German Oncological Data Standard (GOLD)
0.1.0 - CI Build Germany flag

German Oncological Data Standard (GOLD) - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: Profile Clinical Study

Official URL: https://www.vision-zero-oncology.de/fhir/StructureDefinition/clinical-study Version: 0.1.0
Draft as of 2023-12-13 Computable Name: Clinical_Study

Copyright/Legal: CC-BY-SA-4.0

Profile to describe a clinical study in which a patient takes part.

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... Slices for identifier S0..*IdentifierBusiness Identifier for study
Slice: Unordered, Open by pattern:$this
.... identifier:eudraCT 0..1IdentifierEudra CT Number
Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://www.clinicaltrialsregister.eu
..... system S1..1uriThe namespace for the identifier value
Required Pattern: https://www.clinicaltrialsregister.eu
..... value S1..1stringThe value that is unique
.... identifier:NCT 0..1IdentifierNCT number
Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: http://clinicaltrials.gov
..... system S1..1uriThe namespace for the identifier value
Required Pattern: http://clinicaltrials.gov
..... value S1..1stringThe value that is unique
.... identifier:PMID 0..1IdentifierPubmed ID
Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: http://www.ncbi.nlm.nih.gov/pubmed
..... system S1..1uriThe namespace for the identifier value
Required Pattern: http://www.ncbi.nlm.nih.gov/pubmed
..... value S1..1stringThe value that is unique
.... identifier:DOI 0..1IdentifierDigital Object Identifier
Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://doi.org
..... system S1..1uriThe namespace for the identifier value
Required Pattern: https://doi.org
..... value S1..1stringThe value that is unique
.... identifier:URI 0..1IdentifierUniform Resource Identifier
Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: urn:ietf:rfc:3986
..... system S1..1uriThe namespace for the identifier value
Required Pattern: urn:ietf:rfc:3986
..... value S1..1stringThe value that is unique
.... identifier:DRKS 0..1IdentifierDeusches Register Klinischer Studien
Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://www.drks.de
..... system S1..1uriThe namespace for the identifier value
Required Pattern: https://www.drks.de
..... value S1..1stringThe value that is unique
... title S0..1stringName for this study
... status S1..1codeactive | 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
... phase 1..1CodeableConceptn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Binding: ResearchStudyPhase (required)
... Slices for category S1..*CodeableConceptClassifications for the study
Slice: Unordered, Open by pattern:$this
.... category:studyCategory S1..1CodeableConceptClassifications for the study
Binding: ValueSet Studienkategorien NCIt (required)
.... category:studyDesign S0..*CodeableConceptClassifications for the study
Binding: ValueSet Studiendesign NCIt (required)
.... category:typeOfBlinding S0..1CodeableConceptClassifications for the study
Binding: ValueSet Type of Blinding NCIt (required)
.... category:typeOfRandomization S0..1CodeableConceptClassifications for the study
Binding: ValueSet Type of Randomization NCIt (required)
... focus S0..*CodeableConceptDrugs, devices, etc. under study
Binding: ValueSet Study Focus NCIt (extensible)
... arm S0..*BackboneElementDefined path through the study for a subject
.... type S0..1CodeableConceptCategorization of study arm
Binding: ValueSet Type of Study Arm NCIt (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
ResearchStudy.phaserequiredResearchStudyPhase
ResearchStudy.category:studyCategoryrequiredVS_Studienkategorien_NCIT
ResearchStudy.category:studyDesignrequiredVS_Studiendesign_NCIT
ResearchStudy.category:typeOfBlindingrequiredVS_TypeOfBlinding_NCIT
ResearchStudy.category:typeOfRandomizationrequiredVS_TypeOfRandomization_NCIT
ResearchStudy.focusextensibleVS_StudyFocus_NCIT
ResearchStudy.arm.typerequiredVS_TypeOfStudyArm_NCIT
NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... Slices for identifier SΣ0..*IdentifierBusiness Identifier for study
Slice: Unordered, Open by pattern:$this
.... identifier:eudraCT Σ0..1IdentifierEudra CT Number

Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://www.clinicaltrialsregister.eu
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: https://www.clinicaltrialsregister.eu
..... value SΣ1..1stringThe value that is unique
Example General: 123456
.... identifier:NCT Σ0..1IdentifierNCT number

Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: http://clinicaltrials.gov
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: http://clinicaltrials.gov
..... value SΣ1..1stringThe value that is unique
Example General: 123456
.... identifier:PMID Σ0..1IdentifierPubmed ID

Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: http://www.ncbi.nlm.nih.gov/pubmed
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: http://www.ncbi.nlm.nih.gov/pubmed
..... value SΣ1..1stringThe value that is unique
Example General: 123456
.... identifier:DOI Σ0..1IdentifierDigital Object Identifier

Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://doi.org
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: https://doi.org
..... value SΣ1..1stringThe value that is unique
Example General: 123456
.... identifier:URI Σ0..1IdentifierUniform Resource Identifier

Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: urn:ietf:rfc:3986
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: urn:ietf:rfc:3986
..... value SΣ1..1stringThe value that is unique
Example General: 123456
.... identifier:DRKS Σ0..1IdentifierDeusches Register Klinischer Studien

Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://www.drks.de
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: https://www.drks.de
..... value SΣ1..1stringThe value that is unique
Example General: 123456
... status ?!SΣ1..1codeactive | 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
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.

... primaryPurposeType SΣ0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.

... phase Σ1..1CodeableConceptn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Binding: ResearchStudyPhase (required)
... Slices for category SΣ1..*CodeableConceptClassifications for the study
Slice: Unordered, Open by pattern:$this
Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.


.... category:studyCategory SΣ1..1CodeableConceptClassifications for the study
Binding: ValueSet Studienkategorien NCIt (required)
.... category:studyDesign SΣ0..*CodeableConceptClassifications for the study
Binding: ValueSet Studiendesign NCIt (required)
.... category:typeOfBlinding SΣ0..1CodeableConceptClassifications for the study
Binding: ValueSet Type of Blinding NCIt (required)
.... category:typeOfRandomization SΣ0..1CodeableConceptClassifications for the study
Binding: ValueSet Type of Randomization NCIt (required)
... focus SΣ0..*CodeableConceptDrugs, devices, etc. under study
Binding: ValueSet Study Focus NCIt (extensible)
... arm S0..*BackboneElementDefined path through the study for a subject
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringLabel for study arm
.... type S0..1CodeableConceptCategorization of study arm
Binding: ValueSet Type of Study Arm NCIt (required)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
ResearchStudy.identifier:eudraCT.userequiredIdentifierUse
ResearchStudy.identifier:NCT.userequiredIdentifierUse
ResearchStudy.identifier:PMID.userequiredIdentifierUse
ResearchStudy.identifier:DOI.userequiredIdentifierUse
ResearchStudy.identifier:URI.userequiredIdentifierUse
ResearchStudy.identifier:DRKS.userequiredIdentifierUse
ResearchStudy.statusrequiredResearchStudyStatus
ResearchStudy.primaryPurposeTypeextensibleResearchStudyPrimaryPurposeType
ResearchStudy.phaserequiredResearchStudyPhase
ResearchStudy.categoryexample
ResearchStudy.category:studyCategoryrequiredVS_Studienkategorien_NCIT
ResearchStudy.category:studyDesignrequiredVS_Studiendesign_NCIT
ResearchStudy.category:typeOfBlindingrequiredVS_TypeOfBlinding_NCIT
ResearchStudy.category:typeOfRandomizationrequiredVS_TypeOfRandomization_NCIT
ResearchStudy.focusextensibleVS_StudyFocus_NCIT
ResearchStudy.arm.typerequiredVS_TypeOfStudyArm_NCIT

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorResearchStudyIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorResearchStudyIf 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-4errorResearchStudyIf 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-5errorResearchStudyIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceResearchStudyA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... Slices for identifier SΣ0..*IdentifierBusiness Identifier for study
Slice: Unordered, Open by pattern:$this
.... identifier:eudraCT Σ0..1IdentifierEudra CT Number

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... use0..1codeusual | official | temp | secondary | old (If known)
..... type0..1CodeableConceptDescription of identifier
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://www.clinicaltrialsregister.eu
..... value0..1stringThe value that is unique
..... period0..1PeriodTime period when id is/was valid for use
..... assigner0..1Reference(Organization)Organization that issued id (may be just text)
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: https://www.clinicaltrialsregister.eu
..... value SΣ1..1stringThe value that is unique
Example General: 123456
..... period Σ0..1PeriodTime period when id is/was valid for use
..... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
.... identifier:NCT Σ0..1IdentifierNCT number

