2025.2.0 - ci-build

IGTTPFHIRGatewaygICS - Local Development build (v2025.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: ConsentDomain - Detailed Descriptions

Active as of 2025-06-12

Definitions for the ConsentDomain resource profile.

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..*
Alternate NamesClinical Trial, Study
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
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
This element is affected by the following invariants: ele-1
TypeMeta
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. ResearchStudy.meta.extension:created
Slice Namecreated
Definition

Erstellungsdatum der Ressource/Information

ShortCreated
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(Created) (Extension Type: instant)
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())
6. 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
This element is affected by the following invariants: ele-1
Typeinstant
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. 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
This element is affected by the following invariants: ele-1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. 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.

Control10..*
This element is affected by the following invariants: ele-1
TypeExtension
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
  • 12. ResearchStudy.extension:versionFormat
    Slice NameversionFormat
    Definition

    Format von Versionsangaben

    ShortVersionierungsformat der Policies, Modules und Templates für diese Consent Domain
    Comments

    Werden sowohl formatString als auch formatExpression angegeben, müssen diese synonym sein.

    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(Consent Management Version Format) (Complex Extension)
    Standard StatusNormative (from Trial Use)
    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())
    14. ResearchStudy.extension:versionFormat.extension:formatString
    Slice NameformatString
    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.

    ShortBeschreibung des Formats einer Versionsangabe in textueller Form (menschenlesbar)Additional 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..1*
    This element is affected by the following invariants: ele-1
    TypeExtension
    Standard StatusNormative (from Trial Use)
    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())
    16. ResearchStudy.extension:versionFormat.extension:formatString.url
    Definition

    Source of the definition for the extension code - a logical name or a URL.

    Shortidentifies the meaning of the extension
    Comments

    The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

    Control1..1
    Typeuri
    XML FormatIn the XML format, this property is represented as an attribute.
    Fixed ValueformatString
    18. ResearchStudy.extension:versionFormat.extension:formatString.value[x]
    Definition

    Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

    ShortValue of extension
    Control10..1
    This element is affected by the following invariants: ele-1
    Typestring, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Standard StatusNormative (from Trial Use)
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. ResearchStudy.extension:versionFormat.extension:formatExpression
    Slice NameformatExpression
    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.

    ShortRegular Expression, die das erlaubte Format von Versionen bestimmt.Additional 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..1*
    This element is affected by the following invariants: ele-1
    TypeExtension
    Standard StatusNormative (from Trial Use)
    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())
    22. ResearchStudy.extension:versionFormat.extension:formatExpression.url
    Definition

    Source of the definition for the extension code - a logical name or a URL.

    Shortidentifies the meaning of the extension
    Comments

    The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

    Control1..1
    Typeuri
    XML FormatIn the XML format, this property is represented as an attribute.
    Fixed ValueformatExpression
    24. ResearchStudy.extension:versionFormat.extension:formatExpression.value[x]
    Definition

    Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

    ShortValue of extension
    Control10..1
    This element is affected by the following invariants: ele-1
    Typestring, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Standard StatusNormative (from Trial Use)
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. ResearchStudy.extension:versionFormat.url
    Definition

    Source of the definition for the extension code - a logical name or a URL.

    Shortidentifies the meaning of the extension
    Comments

    The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

    Control1..1
    Typeuri
    XML FormatIn the XML format, this property is represented as an attribute.
    Fixed Valuehttp://fhir.de/ConsentManagement/StructureDefinition/VersionFormat
    28. ResearchStudy.extension:versionFormat.value[x]
    Definition

    Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

    ShortValue of extension
    Control0..01
    This element is affected by the following invariants: ele-1
    TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Must Support TypesNo must-support rules about the choice of types/profiles
    Standard StatusNormative (from Trial Use)
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. ResearchStudy.extension:logo
    Slice Namelogo
    Definition

    Logo zur Darstellung auf Einwilligungsvorlagen

    ShortLogo der Studie/des Vorhabens
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(Consent Management Logo) (Extension Type: Attachment)
    Must Supporttrue
    LabelLogo
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    32. ResearchStudy.extension:logo.url
    Definition

    Source of the definition for the extension code - a logical name or a URL.

    Shortidentifies the meaning of the extension
    Comments

    The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

    Control1..1
    Typeuri
    XML FormatIn the XML format, this property is represented as an attribute.
    Fixed Valuehttp://fhir.de/ConsentManagement/StructureDefinition/Logo
    34. ResearchStudy.extension:logo.value[x]
    Definition

    Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

    ShortValue of extension
    Control10..1
    This element is affected by the following invariants: ele-1
    TypeAttachment, date, Meta, Address, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Must Supporttrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    36. ResearchStudy.extension:contextIdentifier
    Slice NamecontextIdentifier
    Definition

    Optional Extension Element - found in all resources.

    ShortHerstellung des Patientenbezugs je Kontext
    Control1..*
    This element is affected by the following invariants: ele-1
    TypeExtension(Consent Management Kontext-Identifikatoren einer Domain) (Complex Extension)
    Must Supporttrue
    LabelSignerIDTypes
    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:contextIdentifier.extension:resourceType
    Slice NameresourceType
    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.

    ShortRessource, in der ein Identifier Verwendung findet.Additional 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.

    Control10..1*
    This element is affected by the following invariants: ele-1
    TypeExtension
    Must Supporttrue
    Standard StatusNormative (from Trial Use)
    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())
    40. ResearchStudy.extension:contextIdentifier.extension:resourceType.url
    Definition

    Source of the definition for the extension code - a logical name or a URL.

    Shortidentifies the meaning of the extension
    Comments

    The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

    Control1..1
    Typeuri
    XML FormatIn the XML format, this property is represented as an attribute.
    Fixed ValueresourceType
    42. ResearchStudy.extension:contextIdentifier.extension:resourceType.value[x]
    Definition

    Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

    ShortValue of extension
    Control10..1
    This element is affected by the following invariants: ele-1
    BindingThe codes SHALL be taken from For codes, see ResourceType
    (required to http://hl7.org/fhir/ValueSet/resource-types)
    TypeCoding, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Must Supporttrue
    Standard StatusNormative (from Trial Use)
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    44. ResearchStudy.extension:contextIdentifier.extension:type
    Slice Nametype
    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..*
    This element is affected by the following invariants: ele-1
    TypeExtension
    Must Supporttrue
    Standard StatusNormative (from Trial Use)
    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())
    46. ResearchStudy.extension:contextIdentifier.extension:type.url
    Definition

    Source of the definition for the extension code - a logical name or a URL.

