MII IG Molekulares Tumorboard DE v2025

Studieneinschluss (Studie): ResearchStudy

Inhalt

Dieses Profil beschreibt als Teil der Studieneinschlussempfehlung die Studie, in die der Einschluss empfohlen wird.

Das vorliegende Profil definiert hauptsächlich drei Identifiersysteme, die im Rahmen von Studien am Molekularen Tumorboard häufig genutzt werden:

Die Verwendung des Studienprofils ist optional - dieses Modul endet formal mit der Studieneinschlussempfehlung.

In zukünftigen Ausbaustufen kann die lokale Studienpopulation einer Studie über bspw. über Group zusammenaggregiert und die tatsächliche Studienteilnahme als Auswertungsparameter genutzt werden. Weiterhin kann in Zukunft definiert werden, inwieweit eine Studienteilnahme im Follow-up getrennt erfasst werden kann.

Zeitliche Zuordnung im Verlauf

Name	Status	Version	Canonical	Basis
MII_PR_MTB_Studie	draft	2024.0.0-ballot	https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studie	https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie

Inhalt

MII_PR_MTB_Studie (ResearchStudy)	I		MII_PR_Studie_Studie	There are no (further) constraints on this element Element id ResearchStudy Short description Investigation to increase healthcare-related patient-independent knowledge Alternate names Clinical Trial, Study Definition A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects. Comments Need to make sure we encompass public health studies. Data type MII_PR_Studie_Studie Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() Mappings rim: Entity. Role, or Act BRIDG5.1: ObservationalStudyProtocolVersion; Study; StudyProtocolVersion v2: OBX rim: Observation[classCode=CLNTRL, moodCode=EVN]
id	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	S Σ	0..1	Meta	There are no (further) constraints on this element Element id ResearchStudy.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.meta.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.meta.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
versionId	Σ	0..1	id	There are no (further) constraints on this element Element id ResearchStudy.meta.versionId Short description Version specific identifier Definition The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted. Comments The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes. Data type id Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
lastUpdated	Σ	0..1	instant	There are no (further) constraints on this element Element id ResearchStudy.meta.lastUpdated Short description When the resource version last changed Definition When the resource last changed - e.g. when the version changed. Comments This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction. Data type instant Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
source	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.meta.source Short description Identifies where the resource comes from Definition A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc. Comments In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
profile	S Σ	0..*	canonical(StructureDefinition)	There are no (further) constraints on this element Element id ResearchStudy.meta.profile Short description Profiles this resource claims to conform to Definition A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url. Comments It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set. Data type canonical(StructureDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
security	Σ	0..*	CodingBinding	There are no (further) constraints on this element Element id ResearchStudy.meta.security Short description Security Labels applied to this resource Definition Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure. Comments The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored. Data type Coding Binding Security Labels from the Healthcare Privacy and Security Classification System. All Security Labels (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
tag	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.meta.tag Short description Tags applied to this resource Definition Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource. Comments The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored. Data type Coding Binding Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". CommonTags (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
language		0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.language Short description Language of the resource content Definition The base language in which the resource is written. Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
text		0..1	Narrative	There are no (further) constraints on this element Element id ResearchStudy.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id ResearchStudy.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. Data type Resource Mappings rim: N/A
extension	S I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
Label	S I	0..*	Extension(Complex)	There are no (further) constraints on this element Element id ResearchStudy.extension:Label Short description MII EX Studie Backport Label Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
AssociatedParty	S I	0..*	Extension(Complex)	There are no (further) constraints on this element Element id ResearchStudy.extension:AssociatedParty Short description MII EX Studie Backport AssociatedParty Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
Ethikvotum	S I	0..*	Extension(Complex)	There are no (further) constraints on this element Element id ResearchStudy.extension:Ethikvotum Short description MII EX Studie Ethikvotum Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
Studienregister	S I	0..*	Extension(Reference(Library))	There are no (further) constraints on this element Element id ResearchStudy.extension:Studienregister Short description MII EX Studie Studienregister Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Reference(Library)) Extension URL https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
Eligibility	S I	0..1	Extension(Reference(Group \| EvidenceVariable))	There are no (further) constraints on this element Element id ResearchStudy.extension:Eligibility Short description MII EX Studie Eligibility Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Reference(Group \| EvidenceVariable)) Extension URL https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
Akronym	S I	0..1	Extension(string)	There are no (further) constraints on this element Element id ResearchStudy.extension:Akronym Short description MII EX Studie Akronym Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(string) Extension URL https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
Rekrutierung	S I	0..1	Extension(Complex)	There are no (further) constraints on this element Element id ResearchStudy.extension:Rekrutierung Short description MII EX Studie Rekrutierung Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
