TEMPLATE Studienteilnahme (Studienteilnahme)

TEMPLATE IDStudienteilnahme
ConceptStudienteilnahme
DescriptionZur Darstellung von Informationen zu einer Person in Bezug auf ihre Teilnahme an einer Studie (unter Umständen, während sie PatientIn in einer Gesundheitseinrichtung ist).
UseDas Template wird verwendet, um Informationen über eine Teilnahme des Patienten an einer klinischen Prüfung, Beobachtungs-, Register-, Diagnostik-, Therapiestudie oder an einem anderen medizinischen Forschungsvorhaben in der Rolle eines Studienpatienten oder Probanden strukturiert darzustellen. Eine Studienteilnahme setzt voraus, dass von der Person eine freiwillige informierte Einwilligung (Einwilligung nach Aufklärung ‐„informed consent“) vor dem Beginn der Teilnahme, vorliegen muss.
MisuseNicht für die Informationen über Teilnahme an Forschungsvorhaben oder Prozeduren, für die keine Einwilligung erforderlich ist.
PurposeZur Darstellung von Informationen zu einer Person in Bezug auf ihre Teilnahme an einer Studie (unter Umständen, während sie PatientIn in einer Gesundheitseinrichtung ist).
References
Authorsdate: 2019-06-26; name: Katrin Tröltzsch; organisation: Universitätsklinikum Heidelberg; email: katrin.troeltzsch@med.uni-heidelberg.de
Other Details Languagedate: 2019-06-26; name: Katrin Tröltzsch; organisation: Universitätsklinikum Heidelberg; email: katrin.troeltzsch@med.uni-heidelberg.de
OtherDetails Language Independent{licence=This work is licensed under the Creative Commons Attribution-ShareAlike 3.0 License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/., custodian_organisation=openEHR Foundation, PARENT:MD5-CAM-1.0.1=005501C1FA493A4838F5F1121F2870EC, original_language=ISO_639-1::de, original_namespace=org.openehr, original_publisher=openEHR Foundation, custodian_namespace=org.openehr, MD5-CAM-1.0.1=76ef6040c36fed34b7f8589d11514474, build_uid=b36d20b1-06a2-47a6-99cb-a9b4b2580c84, sem_ver=13.0.0}
KeywordsStudie; Studienteilnehmer; ProbadIn; Forschungsvorhaben; Einwilligung
Language useden
Citeable Identifier1246.169.336
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B. AIO-HEP-0116., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/description[at0001]/items[openEHR-EHR-CLUSTER.study_participation.v1]/items[openEHR-EHR-CLUSTER.study_details.v1]/items[at0003], code=at0003, itemType=ELEMENT, level=5, text=Studientyp (optional), description=Beschreibt die Art einer Studie., comment=Zum Beispiel: Interventionelle klinische Prüfung, Observationsstudie, Registerstudie, Bioäquivalenz-Studie, Medizinproduktestudie oder andere., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values= Terminology: local_terms
  • AMG 
  • MPG 
  • Anwendungsbeobachtung (AWB) 
  • Registerstudie 
  • Diagnostikstudie 
  • Biomarker-Studie 
  • Präventionsstudie 
  • Epidemiologische Studie 
  • Sonstige Studie 
  • Unbekannt 
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Value set: terminology://fhir.hl7.org/ValueSet/$expand?url=http://hl7.org/fhir/ValueSet/research-study-status
  • In Vorbereitung 
  • Rekrutierung 
  • Einladung zum Screening 
  • Aktiv, keine Rekrutierung 
  • Vorübergehend unterbrochen 
  • Abgeschlossen 
  • Vorzeitiges Ende 
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  • Unbekannt 
  • active | Active 
  • administratively-completed | Administratively Completed 
  • approved | Approved 
  • closed-to-accrual | Closed to Accrual 
  • closed-to-accrual-and-intervention | Closed to Accrual and Intervention 
  • completed | Completed 
  • disapproved | Disapproved 
  • in-review | In Review 
  • temporarily-closed-to-accrual | Temporarily Closed to Accrual 
  • temporarily-closed-to-accrual-and-intervention | Temporarily Closed to Accrual and Intervention 
  • withdrawn | Withdrawn 
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Value set: terminology://fhir.hl7.org/ValueSet/$expand?url=http://hl7.org/fhir/ValueSet/research-study-status
  • In Vorbereitung 
  • Rekrutierung 
  • Einladung zum Screening 
  • Aktiv, keine Rekrutierung 
  • Vorübergehend unterbrochen 
  • Abgeschlossen 
  • Vorzeitiges Ende 
  • Widerrufen 
  • Unbekannt 
  • active | Active 
  • administratively-completed | Administratively Completed 
  • approved | Approved 
  • closed-to-accrual | Closed to Accrual 
  • closed-to-accrual-and-intervention | Closed to Accrual and Intervention 
  • completed | Completed 
  • disapproved | Disapproved 
  • in-review | In Review 
  • temporarily-closed-to-accrual | Temporarily Closed to Accrual 
  • temporarily-closed-to-accrual-and-intervention | Temporarily Closed to Accrual and Intervention 
  • withdrawn | Withdrawn 
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  • Informed 
  • Consented 
  • Screening phase 
  • Included 
  • Revoked 
  • Cancelled/Excluded 
  • Follow-up 
  • Completed 
  • Potential Candidate 
  • Not Registered 
  • Candidate 
  • Eligible 
  • Follow-up 
  • Ineligible 
  • Not Registered 
  • Off-study 
  • On-study 
  • On-study-intervention 
  • On-study-observation 
  • Pending on-study 
  • Potential Candidate 
  • Screening 
  • Withdrawn 
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