    Shortidentifies the meaning of the extension
    Comments

    The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

    Control1..1
    Typeuri
    XML FormatIn the XML format, this property is represented as an attribute.
    Fixed Valuetype
    48. ResearchStudy.extension:contextIdentifier.extension:type.value[x]
    Definition

    Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

    ShortValue of extension
    Control10..1
    This element is affected by the following invariants: ele-1
    BindingUnless not suitable, these codes SHALL be taken from For codes, see ConsentManagementContextIdentifierType
    (extensible to http://fhir.de/ConsentManagement/ValueSet/ContextIdentifierType)
    TypeCodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Must Supporttrue
    Standard StatusNormative (from Trial Use)
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    50. ResearchStudy.extension:contextIdentifier.extension:system
    Slice Namesystem
    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..*
    This element is affected by the following invariants: ele-1
    TypeExtension
    Must Supporttrue
    Standard StatusNormative (from Trial Use)
    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())
    52. ResearchStudy.extension:contextIdentifier.extension:system.url
    Definition

    Source of the definition for the extension code - a logical name or a URL.

    Shortidentifies the meaning of the extension
    Comments

    The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

    Control1..1
    Typeuri
    XML FormatIn the XML format, this property is represented as an attribute.
    Fixed Valuesystem
    54. ResearchStudy.extension:contextIdentifier.extension:system.value[x]
    Definition

    Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

    ShortValue of extension
    Control10..1
    This element is affected by the following invariants: ele-1
    Typeuri, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Standard StatusNormative (from Trial Use)
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    56. ResearchStudy.extension:contextIdentifier.url
    Definition

    Source of the definition for the extension code - a logical name or a URL.

    Shortidentifies the meaning of the extension
    Comments

    The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

    Control1..1
    Typeuri
    XML FormatIn the XML format, this property is represented as an attribute.
    Fixed Valuehttp://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier
    58. ResearchStudy.extension:contextIdentifier.value[x]
    Definition

    Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

    ShortValue of extension
    Control0..01
    This element is affected by the following invariants: ele-1
    TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    60. ResearchStudy.extension:consentMode
    Slice NameconsentMode
    Definition

    Standardverfahren für die Domäne

    ShortStandardverfahren für die Domäne
    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..1
    This element is affected by the following invariants: ele-1
    TypeExtension(Consent Management Consent Mode) (Extension Type: Coding)
    Must Supporttrue
    Standard StatusNormative (from Trial Use)
    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())
    62. ResearchStudy.extension:consentMode.url
    Definition

    Source of the definition for the extension code - a logical name or a URL.

    Shortidentifies the meaning of the extension
    Comments

    The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

    Control1..1
    Typeuri
    XML FormatIn the XML format, this property is represented as an attribute.
    Fixed Valuehttp://fhir.de/ConsentManagement/StructureDefinition/ConsentMode
    64. ResearchStudy.extension:consentMode.value[x]
    Definition

    Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

    ShortValue of extension
    Control10..1
    This element is affected by the following invariants: ele-1
    BindingThe codes SHALL be taken from For codes, see ConsentManagementConsentMode
    (required to http://fhir.de/ConsentManagement/ValueSet/ConsentMode)
    TypeCoding, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Must Supporttrue
    Standard StatusNormative (from Trial Use)
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    66. ResearchStudy.extension:consentMode.value[x].system
    Definition

    The identification of the code system that defines the meaning of the symbol in the code.

    ShortIdentity of the terminology system
    Comments

    The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

    Control10..1
    This element is affected by the following invariants: ele-1
    Typeuri
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Standard StatusNormative (from Trial Use)
    Summarytrue
    Requirements

    Need to be unambiguous about the source of the definition of the symbol.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    68. ResearchStudy.extension:consentMode.value[x].code
    Definition

    A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

    ShortSymbol in syntax defined by the system
    Comments

    Note that FHIR strings SHALL NOT exceed 1MB in size

    Control10..1
    This element is affected by the following invariants: ele-1
    Typecode
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Standard StatusNormative (from Trial Use)
    Summarytrue
    Requirements

    Need to refer to a particular code in the system.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    70. ResearchStudy.extension:policyVersionFormat
    Slice NamepolicyVersionFormat
    Definition

    Versionierungsformat für Policies einer Consent Domain

    ShortVersionierungsformat für Policies einer Consent Domain
    Comments

    Werden sowohl formatString als auch formatExpression angegeben, müssen diese synonym sein.

    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(Policy Version Format) (Extension Type: string)
    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())
    72. ResearchStudy.extension:moduleVersionFormat
    Slice NamemoduleVersionFormat
    Definition

    Versionierungsformat für Module einer Consent Domain

    ShortVersionierungsformat für Module einer Consent Domain
    Comments

    Werden sowohl formatString als auch formatExpression angegeben, müssen diese synonym sein.

    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(Module Version Format) (Extension Type: string)
    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())
    74. ResearchStudy.extension:templateVersionFormat
    Slice NametemplateVersionFormat
    Definition

    Versionierungsformat für Templates einer Consent Domain

    ShortVersionierungsformat für Templates einer Consent Domain
    Comments

    Werden sowohl formatString als auch formatExpression angegeben, müssen diese synonym sein.