Finanzierung	S I	0..*	Extension(string)	There are no (further) constraints on this element Element id ResearchStudy.extension:Finanzierung Short description MII EX Studie Finanzierung Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(string) Extension URL https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
identifier	S Σ	0..*	Identifier	Element id ResearchStudy.identifier Short description Business Identifier for study Definition Identifiers assigned to this research study by the sponsor or other systems. Requirements Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers. Data type Identifier Sliced: Unordered, Open, by system(Value) Slice für Identifikator eines Studienregisters bzw. studiendurchführenden Organisation anhand von `system` Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs w5: FiveWs.identifier BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic) rim: .identifier
(All Slices)				There are no (further) constraints on this element
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.identifier.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.5 rim: Role.code or implied by context
system	S Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.identifier.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments Identifier.system is always case sensitive. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General http://www.acme.com/identifiers/patient Mappings v2: CX.4 / EI-2-4 rim: II.root or Role.id.root servd: ./IdentifierType
value	S Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Mappings v2: CX.1 / EI.1 rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd: ./Value
period	Σ	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.identifier.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.7 + CX.8 rim: Role.effectiveTime or implied by context servd: ./StartDate and ./EndDate
assigner	Σ	0..1	Reference(Organization)	There are no (further) constraints on this element Element id ResearchStudy.identifier.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.4 / (CX.4,CX.9,CX.10) rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd: ./IdentifierIssuingAuthority
NCT	S Σ	0..1	Identifier	There are no (further) constraints on this element Element id ResearchStudy.identifier:NCT Short description Business Identifier for study Definition Identifiers assigned to this research study by the sponsor or other systems. Requirements Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs w5: FiveWs.identifier BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic) rim: .identifier
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier:NCT.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.identifier:NCT.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier:NCT.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier:NCT.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.5 rim: Role.code or implied by context
system	S Σ	1..1	uriPattern	Element id ResearchStudy.identifier:NCT.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments Identifier.system is always case sensitive. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Pattern https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct Mappings v2: CX.4 / EI-2-4 rim: II.root or Role.id.root servd: ./IdentifierType
value	S Σ	1..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier:NCT.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Mappings v2: CX.1 / EI.1 rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd: ./Value
period	Σ	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.identifier:NCT.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.7 + CX.8 rim: Role.effectiveTime or implied by context servd: ./StartDate and ./EndDate
assigner	Σ	0..1	Reference(Organization)	There are no (further) constraints on this element Element id ResearchStudy.identifier:NCT.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.4 / (CX.4,CX.9,CX.10) rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd: ./IdentifierIssuingAuthority
DRKS	S Σ	0..1	Identifier	There are no (further) constraints on this element Element id ResearchStudy.identifier:DRKS Short description Business Identifier for study Definition Identifiers assigned to this research study by the sponsor or other systems. Requirements Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs w5: FiveWs.identifier BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic) rim: .identifier
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier:DRKS.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.identifier:DRKS.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier:DRKS.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier:DRKS.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.5 rim: Role.code or implied by context
system	S Σ	1..1	uriPattern	Element id ResearchStudy.identifier:DRKS.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments Identifier.system is always case sensitive. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Pattern https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks Mappings v2: CX.4 / EI-2-4 rim: II.root or Role.id.root servd: ./IdentifierType
value	S Σ	1..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier:DRKS.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Mappings v2: CX.1 / EI.1 rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd: ./Value
period	Σ	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.identifier:DRKS.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.7 + CX.8 rim: Role.effectiveTime or implied by context servd: ./StartDate and ./EndDate
assigner	Σ	0..1	Reference(Organization)	There are no (further) constraints on this element Element id ResearchStudy.identifier:DRKS.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.4 / (CX.4,CX.9,CX.10) rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd: ./IdentifierIssuingAuthority
EudraCT	S Σ	0..1	Identifier	There are no (further) constraints on this element Element id ResearchStudy.identifier:EudraCT Short description Business Identifier for study Definition Identifiers assigned to this research study by the sponsor or other systems. Requirements Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs w5: FiveWs.identifier BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic) rim: .identifier
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier:EudraCT.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.identifier:EudraCT.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier:EudraCT.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier:EudraCT.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.5 rim: Role.code or implied by context