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... use0..1codeusual | official | temp | secondary | old (If known)
..... type0..1CodeableConceptDescription of identifier
..... system1..1uriThe namespace for the identifier value
Fixed Value: http://clinicaltrials.gov
..... value0..1stringThe value that is unique
..... period0..1PeriodTime period when id is/was valid for use
..... assigner0..1Reference(Organization)Organization that issued id (may be just text)
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: http://clinicaltrials.gov
..... value SΣ1..1stringThe value that is unique
Example General: 123456
..... period Σ0..1PeriodTime period when id is/was valid for use
..... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
.... identifier:PMID Σ0..1IdentifierPubmed ID

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... use0..1codeusual | official | temp | secondary | old (If known)
..... type0..1CodeableConceptDescription of identifier
..... system1..1uriThe namespace for the identifier value
Fixed Value: http://www.ncbi.nlm.nih.gov/pubmed
..... value0..1stringThe value that is unique
..... period0..1PeriodTime period when id is/was valid for use
..... assigner0..1Reference(Organization)Organization that issued id (may be just text)
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: http://www.ncbi.nlm.nih.gov/pubmed
..... value SΣ1..1stringThe value that is unique
Example General: 123456
..... period Σ0..1PeriodTime period when id is/was valid for use
..... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
.... identifier:DOI Σ0..1IdentifierDigital Object Identifier

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... use0..1codeusual | official | temp | secondary | old (If known)
..... type0..1CodeableConceptDescription of identifier
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://doi.org
..... value0..1stringThe value that is unique
..... period0..1PeriodTime period when id is/was valid for use
..... assigner0..1Reference(Organization)Organization that issued id (may be just text)
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: https://doi.org
..... value SΣ1..1stringThe value that is unique
Example General: 123456
..... period Σ0..1PeriodTime period when id is/was valid for use
..... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
.... identifier:URI Σ0..1IdentifierUniform Resource Identifier

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... use0..1codeusual | official | temp | secondary | old (If known)
..... type0..1CodeableConceptDescription of identifier
..... system1..1uriThe namespace for the identifier value
Fixed Value: urn:ietf:rfc:3986
..... value0..1stringThe value that is unique
..... period0..1PeriodTime period when id is/was valid for use
..... assigner0..1Reference(Organization)Organization that issued id (may be just text)
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: urn:ietf:rfc:3986
..... value SΣ1..1stringThe value that is unique
Example General: 123456
..... period Σ0..1PeriodTime period when id is/was valid for use
..... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
.... identifier:DRKS Σ0..1IdentifierDeusches Register Klinischer Studien

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... use0..1codeusual | official | temp | secondary | old (If known)
..... type0..1CodeableConceptDescription of identifier
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://www.drks.de
..... value0..1stringThe value that is unique
..... period0..1PeriodTime period when id is/was valid for use
..... assigner0..1Reference(Organization)Organization that issued id (may be just text)
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: https://www.drks.de
..... value SΣ1..1stringThe value that is unique
Example General: 123456
..... period Σ0..1PeriodTime period when id is/was valid for use
..... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... title SΣ0..1stringName for this study
... protocol Σ0..*Reference(PlanDefinition)Steps followed in executing study
... partOf Σ0..*Reference(ResearchStudy)Part of larger study
... status ?!SΣ1..1codeactive | 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
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.

... primaryPurposeType SΣ0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.

... phase Σ1..1CodeableConceptn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Binding: ResearchStudyPhase (required)
... Slices for category SΣ1..*CodeableConceptClassifications for the study
Slice: Unordered, Open by pattern:$this
Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.


.... category:studyCategory SΣ1..1CodeableConceptClassifications for the study
Binding: ValueSet Studienkategorien NCIt (required)
.... category:studyDesign SΣ0..*CodeableConceptClassifications for the study
Binding: ValueSet Studiendesign NCIt (required)
.... category:typeOfBlinding SΣ0..1CodeableConceptClassifications for the study
Binding: ValueSet Type of Blinding NCIt (required)
.... category:typeOfRandomization SΣ0..1CodeableConceptClassifications for the study
Binding: ValueSet Type of Randomization NCIt (required)
... focus SΣ0..*CodeableConceptDrugs, devices, etc. under study
Binding: ValueSet Study Focus NCIt (extensible)
... condition Σ0..*CodeableConceptCondition being studied
Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.


... contact Σ0..*ContactDetailContact details for the study
... relatedArtifact 0..*RelatedArtifactReferences and dependencies
... keyword Σ0..*CodeableConceptUsed to search for the study
Binding: (unbound) (example): Words associated with the study that may be useful in discovery.


