MII IG Kerndatensatz-Modul Molekulares Tumorboard
2027.0.0-ballot.1 - Germany

This page is part of the MII Implementation Guide Molecular Tumor Board (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Ressourcenprofil: MII PR MTB Studie - Detaillierte Beschreibungen

Active Stand: 2026-09-15

Definitionen für das mii-pr-mtb-studie ressourcenprofil

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

0. ResearchStudy
Definition

A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.

ShortInvestigation to increase healthcare-related patient-independent knowledge
Comments

Need to make sure we encompass public health studies.

Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesClinical Trial, Study
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. ResearchStudy.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()))
4. ResearchStudy.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()))
6. ResearchStudy.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()))
8. ResearchStudy.extension
Definition

An Extension


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.

ShortExtensionAdditional 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
Must Supporttrue
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 ResearchStudy.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 10. ResearchStudy.extension:Label
    Slice NameLabel
    Definition

    Optionales Erweiterungselement – in allen Ressourcen vorhanden.

    ShortLabel
    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(MII EX Studie Backport Label) (Complex Extension)
    Is Modifierfalse
    Must Supporttrue
    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. ResearchStudy.extension:AssociatedParty
    Slice NameAssociatedParty
    Definition

    Optionales Erweiterungselement – in allen Ressourcen vorhanden.

    ShortAssociatedParty
    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(MII EX Studie Backport AssociatedParty) (Complex Extension)
    Is Modifierfalse
    Must Supporttrue
    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())
    14. ResearchStudy.extension:Ethikvotum
    Slice NameEthikvotum
    Definition

    Optionales Erweiterungselement – in allen Ressourcen vorhanden.

    ShortEthikvotum
    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(MII EX Studie Ethikvotum) (Complex Extension)
    Is Modifierfalse
    Must Supporttrue
    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())
    16. ResearchStudy.extension:Studienregister
    Slice NameStudienregister
    Definition

    Optionales Erweiterungselement – in allen Ressourcen vorhanden.

    ShortStudienregister
    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(MII EX Studie Studienregister) (Extension Type: Reference(Library))
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    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())
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    18. ResearchStudy.extension:Eligibility
    Slice NameEligibility
    Definition

    Optionales Erweiterungselement – in allen Ressourcen vorhanden.

    ShortEligibility
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(MII EX Studie Eligibility) (Extension Type: Reference(Group, EvidenceVariable))
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    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())
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    20. ResearchStudy.extension:Akronym
    Slice NameAkronym
    Definition

    Optionales Erweiterungselement – in allen Ressourcen vorhanden.

    ShortAkronym
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(MII EX Studie Akronym) (Extension Type: string)
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    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())
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    22. ResearchStudy.extension:Rekrutierung
    Slice NameRekrutierung
    Definition

    Optionales Erweiterungselement – in allen Ressourcen vorhanden.

    ShortRekrutierung
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(MII EX Studie Rekrutierung) (Complex Extension)
    Is Modifierfalse
    Must Supporttrue
    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())
    24. ResearchStudy.extension:Finanzierung
    Slice NameFinanzierung
    Definition

    Optionales Erweiterungselement – in allen Ressourcen vorhanden.

    ShortFinanzierung
    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(MII EX Studie Finanzierung) (Extension Type: string)
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    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())
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    26. ResearchStudy.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())
    28. ResearchStudy.identifier
    Definition

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


    Identifiers assigned to this research study by the sponsor or other systems.

    ShortName für diese StudieBusiness Identifier for study
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control0..*
    TypeIdentifier
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

    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 ResearchStudy.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ system
    • 30. ResearchStudy.identifier.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()))
      32. ResearchStudy.identifier.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.

      Control0..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()))
      34. ResearchStudy.identifier.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.

      Control0..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()))
      36. ResearchStudy.identifier:NCT
      Slice NameNCT
      Definition

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


      Identifiers assigned to this research study by the sponsor or other systems.

      ShortName für diese StudieBusiness Identifier for study
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..1*
      TypeIdentifier
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      38. ResearchStudy.identifier:NCT.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()))
      40. ResearchStudy.identifier:NCT.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.