    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(Template Version Format) (Extension Type: string)
    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())
    76. ResearchStudy.extension:configurationProperties
    Slice NameconfigurationProperties
    Definition

    Konfigurationsparameter im XML-Format, Base64-codiert

    ShortKonfigurationsparameter im XML-Format, Base64-codiert
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(ConfigurationProperties) (Extension Type: base64Binary)
    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())
    78. ResearchStudy.extension:externalProperty
    Slice NameexternalProperty
    Definition

    Liste frei konfigurierbarer external Properties nach dem KeyValuePrinzip zur Auswertung durch externe Anwendersysteme

    ShortexternalProperties
    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(External Property Element) (Complex Extension)
    Must Supporttrue
    LabelexternalProperties
    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.extension:expirationProperty
    Slice NameexpirationProperty
    Definition

    Liste von automatisierbaren Ablaufeigenschaften der nach dem KeyValuePrinzip

    ShortexpirationProperties
    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(Expiration Property) (Complex Extension)
    Must Supporttrue
    LabelexpirationProperties
    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())
    82. ResearchStudy.extension:validFromProperty
    Slice NamevalidFromProperty
    Definition

    Beginn des Gültigkeitszeitraums der Domäne

    ShortvalidFromProperty
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(ValidFromProperty) (Extension Type: Choice of: date, Duration)
    Must Supporttrue
    LabelvalidFromProperty
    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())
    84. 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..*
    This element is affected by the following invariants: ele-1
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
    Standard StatusNormative (from Trial Use)
    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())
    SlicingThis element introduces a set of slices on ResearchStudy.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 86. ResearchStudy.identifier
      Definition

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

      ShortDomänen-NameBusiness Identifier for study
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control10..*
      This element is affected by the following invariants: ele-1
      TypeIdentifier
      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.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
      This element is affected by the following invariants: ele-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()))
      90. ResearchStudy.identifier.system
      Definition

      Instanzspezifischer Gültigkeitsbereich des Domänen-Namens


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

      ShortInstanzspezifischer Gültigkeitsbereich des Domänen-NamensThe namespace for the identifier value
      Comments

      Identifier.system is always case sensitive.

      Control10..1
      This element is affected by the following invariants: ele-1
      Typeuri
      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.

      Fixed Valuehttps://ths-greifswald.de/fhir/gics/
      ExampleGeneral: http://www.acme.com/identifiers/patient
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      92. ResearchStudy.identifier.value
      Definition

      Maschinenlesbarer Name der Consent Domain, innerhalb der gICS Instanz eindeutig


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

      ShortName der Consent DomainThe 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
      This element is affected by the following invariants: ele-1
      Typestring
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      LabelDomänen-Name
      ExampleGeneral: 123456
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      94. ResearchStudy.title
      Definition

      Menschenlesbarer Name der Consent Domain, sollte innerhalb der gICS Instanz eindeutig sein.


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

      ShortLabel der Consent DomainName for this study
      Comments

      Note that FHIR strings SHALL NOT exceed 1MB in size

      Control10..1
      This element is affected by the following invariants: ele-1
      Typestring
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      LabelDomänen-Label
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      96. ResearchStudy.status
      Definition

      Finalisierungsstatus der Consent Domain Configuration. (Finalized=true ->status=active; Finalized=false->status=in-review)


      The current state of the study.

      Shortactive | in-reviewactive | 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
      Comments

      Note that FHIR strings SHALL NOT exceed 1MB in size

      Control1..1
      This element is affected by the following invariants: ele-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
      LabelFinalized
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      98. ResearchStudy.description
      Definition

      Administrativer Kommentar zur Zweckbeschreibung der Consent Domain


      A full description of how the study is being conducted.

      ShortZweckbeschreibung der Consent DomainWhat this is study doing
      Comments

      Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/

      Control10..1
      This element is affected by the following invariants: ele-1
      Typemarkdown
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      LabelComment
      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
      4. ResearchStudy.meta.extension:created
      Slice Namecreated
      Control0..1
      TypeExtension(Created) (Extension Type: instant)
      Must Supporttrue
      6. ResearchStudy.meta.lastUpdated
      Must Supporttrue
      8. ResearchStudy.extension
      Control1..?
      10. ResearchStudy.extension:logo
      Slice Namelogo
      Definition

      Logo zur Darstellung auf Einwilligungsvorlagen

      ShortLogo der Studie/des Vorhabens
      LabelLogo
      12. ResearchStudy.extension:contextIdentifier
      Slice NamecontextIdentifier
      ShortHerstellung des Patientenbezugs je Kontext
      LabelSignerIDTypes
      14. ResearchStudy.extension:policyVersionFormat
      Slice NamepolicyVersionFormat
      Definition

      Versionierungsformat für Policies einer Consent Domain

      ShortVersionierungsformat für Policies einer Consent Domain
      Control0..1
      TypeExtension(Policy Version Format) (Extension Type: string)
      Must Supporttrue
      16. ResearchStudy.extension:moduleVersionFormat
      Slice NamemoduleVersionFormat
      Definition

      Versionierungsformat für Module einer Consent Domain

      ShortVersionierungsformat für Module einer Consent Domain
      Control0..1
      TypeExtension(Module Version Format) (Extension Type: string)
      Must Supporttrue
      18. ResearchStudy.extension:templateVersionFormat
      Slice NametemplateVersionFormat
      Definition

      Versionierungsformat für Templates einer Consent Domain

      ShortVersionierungsformat für Templates einer Consent Domain
      Control0..1
      TypeExtension(Template Version Format) (Extension Type: string)
      Must Supporttrue
      20. ResearchStudy.extension:configurationProperties
      Slice NameconfigurationProperties
      Definition

      Konfigurationsparameter im XML-Format, Base64-codiert

      ShortKonfigurationsparameter im XML-Format, Base64-codiert
      Control0..1
      TypeExtension(ConfigurationProperties) (Extension Type: base64Binary)
      Must Supporttrue
      22. ResearchStudy.extension:externalProperty
      Slice NameexternalProperty
      Definition

      Liste frei konfigurierbarer external Properties nach dem KeyValuePrinzip zur Auswertung durch externe Anwendersysteme

      ShortexternalProperties
      Control0..*
      TypeExtension(External Property Element) (Complex Extension)
      Must Supporttrue
      LabelexternalProperties
      24. ResearchStudy.extension:expirationProperty
      Slice NameexpirationProperty
      Definition

      Liste von automatisierbaren Ablaufeigenschaften der nach dem KeyValuePrinzip

      ShortexpirationProperties
      Control0..*
      TypeExtension(Expiration Property) (Complex Extension)
      Must Supporttrue
      LabelexpirationProperties
      26. ResearchStudy.extension:validFromProperty
      Slice NamevalidFromProperty
      Definition

      Beginn des Gültigkeitszeitraums der Domäne

      ShortvalidFromProperty
      Control0..1
      TypeExtension(ValidFromProperty) (Extension Type: Choice of: date, Duration)
      Must Supporttrue
      LabelvalidFromProperty
      28. ResearchStudy.identifier
      ShortDomänen-Name
      NoteThis is a business identifier, not a resource identifier (see discussion)
      30. ResearchStudy.identifier.system
      Definition

      Instanzspezifischer Gültigkeitsbereich des Domänen-Namens

      ShortInstanzspezifischer Gültigkeitsbereich des Domänen-Namens
      Fixed Valuehttps://ths-greifswald.de/fhir/gics/
      32. ResearchStudy.identifier.value
      Definition

      Maschinenlesbarer Name der Consent Domain, innerhalb der gICS Instanz eindeutig

      ShortName der Consent Domain
      LabelDomänen-Name
      34. ResearchStudy.title
      Definition

      Menschenlesbarer Name der Consent Domain, sollte innerhalb der gICS Instanz eindeutig sein.

