ARCHETYPE Study participation (openEHR-EHR-CLUSTER.study_participation.v1)

ARCHETYPE IDopenEHR-EHR-CLUSTER.study_participation.v1
ConceptStudy participation
DescriptionDetails 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.
UseTo record details about participation in a clinical trial, observational, registry, diagnostic, therapeutic study, or other medical research project. This archetype is designed for general use within archetypes that describe characteristics of a person, for example DEMOGRAPHIC-PERSON.person-patient, or it can be added to archetypes that need to detail participation in a study, such as in "Details" in the ACTION.informed_consent archetype.
PurposeTo record details about a patient's 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 in a structured manner.
ReferencesICH-GCP E6 - Guideline for Good Clinical Practice of the International Conference on Harmonisation (CPMP/ICH/135/95);
Copyright© openEHR Foundation
AuthorsAuthor name: Natalia Strauch
Organisation: Medizinische Hochschule Hannover
Email: strauch.natalia@mh-hannover.de
Date originally authored: 2019-08-01
Other Details LanguageAuthor name: Natalia Strauch
Organisation: Medizinische Hochschule Hannover
Email: strauch.natalia@mh-hannover.de
Date originally authored: 2019-08-01
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=HiGHmed, references=ICH-GCP E6 - Guideline for Good Clinical Practice of the International Conference on Harmonisation (CPMP/ICH/135/95);, current_contact=Natalia Strauch, Medizinische Hochschule Hannover, strauch.natalia@mh-hannover.de, original_namespace=org.highmed, original_publisher=HiGHmed, custodian_namespace=org.highmed, MD5-CAM-1.0.1=FC149EB72CD23D8A60DD2A8488761581, build_uid=0d7fc18d-1aa1-4186-87bd-76a3808ae5b6, revision=1.0.4}
Keywordsstudy participation, recruitment, randomization, screening, therapy, test person, trial subject, intervention, patient consent, study treatment, clinical trial, research, treatment proband, medication, cohort study, observational study, study inclusion, study enrollment, clinical study, registry study, informed, investigation, participant
Lifecyclepublished
UIDd8f2b17d-adbc-44ba-b458-ba382b3325ed
Language useden
Citeable Identifier1246.145.600
Revision Number1.0.4
AllArchetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=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., archetypeConceptComment=null, otherContributors=, originalLanguage=de, translators=
  • English: Mareike Joseph, Medizinische Hochschule Hannover, Joseph.Mareike@mh-hannover.de

    • , subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={state=[], content=[], source=[], events=[], capabilities=[], details=[], protocol=[], provider=[], data=[], activities=[], contacts=[], identities=[], relationships=[], description=[], ism_transition=[], target=[], credentials=[], items=[ResourceSimplifiedHierarchyItem [path=/items[at0001], code=at0001, itemType=ELEMENT, level=1, 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=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0002], code=at0002, itemType=SLOT, level=1, text=Study, description=Structured information about the study in which the patient is participating., comment=For example: study description, type of study, sponsor, study center, duration of study, etc., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
    openEHR-EHR-CLUSTER.study_details.v0 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0018], code=at0018, itemType=ELEMENT, level=1, 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=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0005], code=at0005, itemType=ELEMENT, level=1, text=Status, 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=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
    •  Coded Text
      • Informed [Patient has been informed about the study but has not yet given consent to participate.]
      • Consented [Consent to participate has been given by the patient, but they have not yet been enrolled in the study.]
      • Screening phase [The patient's eligibility criteria are currently being reviewed before intervention occurs.]
      • Included [The patient has been enrolled in the study.]
      • Revoked [Patient has withdrawn consent after already being enrolled.]
      • Cancelled/Excluded [The patient has dropped out of the study on their own accord for various reasons or they have been excluded by study officials.]
      • Follow-up [The patient is in the follow-up phase.]
      • Completed [The patient has ended his/her participation in a regular manner.]
      • Potential Candidate [A person that is potentially eligible for participation in the study.]
      • Not Registered [A person for whom registration was not completed.]
    •  Text
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0016], code=at0016, itemType=ELEMENT, level=1, text=Identification, description=The name or identifier of the patient in the study., comment=A unique identifier of the patient in the study, usually called a usually called a Patient/Subject number or Patient ID/Subject ID., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0003], code=at0003, itemType=ELEMENT, level=1, 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=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0004], code=at0004, itemType=ELEMENT, level=1, 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=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0015], code=at0015, itemType=SLOT, level=1, text=Study site, description=Details of the study center responsible for the patient., comment=For example: Facility name, address, investigator name, contact details, and other details. Demographic archetypes can be inserted here., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
    All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0021], code=at0021, itemType=ELEMENT, level=1, text=Assigned arm, description=The name of the arm in the study the subject is expected to follow as part of this study., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0022], code=at0022, itemType=ELEMENT, level=1, text=Actual Arm, description=The name of the arm in the study the subject actually followed as part of this study., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0014], code=at0014, itemType=ELEMENT, level=1, text=Comment, description=Additional information about study participation., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], context=[], other_participations=[]}, topLevelItems={items=ResourceSimplifiedHierarchyItem [path=ROOT_/, code=at0000, itemType=CLUSTER, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=null, extendedValues=null]}, addHierarchyItemsTo=items, currentHierarchyItemsForAdding=[ResourceSimplifiedHierarchyItem [path=/items[at0001], code=at0001, itemType=ELEMENT, level=1, 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=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0002], code=at0002, itemType=SLOT, level=1, text=Study, description=Structured information about the study in which the patient is participating., comment=For example: study description, type of study, sponsor, study center, duration of study, etc., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
    openEHR-EHR-CLUSTER.study_details.v0 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0018], code=at0018, itemType=ELEMENT, level=1, 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=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0005], code=at0005, itemType=ELEMENT, level=1, text=Status, 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=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
    •  Coded Text
      • Informed [Patient has been informed about the study but has not yet given consent to participate.]
      • Consented [Consent to participate has been given by the patient, but they have not yet been enrolled in the study.]
      • Screening phase [The patient's eligibility criteria are currently being reviewed before intervention occurs.]
      • Included [The patient has been enrolled in the study.]
      • Revoked [Patient has withdrawn consent after already being enrolled.]
      • Cancelled/Excluded [The patient has dropped out of the study on their own accord for various reasons or they have been excluded by study officials.]
      • Follow-up [The patient is in the follow-up phase.]
      • Completed [The patient has ended his/her participation in a regular manner.]
      • Potential Candidate [A person that is potentially eligible for participation in the study.]
      • Not Registered [A person for whom registration was not completed.]
    •  Text
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0016], code=at0016, itemType=ELEMENT, level=1, text=Identification, description=The name or identifier of the patient in the study., comment=A unique identifier of the patient in the study, usually called a usually called a Patient/Subject number or Patient ID/Subject ID., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0003], code=at0003, itemType=ELEMENT, level=1, 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=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0004], code=at0004, itemType=ELEMENT, level=1, 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=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0015], code=at0015, itemType=SLOT, level=1, text=Study site, description=Details of the study center responsible for the patient., comment=For example: Facility name, address, investigator name, contact details, and other details. Demographic archetypes can be inserted here., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
    All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0021], code=at0021, itemType=ELEMENT, level=1, text=Assigned arm, description=The name of the arm in the study the subject is expected to follow as part of this study., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0022], code=at0022, itemType=ELEMENT, level=1, text=Actual Arm, description=The name of the arm in the study the subject actually followed as part of this study., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0014], code=at0014, itemType=ELEMENT, level=1, text=Comment, description=Additional information about study participation., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], minIndents={}, termBindingRetrievalErrorMessage=null]