... location Σ0..*CodeableConceptGeographic region(s) for study
Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.


... description 0..1markdownWhat this is study doing
... enrollment Σ0..*Reference(Group)Inclusion & exclusion criteria
... period Σ0..1PeriodWhen the study began and ended
... sponsor Σ0..1Reference(Organization)Organization that initiates and is legally responsible for the study
... principalInvestigator Σ0..1Reference(Practitioner | PractitionerRole)Researcher who oversees multiple aspects of the study
... site Σ0..*Reference(Location)Facility where study activities are conducted
... reasonStopped Σ0..1CodeableConceptaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.

... note 0..*AnnotationComments made about the study
... arm S0..*BackboneElementDefined path through the study for a subject
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringLabel for study arm
.... type S0..1CodeableConceptCategorization of study arm
Binding: ValueSet Type of Study Arm NCIt (required)
.... description 0..1stringShort explanation of study path
... objective 0..*BackboneElementA goal for the study
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 0..1stringLabel for the objective
.... type 0..1CodeableConceptprimary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
ResearchStudy.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
ResearchStudy.identifier:eudraCT.userequiredIdentifierUse
ResearchStudy.identifier:eudraCT.typeextensibleIdentifier Type Codes
ResearchStudy.identifier:NCT.userequiredIdentifierUse
ResearchStudy.identifier:NCT.typeextensibleIdentifier Type Codes
ResearchStudy.identifier:PMID.userequiredIdentifierUse
ResearchStudy.identifier:PMID.typeextensibleIdentifier Type Codes
ResearchStudy.identifier:DOI.userequiredIdentifierUse
ResearchStudy.identifier:DOI.typeextensibleIdentifier Type Codes
ResearchStudy.identifier:URI.userequiredIdentifierUse
ResearchStudy.identifier:URI.typeextensibleIdentifier Type Codes
ResearchStudy.identifier:DRKS.userequiredIdentifierUse
ResearchStudy.identifier:DRKS.typeextensibleIdentifier Type Codes
ResearchStudy.statusrequiredResearchStudyStatus
ResearchStudy.primaryPurposeTypeextensibleResearchStudyPrimaryPurposeType
ResearchStudy.phaserequiredResearchStudyPhase
ResearchStudy.categoryexample
ResearchStudy.category:studyCategoryrequiredVS_Studienkategorien_NCIT
ResearchStudy.category:studyDesignrequiredVS_Studiendesign_NCIT
ResearchStudy.category:typeOfBlindingrequiredVS_TypeOfBlinding_NCIT
ResearchStudy.category:typeOfRandomizationrequiredVS_TypeOfRandomization_NCIT
ResearchStudy.focusextensibleVS_StudyFocus_NCIT
ResearchStudy.conditionexampleCondition/Problem/DiagnosisCodes
ResearchStudy.keywordexample
ResearchStudy.locationextensibleJurisdiction ValueSet
ResearchStudy.reasonStoppedexampleResearchStudyReasonStopped
ResearchStudy.arm.typerequiredVS_TypeOfStudyArm_NCIT
ResearchStudy.objective.typepreferredResearchStudyObjectiveType

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorResearchStudyIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorResearchStudyIf 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-4errorResearchStudyIf 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-5errorResearchStudyIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceResearchStudyA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from ResearchStudy

Summary

Mandatory: 3 elements (12 nested mandatory elements)
Must-Support: 24 elements

Slices

This structure defines the following Slices:

  • The element ResearchStudy.identifier is sliced based on the value of pattern:$this
  • The element ResearchStudy.category is sliced based on the value of pattern:$this

