TEMPLATE CAEHR_C_Studienteilnahme (CAEHR_C_Studienteilnahme)

TEMPLATE IDCAEHR_C_Studienteilnahme
ConceptCAEHR_C_Studienteilnahme
DescriptionDas Template CAEHR_C_Studienteilnahme soll innerhalb des CAEHR Use Cases C verwendet werden, um den Einschluss eines Patienten in die Registerstudie zu dokumentieren.
PurposeDas Template CAEHR_C_Studienteilnahme soll innerhalb des CAEHR Use Cases C verwendet werden, um den Einschluss eines Patienten in die Registerstudie zu dokumentieren.
References
Authorsdate: 2021-02-18; name: Kim Sommer; organisation: Medizinische Hochschule Hannover
Other Details Languagedate: 2021-02-18; name: Kim Sommer; organisation: Medizinische Hochschule Hannover
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, is_singleton=ehr, original_namespace=org.openehr, original_publisher=openEHR Foundation, custodian_namespace=org.openehr, MD5-CAM-1.0.1=0079806f48b9b373659e4b62760b65e6, build_uid=d148bb3c-6c0e-4cde-b4dc-326eae2cc1a8, sem_ver=13.0.0}
KeywordsCAEHR, Use Case C
Language useden
Citeable Identifier1246.169.2877
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extendedValues=null], ResourceSimplifiedHierarchyItem [path=null, code=null, itemType=UNSUPPORTEDTOPLEVELATTRIBUTE, level=1, text=Other Context, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=UNSUPPORTEDTOPLEVELATTRIBUTE, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/context/other_context[at0001]/items[openEHR-EHR-CLUSTER.case_identification.v0], code=at0000, itemType=CLUSTER, level=2, text=Case identification, description=To record case identification details for public health purposes., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/context/other_context[at0001]/items[openEHR-EHR-CLUSTER.case_identification.v0]/items[at0001], code=at0001, itemType=ELEMENT, level=3, text=Case identifier, description=The identifier of this case., comment=null, 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]/context/other_context[at0001]/items[openEHR-EHR-CLUSTER.care_journey_metadata.v0], code=at0000, itemType=CLUSTER, level=2, text=Care journey metadata, description=Tp capture Care plan metadata, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/context/other_context[at0001]/items[openEHR-EHR-CLUSTER.care_journey_metadata.v0]/items[at0001], code=at0001, itemType=ELEMENT, level=3, text=Care plan name, description=The name , preferably coded of the Care plan with which this journey is associated, and against which the composition was updated., comment=null, 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]/context/other_context[at0001]/items[openEHR-EHR-CLUSTER.care_journey_metadata.v0]/items[at0002], code=at0002, itemType=ELEMENT, level=3, text=Care plan identifier, description=The identifier , preferably coded, of the Care plan with which this journey is associated, and against which the composition was updated., comment=null, 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]/context/other_context[at0001]/items[openEHR-EHR-CLUSTER.care_journey_metadata.v0]/items[at0003], code=at0003, itemType=ELEMENT, level=3, text=Patient journey identifier, description=A patient-journey specific identifier i.e unique to a patient's journey along a specific care pathway., comment=null, 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], code=at0000, itemType=ACTION, level=1, text=Informed consent, description=Record of status and details of informed consent from an individual (or the individual's agent/proxy) for a proposed procedure, trial or other healthcare-related activity (including treatments and investigations), based upon a clear appreciation and understanding of the facts, implications, and possible future consequences by the consenting party., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ACTION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/description[at0001], code=at0001, itemType=UNSUPPORTEDTOPLEVELATTRIBUTE, level=2, text=Description, description=, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=UNSUPPORTEDTOPLEVELATTRIBUTE, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/description[at0001]/items[at0002], code=at0002, itemType=ELEMENT, level=3, text=Studienteilnahme, description=Identification of the procedure, clinical trial or healthcare-related activity (including correct side/correct site, where appropriate) against which the consent status and details are recorded., comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, 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 and name/value='Study participation'], code=at0000, itemType=CLUSTER, level=3, text=Study participation, description=Details about participation in a clinical