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10303

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E2100 Assessment Compliance Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AC30257A-06A3-20B2-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AC30257A-06A3-20B2-E034-0003BA12F5E7

Stichworte

  1. 27.08.12 27.08.12 -
  2. 23.05.15 23.05.15 -
Hochgeladen am

23. Mai 2015

DOI

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Creative Commons BY-NC 3.0 Legacy

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    E2100 Assessment Compliance Form

    INSTRUCTIONS: This form is to be completed by the CRA as per the protocol. Please consult the protocol for the specific assessment instruments to be completed.

    ECOG Clinical trial administrative data
    Beschreibung

    ECOG Clinical trial administrative data

    ECOG Protocol No.
    Beschreibung

    ECOGProtocolNo.

    Datentyp

    text

    ECOG Patient ID
    Beschreibung

    ECOGPatientID

    Datentyp

    text

    Registration Step
    Beschreibung

    RegistrationStep

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS 2011AA ValueDomain
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    NCI Thesaurus ValueDomain-2
    C16154 (undefined)
    UMLS 2011AA ValueDomain-2
    C1704379 (Treatment Step)
    Patient's Name
    Beschreibung

    Patient'sName

    Datentyp

    text

    Participating Group Protocol No.
    Beschreibung

    ParticipatingGroupProtocolNo.

    Datentyp

    text

    Participating Group Patient ID
    Beschreibung

    ParticipatingGroupPatientID

    Datentyp

    text

    Institution/Affiliate
    Beschreibung

    MainMemberInstitution/Affiliate

    Datentyp

    text

    Are data amended?
    Beschreibung

    AmendedDataInd

    Datentyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25474 (undefined)
    UMLS 2011AA ObjectClass
    C1511726 (Data)
    NCI Thesaurus Property
    C25416 (undefined)
    UMLS 2011AA Property
    C1691222 (Amended)
    Assessment Form information
    Beschreibung

    Assessment Form information

    Assessment Form No.
    Beschreibung

    AssessmentFormNo.

    Datentyp

    text

    Date Assessment Scheduled (M D Y)
    Beschreibung

    DateAssessmentScheduled

    Datentyp

    text

    Was the Assessment Form completed?
    Beschreibung

    WastheAssessmentFormcompleted?

    Datentyp

    boolean

    Time point
    Beschreibung

    Timepoint

    Datentyp

    text

    other, specify (time point)
    Beschreibung

    other,specify(timepoint)

    Datentyp

    text

    If Assessment Was Completed
    Beschreibung

    If Assessment Was Completed

    Date Assessment Form completed (M D Y)
    Beschreibung

    DateAssessmentFormcompleted

    Datentyp

    text

    Was Assessment self-administered?
    Beschreibung

    WasAssessmentself-administered?

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25217 (undefined)
    UMLS 2011AA ObjectClass
    C1516048 (Assessed)
    NCI Thesaurus Property
    C25670 (undefined)
    UMLS 2011AA Property
    C1519231 (Self-Administered)
    If NO (assessment was not self-administered), how was patient assisted?
    Beschreibung

    IfNO,howwaspatientassisted?

    Datentyp

    text

    If NO (assessment was not self-administered), what was the reason?
    Beschreibung

    IfNO,whatwasthereason?

    Datentyp

    text

    language difficulty (questions needed to be translated), specify language
    Beschreibung

    Languagedifficulty,specifylanguage

    Datentyp

    text

    disability, please specify
    Beschreibung

    disability,pleasespecify

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685 (undefined)
    UMLS 2011AA ValueDomain
    C1521902 (To specify)
    other, please specify (reason assessment was not self-administered)
    Beschreibung

    other,pleasespecify(reason)

    Datentyp

    text

    If NO (assessment was not self-administered), who assisted or completed assessment?
    Beschreibung

    IfNO,whoassistedorcompletedassessment?

    Datentyp

    text

    other, please specify (who assisted or completed assessment)
    Beschreibung

    other,pleasespecify(whoassistedorcompletedassessment)

    Datentyp

    text

    If Assessment Was Not Completed
    Beschreibung

    If Assessment Was Not Completed

    Indicate primary reason why form was not completed
    Beschreibung

    Indicateprimaryreasonwhyformwasnotcompleted

    Datentyp

    text

    unable to accommodate disability or language needs please specify
    Beschreibung

    unabletoaccommodatedisabilityorlanguageneedspleasespecify

    Datentyp

    text

    patient did not show up in clinic/office please specify
    Beschreibung

    patientdidnotshowupinclinic/officepleasespecify

    Datentyp

    text

    assessment not required per protocol please specify
    Beschreibung

    assessmentnotrequiredperprotocolpleasespecify

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685 (undefined)
    UMLS 2011AA ValueDomain
    C1521902 (To specify)
    other, please specify (primary reason why form was not completed)
    Beschreibung

    other,pleasespecify(primaryreasonwhyformwasnotcompleted)

    Datentyp

    text

    Comments
    Beschreibung

    Comments

    Comments
    Beschreibung

    Comments

    Datentyp

    text

    Investigator Signature
    Beschreibung

    InvestigatorSignature

    Datentyp

    text

    Alias
    NCI Thesaurus Property
    C25678 (undefined)
    UMLS 2011AA Property
    C1519316 (Signature)
    LOINC
    LP248948-4
    NCI Thesaurus ObjectClass
    C17089 (undefined)
    UMLS 2011AA ObjectClass
    C0035173 (Research Personnel)
    SNOMED
    769038007
    LOINC
    LA23773-7
    Date
    Beschreibung

    Date

    Datentyp

    text

    Ccrr Module For E2100 Assessment Compliance Form
    Beschreibung

    Ccrr Module For E2100 Assessment Compliance Form

    Ähnliche Modelle

    INSTRUCTIONS: This form is to be completed by the CRA as per the protocol. Please consult the protocol for the specific assessment instruments to be completed.