system	S Σ	1..1	uriPattern	Element id ResearchStudy.identifier:EudraCT.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments Identifier.system is always case sensitive. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Pattern https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract Mappings v2: CX.4 / EI-2-4 rim: II.root or Role.id.root servd: ./IdentifierType
value	S Σ	1..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier:EudraCT.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Mappings v2: CX.1 / EI.1 rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd: ./Value
period	Σ	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.identifier:EudraCT.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.7 + CX.8 rim: Role.effectiveTime or implied by context servd: ./StartDate and ./EndDate
assigner	Σ	0..1	Reference(Organization)	There are no (further) constraints on this element Element id ResearchStudy.identifier:EudraCT.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.4 / (CX.4,CX.9,CX.10) rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd: ./IdentifierIssuingAuthority
title	S Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.title Short description Name for this study Definition A short, descriptive user-friendly label for the study. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Brief Title BRIDG5.1: No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
protocol	Σ	0..*	Reference(PlanDefinition)	There are no (further) constraints on this element Element id ResearchStudy.protocol Short description Steps followed in executing study Definition The set of steps expected to be performed as part of the execution of the study. Data type Reference(PlanDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Interventions; Arm/Intervention Cross-Reference BRIDG5.1: StudyProtocolDocumentVersionPublicTitle.name rim: .outboundRelationship[typeCode=DEFN].target
partOf	S Σ	0..*	Reference(ResearchStudy)	There are no (further) constraints on this element Element id ResearchStudy.partOf Short description Part of larger study Alternate names container Definition A larger research study of which this particular study is a component or step. Requirements Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc. Data type Reference(ResearchStudy) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: CompanionStudyRelationship rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
status	S Σ ?!	1..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.status Short description active \| 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 Definition The current state of the study. Data type code Binding Codes that convey the current status of the research study. ResearchStudyStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.status BRIDG5.1: StudyOverallStatus.code rim: .status
primaryPurposeType	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.primaryPurposeType Short description treatment \| prevention \| diagnostic \| supportive-care \| screening \| health-services-research \| basic-science \| device-feasibility Definition The type of study based upon the intent of the study's activities. A classification of the intent of the study. Data type CodeableConcept Binding Codes for the main intent of the study. ResearchStudyPrimaryPurposeType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyProtocolVersion.primaryPurposeTypeCode
phase	Σ	0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.phase Short description n-a \| early-phase-1 \| phase-1 \| phase-1-phase-2 \| phase-2 \| phase-2-phase-3 \| phase-3 \| phase-4 Definition The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. Data type CodeableConcept Binding Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. ResearchStudyPhase (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Phase BRIDG5.1: StudyProtocolVersion.phaseCode
category	S Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.category Short description Classifications for the study Definition Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. Data type CodeableConcept Binding Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention BRIDG5.1: InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
focus	S Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.focus Short description Drugs, devices, etc. under study 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. Data type CodeableConcept Binding Codes for medications, devices and other interventions. (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Focus of Study w5: FiveWs.what[x] BRIDG5.1: InterventionalStudyProtocol.interventionTypeCode
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.focus.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.focus.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.focus.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	S Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.focus.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
condition	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.condition Short description Condition being studied Definition The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code. Data type CodeableConcept Binding Identification of the condition or diagnosis. Condition/Problem/DiagnosisCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Conditions w5: FiveWs.what[x] BRIDG5.1: StudyCondition.code
contact	Σ	0..*	ContactDetail	There are no (further) constraints on this element Element id ResearchStudy.contact Short description Contact details for the study Definition Contact details to assist a user in learning more about or engaging with the study. Data type ContactDetail Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators BRIDG5.1: PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
relatedArtifact		0..*	RelatedArtifact	There are no (further) constraints on this element Element id ResearchStudy.relatedArtifact Short description References and dependencies Definition Citations, references and other related documents. Data type RelatedArtifact Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Citations, Links, Available Study Data/Documents BRIDG5.1: StudyProtocolDocument, StudyProtocolDocumentVersion
keyword	S Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.keyword Short description Used to search for the study Definition Key terms to aid in searching for or filtering the study. Data type CodeableConcept Binding Words associated with the study that may be useful in discovery. (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Keywords BRIDG5.1: DocumentVersion.keywordCode; DocumentVersion.keywordText