      ShortLabel der Consent Domain
      LabelDomänen-Label
      36. ResearchStudy.status
      Definition

      Finalisierungsstatus der Consent Domain Configuration. (Finalized=true ->status=active; Finalized=false->status=in-review)

      Shortactive | in-review
      LabelFinalized
      38. ResearchStudy.description
      Definition

      Administrativer Kommentar zur Zweckbeschreibung der Consent Domain

      LabelComment

      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..*
      Alternate NamesClinical Trial, Study
      Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
      dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
      dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
      dom-6: A resource should have narrative for robust management (text.`div`.exists())
      dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
      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
      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
      This element is affected by the following invariants: ele-1
      TypeMeta
      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
      XML FormatIn the XML format, this property is represented as an attribute.
      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..*
      This element is affected by the following invariants: ele-1
      TypeExtension
      Standard StatusNormative (from Trial Use)
      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.extension:created
        Slice Namecreated
        Definition

        Erstellungsdatum der Ressource/Information

        ShortCreated
        Control0..1
        This element is affected by the following invariants: ele-1
        TypeExtension(Created) (Extension Type: instant)
        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.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
        This element is affected by the following invariants: ele-1
        Typeid
        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.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
        This element is affected by the following invariants: ele-1
        Typeinstant
        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()))
        16. 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
        This element is affected by the following invariants: ele-1
        Typeuri
        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()))
        18. 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..*
        This element is affected by the following invariants: ele-1
        Typecanonical(StructureDefinition)
        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()))
        20. 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..*
        This element is affected by the following invariants: ele-1
        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
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        22. 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..*
        This element is affected by the following invariants: ele-1
        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
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        24. 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
        This element is affected by the following invariants: ele-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()))
        26. 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
        This element is affected by the following invariants: ele-1
        BindingThe codes SHOULD be taken from CommonLanguages
        (preferred to http://hl7.org/fhir/ValueSet/languages)

        A human language.

        Additional BindingsPurpose
        AllLanguagesMax Binding
        Typecode
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        28. 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
        This element is affected by the following invariants: ele-1
        TypeNarrative
        Alternate Namesnarrative, html, xhtml, display
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        30. 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
        Alternate Namesinline resources, anonymous resources, contained resources
        32. ResearchStudy.extension
        Definition

        An Extension

        ShortExtension
        Control1..*
        This element is affected by the following invariants: ele-1
        TypeExtension
        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
        • 34. ResearchStudy.extension:versionFormat
          Slice NameversionFormat
          Definition

          Format von Versionsangaben

          ShortVersionierungsformat der Policies, Modules und Templates für diese Consent Domain
          Comments

          Werden sowohl formatString als auch formatExpression angegeben, müssen diese synonym sein.

          Control0..1
          This element is affected by the following invariants: ele-1
          TypeExtension(Consent Management Version Format) (Complex Extension)
          Standard StatusNormative (from Trial Use)
          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())
          36. ResearchStudy.extension:versionFormat.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
          XML FormatIn the XML format, this property is represented as an attribute.
          38. ResearchStudy.extension:versionFormat.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..*
          This element is affected by the following invariants: ele-1
          TypeExtension
          Standard StatusNormative (from Trial Use)
          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.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 40. ResearchStudy.extension:versionFormat.extension:formatString
            Slice NameformatString
            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.

            ShortBeschreibung des Formats einer Versionsangabe in textueller Form (menschenlesbar)
            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..1
            This element is affected by the following invariants: ele-1
            TypeExtension
            Standard StatusNormative (from Trial Use)
            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())
            42. ResearchStudy.extension:versionFormat.extension:formatString.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
            XML FormatIn the XML format, this property is represented as an attribute.
            44. ResearchStudy.extension:versionFormat.extension:formatString.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..*
            This element is affected by the following invariants: ele-1
            TypeExtension
            Standard StatusNormative (from Trial Use)
            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.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 46. ResearchStudy.extension:versionFormat.extension:formatString.url
              Definition

              Source of the definition for the extension code - a logical name or a URL.

              Shortidentifies the meaning of the extension
              Comments

              The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

              Control1..1
              Typeuri
              XML FormatIn the XML format, this property is represented as an attribute.
              Fixed ValueformatString
              48. ResearchStudy.extension:versionFormat.extension:formatString.value[x]
              Definition

              Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

              ShortValue of extension
              Control1..1
              This element is affected by the following invariants: ele-1
              Typestring
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Standard StatusNormative (from Trial Use)
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              50. ResearchStudy.extension:versionFormat.extension:formatExpression
              Slice NameformatExpression
              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.

              ShortRegular Expression, die das erlaubte Format von Versionen bestimmt.
              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..1
              This element is affected by the following invariants: ele-1
              TypeExtension
              Standard StatusNormative (from Trial Use)
              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())
              52. ResearchStudy.extension:versionFormat.extension:formatExpression.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
              XML FormatIn the XML format, this property is represented as an attribute.
              54. ResearchStudy.extension:versionFormat.extension:formatExpression.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..*
              This element is affected by the following invariants: ele-1
              TypeExtension
              Standard StatusNormative (from Trial Use)
              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.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 56. ResearchStudy.extension:versionFormat.extension:formatExpression.url
                Definition

                Source of the definition for the extension code - a logical name or a URL.