      Pattern Valuehttps://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct
      ExampleGeneral: http://www.acme.com/identifiers/patient
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      42. ResearchStudy.identifier:NCT.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()))
      44. ResearchStudy.identifier:DRKS
      Slice NameDRKS
      Definition

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


      Identifiers assigned to this research study by the sponsor or other systems.

      ShortName für diese StudieBusiness Identifier for study
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..1*
      TypeIdentifier
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      46. ResearchStudy.identifier:DRKS.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()))
      48. ResearchStudy.identifier:DRKS.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.

      Pattern Valuehttps://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks
      ExampleGeneral: http://www.acme.com/identifiers/patient
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      50. ResearchStudy.identifier:DRKS.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()))
      52. ResearchStudy.identifier:EudraCT
      Slice NameEudraCT
      Definition

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


      Identifiers assigned to this research study by the sponsor or other systems.

      ShortName für diese StudieBusiness Identifier for study
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..1*
      TypeIdentifier
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      54. ResearchStudy.identifier:EudraCT.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()))
      56. ResearchStudy.identifier:EudraCT.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.

      Pattern Valuehttps://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract
      ExampleGeneral: http://www.acme.com/identifiers/patient
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      58. ResearchStudy.identifier:EudraCT.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()))
      60. ResearchStudy.title
      Definition

      Ein kurzer, beschreibender und benutzerfreundlicher Bezeichner für die Studie.


      A short, descriptive user-friendly label for the study.

      ShortName für diese StudieName for this study
      Control0..1
      Typestring
      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()))
      62. ResearchStudy.partOf
      Definition

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


      A larger research study of which this particular study is a component or step.

      ShortTeil einer größeren Studie.Part of larger study
      Control0..*
      TypeReference(ResearchStudy)
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

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

      Alternate Namescontainer
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      64. ResearchStudy.status
      Definition

      Der aktuelle Status der Studie.


      The current state of the study.

      Shortaktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogenactive | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
      Control1..1
      BindingThe codes SHALL be taken from ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1
      (required to http://hl7.org/fhir/ValueSet/research-study-status|4.0.1)

      Codes that convey the current status of the research 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()))
      66. ResearchStudy.category
      Definition

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


      Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

      ShortKlassifikationen für die Studie.Classifications for the study
      Control0..*
      Binding

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

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      68. ResearchStudy.focus
      Definition

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


      The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.

      ShortUntersuchte Medikamente, Geräte usw.Drugs, devices, etc. under study
      Control0..*
      Binding

      Codes for medications, devices and other interventions.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      70. ResearchStudy.focus.text
      Definition

      A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

      ShortPlain text representation of the concept
      Comments

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

      Control0..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Requirements

      The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      72. ResearchStudy.keyword
      Definition

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


      Key terms to aid in searching for or filtering the study.

      ShortWird verwendet, um nach der Studie zu suchen.Used to search for the study
      Control0..*
      Binding

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

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      74. ResearchStudy.keyword.text
      Definition

      A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

      ShortPlain text representation of the concept
      Comments

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

      Control0..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Requirements

      The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      76. ResearchStudy.arm
      Definition

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


      Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.

      ShortDefinierter Weg durch die Studie für ein Subjekt.Defined path through the study for a subject
      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supporttrue
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      78. ResearchStudy.arm.modifierExtension
      Definition

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

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

      ShortExtensions that cannot be ignored even if unrecognized
      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 element that contains them
      Summarytrue
      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, modifiers
      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())
      80. ResearchStudy.arm.name
      Definition

      Unique, human-readable label for this arm of the study.

      ShortLabel for study arm
      Control1..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      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. ResearchStudy
      2. ResearchStudy.meta
      Must Supporttrue
      4. ResearchStudy.meta.profile
      Must Supporttrue
      6. ResearchStudy.identifier
      NoteThis is a business identifier, not a resource identifier (see discussion)
      SlicingThis element introduces a set of slices on ResearchStudy.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ system
      • 8. ResearchStudy.identifier:NCT
        Slice NameNCT
        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..1
        10. ResearchStudy.identifier:NCT.system
        Control1..?
        Pattern Valuehttps://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct
        12. ResearchStudy.identifier:NCT.value
        Control1..?
        14. ResearchStudy.identifier:DRKS
        Slice NameDRKS
        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..1
        16. ResearchStudy.identifier:DRKS.system
        Control1..?
        Pattern Valuehttps://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks
        18. ResearchStudy.identifier:DRKS.value
        Control1..?
        20. ResearchStudy.identifier:EudraCT
        Slice NameEudraCT
        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..1
        22. ResearchStudy.identifier:EudraCT.system
        Control1..?
        Pattern Valuehttps://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract
        24. ResearchStudy.identifier:EudraCT.value
        Control1..?

