TEMPLATE UCC_Studienteilnahme (UCC_Studienteilnahme)

TEMPLATE IDUCC_Studienteilnahme
ConceptUCC_Studienteilnahme
DescriptionDas Template UCC_Studienteilnahme soll innerhalb des HiGHmed Use Cases Cardiology verwendet werden, um den Einschluss eines Patienten in die Registerstudie zu dokumentieren.
PurposeDas Template UCC_Studienteilnahme soll innerhalb des HiGHmed Use Cases Cardiology 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=DE0723367AA22BB716CEC5342B21FF60, original_language=ISO_639-1::de, original_namespace=org.openehr, original_publisher=openEHR Foundation, custodian_namespace=org.openehr, MD5-CAM-1.0.1=fe3dbdcae463b5348fcde5fceda86d6e, build_uid=d148bb3c-6c0e-4cde-b4dc-326eae2cc1a8}
KeywordsHiGHmed-UCC, Use Case Cardiology, Use Case Kardiologie
Language useden
Citeable Identifier1246.169.1537
AllOperationalTemplate [rootArchetypeId=openEHR-EHR-COMPOSITION.report.v1, otherContributors=null, tshis=[ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1], code=at0000, itemType=COMPOSITION, level=0, text=Studienteilnahme, description=Document to communicate information to others, commonly in response to a request from another party., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=COMPOSITION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/context, code=null, itemType=EXPOSED_RM_ATTRIBUTE, level=1, text=context, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=EXPOSED_REFERENCE_MODEL_ATTRIBUTE within , bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/category, code=null, itemType=EXPOSED_RM_ATTRIBUTE, level=1, text=category, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=EXPOSED_REFERENCE_MODEL_ATTRIBUTE within , bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/context/other_context, code=null, itemType=EXPOSED_RM_ATTRIBUTE, level=1, text=other_context, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=EXPOSED_REFERENCE_MODEL_ATTRIBUTE within , bindings=null, values=, 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[at0002], code=at0002, itemType=ELEMENT, level=2, text=Report ID, description=Identification information about the report., 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.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]/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], code=at0000, itemType=CLUSTER, level=3, text=Studienteilnahme, description=Detaillierte Informationen über die Teilnahme an einer klinischen Prüfung, Beobachtungs-, Register-, Diagnostik-, Therapiestudie oder an einem anderen medizinischen Forschungsvorhaben in der Rolle eines Studienpatienten oder Probanden., 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]/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]/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=
  • HiGHmed- Use Case Cardiology
Default value: HiGHmed- Use Case Cardiology, 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[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=
  • Etablierung eines Registers von Patienten mit chronischer Herzinsuffizienz im Rahmen des HiGHmed-Konsortiums.
Default value: Etablierung eines Registers von Patienten mit chronischer Herzinsuffizienz im Rahmen des HiGHmed-Konsortiums., 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[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=
  • HiGHmed-UCC
Default value: HiGHmed-UCC, 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, 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
Default value: 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]/items[at0018], code=at0018, itemType=ELEMENT, level=4, text=Rechtsgrundlage, description=Rechtliche Rahmen oder Regeln für die Teilnahme., comment=Zur Sicherheit der Patienten dürfen Forschungen am Menschen nur durchgeführt werden, wenn zahlreiche Gesetze und Richtlinien eingehalten werden. Hier können Gesetze und Richtlinien, nach welchen die Teilnahme an der Studie geregelt wird, benannt werden, z.B. das Arzneimittelgesetz (AMG) und die GCP-Verordnung bei einer in Deutschland durchgeführten klinischen Arzneimittelstudie., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • Einwilligungserklärung liegt vor
Default value: 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]/items[at0005], code=at0005, itemType=ELEMENT, level=4, text=Status der Teilnahme, description=Status der Teilnahme., comment=Ab dem Zeitpunkt, wann ein Patient für eine Studie als Teilnehmer in Frage kommt und darüber informiert wird, kann seine Teilnahme verschiedene Status durchlaufen., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_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]/items[at0003], code=at0003, itemType=ELEMENT, level=4, text=Beginn der Teilnahme, description=Datum, wann der Patient in die Studie eingeschlossen wurde., comment=Das Datumfeld kann leer bleiben, wenn der Teilnahmestatus auf "Informiert" oder "Eingewilligt" gesetzt ist., 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]/items[at0004], code=at0004, itemType=ELEMENT, level=4, text=Ende der Teilnahme, description=Datum, wann der Patient die Studie beendet hat., comment=Das Datumfeld kann leer bleiben, wenn der Teilnahmestatus auf "Informiert", "Eingewilligt", "Screening-Phase", "Eingeschlossen" oder "Follow-up" gesetzt ist., 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]/items[at0014], code=at0014, itemType=ELEMENT, level=4, text=Kommentar, description=Zusätzliche Informationen zu der Studienteilnahme., 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 UCC Hauptstudie'], code=at0033, itemType=CLUSTER, level=3, text=Patienteninformation UCC 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 UCC 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: Etablierung eines Registers von Patienten mit chronischer Herzinsuffizienz im Rahmen des HiGHmed-Konsortiums, HiGHmed Use Case Cardiology (HiGHmed-UCC)
Default value: Patienteninformation zur Hauptstudie: Etablierung eines Registers von Patienten mit chronischer Herzinsuffizienz im Rahmen des HiGHmed-Konsortiums, HiGHmed Use Case Cardiology (HiGHmed-UCC), extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/protocol[at0024]/items[at0033 and name/value='Patienteninformation UCC 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=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/protocol[at0024]/items[at0033 and name/value='Patienteninformation UCC Substudie Sensorik'], code=at0033, itemType=CLUSTER, level=3, text=Patienteninformation UCC Substudie Sensorik, 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 UCC Substudie Sensorik']/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 Substudie: Erhebung sensorbasierter Daten und Patient Reported Outcome (PROs), HiGHmed Use Case Cardiology (HiGHmed-UCC)
Default value: Patienteninformation zur Substudie: Erhebung sensorbasierter Daten und Patient Reported Outcome (PROs), HiGHmed Use Case Cardiology (HiGHmed-UCC), extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report.v1]/content[openEHR-EHR-ACTION.informed_consent.v0]/protocol[at0024]/items[at0033 and name/value='Patienteninformation UCC Substudie Sensorik']/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=, extendedValues=null]], templateType=normal]