trial, observational study, registry study, diagnostic study, therapeutic study, or other medical research project in the role of a study patient or subject., comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, 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 and name/value='Study participation']/items[openEHR-EHR-CLUSTER.study_details.v1], code=at0000, itemType=CLUSTER, level=4, text=Studie/Prüfung, description=Detaillierte Informationen über eine klinische Prüfung, Beobachtungs-, Register-, Diagnostik-, Therapiestudie oder ein anderes medizinisches Forschungsvorhaben an Menschen., comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, 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 and name/value='Study participation']/items[openEHR-EHR-CLUSTER.study_details.v1]/items[at0001], code=at0001, itemType=ELEMENT, level=5, text=Name der Studie, description=Titel des Forschungsvorhabens., comment=Zum Beispiel: "Eine randomisierte Phase-II-Studie mit nal-Iri plus 5-Fluorouracil im Vergleich zu 5-Fluorouracil bei stationären Patienten mit Cholangio- und Gallenblasenkarzinom, die zuvor mit Gemcitabin oder Gemcitabin-haltigen Therapien behandelt wurden.", uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • CAEHR Use Case C
, 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 and name/value='Study participation']/items[openEHR-EHR-CLUSTER.study_details.v1]/items[at0004], code=at0004, itemType=ELEMENT, level=5, text=Beschreibung, description=Kurze Beschreibung des Forschungsvorhabens., comment=Beschreibung des Forschungsvorhabens in leicht verständlicher Formulierung für Laien., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • Register von Patienten mit koronarer Herzkrankheit (KHK) oder Herzinsuffizienz (HF) im Rahmen des CAEHR Digitaler Fortschrittshubs
, 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 and name/value='Study participation']/items[openEHR-EHR-CLUSTER.study_details.v1]/items[at0002], code=at0002, itemType=ELEMENT, level=5, text=Studien Code, description=Die eindeutige Bezeichnung der Studie, welche der Sponsor (Studienverantwortliche) vergeben hat., comment=Jedes Studienvorhaben wird nach einem Prüfplan (Studienprotokoll) durchgeführt, der durch den Verantwortlichen der Studie eindeutig bezeichnet wird, z. B. AIO-HEP-0116., uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • CAEHR Use Case C
, 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 and name/value='Study participation']/items[openEHR-EHR-CLUSTER.study_details.v1]/items[at0003], code=at0003, itemType=ELEMENT, level=5, text=Studientyp, 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_TEXT, bindings=null, values=
  • Registerstudie
, 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 and name/value='Study participation']/items[openEHR-EHR-CLUSTER.study_details.v1]/items[at0016], code=at0016, itemType=ELEMENT, level=5, text=Prä-Phase, description=Angabe, ob es sich um eine klinische Prüfung der Phase 0 handelt., comment=Eine Forschungsphase, die vor traditionellen Phase-I-Studien durchgeführt wird, um zu untersuchen, wie oder ob ein Medikament den menschlichen Körper beeinflusst. Explorative Studie ohne therapeutische oder diagnostische Ziele (z. B. Screening-Studie, Mikrodosis-Studie)., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=null, values=Assumed value: false, 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 and name/value='Study participation']/items[openEHR-EHR-CLUSTER.study_details.v1]/items[at0017], code=at0017, itemType=ELEMENT, level=5, text=Post-Phase, description=Angabe, ob es sich um eine klinische Prüfung der Phase I handelt., comment=Eine Forschungsphase, die sich mit der Sicherheit eines Arzneimittels befasst. Die Studie wird in der Regel mit gesunden Freiwilligen durchgeführt., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=null, values=Assumed value: false, 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 and name/value='Study participation']/items[at0018], code=at0018, itemType=ELEMENT, level=4, text=Legal basis, description=Legal framework or rules for participation., comment=For patient safety, research involving human subjects may only be conducted if numerous laws and guidelines are followed. Laws and guidelines according to which participation in the study is regulated can be named here, e.g. the German Medicinal Products Act (AMG) and the GCP regulation in the case of a clinical drug study conducted in Germany., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • Einwilligungserklärung liegt vor