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

        0. ResearchStudy
        Definition

        A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.

        ShortInvestigation to increase healthcare-related patient-independent knowledge
        Comments

        Need to make sure we encompass public health studies.

        Control0..*
        Is Modifierfalse
        Summaryfalse
        Alternate NamesClinical Trial, Study
        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. ResearchStudy.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
        Summarytrue
        4. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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 ResearchStudy.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 10. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.extension
          Definition

          An Extension

          ShortExtension
          Control0..*
          TypeExtension
          Is Modifierfalse
          Must Supporttrue
          Summaryfalse
          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 ResearchStudy.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 32. ResearchStudy.extension:Label
            Slice NameLabel
            Definition

            Optionales Erweiterungselement – in allen Ressourcen vorhanden.

            ShortLabel
            Control0..*
            This element is affected by the following invariants: ele-1
            TypeExtension(MII EX Studie Backport Label) (Complex Extension)
            Is Modifierfalse
            Must Supporttrue
            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. ResearchStudy.extension:AssociatedParty
            Slice NameAssociatedParty
            Definition

            Optionales Erweiterungselement – in allen Ressourcen vorhanden.

            ShortAssociatedParty
            Control0..*
            This element is affected by the following invariants: ele-1
            TypeExtension(MII EX Studie Backport AssociatedParty) (Complex Extension)
            Is Modifierfalse
            Must Supporttrue
            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())
            36. ResearchStudy.extension:Ethikvotum
            Slice NameEthikvotum
            Definition

            Optionales Erweiterungselement – in allen Ressourcen vorhanden.

            ShortEthikvotum
            Control0..*
            This element is affected by the following invariants: ele-1
            TypeExtension(MII EX Studie Ethikvotum) (Complex Extension)
            Is Modifierfalse
            Must Supporttrue
            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())
            38. ResearchStudy.extension:Studienregister
            Slice NameStudienregister
            Definition

            Optionales Erweiterungselement – in allen Ressourcen vorhanden.

            ShortStudienregister
            Control0..*
            This element is affected by the following invariants: ele-1
            TypeExtension(MII EX Studie Studienregister) (Extension Type: Reference(Library))
            Is Modifierfalse
            Must Supporttrue
            Summaryfalse
            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())
            40. ResearchStudy.extension:Eligibility
            Slice NameEligibility
            Definition

            Optionales Erweiterungselement – in allen Ressourcen vorhanden.

            ShortEligibility
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(MII EX Studie Eligibility) (Extension Type: Reference(Group, EvidenceVariable))
            Is Modifierfalse
            Must Supporttrue
            Summaryfalse
            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())
            42. ResearchStudy.extension:Akronym
            Slice NameAkronym
            Definition

            Optionales Erweiterungselement – in allen Ressourcen vorhanden.

            ShortAkronym
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(MII EX Studie Akronym) (Extension Type: string)
            Is Modifierfalse
            Must Supporttrue
            Summaryfalse
            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())
            44. ResearchStudy.extension:Rekrutierung
            Slice NameRekrutierung
            Definition

            Optionales Erweiterungselement – in allen Ressourcen vorhanden.

            ShortRekrutierung
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(MII EX Studie Rekrutierung) (Complex Extension)
            Is Modifierfalse
            Must Supporttrue
            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())
            46. ResearchStudy.extension:Finanzierung
            Slice NameFinanzierung
            Definition

            Optionales Erweiterungselement – in allen Ressourcen vorhanden.

