TEMPLATE UseCaseC_Studienteilnahme (UseCaseC_Studienteilnahme)

TEMPLATE IDUseCaseC_Studienteilnahme
ConceptUseCaseC_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=005501C1FA493A4838F5F1121F2870EC, original_language=ISO_639-1::de, original_namespace=org.openehr, original_publisher=openEHR Foundation, custodian_namespace=org.openehr, MD5-CAM-1.0.1=e6671c55d1ef9d28386e6ae6e8142b95, build_uid=d148bb3c-6c0e-4cde-b4dc-326eae2cc1a8, sem_ver=1.0.0}
KeywordsHiGHmed-UCC, Use Case Cardiology, Use Case Kardiologie
Language useden
Citeable Identifier1246.169.2800
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=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]/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=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
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=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_CODED_TEXT, bindings=null, values=
  • Included 
  • Revoked 
  • Cancelled/Excluded 
, 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=Start of participation, 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]/items[at0004], code=at0004, itemType=ELEMENT, level=4, text=End of participation, 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]/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 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=Device ID, 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]