{ "resourceType": "StructureDefinition", "id": "mii-pr-studie-studie", "meta": { "extension": [ { "url": "http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-license", "valueCode": "CC-BY-4.0" }, { "url": "http://hl7.org/fhir/StructureDefinition/package-source", "extension": [ { "url": "packageId", "valueId": "de.medizininformatikinitiative.kerndatensatz.studie" }, { "url": "version", "valueString": "2027.0.0-ballot" }, { "url": "uri", "valueUri": "https://www.medizininformatik-initiative.de/fhir/modul-studie" } ] } ], "profile": [ "http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-shareablestructuredefinition", "http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-publishablestructuredefinition" ] }, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm", "valueCoding": { "code": "semver", "system": "http://hl7.org/fhir/version-algorithm", "display": "SemVer" } }, { "url": "http://hl7.org/fhir/StructureDefinition/cqf-knowledgeCapability", "valueCode": "shareable" }, { "url": "http://hl7.org/fhir/StructureDefinition/cqf-knowledgeCapability", "valueCode": "publishable" }, { "url": "http://hl7.org/fhir/StructureDefinition/artifact-versionPolicy", "valueCodeableConcept": { "coding": [ { "code": "package", "system": "http://terminology.hl7.org/CodeSystem/artifact-version-policy-codes", "version": "3.0.0", "display": "Package" } ] } }, { "url": "http://hl7.org/fhir/StructureDefinition/artifact-usage", "valueMarkdown": "Use this profile as the technical FHIR representation of the corresponding Medical Informatics Initiative logical model. The profile constrains a base FHIR resource for the MII module context by specifying how elements are used, which elements are required or not used, which extensions and terminology bindings apply, and how the resource maps to the module-specific content model. Implementers should produce and consume resource instances that conform to this profile when exchanging data for the corresponding MII module." }, { "url": "http://hl7.org/fhir/StructureDefinition/resource-approvalDate", "valueDate": "2026-01-09" }, { "url": "http://hl7.org/fhir/StructureDefinition/resource-effectivePeriod", "valuePeriod": { "start": "2027" } }, { "url": "http://hl7.org/fhir/StructureDefinition/artifact-topic", "valueCodeableConcept": { "coding": [ { "code": "C15206", "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl" } ] } }, { "url": "http://hl7.org/fhir/StructureDefinition/artifact-topic", "valueCodeableConcept": { "coding": [ { "code": "C15429", "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl" } ] } }, { "url": "http://hl7.org/fhir/StructureDefinition/artifact-author", "valueContactDetail": { "name": "Matthias Löbe", "telecom": [ { "system": "email", "value": "matthias.loebe@imise.uni-leipzig.de" } ] } }, { "url": "http://hl7.org/fhir/StructureDefinition/artifact-editor", "valueContactDetail": { "name": "Taskforce Core Data Set" } }, { "url": "http://hl7.org/fhir/StructureDefinition/artifact-editor", "valueContactDetail": { "name": "Thomas Debertshäuser", "telecom": [ { "system": "email", "value": "thomas.debertshaeuser@charite.de" } ] } }, { "url": "http://hl7.org/fhir/StructureDefinition/artifact-editor", "valueContactDetail": { "name": "Margaux Gatrio", "telecom": [ { "system": "email", "value": "margaux.gatrio@bih-charite.de" } ] } }, { "url": "http://hl7.org/fhir/StructureDefinition/artifact-reviewer", "valueContactDetail": { "name": "Interoperability Working Group", "telecom": [ { "system": "url", "value": "https://www.medizininformatik-initiative.de/en/collaboration/interoperability-working-group" } ] } }, { "url": "http://hl7.org/fhir/StructureDefinition/artifact-reviewer", "valueContactDetail": { "name": "National Steering Committee", "telecom": [ { "system": "url", "value": "https://www.medizininformatik-initiative.de/en/collaboration/national-steering-committee" } ] } }, { "url": "http://hl7.org/fhir/StructureDefinition/artifact-endorser", "valueContactDetail": { "name": "Interoperability Working Group", "telecom": [ { "system": "url", "value": "https://www.medizininformatik-initiative.de/en/collaboration/interoperability-working-group" } ] } }, { "url": "http://hl7.org/fhir/StructureDefinition/artifact-endorser", "valueContactDetail": { "name": "National Steering Committee", "telecom": [ { "system": "url", "value": "https://www.medizininformatik-initiative.de/en/collaboration/national-steering-committee" } ] } } ], "url": "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie", "version": "2027.0.0-ballot", "name": "MII_PR_Studie_Studie", "title": "MII PR Studie Studie", "_title": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "MII PR Studie Studie" } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "MII PR Study Study" } ] } ] }, "status": "active", "experimental": false, "date": "2026-01-09", "publisher": "Medizininformatik Initiative", "contact": [ { "telecom": [ { "system": "url", "value": "https://www.medizininformatik-initiative.de" } ] } ], "description": "Dieses Profil beschreibt eine Studie in der Medizininformatik-Initiative.", "_description": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Dieses Profil beschreibt eine Studie in der Medizininformatik-Initiative." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "This profile describes a study within the Medical Informatics Initiative." } ] } ] }, "fhirVersion": "4.0.1", "kind": "resource", "abstract": false, "type": "ResearchStudy", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/ResearchStudy", "derivation": "constraint", "differential": { "element": [ { "id": "ResearchStudy.extension", "path": "ResearchStudy.extension", "mustSupport": true }, { "id": "ResearchStudy.extension:Label", "path": "ResearchStudy.extension", "sliceName": "Label", "short": "Label", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "MII EX Studie Backport Label" } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "MII EX Studie Backport Label" } ] } ] }, "definition": "Optionales Erweiterungselement – in allen Ressourcen vorhanden.