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    ECOG Clinical trial administrative data
    ECOGProtocolNo.
    Item
    ECOG Protocol No.
    text
    ECOGPatientID
    Item
    ECOG Patient ID
    text
    RegistrationStep
    Item
    Registration Step
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16154 (NCI Thesaurus ValueDomain-2)
    C1704379 (UMLS 2011AA ValueDomain-2)
    Patient'sName
    Item
    Patient's Name
    text
    ParticipatingGroupProtocolNo.
    Item
    Participating Group Protocol No.
    text
    ParticipatingGroupPatientID
    Item
    Participating Group Patient ID
    text
    MainMemberInstitution/Affiliate
    Item
    Institution/Affiliate
    text
    AmendedDataInd
    Item
    Are data amended?
    boolean
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    Item Group
    Assessment Form information
    AssessmentFormNo.
    Item
    Assessment Form No.
    text
    DateAssessmentScheduled
    Item
    Date Assessment Scheduled (M D Y)
    text
    WastheAssessmentFormcompleted?
    Item
    Was the Assessment Form completed?
    boolean
    Item
    Time point
    text
    Code List
    Time point
    CL Item
    Baseline (baseline)
    C25213 (NCI Thesaurus)
    C1442488 (UMLS 2011AA)
    CL Item
    Day 1 Of Week 17 (day 1 of week 17)
    CL Item
    Day 1 Of Week 33 (day 1 of week 33)
    CL Item
    Other, Specify (other, specify)
    other,specify(timepoint)
    Item
    other, specify (time point)
    text
    Item Group
    If Assessment Was Completed
    DateAssessmentFormcompleted
    Item
    Date Assessment Form completed (M D Y)
    text
    Item
    Was Assessment self-administered?
    text
    C25217 (NCI Thesaurus ObjectClass)
    C1516048 (UMLS 2011AA ObjectClass)
    C25670 (NCI Thesaurus Property)
    C1519231 (UMLS 2011AA Property)
    Code List
    Was Assessment self-administered?
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    If NO (assessment was not self-administered), how was patient assisted?
    text
    Code List
    If NO (assessment was not self-administered), how was patient assisted?
    CL Item
    Questions Were Read Aloud To Patient (questions were read aloud to patient)
    CL Item
    Patient Required Clarification Of Questions Or Instructions (patient required clarification of questions or instructions)
    CL Item
    Patient Required Other Assistance (patient required other assistance)
    CL Item
    Completed Independently By Another Person (completed independently by another person)
    Item
    If NO (assessment was not self-administered), what was the reason?
    text
    Code List
    If NO (assessment was not self-administered), what was the reason?
    CL Item
    Language Difficulty (questions Needed To Be Translated), Specify Language (language difficulty (questions needed to be translated), specify language)
    CL Item
    Literacy Difficulty (patient Could Not Read Well Enough) (literacy difficulty (patient could not read well enough))
    CL Item
    Disability, Please Specify (disability, please specify)
    CL Item
    Telephone Interview (telephone interview)
    CL Item
    Other, Please Specify (other, please specify)
    Languagedifficulty,specifylanguage
    Item
    language difficulty (questions needed to be translated), specify language
    text
    disability,pleasespecify
    Item
    disability, please specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    other,pleasespecify(reason)
    Item
    other, please specify (reason assessment was not self-administered)
    text
    Item
    If NO (assessment was not self-administered), who assisted or completed assessment?
    text
    Code List
    If NO (assessment was not self-administered), who assisted or completed assessment?
    CL Item
    Staff (staff)
    CL Item
    Family (family)
    C25173 (NCI Thesaurus)
    C0015576 (UMLS 2011AA)
    CL Item
    Friend (friend)
    CL Item
    Other, Please Specify (other, please specify)
    other,pleasespecify(whoassistedorcompletedassessment)
    Item
    other, please specify (who assisted or completed assessment)
    text
    Item Group
    If Assessment Was Not Completed
    Item
    Indicate primary reason why form was not completed
    text
    Code List
    Indicate primary reason why form was not completed
    CL Item
    Patient Refusal (patient refusal)
    CL Item
    Patient Did Not Show Up In Clinic/office Please Specify (patient did not show up in clinic/office please specify)
    CL Item
    Staff Unavailable (staff unavailable)
    CL Item
    Patient Not Given Form By Staff (patient not given form by staff)
    CL Item
    Patient Too Ill (patient too ill)
    CL Item
    Patient Expired (patient expired)
    CL Item
    Assessment Not Required Per Protocol Please Specify (assessment not required per protocol please specify)
    CL Item
    Staff Thought Patient Too Ill (staff thought patient too ill)
    CL Item
    Other, Please Specify (other, please specify)
    unabletoaccommodatedisabilityorlanguageneedspleasespecify
    Item
    unable to accommodate disability or language needs please specify
    text
    patientdidnotshowupinclinic/officepleasespecify
    Item
    patient did not show up in clinic/office please specify
    text
    assessmentnotrequiredperprotocolpleasespecify
    Item
    assessment not required per protocol please specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    other,pleasespecify(primaryreasonwhyformwasnotcompleted)
    Item
    other, please specify (primary reason why form was not completed)
    text
    Item Group
    Comments
    Comments
    Item
    Comments
    text
    InvestigatorSignature
    Item
    Investigator Signature
    text
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    Date
    Item
    Date
    text
    Item Group
    Ccrr Module For E2100 Assessment Compliance Form

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