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  • 94 1 SOP iDD-COPM-001-01 AppendixXX Protocol Violation Log 14 Jan 2020

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    sayali Titarmare
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    This document is a log template for recording protocol deviations that occur during a clinical trial. It includes columns for the protocol number, principal investigator, site details, subject identifiers, date the deviation occurred, date it was identified, description of the deviation, corrective and preventative actions taken, whether the subject continued in the study, and if the ethics committee was notified. The principal investigator must sign and date the completed log.

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    94_1_SOP_iDD-COPM-001-01_AppendixXX_Protocol_Violation_Log_14_Jan_2020

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    This document is a log template for recording protocol deviations that occur during a clinical trial. It includes columns for the protocol number, principal investigator, site details, subject identifiers, date the deviation occurred, date it was identified, description of the deviation, corrective and preventative actions taken, whether the subject continued in the study, and if the ethics committee was notified. The principal investigator must sign and date the completed log.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    12 views1 page

    94 1 SOP iDD-COPM-001-01 AppendixXX Protocol Violation Log 14 Jan 2020

    Uploaded by

    sayali Titarmare
    This document is a log template for recording protocol deviations that occur during a clinical trial. It includes columns for the protocol number, principal investigator, site details, subject identifiers, date the deviation occurred, date it was identified, description of the deviation, corrective and preventative actions taken, whether the subject continued in the study, and if the ethics committee was notified. The principal investigator must sign and date the completed log.

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    of 1

    ANNEXURE XX

    PROTOCOL DEVIATION / VIOLATION LOG


    Protocol Number Sponsor

    Principal Investigator Name (PI) Site Name and Number

    Sr. Subject Date of Date deviation Protocol Description Correctiv Preventiv Did EC
    No. Enrollmen deviation identified Deviation category e Action e Action subject Notification
    t Number / description (Choose Taken Taken continue (Yes/No)
    Initials* from in If Yes,
    legend) study?* provide
    date (DD-
    MMM-

    *If the deviation is not specific to subject(s), please mention ‘NA’ in ‘Subject Enrollment Number / Initials’ column and column ‘Did subject continue in
    study?’.
    *If multiple subjects were affected by same deviation, please mention the Subject Enrollment Number / Initials of all subjects affected. If the information
    for each subject varies, then enter the details in a new row for each subject.
    PI Signature and Date: _______________________

    SOP No.: iDD-COPM-001-01/Annexure-XX Page 1 of 1

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