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.keyword.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.keyword.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	S Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.keyword.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
location	Σ	0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.location Short description Geographic region(s) for study Definition Indicates a country, state or other region where the study is taking place. Data type CodeableConcept Binding Countries and regions within which this artifact is targeted for use. Jurisdiction ValueSet (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyProtocolVersion.participatingLocationCode
description		0..1	markdown	There are no (further) constraints on this element Element id ResearchStudy.description Short description What this is study doing Definition A full description of how the study is being conducted. Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Detailed Description BRIDG5.1: StudyProtocolDocumentVersion.publicDescription
enrollment	Σ	0..*	Reference(Group)	There are no (further) constraints on this element Element id ResearchStudy.enrollment Short description Inclusion & exclusion criteria Alternate names patient Definition Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes". Comments The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource. Data type Reference(Group) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria) w5: FiveWs.subject[x] BRIDG5.1: InterventionalStudyProtocol.interventionGroupQuantity rim: .participation[typeCode=SBJ].role w5: FiveWs.subject
period	Σ	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.period Short description When the study began and ended Alternate names timing Definition Identifies the start date and the expected (or actual, depending on status) end date for the study. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Start Date (start); Study Completion Date (end) w5: FiveWs.done[x] BRIDG5.1: ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration rim: .effectiveTime
sponsor	Σ	0..1	Reference(Organization)	There are no (further) constraints on this element Element id ResearchStudy.sponsor Short description Organization that initiates and is legally responsible for the study Definition An organization that initiates the investigation and is legally responsible for the study. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Sponsor w5: FiveWs.actor BRIDG5.1: RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode rim: .participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
principalInvestigator	Σ	0..1	Reference(Practitioner \| PractitionerRole)	There are no (further) constraints on this element Element id ResearchStudy.principalInvestigator Short description Researcher who oversees multiple aspects of the study Definition A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation. Data type Reference(Practitioner \| PractitionerRole) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Principal Investigator w5: FiveWs.actor BRIDG5.1: StudyInvestigator
site	Σ	0..*	Reference(Location)	There are no (further) constraints on this element Element id ResearchStudy.site Short description Facility where study activities are conducted Definition A facility in which study activities are conducted. Data type Reference(Location) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Facility w5: FiveWs.where[x] BRIDG5.1: PlannedStudySite; StudySite
reasonStopped	Σ	0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.reasonStopped Short description accrual-goal-met \| closed-due-to-toxicity \| closed-due-to-lack-of-study-progress \| temporarily-closed-per-study-design Definition A description and/or code explaining the premature termination of the study. Data type CodeableConcept Binding Codes for why the study ended prematurely. ResearchStudyReasonStopped (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Why Study Stopped w5: FiveWs.why[x] BRIDG5.1: StudyOverallStatus.studyStoppedReasonCode
note		0..*	Annotation	There are no (further) constraints on this element Element id ResearchStudy.note Short description Comments made about the study Definition Comments made about the study by the performer, subject or other participants. Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: No BRIDG mapping rim: .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
arm	S	0..*	BackboneElement	There are no (further) constraints on this element Element id ResearchStudy.arm Short description Defined path through the study for a subject 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. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arms BRIDG5.1: Arm
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.arm.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.arm.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
name	S	1..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.name Short description Label for study arm Definition Unique, human-readable label for this arm of the study. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Label BRIDG5.1: Arm.name
type		0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.arm.type Short description Categorization of study arm Definition Categorization of study arm, e.g. experimental, active comparator, placebo comparater. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Type BRIDG5.1: Arm.typeCode
description		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.description Short description Short explanation of study path Definition A succinct description of the path through the study that would be followed by a subject adhering to this arm. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Description BRIDG5.1: Arm.description
objective		0..*	BackboneElement	There are no (further) constraints on this element Element id ResearchStudy.objective Short description A goal for the study Definition A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyObjective
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.objective.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.objective.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.objective.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
name		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.objective.name Short description Label for the objective Definition Unique, human-readable label for this objective of the study. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: No BRIDG mapping (BRIDG has a description, but not a name)
type		0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.objective.type Short description primary \| secondary \| exploratory Definition The kind of study objective. Data type CodeableConcept Binding Codes for the kind of study objective. ResearchStudyObjectiveType (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyObjective.typeCode

