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

 

Other representations of profile: CSV, Excel, Schematron