband teilnimmt.

      ShortStudie, der der Proband angehört
      Must Supporttrue
      28. ResearchSubject.individual
      Definition

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

      ShortWer an der Studie teilnimmt.
      Must Supporttrue
      30. ResearchSubject.consent
      Definition

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

      ShortEinverständnis zur Studienteilnahme
      Control1..?
      Must Supporttrue

      Guidance on how to interpret the contents of this table can be foundhere

      0. ResearchSubject
      Definition

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

      ShortPhysical entity which is the primary unit of interest in the study
      Comments

      Need to make sure we encompass public health studies.

      Control0..*
      Is Modifierfalse
      Summaryfalse
      Alternate NamesStudy Subject
      Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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-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-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
      dom-6: A resource should have narrative for robust management (text.`div`.exists())
      2. ResearchSubject.id
      Definition

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

      ShortLogical id of this artifact
      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.

      Control0..1
      Typeid
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      4. ResearchSubject.meta
      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.

      ShortMetadata about the resource
      Control0..1
      TypeMeta
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      6. ResearchSubject.meta.id
      Definition

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

      ShortUnique id for inter-element referencing
      Control0..1
      Typestring
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      8. ResearchSubject.meta.extension
      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.

      ShortAdditional content defined by implementations
      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.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-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())
      SlicingThis element introduces a set of slices on ResearchSubject.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 10. ResearchSubject.meta.versionId
        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.

        ShortVersion specific identifier
        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.

        Control0..1
        Typeid
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        12. ResearchSubject.meta.lastUpdated
        Definition

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

        ShortWhen the resource version last 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.

        Control0..1
        Typeinstant
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        14. ResearchSubject.meta.source
        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.

        ShortIdentifies where the resource comes from
        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.

        Control0..1
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        16. ResearchSubject.meta.profile
        Definition

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

        ShortProfiles this resource claims to conform to
        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.

        Control0..*
        Typecanonical(StructureDefinition)
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        18. ResearchSubject.meta.security
        Definition

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

        ShortSecurity Labels applied to this resource
        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.

        Control0..*
        BindingUnless not suitable, these codes SHALL be taken from All Security Labels
        (extensible to http://hl7.org/fhir/ValueSet/security-labels|4.0.1)

        Security Labels from the Healthcare Privacy and Security Classification System.

        TypeCoding
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        20. ResearchSubject.meta.tag
        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.

        ShortTags applied to this 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.

        Control0..*
        BindingFor example codes, see CommonTags
        (example to http://hl7.org/fhir/ValueSet/common-tags|4.0.1)

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

        TypeCoding
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        22. ResearchSubject.implicitRules
        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.

        ShortA set of rules under which this content was created
        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.

        Control0..1
        Typeuri
        Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        24. ResearchSubject.language
        Definition

        The base language in which the resource is written.

        ShortLanguage of the resource content
        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).

        Control0..1
        BindingThe codes SHOULD be taken from CommonLanguages
        (preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

        A human language.

        Additional BindingsPurpose
        AllLanguagesMax Binding
        Typecode
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        26. ResearchSubject.text
        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.

        ShortText summary of the resource, for human interpretation
        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.

        Control0..1
        TypeNarrative
        Is Modifierfalse
        Summaryfalse
        Alternate Namesnarrative, html, xhtml, display
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        28. ResearchSubject.contained
        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.

        ShortContained, inline Resources
        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.

        Control0..*
        TypeResource
        Is Modifierfalse
        Summaryfalse
        Alternate Namesinline resources, anonymous resources, contained resources
        30. ResearchSubject.extension
        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.

        ShortAdditional content defined by implementations
        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.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-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())
        32. ResearchSubject.modifierExtension
        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).

        ShortExtensions that cannot be ignored
        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.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
        Summaryfalse
        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.

        Alternate Namesextensions, user content
        Invariantsele-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())
        34. ResearchSubject.identifier
        Definition

        Kennungen, die dem Probanden vom Sponsor oder anderen Systemen zugewiesen wurden.

        ShortIdentifier des Probanden
        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control1..*
        TypeIdentifier
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        SlicingThis element introduces a set of slices on ResearchSubject.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • pattern @ $this
        • 36. ResearchSubject.identifier:subjectIdentificationCode
          Slice NamesubjectIdentificationCode
          Definition

          Identifiers assigned to this research subject for a study.