Differential View

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... Slices for identifier S0..*IdentifierBusiness Identifier for study
Slice: Unordered, Open by pattern:$this
.... identifier:eudraCT 0..1IdentifierEudra CT Number
Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://www.clinicaltrialsregister.eu
..... system S1..1uriThe namespace for the identifier value
Required Pattern: https://www.clinicaltrialsregister.eu
..... value S1..1stringThe value that is unique
.... identifier:NCT 0..1IdentifierNCT number
Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: http://clinicaltrials.gov
..... system S1..1uriThe namespace for the identifier value
Required Pattern: http://clinicaltrials.gov
..... value S1..1stringThe value that is unique
.... identifier:PMID 0..1IdentifierPubmed ID
Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: http://www.ncbi.nlm.nih.gov/pubmed
..... system S1..1uriThe namespace for the identifier value
Required Pattern: http://www.ncbi.nlm.nih.gov/pubmed
..... value S1..1stringThe value that is unique
.... identifier:DOI 0..1IdentifierDigital Object Identifier
Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://doi.org
..... system S1..1uriThe namespace for the identifier value
Required Pattern: https://doi.org
..... value S1..1stringThe value that is unique
.... identifier:URI 0..1IdentifierUniform Resource Identifier
Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: urn:ietf:rfc:3986
..... system S1..1uriThe namespace for the identifier value
Required Pattern: urn:ietf:rfc:3986
..... value S1..1stringThe value that is unique
.... identifier:DRKS 0..1IdentifierDeusches Register Klinischer Studien
Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://www.drks.de
..... system S1..1uriThe namespace for the identifier value
Required Pattern: https://www.drks.de
..... value S1..1stringThe value that is unique
... title S0..1stringName for this study
... status S1..1codeactive | 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
... phase 1..1CodeableConceptn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Binding: ResearchStudyPhase (required)
... Slices for category S1..*CodeableConceptClassifications for the study
Slice: Unordered, Open by pattern:$this
.... category:studyCategory S1..1CodeableConceptClassifications for the study
Binding: ValueSet Studienkategorien NCIt (required)
.... category:studyDesign S0..*CodeableConceptClassifications for the study
Binding: ValueSet Studiendesign NCIt (required)
.... category:typeOfBlinding S0..1CodeableConceptClassifications for the study
Binding: ValueSet Type of Blinding NCIt (required)
.... category:typeOfRandomization S0..1CodeableConceptClassifications for the study
Binding: ValueSet Type of Randomization NCIt (required)
... focus S0..*CodeableConceptDrugs, devices, etc. under study
Binding: ValueSet Study Focus NCIt (extensible)
... arm S0..*BackboneElementDefined path through the study for a subject
.... type S0..1CodeableConceptCategorization of study arm
Binding: ValueSet Type of Study Arm NCIt (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
ResearchStudy.phaserequiredResearchStudyPhase
ResearchStudy.category:studyCategoryrequiredVS_Studienkategorien_NCIT
ResearchStudy.category:studyDesignrequiredVS_Studiendesign_NCIT
ResearchStudy.category:typeOfBlindingrequiredVS_TypeOfBlinding_NCIT
ResearchStudy.category:typeOfRandomizationrequiredVS_TypeOfRandomization_NCIT
ResearchStudy.focusextensibleVS_StudyFocus_NCIT
ResearchStudy.arm.typerequiredVS_TypeOfStudyArm_NCIT

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... Slices for identifier SΣ0..*IdentifierBusiness Identifier for study
Slice: Unordered, Open by pattern:$this
.... identifier:eudraCT Σ0..1IdentifierEudra CT Number

Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://www.clinicaltrialsregister.eu
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: https://www.clinicaltrialsregister.eu
..... value SΣ1..1stringThe value that is unique
Example General: 123456
.... identifier:NCT Σ0..1IdentifierNCT number

Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: http://clinicaltrials.gov
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: http://clinicaltrials.gov
..... value SΣ1..1stringThe value that is unique
Example General: 123456
.... identifier:PMID Σ0..1IdentifierPubmed ID

Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: http://www.ncbi.nlm.nih.gov/pubmed
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: http://www.ncbi.nlm.nih.gov/pubmed
..... value SΣ1..1stringThe value that is unique
Example General: 123456
.... identifier:DOI Σ0..1IdentifierDigital Object Identifier

Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://doi.org
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: https://doi.org
..... value SΣ1..1stringThe value that is unique
Example General: 123456
.... identifier:URI Σ0..1IdentifierUniform Resource Identifier

Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: urn:ietf:rfc:3986
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: urn:ietf:rfc:3986
..... value SΣ1..1stringThe value that is unique
Example General: 123456
.... identifier:DRKS Σ0..1IdentifierDeusches Register Klinischer Studien

Required Pattern: At least the following
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://www.drks.de
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: https://www.drks.de
..... value SΣ1..1stringThe value that is unique
Example General: 123456
... status ?!SΣ1..1codeactive | 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
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.

... primaryPurposeType SΣ0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.

... phase Σ1..1CodeableConceptn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Binding: ResearchStudyPhase (required)
... Slices for category SΣ1..*CodeableConceptClassifications for the study
Slice: Unordered, Open by pattern:$this
Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.