                Shortidentifies the meaning of the extension
                Comments

                The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                Control1..1
                Typeuri
                XML FormatIn the XML format, this property is represented as an attribute.
                Fixed ValueformatExpression
                58. ResearchStudy.extension:versionFormat.extension:formatExpression.value[x]
                Definition

                Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                ShortValue of extension
                Control1..1
                This element is affected by the following invariants: ele-1
                Typestring
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Standard StatusNormative (from Trial Use)
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                60. ResearchStudy.extension:versionFormat.url
                Definition

                Source of the definition for the extension code - a logical name or a URL.

                Shortidentifies the meaning of the extension
                Comments

                The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                Control1..1
                Typeuri
                XML FormatIn the XML format, this property is represented as an attribute.
                Fixed Valuehttp://fhir.de/ConsentManagement/StructureDefinition/VersionFormat
                62. ResearchStudy.extension:versionFormat.value[x]
                Definition

                Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                ShortValue of extension
                Control0..0
                This element is affected by the following invariants: ele-1
                TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supporttrue
                Must Support TypesNo must-support rules about the choice of types/profiles
                Standard StatusNormative (from Trial Use)
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                64. ResearchStudy.extension:logo
                Slice Namelogo
                Definition

                Logo zur Darstellung auf Einwilligungsvorlagen

                ShortLogo der Studie/des Vorhabens
                Control0..1
                This element is affected by the following invariants: ele-1
                TypeExtension(Consent Management Logo) (Extension Type: Attachment)
                Must Supporttrue
                LabelLogo
                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())
                66. ResearchStudy.extension:logo.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
                XML FormatIn the XML format, this property is represented as an attribute.
                68. ResearchStudy.extension:logo.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..*
                This element is affected by the following invariants: ele-1
                TypeExtension
                Standard StatusNormative (from Trial Use)
                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.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 70. ResearchStudy.extension:logo.url
                  Definition

                  Source of the definition for the extension code - a logical name or a URL.

                  Shortidentifies the meaning of the extension
                  Comments

                  The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                  Control1..1
                  Typeuri
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Fixed Valuehttp://fhir.de/ConsentManagement/StructureDefinition/Logo
                  72. ResearchStudy.extension:logo.value[x]
                  Definition

                  Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                  ShortValue of extension
                  Control1..1
                  This element is affected by the following invariants: ele-1
                  TypeAttachment
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Must Supporttrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  74. ResearchStudy.extension:contextIdentifier
                  Slice NamecontextIdentifier
                  Definition

                  Optional Extension Element - found in all resources.

                  ShortHerstellung des Patientenbezugs je Kontext
                  Control1..*
                  This element is affected by the following invariants: ele-1
                  TypeExtension(Consent Management Kontext-Identifikatoren einer Domain) (Complex Extension)
                  Must Supporttrue
                  LabelSignerIDTypes
                  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())
                  76. ResearchStudy.extension:contextIdentifier.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
                  XML FormatIn the XML format, this property is represented as an attribute.
                  78. ResearchStudy.extension:contextIdentifier.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..*
                  This element is affected by the following invariants: ele-1
                  TypeExtension
                  Standard StatusNormative (from Trial Use)
                  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.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 80. ResearchStudy.extension:contextIdentifier.extension:resourceType
                    Slice NameresourceType
                    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.

                    ShortRessource, in der ein Identifier Verwendung findet.
                    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.

                    Control1..1
                    This element is affected by the following invariants: ele-1
                    TypeExtension
                    Must Supporttrue
                    Standard StatusNormative (from Trial Use)
                    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())
                    82. ResearchStudy.extension:contextIdentifier.extension:resourceType.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
                    XML FormatIn the XML format, this property is represented as an attribute.
                    84. ResearchStudy.extension:contextIdentifier.extension:resourceType.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..*
                    This element is affected by the following invariants: ele-1
                    TypeExtension
                    Standard StatusNormative (from Trial Use)
                    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.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 86. ResearchStudy.extension:contextIdentifier.extension:resourceType.url
                      Definition

                      Source of the definition for the extension code - a logical name or a URL.

                      Shortidentifies the meaning of the extension
                      Comments

                      The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                      Control1..1
                      Typeuri
                      XML FormatIn the XML format, this property is represented as an attribute.
                      Fixed ValueresourceType
                      88. ResearchStudy.extension:contextIdentifier.extension:resourceType.value[x]
                      Definition

                      Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                      ShortValue of extension
                      Control1..1
                      This element is affected by the following invariants: ele-1
                      BindingThe codes SHALL be taken from ResourceType
                      (required to http://hl7.org/fhir/ValueSet/resource-types)
                      TypeCoding
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      Must Supporttrue
                      Standard StatusNormative (from Trial Use)
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      90. ResearchStudy.extension:contextIdentifier.extension:type
                      Slice Nametype
                      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..*
                      This element is affected by the following invariants: ele-1
                      TypeExtension
                      Must Supporttrue
                      Standard StatusNormative (from Trial Use)
                      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())
                      92. ResearchStudy.extension:contextIdentifier.extension:type.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
                      XML FormatIn the XML format, this property is represented as an attribute.
                      94. ResearchStudy.extension:contextIdentifier.extension:type.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..*
                      This element is affected by the following invariants: ele-1
                      TypeExtension
                      Standard StatusNormative (from Trial Use)
                      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.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 96. ResearchStudy.extension:contextIdentifier.extension:type.url
                        Definition

                        Source of the definition for the extension code - a logical name or a URL.

                        Shortidentifies the meaning of the extension
                        Comments

                        The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                        Control1..1
                        Typeuri
                        XML FormatIn the XML format, this property is represented as an attribute.
                        Fixed Valuetype
                        98. ResearchStudy.extension:contextIdentifier.extension:type.value[x]
                        Definition

                        Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                        ShortValue of extension
                        Control1..1
                        This element is affected by the following invariants: ele-1
                        BindingUnless not suitable, these codes SHALL be taken from ConsentManagementContextIdentifierType
                        (extensible to http://fhir.de/ConsentManagement/ValueSet/ContextIdentifierType)
                        TypeCodeableConcept
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        Must Supporttrue
                        Standard StatusNormative (from Trial Use)
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        100. ResearchStudy.extension:contextIdentifier.extension:system
                        Slice Namesystem
                        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..*
                        This element is affected by the following invariants: ele-1
                        TypeExtension
                        Must Supporttrue
                        Standard StatusNormative (from Trial Use)
                        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())
                        102. ResearchStudy.extension:contextIdentifier.extension:system.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
                        XML FormatIn the XML format, this property is represented as an attribute.
                        104. ResearchStudy.extension:contextIdentifier.extension:system.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..*
                        This element is affected by the following invariants: ele-1
                        TypeExtension
                        Standard StatusNormative (from Trial Use)
                        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.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 106. ResearchStudy.extension:contextIdentifier.extension:system.url
                          Definition

                          Source of the definition for the extension code - a logical name or a URL.