            ShortFinanzierung
            Control0..*
            This element is affected by the following invariants: ele-1
            TypeExtension(MII EX Studie Finanzierung) (Extension Type: string)
            Is Modifierfalse
            Must Supporttrue
            Summaryfalse
            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())
            48. ResearchStudy.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())
            50. ResearchStudy.identifier
            Definition

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

            ShortName für diese Studie
            NoteThis is a business identifier, not a resource identifier (see discussion)
            Control0..*
            TypeIdentifier
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

            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 ResearchStudy.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ system
            • 52. ResearchStudy.identifier.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
              54. ResearchStudy.identifier.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 ResearchStudy.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 56. ResearchStudy.identifier.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()))
                58. ResearchStudy.identifier.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
                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()))
                60. ResearchStudy.identifier.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.

                Control0..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()))
                62. ResearchStudy.identifier.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.

                Control0..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()))
                64. ResearchStudy.identifier.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()))
                66. ResearchStudy.identifier.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()))
                68. ResearchStudy.identifier:NCT
                Slice NameNCT
                Definition

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

                ShortName für diese Studie
                NoteThis is a business identifier, not a resource identifier (see discussion)
                Control0..1
                TypeIdentifier
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Requirements

                Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                70. ResearchStudy.identifier:NCT.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
                72. ResearchStudy.identifier:NCT.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 ResearchStudy.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 74. ResearchStudy.identifier:NCT.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()))
                  76. ResearchStudy.identifier:NCT.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
                  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()))
                  78. ResearchStudy.identifier:NCT.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.

                  Pattern Valuehttps://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct
                  ExampleGeneral: http://www.acme.com/identifiers/patient
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  80. ResearchStudy.identifier:NCT.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()))
                  82. ResearchStudy.identifier:NCT.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()))
                  84. ResearchStudy.identifier:NCT.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()))
                  86. ResearchStudy.identifier:DRKS
                  Slice NameDRKS
                  Definition

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

                  ShortName für diese Studie
                  NoteThis is a business identifier, not a resource identifier (see discussion)
                  Control0..1
                  TypeIdentifier
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  88. ResearchStudy.identifier:DRKS.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
                  90. ResearchStudy.identifier:DRKS.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 ResearchStudy.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 92. ResearchStudy.identifier:DRKS.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()))
                    94. ResearchStudy.identifier:DRKS.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
                    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()))
                    96. ResearchStudy.identifier:DRKS.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.

                    Pattern Valuehttps://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks
                    ExampleGeneral: http://www.acme.com/identifiers/patient
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    98. ResearchStudy.identifier:DRKS.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()))
                    100. ResearchStudy.identifier:DRKS.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()))
                    102. ResearchStudy.identifier:DRKS.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()))
                    104. ResearchStudy.identifier:EudraCT
                    Slice NameEudraCT
                    Definition

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

                    ShortName für diese Studie
                    NoteThis is a business identifier, not a resource identifier (see discussion)
                    Control0..1
                    TypeIdentifier
                    Is Modifierfalse
                    Must Supporttrue
                    Summarytrue
                    Requirements

                    Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    106. ResearchStudy.identifier:EudraCT.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
                    108. ResearchStudy.identifier:EudraCT.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 ResearchStudy.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 110. ResearchStudy.identifier:EudraCT.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()))
                      112. ResearchStudy.identifier:EudraCT.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
                      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()))
                      114. ResearchStudy.identifier:EudraCT.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.

                      Pattern Valuehttps://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract
                      ExampleGeneral: http://www.acme.com/identifiers/patient
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      116. ResearchStudy.identifier:EudraCT.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()))
                      118. ResearchStudy.identifier:EudraCT.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()))
                      120. ResearchStudy.identifier:EudraCT.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()))
                      122. ResearchStudy.title
                      Definition

                      Ein kurzer, beschreibender und benutzerfreundlicher Bezeichner für die Studie.

                      ShortName für diese Studie
                      Control0..1
                      Typestring
                      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()))
                      124. ResearchStudy.protocol
                      Definition

                      The set of steps expected to be performed as part of the execution of the study.

                      ShortSteps followed in executing study
                      Control0..*
                      TypeReference(PlanDefinition)
                      Is Modifierfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      126. ResearchStudy.partOf
                      Definition

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

                      ShortTeil einer größeren Studie.
                      Control0..*
                      TypeReference(ResearchStudy)
                      Is Modifierfalse
                      Must Supporttrue
                      Summarytrue
                      Requirements

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

                      Alternate Namescontainer
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      128. ResearchStudy.status
                      Definition

                      Der aktuelle Status der Studie.

