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ID

7104

Description

The Division of Cancer Prevention's AE and conmed evaluation case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C1255DF-0CBA-43D9-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C1255DF-0CBA-43D9-E044-0003BA3F9857

Keywords

Versions (2)
  1. 9/20/12 9/20/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
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January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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    On-Study - AE and Conmed Evaluation - 2803423v1.0

    English

    No Instruction available.

    1 forms  
    1. StudyEvent: AE and Conmed Evaluation
      1. No Instruction available.
    Screening
    Description

    Screening

    DCP Protocol #
    Description

    Protocol ID NCI

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1513882
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C19202
    Institution Code
    Description

    NationalCancerInstituteInstituteCode

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Participant ID
    Description

    ParticipantIdentifier

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25364
    UMLS 2011AA ValueDomain
    C0600091
    Ae And Conmed Evaluation Form
    Description

    Ae And Conmed Evaluation Form

    Visit Type
    Description

    ConcomitantAgentAdverseEventVisitType

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25716
    UMLS 2011AA ObjectClass
    C0545082
    NCI Thesaurus Property
    C25284
    UMLS 2011AA Property
    C0332307
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ValueDomain-2
    C41331
    UMLS 2011AA ValueDomain-2
    C0877248
    NCI Thesaurus ValueDomain-3
    C70902
    UMLS 2011AA ValueDomain-3
    C2347852
    NCI Thesaurus ValueDomain-4
    C25716
    UMLS 2011AA ValueDomain-4
    C0545082
    Visit Date (MM/DD/YYYY)
    Description

    VisitDate

    Data type

    date

    Alias
    NCI Thesaurus Property
    C25164
    UMLS 2011AA Property
    C0011008
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C25716
    UMLS 2011AA ObjectClass
    C0545082
    Not Obtained
    Description

    NotObtainedIndicator

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25180
    UMLS 2011AA Property
    C1522602
    NCI Metathesaurus ObjectClass
    CL310460
    NCI Metathesaurus ObjectClass-2
    CL052458
    NCI Metathesaurus ValueDomain
    C0021212
    Were any new or changes in Adverse Events reported? (either the first report of a new AE or changes to previously reported AEs? - Footnote - If Yes is selected; the Adverse Event form must be completed. If No and/or N/A is selected for ALL visits, NONE must be checked on the AE form)
    Description

    NewOrChangeAdverseEventReportedIndicator

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25586
    UMLS 2011AA ObjectClass
    C0205314
    NCI Thesaurus ObjectClass-2
    C41331
    UMLS 2011AA ObjectClass-2
    C0877248
    NCI Thesaurus ObjectClass-3
    C37998
    UMLS 2011AA ObjectClass-3
    C1518602
    NCI Thesaurus ObjectClass-4
    C25446
    UMLS 2011AA ObjectClass-4
    C0392747
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Were any new or changes in Concomitant Medications reported? (either the first report of a new Conmed or changes to previously reported Conmed? - Footnote - If Yes is selected; the Concomitant Medication form must be completed. If No and/or N/A is selected for ALL visits, NONE must be selected on the Concomitant Medication form)
    Description

    NewOrChangeConcomitantMedicationReportedIndicator

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25586
    UMLS 2011AA ObjectClass
    C0205314
    NCI Thesaurus ObjectClass-2
    C459
    UMLS 2011AA ObjectClass-2
    C0013227
    NCI Thesaurus ObjectClass-3
    C37998
    UMLS 2011AA ObjectClass-3
    C1518602
    NCI Thesaurus ObjectClass-4
    C25446
    UMLS 2011AA ObjectClass-4
    C0392747
    NCI Thesaurus ObjectClass-5
    C25730
    UMLS 2011AA ObjectClass-5
    C0521115
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ValueDomain-2
    C25586
    UMLS 2011AA ValueDomain-2
    C0205314
    NCI Thesaurus ValueDomain-3
    C37998
    UMLS 2011AA ValueDomain-3
    C1518602
    NCI Thesaurus ValueDomain-4
    C25446
    UMLS 2011AA ValueDomain-4
    C0392747
    NCI Thesaurus ValueDomain-5
    C70902
    UMLS 2011AA ValueDomain-5
    C2347852
    Dcp Template Footer
    Description