Onkologische Studie

Feldname
ResearchStudy.meta
ResearchStudy.meta.profile

<StructureDefinition xmlns="http://hl7.org/fhir">
    <id value="mii-pr-mtb-studie" />
    <url value="https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studie" />
    <version value="2024.0.0-ballot" />
    <name value="MII_PR_MTB_Studie" />
    <title value="MII PR MTB Studie" />
    <status value="draft" />
    <publisher value="Medizininformatik Initiative" />
    <contact>
        <telecom>
            <system value="url" />
            <value value="https://www.medizininformatik-initiative.de" />
        </telecom>
    </contact>
    <description value="Onkologische Studie" />
    <fhirVersion value="4.0.1" />
    <kind value="resource" />
    <abstract value="false" />
    <type value="ResearchStudy" />
    <baseDefinition value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie" />
    <derivation value="constraint" />
    <differential>
        <element id="ResearchStudy.meta">
            <path value="ResearchStudy.meta" />
            <mustSupport value="true" />
        </element>
        <element id="ResearchStudy.meta.profile">
            <path value="ResearchStudy.meta.profile" />
            <mustSupport value="true" />
        </element>
        <element id="ResearchStudy.identifier">
            <path value="ResearchStudy.identifier" />
            <slicing>
                <discriminator>
                    <type value="value" />
                    <path value="system" />
                </discriminator>
                <description value="Slice f&#252;r Identifikator eines Studienregisters bzw. studiendurchf&#252;hrenden Organisation anhand von `system`" />
                <ordered value="false" />
                <rules value="open" />
            </slicing>
        </element>
        <element id="ResearchStudy.identifier:NCT">
            <path value="ResearchStudy.identifier" />
            <sliceName value="NCT" />
            <min value="0" />
            <max value="1" />
        </element>
        <element id="ResearchStudy.identifier:NCT.system">
            <path value="ResearchStudy.identifier.system" />
            <min value="1" />
            <patternUri value="https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct" />
        </element>
        <element id="ResearchStudy.identifier:NCT.value">
            <path value="ResearchStudy.identifier.value" />
            <min value="1" />
        </element>
        <element id="ResearchStudy.identifier:DRKS">
            <path value="ResearchStudy.identifier" />
            <sliceName value="DRKS" />
            <min value="0" />
            <max value="1" />
        </element>
        <element id="ResearchStudy.identifier:DRKS.system">
            <path value="ResearchStudy.identifier.system" />
            <min value="1" />
            <patternUri value="https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks" />
        </element>
        <element id="ResearchStudy.identifier:DRKS.value">
            <path value="ResearchStudy.identifier.value" />
            <min value="1" />
        </element>
        <element id="ResearchStudy.identifier:EudraCT">
            <path value="ResearchStudy.identifier" />
            <sliceName value="EudraCT" />
            <min value="0" />
            <max value="1" />
        </element>
        <element id="ResearchStudy.identifier:EudraCT.system">
            <path value="ResearchStudy.identifier.system" />
            <min value="1" />
            <patternUri value="https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract" />
        </element>
        <element id="ResearchStudy.identifier:EudraCT.value">
            <path value="ResearchStudy.identifier.value" />
            <min value="1" />
        </element>
    </differential>
</StructureDefinition>