, 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 and name/value='Study participation']/items[at0005], code=at0005, itemType=ELEMENT, level=4, text=Status der Teilnahme (Hauptstudie), description=Participation status., comment=From the time a patient is eligible and informed to be a participant in a study, their participation may go through different statuses., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • Eingeschlossen
  • Widerrufen
  • Abgebrochen/Ausgeschlossen
, 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 and name/value='Study participation']/items[at0003], code=at0003, itemType=ELEMENT, level=4, text=Beginn der Teilnahme (Hauptstudie), description=Date when the patient was enrolled in the study., comment=The date field may be left blank if the participation status is set to 'Informed' or 'Consented'., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, 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 and name/value='Study participation']/items[at0004], code=at0004, itemType=ELEMENT, level=4, text=Ende der Teilnahme (Hauptstudie), description=Date when the patient completed the study., comment=The date field can be left blank if the participation status is set to 'Informed', 'Consented', 'Screening Phase', 'Included' or 'Follow-up'., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, 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 and name/value='Study participation']/items[at0014], code=at0014, itemType=ELEMENT, level=4, text=Comment, description=Additional information about study participation., comment=null, 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 and name/value='Studienteilnahme Sensorikstudie'], code=at0000, itemType=CLUSTER, level=3, text=Studienteilnahme Sensorikstudie, description=Details about participation in a clinical trial, observational study, registry study, diagnostic study, therapeutic study, or other medical research project in the role of a study patient or subject., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, 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 and name/value='Studienteilnahme Sensorikstudie']/items[at0001], code=at0001, itemType=ELEMENT, level=4, text=Study name, description=Designation of the study or clinical trial in which the patient is participating., comment=The title or study code of the study, e.g. AIO-HEP-0116., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • Sensorikstudie
Default value: Sensorikstudie, 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 and name/value='Studienteilnahme Sensorikstudie']/items[openEHR-EHR-CLUSTER.study_details.v1], code=at0000, itemType=CLUSTER, level=4, text=Studie/Prüfung, description=Detaillierte Informationen über eine klinische Prüfung, Beobachtungs-, Register-, Diagnostik-, Therapiestudie oder ein anderes medizinisches Forschungsvorhaben an Menschen., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, 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 and name/value='Studienteilnahme Sensorikstudie']/items[openEHR-EHR-CLUSTER.study_details.v1]/items[at0001], code=at0001, itemType=ELEMENT, level=5, text=Name der Studie, description=Titel des Forschungsvorhabens., comment=Zum Beispiel: "Eine randomisierte Phase-II-Studie mit nal-Iri plus 5-Fluorouracil im Vergleich zu 5-Fluorouracil bei stationären Patienten mit Cholangio- und Gallenblasenkarzinom, die zuvor mit Gemcitabin oder Gemcitabin-haltigen Therapien behandelt wurden.", uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • CAEHR Use Case C Sensorik
Default value: CAEHR Use Case C Sensorik, 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 and name/value='Studienteilnahme Sensorikstudie']/items[openEHR-EHR-CLUSTER.study_details.v1]/items[at0016], code=at0016, itemType=ELEMENT, level=5, text=Prä-Phase, description=Angabe, ob es sich um eine klinische Prüfung der Phase 0 handelt., comment=Eine Forschungsphase, die vor traditionellen Phase-I-Studien durchgeführt wird, um zu untersuchen, wie oder ob ein Medikament den menschlichen Körper beeinflusst. Explorative Studie ohne therapeutische oder diagnostische Ziele (z. B. Screening-Studie, Mikrodosis-Studie)., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=null, values=Assumed value: false, 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 and name/value='Studienteilnahme Sensorikstudie']/items[openEHR-EHR-CLUSTER.study_details.v1]/items[at0017], code=at0017, itemType=ELEMENT, level=5, text=Post-Phase, description=Angabe, ob es sich um eine klinische Prüfung der Phase I handelt., comment=Eine Forschungsphase, die sich mit der Sicherheit eines Arzneimittels befasst. Die Studie wird in der Regel mit gesunden Freiwilligen durchgeführt., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=null, values=Assumed value: false, 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 and name/value='Studienteilnahme Sensorikstudie']/items[at0005], code=at0005, itemType=ELEMENT, level=4, text=Status der Teilnahme (Sensorikstudie), description=Participation status., comment=From the time a patient is eligible and informed to be a participant in a study, their participation may go through different statuses., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • Eingeschlossen