                          Shortidentifies the meaning of the extension
                          Comments

                          The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                          Control1..1
                          Typeuri
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Fixed Valuesystem
                          108. ResearchStudy.extension:contextIdentifier.extension:system.value[x]
                          Definition

                          Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                          ShortValue of extension
                          Control1..1
                          This element is affected by the following invariants: ele-1
                          Typeuri
                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supporttrue
                          Standard StatusNormative (from Trial Use)
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          110. ResearchStudy.extension:contextIdentifier.url
                          Definition

                          Source of the definition for the extension code - a logical name or a URL.

                          Shortidentifies the meaning of the extension
                          Comments

                          The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                          Control1..1
                          Typeuri
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Fixed Valuehttp://fhir.de/ConsentManagement/StructureDefinition/ContextIdentifier
                          112. ResearchStudy.extension:contextIdentifier.value[x]
                          Definition

                          Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                          ShortValue of extension
                          Control0..0
                          This element is affected by the following invariants: ele-1
                          TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          114. ResearchStudy.extension:consentMode
                          Slice NameconsentMode
                          Definition

                          Standardverfahren für die Domäne

                          ShortStandardverfahren für die Domäne
                          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..1
                          This element is affected by the following invariants: ele-1
                          TypeExtension(Consent Management Consent Mode) (Extension Type: Coding)
                          Must Supporttrue
                          Standard StatusNormative (from Trial Use)
                          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())
                          116. ResearchStudy.extension:consentMode.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
                          XML FormatIn the XML format, this property is represented as an attribute.
                          118. ResearchStudy.extension:consentMode.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..*
                          This element is affected by the following invariants: ele-1
                          TypeExtension
                          Standard StatusNormative (from Trial Use)
                          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.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 120. ResearchStudy.extension:consentMode.url
                            Definition

                            Source of the definition for the extension code - a logical name or a URL.

                            Shortidentifies the meaning of the extension
                            Comments

                            The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                            Control1..1
                            Typeuri
                            XML FormatIn the XML format, this property is represented as an attribute.
                            Fixed Valuehttp://fhir.de/ConsentManagement/StructureDefinition/ConsentMode
                            122. ResearchStudy.extension:consentMode.value[x]
                            Definition

                            Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                            ShortValue of extension
                            Control1..1
                            This element is affected by the following invariants: ele-1
                            BindingThe codes SHALL be taken from ConsentManagementConsentMode
                            (required to http://fhir.de/ConsentManagement/ValueSet/ConsentMode)
                            TypeCoding
                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                            Must Supporttrue
                            Standard StatusNormative (from Trial Use)
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            124. ResearchStudy.extension:consentMode.value[x].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
                            XML FormatIn the XML format, this property is represented as an attribute.
                            126. ResearchStudy.extension:consentMode.value[x].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..*
                            This element is affected by the following invariants: ele-1
                            TypeExtension
                            Standard StatusNormative (from Trial Use)
                            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.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 128. ResearchStudy.extension:consentMode.value[x].system
                              Definition

                              The identification of the code system that defines the meaning of the symbol in the code.

                              ShortIdentity of the terminology system
                              Comments

                              The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

                              Control1..1
                              This element is affected by the following invariants: ele-1
                              Typeuri
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supporttrue
                              Standard StatusNormative (from Trial Use)
                              Summarytrue
                              Requirements

                              Need to be unambiguous about the source of the definition of the symbol.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              130. ResearchStudy.extension:consentMode.value[x].version
                              Definition

                              The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                              ShortVersion of the system - if relevant
                              Comments

                              Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                              NoteThis is a business version Id, not a resource version Id (see discussion)
                              Control0..1
                              This element is affected by the following invariants: ele-1
                              Typestring
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Standard StatusNormative (from Trial Use)
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              132. ResearchStudy.extension:consentMode.value[x].code
                              Definition

                              A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                              ShortSymbol in syntax defined by the system
                              Comments

                              Note that FHIR strings SHALL NOT exceed 1MB in size

                              Control1..1
                              This element is affected by the following invariants: ele-1
                              Typecode
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supporttrue
                              Standard StatusNormative (from Trial Use)
                              Summarytrue
                              Requirements

                              Need to refer to a particular code in the system.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              134. ResearchStudy.extension:consentMode.value[x].display
                              Definition

                              A representation of the meaning of the code in the system, following the rules of the system.

                              ShortRepresentation defined by the system
                              Comments

                              Note that FHIR strings SHALL NOT exceed 1MB in size

                              Control0..1
                              This element is affected by the following invariants: ele-1
                              Typestring
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Standard StatusNormative (from Trial Use)
                              Summarytrue
                              Requirements

                              Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              136. ResearchStudy.extension:consentMode.value[x].userSelected
                              Definition

                              Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                              ShortIf this coding was chosen directly by the user
                              Comments

                              Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                              Control0..1
                              This element is affected by the following invariants: ele-1
                              Typeboolean
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Standard StatusNormative (from Trial Use)
                              Summarytrue
                              Requirements

                              This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              138. ResearchStudy.extension:policyVersionFormat
                              Slice NamepolicyVersionFormat
                              Definition

                              Versionierungsformat für Policies einer Consent Domain

                              ShortVersionierungsformat für Policies einer Consent Domain
                              Comments

                              Werden sowohl formatString als auch formatExpression angegeben, müssen diese synonym sein.

                              Control0..1
                              This element is affected by the following invariants: ele-1
                              TypeExtension(Policy Version Format) (Extension Type: string)
                              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())
                              140. ResearchStudy.extension:moduleVersionFormat
                              Slice NamemoduleVersionFormat
                              Definition

                              Versionierungsformat für Module einer Consent Domain

                              ShortVersionierungsformat für Module einer Consent Domain
                              Comments

                              Werden sowohl formatString als auch formatExpression angegeben, müssen diese synonym sein.