.... category:studyCategory SΣ1..1CodeableConceptClassifications for the study
Binding: ValueSet Studienkategorien NCIt (required)
.... category:studyDesign SΣ0..*CodeableConceptClassifications for the study
Binding: ValueSet Studiendesign NCIt (required)
.... category:typeOfBlinding SΣ0..1CodeableConceptClassifications for the study
Binding: ValueSet Type of Blinding NCIt (required)
.... category:typeOfRandomization SΣ0..1CodeableConceptClassifications for the study
Binding: ValueSet Type of Randomization NCIt (required)
... focus SΣ0..*CodeableConceptDrugs, devices, etc. under study
Binding: ValueSet Study Focus NCIt (extensible)
... arm S0..*BackboneElementDefined path through the study for a subject
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringLabel for study arm
.... type S0..1CodeableConceptCategorization of study arm
Binding: ValueSet Type of Study Arm NCIt (required)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
ResearchStudy.identifier:eudraCT.userequiredIdentifierUse
ResearchStudy.identifier:NCT.userequiredIdentifierUse
ResearchStudy.identifier:PMID.userequiredIdentifierUse
ResearchStudy.identifier:DOI.userequiredIdentifierUse
ResearchStudy.identifier:URI.userequiredIdentifierUse
ResearchStudy.identifier:DRKS.userequiredIdentifierUse
ResearchStudy.statusrequiredResearchStudyStatus
ResearchStudy.primaryPurposeTypeextensibleResearchStudyPrimaryPurposeType
ResearchStudy.phaserequiredResearchStudyPhase
ResearchStudy.categoryexample
ResearchStudy.category:studyCategoryrequiredVS_Studienkategorien_NCIT
ResearchStudy.category:studyDesignrequiredVS_Studiendesign_NCIT
ResearchStudy.category:typeOfBlindingrequiredVS_TypeOfBlinding_NCIT
ResearchStudy.category:typeOfRandomizationrequiredVS_TypeOfRandomization_NCIT
ResearchStudy.focusextensibleVS_StudyFocus_NCIT
ResearchStudy.arm.typerequiredVS_TypeOfStudyArm_NCIT

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorResearchStudyIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorResearchStudyIf 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-4errorResearchStudyIf 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-5errorResearchStudyIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceResearchStudyA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... Slices for identifier SΣ0..*IdentifierBusiness Identifier for study
Slice: Unordered, Open by pattern:$this
.... identifier:eudraCT Σ0..1IdentifierEudra CT Number

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... use0..1codeusual | official | temp | secondary | old (If known)
..... type0..1CodeableConceptDescription of identifier
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://www.clinicaltrialsregister.eu
..... value0..1stringThe value that is unique
..... period0..1PeriodTime period when id is/was valid for use
..... assigner0..1Reference(Organization)Organization that issued id (may be just text)
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: https://www.clinicaltrialsregister.eu
..... value SΣ1..1stringThe value that is unique
Example General: 123456
..... period Σ0..1PeriodTime period when id is/was valid for use
..... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
.... identifier:NCT Σ0..1IdentifierNCT number

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... use0..1codeusual | official | temp | secondary | old (If known)
..... type0..1CodeableConceptDescription of identifier
..... system1..1uriThe namespace for the identifier value
Fixed Value: http://clinicaltrials.gov
..... value0..1stringThe value that is unique
..... period0..1PeriodTime period when id is/was valid for use
..... assigner0..1Reference(Organization)Organization that issued id (may be just text)
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: http://clinicaltrials.gov
..... value SΣ1..1stringThe value that is unique
Example General: 123456
..... period Σ0..1PeriodTime period when id is/was valid for use
..... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
.... identifier:PMID Σ0..1IdentifierPubmed ID

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... use0..1codeusual | official | temp | secondary | old (If known)
..... type0..1CodeableConceptDescription of identifier
..... system1..1uriThe namespace for the identifier value
Fixed Value: http://www.ncbi.nlm.nih.gov/pubmed
..... value0..1stringThe value that is unique
..... period0..1PeriodTime period when id is/was valid for use
..... assigner0..1Reference(Organization)Organization that issued id (may be just text)
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: http://www.ncbi.nlm.nih.gov/pubmed
..... value SΣ1..1stringThe value that is unique
Example General: 123456
..... period Σ0..1PeriodTime period when id is/was valid for use
..... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
.... identifier:DOI Σ0..1IdentifierDigital Object Identifier

