ARCHETYPE Informed Consent (openEHR-EHR-ACTION.informed_consent.v0)

ARCHETYPE IDopenEHR-EHR-ACTION.informed_consent.v0
ConceptInformed Consent
DescriptionRecord of status and details of informed consent from a patient (or patient's agent) 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 patient or patient's agent.
UseUse to record the status of an order to obtain informed consent, including what is planned, scheduled, requested, provided, or withdrawn. This archetype has been designed to be a framework that will be adequate for requesting and recording a simple consent, but allow for additional details to be optionally added within the 'Details' SLOT to meet the specific requirements of a more complex clinical scenario. For example, additional consent details can be included using the CLUSTER.consent_details archetype. Other archetypes can be developed and optionally included in the same SLOT for the purpose of recording specific details about the procedure, trial or activity. The status of the informed consent is reflected by the pathway steps - requested, refused, provided, withdrawn etc.
PurposeTo record the status of a request for, or record of, informed consent prior to performing a procedure, clinical trial or healthcare-related activity.
ReferencesASTM Standard E2369 - 05, "Standard Specification for Continuity of Care Record (CCR)", ASTM International, West Conshohocken, PA, 2003, DOI: 10.1520/E2369-05E02, www.astm.org.
Copyright© openEHR Foundation
AuthorsAuthor name: Heather Leslie
Organisation: Ocean Informatics
Email: heather.leslie@oceaninformatics.com
Date originally authored: 09-10-2012
Other Details LanguageAuthor name: Heather Leslie
Organisation: Ocean Informatics
Email: heather.leslie@oceaninformatics.com
Date originally authored: 09-10-2012
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, references=ASTM Standard E2369 - 05, "Standard Specification for Continuity of Care Record (CCR)", ASTM International, West Conshohocken, PA, 2003, DOI: 10.1520/E2369-05E02, www.astm.org., current_contact=Heather Leslie, Ocean Informatics, heather.leslie@oceaninformatics.com, original_namespace=org.openehr, original_publisher=openEHR Foundation, custodian_namespace=org.openehr, MD5-CAM-1.0.1=946987A1D182E9C9FEE624EF6065E29D, build_uid=faa091cc-551b-43cb-9068-60ff719a25e6, revision=0.0.1-alpha}
Keywordsconsent, informed, caveat
Lifecyclein_development
UIDb016cdb3-d685-4f86-a623-dba44ebe1586
Language useden
Citeable Identifier1013.1.1303
Revision Number0.0.1-alpha
AllArchetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=Record of status and details of informed consent from a patient (or patient's agent) 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 patient or patient's agent., archetypeConceptComment=null, otherContributors=, originalLanguage=en, translators=Russian: Art Latyp; Латыпов Артур Шамилевич, RusBITech РусБИТех, hmm
, subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={details=[], identities=[], source=[], credentials=[], context=[], description=[ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0002], code=at0002, itemType=ELEMENT, level=2, text=Procedure/Trial/Activity, 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..*, occurencesText=Mandatory, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0030], code=at0030, itemType=ELEMENT, level=2, text=Procedure/Trial/Activity Description, description=Narrative description of the procedure, clinical trial or healthcare-related activity., 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=/description[at0001]/items[at0031], code=at0031, itemType=ELEMENT, level=2, text=Intent, description=Description of the intent of the procedure, clinical trial or healthcare-related activity., 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=/description[at0001]/items[at0011], code=at0011, itemType=ELEMENT, level=2, text=Consent Description, description=Narrative description of the informed consent required or recorded prior to performing the proposed procedure, clinical trial or healthcare-related activity., 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=/description[at0001]/items[at0003], code=at0003, itemType=SLOT, level=2, text=Details, description=Additional structured details about the procedure/trial/activity itself or additional structured consent details., comment=For example: intent/purpose; anaesthetic details; disclosure of material risks; and proposed benefits discussed., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.consent_details.v1 and specialisations Or
openEHR-EHR-CLUSTER.procedure_details.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0004], code=at0004, itemType=ELEMENT, level=2, text=Form of Consent, description=Form of the consent sought or provided., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Written [Format of the consent is written.]