  • Widerrufen
  • Abgebrochen/Ausgeschlossen
, 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 and name/value='Studienteilnahme Sensorikstudie']/items[at0003], code=at0003, itemType=ELEMENT, level=4, text=Beginn der Teilnahme (Sensorikstudie), description=Date when the patient was enrolled in the study., comment=The date field may be left blank if the participation status is set to 'Informed' or 'Consented'., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, 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 and name/value='Studienteilnahme Sensorikstudie']/items[at0004], code=at0004, itemType=ELEMENT, level=4, text=Ende der Teilnahme (Sensorikstudie), description=Date when the patient completed the study., comment=The date field can be left blank if the participation status is set to 'Informed', 'Consented', 'Screening Phase', 'Included' or 'Follow-up'., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, 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 and name/value='Studienteilnahme Sensorikstudie']/items[at0014], code=at0014, itemType=ELEMENT, level=4, text=Comment, description=Additional information about study participation., comment=null, 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[at0036], code=at0036, itemType=ELEMENT, level=3, text=Comment, description=Additional narrative about the informed consent activity, not captured in other fields., comment=null, 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]/protocol[at0024], code=at0024, itemType=UNSUPPORTEDTOPLEVELATTRIBUTE, level=2, text=Protocol, description=, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=UNSUPPORTEDTOPLEVELATTRIBUTE, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/protocol[at0024]/items[at0033 and name/value='Patienteninformation Hauptstudie'], code=at0033, itemType=CLUSTER, level=3, text=Patienteninformation Hauptstudie, description=Details about Patient Information made available to the subject or subject's agent., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/protocol[at0024]/items[at0033 and name/value='Patienteninformation Hauptstudie']/items[at0032], code=at0032, itemType=ELEMENT, level=4, text=Name, description=Identification of the information made available., comment=For example, the name of the form., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • Patienteninformation zur Hauptstudie: Register von Patienten mit koronarer Herzkrankheit (KHK) oder Herzinsuffizienz (HF) im Rahmen des CAEHR Digitaler Fortschrittshubs
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/protocol[at0024]/items[at0033 and name/value='Patienteninformation Hauptstudie']/items[at0035], code=at0035, itemType=ELEMENT, level=4, text=Description, description=Narrative description of the patient information made available., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • Version 2.0 vom 06.06.2023
Default value: Version 2.0 vom 06.06.2023, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/protocol[at0024]/items[at0033 and name/value='Patienteninformation Sensorikstudie'], code=at0033, itemType=CLUSTER, level=3, text=Patienteninformation Sensorikstudie, description=Details about Patient Information made available to the subject or subject's agent., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/protocol[at0024]/items[at0033 and name/value='Patienteninformation Sensorikstudie']/items[at0032], code=at0032, itemType=ELEMENT, level=4, text=Name, description=Identification of the information made available., comment=For example, the name of the form., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • Patienteninformation zur Sensorikstudie: Register von Patienten mit koronarer Herzkrankheit (KHK) oder Herzinsuffizienz (HF) im Rahmen des CAEHR Digitaler Fortschrittshubs
Default value: Patienteninformation zur Sensorikstudie: Register von Patienten mit koronarer Herzkrankheit (KHK) oder Herzinsuffizienz (HF) im Rahmen des CAEHR Digitaler Fortschrittshubs, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/protocol[at0024]/items[at0033 and name/value='Patienteninformation Sensorikstudie']/items[at0035], code=at0035, itemType=ELEMENT, level=4, text=Description, description=Narrative description of the patient information made available., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • Version 1.0 vom 31.03.2023