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... use0..1codeusual | official | temp | secondary | old (If known)
..... type0..1CodeableConceptDescription of identifier
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://doi.org
..... value0..1stringThe value that is unique
..... period0..1PeriodTime period when id is/was valid for use
..... assigner0..1Reference(Organization)Organization that issued id (may be just text)
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: https://doi.org
..... value SΣ1..1stringThe value that is unique
Example General: 123456
..... period Σ0..1PeriodTime period when id is/was valid for use
..... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
.... identifier:URI Σ0..1IdentifierUniform Resource Identifier

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... use0..1codeusual | official | temp | secondary | old (If known)
..... type0..1CodeableConceptDescription of identifier
..... system1..1uriThe namespace for the identifier value
Fixed Value: urn:ietf:rfc:3986
..... value0..1stringThe value that is unique
..... period0..1PeriodTime period when id is/was valid for use
..... assigner0..1Reference(Organization)Organization that issued id (may be just text)
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: urn:ietf:rfc:3986
..... value SΣ1..1stringThe value that is unique
Example General: 123456
..... period Σ0..1PeriodTime period when id is/was valid for use
..... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
.... identifier:DRKS Σ0..1IdentifierDeusches Register Klinischer Studien

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... use0..1codeusual | official | temp | secondary | old (If known)
..... type0..1CodeableConceptDescription of identifier
..... system1..1uriThe namespace for the identifier value
Fixed Value: https://www.drks.de
..... value0..1stringThe value that is unique
..... period0..1PeriodTime period when id is/was valid for use
..... assigner0..1Reference(Organization)Organization that issued id (may be just text)
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system SΣ1..1uriThe namespace for the identifier value
Required Pattern: https://www.drks.de
..... value SΣ1..1stringThe value that is unique
Example General: 123456
..... period Σ0..1PeriodTime period when id is/was valid for use
..... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... title SΣ0..1stringName for this study
... protocol Σ0..*Reference(PlanDefinition)Steps followed in executing study
... partOf Σ0..*Reference(ResearchStudy)Part of larger study
... status ?!SΣ1..1codeactive | 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
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.

... primaryPurposeType SΣ0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.

... phase Σ1..1CodeableConceptn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Binding: ResearchStudyPhase (required)
... Slices for category SΣ1..*CodeableConceptClassifications for the study
Slice: Unordered, Open by pattern:$this
Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.


.... category:studyCategory SΣ1..1CodeableConceptClassifications for the study
Binding: ValueSet Studienkategorien NCIt (required)
.... category:studyDesign SΣ0..*CodeableConceptClassifications for the study
Binding: ValueSet Studiendesign NCIt (required)
.... category:typeOfBlinding SΣ0..1CodeableConceptClassifications for the study
Binding: ValueSet Type of Blinding NCIt (required)
.... category:typeOfRandomization SΣ0..1CodeableConceptClassifications for the study
Binding: ValueSet Type of Randomization NCIt (required)
... focus SΣ0..*CodeableConceptDrugs, devices, etc. under study
Binding: ValueSet Study Focus NCIt (extensible)
... condition Σ0..*CodeableConceptCondition being studied
Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.


... contact Σ0..*ContactDetailContact details for the study
... relatedArtifact 0..*RelatedArtifactReferences and dependencies
... keyword Σ0..*CodeableConceptUsed to search for the study
Binding: (unbound) (example): Words associated with the study that may be useful in discovery.


... location Σ0..*CodeableConceptGeographic region(s) for study
Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.


... description 0..1markdownWhat this is study doing
... enrollment Σ0..*Reference(Group)Inclusion & exclusion criteria
... period Σ0..1PeriodWhen the study began and ended
... sponsor Σ0..1Reference(Organization)Organization that initiates and is legally responsible for the study
... principalInvestigator Σ0..1Reference(Practitioner | PractitionerRole)Researcher who oversees multiple aspects of the study
... site Σ0..*Reference(Location)Facility where study activities are conducted
... reasonStopped Σ0..1CodeableConceptaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.

... note 0..*AnnotationComments made about the study
... arm S0..*BackboneElementDefined path through the study for a subject
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringLabel for study arm
.... type S0..1CodeableConceptCategorization of study arm
Binding: ValueSet Type of Study Arm NCIt (required)
.... description 0..1stringShort explanation of study path
.