                      Shortaktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen
                      Control1..1
                      BindingThe codes SHALL be taken from ResearchStudyStatus
                      (required to http://hl7.org/fhir/ValueSet/research-study-status|4.0.1)

                      Codes that convey the current status of the research 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()))
                      130. ResearchStudy.primaryPurposeType
                      Definition

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

                      Shorttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
                      Control0..1
                      BindingUnless not suitable, these codes SHALL be taken from ResearchStudyPrimaryPurposeType
                      (extensible to http://hl7.org/fhir/ValueSet/research-study-prim-purp-type|4.0.1)

                      Codes for the main intent of the study.

                      TypeCodeableConcept
                      Is Modifierfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      132. ResearchStudy.phase
                      Definition

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

                      Shortn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
                      Control0..1
                      BindingFor example codes, see ResearchStudyPhase
                      (example to http://hl7.org/fhir/ValueSet/research-study-phase|4.0.1)

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

                      TypeCodeableConcept
                      Is Modifierfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      134. ResearchStudy.category
                      Definition

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

                      ShortKlassifikationen für die Studie.
                      Control0..*
                      Binding

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

                      TypeCodeableConcept
                      Is Modifierfalse
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      136. ResearchStudy.focus
                      Definition

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

                      ShortUntersuchte Medikamente, Geräte usw.
                      Control0..*
                      Binding

                      Codes for medications, devices and other interventions.

                      TypeCodeableConcept
                      Is Modifierfalse
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      138. ResearchStudy.focus.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
                      140. ResearchStudy.focus.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 ResearchStudy.focus.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 142. ResearchStudy.focus.coding
                        Definition

                        A reference to a code defined by a terminology system.

                        ShortCode defined by a terminology system
                        Comments

                        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                        Control0..*
                        TypeCoding
                        Is Modifierfalse
                        Summarytrue
                        Requirements

                        Allows for alternative encodings within a code system, and translations to other code systems.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        144. ResearchStudy.focus.text
                        Definition

                        A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                        ShortPlain text representation of the concept
                        Comments

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

                        Control0..1
                        Typestring
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Must Supporttrue
                        Summarytrue
                        Requirements

                        The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        146. ResearchStudy.condition
                        Definition

                        The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.

                        ShortCondition being studied
                        Control0..*
                        BindingFor example codes, see Condition/Problem/DiagnosisCodes
                        (example to http://hl7.org/fhir/ValueSet/condition-code|4.0.1)

                        Identification of the condition or diagnosis.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        148. ResearchStudy.contact
                        Definition

                        Contact details to assist a user in learning more about or engaging with the study.

                        ShortContact details for the study
                        Control0..*
                        TypeContactDetail
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        150. ResearchStudy.relatedArtifact
                        Definition

                        Citations, references and other related documents.

                        ShortReferences and dependencies
                        Control0..*
                        TypeRelatedArtifact
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        152. ResearchStudy.keyword
                        Definition

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

                        ShortWird verwendet, um nach der Studie zu suchen.
                        Control0..*
                        Binding

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

                        TypeCodeableConcept
                        Is Modifierfalse
                        Must Supporttrue
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        154. ResearchStudy.keyword.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
                        156. ResearchStudy.keyword.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 ResearchStudy.keyword.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 158. ResearchStudy.keyword.coding
                          Definition

                          A reference to a code defined by a terminology system.

                          ShortCode defined by a terminology system
                          Comments

                          Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                          Control0..*
                          TypeCoding
                          Is Modifierfalse
                          Summarytrue
                          Requirements

                          Allows for alternative encodings within a code system, and translations to other code systems.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          160. ResearchStudy.keyword.text
                          Definition

                          A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                          ShortPlain text representation of the concept
                          Comments

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

                          Control0..1
                          Typestring
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supporttrue
                          Summarytrue
                          Requirements

                          The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          162. ResearchStudy.location
                          Definition

                          Indicates a country, state or other region where the study is taking place.