    Dcp Template Footer

    Protocol Title
    Description

    Protocol Title

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986303
    NCI Thesaurus ObjectClass
    C25320
    NCI Thesaurus Property
    C42774
    Protocol Version
    Description

    Protocol Version

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C2985700
    NCI Thesaurus ObjectClass
    C25320
    NCI Thesaurus Property
    C25364
    Protocol Date
    Description

    Protocol Version Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2985700
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C0011008
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain-2
    C25367
    Page #
    Description

    PageNumber

    Data type

    float

    Alias
    NCI Thesaurus Property
    C25337
    UMLS 2011AA Property
    C0237753
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Metathesaurus ObjectClass
    C0439643
    Total Page Number
    Description

    CaseReportFormTotalPageNumber

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C40988
    UMLS 2011AA ObjectClass
    C1516308
    NCI Thesaurus Property
    C25337
    UMLS 2011AA Property
    C0237753
    NCI Thesaurus Property-2
    C25304
    UMLS 2011AA Property-2
    C0439810
    NCI Thesaurus Property-3
    C42783
    UMLS 2011AA Property-3
    C1704732
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    DCP Template Version
    Description

    DCPTemplateVersionText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Metathesaurus ObjectClass
    C0728990
    NCI Thesaurus Property
    C25714
    UMLS 2011AA Property
    C0333052
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    Similar models

    No Instruction available.

