ID

16996

Description

ODM derived from: http://www.qmcr.ualberta.ca/en/ToolsandTemplates/CaseReportFormCRFTemplates.aspx. Template Name: Protocol Deviations Log. University of Alberta, Quality Management in Clinical Research. Copyright: 2002-2016 University of Alberta.

Link

http://www.qmcr.ualberta.ca/en/ToolsandTemplates/CaseReportFormCRFTemplates.aspx

Keywords

  1. 8/19/16 8/19/16 -
Uploaded on

August 19, 2016

DOI

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License

Creative Commons BY-NC 3.0

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    Protocol Deviations Log: CRF QMCR University of Alberta

    Protocol Deviations Log: CRF QMCR University of Alberta

    General Information
    Description

    General Information

    Study Name
    Description

    Study Name

    Data type

    text

    Site Number
    Description

    Site Number

    Data type

    integer

    Pt_ID
    Description

    Pt_ID

    Data type

    integer

    Visit Date
    Description

    Visit Date

    Data type

    date

    Did this participant have any protocol deviations?
    Description

    Did this participant have any protocol deviations?

    Data type

    boolean

    Protocol Deviations
    Description

    Protocol Deviations

    Description of Protocol Deviation
    Description

    Description of Protocol Deviation

    Data type

    text

    Deviation Category (See Description)
    Description

    A. Safety B. Informed Consent C. Eligibility D. Protocol implementation E. Other, specify in log

    Data type

    text

    Deviation Code
    Description

    Deviation Code

    Data type

    integer

    Date Deviation Occurred
    Description

    Date Deviation Occurred

    Data type

    date

    Date IRB Notified (if applicable)
    Description

    Date IRB Notified (if applicable)

    Data type

    date

    Principal Investigator´s Signature
    Description

    Principal Investigator´s Signature

    Data type

    text

    Date Signed
    Description

    Date Signed

    Data type

    date

    Similar models

    Protocol Deviations Log: CRF QMCR University of Alberta

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    General Information
    Study Name
    Item
    Study Name
    text
    Site Number
    Item
    Site Number
    integer
    Pt_ID
    Item
    Pt_ID
    integer
    Visit Date
    Item
    Visit Date
    date
    Did this participant have any protocol deviations?
    Item
    Did this participant have any protocol deviations?
    boolean
    Item Group
    Protocol Deviations
    Description of Protocol Deviation
    Item
    Description of Protocol Deviation
    text
    Deviation Category (See Description)
    Item
    Deviation Category (See Description)
    text
    Deviation Code
    Item
    Deviation Code
    integer
    Date Deviation Occurred
    Item
    Date Deviation Occurred
    date
    Date IRB Notified (if applicable)
    Item
    Date IRB Notified (if applicable)
    date
    Principal Investigator´s Signature
    Item
    Principal Investigator´s Signature
    text
    Date Signed
    Item
    Date Signed
    date

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