                          ShortGeographic region(s) for study
                          Control0..*
                          BindingUnless not suitable, these codes SHALL be taken from Jurisdiction ValueSet
                          (extensible to http://hl7.org/fhir/ValueSet/jurisdiction|4.0.1)

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

                          TypeCodeableConcept
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          164. ResearchStudy.description
                          Definition

                          A full description of how the study is being conducted.

                          ShortWhat this is study doing
                          Control0..1
                          Typemarkdown
                          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()))
                          166. ResearchStudy.enrollment
                          Definition

                          Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".

                          ShortInclusion & exclusion criteria
                          Comments

                          The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.

                          Control0..*
                          TypeReference(Group)
                          Is Modifierfalse
                          Summarytrue
                          Alternate Namespatient
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          168. ResearchStudy.period
                          Definition

                          Identifies the start date and the expected (or actual, depending on status) end date for the study.

                          ShortWhen the study began and ended
                          Control0..1
                          TypePeriod
                          Is Modifierfalse
                          Summarytrue
                          Alternate Namestiming
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          170. ResearchStudy.sponsor
                          Definition

                          An organization that initiates the investigation and is legally responsible for the study.

                          ShortOrganization that initiates and is legally responsible for the study
                          Control0..1
                          TypeReference(Organization)
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          172. ResearchStudy.principalInvestigator
                          Definition

                          A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.

                          ShortResearcher who oversees multiple aspects of the study
                          Control0..1
                          TypeReference(Practitioner, PractitionerRole)
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          174. ResearchStudy.site
                          Definition

                          A facility in which study activities are conducted.

                          ShortFacility where study activities are conducted
                          Control0..*
                          TypeReference(Location)
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          176. ResearchStudy.reasonStopped
                          Definition

                          A description and/or code explaining the premature termination of the study.

                          Shortaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
                          Control0..1
                          BindingFor example codes, see ResearchStudyReasonStopped
                          (example to http://hl7.org/fhir/ValueSet/research-study-reason-stopped|4.0.1)

                          Codes for why the study ended prematurely.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          178. ResearchStudy.note
                          Definition

                          Comments made about the study by the performer, subject or other participants.

                          ShortComments made about the study
                          Control0..*
                          TypeAnnotation
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          180. ResearchStudy.arm
                          Definition

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

                          ShortDefinierter Weg durch die Studie für ein Subjekt.
                          Control0..*
                          TypeBackboneElement
                          Is Modifierfalse
                          Must Supporttrue
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          182. ResearchStudy.arm.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
                          184. ResearchStudy.arm.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())
                          186. ResearchStudy.arm.modifierExtension
                          Definition

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

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

                          ShortExtensions that cannot be ignored even if unrecognized
                          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 element that contains them
                          Summarytrue
                          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, modifiers
                          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())
                          188. ResearchStudy.arm.name
                          Definition

                          Unique, human-readable label for this arm of the study.

                          ShortLabel for study arm
                          Control1..1
                          Typestring
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supporttrue
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          190. ResearchStudy.arm.type
                          Definition

                          Categorization of study arm, e.g. experimental, active comparator, placebo comparater.

                          ShortCategorization of study arm
                          Control0..1
                          TypeCodeableConcept
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          192. ResearchStudy.arm.description
                          Definition

                          A succinct description of the path through the study that would be followed by a subject adhering to this arm.

                          ShortShort explanation of study path
                          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()))
                          194. ResearchStudy.objective
                          Definition

                          A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.

                          ShortA goal for the study
                          Control0..*
                          TypeBackboneElement
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          196. ResearchStudy.objective.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
                          198. ResearchStudy.objective.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())
                          200. ResearchStudy.objective.modifierExtension
                          Definition

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

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

                          ShortExtensions that cannot be ignored even if unrecognized
                          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 element that contains them
                          Summarytrue
                          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, modifiers
                          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())
                          202. ResearchStudy.objective.name
                          Definition

                          Unique, human-readable label for this objective of the study.

                          ShortLabel for the objective
                          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()))
                          204. ResearchStudy.objective.type
                          Definition

                          The kind of study objective.

                          Shortprimary | secondary | exploratory
                          Control0..1
                          BindingThe codes SHOULD be taken from ResearchStudyObjectiveType
                          (preferred to http://hl7.org/fhir/ValueSet/research-study-objective-type|4.0.1)

                          Codes for the kind of study objective.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))