  • Verbal [Format of the consent is verbal.]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0007], code=at0007, itemType=ELEMENT, level=2, text=Reason, description=Reason that the care pathway step for the identified procedure, clinical trial or healthcare-related activity was carried out., comment=For example, the reason for 'consent refused' or 'consent withdrawn'., 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=/description[at0001]/items[at0008], code=at0008, itemType=ELEMENT, level=2, text=Start Date, description=Date, and optional time, when validity of the informed consent becomes active., comment=null, 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=/description[at0001]/items[at0009], code=at0009, itemType=ELEMENT, level=2, text=End Date, description=Date, and optional time, when validity of the informed consent ceased., comment=null, 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=/description[at0001]/items[at0010], code=at0010, itemType=ELEMENT, level=2, text=Caveat, description=Details of any qualifications or exemptions to the informed consent., comment=null, 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=/description[at0001]/items[at0012], code=at0012, itemType=ELEMENT, level=2, text=Evidence of Consent, description=Evidence of consent status., comment=For example, audio of consent being requested or image of written consent obtained., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_MULTIMEDIA, bindings=null, values=audio/DVI4, audio/G722, audio/G723, audio/G726-16, audio/G726-24, audio/G726-32, audio/G726-40, audio/G728, audio/L8, audio/L16, audio/LPC, audio/G729, audio/G729D, audio/G729E, audio/mpeg, audio/mpeg4-generic, audio/L20, audio/L24, audio/telephone-event, image/cgm, image/gif, image/png, image/tiff, image/jpeg, text/calendar, text/directory, text/html, text/plain, text/rtf, text/sgml, text/tab-separated-values, text/uri-list, text/xml, text/xml-external-parsed-entity, video/BT656, video/CelB, video/H261, video/H263, video/H263-1998, video/H263-2000, video/quicktime, extendedValues=null]], ism_transition=[ResourceSimplifiedHierarchyItem [path=/ism_transition[at0013]_526_at0013, code=at0013, itemType=ISM_TRANSITION, level=1, text=Planned, description=Need for informed consent is identified., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, values=Current state: planned, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/ism_transition[at0019]_527_at0019, code=at0019, itemType=ISM_TRANSITION, level=1, text=Postponed, description=Intent to request informed consent has been postponed., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, values=Current state: postponed, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/ism_transition[at0018]_528_at0018, code=at0018, itemType=ISM_TRANSITION, level=1, text=Cancelled, description=Intent to request informed consent has been cancelled, prior to requesting consent from patient or patient's agent.., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, values=Current state: cancelled, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/ism_transition[at0027]_529_at0027, code=at0027, itemType=ISM_TRANSITION, level=1, text=Appointment Scheduled, description=An appointment has been scheduled to request consent., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, values=Current state: scheduled, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/ism_transition[at0014]_245_526_at0014, code=at0014, itemType=ISM_TRANSITION, level=1, text=Informed Consent Requested, description=Informed consent has been requested from the patient or patient's agent, but no response has been received., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, values=Current state: active, planned, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/ism_transition[at0015]_245_at0015, code=at0015, itemType=ISM_TRANSITION, level=1, text=Informed Consent Provided, description=Informed consent has been provided by the patient or patient's agent., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, values=Current state: active, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/ism_transition[at0021]_245_at0021, code=at0021, itemType=ISM_TRANSITION, level=1, text=Informed Consent Not Obtained, description=Informed consent was not obtainable from either the patient or patient's advocate., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, values=Current state: active, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/ism_transition[at0016]_531_at0016, code=at0016, itemType=ISM_TRANSITION, level=1, text=Informed Consent Refused, description=In response to a request for informed consent, it has been refused by patient or patient's agent., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, values=Current state: aborted, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/ism_transition[at0017]_531_at0017, code=at0017, itemType=ISM_TRANSITION, level=1, text=Informed Consent Withdrawn, description=Following initial provision of informed consent, it has been withrawn by the patient or patient's agent., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, values=Current state: aborted, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/ism_transition[at0022]_532_at0022, code=at0022, itemType=ISM_TRANSITION, level=1, text=Completed, description=Informed consent has been provided by the patient or patient's agent and the activity is now complete., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, values=Current state: completed, extendedValues=null]], events=[], content=[], items=[], capabilities=[], other_participations=[], contacts=[], target=[], data=[], relationships=[], state=[], protocol=[ResourceSimplifiedHierarchyItem [path=/protocol[at0024]/items[at0025], code=at0025, itemType=ELEMENT, level=2, text=Consent Document Used, description=Identification of the consent form or document used., 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=/protocol[at0024]/items[at0026], code=at0026, itemType=ELEMENT, level=2, text=Review Date, description=Date when consent status is due for review., comment=null, 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=/protocol[at0024]/items[at0028], code=at0028, itemType=SLOT, level=2, text=Consent Requester, description=Details