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Optionales Erweiterungselement – in allen Ressourcen vorhanden." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Optional Extension Element - found in all resources." } ] } ] }, "min": 0, "max": "*", "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label" ] } ], "mustSupport": true }, { "id": "ResearchStudy.extension:AssociatedParty", "path": "ResearchStudy.extension", "sliceName": "AssociatedParty", "short": "AssociatedParty", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "MII EX Studie Backport AssociatedParty" } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "MII EX Studie Backport AssociatedParty" } ] } ] }, "definition": "Optionales Erweiterungselement – in allen Ressourcen vorhanden.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Optionales Erweiterungselement – in allen Ressourcen vorhanden." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Optional Extension Element - found in all resources." } ] } ] }, "min": 0, "max": "*", "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty" ] } ], "mustSupport": true }, { "id": "ResearchStudy.extension:Ethikvotum", "path": "ResearchStudy.extension", "sliceName": "Ethikvotum", "short": "Ethikvotum", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "MII EX Studie Ethikvotum" } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "MII EX Studie Ethikvotum" } ] } ] }, "definition": "Optionales Erweiterungselement – in allen Ressourcen vorhanden.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Optionales Erweiterungselement – in allen Ressourcen vorhanden." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Optional Extension Element - found in all resources." } ] } ] }, "min": 0, "max": "*", "type": [ { "code": "Extension", "profile": [ "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum" ] } ], "mustSupport": true }, { "id": "ResearchStudy.extension:Studienregister", "path": "ResearchStudy.extension", "sliceName": "Studienregister", "short": "Studienregister", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "MII EX Studie Studienregister" } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "MII EX Studie Studienregister" } ] } ] }, "definition": "Optionales Erweiterungselement – in allen Ressourcen vorhanden.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Optionales Erweiterungselement – in allen Ressourcen vorhanden." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Optional Extension Element - found in all resources." } ] } ] }, "min": 0, "max": "*", "type": [ { "code": "Extension", "profile": [ "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister" ] } ], "mustSupport": true }, { "id": "ResearchStudy.extension:Eligibility", "path": "ResearchStudy.extension", "sliceName": "Eligibility", "short": "Eligibility", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "MII EX Studie Eligibility" } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "MII EX Studie Eligibility" } ] } ] }, "definition": "Optionales Erweiterungselement – in allen Ressourcen vorhanden.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Optionales Erweiterungselement – in allen Ressourcen vorhanden." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Optional Extension Element - found in all resources." } ] } ] }, "min": 0, "max": "1", "type": [ { "code": "Extension", "profile": [ "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility" ] } ], "mustSupport": true }, { "id": "ResearchStudy.extension:Akronym", "path": "ResearchStudy.extension", "sliceName": "Akronym", "short": "Akronym", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "MII EX Studie Akronym" } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "MII EX Studie Akronym" } ] } ] }, "definition": "Optionales Erweiterungselement – in allen Ressourcen vorhanden.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Optionales Erweiterungselement – in allen Ressourcen vorhanden." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Optional Extension Element - found in all resources." } ] } ] }, "min": 0, "max": "1", "type": [ { "code": "Extension", "profile": [ "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym" ] } ], "mustSupport": true }, { "id": "ResearchStudy.extension:Rekrutierung", "path": "ResearchStudy.extension", "sliceName": "Rekrutierung", "short": "Rekrutierung", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "MII EX Studie Rekrutierung" } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "MII EX Studie Rekrutierung" } ] } ] }, "definition": "Optionales Erweiterungselement – in allen Ressourcen vorhanden.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Optionales Erweiterungselement – in allen Ressourcen vorhanden." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Optional Extension Element - found in all resources." } ] } ] }, "min": 0, "max": "1", "type": [ { "code": "Extension", "profile": [ "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung" ] } ], "mustSupport": true }, { "id": "ResearchStudy.extension:Finanzierung", "path": "ResearchStudy.extension", "sliceName": "Finanzierung", "short": "Finanzierung", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "MII EX Studie Finanzierung" } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "MII EX Studie Finanzierung" } ] } ] }, "definition": "Optionales Erweiterungselement – in allen Ressourcen vorhanden.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Optionales Erweiterungselement – in allen Ressourcen vorhanden." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Optional Extension Element - found in all resources." } ] } ] }, "min": 0, "max": "*", "type": [ { "code": "Extension", "profile": [ "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung" ] } ], "mustSupport": true }, { "id": "ResearchStudy.identifier", "path": "ResearchStudy.identifier", "short": "Name für diese Studie", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Name für diese Studie." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Business Identifier for study." } ] } ] }, "definition": "Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Identifiers assigned to this research study by the sponsor or other systems." } ] } ] }, "mustSupport": true }, { "id": "ResearchStudy.identifier.system", "path": "ResearchStudy.identifier.system", "mustSupport": true }, { "id": "ResearchStudy.identifier.value", "path": "ResearchStudy.identifier.value", "mustSupport": true }, { "id": "ResearchStudy.title", "path": "ResearchStudy.title", "short": "Name für diese Studie", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Name für diese Studie." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Name for this study." } ] } ] }, "definition": "Ein kurzer, beschreibender und benutzerfreundlicher Bezeichner für die Studie.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Ein kurzer, beschreibender und benutzerfreundlicher Bezeichner für die Studie." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "A short, descriptive user-friendly label for the study." } ] } ] }, "mustSupport": true }, { "id": "ResearchStudy.partOf", "path": "ResearchStudy.partOf", "short": "Teil einer größeren Studie.", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Teil einer größeren Studie." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Part of larger study." } ] } ] }, "definition": "Eine größere Forschungsstudie, von der diese spezielle Studie ein Bestandteil oder ein Schritt ist.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Eine größere Forschungsstudie, von der diese spezielle Studie ein Bestandteil oder ein Schritt ist." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "A larger research study of which this particular study is a component or step." } ] } ] }, "mustSupport": true }, { "id": "ResearchStudy.status", "path": "ResearchStudy.status", "short": "aktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "aktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen" } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "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": "Der aktuelle Status der Studie.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Der aktuelle Status der Studie." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "The current state of the study." } ] } ] }, "mustSupport": true }, { "id": "ResearchStudy.category", "path": "ResearchStudy.category", "short": "Klassifikationen für die Studie.", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Klassifikationen für die Studie." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Classifications for the study." } ] } ] }, "definition": "Codes zur Kategorisierung des Studientyps, wie z. B. experimentell vs. beobachtend, Art der Verblindung, Art der Randomisierung, Sicherheit vs. Wirksamkeit usw.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Codes zur Kategorisierung des Studientyps, wie z. B. experimentell vs. beobachtend, Art der Verblindung, Art der Randomisierung, Sicherheit vs. Wirksamkeit usw." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc." } ] } ] }, "mustSupport": true }, { "id": "ResearchStudy.focus", "path": "ResearchStudy.focus", "short": "Untersuchte Medikamente, Geräte usw.", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Untersuchte Medikamente, Geräte usw." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Drugs, devices, etc. under study" } ] } ] }, "definition": "Die Medikamente, Nahrungsmittel, Therapien, Geräte oder andere Anliegen oder Interventionen, über die die Studie mehr Informationen gewinnen möchte.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Die Medikamente, Nahrungsmittel, Therapien, Geräte oder andere Anliegen oder Interventionen, über die die Studie mehr Informationen gewinnen möchte." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "The medication, food, therapy, device or other concerns or interventions that the study is seeking to gain more information about." } ] } ] }, "mustSupport": true }, { "id": "ResearchStudy.focus.text", "path": "ResearchStudy.focus.text", "mustSupport": true }, { "id": "ResearchStudy.keyword", "path": "ResearchStudy.keyword", "short": "Wird verwendet, um nach der Studie zu suchen.", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Wird verwendet, um nach der Studie zu suchen." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Used to search for the study." } ] } ] }, "definition": "Schlüsselbegriffe, die bei der Suche nach oder Filterung der Studie helfen.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Schlüsselbegriffe, die bei der Suche nach oder Filterung der Studie helfen." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Key terms to aid in searching for or filtering the study." } ] } ] }, "mustSupport": true }, { "id": "ResearchStudy.keyword.text", "path": "ResearchStudy.keyword.text", "mustSupport": true }, { "id": "ResearchStudy.arm", "path": "ResearchStudy.arm", "short": "Definierter Weg durch die Studie für ein Subjekt.", "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Definierter Weg durch die Studie für ein Subjekt." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "Defined path through the study for a subject." } ] } ] }, "definition": "Beschreibt eine erwartete Abfolge von Ereignissen für einen der Teilnehmer einer Studie. Z. B. Exposition gegenüber Medikament A, Auswaschphase, Exposition gegenüber Medikament B, Auswaschphase, Nachverfolgung.", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "de" }, { "url": "content", "valueString": "Beschreibt eine erwartete Abfolge von Ereignissen für einen der Teilnehmer einer Studie. Z. B. Exposition gegenüber Medikament A, Auswaschphase, Exposition gegenüber Medikament B, Auswaschphase, Nachverfolgung." } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "en" }, { "url": "content", "valueString": "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." } ] } ] }, "mustSupport": true }, { "id": "ResearchStudy.arm.name", "path": "ResearchStudy.arm.name", "mustSupport": true } ] } }