                              Control0..1
                              This element is affected by the following invariants: ele-1
                              TypeExtension(Module Version Format) (Extension Type: string)
                              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())
                              142. ResearchStudy.extension:templateVersionFormat
                              Slice NametemplateVersionFormat
                              Definition

                              Versionierungsformat für Templates einer Consent Domain

                              ShortVersionierungsformat für Templates einer Consent Domain
                              Comments

                              Werden sowohl formatString als auch formatExpression angegeben, müssen diese synonym sein.

                              Control0..1
                              This element is affected by the following invariants: ele-1
                              TypeExtension(Template Version Format) (Extension Type: string)
                              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())
                              144. ResearchStudy.extension:configurationProperties
                              Slice NameconfigurationProperties
                              Definition

                              Konfigurationsparameter im XML-Format, Base64-codiert

                              ShortKonfigurationsparameter im XML-Format, Base64-codiert
                              Control0..1
                              This element is affected by the following invariants: ele-1
                              TypeExtension(ConfigurationProperties) (Extension Type: base64Binary)
                              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())
                              146. ResearchStudy.extension:externalProperty
                              Slice NameexternalProperty
                              Definition

                              Liste frei konfigurierbarer external Properties nach dem KeyValuePrinzip zur Auswertung durch externe Anwendersysteme

                              ShortexternalProperties
                              Control0..*
                              This element is affected by the following invariants: ele-1
                              TypeExtension(External Property Element) (Complex Extension)
                              Must Supporttrue
                              LabelexternalProperties
                              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())
                              148. ResearchStudy.extension:expirationProperty
                              Slice NameexpirationProperty
                              Definition

                              Liste von automatisierbaren Ablaufeigenschaften der nach dem KeyValuePrinzip

                              ShortexpirationProperties
                              Control0..*
                              This element is affected by the following invariants: ele-1
                              TypeExtension(Expiration Property) (Complex Extension)
                              Must Supporttrue
                              LabelexpirationProperties
                              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())
                              150. ResearchStudy.extension:validFromProperty
                              Slice NamevalidFromProperty
                              Definition

                              Beginn des Gültigkeitszeitraums der Domäne

                              ShortvalidFromProperty
                              Control0..1
                              This element is affected by the following invariants: ele-1
                              TypeExtension(ValidFromProperty) (Extension Type: Choice of: date, Duration)
                              Must Supporttrue
                              LabelvalidFromProperty
                              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())
                              152. 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..*
                              This element is affected by the following invariants: ele-1
                              TypeExtension
                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                              Standard StatusNormative (from Trial Use)
                              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())
                              SlicingThis element introduces a set of slices on ResearchStudy.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • value @ url
                              • 154. ResearchStudy.identifier
                                Definition

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

                                ShortDomänen-Name
                                NoteThis is a business identifier, not a resource identifier (see discussion)
                                Control1..*
                                This element is affected by the following invariants: ele-1
                                TypeIdentifier
                                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()))
                                156. 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
                                XML FormatIn the XML format, this property is represented as an attribute.
                                158. 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..*
                                This element is affected by the following invariants: ele-1
                                TypeExtension
                                Standard StatusNormative (from Trial Use)
                                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
                                • 160. 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
                                  This element is affected by the following invariants: ele-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()))
                                  162. 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
                                  This element is affected by the following invariants: ele-1
                                  BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes
                                  (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

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

                                  TypeCodeableConcept
                                  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()))
                                  164. ResearchStudy.identifier.system
                                  Definition

                                  Instanzspezifischer Gültigkeitsbereich des Domänen-Namens

                                  ShortInstanzspezifischer Gültigkeitsbereich des Domänen-Namens
                                  Comments

                                  Identifier.system is always case sensitive.

                                  Control1..1
                                  This element is affected by the following invariants: ele-1
                                  Typeuri
                                  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.

                                  Fixed Valuehttps://ths-greifswald.de/fhir/gics/
                                  ExampleGeneral: http://www.acme.com/identifiers/patient
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  166. ResearchStudy.identifier.value
                                  Definition

                                  Maschinenlesbarer Name der Consent Domain, innerhalb der gICS Instanz eindeutig

                                  ShortName der Consent Domain
                                  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
                                  This element is affected by the following invariants: ele-1
                                  Typestring
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  LabelDomänen-Name
                                  ExampleGeneral: 123456
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  168. ResearchStudy.identifier.period
                                  Definition

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

                                  ShortTime period when id is/was valid for use
                                  Comments

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

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

                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  TypePeriod
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  per-1: If present, start SHALL have a lower value than end (start.hasValue().not() or end.hasValue().not() or (start <= end))
                                  170. 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
                                  This element is affected by the following invariants: ele-1
                                  TypeReference(Organization)
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                  172. ResearchStudy.title
                                  Definition

                                  Menschenlesbarer Name der Consent Domain, sollte innerhalb der gICS Instanz eindeutig sein.

                                  ShortLabel der Consent Domain
                                  Comments

                                  Note that FHIR strings SHALL NOT exceed 1MB in size

                                  Control1..1
                                  This element is affected by the following invariants: ele-1
                                  Typestring
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  LabelDomänen-Label
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  174. ResearchStudy.protocol
                                  Definition

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

                                  ShortSteps followed in executing study
                                  Comments

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

                                  Control0..*
                                  This element is affected by the following invariants: ele-1
                                  TypeReference(PlanDefinition)
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                  176. ResearchStudy.partOf
                                  Definition

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

                                  ShortPart of larger study
                                  Comments

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

                                  Control0..*
                                  This element is affected by the following invariants: ele-1
                                  TypeReference(ResearchStudy)
                                  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()))
                                  ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                  178. ResearchStudy.status
                                  Definition

                                  Finalisierungsstatus der Consent Domain Configuration. (Finalized=true ->status=active; Finalized=false->status=in-review)

                                  Shortactive | in-review
                                  Comments

                                  Note that FHIR strings SHALL NOT exceed 1MB in size

                                  Control1..1
                                  This element is affected by the following invariants: ele-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
                                  LabelFinalized
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  180. 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
                                  Comments

                                  Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  BindingUnless not suitable, these codes SHALL be taken from ResearchStudyPrimaryPurposeType
                                  (extensible to http://hl7.org/fhir/ValueSet/research-study-prim-purp-type)

                                  Codes for the main intent of the study.