about the healthcare provider who is requesting or recording the consent., comment=Insert archetyped demographic details in this SLOT if it is not possible to use other_participations., 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=/protocol[at0024]/items[at0029], code=at0029, itemType=SLOT, level=2, text=Consent Provider, description=Details about the subject (or subject's agent) who is being requested for, or providing, the consent for the procedure, clinical trial or healthcare-related activity., comment=Insert archetyped demographic details in this SLOT if it is not possible to use other_participations., 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=/protocol[at0024]/items[at0033], code=at0033, itemType=CLUSTER, level=2, text=Patient Information, description=Details about Patient Information made available to the subject or subject's agent., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0024]/items[at0033]/items[at0032], code=at0032, itemType=ELEMENT, level=3, text=Name, description=Identification of the information made available., comment=For example, the name of the form., 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=/protocol[at0024]/items[at0033]/items[at0035], code=at0035, itemType=ELEMENT, level=3, text=Description, description=Narrative description of the patient information made available., 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=/protocol[at0024]/items[at0033]/items[at0034], code=at0034, itemType=ELEMENT, level=3, text=Multimedia Representation, description=Digital representation of the Patient Information made available., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_MULTIMEDIA, bindings=null, values=audio/DVI4, audio/G722, audio/G723, audio/G726-16, audio/G726-24, audio/G726-32, audio/G726-40, audio/G728, audio/L8, audio/L16, audio/LPC, audio/G729, audio/G729D, audio/G729E, audio/mpeg, audio/mpeg4-generic, audio/L20, audio/L24, audio/telephone-event, image/cgm, image/gif, image/png, image/tiff, image/jpeg, text/calendar, text/directory, text/html, text/plain, text/rtf, text/sgml, text/tab-separated-values, text/uri-list, text/xml, text/xml-external-parsed-entity, video/BT656, video/CelB, video/H261, video/H263, video/H263-1998, video/H263-2000, video/quicktime, extendedValues=null]], activities=[], provider=[]}, topLevelItems={description=ResourceSimplifiedHierarchyItem [path=ROOT_/description[at0001], code=at0001, itemType=ITEM_TREE, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=1..1, cardinalityText=mandatory, subCardinalityFormal=1..*, subCardinalityText=, dataType=ITEM_TREE, bindings=null, values=null, extendedValues=null], protocol=ResourceSimplifiedHierarchyItem [path=ROOT_/protocol[at0024], code=at0024, itemType=ITEM_TREE, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=1..1, cardinalityText=mandatory, subCardinalityFormal=0..*, subCardinalityText=Minimum of 0 items, dataType=ITEM_TREE, bindings=null, values=null, extendedValues=null], ism_transition=ResourceSimplifiedHierarchyItem [path=ROOT_/ism_transition[at0013], code=at0013, itemType=ISM_TRANSITION, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=1..1, cardinalityText=mandatory, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, values=null, extendedValues=null]}, addHierarchyItemsTo=protocol, currentHierarchyItemsForAdding=[ResourceSimplifiedHierarchyItem [path=/protocol[at0024]/items[at0025], code=at0025, itemType=ELEMENT, level=2, text=Consent Document Used, description=Identification of the consent form or document used., 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=/protocol[at0024]/items[at0026], code=at0026, itemType=ELEMENT, level=2, text=Review Date, description=Date when consent status is due for review., comment=null, 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=/protocol[at0024]/items[at0028], code=at0028, itemType=SLOT, level=2, text=Consent Requester, description=Details about the healthcare provider who is requesting or recording the consent., comment=Insert archetyped demographic details in this SLOT if it is not possible to use other_participations., 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=/protocol[at0024]/items[at0029], code=at0029, itemType=SLOT, level=2, text=Consent Provider, description=Details about the subject (or subject's agent) who is being requested for, or providing, the consent for the procedure, clinical trial or healthcare-related activity., comment=Insert archetyped demographic details in this SLOT if it is not possible to use other_participations., 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=/protocol[at0024]/items[at0033], code=at0033, itemType=CLUSTER, level=2, text=Patient Information, description=Details about Patient Information made available to the subject or subject's agent., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0024]/items[at0033]/items[at0032], code=at0032, itemType=ELEMENT, level=3, text=Name, description=Identification of the information made available., comment=For example, the name of the form., 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=/protocol[at0024]/items[at0033]/items[at0035], code=at0035, itemType=ELEMENT, level=3, text=Description, description=Narrative description of the patient information made available., 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=/protocol[at0024]/items[at0033]/items[at0034], code=at0034, itemType=ELEMENT, level=3, text=Multimedia Representation, description=Digital representation of the Patient Information made available., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_MULTIMEDIA, bindings=null, values=audio/DVI4, audio/G722, audio/G723, audio/G726-16, audio/G726-24, audio/G726-32, audio/G726-40, audio/G728, audio/L8, audio/L16, audio/LPC, audio/G729, audio/G729D, audio/G729E, audio/mpeg, audio/mpeg4-generic, audio/L20, audio/L24, audio/telephone-event, image/cgm, image/gif, image/png, image/tiff, image/jpeg, text/calendar, text/directory, text/html, text/plain, text/rtf, text/sgml, text/tab-separated-values, text/uri-list, text/xml, text/xml-external-parsed-entity, video/BT656, video/CelB, video/H261, video/H263, video/H263-1998, video/H263-2000, video/quicktime, extendedValues=null]], minIndents={}, termBindingRetrievalErrorMessage=null]