{
    "resourceType": "StructureDefinition",
    "id": "mii-pr-mtb-studie",
    "url": "https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studie",
    "version": "2024.0.0-ballot",
    "name": "MII_PR_MTB_Studie",
    "title": "MII PR MTB Studie",
    "status": "draft",
    "publisher": "Medizininformatik Initiative",
    "contact":  [
        {
            "telecom":  [
                {
                    "system": "url",
                    "value": "https://www.medizininformatik-initiative.de"
                }
            ]
        }
    ],
    "description": "Onkologische Studie",
    "fhirVersion": "4.0.1",
    "kind": "resource",
    "abstract": false,
    "type": "ResearchStudy",
    "baseDefinition": "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie",
    "derivation": "constraint",
    "differential": {
        "element":  [
            {
                "id": "ResearchStudy.meta",
                "path": "ResearchStudy.meta",
                "mustSupport": true
            },
            {
                "id": "ResearchStudy.meta.profile",
                "path": "ResearchStudy.meta.profile",
                "mustSupport": true
            },
            {
                "id": "ResearchStudy.identifier",
                "path": "ResearchStudy.identifier",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "value",
                            "path": "system"
                        }
                    ],
                    "rules": "open",
                    "description": "Slice für Identifikator eines Studienregisters bzw. studiendurchführenden Organisation anhand von `system`",
                    "ordered": false
                }
            },
            {
                "id": "ResearchStudy.identifier:NCT",
                "path": "ResearchStudy.identifier",
                "sliceName": "NCT",
                "min": 0,
                "max": "1"
            },
            {
                "id": "ResearchStudy.identifier:NCT.system",
                "path": "ResearchStudy.identifier.system",
                "min": 1,
                "patternUri": "https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct"
            },
            {
                "id": "ResearchStudy.identifier:NCT.value",
                "path": "ResearchStudy.identifier.value",
                "min": 1
            },
            {
                "id": "ResearchStudy.identifier:DRKS",
                "path": "ResearchStudy.identifier",
                "sliceName": "DRKS",
                "min": 0,
                "max": "1"
            },
            {
                "id": "ResearchStudy.identifier:DRKS.system",
                "path": "ResearchStudy.identifier.system",
                "min": 1,
                "patternUri": "https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks"
            },
            {
                "id": "ResearchStudy.identifier:DRKS.value",
                "path": "ResearchStudy.identifier.value",
                "min": 1
            },
            {
                "id": "ResearchStudy.identifier:EudraCT",
                "path": "ResearchStudy.identifier",
                "sliceName": "EudraCT",
                "min": 0,
                "max": "1"
            },
            {
                "id": "ResearchStudy.identifier:EudraCT.system",
                "path": "ResearchStudy.identifier.system",
                "min": 1,
                "patternUri": "https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract"
            },
            {
                "id": "ResearchStudy.identifier:EudraCT.value",
                "path": "ResearchStudy.identifier.value",
                "min": 1
            }
        ]
    }
}

MII PR MTB Studie

Mapping Datensatz zu FHIR

Datensatz	Erklaerung	FHIR
NCT-Nummer	Identifikator NCT Studie	ServiceRequest.supportingInfo:Reference(ResearchStudy)
Eudra-CT-Nummer	Identifikator Eudra-CT Studie	ServiceRequest.supportingInfo:Reference(ResearchStudy)
DRKS-Nummer	Identifikator DRKS Studie	ServiceRequest.supportingInfo:Reference(ResearchStudy)

TODO: FHIR LM Mappings korrigieren

Suchparameter

Folgende Suchparameter sind für diese Modul relevant, auch in Kombination:

Der Suchparameter "_id" MUSS unterstützt werden:

Beispiele:

GET [base]/ResearchStudy?_id=12345

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

Beispiele:

GET [base]/ResearchStudy?_profile=https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studie

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

Beispiele

GET [base]/ResearchStudy?identifier=DRKS00031294

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

Beispiele

GET [base]/ResearchStudy?title=Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue

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

Beispiele

GET [base]/ResearchStudy?status=active

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

Beispiele

GET [base]/ResearchStudy?partOf=ResearchStudy/researchstudy-test

Anwendungshinweise: Weitere Informationen zur Suche nach "partOf" finden sich in der FHIR-Basisspezifikation - Abschnitt "Reference Search".
Der Suchparameter "category" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?category=interventional

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

Beispiele

GET [base]/ResearchStudy?armName=frontale anodale tDCS (verum condition)

Anwendungshinweise: Weitere Informationen zur Suche nach "arm.name" finden sich in der FHIR-Basisspezifikation - Abschnitt "String Search".
Der Suchparameter "category" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?category=Long-COVID bedingter Fatigue

Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Studienfokus" finden sich in der FHIR-Basisspezifikation - Abschnitt "String Search".
Der Suchparameter "keyword" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?keyword=COVID

Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Schlagwort" finden sich in der FHIR-Basisspezifikation - Abschnitt "String Search".
Der Suchparameter "label" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?label=Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue

Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Label" finden sich in der FHIR-Basisspezifikation - Abschnitt "String Search".
Der Suchparameter "studienregister" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?studienregister=Library/example

Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Studienregister" finden sich in der FHIR-Basisspezifikation - Abschnitt "Reference Search".
Der Suchparameter "rekrutierungsstand-datum" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?rekrutierungsstand-datum=2023-02-17

Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Rekrutierung.extension:rekrutierungsstand-datum" finden sich in der FHIR-Basisspezifikation - Abschnitt "Date Search".
Der Suchparameter "rekrutierungsstand-genauigkeit" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?rekrutierungsstand-genauigkeit=good

Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Rekrutierung.extension:rekrutierungsstand-genauigkeit" finden sich in der [FHIR-Basisspezifikation - Abschnitt "String Search"].(http://hl7.org/fhir/R4/search.html#string).
Der Suchparameter "rekrutierungsstand-rekrutierungsstand" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?rekrutierungsstand=35

Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Rekrutierung.extension:rekrutierungsstand" finden sich in der FHIR-Basisspezifikation - Abschnitt "Number Search".
Der Suchparameter "rekrutierungsstand-rekrutierungsziel" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?rekrutierungsziel=40

Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Rekrutierung.extension:rekrutierungsziel" finden sich in der FHIR-Basisspezifikation - Abschnitt "Number Search".
Der Suchparameter "rekrutierungsstand-rekrutierungsstart" MUSS unterstützt werden:

Beispiele

GET [base]/ResearchStudy?rekrutierungsstart=2023-01-12

Anwendungshinweise: Weitere Informationen zur Suche nach "extension:Rekrutierung.extension:rekrutierungsstart" finden sich in der FHIR-Basisspezifikation - Abschnitt "Date Search".

Beispiele

Beispiel: Empfohlene Studie für Kim Musterperson vom 28.03.2023 (siehe Beschreibung von Szenarien fuer die Anwendung der Module)

Tabelle
JSON

ResearchStudy.id[0]	mii-exa-mtb-study-cldn6
ResearchStudy.meta[0].profile[0]	https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studie
ResearchStudy.identifier[0].system[0]	https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct
ResearchStudy.identifier[0].value[0]	04503278
ResearchStudy.status[0]	active
ResearchStudy.primaryPurposeType[0].coding[0].code[0]	treatment
ResearchStudy.phase[0].coding[0].code[0]	phase-1
ResearchStudy.condition[0].coding[0].system[0]	http://snomed.info/sct
ResearchStudy.condition[0].coding[0].code[0]	369757002
ResearchStudy.condition[0].coding[0].display[0]	Solid tumor configuration
ResearchStudy.keyword[0].text[0]	Non-small cell lung cancer (NSCLC)
ResearchStudy.enrollment[0].reference[0]	Group/mii-exa-mtb-study-cldn6-eligibility-criteria
ResearchStudy.period[0].start[0]	2020-09-16
ResearchStudy.period[0].end[0]	2040-01
ResearchStudy.sponsor[0].reference[0]	Organization/mii-exa-mtb-study-sponsor-biontech
ResearchStudy.principalInvestigator[0].reference[0]	PractitionerRole/mii-exa-mtb-study-investigator-biontech
ResearchStudy.site[0].reference[0]	Location/mii-exa-mtb-study-cldn6-location-11
ResearchStudy.arm[0].name[0]	Part 1 - CLDN6 CAR-T: Dose escalation in lymphodepleted patients until the MTD and/or RP2D
ResearchStudy.arm[0].type[0].coding[0].system[0]	http://hl7.org/fhir/research-study-arm-type
ResearchStudy.arm[0].type[0].coding[0].code[0]	experimental
ResearchStudy.arm[1].name[0]	Part 2 Vaccine-modulated - CLDN6 uRNA-LPX/CLDN6 modRNA-LPX: Dose escalation until the MTD and/or RP2D
ResearchStudy.arm[1].type[0].coding[0].system[0]	http://hl7.org/fhir/research-study-arm-type
ResearchStudy.arm[1].type[0].coding[0].code[0]	experimental
ResearchStudy.objective[0].name[0]	Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship
ResearchStudy.objective[0].type[0].coding[0].code[0]	primary
ResearchStudy.objective[1].name[0]	Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs
ResearchStudy.objective[1].type[0].coding[0].code[0]	primary
ResearchStudy.objective[2].name[0]	Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period
ResearchStudy.objective[2].type[0].coding[0].code[0]	primary
ResearchStudy.objective[3].name[0]	Change from baseline in the levels and kinetics of soluble immune factors measured by cytokine multiplex assay
ResearchStudy.objective[3].type[0].coding[0].code[0]	secondary
ResearchStudy.objective[4].name[0]	Objective response rate (ORR) defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per response evaluation criteria in solid tumors [RECIST 1.1]) is observed as best overall response
ResearchStudy.objective[4].type[0].coding[0].code[0]	secondary
ResearchStudy.objective[5].name[0]	Disease control rate (DCR) defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, SD assessed at least 6 weeks after the first dose) is observed as best overall response
ResearchStudy.objective[5].type[0].coding[0].code[0]	secondary
ResearchStudy.objective[6].name[0]	Duration of response (DOR) defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective progressive disease (PD) per RECIST 1.1/recurrence or death from any cause, whichever occurs first
ResearchStudy.objective[6].type[0].coding[0].code[0]	secondary