Default value: Version 1.0 vom 31.03.2023, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/protocol[at0024]/items[at0033 and name/value='Patienteninformation Sensorikstudie']/items[openEHR-EHR-CLUSTER.device.v1 and name/value='Smartwatch'], code=at0000, itemType=CLUSTER, level=4, text=Smartwatch, description=An instrument, apparatus, implant, material or similar, used in the provision of healthcare. In this context, a medical device includes a broad range of devices which act through a variety of physical, mechanical, thermal or similar means but specifically excludes devices which act through medicinal means such as pharmacological, metabolic or immunological methods. The scope is inclusive of disposable devices as well as durable or persisting devices that require tracking, maintenance activities or regular calibration, recognising that each type of device has specific data recording requirements., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/protocol[at0024]/items[at0033 and name/value='Patienteninformation Sensorikstudie']/items[openEHR-EHR-CLUSTER.device.v1 and name/value='Smartwatch']/items[at0001], code=at0001, itemType=ELEMENT, level=5, text=Device name, description=Identification of the medical device, preferably by a common name, a formal fully descriptive name or, if required, by class or category of device., comment=This data element will capture the term, phrase or category used in clinical practice. For example: <brand name><machine> (XYZ Audiometer); <size> <brand name> <intravenous catheter> (14G Jelco IV catheter); or <brand name/type> <implant>. Coding with a terminology is desirable, where possible, although this may be local and depending on local supplies available., uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, 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]/protocol[at0024]/items[at0033 and name/value='Patienteninformation Sensorikstudie']/items[openEHR-EHR-CLUSTER.device.v1 and name/value='Smartwatch']/items[at0021], code=at0021, itemType=ELEMENT, level=5, text=Unique device identifier (UDI), description=A numeric or alphanumeric string that is associated with this device within a given system., comment=Often fixed to the device as a barcode., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/protocol[at0024]/items[at0033 and name/value='Patienteninformation Sensorikstudie']/items[openEHR-EHR-CLUSTER.device.v1 and name/value='Smartphone'], code=at0000, itemType=CLUSTER, level=4, text=Smartphone, description=An instrument, apparatus, implant, material or similar, used in the provision of healthcare. In this context, a medical device includes a broad range of devices which act through a variety of physical, mechanical, thermal or similar means but specifically excludes devices which act through medicinal means such as pharmacological, metabolic or immunological methods. The scope is inclusive of disposable devices as well as durable or persisting devices that require tracking, maintenance activities or regular calibration, recognising that each type of device has specific data recording requirements., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/protocol[at0024]/items[at0033 and name/value='Patienteninformation Sensorikstudie']/items[openEHR-EHR-CLUSTER.device.v1 and name/value='Smartphone']/items[at0001], code=at0001, itemType=ELEMENT, level=5, text=Device name, description=Identification of the medical device, preferably by a common name, a formal fully descriptive name or, if required, by class or category of device., comment=This data element will capture the term, phrase or category used in clinical practice. For example: <brand name><machine> (XYZ Audiometer); <size> <brand name> <intravenous catheter> (14G Jelco IV catheter); or <brand name/type> <implant>. Coding with a terminology is desirable, where possible, although this may be local and depending on local supplies available., uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, 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]/protocol[at0024]/items[at0033 and name/value='Patienteninformation Sensorikstudie']/items[openEHR-EHR-CLUSTER.device.v1 and name/value='Smartphone']/items[at0021], code=at0021, itemType=ELEMENT, level=5, text=Unique device identifier (UDI), description=A numeric or alphanumeric string that is associated with this device within a given system., comment=Often fixed to the device as a barcode., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null]], templateType=normal]