                                  TypeCodeableConcept
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  182. 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
                                  Comments

                                  Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  BindingFor example codes, see ResearchStudyPhase
                                  (example to http://hl7.org/fhir/ValueSet/research-study-phase)

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

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

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

                                  ShortClassifications for the study
                                  Comments

                                  Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                                  Control0..*
                                  This element is affected by the following invariants: ele-1
                                  Binding

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

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

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

                                  ShortDrugs, devices, etc. under study
                                  Comments

                                  Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                                  Control0..*
                                  This element is affected by the following invariants: ele-1
                                  Binding

                                  Codes for medications, devices and other interventions.

                                  TypeCodeableConcept
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  188. 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
                                  Comments

                                  Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                                  Control0..*
                                  This element is affected by the following invariants: ele-1
                                  BindingFor example codes, see Condition/Problem/DiagnosisCodes
                                  (example to http://hl7.org/fhir/ValueSet/condition-code)

                                  Identification of the condition or diagnosis.

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

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

                                  ShortContact details for the study
                                  Control0..*
                                  This element is affected by the following invariants: ele-1
                                  TypeContactDetail
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  192. ResearchStudy.relatedArtifact
                                  Definition

                                  Citations, references and other related documents.

                                  ShortReferences and dependencies
                                  Comments

                                  Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.

                                  Control0..*
                                  This element is affected by the following invariants: ele-1
                                  TypeRelatedArtifact
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  194. ResearchStudy.keyword
                                  Definition

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

                                  ShortUsed to search for the study
                                  Comments

                                  Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                                  Control0..*
                                  This element is affected by the following invariants: ele-1
                                  Binding

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

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

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

                                  ShortGeographic region(s) for study
                                  Comments

                                  Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                                  Control0..*
                                  This element is affected by the following invariants: ele-1
                                  BindingUnless not suitable, these codes SHALL be taken from Jurisdiction ValueSet
                                  (extensible to http://hl7.org/fhir/ValueSet/jurisdiction)

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

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

                                  Administrativer Kommentar zur Zweckbeschreibung der Consent Domain

                                  ShortZweckbeschreibung der Consent Domain
                                  Comments

                                  Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/

                                  Control1..1
                                  This element is affected by the following invariants: ele-1
                                  Typemarkdown
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  LabelComment
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  200. 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..*
                                  This element is affected by the following invariants: ele-1
                                  TypeReference(Group)
                                  Summarytrue
                                  Alternate Namespatient
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                  202. 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
                                  Comments

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

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

                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  TypePeriod
                                  Summarytrue
                                  Alternate Namestiming
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  per-1: If present, start SHALL have a lower value than end (start.hasValue().not() or end.hasValue().not() or (start <= end))
                                  204. 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
                                  Comments

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

                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  TypeReference(Organization)
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                  206. 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
                                  Comments

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

                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  TypeReference(Practitioner, PractitionerRole)
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                  208. ResearchStudy.site
                                  Definition

                                  A facility in which study activities are conducted.

                                  ShortFacility where study activities are conducted
                                  Comments

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

                                  Control0..*
                                  This element is affected by the following invariants: ele-1
                                  TypeReference(Location)
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                  210. 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
                                  Comments

                                  Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  BindingFor example codes, see ResearchStudyReasonStopped
                                  (example to http://hl7.org/fhir/ValueSet/research-study-reason-stopped)

                                  Codes for why the study ended prematurely.

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

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

                                  ShortComments made about the study
                                  Comments

                                  For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).

                                  Control0..*
                                  This element is affected by the following invariants: ele-1
                                  TypeAnnotation
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  214. ResearchStudy.arm
                                  Definition

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

                                  ShortDefined path through the study for a subject
                                  Control0..*
                                  This element is affected by the following invariants: ele-1
                                  TypeBackboneElement
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  216. 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
                                  XML FormatIn the XML format, this property is represented as an attribute.
                                  218. 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..*
                                  This element is affected by the following invariants: ele-1
                                  TypeExtension
                                  Standard StatusNormative (from Trial Use)
                                  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.arm.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                  • value @ url
                                  • 220. 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..*
                                    This element is affected by the following invariants: ele-1
                                    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())
                                    222. ResearchStudy.arm.name
                                    Definition

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

                                    ShortLabel for study arm
                                    Comments

                                    Note that FHIR strings SHALL NOT exceed 1MB in size

                                    Control1..1
                                    This element is affected by the following invariants: ele-1
                                    Typestring
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    224. ResearchStudy.arm.type
                                    Definition

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

                                    ShortCategorization of study arm
                                    Comments

                                    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                                    Control0..1
                                    This element is affected by the following invariants: ele-1
                                    TypeCodeableConcept
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    226. 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
                                    Comments

                                    Note that FHIR strings SHALL NOT exceed 1MB in size

                                    Control0..1
                                    This element is affected by the following invariants: ele-1
                                    Typestring
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    228. 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..*
                                    This element is affected by the following invariants: ele-1
                                    TypeBackboneElement
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    230. 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
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    232. 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..*
                                    This element is affected by the following invariants: ele-1
                                    TypeExtension
                                    Standard StatusNormative (from Trial Use)
                                    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.objective.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                    • value @ url
                                    • 234. 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..*
                                      This element is affected by the following invariants: ele-1
                                      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())
                                      236. ResearchStudy.objective.name
                                      Definition

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

                                      ShortLabel for the objective
                                      Comments

                                      Note that FHIR strings SHALL NOT exceed 1MB in size

                                      Control0..1
                                      This element is affected by the following invariants: ele-1
                                      Typestring
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      238. ResearchStudy.objective.type
                                      Definition

                                      The kind of study objective.

                                      Shortprimary | secondary | exploratory
                                      Comments

                                      Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                                      Control0..1
                                      This element is affected by the following invariants: ele-1
                                      BindingThe codes SHOULD be taken from ResearchStudyObjectiveType
                                      (preferred to http://hl7.org/fhir/ValueSet/research-study-objective-type)

                                      Codes for the kind of study objective.

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