    1 forms
    1. StudyEvent: AE and Conmed Evaluation
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Screening
    Protocol ID NCI
    Item
    DCP Protocol #
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1513882 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C19202 (NCI Thesaurus Property-2)
    NationalCancerInstituteInstituteCode
    Item
    Institution Code
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    ParticipantIdentifier
    Item
    Participant ID
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25364 (NCI Thesaurus ValueDomain)
    C0600091 (UMLS 2011AA ValueDomain)
    Item Group
    Ae And Conmed Evaluation Form
    Item
    Visit Type
    text
    C25716 (NCI Thesaurus ObjectClass)
    C0545082 (UMLS 2011AA ObjectClass)
    C25284 (NCI Thesaurus Property)
    C0332307 (UMLS 2011AA Property)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ValueDomain-2)
    C0877248 (UMLS 2011AA ValueDomain-2)
    C70902 (NCI Thesaurus ValueDomain-3)
    C2347852 (UMLS 2011AA ValueDomain-3)
    C25716 (NCI Thesaurus ValueDomain-4)
    C0545082 (UMLS 2011AA ValueDomain-4)
    CL.1
    Code List
    Visit Type
    CL Item
    Registration/randomization (Registration/Randomization)
    CL Item
    Month 1 (Month 1)
    CL Item
    Month 2 (Month 2)
    CL Item
    Month 3 (Month 3)
    CL Item
    Month 4 (Month 4)
    CL Item
    Month 5 (Month 5)
    CL Item
    Month 6 (Month 6)
    CL Item
    Follow Up (Follow up)
    VisitDate
    Item
    Visit Date (MM/DD/YYYY)
    date
    C25164 (NCI Thesaurus Property)
    C0011008 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25716 (NCI Thesaurus ObjectClass)
    C0545082 (UMLS 2011AA ObjectClass)
    Item
    Not Obtained
    text
    C25180 (NCI Thesaurus Property)
    C1522602 (UMLS 2011AA Property)
    CL310460 (NCI Metathesaurus ObjectClass)
    CL052458 (NCI Metathesaurus ObjectClass-2)
    C0021212 (NCI Metathesaurus ValueDomain)
    CL.2
    Code List
    Not Obtained
    CL Item
    Not Applicable (Not Applicable)
    C48660 (NCI Thesaurus)
    C1272460 (UMLS 2011AA)
    Item
    Were any new or changes in Adverse Events reported? (either the first report of a new AE or changes to previously reported AEs? - Footnote - If Yes is selected; the Adverse Event form must be completed. If No and/or N/A is selected for ALL visits, NONE must be checked on the AE form)
    text
    C25586 (NCI Thesaurus ObjectClass)
    C0205314 (UMLS 2011AA ObjectClass)
    C41331 (NCI Thesaurus ObjectClass-2)
    C0877248 (UMLS 2011AA ObjectClass-2)
    C37998 (NCI Thesaurus ObjectClass-3)
    C1518602 (UMLS 2011AA ObjectClass-3)
    C25446 (NCI Thesaurus ObjectClass-4)
    C0392747 (UMLS 2011AA ObjectClass-4)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    CL.3
    Code List
    Were any new or changes in Adverse Events reported? (either the first report of a new AE or changes to previously reported AEs? - Footnote - If Yes is selected; the Adverse Event form must be completed. If No and/or N/A is selected for ALL visits, NONE must be checked on the AE form)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Not Applicable (N/A)
    C48660 (NCI Thesaurus)
    C1272460 (UMLS 2011AA)
    Item
    Were any new or changes in Concomitant Medications reported? (either the first report of a new Conmed or changes to previously reported Conmed? - Footnote - If Yes is selected; the Concomitant Medication form must be completed. If No and/or N/A is selected for ALL visits, NONE must be selected on the Concomitant Medication form)
    text
    C25586 (NCI Thesaurus ObjectClass)
    C0205314 (UMLS 2011AA ObjectClass)
    C459 (NCI Thesaurus ObjectClass-2)
    C0013227 (UMLS 2011AA ObjectClass-2)
    C37998 (NCI Thesaurus ObjectClass-3)
    C1518602 (UMLS 2011AA ObjectClass-3)
    C25446 (NCI Thesaurus ObjectClass-4)
    C0392747 (UMLS 2011AA ObjectClass-4)
    C25730 (NCI Thesaurus ObjectClass-5)
    C0521115 (UMLS 2011AA ObjectClass-5)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C25586 (NCI Thesaurus ValueDomain-2)
    C0205314 (UMLS 2011AA ValueDomain-2)
    C37998 (NCI Thesaurus ValueDomain-3)
    C1518602 (UMLS 2011AA ValueDomain-3)
    C25446 (NCI Thesaurus ValueDomain-4)
    C0392747 (UMLS 2011AA ValueDomain-4)
    C70902 (NCI Thesaurus ValueDomain-5)
    C2347852 (UMLS 2011AA ValueDomain-5)
    CL.4
    Code List
    Were any new or changes in Concomitant Medications reported? (either the first report of a new Conmed or changes to previously reported Conmed? - Footnote - If Yes is selected; the Concomitant Medication form must be completed. If No and/or N/A is selected for ALL visits, NONE must be selected on the Concomitant Medication form)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Not Evaluated (Not Evaluated)
    CL Item
    Not Applicable (N/A)
    C48660 (NCI Thesaurus)
    C1272460 (UMLS 2011AA)
    Item Group
    Dcp Template Footer
    Protocol Title
    Item
    Protocol Title
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986303 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C42774 (NCI Thesaurus Property)
    Protocol Version
    Item
    Protocol Version
    text
    C25704 (NCI Thesaurus ValueDomain)
    C2985700 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    Protocol Version Date
    Item
    Protocol Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2985700 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C0011008 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25367 (NCI Thesaurus ValueDomain-2)
    PageNumber
    Item
    Page #
    float
    C25337 (NCI Thesaurus Property)
    C0237753 (UMLS 2011AA Property)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C0439643 (NCI Metathesaurus ObjectClass)
    CaseReportFormTotalPageNumber
    Item
    Total Page Number
    text
    C40988 (NCI Thesaurus ObjectClass)
    C1516308 (UMLS 2011AA ObjectClass)
    C25337 (NCI Thesaurus Property)
    C0237753 (UMLS 2011AA Property)
    C25304 (NCI Thesaurus Property-2)
    C0439810 (UMLS 2011AA Property-2)
    C42783 (NCI Thesaurus Property-3)
    C1704732 (UMLS 2011AA Property-3)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    DCPTemplateVersionText
    Item
    DCP Template Version
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C0728990 (NCI Metathesaurus ObjectClass)
    C25714 (NCI Thesaurus Property)
    C0333052 (UMLS 2011AA Property)
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