          ShortBusiness Identifier for research subject in a study
          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control1..1
          TypeIdentifier
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Pattern Value{
            "type" : {
              "coding" : [{
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
                "code" : "ANON"
              }]
            }
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          38. ResearchSubject.identifier:subjectIdentificationCode.id
          Definition

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

          ShortUnique id for inter-element referencing
          Control0..1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          40. ResearchSubject.identifier:subjectIdentificationCode.extension
          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.

          ShortAdditional content defined by implementations
          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.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-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())
          SlicingThis element introduces a set of slices on ResearchSubject.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 42. ResearchSubject.identifier:subjectIdentificationCode.use
            Definition

            The purpose of this identifier.

            Shortusual | official | temp | secondary | old (If known)
            Comments

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

            Control0..1
            BindingThe codes SHALL be taken from IdentifierUse
            (required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1)

            Identifies the purpose for this identifier, if known .

            Typecode
            Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            44. ResearchSubject.identifier:subjectIdentificationCode.type
            Definition

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

            ShortDescription of identifier
            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.

            Control0..1
            BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes
            (extensible to http://hl7.org/fhir/ValueSet/identifier-type|4.0.1)

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

            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            46. ResearchSubject.identifier:subjectIdentificationCode.system
            Definition

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

            ShortThe namespace for the identifier value
            Comments

            Identifier.system is always case sensitive.

            Control1..1
            Typeuri
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            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.

            ExampleGeneral: http://www.acme.com/identifiers/patient
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            48. ResearchSubject.identifier:subjectIdentificationCode.value
            Definition

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

            ShortThe value that is unique
            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.

            Control1..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            ExampleGeneral: 123456
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            50. ResearchSubject.identifier:subjectIdentificationCode.period
            Definition

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

            ShortTime period when id is/was valid for use
            Control0..1
            TypePeriod
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            52. ResearchSubject.identifier:subjectIdentificationCode.assigner
            Definition

            Organization that issued/manages the identifier.

            ShortOrganization that issued id (may be just text)
            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.

            Control0..1
            TypeReference(Organization)
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            54. ResearchSubject.status
            Definition

            Status der Teilnahme.

            ShortKandidat | geeignet | Nachverfolgung | ungeeignet | nicht registriert | außer Studie | in Studie | Studienintervention in Studie | Studienbeobachtung in Studie | ausstehend in Studie | potenzieller Kandidat | Screening | zurückgezogen
            Control1..1
            BindingThe codes SHALL be taken from ResearchSubjectStatus
            (required to http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1)

            Indicates the progression of a study subject through a study.

            Typecode
            Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            56. ResearchSubject.period
            Definition

            Zeitraum, in dem die Teilnahme an der Studie begann und endete.

            ShortAnfang und Ende der Teilnahme
            Control1..1
            TypePeriod
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Alternate Namestiming
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            58. ResearchSubject.period.id
            Definition

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

            ShortUnique id for inter-element referencing
            Control0..1
            Typestring
            Is Modifierfalse
            XML FormatIn the XML format, this property is represented as an attribute.
            Summaryfalse
            60. ResearchSubject.period.extension
            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.

            ShortAdditional content defined by implementations
            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.

            Control0..*
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Alternate Namesextensions, user content
            Invariantsele-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())
            SlicingThis element introduces a set of slices on ResearchSubject.period.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 62. ResearchSubject.period.start
              Definition

              The start of the period. The boundary is inclusive.

              ShortStarting time with inclusive boundary
              Comments

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

              Control1..1
              This element is affected by the following invariants: per-1
              TypedateTime
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              64. ResearchSubject.period.end
              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.

              ShortEnd time with inclusive boundary, if not ongoing
              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.

              Control0..1
              This element is affected by the following invariants: per-1
              TypedateTime
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              66. ResearchSubject.study
              Definition

              Referenz auf die Studie, an der der Proband teilnimmt.

              ShortStudie, der der Proband angehört
              Control1..1
              TypeReference(ResearchStudy)
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              68. ResearchSubject.individual
              Definition

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

              ShortWer an der Studie teilnimmt.
              Control1..1
              TypeReference(Patient)
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              70. ResearchSubject.assignedArm
              Definition

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

              ShortWhat path should be followed
              Control0..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              72. ResearchSubject.actualArm
              Definition

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

              ShortWhat path was followed
              Control0..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              74. ResearchSubject.consent
              Definition

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

              ShortEinverständnis zur Studienteilnahme
              Control1..1
              TypeReference(Consent)
              Is Modifierfalse
              Must Supporttrue
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))