{
    "resourceType": "ResearchStudy",
    "id": "mii-exa-mtb-study-cldn6",
    "meta": {
        "profile":  [
            "https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studie"
        ]
    },
    "identifier":  [
        {
            "system": "https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct",
            "value": "04503278"
        }
    ],
    "condition":  [
        {
            "coding":  [
                {
                    "code": "369757002",
                    "system": "http://snomed.info/sct",
                    "display": "Solid tumor configuration"
                }
            ]
        }
    ],
    "keyword":  [
        {
            "text": "Non-small cell lung cancer (NSCLC)"
        }
    ],
    "enrollment":  [
        {
            "reference": "Group/mii-exa-mtb-study-cldn6-eligibility-criteria"
        }
    ],
    "period": {
        "start": "2020-09-16",
        "end": "2040-01"
    },
    "site":  [
        {
            "reference": "Location/mii-exa-mtb-study-cldn6-location-11"
        }
    ],
    "arm":  [
        {
            "name": "Part 1 - CLDN6 CAR-T: Dose escalation in lymphodepleted patients until the MTD and/or RP2D",
            "type": {
                "coding":  [
                    {
                        "code": "experimental",
                        "system": "http://hl7.org/fhir/research-study-arm-type"
                    }
                ]
            }
        },
        {
            "name": "Part 2 Vaccine-modulated - CLDN6 uRNA-LPX/CLDN6 modRNA-LPX: Dose escalation until the MTD and/or RP2D",
            "type": {
                "coding":  [
                    {
                        "code": "experimental",
                        "system": "http://hl7.org/fhir/research-study-arm-type"
                    }
                ]
            }
        }
    ],
    "objective":  [
        {
            "type": {
                "coding":  [
                    {
                        "code": "primary"
                    }
                ]
            },
            "name": "Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship"
        },
        {
            "type": {
                "coding":  [
                    {
                        "code": "primary"
                    }
                ]
            },
            "name": "Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs"
        },
        {
            "type": {
                "coding":  [
                    {
                        "code": "primary"
                    }
                ]
            },
            "name": "Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period"
        },
        {
            "type": {
                "coding":  [
                    {
                        "code": "secondary"
                    }
                ]
            },
            "name": "Change from baseline in the levels and kinetics of soluble immune factors measured by cytokine multiplex assay"
        },
        {
            "type": {
                "coding":  [
                    {
                        "code": "secondary"
                    }
                ]
            },
            "name": "Objective response rate (ORR) defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per response evaluation criteria in solid tumors [RECIST 1.1]) is observed as best overall response"
        },
        {
            "type": {
                "coding":  [
                    {
                        "code": "secondary"
                    }
                ]
            },
            "name": "Disease control rate (DCR) defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, SD assessed at least 6 weeks after the first dose) is observed as best overall response"
        },
        {
            "type": {
                "coding":  [
                    {
                        "code": "secondary"
                    }
                ]
            },
            "name": "Duration of response (DOR) defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective progressive disease (PD) per RECIST 1.1/recurrence or death from any cause, whichever occurs first"
        }
    ],
    "status": "active",
    "primaryPurposeType": {
        "coding":  [
            {
                "code": "treatment"
            }
        ]
    },
    "phase": {
        "coding":  [
            {
                "code": "phase-1"
            }
        ]
    },
    "sponsor": {
        "reference": "Organization/mii-exa-mtb-study-sponsor-biontech"
    },
    "principalInvestigator": {
        "reference": "PractitionerRole/mii-exa-mtb-study-investigator-biontech"
    }
}